- TXT
-
PDF
(PDF provides a complete and accurate display of this text.)
Tip
?
115th Congress } { Rept. 115-764
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
MEDICARE AND OPIOID SAFE TREATMENT ACT OF 2018
_______
June 19, 2018.--Ordered to be printed
_______
Mr. Brady of Texas, from the Committee on Ways and Means, submitted the
following
R E P O R T
[To accompany H.R. 5776]
[Including cost estimate of the Congressional Budget Office]
The Committee on Ways and Means, to whom was referred the
bill (H.R. 5776) to amend title XVIII to provide for Medicare
coverage of certain services furnished by opioid treatment
programs, and for other purposes, having considered the same,
report favorably thereon with amendments and recommend that the
bill as amended do pass.
CONTENTS
Page
I. SUMMARY AND BACKGROUND............................................7
A. Purpose and Summary................................... 7
B. Background and Need for Legislation................... 8
C. Legislative History................................... 8
II. EXPLANATION OF THE BILL...........................................9
A. Medicare and Opioid Safe Treatment Act................ 9
III.VOTES OF THE COMMITTEE...........................................11
IV. BUDGET EFFECTS OF THE BILL.......................................12
A. Committee Estimate of Budgetary Effects............... 12
B. Statement Regarding New Budget Authority and Tax
Expenditures Budget Authority........................ 12
C. Cost Estimate Prepared by the Congressional Budget
Office............................................... 12
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE.......20
A. Committee Oversight Findings and Recommendations...... 20
B. Statement of General Performance Goals and Objectives. 20
C. Information Relating to Unfunded Mandates............. 20
D. Congressional Earmarks, Limited Tax Benefits, and
Limited Tariff Benefits.............................. 20
E. Duplication of Federal Programs....................... 20
F. Disclosure of Directed Rule Makings................... 20
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED............21
A. Text of Existing Law Amended or Repealed by the Bill,
as Reported.......................................... 21
B. Changes in Existing Law Proposed by the Bill, as
Reported............................................. 21
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Medicare and Opioid Safe Treatment Act
of 2018'' or the ``MOST Act of 2018''.
SEC. 2. MEDICARE COVERAGE OF CERTAIN SERVICES FURNISHED BY OPIOID
TREATMENT PROGRAMS.
(a) Coverage.--Section 1861(s)(2) of the Social Security Act (42
U.S.C. 1395x(s)(2)) is amended--
(1) in subparagraph (FF), by striking at the end ``and'';
(2) in subparagraph (GG), by inserting at the end ``; and'';
and
(3) by adding at the end the following new subparagraph:
``(HH) opioid use disorder treatment services (as
defined in subsection (jjj)).''.
(b) Opioid Use Disorder Treatment Services and Opioid Treatment
Program Defined.--Section 1861 of the Social Security Act is amended by
adding at the end the following new subsection:
``(jjj) Opioid Use Disorder Treatment Services; Opioid Treatment
Program.--
``(1) Opioid use disorder treatment services.--The term
`opioid use disorder treatment services' means items and
services that are furnished by an opioid treatment program for
the treatment of opioid use disorder, including--
``(A) opioid agonist and antagonist treatment
medications (including oral, injected, or implanted
versions) that are approved by the Food and Drug
Administration under section 505 of the Federal Food,
Drug and Cosmetic Act for use in the treatment of
opioid use disorder;
``(B) dispensing and administration of such
medications, if applicable;
``(C) substance use counseling by a professional to
the extent authorized under State law to furnish such
services;
``(D) individual and group therapy with a physician
or psychologist (or other mental health professional to
the extent authorized under State law);
``(E) toxicology testing, and
``(F) other items and services that the Secretary
determines are appropriate (other than meals or
transportation).
``(2) Opioid treatment program.--The term `opioid treatment
program' means an entity that is opioid treatment program (as
defined in section 8.2 of title 42 of the Code of Federal
Regulations, or any successor regulation) that--
``(A) is enrolled under section 1866(j);
``(B) has in effect a certification by the Substance
Abuse and Mental Health Services Administration for
such a program;
``(C) is accredited by an accrediting body approved
by the Substance Abuse and Mental Health Services
Administration; and
``(D) meets such additional conditions as the
Secretary may find necessary to ensure--
``(i) the health and safety of individuals
being furnished services under such program;
and
``(ii) the effective and efficient furnishing
of such services.''.
(c) Payment.--
(1) In general.--Section 1833(a)(1) of the Social Security
Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and (BB)'' and inserting ``(BB)'';
and
(B) by inserting before the semicolon at the end the
following ``, and (CC) with respect to opioid use
disorder treatment services furnished during an episode
of care, the amount paid shall be equal to the amount
payable under section 1834(w) less any copayment
required as specified by the Secretary''.
(2) Payment determination.--Section 1834 of the Social
Security Act (42 U.S.C. 1395m) is amended by adding at the end
the following new subsection:
``(w) Opioid Use Disorder Treatment Services.--
``(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of section
1861(jjj)) an amount that is equal to 100 percent of a bundled
payment under this part for opioid use disorder treatment
services (as defined in paragraph (1) of such section) that are
furnished by such program to an individual during an episode of
care (as defined by the Secretary) beginning on or after
January 1, 2020. The Secretary shall ensure, as determined
appropriate by the Secretary, that no duplicative payments are
made under this part or part D for items and services furnished
by an opioid treatment program.
``(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the type of
medication provided (such as buprenorphine, methadone,
naltrexone, or a new innovative drug), the frequency of
services, the scope of services furnished, characteristics of
the individuals furnished such services, or other factors as
the Secretary determine appropriate. In developing such
bundles, the Secretary may consider payment rates paid to
opioid treatment programs for comparable services under State
plans under title XIX or under the TRICARE program under
chapter 55 of title 10 of the United States Code.
``(3) Annual updates.--The Secretary shall provide an update
each year to the bundled payment amounts under this
subsection.''.
(d) Including Opioid Treatment Programs as Medicare Providers.--
Section 1866(e) of the Social Security Act (42 U.S.C. 1395cc(e)) is
amended--
(1) in paragraph (1), by striking at the end ``and'';
(2) in paragraph (2), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following new paragraph:
``(3) opioid treatment programs (as defined in paragraph (2)
of section 1861(jjj)), but only with respect to the furnishing
of opioid use disorder treatment services (as defined in
paragraph (1) of such section).''.
SEC. 3. REVIEW AND ADJUSTMENT OF PAYMENTS UNDER THE MEDICARE OUTPATIENT
PROSPECTIVE PAYMENT SYSTEM TO AVOID FINANCIAL
INCENTIVES TO USE OPIOIDS INSTEAD OF NON-OPIOID
ALTERNATIVE TREATMENTS.
(a) Outpatient Prospective Payment System.--Section 1833(t) of the
Social Security Act (42 U.S.C. 1395l(t)) is amended by adding at the
end the following new paragraph:
``(22) Review and revisions of payments for non-opioid
alternative treatments.--
``(A) In general.--With respect to payments made
under this subsection for covered OPD services (or
groups of services), including covered OPD services
assigned to a comprehensive ambulatory payment
classification, the Secretary--
``(i) shall, as soon as practicable, conduct
a review (part of which may include a request
for information) of payments for opioids and
evidence-based non-opioid alternatives for pain
management (including drugs and devices, nerve
blocks, surgical injections, and
neuromodulation) with a goal of ensuring that
there are not financial incentives to use
opioids instead of non-opioid alternatives;
``(ii) may, as the Secretary determines
appropriate, conduct subsequent reviews of such
payments; and
``(iii) shall consider the extent to which
revisions under this subsection to such
payments (such as the creation of additional
groups of covered OPD services to classify
separately those procedures that utilize
opioids and non-opioid alternatives for pain
management) would reduce payment incentives to
use opioids instead of non-opioid alternatives
for pain management.
``(B) Priority.--In conducting the review under
clause (i) of subparagraph (A) and considering
revisions under clause (iii) of such subparagraph, the
Secretary shall focus on covered OPD services (or
groups of services) assigned to a comprehensive
ambulatory payment classification, ambulatory payment
classifications that primarily include surgical
services, and other services determined by the
Secretary which generally involve treatment for pain
management.
``(C) Revisions.--If the Secretary identifies
revisions to payments pursuant to subparagraph
(A)(iii), the Secretary shall, as determined
appropriate, begin making such revisions for services
furnished on or after January 1, 2020. Revisions under
the previous sentence shall be treated as adjustments
for purposes of application of paragraph (9)(B).
``(D) Rules of construction.--Nothing in this
paragraph shall be construed to preclude the
Secretary--
``(i) from conducting a demonstration before
making the revisions described in subparagraph
(C); or
``(ii) prior to implementation of this
paragraph, from changing payments under this
subsection for covered OPD services (or groups
of services) which include opioids or non-
opioid alternatives for pain management.''.
(b) Ambulatory Surgical Centers.--Section 1833(i) of the Social
Security Act (42 U.S.C. 1395l(i)) is amended by adding at the end the
following new paragraph:
``(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including the second
sentence of subparagraph (C) of such paragraph, to payment for services
under this subsection, and make such revisions under this paragraph, in
an appropriate manner (as determined by the Secretary).''.
SEC. 4. EXPANDING ACCESS UNDER THE MEDICARE PROGRAM TO ADDICTION
TREATMENT IN FEDERALLY QUALIFIED HEALTH CENTERS AND
RURAL HEALTH CLINICS.
(a) Federally Qualified Health Centers.--Section 1834(o) of the
Social Security Act (42 U.S.C. 1395m(o)) is amended by adding at the
end the following new paragraph:
``(3) Additional payments for certain fqhcs with physicians
or other practitioners receiving data 2000 waivers.--
``(A) In general.--In the case of a Federally
qualified health center with respect to which,
beginning on or after January 1, 2019, Federally-
qualified health center services (as defined in section
1861(aa)(3)) are furnished for the treatment of opioid
use disorder by a physician or practitioner who meets
the requirements described in subparagraph (C) the
Secretary shall, subject to availability of funds under
subparagraph (D), make a payment (at such time and in
such manner as specified by the Secretary) to such
Federally qualified health center after receiving and
approving an application submitted by such Federally
qualified health center under subparagraph (B). Such a
payment shall be in an amount determined by the
Secretary, based on an estimate of the average costs of
training for purposes of receiving a waiver described
in subparagraph (C)(ii). Such a payment may be made
only one time with respect to each such physician or
practitioner.
``(B) Application.--In order to receive a payment
described in subparagraph (A), a Federally-qualified
health center shall submit to the Secretary an
application for such a payment at such time, in such
manner, and containing such information as specified by
the Secretary. A Federally-qualified health center may
apply for such a payment for each physician or
practitioner described in subparagraph (A) furnishing
services described in such subparagraph at such center.
``(C) Requirements.--For purposes of subparagraph
(A), the requirements described in this subparagraph,
with respect to a physician or practitioner, are the
following:
``(i) The physician or practitioner is
employed by or working under contract with a
Federally qualified health center described in
subparagraph (A) that submits an application
under subparagraph (B).
``(ii) The physician or practitioner first
receives a waiver under section 303(g) of the
Controlled Substances Acton or after January 1,
2019.
``(D) Funding.--For purposes of making payments under
this paragraph, there are appropriated, out of amounts
in the Treasury not otherwise appropriated, $6,000,000,
which shall remain available until expended.''.
(b) Rural Health Clinic.--Section 1833 of the Social Security Act (42
U.S.C. 1395l) is amended--
(1) by redesignating the subsection (z) relating to medical
review of spinal subluxation services as subsection (aa); and
(2) by adding at the end the following new subsection:
``(bb) Additional Payments for Certain Rural Health Clinics With
Physicians or Practitioners Receiving DATA 2000 Waivers.--
``(1) In general.--In the case of a rural health clinic with
respect to which, beginning on or after January 1, 2019, rural
health clinic services (as defined in section 1861(aa)(1)) are
furnished for the treatment of opioid use disorder by a
physician or practitioner who meets the requirements described
in paragraph (3), the Secretary shall, subject to availability
of funds under paragraph (4), make a payment (at such time and
in such manner as specified by the Secretary) to such rural
health clinic after receiving and approving an application
described in paragraph (2). Such payment shall be in an amount
determined by the Secretary, based on an estimate of the
average costs of training for purposes of receiving a waiver
described in paragraph (3)(B). Such payment may be made only
one time with respect to each such physician or practitioner.
``(2) Application.--In order to receive a payment described
in paragraph (1), a rural health clinic shall submit to the
Secretary an application for such a payment at such time, in
such manner, and containing such information as specified by
the Secretary. A rural health clinic may apply for such a
payment for each physician or practitioner described in
paragraph (1) furnishing services described in such paragraph
at such clinic.
``(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect to a
physician or practitioner, are the following:
``(A) The physician or practitioner is employed by or
working under contract with a rural health clinic
described in paragraph (1) that submits an application
under paragraph (2).
``(B) The physician or practitioner first receives a
waiver under section 303(g) of the Controlled
Substances Acton or after January 1, 2019.
``(4) Funding.--For purposes of making payments under this
subsection, there are appropriated, out of amounts in the
Treasury not otherwise appropriated, $2,000,000, which shall
remain available until expended.''.
SEC. 5. STUDYING THE AVAILABILITY OF SUPPLEMENTAL BENEFITS DESIGNED TO
TREAT OR PREVENT SUBSTANCE USE DISORDERS UNDER
MEDICARE ADVANTAGE PLANS.
(a) In General.--Not later than 2 years after the date of the
enactment of this Act, the Secretary of Health and Human Services (in
this section referred to as the ``Secretary'') shall submit to Congress
a report on the availability of supplemental health care benefits (as
described in section 1852(a)(3)(A) of the Social Security Act (42
U.S.C. 1395w-22(a)(3)(A))) designed to treat or prevent substance use
disorders under Medicare Advantage plans offered under part C of title
XVIII of such Act. Such report shall include the analysis described in
subsection (c) and any differences in the availability of such benefits
under specialized MA plans for special needs individuals (as defined in
section 1859(b)(6) of such Act (42 U.S.C. 1395w-28(b)(6))) offered to
individuals entitled to medical assistance under title XIX of such Act
and other such Medicare Advantage plans.
(b) Consultation.--The Secretary shall develop the report described
in subsection (a) in consultation with relevant stakeholders,
including--
(1) individuals entitled to benefits under part A or enrolled
under part B of title XVIII of the Social Security Act;
(2) entities who advocate on behalf of such individuals;
(3) Medicare Advantage organizations;
(4) pharmacy benefit managers; and
(5) providers of services and suppliers (as such terms are
defined in section 1861 of such Act (42 U.S.C. 1395x)).
(c) Contents.--The report described in subsection (a) shall include
an analysis on the following:
(1) The extent to which plans described in such subsection
offer supplemental health care benefits relating to coverage
of--
(A) medication-assisted treatments for opioid use,
substance use disorder counseling, peer recovery
support services, or other forms of substance use
disorder treatments (whether furnished in an inpatient
or outpatient setting); and
(B) non-opioid alternatives for the treatment of
pain.
(2) Challenges associated with such plans offering
supplemental health care benefits relating to coverage of items
and services described in subparagraph (A) or (B) of paragraph
(1).
(3) The impact, if any, of increasing the applicable rebate
percentage determined under section 1854(b)(1)(C) of the Social
Security Act (42 U.S.C. 1395w-24(b)(1)(C)) for plans offering
such benefits relating to such coverage would have on the
availability of such benefits relating to such coverage offered
under Medicare Advantage plans.
(4) Potential ways to improve upon such coverage or to
incentivize such plans to offer additional supplemental health
care benefits relating to such coverage.
SEC. 6. CLINICAL PSYCHOLOGIST SERVICES MODELS UNDER THE CENTER FOR
MEDICARE AND MEDICAID INNOVATION; GAO STUDY AND
REPORT.
(a) CMI Models.--Section 1115A(b)(2)(B) of the Social Security Act
(42 U.S.C. 1315a(b)(2)(B) is amended by adding at the end the following
new clauses:
``(xxv) Supporting ways to familiarize
individuals with the availability of coverage
under part B of title XVIII for qualified
psychologist services (as defined in section
1861(ii)).
``(xxvi) Exploring ways to avoid unnecessary
hospitalizations or emergency department visits
for mental and behavioral health services (such
as for treating depression) through use of a
24-hour, 7-day a week help line that may inform
individuals about the availability of treatment
options, including the availability of
qualified psychologist services (as defined in
section 1861(ii)).''.
(b) GAO Study and Report.--Not later than 18 months after the date of
the enactment of this Act, the Comptroller General of the United States
shall conduct a study, and submit to Congress a report, on mental and
behavioral health services under the Medicare program under title XVIII
of the Social Security Act, including an examination of the following:
(1) Information about services furnished by psychiatrists,
clinical psychologists, and other professionals.
(2) Information about ways that Medicare beneficiaries
familiarize themselves about the availability of Medicare
payment for qualified psychologist services (as defined in
section 1861(ii) of the Social Security Act (42 U.S.C.
1395x(ii)) and ways that the provision of such information
could be improved.
SEC. 7. PAIN MANAGEMENT STUDY.
(a) In General.--Not later than 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services (referred to in
this section as the ``Secretary'') shall conduct a study and submit to
the Committee on Ways and Means and the Committee on Energy and
Commerce of the House of Representatives and the Committee on Finance
of the Senate a report containing recommendations on whether and how
payment to providers and suppliers of services and coverage related to
the use of multi-disciplinary, evidence-based, non-opioid treatments
for acute and chronic pain management for individuals entitled to
benefits under part A or enrolled under part B of title XVIII of the
Social Security Act should be revised. The Secretary shall make such
report available on the public website of the Centers for Medicare &
Medicaid Services.
(b) Consultation.--In developing the report described in subsection
(a), the Secretary shall consult with--
(1) relevant agencies within the Department of Health and
Human Services;
(2) licensed and practicing osteopathic and allopathic
physicians, behavioral health practitioners, physician
assistants, nurse practitioners, dentists, pharmacists, and
other providers of health services;
(3) providers and suppliers of services (as such terms are
defined in section 1861 of the Social Security Act (42 U.S.C.
1395x));
(4) substance abuse and mental health professional
organizations;
(5) pain management professional organizations and advocacy
entities, including individuals who personally suffer chronic
pain;
(6) medical professional organizations and medical specialty
organizations;
(7) licensed health care providers who furnish alternative
pain management services;
(8) organizations with expertise in the development of
innovative medical technologies for pain management;
(9) beneficiary advocacy organizations; and
(10) other organizations with expertise in the assessment,
diagnosis, treatment, and management of pain, as determined
appropriate by the Secretary.
(c) Contents.--The report described in subsection (a) shall include
the following:
(1) The recommendations described in subsection (d).
(2) The impact analysis described in subsection (e).
(3) An assessment of pain management guidance published by
the Federal Government that may be relevant to coverage
determinations or other coverage requirements under title XVIII
of the Social Security Act. Such assessment shall consider
incorporating into such guidance relevant elements of the ``Va/
DoD Clinical Practice Guideline for Opioid Therapy for Chronic
Pain'' published in February 2017 by the Department of Veterans
Affairs and Department of Defense, including adoption of
elements of the Department of Defense and Veterans
Administration pain rating scale.
(4) An evaluation of the following:
(A) Barriers inhibiting individuals entitled to
benefits under part A or enrolled under part B of such
title from accessing treatments and technologies
described in subparagraphs (A) through (F) of paragraph
(5).
(B) Potential legislative and administrative changes
under such title to improve individuals' access to
items and services currently covered under such title
and used for the treatment of pain, such as cognitive
behavioral interventions, physical therapy,
occupational therapy, physical medicine, and
chiropractic therapy, and other pain treatments
services furnished in a hospital or post-acute care
setting.
(C) Costs and benefits associated with potential
expansion of coverage under such title to include items
and services not covered under such title that may be
used for the treatment of pain, such as acupuncture,
therapeutic massage, and items and services furnished
by integrated pain management programs.
(5) An analysis on payment and coverage under title XVIII of
the Social Security Act with respect to the following:
(A) Evidence-based treatments and technologies for
chronic or acute pain, including such treatments that
are covered, not covered, or have limited coverage
under such title.
(B) Evidence-based treatments and technologies that
monitor substance use withdrawal and prevent overdoses
of opioids.
(C) Evidence-based treatments and technologies that
treat substance use disorders.
(D) Items and services furnished by practitioners
through a multi-disciplinary treatment model for pain
management, including the patient-centered medical
home.
(E) Medical devices, non-opioid based drugs, and
other therapies (including interventional and
integrative pain therapies) approved or cleared by the
Food and Drug Administration for the treatment of pain.
(F) Items and services furnished to beneficiaries
with psychiatric disorders, substance use disorders, or
who are at risk of suicide, or have comorbidities and
require consultation or management of pain with one or
more specialists in pain management, mental health, or
addiction treatment.
(d) Recommendations.--The recommendations described in this
subsection are, with respect to individuals entitled to benefits under
part A or enrolled under part B of title XVIII of the Social Security
Act, legislative and administrative recommendations on the following:
(1) Options for additional coverage of pain management
therapies without the use of opioids, including interventional
pain therapies, and options to augment opioid therapy with
other clinical and complementary, integrative health services
to minimize the risk of substance use disorder, including in a
hospital setting.
(2) Options for coverage and payment modifications of medical
devices and non-opioid based pharmacological and non-
pharmacological therapies (including interventional and
integrative pain therapies) approved or cleared by the Food and
Drug Administration for the treatment of pain as an alternative
or augment to opioid therapy.
(3) Treatment strategies for beneficiaries with psychiatric
disorders, substance use disorders, or who are at risk of
suicide, and treatment strategies to address health disparities
related to opioid use and opioid abuse treatment.
(4) Treatment strategies for beneficiaries with comorbidities
who require a consultation or comanagement of pain with one or
more specialists in pain management, mental health, or
addiction treatment, including in a hospital setting.
(5) Coadministration of opioids and other drugs, particularly
benzodiazepines.
(6) Appropriate case management for beneficiaries who
transition between inpatient and outpatient hospital settings,
or between opioid therapy to non-opioid therapy, which may
include the use of care transition plans.
(7) Outreach activities designed to educate providers of
services and suppliers under the Medicare program and
individuals entitled to benefits under part A or under part B
of such title on alternative, non-opioid therapies to manage
and treat acute and chronic pain.
(8) Creation of a beneficiary education tool on alternatives
to opioids for chronic pain management.
(e) Impact Analysis.--The impact analysis described in this
subsection consists of an analysis of any potential effects
implementing the recommendations described in subsection (d) would
have--
(1) on expenditures under the Medicare program; and
(2) on preventing or reducing opioid addiction for
individuals receiving benefits under the Medicare program.
Amend the title so as to read:
A bill to amend title XVIII to provide for Medicare
coverage of certain services furnished by opioid treatment
programs, and for other purposes.
I. SUMMARY AND BACKGROUND
A. Purpose and Summary
The bill, H.R. 5776, the ``Medicare and Opioid Safe
Treatment (MOST) Act of 2018,'' as ordered reported by the
Committee on Ways and Means on May 16, 2018, increases
treatment coverage in Medicare for individuals suffering from
opioid use disorder.
B. Background and Need for Legislation
Although overdose rates are highest for people ages 25 to
54, the opioid epidemic has also had dramatic effects on
Medicare beneficiaries. A July 2017 Department of Health and
Human Services (HHS) Office of the Inspector General (OIG)
report found that one-third of Part D beneficiaries received an
opioid prescription in 2016, costing the program $4.1 billion
and representing 79.4 million prescriptions. Currently,
Medicare covers substance use treatment when it is ``medically
necessary,'' but there are still significant gaps in access to
treatment and services for some Medicare beneficiaries at risk
for or suffering from opioid use disorder. Specifically,
Medicare covers Medication-Assisted Treatment (MAT), the
evidence-based long-term treatment approach for opioid use
disorders that combines medication with counseling and
behavioral therapies, if prescribed in an inpatient setting
only. Medicare generally does not cover such medications
prescribed or dispensed to patients in an outpatient setting,
resulting in coverage gaps for many beneficiaries.
There may also be coverage gaps or barriers to coverage for
certain non-opioid pain management treatments in the Medicare
program. Providers often have a choice regarding the types of
medicines or other items used in a procedure for a patient, and
Medicare payments should be neutral, encouraging providers to
select the items and services most appropriate for a given
patient not based on reimbursement rates. Sometimes, payment
incentives in Medicare become misaligned, potentially providing
a financial incentive to choose one item over another.
The MOST Act fills coverage gaps for substance use disorder
treatment and explores the potential for perverse incentives to
prescribing opioids.
C. Legislative History
Background
H.R. 5776 was introduced on May 11, 2018, and was referred
to the Committee on Ways and Means and additionally the
Committee on Energy and Commerce.
Committee hearings
On January 17, 2018, the Subcommittee on Oversight held a
hearing on the current landscape and CMS actions to prevent
opioid misuse.
On February 6, 2018, the Subcommittee on Health held a
hearing on removing barriers to prevent and treat opioid abuse
and dependence in Medicare.
On April 12, 2018, the Subcommittee on Human Resources held
a hearing on local perspectives on the jobs gap that discussed
problems the opioid epidemic is creating in finding qualified
workers.
On April 25, 2018, the Subcommittee on Trade held a hearing
on stopping the flow of synthetic opioids in the international
mail system.
Committee action
The Committee on Ways and Means marked up H.R. 5776, the
``Medicare and Opioid Safe Treatment (MOST) Act of 2018,'' on
May 16, 2018, and ordered the bill, as amended, favorably
reported (with a quorum being present).
II. EXPLANATION OF THE BILL
A. Medicare and Opioid Safe Treatment Act
PRESENT LAW
Currently, Medicare covers substance use treatment when it
is ``medically necessary,'' but there are still significant
gaps in access to treatment and services for some Medicare
beneficiaries at risk for or suffering from opioid use
disorder. Medicare covers MAT, the evidence-based long-term
treatment approach for opioid use disorders that combines
medication with counseling and behavioral therapies, if
prescribed in an inpatient setting only. Medicare generally
does not cover such medications prescribed or dispensed to
patients in an outpatient setting, resulting in coverage gaps
for many beneficiaries.
REASONS FOR CHANGE
Although overdose rates are highest for people ages 25 to
54, the opioid epidemic has also had dramatic effects on
Medicare beneficiaries. A July 2017 HHS OIG report found that
one-third of Part D beneficiaries received an opioid
prescription in 2016, costing the program $4.1 billion and
representing 79.4 million prescriptions.
There may also be coverage gaps or barriers to coverage for
certain non-opioid pain management treatments in the Medicare
program. Providers often have a choice regarding the types of
medicines or other items used in a procedure for a patient, and
Medicare payments should be neutral, encouraging providers to
select the items and services most appropriate for a given
patient--not based on reimbursement rates. Sometimes, payment
incentives in Medicare become misaligned, potentially providing
a financial incentive to choose one treatment over another.
EXPLANATION OF PROVISIONS
Section 1: This section states the short title as the
``Medicare and Opioid Safe Treatment (MOST) Act of 2018.''
Section 2: Medicare Coverage of Certain Services Furnished
by Opioid Treatment Programs (OTPs).
This section would expand Medicare coverage to include OTPs
for the purposes of delivering MAT--including with methadone--
to Medicare beneficiaries. Medicare will pay OTPs through
bundled payments for services, including necessary medications,
counseling, and testing.
Section 3: Review and Adjustment of Payments under the
Medicare Outpatient Prospective Payment System to Avoid
Financial Incentives to Use Opioids Instead of Non-Opioid
Alternative Treatments.
This section would require the Secretary of the HHS to
review Medicare's payments made through the Outpatient
Prospective Payment System (OPPS) and payments to ambulatory
surgery centers (ASCs) to ensure there are no financial
incentives to use opioids instead of evidence-based non-opioid
alternatives. Under the OPPS, the Secretary will focus
primarily on payments made through Ambulatory Payment
Classifications (APCs) and Complex Ambulatory Payment
Classifications (C-APCs) that primarily include surgical
services. If the Secretary identifies financial incentives to
use opioids instead of evidence-based non-opioid alternatives,
the Secretary will make such revisions to OPPS and ASC payments
through rulemaking. The Secretary may also make changes to
these payment systems through a demonstration.
When the Secretary conducts the review of the OPPS and ASC
payment systems to achieve the goal of ensuring that there are
not financial incentives to use opioids instead of non-opioid
alternatives, or improve the appropriate use of or access to
such non-opioid alternative treatments, the Committee expects
the Secretary to examine, among other possible options,
creating additional groups of covered outpatient department
services that use non-opioid alternative treatments. CMS should
consider differences in structure and function of such
treatments that impact pain relief, cost-effectiveness, patient
safety, and whether it reduces dependence on opioids.
Section 4: Expanding Access under the Medicare Program to
Addiction Treatment in Federally Qualified Health Centers and
Rural Health Centers.
This section would provide payments to Federally Qualified
Health Centers (FQHCs) and Rural Health Centers (RHCs) to
offset the cost of their providers receiving training to become
Drug Addiction Treatment Act of 2000 (DATA 2000) compliant.
This means that providers who work in FQHCs and RHCs and
receive training to provide MAT can get reimbursed for that
training.
Section 5: Studying the Availability of Supplemental
Benefits Designed to Treat or Prevent Substance Use Disorders
under Medicare Advantage Plans.
No later than two years after the date of enactment, the
Secretary of HHS is required to evaluate the extent to which MA
plans offer MAT and cover non-opioid alternative treatments not
otherwise covered under Medicare FFS as part of a supplemental
benefit.
Consultation: The Secretary is required to develop the
report in consultation with relevant stakeholders.
Content: The report is required to include an analysis of
the extent to which plans offer supplemental health care
benefits relating to the coverage of (1) medication assisted
treatments for opioid use, substance use disorder counseling,
peer recovery support services, or other forms of substance use
disorder treatments and (2) non-opioid alternatives for the
treatment of pain. The Committee's intent is not to limit the
types of treatments being analyzed to treat pain. The Secretary
may include non-pharmacologic therapies such as physical
therapy.
The report must also analyze the challenges associated with
plans offering supplemental health care benefits relating to
coverage of these items and services and the impact of
increasing the applicable rebate percentage to incentivize
coverage or availability of such benefits.
Lastly, the report is required to provide recommendations
to improve upon such coverage or to incentivize plans to offer
these types of additional supplemental health care benefits.
Section 6: Clinical Psychologist Services Models under the
Center for Medicare and Medicaid Innovation; GAO Study and
Report.
This section would direct the Secretary of HHS, under the
Center for Medicare & Medicaid Innovation, to educate patients
on the availability of psychologist services and explore the
use of hotlines to reduce unnecessary hospitalizations in
Medicare. This provision also mandates the Comptroller General
of the United States to issue a report on mental and behavioral
health under the Medicare program with information about
services offered by psychiatrists, clinical psychologists, and
other professionals.
Section 7: Pain Management Study.
This section would require the Secretary of HHS to issue a
report, in consultation with relevant stakeholders, containing
options for improving payment and coverage for multi-
disciplinary, evidence-based, non-opioid treatments for acute
and chronic pain management for Medicare FFS beneficiaries. The
report will also include: (1) an assessment of costs and
benefits of potential expansion of pain management coverage;
(2) options for improving treatment strategies and case
management for various high-risk patient populations; and (3)
options for improving and disseminating pain management
education tools. It will also consider relevant elements of the
``VA/DoD Clinical Practice Guideline for Opioid Therapy for
Chronic Pain,'' published in February 2017 by the Department of
Veterans Affairs and Department of Defense for updates of HHS
guidance.
EFFECTIVE DATE
Section 2: Beginning on or after January 1, 2020.
Section 3: Upon date of enactment, with the Secretary
making revisions on or after January 1, 2020.
Section 4: Beginning January 1, 2019.
Section 5: No later than two years after the date of
enactment.
Section 6: Not later than 18 months after the date of the
enactment of this Act.
Section 7: Not later than 1 year after the date of the
enactment of this Act.
III. VOTES OF THE COMMITTEE
In compliance with clause 3(b) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the votes of the Committee on Ways and Means in its
consideration of H.R. 5776, the MOST Act of 2018, on May 16,
2018.
The Chairman's amendment in the nature of a substitute was
adopted by a voice vote (with a quorum being present).
The bill, H.R. 5776, was ordered favorably reported as
amended by voice vote (with a quorum being present).
IV. BUDGET EFFECTS OF THE BILL
A. Committee Estimate of Budgetary Effects
In compliance with clause 3(d) of rule XIII of the Rules of
the House of Representatives, the following statement is made
concerning the effects on the budget of the bill, H.R. 5776, as
reported. The Committee agrees with the estimate prepared by
the Congressional Budget Office (CBO), which is included below.
B. Statement Regarding New Budget Authority and Tax Expenditures Budget
Authority
In compliance with clause 3(c)(2) of rule XIII of the Rules
of the House of Representatives, the Committee states that the
bill involves no new or increased budget authority. The
Committee states further that the bill involves no new or
increased tax expenditures.
C. Cost Estimate Prepared by the Congressional Budget Office
In compliance with clause 3(c)(3) of rule XIII of the Rules
of the House of Representatives, requiring a cost estimate
prepared by the CBO, the following statement by CBO is
provided.
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2018.
Hon. Kevin Brady,
Chairman, Committee on Ways and Means,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for the opioid-related
legislation ordered to be reported on May 16, 2018.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Tom Bradley.
Sincerely,
Mark P. Hadley
(For Keith Hall, Director).
Enclosure.
Opioid Legislation
Summary: On May 16, 2018, the House Committee on Ways and
Means ordered seven bills to be reported related to the
nation's response to the opioid epidemic. Generally, the bills
would:
Expand Medicare coverage of treatment for
opioid use disorder;
Give Medicare providers and health plans
additional tools to curtail inappropriate prescribing
and use of opioids;
Require the completion of studies and
reports related to opioid use and misuse in Medicare;
and
Require the United States Postal Service and
Customs and Border Protection (CBP) to reduce illegal
shipment of opioids across international borders.
Because the bills are related, CBO is publishing a single
comprehensive document that includes estimates for each piece
of legislation.
CBO estimates that enacting four of the bills would affect
direct spending; therefore, pay-as-you-go procedures apply for
those bills. None of the bills would affect revenues.
CBO estimates that although enacting one bill of the seven
included in this document (H.R. 5776) would increase net direct
spending and on-budget deficits over the four consecutive 10-
year periods beginning in 2029, those effects would not exceed
the threshold established by the Congress for long-term costs.
CBO estimates that none of the remaining bills would increase
net direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2029.
None of the bills contain intergovernmental or private-
sector mandates as defined in the Unfunded Mandates Reform Act
(UMRA).
Estimated cost to the Federal Government: The estimates in
this document do not include the effects of interactions among
the bills. If all seven bills were combined and enacted as one
piece of legislation, the budgetary effects would be different
from the sum of the estimates in this document, although CBO
expects that those differences would be small. The effects of
this legislation fall within functions 550 (health), 570
(Medicare), and 750 (administration of justice).
Basis of estimate: For this estimate, CBO assumes that all
of the legislation will be enacted late in 2018 and that
authorized and estimated amounts will be appropriated each
year. Outlays for discretionary programs are estimated based on
historical spending patterns for similar programs.
Uncertainty
CBO aims to produce estimates that generally reflect the
middle of a range of the most likely budgetary outcomes that
would result if the legislation was enacted. Because data on
the utilization of mental health and substance abuse treatment
under Medicaid and Medicare is scarce, CBO cannot precisely
predict how patients or providers would respond to some policy
changes or what budgetary effects would result. In addition,
several of the bills would give the Department of Health and
Human Services (HHS) considerable latitude in designing and
implementing policies. Budgetary effects could differ from
those provided in CBO's analyses depending on those decisions.
Direct Spending
Table 1 lists the four bills included in this estimate that
would affect direct spending.
H.R. 5676, the Stop Excessive Narcotics in our Retirement
Communities Protection Act of 2018, would allow prescription
drug plans to suspend payments to pharmacies while fraud
investigations are pending. CBO expects that enacting the
legislation would reduce payments by those plans to phannacies
and result in lower premiums for benefits under Medicare's Part
D. CBO estimates that the reduction in premiums would lower
federal spending for Part D by $9 million over the 2019-2028
period.
TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
----------------------------------------------------------------------------------------------------------------------
2019-
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
H.R. 5676, Stop Excessive
Narcotics in our Retirement
Communities Protection Act of
2018:
Budget Authority............. 0 0 -1 -1 -1 -1 -1 -1 -1 -1 -1 -4 -9
Outlays...................... 0 0 -1 -1 -1 -1 -1 -1 -1 -1 -1 -4 -9
H.R. 5773, Preventing Addiction
for Susceptible Seniors Act of
2018:a
Budget Authority............. 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
Outlays...................... 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
H.R. 5776, the Medicare and
Opioid Safe Treatment Act of
2018:a
Budget Authority............. 0 8 0 20 20 25 30 30 35 35 40 73 243
Outlays...................... 0 2 4 22 20 25 30 30 35 35 40 73 243
H.R. 5788, Securing the
International Mail Against
Opioids Act of 2018:a
Budget Authority............. 0 0 * * * * * * * * * * *
Outlays...................... 0 0 * * * * * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding * = between -$500,000 and $500,000
a This bill also would affect spending subject to appropriation.
H.R. 5773, the Preventing Addiction for Susceptible Seniors
Act of 2018, would require Part D prescription drug plans to
provide drug management programs for Medicare beneficiaries who
are at risk for prescription drug abuse. (Under current law,
Part D plans are permitted but not required to establish such
programs as of 2019.) Based on an analysis of the number of
plans currently providing those programs, CBO estimates that
enacting H.R. 5773 would lower federal spending by $64 million
over the 2019-2028 period by reducing the number of
prescriptions filled and Medicare's payments for controlled
substances.
Two provisions of H.R. 5773 would have no significant
budgetary effect; they are described later in this document.
H.R. 5776, the Medicare and Opioid Safe Treatment Act of
2018, would appropriate $8 million in 2019, which would be
available until expended, for Federally Qualified Health
Centers and Rural Health Clinics to support training in the
treatment of opioid use disorder. CBO expects that $8 million
would be spent between 2019 and 2021.
H.R. 5776 also would expand the availability of medication-
assisted treatment (MAT) for Medicare beneficiaries with opioid
use disorder. The bill would allow treatment programs certified
by the Substance Abuse and Mental Health Services
Administration (SAMHSA) to become Medicare-participating
providers.\1\ H.R. 5776 also would direct the Secretary of HHS
to create a new schedule of bundled payments for MAT through
certified programs and grant the Secretary considerable
discretion for defining bundles and establishing payment rates.
---------------------------------------------------------------------------
\1\MAT combines behavioral therapy and pharmaceutical treatment for
substance use disorders. Under current law, methadone (an opioid used
to treat and manage dependence on other drugs, such as heroin) can be
dispensed only by SAMHSA-certified treatment programs, which do not
participate in Medicare. Other drugs used in MAT, including
buprenorphine and naltrexone, can be dispensed more widely.
---------------------------------------------------------------------------
CBO projects that, beginning in 2021, about 3,000 Medicare
beneficiaries who would not be treated for opioid abuse under
current law would newly enroll each year in treatment offered
by SAMHSA-certified programs and that the annual cost per
participant would range from about $6,000 to about $10,000,
depending largely on the medications dispensed and the period
for which beneficiaries adhered to the protocol. CBO's
projection of the number of beneficiaries who would receive
treatment takes into consideration the number of beneficiaries
estimated to have opioid-use disorder, the number already
receiving some form of treatment, and the availability of
providers to treat those who newly enroll in MAT. To develop a
per capita treatment cost, CBO analyzed rates for MAT paid by
other payers, as well as Medicare spending for health care
services typically used by people receiving MAT. CBO estimates
that the new MAT benefit would increase direct spending by $235
million over the 2019-2028 period.
CBO estimates that enacting H.R. 5776 would increase net
Medicare spending by $243 million over the 2019-2028 period.
(If enacted, H.R. 5776 would also affect spending subject to
appropriation; CBO has not completed an estimate of that
amount.)
H.R. 5788, the Securing the International Mail Against
Opioids Act of 2018, would establish a new fee for certain
items mailed to the United States from overseas, beginning
January 1, 2020. Initially, the fee for most such items would
be one dollar, but the amount could be adjusted annually
thereafter. Using information provided by CBP, CBO estimates
that about $100 million in new fees would be collected over the
2020-2028 period. The collections would be divided equally
between CBP and the Postal Service and spent by those agencies
on activities related to the processing of inbound mail. CBO
estimates that the net effect on federal spending in each year
would be insignificant. (If enacted, H.R. 5788 would also
affect spending subject to appropriation; those effects are
described below.)
Spending subject to appropriation
For this document, CBO has grouped bills with spending that
would be subject to appropriation into three general
categories:
Bills with provisions that would have no
budgetary effect;
Bills with provisions for which CBO has
estimated an authorization of appropriations (see Table
2); and
Bills with provisions that would affect
spending subject to appropriation for which CBO has not
yet completed an estimate.
No Budgetary Effect. CBO estimates that three of the bills
have provisions that would not significantly affect direct
spending, revenues, or spending subject to appropriation.
H.R. 5773, the Preventing Addiction for Susceptible Seniors
Act of 2018, would require health care professionals to submit
prior authorization requests electronically, starting on
January 1, 2021, for drugs covered under Medicare Part D.
Taking into account that many prescribers already use
electronic methods to submit such requests, CBO estimates that
enacting that Section 3 of H.R. 5773 would not significantly
affect direct spending for Part D.
Section 5 of that bill would expand medication therapy
management programs under Medicare Part D to include
beneficiaries who are at risk for prescription drug abuse.
Because relatively few beneficiaries would be affected by this
provision, CBO estimates that its enactment would not
significantly affect direct spending for Part D.
Section 6 of that bill would require the Secretary of HHS
on an annual basis to identify high prescribers of opioids and
furnish them with information about proper prescribing methods.
Because HHS already has the capacity to meet those
requirements, CBO estimates that enacting that provision would
not impose additional administrative costs on the agency.
H.R. 5775, the Providing Reliable Options for Patients and
Educational Resources Act of 2018, would require prescription
drug plans that provide coverage under Medicare Part D to
furnish information to beneficiaries about the risks of opioid
use and the availability of alternative treatments for pain.
The bill also would require Medicare Advantage plans and
prescription drug plans to provide information regarding safe
disposal of controlled substances in home health risk
assessments and medication therapy management programs,
respectively. In CBO's estimation, neither proposal would have
a budgetary effect because those activities would not impose
significant administrative costs on plans or federal agencies.
In addition, H.R. 5775 would restrict the use of certain
pain-related questions on the Hospital Consumer Assessment of
Healthcare Providers and Systems (HCAHPS) survey, which is
administered by the Centers for Medicare & Medicaid Services
(CMS). The survey is one measure used in CMS's Hospital Value-
Based Purchasing (VBP) Program, which adjusts payments to acute
care hospitals on the basis of the quality of care they provide
to Medicare beneficiaries. Because the VBP program is funded by
reducing base payments to all hospitals, CBO estimates that
changing the HCAHPS survey would not affect the total amount
paid by Medicare.
H.R. 5776, the Medicare and Opioid Safe Treatment Act of
2018, in section 3, would require CMS, beginning on January 1,
2020, to review and possibly modify payments made through
Medicare's Hospital Outpatient Prospective Payment System for
certain opioid and nonopioid pain management treatments and
technologies. CMS could revise payments if the Secretary of HHS
determined that there was a financial incentive to use opioids
in place of nonopioid medications. The budget neutrality
requirement under current law would apply to such revisions,
and the rest of the payment rates within the system would be
subject to offsetting adjustments. Because the changes would be
made in a budget-neutral manner, CBO estimates that this
provision would have no budgetary effect.
Section 6 of H.R. 5776 would explicitly authorize the
Center for Medicare and Medicaid Innovation (CMMI) to test
approaches for expanding beneficiaries' awareness of
psychological services and to help those beneficiaries curtail
use of hospital-based mental health or behavioral health
services. Because CMMI already has that authority, CBO
estimates that enacting the legislation would not affect
federal spending.
Estimated Authorizations. Table 2 shows CBO's estimates of
the authorization of appropriations for provisions in four
bills. For those estimates, CBO assumes that appropriated funds
would be available to implement those provisions.
H.R. 5723, the Expanding Oversight of Opioid Prescribing
and Payment Act of 2018, would require the Medicare Payment
Advisory Commission to report to the Congress on payments for
pain treatment, incentives for prescribing opioids in inpatient
and outpatient settings, and documented tracking of opioid use
from Medicare claims data. CBO estimates that producing such a
report would cost less than $500,000 over the 2019-2023 period.
TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH ESTIMATED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
----------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 5723, Expanding Oversight of Opioid Prescribing
and Payment Act of 2018:
Estimated Authorization Level.................... 0 * 0 0 0 0 *
Estimated Outlays................................ 0 * 0 0 0 0 *
H.R. 5773, Preventing Addiction for Susceptible
Seniors Act of 2018:a
Estimated Authorization Level.................... 0 2 2 2 2 2 9
Estimated Outlays................................ 0 2 2 2 2 2 9
H.R. 5776, Medicare and Opioid Safe Treatment Act of
2018:a
Estimated Authorization Level.................... 0 1 0 0 0 0 1
Estimated Outlays................................ 0 1 0 0 0 0 1
H.R. 5788, Securing the International Mail Against
Opioids Act of 2018:a
Estimated Authorization Level.................... 0 100 0 0 0 0 100
Estimated Outlays................................ 0 40 40 20 0 0 100
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000
aThis bill also would affect mandatory spending.
H.R. 5773, the Preventing Addiction for Susceptible Seniors
Act of 2018, would require the Secretary of HHS to establish a
secure Internet portal to allow HHS, Medicare Advantage plans,
and Medicare Part D plans to exchange information about fraud,
waste, and abuse among providers and suppliers no later than
two years after enactment. H.R. 5773 also would require
organizations with Medicare Advantage contracts to submit
information on investigations related to providers suspected of
prescribing large volumes of opioids through a process
established by the Secretary no later than January 2021. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5773 would cost approximately
$9 million over the 2019-2023 period.
H.R. 5776, the Medicare and Opioid Safe Treatment Act of
2018, would direct the Secretary of HHS to report to the
Congress on the availability of supplemental benefits to pay
for treatment or prevention of substance abuse among enrollees
in Medicare Advantage plans. The Secretary also would report on
coverage of and payment for pain treatment and substance use
disorders under Medicare. CBO estimates that producing those
reports would cost $1 million over five years.
H.R. 5788, the Securing the International Mail Against
Opioids Act of 2018, would direct the Postal Service, CBP, and
other federal agencies to collaborate to develop technology to
detect opioids and other drugs that enter the United States in
the mail. Using information provided by CBP, CBO estimates that
it would cost roughly $100 million over the 2019-2021 period to
deploy drug detection systems at international mail facilities.
Other Authorizations. CBO has determined that provisions in
two bills--H.R. 5774, Combating Opioid Abuse for Care in
Hospitals Act of 2018; and H.R. 5776, the Medicare and Safe
Opioid Treatment Act of 2018--would increase authorization
levels, but has not completed estimates of amounts. Any
spending that would result from those authorizations would be
subject to future appropriation action.
Pay-As-You-Go considerations: The Statutory Pay-As-You-Go
Act of 2010 establishes budget-reporting and enforcement
procedures for legislation affecting direct spending or
revenues. Four of the bills discussed in this document contain
direct spending and are subject to pay-as-you-go procedures.
Details about the amount of direct spending in those bills can
be found in Table 1.
Increase in Long-term direct spending and deficits: CBO
estimates that although enacting H.R. 5776, the Medicare and
Opioid Safe Treatment Act of 2018, would increase net direct
spending and on-budget deficits over the four consecutive 10-
year periods beginning in 2029, those effects would not exceed
the threshold established by the Congress for long-term costs
($2.5 billion for net direct spending and $5 billion for on-
budget deficits). CBO estimates that none of the remaining
bills would increase net direct spending or on-budget deficits
in any of the four consecutive 10-year periods beginning in
2029.
Mandates: None of the bills contains intergovernmental or
private-sector mandates as defined in UMRA.
Previous CBO estimate: On June 6, 2018, CBO issued an
estimate for 59 opioid-related bills ordered reported by the
House Committee on Energy and Commerce on May 9 and May 17,
2018. Several of those bills contain provisions that are
identical or similar to those in the legislation ordered
reported by the Committee on Ways and Means, and for those
provisions, CBO's estimates are the same.
In particular, several sections in H.R. 5773, the
Preventing Addiction for Susceptible Seniors Act of 2018,
contain provisions that are identical or similar to those in
five bills listed in the other estimate:
Section 2, which would require prescription
drug plans to implement drug management programs, is
identical to a provision in H.R. 5675.
Section 3, regarding electronic prior
authorization for prescriptions under Medicare's Part
D, is similar to a provision in H.R. 4841.
Section 4, which would mandate the creation
of a new Internet portal to allow various stakeholders
to exchange information, is identical to a provision in
H.R. 5715.
Section 5, which would expand medication
therapy management, is the same as a provision in H.R.
5684.
Section 6, regarding prescriber
notification, is identical to H.R. 5716.
In addition, in this estimate, a provision related to
Medicare beneficiary education in section 2 of H.R. 5775, the
Providing Reliable Options for Patients and Educational
Resources Act of 2018, is the same as a provision in H.R. 5686,
the Medicare Clear Health Options in Care for Enrollees Act of
2018, in CBO's estimate for the Committee on Energy and
Commerce.
Estimate prepared by: Federal costs--Medicare: Philippa
Haven, Lori Housman, Jamease Kowalczyk, Lara Robillard, Sarah
Sajewski, Colin Yee, and Rebecca Yip; U.S. Postal Service and
Customs and Border Protection: Mark Grabowicz; Mandates: Andrew
Laughlin; Fact Checking: Zachary Byrum and Kate Kelly.
Estimate reviewed by: Tom Bradley, Chief, Health Systems
and Medicare Cost Estimates Unit; Kim P. Cawley, Chief, Natural
Resources Cost Estimates Unit; Susan Willie, Chief, Mandates
Unit; Leo Lex, Deputy Assistant Director for Budget Analysis;
Theresa A. Gullo, Assistant Director for Budget Analysis.
V. OTHER MATTERS TO BE DISCUSSED UNDER THE RULES OF THE HOUSE
A. Committee Oversight Findings and Recommendations
With respect to clause 3(c)(1) of rule XIII of the Rules of
the House of Representatives, the Committee made findings and
recommendations that are reflected in this report.
B. Statement of General Performance Goals and Objectives
With respect to clause 3(c)(4) of rule XIII of the Rules of
the House of Representatives, the Committee advises that the
bill contains no measure that authorizes funding, so no
statement of general performance goals and objectives for which
any measure authorizes funding is required.
C. Information Relating to Unfunded Mandates
This information is provided in accordance with section 423
of the Unfunded Mandates Reform Act of 1995 (Pub. L. No. 104-
4).
The Committee has determined that the bill does not contain
Federal mandates on the private sector. The Committee has
determined that the bill does not impose a Federal
intergovernmental mandate on State, local, or tribal
governments.
D. Congressional Earmarks, Limited Tax Benefits, and Limited Tariff
Benefits
With respect to clause 9 of rule XXI of the Rules of the
House of Representatives, the Committee has carefully reviewed
the provisions of the bill, and states that the provisions of
the bill do not contain any congressional earmarks, limited tax
benefits, or limited tariff benefits within the meaning of the
rule.
E. Duplication of Federal Programs
In compliance with Sec. 3(g)(2) of H. Res. 5 (114th
Congress), the Committee states that no provision of the bill
establishes or reauthorizes: (1) a program of the Federal
Government known to be duplicative of another Federal program;
(2) a program included in any report from the Government
Accountability Office to Congress pursuant to section 21 of
Public Law 111-139; or (3) a program related to a program
identified in the most recent Catalog of Federal Domestic
Assistance, published pursuant to the Federal Program
Information Act (Pub. L. No. 95-220, as amended by Pub. L. No.
98-169).
F. Disclosure of Directed Rule Makings
In compliance with Sec. 3(i) of H. Res. 5 (114th Congress),
the following statement is made concerning directed rule
makings: The Committee estimates that the bill requires no
directed rule makings within the meaning of such section.
VI. CHANGES IN EXISTING LAW MADE BY THE BILL, AS REPORTED
In compliance with clause 3(e)(1)(B) of rule XIII of the
Rules of the House of Representatives, changes in existing law
proposed by the bill, as reported, are shown as follows
(existing law proposed to be omitted is enclosed in black
brackets, new matter is printed in italic, existing law in
which no change is proposed is shown in roman):
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE
SIMPLIFICATION
Part A--General Provisions
* * * * * * *
center for medicare and medicaid innovation
Sec. 1115A. (a) Center for Medicare and Medicaid Innovation
Established.--
(1) In general.--There is created within the Centers
for Medicare & Medicaid Services a Center for Medicare
and Medicaid Innovation (in this section referred to as
the ``CMI'') to carry out the duties described in this
section. The purpose of the CMI is to test innovative
payment and service delivery models to reduce program
expenditures under the applicable titles while
preserving or enhancing the quality of care furnished
to individuals under such titles. In selecting such
models, the Secretary shall give preference to models
that also improve the coordination, quality, and
efficiency of health care services furnished to
applicable individuals defined in paragraph (4)(A).
(2) Deadline.--The Secretary shall ensure that the
CMI is carrying out the duties described in this
section by not later than January 1, 2011.
(3) Consultation.--In carrying out the duties under
this section, the CMI shall consult representatives of
relevant Federal agencies, and clinical and analytical
experts with expertise in medicine and health care
management. The CMI shall use open door forums or other
mechanisms to seek input from interested parties.
(4) Definitions.--In this section:
(A) Applicable individual.--The term
``applicable individual'' means--
(i) an individual who is entitled to,
or enrolled for, benefits under part A
of title XVIII or enrolled for benefits
under part B of such title;
(ii) an individual who is eligible
for medical assistance under title XIX,
under a State plan or waiver; or
(iii) an individual who meets the
criteria of both clauses (i) and (ii).
(B) Applicable title.--The term ``applicable
title'' means title XVIII, title XIX, or both.
(5) Testing within certain geographic areas.--For
purposes of testing payment and service delivery models
under this section, the Secretary may elect to limit
testing of a model to certain geographic areas.
(b) Testing of Models (Phase I).--
(1) In general.--The CMI shall test payment and
service delivery models in accordance with selection
criteria under paragraph (2) to determine the effect of
applying such models under the applicable title (as
defined in subsection (a)(4)(B)) on program
expenditures under such titles and the quality of care
received by individuals receiving benefits under such
title.
(2) Selection of models to be tested.--
(A) In general.--The Secretary shall select
models to be tested from models where the
Secretary determines that there is evidence
that the model addresses a defined population
for which there are deficits in care leading to
poor clinical outcomes or potentially avoidable
expenditures. The Secretary shall focus on
models expected to reduce program costs under
the applicable title while preserving or
enhancing the quality of care received by
individuals receiving benefits under such
title. The models selected under this
subparagraph may include, but are not limited
to, the models described in subparagraph (B).
(B) Opportunities.--The models described in
this subparagraph are the following models:
(i) Promoting broad payment and
practice reform in primary care,
including patient-centered medical home
models for high-need applicable
individuals, medical homes that address
women's unique health care needs, and
models that transition primary care
practices away from fee-for-service
based reimbursement and toward
comprehensive payment or salary-based
payment.
(ii) Contracting directly with groups
of providers of services and suppliers
to promote innovative care delivery
models, such as through risk-based
comprehensive payment or salary-based
payment.
(iii) Utilizing geriatric assessments
and comprehensive care plans to
coordinate the care (including through
interdisciplinary teams) of applicable
individuals with multiple chronic
conditions and at least one of the
following:
(I) An inability to perform 2
or more activities of daily
living.
(II) Cognitive impairment,
including dementia.
(iv) Promote care coordination
between providers of services and
suppliers that transition health care
providers away from fee-for-service
based reimbursement and toward salary-
based payment.
(v) Supporting care coordination for
chronically-ill applicable individuals
at high risk of hospitalization through
a health information technology-enabled
provider network that includes care
coordinators, a chronic disease
registry, and home tele-health
technology.
(vi) Varying payment to physicians
who order advanced diagnostic imaging
services (as defined in section
1834(e)(1)(B)) according to the
physician's adherence to
appropriateness criteria for the
ordering of such services, as
determined in consultation with
physician specialty groups and other
relevant stakeholders.
(vii) Utilizing medication therapy
management services, such as those
described in section 935 of the Public
Health Service Act.
(viii) Establishing community-based
health teams to support small-practice
medical homes by assisting the primary
care practitioner in chronic care
management, including patient self-
management, activities.
(ix) Assisting applicable individuals
in making informed health care choices
by paying providers of services and
suppliers for using patient decision-
support tools, including tools that
meet the standards developed and
identified under section 936(c)(2)(A)
of the Public Health Service Act, that
improve applicable individual and
caregiver understanding of medical
treatment options.
(x) Allowing States to test and
evaluate fully integrating care for
dual eligible individuals in the State,
including the management and oversight
of all funds under the applicable
titles with respect to such
individuals.
(xi) Allowing States to test and
evaluate systems of all-payer payment
reform for the medical care of
residents of the State, including dual
eligible individuals.
(xii) Aligning nationally recognized,
evidence-based guidelines of cancer
care with payment incentives under
title XVIII in the areas of treatment
planning and follow-up care planning
for applicable individuals described in
clause (i) or (iii) of subsection
(a)(4)(A) with cancer, including the
identification of gaps in applicable
quality measures.
(xiii) Improving post-acute care
through continuing care hospitals that
offer inpatient rehabilitation, long-
term care hospitals, and home health or
skilled nursing care during an
inpatient stay and the 30 days
immediately following discharge.
(xiv) Funding home health providers
who offer chronic care management
services to applicable individuals in
cooperation with interdisciplinary
teams.
(xv) Promoting improved quality and
reduced cost by developing a
collaborative of high-quality, low-cost
health care institutions that is
responsible for--
(I) developing, documenting,
and disseminating best
practices and proven care
methods;
(II) implementing such best
practices and proven care
methods within such
institutions to demonstrate
further improvements in quality
and efficiency; and
(III) providing assistance to
other health care institutions
on how best to employ such best
practices and proven care
methods to improve health care
quality and lower costs.
(xvi) Facilitate inpatient care,
including intensive care, of
hospitalized applicable individuals at
their local hospital through the use of
electronic monitoring by specialists,
including intensivists and critical
care specialists, based at integrated
health systems.
(xvii) Promoting greater efficiencies
and timely access to outpatient
services (such as outpatient physical
therapy services) through models that
do not require a physician or other
health professional to refer the
service or be involved in establishing
the plan of care for the service, when
such service is furnished by a health
professional who has the authority to
furnish the service under existing
State law.
(xviii) Establishing comprehensive
payments to Healthcare Innovation
Zones, consisting of groups of
providers that include a teaching
hospital, physicians, and other
clinical entities, that, through their
structure, operations, and joint-
activity deliver a full spectrum of
integrated and comprehensive health
care services to applicable individuals
while also incorporating innovative
methods for the clinical training of
future health care professionals.
(xix) Utilizing, in particular in
entities located in medically
underserved areas and facilities of the
Indian Health Service (whether operated
by such Service or by an Indian tribe
or tribal organization (as those terms
are defined in section 4 of the Indian
Health Care Improvement Act)),
telehealth services--
(I) in treating behavioral
health issues (such as post-
traumatic stress disorder) and
stroke; and
(II) to improve the capacity
of non-medical providers and
non-specialized medical
providers to provide health
services for patients with
chronic complex conditions.
(xx) Utilizing a diverse network of
providers of services and suppliers to
improve care coordination for
applicable individuals described in
subsection (a)(4)(A)(i) with 2 or more
chronic conditions and a history of
prior-year hospitalization through
interventions developed under the
Medicare Coordinated Care Demonstration
Project under section 4016 of the
Balanced Budget Act of 1997 (42 U.S.C.
1395b-1 note).
(xxi) Focusing primarily on
physicians' services (as defined in
section 1848(j)(3)) furnished by
physicians who are not primary care
practitioners.
(xxii) Focusing on practices of 15 or
fewer professionals.
(xxiii) Focusing on risk-based models
for small physician practices which may
involve two-sided risk and prospective
patient assignment, and which examine
risk-adjusted decreases in mortality
rates, hospital readmissions rates, and
other relevant and appropriate clinical
measures.
(xxiv) Focusing primarily on title
XIX, working in conjunction with the
Center for Medicaid and CHIP Services.
(xxv) Supporting ways to familiarize
individuals with the availability of
coverage under part B of title XVIII
for qualified psychologist services (as
defined in section 1861(ii)).
(xxvi) Exploring ways to avoid
unnecessary hospitalizations or
emergency department visits for mental
and behavioral health services (such as
for treating depression) through use of
a 24-hour, 7-day a week help line that
may inform individuals about the
availability of treatment options,
including the availability of qualified
psychologist services (as defined in
section 1861(ii)).
(C) Additional factors for consideration.--In
selecting models for testing under subparagraph
(A), the CMI may consider the following
additional factors:
(i) Whether the model includes a
regular process for monitoring and
updating patient care plans in a manner
that is consistent with the needs and
preferences of applicable individuals.
(ii) Whether the model places the
applicable individual, including family
members and other informal caregivers
of the applicable individual, at the
center of the care team of the
applicable individual.
(iii) Whether the model provides for
in-person contact with applicable
individuals.
(iv) Whether the model utilizes
technology, such as electronic health
records and patient-based remote
monitoring systems, to coordinate care
over time and across settings.
(v) Whether the model provides for
the maintenance of a close relationship
between care coordinators, primary care
practitioners, specialist physicians,
community-based organizations, and
other providers of services and
suppliers.
(vi) Whether the model relies on a
team-based approach to interventions,
such as comprehensive care assessments,
care planning, and self-management
coaching.
(vii) Whether, under the model,
providers of services and suppliers are
able to share information with
patients, caregivers, and other
providers of services and suppliers on
a real time basis.
(viii) Whether the model demonstrates
effective linkage with other public
sector payers, private sector payers,
or statewide payment models.
(3) Budget neutrality.--
(A) Initial period.--The Secretary shall not
require, as a condition for testing a model
under paragraph (1), that the design of such
model ensure that such model is budget neutral
initially with respect to expenditures under
the applicable title.
(B) Termination or modification.--The
Secretary shall terminate or modify the design
and implementation of a model unless the
Secretary determines (and the Chief Actuary of
the Centers for Medicare & Medicaid Services,
with respect to program spending under the
applicable title, certifies), after testing has
begun, that the model is expected to--
(i) improve the quality of care (as
determined by the Administrator of the
Centers for Medicare & Medicaid
Services) without increasing spending
under the applicable title;
(ii) reduce spending under the
applicable title without reducing the
quality of care; or
(iii) improve the quality of care and
reduce spending.
Such termination may occur at any time after
such testing has begun and before completion of
the testing.
(4) Evaluation.--
(A) In general.--The Secretary shall conduct
an evaluation of each model tested under this
subsection. Such evaluation shall include an
analysis of--
(i) the quality of care furnished
under the model, including the
measurement of patient-level outcomes
and patient-centeredness criteria
determined appropriate by the
Secretary; and
(ii) the changes in spending under
the applicable titles by reason of the
model.
(B) Information.--The Secretary shall make
the results of each evaluation under this
paragraph available to the public in a timely
fashion and may establish requirements for
States and other entities participating in the
testing of models under this section to collect
and report information that the Secretary
determines is necessary to monitor and evaluate
such models.
(C) Measure selection.--To the extent
feasible, the Secretary shall select measures
under this paragraph that reflect national
priorities for quality improvement and patient-
centered care consistent with the measures
described in 1890(b)(7)(B).
(c) Expansion of Models (Phase II).--Taking into account the
evaluation under subsection (b)(4), the Secretary may, through
rulemaking, expand (including implementation on a nationwide
basis) the duration and the scope of a model that is being
tested under subsection (b) or a demonstration project under
section 1866C, to the extent determined appropriate by the
Secretary, if--
(1) the Secretary determines that such expansion is
expected to--
(A) reduce spending under applicable title
without reducing the quality of care; or
(B) improve the quality of patient care
without increasing spending;
(2) the Chief Actuary of the Centers for Medicare &
Medicaid Services certifies that such expansion would
reduce (or would not result in any increase in) net
program spending under applicable titles; and
(3) the Secretary determines that such expansion
would not deny or limit the coverage or provision of
benefits under the applicable title for applicable
individuals.
In determining which models or demonstration projects to expand
under the preceding sentence, the Secretary shall focus on
models and demonstration projects that improve the quality of
patient care and reduce spending.
(d) Implementation.--
(1) Waiver authority.--The Secretary may waive such
requirements of titles XI and XVIII and of sections
1902(a)(1), 1902(a)(13), 1903(m)(2)(A)(iii), and 1934
(other than subsections (b)(1)(A) and (c)(5) of such
section) as may be necessary solely for purposes of
carrying out this section with respect to testing
models described in subsection (b).
(2) Limitations on review.--There shall be no
administrative or judicial review under section 1869,
section 1878, or otherwise of--
(A) the selection of models for testing or
expansion under this section;
(B) the selection of organizations, sites, or
participants to test those models selected;
(C) the elements, parameters, scope, and
duration of such models for testing or
dissemination;
(D) determinations regarding budget
neutrality under subsection (b)(3);
(E) the termination or modification of the
design and implementation of a model under
subsection (b)(3)(B); and
(F) determinations about expansion of the
duration and scope of a model under subsection
(c), including the determination that a model
is not expected to meet criteria described in
paragraph (1) or (2) of such subsection.
(3) Administration.--Chapter 35 of title 44, United
States Code, shall not apply to the testing and
evaluation of models or expansion of such models under
this section.
(e) Application to CHIP.--The Center may carry out activities
under this section with respect to title XXI in the same manner
as provided under this section with respect to the program
under the applicable titles.
(f) Funding.--
(1) In general.--There are appropriated, from amounts
in the Treasury not otherwise appropriated--
(A) $5,000,000 for the design,
implementation, and evaluation of models under
subsection (b) for fiscal year 2010;
(B) $10,000,000,000 for the activities
initiated under this section for the period of
fiscal years 2011 through 2019; and
(C) the amount described in subparagraph (B)
for the activities initiated under this section
for each subsequent 10-year fiscal period
(beginning with the 10-year fiscal period
beginning with fiscal year 2020).
Amounts appropriated under the preceding sentence shall
remain available until expended.
(2) Use of certain funds.--Out of amounts
appropriated under subparagraphs (B) and (C) of
paragraph (1), not less than $25,000,000 shall be made
available each such fiscal year to design, implement,
and evaluate models under subsection (b).
(g) Report to Congress.--Beginning in 2012, and not less than
once every other year thereafter, the Secretary shall submit to
Congress a report on activities under this section. Each such
report shall describe the models tested under subsection (b),
including the number of individuals described in subsection
(a)(4)(A)(i) and of individuals described in subsection
(a)(4)(A)(ii) participating in such models and payments made
under applicable titles for services on behalf of such
individuals, any models chosen for expansion under subsection
(c), and the results from evaluations under subsection (b)(4).
In addition, each such report shall provide such
recommendations as the Secretary determines are appropriate for
legislative action to facilitate the development and expansion
of successful payment models.
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part B--Supplementary Medical Insurance Benefits for the Aged and
Disabled
* * * * * * *
PAYMENT OF BENEFITS
Sec. 1833 . (a) Except as provided in section 1876, and
subject to the succeeding provisions of this section, there
shall be paid from the Federal Supplementary Medical Insurance
Trust Fund, in the case of each individual who is covered under
the insurance program established by this part and incurs
expenses for services with respect to which benefits are
payable under this part, amounts equal to--(1) in the case of
services described in section 1832(a)(1)--80 percent of the
reasonable charges for the services; except that (A) an
organization which provides medical and other health services
(or arranges for their availability) on a prepayment basis (and
either is sponsored by a union or employer, or does not
provide, or arrange for the provision of, any inpatient
hospital services) may elect to be paid 80 percent of the
reasonable cost of services for which payment may be made under
this part on behalf of individuals enrolled in such
organization in lieu of 80 percent of the reasonable charges
for such services if the organization undertakes to charge such
individuals no more than 20 percent of such reasonable cost
plus any amounts payable by them as a result of subsection (b),
(B) with respect to items and services described in section
1861(s)(10)(A), the amounts paid shall be 100 percent of the
reasonable charges for such items and services, (C) with
respect to expenses incurred for those physicians' services for
which payment may be made under this part that are described in
section 1862(a)(4), the amounts paid shall be subject to such
limitations as may be prescribed by regulations, (D) with
respect to clinical diagnostic laboratory tests for which
payment is made under this part (i)(I) on the basis of a fee
schedule under subsection (h)(1) (for tests furnished before
January 1, 2017) or section 1834(d)(1), the amount paid shall
be equal to 80 percent (or 100 percent, in the case of such
tests for which payment is made on an assignment-related basis)
of the lesser of the amount determined under such fee schedule,
the limitation amount for that test determined under subsection
(h)(4)(B), or the amount of the charges billed for the tests,
or (II) undersection 1834A (for tests furnished on or after
January1, 2017), the amount paid shall be equal to 80
percent(or 100 percent, in the case of such tests for
whichpayment is made on an assignment-related basis) ofthe
lesser of the amount determined under such sectionor the amount
of the charges billed for the tests, or (ii) for tests
furnished before January 1, 2017,on the basis of a negotiated
rate established under subsection (h)(6), the amount paid shall
be equal to 100 percent of such negotiated rate,,(E) with
respect to services furnished to individuals who have been
determined to have end stage renal disease, the amounts paid
shall be determined subject to the provisions of section
1881,(F) with respect to clinical social worker services under
section 1861(s)(2)(N), the amounts paid shall be 80 percent of
the lesser of (i) the actual charge for the services or (ii) 75
percent of the amount determined for payment of a psychologist
under clause (L),
(G) with respect to facility services
furnished in connection with a surgical
procedure specified pursuant to subsection
(i)(1)(A) and furnished to an individual in an
ambulatory surgical center described in such
subsection, for services furnished beginning
with the implementation date of a revised
payment system for such services in such
facilities specified in subsection (i)(2)(D),
the amounts paid shall be 80 percent of the
lesser of the actual charge for the services or
the amount determined by the Secretary under
such revised payment system,
(H) with respect to services of a certified
registered nurse anesthetist under section 1861(s)(11),
the amounts paid shall be 80 percent of the least of
the actual charge, the prevailing charge that would be
recognized (or, for services furnished on or after
January 1, 1992, the fee schedule amount provided under
section 1848) if the services had been performed by an
anesthesiologist, or the fee schedule for such services
established by the Secretary in accordance with
subsection (l), (I) with respect to covered items
(described in section 1834(a)(13)), the amounts paid
shall be the amounts described in section 1834(a)(1),
and(J) with respect to expenses incurred for
radiologist services (as defined in section
1834(b)(6)), subject to section 1848, the amounts paid
shall be 80 percent of the lesser of the actual charge
for the services or the amount provided under the fee
schedule established under section 1834(b), (K) with
respect to certified nurse-midwife services under
section 1861(s)(2)(L), the amounts paid shall be 80
percent of the lesser of the actual charge for the
services or the amount determined by a fee schedule
established by the Secretary for the purposes of this
subparagraph (but in no event shall such fee schedule
exceed 65 percent of the prevailing charge that would
be allowed for the same service performed by a
physician, or, for services furnished on or after
January 1, 1992, 65 percent (or 100 percent for
services furnished on or after January 1, 2011) of the
fee schedule amount provided under section 1848 for the
same service performed by a physician), (L) with
respect to qualified psychologist services under
section 1861(s)(2)(M), the amounts paid shall be 80
percent of the lesser of the actual charge for the
services or the amount determined by a fee schedule
established by the Secretary for the purposes of this
subparagraph, (M) with respect to prosthetic devices
and orthotics and prosthetics (as defined in section
1834(h)(4)), the amounts paid shall be the amounts
described in section 1834(h)(1), (N) with respect to
expenses incurred for physicians' services (as defined
in section 1848(j)(3)) other than personalized
prevention plan services (as defined in section
1861(hhh)(1)), the amounts paid shall be 80 percent of
the payment basis determined under section 1848(a)(1),
(O) with respect to services described in section
1861(s)(2)(K) (relating to services furnished by
physician assistants, nurse practitioners, or clinic
nurse specialists), the amounts paid shall be equal to
80 percent of (i) the lesser of the actual charge or 85
percent of the fee schedule amount provided under
section 1848, or (ii) in the case of services as an
assistant at surgery, the lesser of the actual charge
or 85 percent of the amount that would otherwise be
recognized if performed by a physician who is serving
as an assistant at surgery, (P) with respect to
surgical dressings, the amounts paid shall be the
amounts determined under section 1834(i), (Q) with
respect to items or services for which fee schedules
are established pursuant to section 1842(s), the
amounts paid shall be 80 percent of the lesser of the
actual charge or the fee schedule established in such
section, (R) with respect to ambulance services, (i)
the amounts paid shall be 80 percent of the lesser of
the actual charge for the services or the amount
determined by a fee schedule established by the
Secretary under section 1834(l) and (ii) with respect
to ambulance services described in section 1834(l)(8),
the amounts paid shall be the amounts determined under
section 1834(g) for outpatient critical access hospital
services, (S) with respect to drugs and biologicals
(including intravenous immune globulin (as defined in
section 1861(zz))) not paid on a cost or prospective
payment basis as otherwise provided in this part (other
than items and services described in subparagraph (B)),
the amounts paid shall be 80 percent of the lesser of
the actual charge or the payment amount established in
section 1842(o) (or, if applicable, under section 1847,
1847A, or 1847B), (T) with respect to medical nutrition
therapy services (as defined in section 1861(vv)), the
amount paid shall be 80 percent (or 100 percent if such
services are recommended with a grade of A or B by the
United States Preventive Services Task Force for any
indication or population and are appropriate for the
individual) of the lesser of the actual charge for the
services or 85 percent of the amount determined under
the fee schedule established under section 1848(b) for
the same services if furnished by a physician, (U) with
respect to facility fees described in section
1834(m)(2)(B), the amounts paid shall be 80 percent of
the lesser of the actual charge or the amounts
specified in such section, (V) notwithstanding
subparagraphs (I) (relating to durable medical
equipment), (M) (relating to prosthetic devices and
orthotics and prosthetics), and (Q) (relating to
1842(s) items), with respect to competitively priced
items and services (described in section 1847(a)(2))
that are furnished in a competitive area, the amounts
paid shall be the amounts described in section
1847(b)(5), (W) with respect to additional preventive
services (as defined in section 1861(ddd)(1)), the
amount paid shall be (i) in the case of such services
which are clinical diagnostic laboratory tests, the
amount determined under subparagraph (D) (if such
subparagraph were applied, by substituting ``100
percent'' for ``80 percent''), and (ii) in the case of
all other such services, 100 percent of the lesser of
the actual charge for the service or the amount
determined under a fee schedule established by the
Secretary for purposes of this subparagraph, (X) with
respect to personalized prevention plan services (as
defined in section 1861(hhh)(1)), the amount paid shall
be 100 percent of the lesser of the actual charge for
the services or the amount determined under the payment
basis determined under section 1848, (Y) with respect
to preventive services described in subparagraphs (A)
and (B) of section 1861(ddd)(3) that are appropriate
for the individual and, in the case of such services
described in subparagraph (A), are recommended with a
grade of A or B by the United States Preventive
Services Task Force for any indication or population,
the amount paid shall be 100 percent of (i) except as
provided in clause (ii), the lesser of the actual
charge for the services or the amount determined under
the fee schedule that applies to such services under
this part, and (ii) in the case of such services that
are covered OPD services (as defined in subsection
(t)(1)(B)), the amount determined under subsection (t),
(Z) with respect to Federally qualified health center
services for which payment is made under section
1834(o), the amounts paid shall be 80 percent of the
lesser of the actual charge or the amount determined
under such section, (AA) with respect to an applicable
disposable device (as defined in paragraph (2) of
section 1834(s)) furnished to an individual pursuant to
paragraph (1) of such section, the amount paid shall be
equal to 80 percent of the lesser of the actual charge
or the amount determined under paragraph (3) of such
section, [and (BB)] (BB) with respect to home infusion
therapy, the amount paid shall be an amount equal to 80
percent of the lesser of the actual charge for the
services or the amount determined under section
1834(u), and (CC) with respect to opioid use disorder
treatment services furnished during an episode of care,
the amount paid shall be equal to the amount payable
under section 1834(w) less any copayment required as
specified by the Secretary ;
(2) in the case of services described in section
1832(a)(2) (except those services described in
subparagraphs (C), (D), (E), (F), (G), (H), and (I) of
such section and unless otherwise specified in section
1881)--
(A) with respect to home health services
(other than a covered osteoporosis drug) (as
defined in section 1861(kk)), the amount
determined under the prospective payment system
under section 1895;
(B) with respect to other items and services
(except those described in subparagraph (C),
(D), or (E) of this paragraph and except as may
be provided in section 1886 or section
1888(e)(9))--
(i) furnished before January 1, 1999,
the lesser of--
(I) the reasonable cost of
such services, as determined
under section 1861(v), or
(II) the customary charges
with respect to such
services,--less the amount a
provider may charge as
described in clause (ii) of
section 1866(a)(2)(A), but in
no case may the payment for
such other services exceed 80
percent of such reasonable
cost, or
(ii) if such services are furnished
before January 1, 1999, by a public
provider of services, or by another
provider which demonstrates to the
satisfaction of the Secretary that a
significant portion of its patients are
low-income (and requests that payment
be made under this clause), free of
charge or at nominal charges to the
public, 80 percent of the amount
determined in accordance with section
1814(b)(2), or
(iii) if such services are furnished
on or after January 1, 1999, the amount
determined under subsection (t), or
(iv) if (and for so long as) the
conditions described in section
1814(b)(3) are met, the amounts
determined under the reimbursement
system described in such section;
(C) with respect to services described in the
second sentence of section 1861(p), 80 percent
of the reasonable charges for such services;
(D) with respect to clinical diagnostic
laboratory tests for which payment is made
under this part (i)(I)on the basis of a fee
schedule determined under subsection(h)(1) (for
tests furnished before January 1, 2017) or
section 1834(d)(1), the amount paid shall be
equal to 80 percent (or 100 percent, in the
case of such tests for which payment is made on
an assignment-related basis or to a provider
having an agreement under section 1866) of the
lesser of the amount determined under such fee
schedule, the limitation amount for that test
determined under subsection (h)(4)(B), or the
amount of the charges billed for the tests, or
(II) under section 1834A (for tests furnished
on or after January 1, 2017), the amount paid
shall be equal to 80 percent (or 100 percent,
in the case of such tests for which payment is
made on an assignment-related basis or to a
provider having an agreement under section
1866) of the lesser of the amount determined
under such section or the amount of the charges
billed for the tests, or (ii) for tests
furnished before January 1, 2017, on the basis
of a negotiated rate established under
subsection (h)(6), the amount paid shall be
equal to 100 percent of such negotiated rate
for such tests;
(E) with respect to--
(i) outpatient hospital radiology
services (including diagnostic and
therapeutic radiology, nuclear medicine
and CAT scan procedures, magnetic
resonance imaging, and ultrasound and
other imaging services, but excluding
screening mammography and, for services
furnished on or after January 1, 2005,
diagnostic mammography), and
(ii) effective for procedures
performed on or after October 1, 1989,
diagnostic procedures (as defined by
the Secretary) described in section
1861(s)(3) (other than diagnostic x-ray
tests and diagnostic laboratory tests),
the amount determined under subsection (n) or,
for services or procedures performed on or
after January 1, 1999, subsection (t);
(F) with respect to a covered osteoporosis
drug (as defined in section 1861(kk)) furnished
by a home health agency, 80 percent of the
reasonable cost of such service, as determined
under section 1861(v);
(G) with respect to items and services
described in section 1861(s)(10)(A), the lesser
of--
(i) the reasonable cost of such
services, as determined under section
1861(v), or
(ii) the customary charges with
respect to such services; and
(H) with respect to personalized prevention
plan services (as defined in section
1861(hhh)(1)) furnished by an outpatient
department of a hospital, the amount determined
under paragraph (1)(X),
or, if such services are furnished by a public
provider of services, or by another provider
which demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low-income (and requests that
payment be made under this provision), free of
charge or at nominal charges to the public, the
amount determined in accordance with section
1814(b)(2);
(3) in the case of services described in section
1832(a)(2)(D)--
(A) except as provided in subparagraph (B),
the costs which are reasonable and related to
the cost of furnishing such services or which
are based on such other tests of reasonableness
as the Secretary may prescribe in regulations,
including those authorized under section
1861(v)(1)(A), less the amount a provider may
charge as described in clause (ii) of section
1866(a)(2)(A), but in no case may the payment
for such services (other than for items and
services described in section 1861(s)(10)(A))
exceed 80 percent of such costs; or
(B) with respect to the services described in
clause (ii) of section 1832(a)(2)(D) that are
furnished to an individual enrolled with a MA
plan under part C pursuant to a written
agreement described in section 1853(a)(4), the
amount (if any) by which--
(i) the amount of payment that would
have otherwise been provided (I) under
subparagraph (A) (calculated as if
``100 percent'' were substituted for
``80 percent'' in such subparagraph)
for such services if the individual had
not been so enrolled, or (II) in the
case of such services furnished on or
after the implementation date of the
prospective payment system under
section 1834(o), under such section
(calculated as if ``100 percent'' were
substituted for ``80 percent'' in such
section) for such services if the
individual had not been so enrolled;
exceeds
(ii) the amount of the payments
received under such written agreement
for such services (not including any
financial incentives provided for in
such agreement such as risk pool
payments, bonuses, or withholds),
less the amount the federally qualified health
center may charge as described in section
1857(e)(3)(B);
(4) in the case of facility services described in
section 1832(a)(2)(F), and outpatient hospital facility
services furnished in connection with surgical
procedures specified by the Secretary pursuant to
section 1833(i)(1)(A), the applicable amount as
determined under paragraph (2) or (3) of subsection (i)
or subsection (t);
(5) in the case of covered items (described in
section 1834(a)(13)) the amounts described in section
1834(a)(1);
(6) in the case of outpatient critical access
hospital services, the amounts described in section
1834(g);
(7) in the case of prosthetic devices and orthotics
and prosthetics (as described in section 1834(h)(4)),
the amounts described in section 1834(h);
(8) in the case of--
(A) outpatient physical therapy services,
outpatient speech-language pathology services,
and outpatient occupational therapy services
furnished--
(i) by a rehabilitation agency,
public health agency, clinic,
comprehensive outpatient rehabilitation
facility, or skilled nursing facility,
(ii) by a home health agency to an
individual who is not homebound, or
(iii) by another entity under an
arrangement with an entity described in
clause (i) or (ii); and
(B) outpatient physical therapy services,
outpatient speech-language pathology services,
and outpatient occupational therapy services
furnished--
(i) by a hospital to an outpatient or
to a hospital inpatient who is entitled
to benefits under part A but has
exhausted benefits for inpatient
hospital services during a spell of
illness or is not so entitled to
benefits under part A, or
(ii) by another entity under an
arrangement with a hospital described
in clause (i),
the amounts described in section 1834(k); and
(9) in the case of services described in section
1832(a)(2)(E) that are not described in paragraph (8),
the amounts described in section 1834(k).
Paragraph (3)(A) shall not apply to Federally
qualified health center services furnished on or after
the implementation date of the prospective payment
system under section 1834(0).
(b) Before applying subsection (a) with respect to expenses
incurred by an individual during any calendar year, the total
amount of the expenses incurred by such individual during such
year (which would, except for this subsection, constitute
incurred expenses from which benefits payable under subsection
(a) are determinable) shall be reduced by a deductible of $75
for calendar years before 1991, $100 for 1991 through 2004,
$110 for 2005, and for a subsequent year the amount of such
deductible for the previous year increased by the annual
percentage increase in the monthly actuarial rate under section
1839(a)(1) ending with such subsequent year (rounded to the
nearest $1); except that (1) such total amount shall not
include expenses incurred for preventive services described in
subparagraph (A) of section 1861(ddd)(3) that are recommended
with a grade of A or B by the United States Preventive Services
Task Force for any indication or population and are appropriate
for the individual., (2) such deductible shall not apply with
respect to home health services (other than a covered
osteoporosis drug (as defined in section 1861(kk))), (3) such
deductible shall not apply with respect to clinical diagnostic
laboratory tests for which payment is made under this part (A)
under subsection (a)(1)(D)(i) or (a)(2)(D)(i) on an assignment-
related basis, or to a provider having an agreement under
section 1866, or (B) for tests furnished before January 1,
2017,on the basis of a negotiated rate determined under
subsection (h)(6), (4) such deductible shall not apply to
Federally qualified health center services, (5) such deductible
shall not apply with respect to screening mammography (as
described in section 1861(jj)), (6) such deductible shall not
apply with respect to screening pap smear and screening pelvic
exam (as described in section 1861(nn)), (7) such deductible
shall not apply with respect to ultrasound screening for
abdominal aortic aneurysm (as defined in section 1861(bbb)),
(8) such deductible shall not apply with respect to colorectal
cancer screening tests (as described in section 1861(pp)(1)),
(9) such deductible shall not apply with respect to an initial
preventive physical examination (as defined in section
1861(ww)), and (10) such deductible shall not apply with
respect to personalized prevention plan services (as defined in
section 1861(hhh)(1)). The total amount of the expenses
incurred by an individual as determined under the preceding
sentence shall, after the reduction specified in such sentence,
be further reduced by an amount equal to the expenses incurred
for the first three pints of whole blood (or equivalent
quantities of packed red blood cells, as defined under
regulations) furnished to the individual during the calendar
year, except that such deductible for such blood shall in
accordance with regulations be appropriately reduced to the
extent that there has been a replacement of such blood (or
equivalent quantities of packed red blood cells, as so
defined); and for such purposes blood (or equivalent quantities
of packed red blood cells, as so defined) furnished such
individual shall be deemed replaced when the institution or
other person furnishing such blood (or such equivalent
quantities of packed red blood cells, as so defined) is given
one pint of blood for each pint of blood (or equivalent
quantities of packed red blood cells, as so defined) furnished
such individual with respect to which a deduction is made under
this sentence. The deductible under the previous sentence for
blood or blood cells furnished an individual in a year shall be
reduced to the extent that a deductible has been imposed under
section 1813(a)(2) to blood or blood cells furnished the
individual in the year. Paragraph (1) of the first sentence of
this subsection shall apply with respect to a colorectal cancer
screening test regardless of the code that is billed for the
establishment of a diagnosis as a result of the test, or for
the removal of tissue or other matter or other procedure that
is furnished in connection with, as a result of, and in the
same clinical encounter as the screening test.
(c)(1) Notwithstanding any other provision of this part, with
respect to expenses incurred in a calendar year in connection
with the treatment of mental, psychoneurotic, and personality
disorders of an individual who is not an inpatient of a
hospital at the time such expenses are incurred, there shall be
considered as incurred expenses for purposes of subsections (a)
and (b)--
(A) for expenses incurred in years prior to 2010,
only 62\1/2\ percent of such expenses;
(B) for expenses incurred in 2010 or 2011, only 68\3/
4\ percent of such expenses;
(C) for expenses incurred in 2012, only 75 percent of
such expenses;
(D) for expenses incurred in 2013, only 81\1/4\
percent of such expenses; and
(E) for expenses incurred in 2014 or any subsequent
calendar year, 100 percent of such expenses.
(2) For purposes of subparagraphs (A) through (D) of
paragraph (1), the term ``treatment'' does not include brief
office visits (as defined by the Secretary) for the sole
purpose of monitoring or changing drug prescriptions used in
the treatment of such disorders or partial hospitalization
services that are not directly provided by a physician
(d) No payment may be made under this part with respect to
any services furnished an individual to the extent that such
individual is entitled (or would be entitled except for section
1813) to have payment made with respect to such services under
part A.
(e) No payment shall be made to any provider of services or
other person under this part unless there has been furnished
such information as may be necessary in order to determine the
amounts due such provider or other person under this part for
the period with respect to which the amounts are being paid or
for any prior period.
(f) In establishing limits under subsection (a) on payment
for rural health clinic services provided by rural health
clinics (other than such clinics in hospitals with less than 50
beds), the Secretary shall establish such limit, for services
provided--
(1) in 1988, after March 31, at $46 per visit, and
(2) in a subsequent year, at the limit established
under this subsection for the previous year increased
by the percentage increase in the MEI (as defined in
section 1842(i)(3)) applicable to primary care services
(as defined in section 1842(i)(4)) furnished as of the
first day of that year.
(g)(1)(A) Subject to paragraphs (4) and (5), in the case of
physical therapy services of the type described in section
1861(p) and speech-language pathology services of the type
described in such section through the application of section
1861(ll)(2), but (except as provided in paragraph (6)) not
described in subsection (a)(8)(B), and physical therapy
services and speech-language pathology services of such type
which are furnished by a physician or as incident to
physicians' services, with respect to expenses incurred in any
calendar year, no more than the amount specified in paragraph
(2) for the year shall be considered as incurred expenses for
purposes of subsections (a) and (b). The preceding sentence
shall not apply to expenses incurred with respect to services
furnished after December 31, 2017.
(B) With respect to services furnished during 2018 or a
subsequent year, in the case of physical therapy services of
the type described in section 1861(p), speech-language
pathology services of the type described in such section
through the application of section 1861(ll)(2), and physical
therapy services and speech-language pathology services of such
type which are furnished by a physician or as incident to
physicians' services, with respect to expenses incurred in any
calendar year, any amount that is more than the amount
specified in paragraph (2) for the year shall not be considered
as incurred expenses for purposes of subsections (a) and (b)
unless the applicable requirements of paragraph (7) are met.
(2) The amount specified in this paragraph--
(A) for 1999, 2000, and 2001, is $1,500, and
(B) for a subsequent year is the amount specified in
this paragraph for the preceding year increased by the
percentage increase in the MEI (as defined in section
1842(i)(3)) for such subsequent year;
except that if an increase under subparagraph (B) for a year is
not a multiple of $10, it shall be rounded to the nearest
multiple of $10.
(3)(A) Subject to paragraphs (4) and (5), in the case of
occupational therapy services (of the type that are described
in section 1861(p) (but (except as provided in paragraph (6))
not described in subsection (a)(8)(B)) through the operation of
section 1861(g) and of such type which are furnished by a
physician or as incident to physicians' services), with respect
to expenses incurred in any calendar year, no more than the
amount specified in paragraph (2) for the year shall be
considered as incurred expenses for purposes of subsections (a)
and (b). The preceding sentence shall not apply to expenses
incurred with respect to services furnished after December 31,
2017.
(B) With respect to services furnished during 2018 or a
subsequent year, in the case of occupational therapy services
(of the type that are described in section 1861(p) through the
operation of section 1861(g) and of such type which are
furnished by a physician or as incident to physicians'
services), with respect to expenses incurred in any calendar
year, any amount that is more than the amount specified in
paragraph (2) for the year shall not be considered as incurred
expenses for purposes of subsections (a) and (b) unless the
applicable requirements of paragraph (7) are met.
(4) This subsection shall not apply to expenses incurred with
respect to services furnished during 2000, 2001, 2002, 2004,
and 2005.
(5)(A) With respect to expenses incurred during the period
beginning on January 1, 2006, and ending on December 31, 2017,
for services, the Secretary shall implement a process under
which an individual enrolled under this part may, upon request
of the individual or a person on behalf of the individual,
obtain an exception from the uniform dollar limitation
specified in paragraph (2), for services described in
paragraphs (1) and (3) if the provision of such services is
determined to be medically necessary and if the requirement of
subparagraph (B) is met. Under such process, if the Secretary
does not make a decision on such a request for an exception
within 10 business days of the date of the Secretary's receipt
of the request made in accordance with such requirement, the
Secretary shall be deemed to have found the services to be
medically necessary.
(B) In the case of outpatient therapy services for which an
exception is requested under the first sentence of subparagraph
(A), the claim for such services shall contain an appropriate
modifier (such as the KX modifier used as of the date of the
enactment of this subparagraph) indicating that such services
are medically necessary as justified by appropriate
documentation in the medical record involved.
(C)(i) In applying this paragraph with respect to a request
for an exception with respect to expenses that would be
incurred for outpatient therapy services (including services
described in subsection (a)(8)(B)) that would exceed the
threshold described in clause (ii) for a year, the request for
such an exception, for services furnished on or after October
1, 2012, shall be subject to a manual medical review process
that, subject to subparagraph (E), is similar to the manual
medical review process used for certain exceptions under this
paragraph in 2006.
(ii) The threshold under this clause for a year is $3,700.
Such threshold shall be applied separately--
(I) for physical therapy services and speech-language
pathology services; and
(II) for occupational therapy services.
(E)(i) In place of the manual medical review process under
subparagraph (C)(i), the Secretary shall implement a process
for medical review under this subparagraph under which the
Secretary shall identify and conduct medical review for
services described in subparagraph (C)(i) furnished by a
provider of services or supplier (in this subparagraph referred
to as a ``therapy provider'') using such factors as the
Secretary determines to be appropriate.
(ii) Such factors may include the following:
(I) The therapy provider has had a high claims denial
percentage for therapy services under this part or is
less compliant with applicable requirements under this
title.
(II) The therapy provider has a pattern of billing
for therapy services under this part that is aberrant
compared to peers or otherwise has questionable billing
practices for such services, such as billing medically
unlikely units of services in a day.
(III) The therapy provider is newly enrolled under
this title or has not previously furnished therapy
services under this part.
(IV) The services are furnished to treat a type of
medical condition.
(V) The therapy provider is part of group that
includes another therapy provider identified using the
factors determined under this subparagraph.
(iii) For purposes of carrying out this subparagraph, the
Secretary shall provide for the transfer, from the Federal
Supplementary Medical Insurance Trust Fund under section 1841,
of $5,000,000 to the Centers for Medicare & Medicaid Services
Program Management Account for fiscal years 2015 and 2016, to
remain available until expended. Such funds may not be used by
a contractor under section 1893(h) for medical reviews under
this subparagraph.
(iv) The targeted review process under this subparagraph
shall not apply to services for which expenses are incurred
beyond the period for which the exceptions process under
subparagraph (A) is implemented, except as such process is
applied under paragraph (7)(B).
(6)(A) In applying paragraphs (1) and (3) to services
furnished during the period beginning not later than October 1,
2012, and ending on December 31, 2017, the exclusion of
services described in subsection (a)(8)(B) from the uniform
dollar limitation specified in paragraph (2) shall not apply to
such services furnished during 2012 through 2017.
(B)(i) With respect to outpatient therapy services furnished
beginning on or after January 1, 2013, and before January 1,
2014, for which payment is made under section 1834(g), the
Secretary shall count toward the uniform dollar limitations
described in paragraphs (1) and (3) and the threshold described
in paragraph (5)(C) the amount that would be payable under this
part if such services were paid under section 1834(k)(1)(B)
instead of being paid under section 1834(g).
(ii) Nothing in clause (i) shall be construed as changing the
method of payment for outpatient therapy services under section
1834(g).
(7) For purposes of paragraphs (1)(B) and (3)(B), with
respect to services described in such paragraphs, the
requirements described in this paragraph are as follows:
(A) Inclusion of appropriate modifier.--The claim for
such services contains an appropriate modifier (such as
the KX modifier described in paragraph (5)(B))
indicating that such services are medically necessary
as justified by appropriate documentation in the
medical record involved.
(B) Targeted medical review for certain services
above threshold.--
(i) In general.--In the case where expenses
that would be incurred for such services would
exceed the threshold described in clause (ii)
for the year, such services shall be subject to
the process for medical review implemented
under paragraph (5)(E).
(ii) Threshold.--The threshold under this
clause for--
(I) a year before 2028, is $3,000;
(II) 2028, is the amount specified in
subclause (I) increased by the
percentage increase in the MEI (as
defined in section 1842(i)(3)) for
2028; and
(III) a subsequent year, is the
amount specified in this clause for the
preceding year increased by the
percentage increase in the MEI (as
defined in section 1842(i)(3)) for such
subsequent year;
except that if an increase under subclause (II)
or (III) for a year is not a multiple of $10,
it shall be rounded to the nearest multiple of
$10.
(iii) Application.--The threshold under
clause (ii) shall be applied separately--
(I) for physical therapy services and
speech-language pathology services; and
(II) for occupational therapy
services.
(iv) Funding.--For purposes of carrying out
this subparagraph, the Secretary shall provide
for the transfer, from the Federal
Supplementary Medical Insurance Trust Fund
under section 1841 to the Centers for Medicare
& Medicaid Services Program Management Account,
of $5,000,000 for each fiscal year beginning
with fiscal year 2018, to remain available
until expended. Such funds may not be used by a
contractor under section 1893(h) for medical
reviews under this subparagraph.
(8) With respect to services furnished on or after January 1,
2013, where payment may not be made as a result of application
of paragraphs (1) and (3), section 1879 shall apply in the same
manner as such section applies to a denial that is made by
reason of section 1862(a)(1).
(h)(1)(A) Subject to section 1834(d)(1), the Secretary shall
establish fee schedules for clinical diagnostic laboratory
tests (including prostate cancer screening tests under section
1861(oo) consisting of prostate-specific antigen blood tests)
for which payment is made under this part, other than such
tests performed by a provider of services for an inpatient of
such provider.
(B) In the case of clinical diagnostic laboratory tests
performed by a physician or by a laboratory (other than tests
performed by a qualified hospital laboratory (as defined in
subparagraph (D)) for outpatients of such hospital), the fee
schedules established under subparagraph (A) shall be
established on a regional, statewide, or carrier service area
basis (as the Secretary may determine to be appropriate) for
tests furnished on or after July 1, 1984.
(C) In the case of clinical diagnostic laboratory tests
performed by a qualified hospital laboratory (as defined in
subparagraph (D)) for outpatients of such hospital, the fee
schedules established under subparagraph (A) shall be
established on a regional, statewide, or carrier service area
basis (as the Secretary may determine to be appropriate) for
tests furnished on or after July 1, 1984.
(D) In this subsection, the term ``qualified hospital
laboratory'' means a hospital laboratory, in a sole community
hospital (as defined in section 1886(d)(5)(D)(iii)), which
provides some clinical diagnostic laboratory tests 24 hours a
day in order to serve a hospital emergency room which is
available to provide services 24 hours a day and 7 days a week.
(2)(A)(i) Except as provided in clause (v), subparagraph (B),
and paragraph (4), the Secretary shall set the fee schedules at
60 percent (or, in the case of a test performed by a qualified
hospital laboratory (as defined in paragraph (1)(D)) for
outpatients of such hospital, 62 percent) of the prevailing
charge level determined pursuant to the third and fourth
sentences of section 1842(b)(3) for similar clinical diagnostic
laboratory tests for the applicable region, State, or area for
the 12-month period beginning July 1, 1984, adjusted annually
(to become effective on January 1 of each year) by, subject to
clause (iv), a percentage increase or decrease equal to the
percentage increase or decrease in the Consumer Price Index for
All Urban Consumers (United States city average) minus, for
each of the years 2009 and 2010, 0.5 percentage points, and,
for tests furnished before the dateof enactment of section
1834A, subject to such other adjustments as the Secretary
determines are justified by technological changes.
(ii) Notwithstanding clause (i)--
(I) any change in the fee schedules which would have
become effective under this subsection for tests
furnished on or after January 1, 1988, shall not be
effective for tests furnished during the 3-month period
beginning on January 1, 1988,
(II) the Secretary shall not adjust the fee schedules
under clause (i) to take into account any increase in
the consumer price index for 1988,
(III) the annual adjustment in the fee schedules
determined under clause (i) for each of the years 1991,
1992, and 1993 shall be 2 percent, and
(IV) the annual adjustment in the fee schedules
determined under clause (i) for each of the years 1994
and 1995, 1998 through 2002, and 2004 through 2008
shall be 0 percent.
(iii) In establishing fee schedules under clause (i) with
respect to automated tests and tests (other than cytopathology
tests) which before July 1, 1984, the Secretary made subject to
a limit based on lowest charge levels under the sixth sentence
of section 1842(b)(3) performed after March 31, 1988, the
Secretary shall reduce by 8.3 percent the fee schedules
otherwise established for 1988, and such reduced fee schedules
shall serve as the base for 1989 and subsequent years.
(iv) After determining the adjustment to the fee schedules
under clause (i), the Secretary shall reduce such adjustment--
(I) for 2011 and each subsequent year, by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II); and
(II) for each of 2011 through 2015, by 1.75
percentage points.
Subclause (I) shall not apply in a year where the adjustment to
the fee schedules determined under clause (i) is 0.0 or a
percentage decrease for a year. The application of the
productivity adjustment under subclause (I) shall not result in
an adjustment to the fee schedules under clause (i) being less
than 0.0 for a year. The application of subclause (II) may
result in an adjustment to the fee schedules under clause (i)
being less than 0.0 for a year, and may result in payment rates
for a year being less than such payment rates for the preceding
year.
(v) The Secretary shall reduce by 2 percent the fee schedules
otherwise determined under clause (i) for 2013, and such
reduced fee schedules shall serve as the base for 2014 and
subsequent years.
(B) The Secretary may make further adjustments or exceptions
to the fee schedules to assure adequate reimbursement of (i)
emergency laboratory tests needed for the provision of bona
fide emergency services, and (ii) certain low volume high-cost
tests where highly sophisticated equipment or extremely skilled
personnel are necessary to assure quality.
(3) In addition to the amounts provided under the fee
schedules (for tests furnished before January 1, 2017)or under
section 1834A (for tests furnished on or afterJanuary 1, 2017),
subject to subsection (b)(5) of such section, the Secretary
shall provide for and establish (A) a nominal fee to cover the
appropriate costs in collecting the sample on which a clinical
diagnostic laboratory test was performed and for which payment
is made under this part, except that not more than one such fee
may be provided under this paragraph with respect to samples
collected in the same encounter, and (B) a fee to cover the
transportation and personnel expenses for trained personnel to
travel to the location of an individual to collect the sample,
except that such a fee may be provided only with respect to an
individual who is homebound or an inpatient in an inpatient
facility (other than a hospital). In establishing a fee to
cover the transportation and personnel expenses for trained
personnel to travel to the location of an individual to collect
a sample, the Secretary shall provide a method for computing
the fee based on the number of miles traveled and the personnel
costs associated with the collection of each individual sample,
but the Secretary shall only be required to apply such method
in the case of tests furnished during the period beginning on
April 1, 1989, and ending on December 31, 1990, by a laboratory
that establishes to the satisfaction of the Secretary (based on
data for the 12-month period ending June 30, 1988) that (i) the
laboratory is dependent upon payments under this title for at
least 80 percent of its collected revenues for clinical
diagnostic laboratory tests, (ii) at least 85 percent of its
gross revenues for such tests are attributable to tests
performed with respect to individuals who are homebound or who
are residents in a nursing facility, and (iii) the laboratory
provided such tests for residents in nursing facilities
representing at least 20 percent of the number of such
facilities in the State in which the laboratory is located.
(4)(A) In establishing any fee schedule under this
subsection, the Secretary may provide for an adjustment to take
into account, with respect to the portion of the expenses of
clinical diagnostic laboratory tests attributable to wages, the
relative difference between a region's or local area's wage
rates and the wage rate presumed in the data on which the
schedule is based.
(B) For purposes of subsections (a)(1)(D)(i) and
(a)(2)(D)(i), the limitation amount for a clinical diagnostic
laboratory test performed--
(i) on or after July 1, 1986, and before April 1,
1988, is equal to 115 percent of the median of all the
fee schedules established for that test for that
laboratory setting under paragraph (1),
(ii) after March 31, 1988, and before January 1,
1990, is equal to the median of all the fee schedules
established for that test for that laboratory setting
under paragraph (1),
(iii) after December 31, 1989, and before January 1,
1991, is equal to 93 percent of the median of all the
fee schedules established for that test for that
laboratory setting under paragraph (1),
(iv) after December 31, 1990, and before January 1,
1994, is equal to 88 percent of such median,
(v) after December 31, 1993, and before January 1,
1995, is equal to 84 percent of such median,
(vi) after December 31, 1994, and before January 1,
1996, is equal to 80 percent of such median,
(vii) after December 31, 1995, and before January 1,
1998, is equal to 76 percent of such median, and
(viii) after December 31, 1997, is equal to 74
percent of such median (or 100 percent of such median
in the case of a clinical diagnostic laboratory test
performed on or after January 1, 2001, that the
Secretary determines is a new test for which no
limitation amount has previously been established under
this subparagraph).
(5)(A) In the case of a bill or request for payment for a
clinical diagnostic laboratory test for which payment may
otherwise be made under this part on an assignment-related
basis or under a provider agreement under section 1866, payment
may be made only to the person or entity which performed or
supervised the performance of such test; except that--
(i) if a physician performed or supervised the
performance of such test, payment may be made to
another physician with whom he shares his practice,
(ii) in the case of a test performed at the request
of a laboratory by another laboratory, payment may be
made to the referring laboratory but only if--
(I) the referring laboratory is located in,
or is part of, a rural hospital,
(II) the referring laboratory is wholly owned
by the entity performing such test, the
referring laboratory wholly owns the entity
performing such test, or both the referring
laboratory and the entity performing such test
are wholly-owned by a third entity, or
(III) not more than 30 percent of the
clinical diagnostic laboratory tests for which
such referring laboratory (but not including a
laboratory described in subclause (II)),
receives requests for testing during the year
in which the test is performed are performed by
another laboratory, and
(iii) in the case of a clinical diagnostic laboratory
test provided under an arrangement (as defined in
section 1861(w)(1)) made by a hospital, critical access
hospital, or skilled nursing facility, payment shall be
made to the hospital or skilled nursing facility.
(B) In the case of such a bill or request for payment for a
clinical diagnostic laboratory test for which payment may
otherwise be made under this part, and which is not described
in subparagraph (A), payment may be made to the beneficiary
only on the basis of the itemized bill of the person or entity
which performed or supervised the performance of the test.
(C) Payment for a clinical diagnostic laboratory test,
including a test performed in a physician's office but
excluding a test performed by a rural health clinic may only be
made on an assignment-related basis or to a provider of
services with an agreement in effect under section 1866.
(D) A person may not bill for a clinical diagnostic
laboratory test, including a test performed in a physician's
office but excluding a test performed by a rural health clinic,
other than on an assignment-related basis. If a person
knowingly and willfully and on a repeated basis bills for a
clinical diagnostic laboratory test in violation of the
previous sentence, the Secretary may apply sanctions against
the person in the same manner as the Secretary may apply
sanctions against a physician in accordance with paragraph (2)
of section 1842(j) in the same manner such paragraphs apply
with respect to a physician. Paragraph (4) of such section
shall apply in this subparagraph in the same manner as such
paragraph applies to such section.
(6) For tests furnished before January 1, 2017, inthe case of
any diagnostic laboratory test payment for which is not made on
the basis of a fee schedule under paragraph (1), the Secretary
may establish a payment rate which is acceptable to the person
or entity performing the test and which would be considered the
full charge for such tests. Such negotiated rate shall be
limited to an amount not in excess of the total payment that
would have been made for the services in the absence of such
rate.
(7) Notwithstanding paragraphs (1) and (4)and section 1834A,
the Secretary shall establish a national minimum payment amount
under this part for a diagnostic or screening pap smear
laboratory test (including all cervical cancer screening
technologies that have been approved by the Food and Drug
Administration as a primary screening method for detection of
cervical cancer) equal to $14.60 for tests furnished in 2000.
For such tests furnished in subsequent years, such national
minimum payment amount shall be adjusted annually as provided
in paragraph (2).
(8)(A) The Secretary shall establish by regulation procedures
for determining the basis for, and amount of, payment under
this subsection for any clinical diagnostic laboratory test
with respect to which a new or substantially revised HCPCS code
is assigned on or after January 1, 2005 (in this paragraph
referred to as ``new tests'').
(B) Determinations under subparagraph (A) shall be made only
after the Secretary--
(i) makes available to the public (through an
Internet website and other appropriate mechanisms) a
list that includes any such test for which
establishment of a payment amount under this subsection
is being considered for a year;
(ii) on the same day such list is made available,
causes to have published in the Federal Register notice
of a meeting to receive comments and recommendations
(and data on which recommendations are based) from the
public on the appropriate basis under this subsection
for establishing payment amounts for the tests on such
list;
(iii) not less than 30 days after publication of such
notice convenes a meeting, that includes
representatives of officials of the Centers for
Medicare & Medicaid Services involved in determining
payment amounts, to receive such comments and
recommendations (and data on which the recommendations
are based);
(iv) taking into account the comments and
recommendations (and accompanying data) received at
such meeting, develops and makes available to the
public (through an Internet website and other
appropriate mechanisms) a list of proposed
determinations with respect to the appropriate basis
for establishing a payment amount under this subsection
for each such code, together with an explanation of the
reasons for each such determination, the data on which
the determinations are based, and a request for public
written comments on the proposed determination; and
(v) taking into account the comments received during
the public comment period, develops and makes available
to the public (through an Internet website and other
appropriate mechanisms) a list of final determinations
of the payment amounts for such tests under this
subsection, together with the rationale for each such
determination, the data on which the determinations are
based, and responses to comments and suggestions
received from the public.
(C) Under the procedures established pursuant to subparagraph
(A), the Secretary shall--
(i) set forth the criteria for making determinations
under subparagraph (A); and
(ii) make available to the public the data (other
than proprietary data) considered in making such
determinations.
(D) The Secretary may convene such further public meetings to
receive public comments on payment amounts for new tests under
this subsection as the Secretary deems appropriate.
(E) For purposes of this paragraph:
(i) The term ``HCPCS'' refers to the Health Care
Procedure Coding System.
(ii) A code shall be considered to be ``substantially
revised'' if there is a substantive change to the
definition of the test or procedure to which the code
applies (such as a new analyte or a new methodology for
measuring an existing analyte-specific test).
(9) Notwithstanding any other provision in this part, in the
case of any diagnostic laboratory test for HbA1c that is
labeled by the Food and Drug Administration for home use and is
furnished on or after April 1, 2008, the payment rate for such
test shall be the payment rate established under this part for
a glycated hemoglobin test (identified as of October 1, 2007,
by HCPCS code 83036 (and any succeeding codes)).
(i)(1) The Secretary shall, in consultation with appropriate
medical organizations--
(A) specify those surgical procedures which are
appropriately (when considered in terms of the proper
utilization of hospital inpatient facilities) performed
on an inpatient basis in a hospital but which also can
be performed safely on an ambulatory basis in an
ambulatory surgical center (meeting the standards
specified under section 1832(a)(2)(F)(i)), critical
access hospital, or hospital outpatient department, and
(B) specify those surgical procedures which are
appropriately (when considered in terms of the proper
utilization of hospital inpatient facilities) performed
on an inpatient basis in a hospital but which also can
be performed safely on an ambulatory basis in a
physician's office.
The lists of procedures established under subparagraphs (A) and
(B) shall be reviewed and updated not less often than every 2
years, in consultation with appropriate trade and professional
organizations.
(2)(A) For services furnished prior to the implementation of
the system described in subparagraph (D), subject to
subparagraph (E), the amount of payment to be made for facility
services furnished in connection with a surgical procedure
specified pursuant to paragraph (1)(A) and furnished to an
individual in an ambulatory surgical center described in such
paragraph shall be equal to 80 percent of a standard overhead
amount established by the Secretary (with respect to each such
procedure) on the basis of the Secretary's estimate of a fair
fee which--
(i) takes into account the costs incurred by such
centers, or classes of centers, generally in providing
services furnished in connection with the performance
of such procedure, as determined in accordance with a
survey (based upon a representative sample of
procedures and facilities) of the actual audited costs
incurred by such centers in providing such services,
(ii) takes such costs into account in such a manner
as will assure that the performance of the procedure in
such a center will result in substantially less amounts
paid under this title than would have been paid if the
procedure had been performed on an inpatient basis in a
hospital, and
(iii) in the case of insertion of an intraocular lens
during or subsequent to cataract surgery includes
payment which is reasonable and related to the cost of
acquiring the class of lens involved.
Each amount so established shall be reviewed and updated not
later than July 1, 1987, and annually thereafter to take
account of varying conditions in different areas.
(B) The amount of payment to be made under this part for
facility services furnished, in connection with a surgical
procedure specified pursuant to paragraph (1)(B), in a
physician's office shall be equal to 80 percent of a standard
overhead amount established by the Secretary (with respect to
each such procedure) on the basis of the Secretary's estimate
of a fair fee which--
(i) takes into account additional costs, not usually
included in the professional fee, incurred by
physicians in securing, maintaining, and staffing the
facilities and ancillary services appropriate for the
performance of such procedure in the physician's
office, and
(ii) takes such items into account in such a manner
which will assure that the performance of such
procedure in the physician's office will result in
substantially less amounts paid under this title than
would have been paid if the services had been furnished
on an inpatient basis in a hospital.
Each amount so established shall be reviewed and updated not
later than July 1, 1987, and annually thereafter to take
account of varying conditions in different areas.
(C)(i) Notwithstanding the second sentence of each of
subparagraphs (A) and (B), except as otherwise specified in
clauses (ii), (iii), and (iv), if the Secretary has not updated
amounts established under such subparagraphs or under
subparagraph (D), with respect to facility services furnished
during a fiscal year (beginning with fiscal year 1986 or a
calendar year (beginning with 2006)), such amounts shall be
increased by the percentage increase in the Consumer Price
Index for all urban consumers (U.S. city average) as estimated
by the Secretary for the 12-month period ending with the
midpoint of the year involved.
(ii) In each of the fiscal years 1998 through 2002, the
increase under this subparagraph shall be reduced (but not
below zero) by 2.0 percentage points.
(iii) In fiscal year 2004, beginning with April 1, 2004, the
increase under this subparagraph shall be the Consumer Price
Index for all urban consumers (U.S. city average) as estimated
by the Secretary for the 12-month period ending with March 31,
2003, minus 3.0 percentage points.
(iv) In fiscal year 2005, the last quarter of calendar year
2005, and each of calendar years 2006 through 2009, the
increase under this subparagraph shall be 0 percent.
(D)(i) Taking into account the recommendations in the report
under section 626(d) of Medicare Prescription Drug,
Improvement, and Modernization Act of 2003, the Secretary shall
implement a revised payment system for payment of surgical
services furnished in ambulatory surgical centers.
(ii) In the year the system described in clause (i) is
implemented, such system shall be designed to result in the
same aggregate amount of expenditures for such services as
would be made if this subparagraph did not apply, as estimated
by the Secretary and taking into account reduced expenditures
that would apply if subparagraph (E) were to continue to apply,
as estimated by the Secretary.
(iii) The Secretary shall implement the system described in
clause (i) for periods in a manner so that it is first
effective beginning on or after January 1, 2006, and not later
than January 1, 2008.
(iv) The Secretary may implement such system in a manner so
as to provide for a reduction in any annual update for failure
to report on quality measures in accordance with paragraph (7).
(v) In implementing the system described in clause
(i) for 2011 and each subsequent year, any annual
update under such system for the year, after
application of clause (iv), shall be reduced by the
productivity adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the preceding
sentence may result in such update being less than 0.0
for a year, and may result in payment rates under the
system described in clause (i) for a year being less
than such payment rates for the preceding year.
(vi) There shall be no administrative or judicial review
under section 1869, 1878, or otherwise, of the classification
system, the relative weights, payment amounts, and the
geographic adjustment factor, if any, under this subparagraph.
(E) With respect to surgical procedures furnished on or after
January 1, 2007, and before the effective date of the
implementation of a revised payment system under subparagraph
(D), if--
(i) the standard overhead amount under subparagraph
(A) for a facility service for such procedure, without
the application of any geographic adjustment, exceeds
(ii) the Medicare OPD fee schedule amount established
under the prospective payment system for hospital
outpatient department services under paragraph (3)(D)
of section 1833(t) for such service for such year,
determined without regard to geographic adjustment
under paragraph (2)(D) of such section,
the Secretary shall substitute under subparagraph (A) the
amount described in clause (ii) for the standard overhead
amount for such service referred to in clause (i).
(3)(A) The aggregate amount of the payments to be made under
this part for outpatient hospital facility services or critical
access hospital services furnished before January 1, 1999, in
connection with surgical procedures specified under paragraph
(1)(A) shall be equal to the lesser of--
(i) the amount determined with respect to such
services under subsection (a)(2)(B); or
(ii) the blend amount (described in subparagraph
(B)).
(B)(i) The blend amount for a cost reporting period is the
sum of--
(I) the cost proportion (as defined in clause
(ii)(I)) of the amount described in subparagraph
(A)(i), and
(II) the ASC proportion (as defined in clause
(ii)(II)) of the standard overhead amount payable with
respect to the same surgical procedure as if it were
provided in an ambulatory surgical center in the same
area, as determined under paragraph (2)(A), less the
amount a provider may charge as described in clause
(ii) of section 1866(a)(2)(A).
(ii) Subject to paragraph (4), in this paragraph:
(I) The term ``cost proportion'' means 75 percent for
cost reporting periods beginning in fiscal year 1988,
50 percent for portions of cost reporting periods
beginning on or after October 1, 1988, and ending on or
before December 31, 1990, and 42 percent for portions
of cost reporting periods beginning on or after January
1, 1991.
(II) The term ``ASC proportion'' means 25 percent for
cost reporting periods beginning in fiscal year 1988,
50 percent for portions of cost reporting periods
beginning on or after October 1, 1988, and ending on or
before December 31, 1990, and 58 percent for portions
of cost reporting periods beginning on or after January
1, 1991.
(4)(A) In the case of a hospital that--
(i) makes application to the Secretary and
demonstrates that it specializes in eye services or eye
and ear services (as determined by the Secretary),
(ii) receives more than 30 percent of its total
revenues from outpatient services, and
(iii) on October 1, 1987--
(I) was an eye specialty hospital or an eye
and ear specialty hospital, or
(II) was operated as an eye or eye and ear
unit (as defined in subparagraph (B)) of a
general acute care hospital which, on the date
of the application described in clause (i),
operates less than 20 percent of the beds that
the hospital operated on October 1, 1987, and
has sold or otherwise disposed of a substantial
portion of the hospital's other acute care
operations,
the cost proportion and ASC proportion in effect under
subclauses (I) and (II) of paragraph (3)(B)(ii) for cost
reporting periods beginning in fiscal year 1988 shall remain in
effect for cost reporting periods beginning on or after October
1, 1988, and before January 1, 1995.
(B) For purposes of this subparagraph (A)(iii)(II), the term
``eye or eye and ear unit'' means a physically separate or
distinct unit containing separate surgical suites devoted
solely to eye or eye and ear services.
(5)(A) The Secretary is authorized to provide by regulations
that in the case of a surgical procedure, specified by the
Secretary pursuant to paragraph (1)(A), performed in an
ambulatory surgical center described in such paragraph, there
shall be paid (in lieu of any amounts otherwise payable under
this part) with respect to the facility services furnished by
such center and with respect to all related services (including
physicians' services, laboratory, X-ray, and diagnostic
services) a single all-inclusive fee established pursuant to
subparagraph (B), if all parties furnishing all such services
agree to accept such fee (to be divided among the parties
involved in such manner as they shall have previously agreed
upon) as full payment for the services furnished.
(B) In implementing this paragraph, the Secretary shall
establish with respect to each surgical procedure specified
pursuant to paragraph (1)(A) the amount of the all-inclusive
fee for such procedure, taking into account such factors as may
be appropriate. The amount so established with respect to any
surgical procedure shall be reviewed periodically and may be
adjusted by the Secretary, when appropriate, to take account of
varying conditions in different areas.
(6) Any person, including a facility having an agreement
under section 1832(a)(2)(F)(i), who knowingly and willfully
presents, or causes to be presented, a bill or request for
payment, for an intraocular lens inserted during or subsequent
to cataract surgery for which payment may be made under
paragraph (2)(A)(iii), is subject to a civil money penalty of
not to exceed $2,000. The provisions of section 1128A (other
than subsections (a) and (b)) shall apply to a civil money
penalty under the previous sentence in the same manner as such
provisions apply to a penalty or proceeding under section
1128A(a).
(7)(A) For purposes of paragraph (2)(D)(iv), the Secretary
may provide, in the case of an ambulatory surgical center that
does not submit, to the Secretary in accordance with this
paragraph, data required to be submitted on measures selected
under this paragraph with respect to a year, any annual
increase provided under the system established under paragraph
(2)(D) for such year shall be reduced by 2.0 percentage points.
A reduction under this subparagraph shall apply only with
respect to the year involved and the Secretary shall not take
into account such reduction in computing any annual increase
factor for a subsequent year.
(B) Except as the Secretary may otherwise provide, the
provisions of subparagraphs (B), (C), (D), and (E) of paragraph
(17) of section 1833(t) shall apply with respect to services of
ambulatory surgical centers under this paragraph in a similar
manner to the manner in which they apply under such paragraph
and, for purposes of this subparagraph, any reference to a
hospital, outpatient setting, or outpatient hospital services
is deemed a reference to an ambulatory surgical center, the
setting of such a center, or services of such a center,
respectively.
(8) The Secretary shall conduct a similar type of review as
required under paragraph (22) of section 1833(t)), including
the second sentence of subparagraph (C) of such paragraph, to
payment for services under this subsection, and make such
revisions under this paragraph, in an appropriate manner (as
determined by the Secretary).
(j) Whenever a final determination is made that the amount of
payment made under this part either to a provider of services
or to another person pursuant to an assignment under section
1842(b)(3)(B)(ii) was in excess of or less than the amount of
payment that is due, and payment of such excess or deficit is
not made (or effected by offset) within 30 days of the date of
the determination, interest shall accrue on the balance of such
excess or deficit not paid or offset (to the extent that the
balance is owed by or owing to the provider) at a rate
determined in accordance with the regulations of the Secretary
of the Treasury applicable to charges for late payments.
(k) With respect to services described in section
1861(s)(10)(B), the Secretary may provide, instead of the
amount of payment otherwise provided under this part, for
payment of such an amount or amounts as reasonably reflects the
general cost of efficiently providing such services.
(l)(1)(A) The Secretary shall establish a fee schedule for
services of certified registered nurse anesthetists under
section 1861(s)(11).
(B) In establishing the fee schedule under this paragraph the
Secretary may utilize a system of time units, a system of base
and time units, or any appropriate methodology.
(C) The provisions of this subsection shall not apply to
certain services furnished in certain hospitals in rural areas
under the provisions of section 9320(k) of the Omnibus Budget
Reconciliation Act of 1986, as amended by section 6132 of the
Omnibus Budget Reconciliation Act of 1989.
(2) Except as provided in paragraph (3), the fee schedule
established under paragraph (1) shall be initially based on
audited data from cost reporting periods ending in fiscal year
1985 and such other data as the Secretary determines necessary.
(3)(A) In establishing the initial fee schedule for those
services, the Secretary shall adjust the fee schedule to the
extent necessary to ensure that the estimated total amount
which will be paid under this title for those services plus
applicable coinsurance in 1989 will equal the estimated total
amount which would be paid under this title for those services
in 1989 if the services were included as inpatient hospital
services and payment for such services was made under part A in
the same manner as payment was made in fiscal year 1987,
adjusted to take into account changes in prices and technology
relating to the administration of anesthesia.
(B) The Secretary shall also reduce the prevailing charge of
physicians for medical direction of a certified registered
nurse anesthetist, or the fee schedule for services of
certified registered nurse anesthetists, or both, to the extent
necessary to ensure that the estimated total amount which will
be paid under this title plus applicable coinsurance for such
medical direction and such services in 1989 and 1990 will not
exceed the estimated total amount which would have been paid
plus applicable coinsurance but for the enactment of the
amendments made by section 9320 of the Omnibus Budget
Reconciliation Act of 1986. A reduced prevailing charge under
this subparagraph shall become the prevailing charge but for
subsequent years for purposes of applying the economic index
under the fourth sentence of section 1842(b)(3).
(4)(A) Except as provided in subparagraphs (C) and (D), in
determining the amount paid under the fee schedule under this
subsection for services furnished on or after January 1, 1991,
by a certified registered nurse anesthetist who is not
medically directed--
(i) the conversion factor shall be--
(I) for services furnished in 1991, $15.50,
(II) for services furnished in 1992, $15.75,
(III) for services furnished in 1993, $16.00,
(IV) for services furnished in 1994, $16.25,
(V) for services furnished in 1995, $16.50,
(VI) for services furnished in 1996, $16.75,
and
(VII) for services furnished in calendar
years after 1996, the previous year's
conversion factor increased by the update
determined under section 1848(d) for physician
anesthesia services for that year;
(ii) the payment areas to be used shall be the fee
schedule areas used under section 1848 (or, in the case
of services furnished during 1991, the localities used
under section 1842(b)) for purposes of computing
payments for physicians' services that are anesthesia
services;
(iii) the geographic adjustment factors to be applied
to the conversion factor under clause (i) for services
in a fee schedule area or locality is--
(I) in the case of services furnished in
1991, the geographic work index value and the
geographic practice cost index value specified
in section 1842(q)(1)(B) for physicians'
services that are anesthesia services furnished
in the area or locality, and
(II) in the case of services furnished after
1991, the geographic work index value, the
geographic practice cost index value, and the
geographic malpractice index value used for
determining payments for physicians' services
that are anesthesia services under section
1848,
with 70 percent of the conversion factor treated as
attributable to work and 30 percent as attributable to
overhead for services furnished in 1991 (and the
portions attributable to work, practice expenses, and
malpractice expenses in 1992 and thereafter being the
same as is applied under section 1848).
(B)(i) Except as provided in clause (ii) and subparagraph
(D), in determining the amount paid under the fee schedule
under this subsection for services furnished on or after
January 1, 1991, and before January 1, 1994, by a certified
registered nurse anesthetist who is medically directed, the
Secretary shall apply the same methodology specified in
subparagraph (A).
(ii) The conversion factor used under clause (i) shall be--
(I) for services furnished in 1991, $10.50,
(II) for services furnished in 1992, $10.75, and
(III) for services furnished in 1993, $11.00.
(iii) In the case of services of a certified registered nurse
anesthetist who is medically directed or medically supervised
by a physician which are furnished on or after January 1, 1994,
the fee schedule amount shall be one-half of the amount
described in section 1848(a)(5)(B) with respect to the
physician.
(C) Notwithstanding subclauses (I) through (V) of
subparagraph (A)(i)--
(i) in the case of a 1990 conversion factor that is
greater than $16.50, the conversion factor for a
calendar year after 1990 and before 1996 shall be the
1990 conversion factor reduced by the product of the
last digit of the calendar year and one-fifth of the
amount by which the 1990 conversion factor exceeds
$16.50; and
(ii) in the case of a 1990 conversion factor that is
greater than $15.49 but less than $16.51, the
conversion factor for a calendar year after 1990 and
before 1996 shall be the greater of--
(I) the 1990 conversion factor, or
(II) the conversion factor specified in
subparagraph (A)(i) for the year involved.
(D) Notwithstanding subparagraph (C), in no case may the
conversion factor used to determine payment for services in a
fee schedule area or locality under this subsection, as
adjusted by the adjustment factors specified in subparagraphs
(A)(iii), exceed the conversion factor used to determine the
amount paid for physicians' services that are anesthesia
services in the area or locality.
(5)(A) Payment for the services of a certified registered
nurse anesthetist (for which payment may otherwise be made
under this part) may be made on the basis of a claim or request
for payment presented by the certified registered nurse
anesthetist furnishing such services, or by a hospital,
critical access hospital, physician, group practice, or
ambulatory surgical center with which the certified registered
nurse anesthetist furnishing such services has an employment or
contractual relationship that provides for payment to be made
under this part for such services to such hospital, critical
access hospital, physician, group practice, or ambulatory
surgical center.
(B) No hospital or critical access hospital that presents a
claim or request for payment for services of a certified nurse
anesthetist under this part may treat any uncollected
coinsurance amount imposed under this part with respect to such
services as a bad debt of such hospital or critical access
hospital for purposes of this title.
(6) If an adjustment under paragraph (3)(B) results in a
reduction in the reasonable charge for a physicians' service
and a nonparticipating physician furnishes the service to an
individual entitled to benefits under this part after the
effective date of the reduction, the physician's actual charge
is subject to a limit under section 1842(j)(1)(D).
(m)(1) In the case of physicians' services furnished in a
year to an individual, who is covered under the insurance
program established by this part and who incurs expenses for
such services, in an area that is designated (under section
332(a)(1)(A) of the Public Health Service Act) as a health
professional shortage area as identified by the Secretary prior
to the beginning of such year, in addition to the amount
otherwise paid under this part, there also shall be paid to the
physician (or to an employer or facility in the cases described
in clause (A) of section 1842(b)(6)) (on a monthly or quarterly
basis) from the Federal Supplementary Medical Insurance Trust
Fund an amount equal to 10 percent of the payment amount for
the service under this part.
(2) For each health professional shortage area identified in
paragraph (1) that consists of an entire county, the Secretary
shall provide for the additional payment under paragraph (1)
without any requirement on the physician to identify the health
professional shortage area involved. The Secretary may
implement the previous sentence using the method specified in
subsection (u)(4)(C).
(3) The Secretary shall post on the Internet website of the
Centers for Medicare & Medicaid Services a list of the health
professional shortage areas identified in paragraph (1) that
consist of a partial county to facilitate the additional
payment under paragraph (1) in such areas.
(4) There shall be no administrative or judicial review under
section 1869, section 1878, or otherwise, respecting--
(A) the identification of a county or area;
(B) the assignment of a specialty of any physician
under this paragraph;
(C) the assignment of a physician to a county under
this subsection; or
(D) the assignment of a postal ZIP Code to a county
or other area under this subsection.
(n)(1)(A) The aggregate amount of the payments to be made for
all or part of a cost reporting period for services described
in subsection (a)(2)(E)(i) furnished under this part on or
after October 1, 1988, and before January 1, 1999, and for
services described in subsection (a)(2)(E)(ii) furnished under
this part on or after October 1, 1989, and before January 1,
1999, shall be equal to the lesser of--
(i) the amount determined with respect to such
services under subsection (a)(2)(B), or
(ii) the blend amount for radiology services and
diagnostic procedures determined in accordance with
subparagraph (B).
(B)(i) The blend amount for radiology services and diagnostic
procedures for a cost reporting period is the sum of--
(I) the cost proportion (as defined in clause (ii))
of the amount described in subparagraph (A)(i); and
(II) the charge proportion (as defined in clause
(ii)(II)) of 62 percent (for services described in
subsection (a)(2)(E)(i)), or (for procedures described
in subsection (a)(2)(E)(ii)), 42 percent or such other
percent established by the Secretary (or carriers
acting pursuant to guidelines issued by the Secretary)
based on prevailing charges established with actual
charge data, of the prevailing charge or (for services
described in subsection (a)(2)(E)(i) furnished on or
after January 1, 1989) the fee schedule amount
established for participating physicians for the same
services as if they were furnished in a physician's
office in the same locality as determined under section
1842(b), less the amount a provider may charge as
described in clause (ii) of section 1866(a)(2)(A).
(ii) In this subparagraph:
(I) The term ``cost proportion'' means 50 percent,
except that such term means 65 percent in the case of
outpatient radiology services for portions of cost
reporting periods which occur in fiscal year 1989 and
in the case of diagnostic procedures described in
subsection (a)(2)(E)(ii) for portions of cost reporting
periods which occur in fiscal year 1990, and such term
means 42 percent in the case of outpatient radiology
services for portions of cost reporting periods
beginning on or after January 1, 1991.
(II) The term ``charge proportion'' means 100 percent
minus the cost proportion.
(o)(1) In the case of shoes described in section
1861(s)(12)--
(A) no payment may be made under this part, with
respect to any individual for any year, for the
furnishing of--
(i) more than one pair of custom molded shoes
(including inserts provided with such shoes)
and 2 additional pairs of inserts for such
shoes, or
(ii) more than one pair of extra-depth shoes
(not including inserts provided with such
shoes) and 3 pairs of inserts for such shoes,
and
(B) with respect to expenses incurred in any calendar
year, no more than the amount of payment applicable
under paragraph (2) shall be considered as incurred
expenses for purposes of subsections (a) and (b).
Payment for shoes (or inserts) under this part shall be
considered to include payment for any expenses for the fitting
of such shoes (or inserts).
(2)(A) Except as provided by the Secretary under
subparagraphs (B) and (C), the amount of payment under this
paragraph for custom molded shoes, extra-depth shoes, and
inserts shall be the amount determined for such items by the
Secretary under section 1834(h).
(B) The Secretary may establish payment amounts for shoes and
inserts that are lower than the amount established under
section 1834(h) if the Secretary finds that shoes and inserts
of an appropriate quality are readily available at or below the
amount established under such section.
(C) In accordance with procedures established by the
Secretary, an individual entitled to benefits with respect to
shoes described in section 1861(s)(12) may substitute
modification of such shoes instead of obtaining one (or more,
as specified by the Secretary) pair of inserts (other than the
original pair of inserts with respect to such shoes). In such
case, the Secretary shall substitute, for the payment amount
established under section 1834(h), a payment amount that the
Secretary estimates will assure that there is no net increase
in expenditures under this subsection as a result of this
subparagraph.
(3) In this title, the term ``shoes'' includes, except for
purposes of subparagraphs (A)(ii) and (B) of paragraph (2),
inserts for extra-depth shoes.
(q)(1) Each request for payment, or bill submitted, for an
item or service furnished by an entity for which payment may be
made under this part and for which the entity knows or has
reason to believe there has been a referral by a referring
physician (within the meaning of section 1877) shall include
the name and unique physician identification number for the
referring physician.
(2)(A) In the case of a request for payment for an item or
service furnished by an entity under this part on an
assignment-related basis and for which information is required
to be provided under paragraph (1) but not included, payment
may be denied under this part.
(B) In the case of a request for payment for an item or
service furnished by an entity under this part not submitted on
an assignment-related basis and for which information is
required to be provided under paragraph (1) but not included--
(i) if the entity knowingly and willfully fails to
provide such information promptly upon request of the
Secretary or a carrier, the entity may be subject to a
civil money penalty in an amount not to exceed $2,000,
and
(ii) if the entity knowingly, willfully, and in
repeated cases fails, after being notified by the
Secretary of the obligations and requirements of this
subsection to provide the information required under
paragraph (1), the entity may be subject to exclusion
from participation in the programs under this Act for a
period not to exceed 5 years, in accordance with the
procedures of subsections (c), (f), and (g) of section
1128.
The provisions of section 1128A (other than subsections (a) and
(b)) shall apply to civil money penalties under clause (i) in
the same manner as they apply to a penalty or proceeding under
section 1128A(a).
(r)(1) With respect to services described in section
1861(s)(2)(K)(ii) (relating to nurse practitioner or clinical
nurse specialist services), payment may be made on the basis of
a claim or request for payment presented by the nurse
practitioner or clinical nurse specialist furnishing such
services, or by a hospital, critical access hospital, skilled
nursing facility or nursing facility (as defined in section
1919(a)), physician, group practice, or ambulatory surgical
center with which the nurse practitioner or clinical nurse
specialist has an employment or contractual relationship that
provides for payment to be made under this part for such
services to such hospital, physician, group practice, or
ambulatory surgical center.
(2) No hospital or critical access hospital that presents a
claim or request for payment under this part for services
described in section 1861(s)(2)(K)(ii) may treat any
uncollected coinsurance amount imposed under this part with
respect to such services as a bad debt of such hospital for
purposes of this title.
(s) The Secretary may not provide for payment under
subsection (a)(1)(A) with respect to an organization unless the
organization provides assurances satisfactory to the Secretary
that the organization meets the requirement of section 1866(f)
(relating to maintaining written policies and procedures
respecting advance directives).
(t) Prospective Payment System for Hospital Outpatient
Department Services.--
(1) Amount of payment.--
(A) In general.--With respect to covered OPD
services (as defined in subparagraph (B))
furnished during a year beginning with 1999,
the amount of payment under this part shall be
determined under a prospective payment system
established by the Secretary in accordance with
this subsection.
(B) Definition of covered opd services.--For
purposes of this subsection, the term ``covered
OPD services''--
(i) means hospital outpatient
services designated by the Secretary;
(ii) subject to clause (iv), includes
inpatient hospital services designated
by the Secretary that are covered under
this part and furnished to a hospital
inpatient who (I) is entitled to
benefits under part A but has exhausted
benefits for inpatient hospital
services during a spell of illness, or
(II) is not so entitled;
(iii) includes implantable items
described in paragraph (3), (6), or (8)
of section 1861(s);
(iv) does not include any therapy
services described in subsection (a)(8)
or ambulance services, for which
payment is made under a fee schedule
described in section 1834(k) or section
1834(l) and does not include screening
mammography (as defined in section
1861(jj)), diagnostic mammography, or
personalized prevention plan services
(as defined in section 1861(hhh)(1));
and
(v) does not include applicable items
and services (as defined in
subparagraph (A) of paragraph (21))
that are furnished on or after January
1, 2017, by an off-campus outpatient
department of a provider (as defined in
subparagraph (B) of such paragraph).
(2) System requirements.--Under the payment system--
(A) the Secretary shall develop a
classification system for covered OPD services;
(B) the Secretary may establish groups of
covered OPD services, within the classification
system described in subparagraph (A), so that
services classified within each group are
comparable clinically and with respect to the
use of resources and so that an implantable
item is classified to the group that includes
the service to which the item relates;
(C) the Secretary shall, using data on claims
from 1996 and using data from the most recent
available cost reports, establish relative
payment weights for covered OPD services (and
any groups of such services described in
subparagraph (B)) based on median (or, at the
election of the Secretary, mean) hospital costs
and shall determine projections of the
frequency of utilization of each such service
(or group of services) in 1999;
(D) subject to paragraph (19), the Secretary
shall determine a wage adjustment factor to
adjust the portion of payment and coinsurance
attributable to labor-related costs for
relative differences in labor and labor-related
costs across geographic regions in a budget
neutral manner;
(E) the Secretary shall establish, in a
budget neutral manner, outlier adjustments
under paragraph (5) and transitional pass-
through payments under paragraph (6) and other
adjustments as determined to be necessary to
ensure equitable payments, such as adjustments
for certain classes of hospitals;
(F) the Secretary shall develop a method for
controlling unnecessary increases in the volume
of covered OPD services;
(G) the Secretary shall create additional
groups of covered OPD services that classify
separately those procedures that utilize
contrast agents from those that do not; and
(H) with respect to devices of brachytherapy
consisting of a seed or seeds (or radioactive
source), the Secretary shall create additional
groups of covered OPD services that classify
such devices separately from the other services
(or group of services) paid for under this
subsection in a manner reflecting the number,
isotope, and radioactive intensity of such
devices furnished, including separate groups
for palladium-103 and iodine-125 devices and
for stranded and non-stranded devices furnished
on or after July 1, 2007.
For purposes of subparagraph (B), items and services
within a group shall not be treated as ``comparable
with respect to the use of resources'' if the highest
median cost (or mean cost, if elected by the Secretary
under subparagraph (C)) for an item or service within
the group is more than 2 times greater than the lowest
median cost (or mean cost, if so elected) for an item
or service within the group; except that the Secretary
may make exceptions in unusual cases, such as low
volume items and services, but may not make such an
exception in the case of a drug or biological that has
been designated as an orphan drug under section 526 of
the Federal Food, Drug and Cosmetic Act.
(3) Calculation of base amounts.--
(A) Aggregate amounts that would be payable
if deductibles were disregarded.--The Secretary
shall estimate the sum of--
(i) the total amounts that would be
payable from the Trust Fund under this
part for covered OPD services in 1999,
determined without regard to this
subsection, as though the deductible
under section 1833(b) did not apply,
and
(ii) the total amounts of copayments
estimated to be paid under this
subsection by beneficiaries to
hospitals for covered OPD services in
1999, as though the deductible under
section 1833(b) did not apply.
(B) Unadjusted copayment amount.--
(i) In general.--For purposes of this
subsection, subject to clause (ii), the
``unadjusted copayment amount''
applicable to a covered OPD service (or
group of such services) is 20 percent
of the national median of the charges
for the service (or services within the
group) furnished during 1996, updated
to 1999 using the Secretary's estimate
of charge growth during the period.
(ii) Adjusted to be 20 percent when
fully phased in.--If the pre-deductible
payment percentage for a covered OPD
service (or group of such services)
furnished in a year would be equal to
or exceed 80 percent, then the
unadjusted copayment amount shall be 20
percent of amount determined under
subparagraph (D).
(iii) Rules for new services.--The
Secretary shall establish rules for
establishment of an unadjusted
copayment amount for a covered OPD
service not furnished during 1996,
based upon its classification within a
group of such services.
(C) Calculation of conversion factors.--
(i) For 1999.--
(I) In general.--The
Secretary shall establish a
1999 conversion factor for
determining the medicare OPD
fee schedule amounts for each
covered OPD service (or group
of such services) furnished in
1999. Such conversion factor
shall be established on the
basis of the weights and
frequencies described in
paragraph (2)(C) and in such a
manner that the sum for all
services and groups of the
products (described in
subclause (II) for each such
service or group) equals the
total projected amount
described in subparagraph (A).
(II) Product described.--The
Secretary shall determine for
each service or group the
product of the medicare OPD fee
schedule amounts (taking into
account appropriate adjustments
described in paragraphs (2)(D)
and (2)(E)) and the estimated
frequencies for such service or
group.
(ii) Subsequent years.--Subject to
paragraph (8)(B), the Secretary shall
establish a conversion factor for
covered OPD services furnished in
subsequent years in an amount equal to
the conversion factor established under
this subparagraph and applicable to
such services furnished in the previous
year increased by the OPD fee schedule
increase factor specified under clause
(iv) for the year involved.
(iii) Adjustment for service mix
changes.--Insofar as the Secretary
determines that the adjustments for
service mix under paragraph (2) for a
previous year (or estimates that such
adjustments for a future year) did (or
are likely to) result in a change in
aggregate payments under this
subsection during the year that are a
result of changes in the coding or
classification of covered OPD services
that do not reflect real changes in
service mix, the Secretary may adjust
the conversion factor computed under
this subparagraph for subsequent years
so as to eliminate the effect of such
coding or classification changes.
(iv) OPD fee schedule increase
factor.--For purposes of this
subparagraph, subject to paragraph (17)
and subparagraph (F) of this paragraph,
the ``OPD fee schedule increase
factor'' for services furnished in a
year is equal to the market basket
percentage increase applicable under
section 1886(b)(3)(B)(iii) to hospital
discharges occurring during the fiscal
year ending in such year, reduced by 1
percentage point for such factor for
services furnished in each of 2000 and
2002. In applying the previous sentence
for years beginning with 2000, the
Secretary may substitute for the market
basket percentage increase an annual
percentage increase that is computed
and applied with respect to covered OPD
services furnished in a year in the
same manner as the market basket
percentage increase is determined and
applied to inpatient hospital services
for discharges occurring in a fiscal
year.
(D) Calculation of medicare opd fee schedule
amounts.--The Secretary shall compute a
medicare OPD fee schedule amount for each
covered OPD service (or group of such services)
furnished in a year, in an amount equal to the
product of--
(i) the conversion factor computed
under subparagraph (C) for the year,
and
(ii) the relative payment weight
(determined under paragraph (2)(C)) for
the service or group.
(E) Pre-deductible payment percentage.--The
pre-deductible payment percentage for a covered
OPD service (or group of such services)
furnished in a year is equal to the ratio of--
(i) the medicare OPD fee schedule
amount established under subparagraph
(D) for the year, minus the unadjusted
copayment amount determined under
subparagraph (B) for the service or
group, to
(ii) the medicare OPD fee schedule
amount determined under subparagraph
(D) for the year for such service or
group.
(F) Productivity and other adjustment.--After
determining the OPD fee schedule increase
factor under subparagraph (C)(iv), the
Secretary shall reduce such increase factor--
(i) for 2012 and subsequent years, by
the productivity adjustment described
in section 1886(b)(3)(B)(xi)(II); and
(ii) for each of 2010 through 2019,
by the adjustment described in
subparagraph (G).
The application of this subparagraph may result
in the increase factor under subparagraph
(C)(iv) being less than 0.0 for a year, and may
result in payment rates under the payment
system under this subsection for a year being
less than such payment rates for the preceding
year.
(G) Other adjustment.--For purposes of
subparagraph (F)(ii), the adjustment described
in this subparagraph is--
(i) for each of 2010 and 2011, 0.25
percentage point;
(ii) for each of 2012 and 2013, 0.1
percentage point;
(iii) for 2014, 0.3 percentage point;
(iv) for each of 2015 and 2016, 0.2
percentage point; and
(v) for each of 2017, 2018, and 2019,
0.75 percentage point.
(4) Medicare payment amount.--The amount of payment
made from the Trust Fund under this part for a covered
OPD service (and such services classified within a
group) furnished in a year is determined, subject to
paragraph (7), as follows:
(A) Fee schedule adjustments.--The medicare
OPD fee schedule amount (computed under
paragraph (3)(D)) for the service or group and
year is adjusted for relative differences in
the cost of labor and other factors determined
by the Secretary, as computed under paragraphs
(2)(D) and (2)(E).
(B) Subtract applicable deductible.--Reduce
the adjusted amount determined under
subparagraph (A) by the amount of the
deductible under section 1833(b), to the extent
applicable.
(C) Apply payment proportion to remainder.--
The amount of payment is the amount so
determined under subparagraph (B) multiplied by
the pre-deductible payment percentage (as
determined under paragraph (3)(E)) for the
service or group and year involved, plus the
amount of any reduction in the copayment amount
attributable to paragraph (8)(C).
(5) Outlier adjustment.--
(A) In general.--Subject to subparagraph (D),
the Secretary shall provide for an additional
payment for each covered OPD service (or group
of services) for which a hospital's charges,
adjusted to cost, exceed--
(i) a fixed multiple of the sum of--
(I) the applicable medicare
OPD fee schedule amount
determined under paragraph
(3)(D), as adjusted under
paragraph (4)(A) (other than
for adjustments under this
paragraph or paragraph (6));
and
(II) any transitional pass-
through payment under paragraph
(6); and
(ii) at the option of the Secretary,
such fixed dollar amount as the
Secretary may establish.
(B) Amount of adjustment.--The amount of the
additional payment under subparagraph (A) shall
be determined by the Secretary and shall
approximate the marginal cost of care beyond
the applicable cutoff point under such
subparagraph.
(C) Limit on aggregate outlier adjustments.--
(i) In general.--The total of the
additional payments made under this
paragraph for covered OPD services
furnished in a year (as estimated by
the Secretary before the beginning of
the year) may not exceed the applicable
percentage (specified in clause (ii))
of the total program payments estimated
to be made under this subsection for
all covered OPD services furnished in
that year. If this paragraph is first
applied to less than a full year, the
previous sentence shall apply only to
the portion of such year.
(ii) Applicable percentage.--For
purposes of clause (i), the term
``applicable percentage'' means a
percentage specified by the Secretary
up to (but not to exceed)--
(I) for a year (or portion of
a year) before 2004, 2.5
percent; and
(II) for 2004 and thereafter,
3.0 percent.
(D) Transitional authority.--In applying
subparagraph (A) for covered OPD services
furnished before January 1, 2002, the Secretary
may--
(i) apply such subparagraph to a bill
for such services related to an
outpatient encounter (rather than for a
specific service or group of services)
using OPD fee schedule amounts and
transitional pass-through payments
covered under the bill; and
(ii) use an appropriate cost-to-
charge ratio for the hospital involved
(as determined by the Secretary),
rather than for specific departments
within the hospital.
(E) Exclusion of separate drug and biological
apcs from outlier payments.--No additional
payment shall be made under subparagraph (A) in
the case of ambulatory payment classification
groups established separately for drugs or
biologicals.
(6) Transitional pass-through for additional costs of
innovative medical devices, drugs, and biologicals.--
(A) In general.--The Secretary shall provide
for an additional payment under this paragraph
for any of the following that are provided as
part of a covered OPD service (or group of
services):
(i) Current orphan drugs.--A drug or
biological that is used for a rare
disease or condition with respect to
which the drug or biological has been
designated as an orphan drug under
section 526 of the Federal Food, Drug
and Cosmetic Act if payment for the
drug or biological as an outpatient
hospital service under this part was
being made on the first date that the
system under this subsection is
implemented.
(ii) Current cancer therapy drugs and
biologicals and brachytherapy.--A drug
or biological that is used in cancer
therapy, including (but not limited to)
a chemotherapeutic agent, an
antiemetic, a hematopoietic growth
factor, a colony stimulating factor, a
biological response modifier, a
bisphosphonate, and a device of
brachytherapy or temperature monitored
cryoablation, if payment for such drug,
biological, or device as an outpatient
hospital service under this part was
being made on such first date.
(iii) Current radiopharmaceutical
drugs and biological products.--A
radiopharmaceutical drug or biological
product used in diagnostic, monitoring,
and therapeutic nuclear medicine
procedures if payment for the drug or
biological as an outpatient hospital
service under this part was being made
on such first date.
(iv) New medical devices, drugs, and
biologicals.--A medical device, drug,
or biological not described in clause
(i), (ii), or (iii) if--
(I) payment for the device,
drug, or biological as an
outpatient hospital service
under this part was not being
made as of December 31, 1996;
and
(II) the cost of the drug or
biological or the average cost
of the category of devices is
not insignificant in relation
to the OPD fee schedule amount
(as calculated under paragraph
(3)(D)) payable for the service
(or group of services)
involved.
(B) Use of categories in determining
eligibility of a device for pass-through
payments.--The following provisions apply for
purposes of determining whether a medical
device qualifies for additional payments under
clause (ii) or (iv) of subparagraph (A):
(i) Establishment of initial
categories.--
(I) In general.--The
Secretary shall initially
establish under this clause
categories of medical devices
based on type of device by
April 1, 2001. Such categories
shall be established in a
manner such that each medical
device that meets the
requirements of clause (ii) or
(iv) of subparagraph (A) as of
January 1, 2001, is included in
such a category and no such
device is included in more than
one category. For purposes of
the preceding sentence, whether
a medical device meets such
requirements as of such date
shall be determined on the
basis of the program memoranda
issued before such date.
(II) Authorization of
implementation other than
through regulations.--The
categories may be established
under this clause by program
memorandum or otherwise, after
consultation with groups
representing hospitals,
manufacturers of medical
devices, and other affected
parties.
(ii) Establishing criteria for
additional categories.--
(I) In general.--The
Secretary shall establish
criteria that will be used for
creation of additional
categories (other than those
established under clause (i))
through rulemaking (which may
include use of an interim final
rule with comment period).
(II) Standard.--Such
categories shall be established
under this clause in a manner
such that no medical device is
described by more than one
category. Such criteria shall
include a test of whether the
average cost of devices that
would be included in a category
and are in use at the time the
category is established is not
insignificant, as described in
subparagraph (A)(iv)(II).
(III) Deadline.--Criteria
shall first be established
under this clause by July 1,
2001. The Secretary may
establish in compelling
circumstances categories under
this clause before the date
such criteria are established.
(IV) Adding categories.--The
Secretary shall promptly
establish a new category of
medical devices under this
clause for any medical device
that meets the requirements of
subparagraph (A)(iv) and for
which none of the categories in
effect (or that were previously
in effect) is appropriate.
(iii) Period for which category is in
effect.--A category of medical devices
established under clause (i) or (ii)
shall be in effect for a period of at
least 2 years, but not more than 3
years, that begins--
(I) in the case of a category
established under clause (i),
on the first date on which
payment was made under this
paragraph for any device
described by such category
(including payments made during
the period before April 1,
2001); and
(II) in the case of any other
category, on the first date on
which payment is made under
this paragraph for any medical
device that is described by
such category.
(iv) Requirements treated as met.--A
medical device shall be treated as
meeting the requirements of
subparagraph (A)(iv), regardless of
whether the device meets the
requirement of subclause (I) of such
subparagraph, if--
(I) the device is described
by a category established and
in effect under clause (i); or
(II) the device is described
by a category established and
in effect under clause (ii) and
an application under section
515 of the Federal Food, Drug,
and Cosmetic Act has been
approved with respect to the
device, or the device has been
cleared for market under
section 510(k) of such Act, or
the device is exempt from the
requirements of section 510(k)
of such Act pursuant to
subsection (l) or (m) of
section 510 of such Act or
section 520(g) of such Act.
Nothing in this clause shall be
construed as requiring an application
or prior approval (other than that
described in subclause (II)) in order
for a covered device described by a
category to qualify for payment under
this paragraph.
(C) Limited period of payment.--
(i) Drugs and biologicals.--Subject
to subparagraph (G), the payment under
this paragraph with respect to a drug
or biological shall only apply during a
period of at least 2 years, but not
more than 3 years, that begins--
(I) on the first date this
subsection is implemented in
the case of a drug or
biological described in clause
(i), (ii), or (iii) of
subparagraph (A) and in the
case of a drug or biological
described in subparagraph
(A)(iv) and for which payment
under this part is made as an
outpatient hospital service
before such first date; or
(II) in the case of a drug or
biological described in
subparagraph (A)(iv) not
described in subclause (I), on
the first date on which payment
is made under this part for the
drug or biological as an
outpatient hospital service.
(ii) Medical devices.--Payment shall
be made under this paragraph with
respect to a medical device only if
such device--
(I) is described by a
category of medical devices
established and in effect under
subparagraph (B); and
(II) is provided as part of a
service (or group of services)
paid for under this subsection
and provided during the period
for which such category is in
effect under such subparagraph.
(D) Amount of additional payment.--Subject to
subparagraph (E)(iii), the amount of the
payment under this paragraph with respect to a
device, drug, or biological provided as part of
a covered OPD service is--
(i) subject to subparagraph (H), in
the case of a drug or biological, the
amount by which the amount determined
under section 1842(o) (or if the drug
or biological is covered under a
competitive acquisition contract under
section 1847B, an amount determined by
the Secretary equal to the average
price for the drug or biological for
all competitive acquisition areas and
year established under such section as
calculated and adjusted by the
Secretary for purposes of this
paragraph) for the drug or biological
exceeds the portion of the otherwise
applicable medicare OPD fee schedule
that the Secretary determines is
associated with the drug or biological;
or
(ii) in the case of a medical device,
the amount by which the hospital's
charges for the device, adjusted to
cost, exceeds the portion of the
otherwise applicable medicare OPD fee
schedule that the Secretary determines
is associated with the device.
(E) Limit on aggregate annual adjustment.--
(i) In general.--The total of the
additional payments made under this
paragraph for covered OPD services
furnished in a year (as estimated by
the Secretary before the beginning of
the year) may not exceed the applicable
percentage (specified in clause (ii))
of the total program payments estimated
to be made under this subsection for
all covered OPD services furnished in
that year. If this paragraph is first
applied to less than a full year, the
previous sentence shall apply only to
the portion of such year. This clause
shall not apply for 2018.
(ii) Applicable percentage.--For
purposes of clause (i), the term
``applicable percentage'' means--
(I) for a year (or portion of
a year) before 2004, 2.5
percent; and
(II) for 2004 and thereafter,
a percentage specified by the
Secretary up to (but not to
exceed) 2.0 percent.
(iii) Uniform prospective reduction
if aggregate limit projected to be
exceeded.--If the Secretary estimates
before the beginning of a year that the
amount of the additional payments under
this paragraph for the year (or portion
thereof) as determined under clause (i)
without regard to this clause will
exceed the limit established under such
clause, the Secretary shall reduce pro
rata the amount of each of the
additional payments under this
paragraph for that year (or portion
thereof) in order to ensure that the
aggregate additional payments under
this paragraph (as so estimated) do not
exceed such limit.
(F) Limitation of application of functional
equivalence standard.--
(i) In general.--The Secretary may
not publish regulations that apply a
functional equivalence standard to a
drug or biological under this
paragraph.
(ii) Application.--Clause (i) shall
apply to the application of a
functional equivalence standard to a
drug or biological on or after the date
of enactment of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 unless--
(I) such application was
being made to such drug or
biological prior to such date
of enactment; and
(II) the Secretary applies
such standard to such drug or
biological only for the purpose
of determining eligibility of
such drug or biological for
additional payments under this
paragraph and not for the
purpose of any other payments
under this title.
(iii) Rule of construction.--Nothing
in this subparagraph shall be construed
to effect the Secretary's authority to
deem a particular drug to be identical
to another drug if the 2 products are
pharmaceutically equivalent and
bioequivalent, as determined by the
Commissioner of Food and Drugs.
(G) Pass-through extension for certain drugs
and biologicals.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment for a
covered OPD service (or group of services)
furnished beginning January 1, 2018, such pass-
through status shall be extended for a 2-year
period beginning on October 1, 2018.
(H) Temporary payment rule for certain drugs
and biologicals.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment for a
covered OPD service (or group of services)
furnished beginning January 1, 2018, the
payment amount for such drug or biological
under this subsection that is furnished during
the period beginning on October 1, 2018, and
ending on March 31, 2019, shall be the greater
of--
(i) the payment amount that would
otherwise apply under subparagraph
(D)(i) for such drug or biological
during such period; or
(ii) the payment amount that applied
under such subparagraph (D)(i) for such
drug or biological on December 31,
2017.
(I) Special payment adjustment rules for last
quarter of 2018.--In the case of a drug or
biological whose period of pass-through status
under this paragraph ended on December 31,
2017, and for which payment under this
subsection was packaged into a payment amount
for a covered OPD service (or group of
services) beginning January 1, 2018, the
following rules shall apply with respect to
payment amounts under this subsection for
covered a OPD service (or group of services)
furnished during the period beginning on
October 1, 2018, and ending on December 31,
2018:
(i) The Secretary shall remove the
packaged costs of such drug or
biological (as determined by the
Secretary) from the payment amount
under this subsection for the covered
OPD service (or group of services) with
which it is packaged.
(ii) The Secretary shall not make any
adjustments to payment amounts under
this subsection for a covered OPD
service (or group of services) for
which no costs were removed under
clause (i).
(7) Transitional adjustment to limit decline in
payment.--
(A) Before 2002.--Subject to subparagraph
(D), for covered OPD services furnished before
January 1, 2002, for which the PPS amount (as
defined in subparagraph (E)) is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA amount
(as defined in subparagraph (F)), the
amount of payment under this subsection
shall be increased by 80 percent of the
amount of such difference;
(ii) at least 80 percent, but less
than 90 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.71
and the pre-BBA amount, exceeds (II)
the product of 0.70 and the PPS amount;
(iii) at least 70 percent, but less
than 80 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.63
and the pre-BBA amount, exceeds (II)
the product of 0.60 and the PPS amount;
or
(iv) less than 70 percent of the pre-
BBA amount, the amount of payment under
this subsection shall be increased by
21 percent of the pre-BBA amount.
(B) 2002.--Subject to subparagraph (D), for
covered OPD services furnished during 2002, for
which the PPS amount is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
70 percent of the amount of such
difference;
(ii) at least 80 percent, but less
than 90 percent, of the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
amount by which (I) the product of 0.61
and the pre-BBA amount, exceeds (II)
the product of 0.60 and the PPS amount;
or
(iii) less than 80 percent of the
pre-BBA amount, the amount of payment
under this subsection shall be
increased by 13 percent of the pre-BBA
amount.
(C) 2003.--Subject to subparagraph (D), for
covered OPD services furnished during 2003, for
which the PPS amount is--
(i) at least 90 percent, but less
than 100 percent, of the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
60 percent of the amount of such
difference; or
(ii) less than 90 percent of the pre-
BBA amount, the amount of payment under
this subsection shall be increased by 6
percent of the pre-BBA amount.
(D) Hold harmless provisions.--
(i) Temporary treatment for certain
rural hospitals.--(I) In the case of a
hospital located in a rural area and
that has not more than 100 beds or a
sole community hospital (as defined in
section 1886(d)(5)(D)(iii)) located in
a rural area, for covered OPD services
furnished before January 1, 2006, for
which the PPS amount is less than the
pre-BBA amount, the amount of payment
under this subsection shall be
increased by the amount of such
difference.
(II) In the case of a hospital
located in a rural area and that has
not more than 100 beds and that is not
a sole community hospital (as defined
in section 1886(d)(5)(D)(iii)), for
covered OPD services furnished on or
after January 1, 2006, and before
January 1, 2013, for which the PPS
amount is less than the pre-BBA amount,
the amount of payment under this
subsection shall be increased by the
applicable percentage of the amount of
such difference. For purposes of the
preceding sentence, the applicable
percentage shall be 95 percent with
respect to covered OPD services
furnished in 2006, 90 percent with
respect to such services furnished in
2007, and 85 percent with respect to
such services furnished in 2008, 2009,
2010, 2011, or 2012.
(III) In the case of a sole community
hospital (as defined in section
1886(d)(5)(D)(iii)) that has not more
than 100 beds, for covered OPD services
furnished on or after January 1, 2009,
and before January 1, 2013, for which
the PPS amount is less than the pre-BBA
amount, the amount of payment under
this subsection shall be increased by
85 percent of the amount of such
difference. In the case of covered OPD
services furnished on or after January
1, 2010, and before March 1, 2012, the
preceding sentence shall be applied
without regard to the 100-bed
limitation.
(ii) Permanent treatment for cancer
hospitals and children's hospitals.--In
the case of a hospital described in
clause (iii) or (v) of section
1886(d)(1)(B), for covered OPD services
for which the PPS amount is less than
the pre-BBA amount, the amount of
payment under this subsection shall be
increased by the amount of such
difference.
(E) PPS amount defined.--In this paragraph,
the term ``PPS amount'' means, with respect to
covered OPD services, the amount payable under
this title for such services (determined
without regard to this paragraph), including
amounts payable as copayment under paragraph
(8), coinsurance under section
1866(a)(2)(A)(ii), and the deductible under
section 1833(b).
(F) Pre-BBA amount defined.--
(i) In general.--In this paragraph,
the ``pre-BBA amount'' means, with
respect to covered OPD services
furnished by a hospital in a year, an
amount equal to the product of the
reasonable cost of the hospital for
such services for the portions of the
hospital's cost reporting period (or
periods) occurring in the year and the
base OPD payment-to-cost ratio for the
hospital (as defined in clause (ii)).
(ii) Base payment-to-cost-ratio
defined.--For purposes of this
subparagraph, the ``base payment-to-
cost ratio'' for a hospital means the
ratio of--
(I) the hospital's
reimbursement under this part
for covered OPD services
furnished during the cost
reporting period ending in 1996
(or in the case of a hospital
that did not submit a cost
report for such period, during
the first subsequent cost
reporting period ending before
2001 for which the hospital
submitted a cost report),
including any reimbursement for
such services through cost-
sharing described in
subparagraph (E), to
(II) the reasonable cost of
such services for such period.
The Secretary shall determine such
ratios as if the amendments made by
section 4521 of the Balanced Budget Act
of 1997 were in effect in 1996.
(G) Interim payments.--The Secretary shall
make payments under this paragraph to hospitals
on an interim basis, subject to retrospective
adjustments based on settled cost reports.
(H) No effect on copayments.--Nothing in this
paragraph shall be construed to affect the
unadjusted copayment amount described in
paragraph (3)(B) or the copayment amount under
paragraph (8).
(I) Application without regard to budget
neutrality.--The additional payments made under
this paragraph--
(i) shall not be considered an
adjustment under paragraph (2)(E); and
(ii) shall not be implemented in a
budget neutral manner.
(8) Copayment amount.--
(A) In general.--Except as provided in
subparagraphs (B) and (C), the copayment amount
under this subsection is the amount by which
the amount described in paragraph (4)(B)
exceeds the amount of payment determined under
paragraph (4)(C).
(B) Election to offer reduced copayment
amount.--The Secretary shall establish a
procedure under which a hospital, before the
beginning of a year (beginning with 1999), may
elect to reduce the copayment amount otherwise
established under subparagraph (A) for some or
all covered OPD services to an amount that is
not less than 20 percent of the medicare OPD
fee schedule amount (computed under paragraph
(3)(D)) for the service involved. Under such
procedures, such reduced copayment amount may
not be further reduced or increased during the
year involved and the hospital may disseminate
information on the reduction of copayment
amount effected under this subparagraph.
(C) Limitation on copayment amount.--
(i) To inpatient hospital deductible
amount.--In no case shall the copayment
amount for a procedure performed in a
year exceed the amount of the inpatient
hospital deductible established under
section 1813(b) for that year.
(ii) To specified percentage.--The
Secretary shall reduce the national
unadjusted copayment amount for a
covered OPD service (or group of such
services) furnished in a year in a
manner so that the effective copayment
rate (determined on a national
unadjusted basis) for that service in
the year does not exceed the following
percentage:
(I) For procedures performed
in 2001, on or after April 1,
2001, 57 percent.
(II) For procedures performed
in 2002 or 2003, 55 percent.
(III) For procedures
performed in 2004, 50 percent.
(IV) For procedures performed
in 2005, 45 percent.
(V) For procedures performed
in 2006 and thereafter, 40
percent.
(D) No impact on deductibles.--Nothing in
this paragraph shall be construed as affecting
a hospital's authority to waive the charging of
a deductible under section 1833(b).
(E) Computation ignoring outlier and pass-
through adjustments.--The copayment amount
shall be computed under subparagraph (A) as if
the adjustments under paragraphs (5) and (6)
(and any adjustment made under paragraph (2)(E)
in relation to such adjustments) had not
occurred.
(9) Periodic review and adjustments components of
prospective payment system.--
(A) Periodic review.--The Secretary shall
review not less often than annually and revise
the groups, the relative payment weights, and
the wage and other adjustments described in
paragraph (2) to take into account changes in
medical practice, changes in technology, the
addition of new services, new cost data, and
other relevant information and factors. The
Secretary shall consult with an expert outside
advisory panel composed of an appropriate
selection of representatives of providers to
review (and advise the Secretary concerning)
the clinical integrity of the groups and
weights. Such panel may use data collected or
developed by entities and organizations (other
than the Department of Health and Human
Services) in conducting such review.
(B) Budget neutrality adjustment.--If the
Secretary makes adjustments under subparagraph
(A), then the adjustments for a year may not
cause the estimated amount of expenditures
under this part for the year to increase or
decrease from the estimated amount of
expenditures under this part that would have
been made if the adjustments had not been made.
In determining adjustments under the preceding
sentence for 2004 and 2005, the Secretary shall
not take into account under this subparagraph
or paragraph (2)(E) any expenditures that would
not have been made but for the application of
paragraph (14).
(C) Update factor.--If the Secretary
determines under methodologies described in
paragraph (2)(F) that the volume of services
paid for under this subsection increased beyond
amounts established through those
methodologies, the Secretary may appropriately
adjust the update to the conversion factor
otherwise applicable in a subsequent year.
(10) Special rule for ambulance services.--The
Secretary shall pay for hospital outpatient services
that are ambulance services on the basis described in
section 1861(v)(1)(U), or, if applicable, the fee
schedule established under section 1834(l).
(11) Special rules for certain hospitals.--In the
case of hospitals described in clause (iii) or (v) of
section 1886(d)(1)(B)--
(A) the system under this subsection shall
not apply to covered OPD services furnished
before January 1, 2000; and
(B) the Secretary may establish a separate
conversion factor for such services in a manner
that specifically takes into account the unique
costs incurred by such hospitals by virtue of
their patient population and service intensity.
(12) Limitation on review.--There shall be no
administrative or judicial review under section 1869,
1878, or otherwise of--
(A) the development of the classification
system under paragraph (2), including the
establishment of groups and relative payment
weights for covered OPD services, of wage
adjustment factors, other adjustments, and
methods described in paragraph (2)(F);
(B) the calculation of base amounts under
paragraph (3);
(C) periodic adjustments made under paragraph
(6);
(D) the establishment of a separate
conversion factor under paragraph (8)(B); and
(E) the determination of the fixed multiple,
or a fixed dollar cutoff amount, the marginal
cost of care, or applicable percentage under
paragraph (5) or the determination of
insignificance of cost, the duration of the
additional payments, the determination and
deletion of initial and new categories
(consistent with subparagraphs (B) and (C) of
paragraph (6)), the portion of the medicare OPD
fee schedule amount associated with particular
devices, drugs, or biologicals, and the
application of any pro rata reduction under
paragraph (6).
(13) Authorization of adjustment for rural
hospitals.--
(A) Study.--The Secretary shall conduct a
study to determine if, under the system under
this subsection, costs incurred by hospitals
located in rural areas by ambulatory payment
classification groups (APCs) exceed those costs
incurred by hospitals located in urban areas.
(B) Authorization of adjustment.--Insofar as
the Secretary determines under subparagraph (A)
that costs incurred by hospitals located in
rural areas exceed those costs incurred by
hospitals located in urban areas, the Secretary
shall provide for an appropriate adjustment
under paragraph (2)(E) to reflect those higher
costs by January 1, 2006.
(14) Drug apc payment rates.--
(A) In general.--The amount of payment under
this subsection for a specified covered
outpatient drug (defined in subparagraph (B))
that is furnished as part of a covered OPD
service (or group of services)--
(i) in 2004, in the case of--
(I) a sole source drug shall
in no case be less than 88
percent, or exceed 95 percent,
of the reference average
wholesale price for the drug;
(II) an innovator multiple
source drug shall in no case
exceed 68 percent of the
reference average wholesale
price for the drug; or
(III) a noninnovator multiple
source drug shall in no case
exceed 46 percent of the
reference average wholesale
price for the drug;
(ii) in 2005, in the case of--
(I) a sole source drug shall
in no case be less than 83
percent, or exceed 95 percent,
of the reference average
wholesale price for the drug;
(II) an innovator multiple
source drug shall in no case
exceed 68 percent of the
reference average wholesale
price for the drug; or
(III) a noninnovator multiple
source drug shall in no case
exceed 46 percent of the
reference average wholesale
price for the drug; or
(iii) in a subsequent year, shall be
equal, subject to subparagraph (E)--
(I) to the average
acquisition cost for the drug
for that year (which, at the
option of the Secretary, may
vary by hospital group (as
defined by the Secretary based
on volume of covered OPD
services or other relevant
characteristics)), as
determined by the Secretary
taking into account the
hospital acquisition cost
survey data under subparagraph
(D); or
(II) if hospital acquisition
cost data are not available,
the average price for the drug
in the year established under
section 1842(o), section 1847A,
or section 1847B, as the case
may be, as calculated and
adjusted by the Secretary as
necessary for purposes of this
paragraph.
(B) Specified covered outpatient drug
defined.--
(i) In general.--In this paragraph,
the term ``specified covered outpatient
drug'' means, subject to clause (ii), a
covered outpatient drug (as defined in
section 1927(k)(2)) for which a
separate ambulatory payment
classification group (APC) has been
established and that is--
(I) a radiopharmaceutical; or
(II) a drug or biological for
which payment was made under
paragraph (6) (relating to
pass-through payments) on or
before December 31, 2002.
(ii) Exception.--Such term does not
include--
(I) a drug or biological for
which payment is first made on
or after January 1, 2003, under
paragraph (6);
(II) a drug or biological for
which a temporary HCPCS code
has not been assigned; or
(III) during 2004 and 2005,
an orphan drug (as designated
by the Secretary).
(C) Payment for designated orphan drugs
during 2004 and 2005.--The amount of payment
under this subsection for an orphan drug
designated by the Secretary under subparagraph
(B)(ii)(III) that is furnished as part of a
covered OPD service (or group of services)
during 2004 and 2005 shall equal such amount as
the Secretary may specify.
(D) Acquisition cost survey for hospital
outpatient drugs.--
(i) Annual gao surveys in 2004 and
2005.--
(I) In general.--The
Comptroller General of the
United States shall conduct a
survey in each of 2004 and 2005
to determine the hospital
acquisition cost for each
specified covered outpatient
drug. Not later than April 1,
2005, the Comptroller General
shall furnish data from such
surveys to the Secretary for
use in setting the payment
rates under subparagraph (A)
for 2006.
(II) Recommendations.--Upon
the completion of such surveys,
the Comptroller General shall
recommend to the Secretary the
frequency and methodology of
subsequent surveys to be
conducted by the Secretary
under clause (ii).
(ii) Subsequent secretarial
surveys.--The Secretary, taking into
account such recommendations, shall
conduct periodic subsequent surveys to
determine the hospital acquisition cost
for each specified covered outpatient
drug for use in setting the payment
rates under subparagraph (A).
(iii) Survey requirements.--The
surveys conducted under clauses (i) and
(ii) shall have a large sample of
hospitals that is sufficient to
generate a statistically significant
estimate of the average hospital
acquisition cost for each specified
covered outpatient drug. With respect
to the surveys conducted under clause
(i), the Comptroller General shall
report to Congress on the justification
for the size of the sample used in
order to assure the validity of such
estimates.
(iv) Differentiation in cost.--In
conducting surveys under clause (i),
the Comptroller General shall determine
and report to Congress if there is (and
the extent of any) variation in
hospital acquisition costs for drugs
among hospitals based on the volume of
covered OPD services performed by such
hospitals or other relevant
characteristics of such hospitals (as
defined by the Comptroller General).
(v) Comment on proposed rates.--Not
later than 30 days after the date the
Secretary promulgated proposed rules
setting forth the payment rates under
subparagraph (A) for 2006, the
Comptroller General shall evaluate such
proposed rates and submit to Congress a
report regarding the appropriateness of
such rates based on the surveys the
Comptroller General has conducted under
clause (i).
(E) Adjustment in payment rates for overhead
costs.--
(i) Medpac report on drug apc
design.--The Medicare Payment Advisory
Commission shall submit to the
Secretary, not later than July 1, 2005,
a report on adjustment of payment for
ambulatory payment classifications for
specified covered outpatient drugs to
take into account overhead and related
expenses, such as pharmacy services and
handling costs. Such report shall
include--
(I) a description and
analysis of the data available
with regard to such expenses;
(II) a recommendation as to
whether such a payment
adjustment should be made; and
(III) if such adjustment
should be made, a
recommendation regarding the
methodology for making such an
adjustment.
(ii) Adjustment authorized.--The
Secretary may adjust the weights for
ambulatory payment classifications for
specified covered outpatient drugs to
take into account the recommendations
contained in the report submitted under
clause (i).
(F) Classes of drugs.--For purposes of this
paragraph:
(i) Sole source drugs.--The term
``sole source drug'' means--
(I) a biological product (as
defined under section
1861(t)(1)); or
(II) a single source drug (as
defined in section
1927(k)(7)(A)(iv)).
(ii) Innovator multiple source
drugs.--The term ``innovator multiple
source drug'' has the meaning given
such term in section 1927(k)(7)(A)(ii).
(iii) Noninnovator multiple source
drugs.--The term ``noninnovator
multiple source drug'' has the meaning
given such term in section
1927(k)(7)(A)(iii).
(G) Reference average wholesale price.--The
term ``reference average wholesale price''
means, with respect to a specified covered
outpatient drug, the average wholesale price
for the drug as determined under section
1842(o) as of May 1, 2003.
(H) Inapplicability of expenditures in
determining conversion, weighting, and other
adjustment factors.--Additional expenditures
resulting from this paragraph shall not be
taken into account in establishing the
conversion, weighting, and other adjustment
factors for 2004 and 2005 under paragraph (9),
but shall be taken into account for subsequent
years.
(15) Payment for new drugs and biologicals until
hcpcs code assigned.--With respect to payment under
this part for an outpatient drug or biological that is
covered under this part and is furnished as part of
covered OPD services for which a HCPCS code has not
been assigned, the amount provided for payment for such
drug or biological under this part shall be equal to 95
percent of the average wholesale price for the drug or
biological.
(16) Miscellaneous provisions.--
(A) Application of reclassification of
certain hospitals.--If a hospital is being
treated as being located in a rural area under
section 1886(d)(8)(E), that hospital shall be
treated under this subsection as being located
in that rural area.
(B) Threshold for establishment of separate
apcs for drugs.--The Secretary shall reduce the
threshold for the establishment of separate
ambulatory payment classification groups (APCs)
with respect to drugs or biologicals to $50 per
administration for drugs and biologicals
furnished in 2005 and 2006.
(C) Payment for devices of brachytherapy and
therapeutic radiopharmaceuticals at charges
adjusted to cost.--Notwithstanding the
preceding provisions of this subsection, for a
device of brachytherapy consisting of a seed or
seeds (or radioactive source) furnished on or
after January 1, 2004, and before January 1,
2010, and for therapeutic radiopharmaceuticals
furnished on or after January 1, 2008, and
before January 1, 2010, the payment basis for
the device or therapeutic radiopharmaceutical
under this subsection shall be equal to the
hospital's charges for each device or
therapeutic radiopharmaceutical furnished,
adjusted to cost. Charges for such devices or
therapeutic radiopharmaceuticals shall not be
included in determining any outlier payment
under this subsection.
(D) Special payment rule.--
(i) In general.--In the case of
covered OPD services furnished on or
after April 1, 2013, in a hospital
described in clause (ii), if--
(I) the payment rate that
would otherwise apply under
this subsection for
stereotactic radiosurgery,
complete course of treatment of
cranial lesion(s) consisting of
1 session that is multi-source
Cobalt 60 based (identified as
of January 1, 2013, by HCPCS
code 77371 (and any succeeding
code) and reimbursed as of such
date under APC 0127 (and any
succeeding classification
group)); exceeds
(II) the payment rate that
would otherwise apply under
this subsection for linear
accelerator based stereotactic
radiosurgery, complete course
of therapy in one session
(identified as of January 1,
2013, by HCPCS code G0173 (and
any succeeding code) and
reimbursed as of such date
under APC 0067 (and any
succeeding classification
group)),
the payment rate for the service
described in subclause (I) shall be
reduced to an amount equal to the
payment rate for the service described
in subclause (II).
(ii) Hospital described.--A hospital
described in this clause is a hospital
that is not--
(I) located in a rural area
(as defined in section
1886(d)(2)(D));
(II) classified as a rural
referral center under section
1886(d)(5)(C); or
(III) a sole community
hospital (as defined in section
1886(d)(5)(D)(iii)).
(iii) Not budget neutral.--In making
any budget neutrality adjustments under
this subsection for 2013 (with respect
to covered OPD services furnished on or
after April 1, 2013, and before January
1, 2014) or a subsequent year, the
Secretary shall not take into account
the reduced expenditures that result
from the application of this
subparagraph.
(E) Application of appropriate use criteria
for certain imaging services.--For provisions
relating to the application of appropriate use
criteria for certain imaging services, see
section 1834(q).
(F) Payment incentive for the transition from
traditional x-ray imaging to digital
radiography.--Notwithstanding the previous
provisions of this subsection:
(i) Limitation on payment for film x-
ray imaging services.--In the case of
an imaging service that is an X-ray
taken using film and that is furnished
during 2017 or a subsequent year, the
payment amount for such service
(including the X-ray component of a
packaged service) that would otherwise
be determined under this section
(without application of this paragraph
and before application of any other
adjustment under this subsection) for
such year shall be reduced by 20
percent.
(ii) Phased-in limitation on payment
for computed radiography imaging
services.--In the case of an imaging
service that is an X-ray taken using
computed radiography technology (as
defined in section 1848(b)(9)(C))--
(I) in the case of such a
service furnished during 2018,
2019, 2020, 2021, or 2022, the
payment amount for such service
(including the X-ray component
of a packaged service) that
would otherwise be determined
under this section (without
application of this paragraph
and before application of any
other adjustment under this
subsection) for such year shall
be reduced by 7 percent; and
(II) in the case of such a
service furnished during 2023
or a subsequent year, the
payment amount for such service
(including the X-ray component
of a packaged service) that
would otherwise be determined
under this section (without
application of this paragraph
and before application of any
other adjustment under this
subsection) for such year shall
be reduced by 10 percent.
(iii) Application without regard to
budget neutrality.--The reductions made
under this subparagraph--
(I) shall not be considered
an adjustment under paragraph
(2)(E); and
(II) shall not be implemented
in a budget neutral manner.
(iv) Implementation.--In order to
implement this subparagraph, the
Secretary shall adopt appropriate
mechanisms which may include use of
modifiers.
(17) Quality reporting.--
(A) Reduction in update for failure to
report.--
(i) In general.--For purposes of
paragraph (3)(C)(iv) for 2009 and each
subsequent year, in the case of a
subsection (d) hospital (as defined in
section 1886(d)(1)(B)) that does not
submit, to the Secretary in accordance
with this paragraph, data required to
be submitted on measures selected under
this paragraph with respect to such a
year, the OPD fee schedule increase
factor under paragraph (3)(C)(iv) for
such year shall be reduced by 2.0
percentage points.
(ii) Non-cumulative application.--A
reduction under this subparagraph shall
apply only with respect to the year
involved and the Secretary shall not
take into account such reduction in
computing the OPD fee schedule increase
factor for a subsequent year.
(B) Form and manner of submission.--Each
subsection (d) hospital shall submit data on
measures selected under this paragraph to the
Secretary in a form and manner, and at a time,
specified by the Secretary for purposes of this
paragraph.
(C) Development of outpatient measures.--
(i) In general.--The Secretary shall
develop measures that the Secretary
determines to be appropriate for the
measurement of the quality of care
(including medication errors) furnished
by hospitals in outpatient settings and
that reflect consensus among affected
parties and, to the extent feasible and
practicable, shall include measures set
forth by one or more national consensus
building entities.
(ii) Construction.--Nothing in this
paragraph shall be construed as
preventing the Secretary from selecting
measures that are the same as (or a
subset of) the measures for which data
are required to be submitted under
section 1886(b)(3)(B)(viii).
(D) Replacement of measures.--For purposes of
this paragraph, the Secretary may replace any
measures or indicators in appropriate cases,
such as where all hospitals are effectively in
compliance or the measures or indicators have
been subsequently shown not to represent the
best clinical practice.
(E) Availability of data.--The Secretary
shall establish procedures for making data
submitted under this paragraph available to the
public. Such procedures shall ensure that a
hospital has the opportunity to review the data
that are to be made public with respect to the
hospital prior to such data being made public.
The Secretary shall report quality measures of
process, structure, outcome, patients'
perspectives on care, efficiency, and costs of
care that relate to services furnished in
outpatient settings in hospitals on the
Internet website of the Centers for Medicare &
Medicaid Services.
(18) Authorization of adjustment for cancer
hospitals.--
(A) Study.--The Secretary shall conduct a
study to determine if, under the system under
this subsection, costs incurred by hospitals
described in section 1886(d)(1)(B)(v) with
respect to ambulatory payment classification
groups exceed those costs incurred by other
hospitals furnishing services under this
subsection (as determined appropriate by the
Secretary). In conducting the study under this
subparagraph, the Secretary shall take into
consideration the cost of drugs and biologicals
incurred by such hospitals.
(B) Authorization of adjustment.--Insofar as
the Secretary determines under subparagraph (A)
that costs incurred by hospitals described in
section 1886(d)(1)(B)(v) exceed those costs
incurred by other hospitals furnishing services
under this subsection, the Secretary shall,
subject to subparagraph (C), provide for an
appropriate adjustment under paragraph (2)(E)
to reflect those higher costs effective for
services furnished on or after January 1, 2011.
(C) Target pcr adjustment.--In applying
section 419.43(i) of title 42 of the Code of
Federal Regulations to implement the
appropriate adjustment under this paragraph for
services furnished on or after January 1, 2018,
the Secretary shall use a target PCR that is
1.0 percentage points less than the target PCR
that would otherwise apply. In addition to the
percentage point reduction under the previous
sentence, the Secretary may consider making an
additional percentage point reduction to such
target PCR that takes into account payment
rates for applicable items and services
described in paragraph (21)(C) other than for
services furnished by hospitals described in
section 1886(d)(1)(B)(v). In making any budget
neutrality adjustments under this subsection
for 2018 or a subsequent year, the Secretary
shall not take into account the reduced
expenditures that result from the application
of this subparagraph.
(19) Floor on area wage adjustment factor for
hospital outpatient department services in frontier
states.--
(A) In general.--Subject to subparagraph (B),
with respect to covered OPD services furnished
on or after January 1, 2011, the area wage
adjustment factor applicable under the payment
system established under this subsection to any
hospital outpatient department which is located
in a frontier State (as defined in section
1886(d)(3)(E)(iii)(II)) may not be less than
1.00. The preceding sentence shall not be
applied in a budget neutral manner.
(B) Limitation.--This paragraph shall not
apply to any hospital outpatient department
located in a State that receives a non-labor
related share adjustment under section
1886(d)(5)(H).
(20) Not budget neutral application of reduced
expenditures resulting from quality incentives for
computed tomography.--The Secretary shall not take into
account the reduced expenditures that result from the
application of section 1834(p) in making any budget
neutrality adjustments this subsection.
(21) Services furnished by an off-campus outpatient
department of a provider.--
(A) Applicable items and services.--For
purposes of paragraph (1)(B)(v) and this
paragraph, the term ``applicable items and
services'' means items and services other than
items and services furnished by a dedicated
emergency department (as defined in section
489.24(b) of title 42 of the Code of Federal
Regulations).
(B) Off-campus outpatient department of a
provider.--
(i) In general.--For purposes of
paragraph (1)(B)(v) and this paragraph,
subject to the subsequent provisions of
this subparagraph, the term ``off-
campus outpatient department of a
provider'' means a department of a
provider (as defined in section
413.65(a)(2) of title 42 of the Code of
Federal Regulations, as in effect as of
the date of the enactment of this
paragraph) that is not located--
(I) on the campus (as defined
in such section 413.65(a)(2))
of such provider; or
(II) within the distance
(described in such definition
of campus) from a remote
location of a hospital facility
(as defined in such section
413.65(a)(2)).
(ii) Exception.--For purposes of
paragraph (1)(B)(v) and this paragraph,
the term ``off-campus outpatient
department of a provider'' shall not
include a department of a provider (as
so defined) that was billing under this
subsection with respect to covered OPD
services furnished prior to the date of
the enactment of this paragraph.
(iii) Deemed treatment for 2017.--For
purposes of applying clause (ii) with
respect to applicable items and
services furnished during 2017, a
department of a provider (as so
defined) not described in such clause
is deemed to be billing under this
subsection with respect to covered OPD
services furnished prior to November 2,
2015, if the Secretary received from
the provider prior to December 2, 2015,
an attestation (pursuant to section
413.65(b)(3) of title 42 of the Code of
Federal Regulations) that such
department was a department of a
provider (as so defined).
(iv) Alternative exception beginning
with 2018.--For purposes of paragraph
(1)(B)(v) and this paragraph with
respect to applicable items and
services furnished during 2018 or a
subsequent year, the term ``off-campus
outpatient department of a provider''
also shall not include a department of
a provider (as so defined) that is not
described in clause (ii) if--
(I) the Secretary receives
from the provider an
attestation (pursuant to such
section 413.65(b)(3)) not later
than December 31, 2016 (or, if
later, 60 days after the date
of the enactment of this
clause), that such department
met the requirements of a
department of a provider
specified in section 413.65 of
title 42 of the Code of Federal
Regulations;
(II) the provider includes
such department as part of the
provider on its enrollment form
in accordance with the
enrollment process under
section 1866(j); and
(III) the department met the
mid-build requirement of clause
(v) and the Secretary receives,
not later than 60 days after
the date of the enactment of
this clause, from the chief
executive officer or chief
operating officer of the
provider a written
certification that the
department met such
requirement.
(v) Mid-build requirement
described.--The mid-build requirement
of this clause is, with respect to a
department of a provider, that before
November 2, 2015, the provider had a
binding written agreement with an
outside unrelated party for the actual
construction of such department.
(vi) Exclusion for certain cancer
hospitals.--For purposes of paragraph
(1)(B)(v) and this paragraph with
respect to applicable items and
services furnished during 2017 or a
subsequent year, the term ``off-campus
outpatient department of a provider''
also shall not include a department of
a provider (as so defined) that is not
described in clause (ii) if the
provider is a hospital described in
section 1886(d)(1)(B)(v) and--
(I) in the case of a
department that met the
requirements of section 413.65
of title 42 of the Code of
Federal Regulations after
November 1, 2015, and before
the date of the enactment of
this clause, the Secretary
receives from the provider an
attestation that such
department met such
requirements not later than 60
days after such date of
enactment; or
(II) in the case of a
department that meets such
requirements after such date of
enactment, the Secretary
receives from the provider an
attestation that such
department meets such
requirements not later than 60
days after the date such
requirements are first met with
respect to such department.
(vii) Audit.--Not later than December
31, 2018, the Secretary shall audit the
compliance with requirements of clause
(iv) with respect to each department of
a provider to which such clause
applies. Not later than 2 years after
the date the Secretary receives an
attestation under clause (vi) relating
to compliance of a department of a
provider with requirements referred to
in such clause, the Secretary shall
audit the compliance with such
requirements with respect to the
department. If the Secretary finds as a
result of an audit under this clause
that the applicable requirements were
not met with respect to such
department, the department shall not be
excluded from the term ``off-campus
outpatient department of a provider''
under such clause.
(viii) Implementation.--For purposes
of implementing clauses (iii) through
(vii):
(I) Notwithstanding any other
provision of law, the Secretary
may implement such clauses by
program instruction or
otherwise.
(II) Subchapter I of chapter
35 of title 44, United States
Code, shall not apply.
(III) For purposes of
carrying out this subparagraph
with respect to clauses (iii)
and (iv) (and clause (vii)
insofar as it relates to clause
(iv)), $10,000,000 shall be
available from the Federal
Supplementary Medical Insurance
Trust Fund under section 1841,
to remain available until
December 31, 2018. For purposes
of carrying out this
subparagraph with respect to
clause (vi) (and clause (vii)
insofar as it relates to such
clause), $2,000,000 shall be
available from the Federal
Supplementary Medical Insurance
Trust Fund under section 1841,
to remain available until
expended.
(C) Availability of payment under other
payment systems.--Payments for applicable items
and services furnished by an off-campus
outpatient department of a provider that are
described in paragraph (1)(B)(v) shall be made
under the applicable payment system under this
part (other than under this subsection) if the
requirements for such payment are otherwise
met.
(D) Information needed for implementation.--
Each hospital shall provide to the Secretary
such information as the Secretary determines
appropriate to implement this paragraph and
paragraph (1)(B)(v) (which may include
reporting of information on a hospital claim
using a code or modifier and reporting
information about off-campus outpatient
departments of a provider on the enrollment
form described in section 1866(j)).
(E) Limitations.--There shall be no
administrative or judicial review under section
1869, section 1878, or otherwise of the
following:
(i) The determination of the
applicable items and services under
subparagraph (A) and applicable payment
systems under subparagraph (C).
(ii) The determination of whether a
department of a provider meets the term
described in subparagraph (B).
(iii) Any information that hospitals
are required to report pursuant to
subparagraph (D).
(iv) The determination of an audit
under subparagraph (B)(vii).
(22) Review and revisions of payments for non-opioid
alternative treatments.--
(A) In general.--With respect to payments
made under this subsection for covered OPD
services (or groups of services), including
covered OPD services assigned to a
comprehensive ambulatory payment
classification, the Secretary--
(i) shall, as soon as practicable,
conduct a review (part of which may
include a request for information) of
payments for opioids and evidence-based
non-opioid alternatives for pain
management (including drugs and
devices, nerve blocks, surgical
injections, and neuromodulation) with a
goal of ensuring that there are not
financial incentives to use opioids
instead of non-opioid alternatives;
(ii) may, as the Secretary determines
appropriate, conduct subsequent reviews
of such payments; and
(iii) shall consider the extent to
which revisions under this subsection
to such payments (such as the creation
of additional groups of covered OPD
services to classify separately those
procedures that utilize opioids and
non-opioid alternatives for pain
management) would reduce payment
incentives to use opioids instead of
non-opioid alternatives for pain
management.
(B) Priority.--In conducting the review under
clause (i) of subparagraph (A) and considering
revisions under clause (iii) of such
subparagraph, the Secretary shall focus on
covered OPD services (or groups of services)
assigned to a comprehensive ambulatory payment
classification, ambulatory payment
classifications that primarily include surgical
services, and other services determined by the
Secretary which generally involve treatment for
pain management.
(C) Revisions.--If the Secretary identifies
revisions to payments pursuant to subparagraph
(A)(iii), the Secretary shall, as determined
appropriate, begin making such revisions for
services furnished on or after January 1, 2020.
Revisions under the previous sentence shall be
treated as adjustments for purposes of
application of paragraph (9)(B).
(D) Rules of construction.--Nothing in this
paragraph shall be construed to preclude the
Secretary--
(i) from conducting a demonstration
before making the revisions described
in subparagraph (C); or
(ii) prior to implementation of this
paragraph, from changing payments under
this subsection for covered OPD
services (or groups of services) which
include opioids or non-opioid
alternatives for pain management.
(u) Incentive Payments for Physician Scarcity Areas.--
(1) In general.--In the case of physicians' services
furnished on or after January 1, 2005, and before July
1, 2008--
(A) by a primary care physician in a primary
care scarcity county (identified under
paragraph (4)); or
(B) by a physician who is not a primary care
physician in a specialist care scarcity county
(as so identified),
in addition to the amount of payment that would
otherwise be made for such services under this part,
there also shall be paid an amount equal to 5 percent
of the payment amount for the service under this part.
(2) Determination of ratios of physicians to medicare
beneficiaries in area.--Based upon available data, the
Secretary shall establish for each county or equivalent
area in the United States, the following:
(A) Number of physicians practicing in the
area.--The number of physicians who furnish
physicians' services in the active practice of
medicine or osteopathy in that county or area,
other than physicians whose practice is
exclusively for the Federal Government,
physicians who are retired, or physicians who
only provide administrative services. Of such
number, the number of such physicians who are--
(i) primary care physicians; or
(ii) physicians who are not primary
care physicians.
(B) Number of medicare beneficiaries residing
in the area.--The number of individuals who are
residing in the county and are entitled to
benefits under part A or enrolled under this
part, or both (in this subsection referred to
as ``individuals'').
(C) Determination of ratios.--
(i) Primary care ratio.--The ratio
(in this paragraph referred to as the
``primary care ratio'') of the number
of primary care physicians (determined
under subparagraph (A)(i)), to the
number of individuals determined under
subparagraph (B).
(ii) Specialist care ratio.--The
ratio (in this paragraph referred to as
the ``specialist care ratio'') of the
number of other physicians (determined
under subparagraph (A)(ii)), to the
number of individuals determined under
subparagraph (B).
(3) Ranking of counties.--The Secretary shall rank
each such county or area based separately on its
primary care ratio and its specialist care ratio.
(4) Identification of counties.--
(A) In general.--The Secretary shall
identify--
(i) those counties and areas (in this
paragraph referred to as ``primary care
scarcity counties'') with the lowest
primary care ratios that represent, if
each such county or area were weighted
by the number of individuals determined
under paragraph (2)(B), an aggregate
total of 20 percent of the total of the
individuals determined under such
paragraph; and
(ii) those counties and areas (in
this subsection referred to as
``specialist care scarcity counties'')
with the lowest specialist care ratios
that represent, if each such county or
area were weighted by the number of
individuals determined under paragraph
(2)(B), an aggregate total of 20
percent of the total of the individuals
determined under such paragraph.
(B) Periodic revisions.--The Secretary shall
periodically revise the counties or areas
identified in subparagraph (A) (but not less
often than once every three years) unless the
Secretary determines that there is no new data
available on the number of physicians
practicing in the county or area or the number
of individuals residing in the county or area,
as identified in paragraph (2).
(C) Identification of counties where service
is furnished.--For purposes of paying the
additional amount specified in paragraph (1),
if the Secretary uses the 5-digit postal ZIP
Code where the service is furnished, the
dominant county of the postal ZIP Code (as
determined by the United States Postal Service,
or otherwise) shall be used to determine
whether the postal ZIP Code is in a scarcity
county identified in subparagraph (A) or
revised in subparagraph (B).
(D) Special rule.--With respect to
physicians' services furnished on or after
January 1, 2008, and before July 1, 2008, for
purposes of this subsection, the Secretary
shall use the primary care scarcity counties
and the specialty care scarcity counties (as
identified under the preceding provisions of
this paragraph) that the Secretary was using
under this subsection with respect to
physicians' services furnished on December 31,
2007.
(E) Judicial review.--There shall be no
administrative or judicial review under section
1869, 1878, or otherwise, respecting--
116.(i) the identification of a
county or area;
(ii) the assignment of a specialty of
any physician under this paragraph;
(iii) the assignment of a physician
to a county under paragraph (2); or
(iv) the assignment of a postal ZIP
Code to a county or other area under
this subsection.
(5) Rural census tracts.--To the extent feasible, the
Secretary shall treat a rural census tract of a
metropolitan statistical area (as determined under the
most recent modification of the Goldsmith Modification,
originally published in the Federal Register on
February 27, 1992 (57 Fed. Reg. 6725)), as an
equivalent area for purposes of qualifying as a primary
care scarcity county or specialist care scarcity county
under this subsection.
(6) Physician Defined.--For purposes of this
paragraph, the term ``physician'' means a physician
described in section 1861(r)(1) and the term ``primary
care physician'' means a physician who is identified in
the available data as a general practitioner, family
practice practitioner, general internist, or
obstetrician or gynecologist.
(7) Publication of list of counties; posting on
website.--With respect to a year for which a county or
area is identified or revised under paragraph (4), the
Secretary shall identify such counties or areas as part
of the proposed and final rule to implement the
physician fee schedule under section 1848 for the
applicable year. The Secretary shall post the list of
counties identified or revised under paragraph (4) on
the Internet website of the Centers for Medicare &
Medicaid Services.
(v) Increase of FQHC Payment Limits.--In the case of services
furnished by Federally qualified health centers (as defined in
section 1861(aa)(4)), the Secretary shall establish payment
limits with respect to such services under this part for
services furnished--
(1) in 2010, at the limits otherwise established
under this part for such year increased by $5; and
(2) in a subsequent year, at the limits established
under this subsection for the previous year increased
by the percentage increase in the MEI (as defined in
section 1842(i)(3)) for such subsequent year.
(w) Methods of Payment.--The Secretary may develop
alternative methods of payment for items and services provided
under clinical trials and comparative effectiveness studies
sponsored or supported by an agency of the Department of Health
and Human Services, as determined by the Secretary, to those
that would otherwise apply under this section, to the extent
such alternative methods are necessary to preserve the
scientific validity of such trials or studies, such as in the
case where masking the identity of interventions from patients
and investigators is necessary to comply with the particular
trial or study design.
(x) Incentive Payments for Primary Care Services.--
(1) In general.--In the case of primary care services
furnished on or after January 1, 2011, and before
January 1, 2016, by a primary care practitioner, in
addition to the amount of payment that would otherwise
be made for such services under this part, there also
shall be paid (on a monthly or quarterly basis) an
amount equal to 10 percent of the payment amount for
the service under this part.
(2) Definitions.--In this subsection:
(A) Primary care practitioner.--The term
``primary care practitioner'' means an
individual--
(i) who--
(I) is a physician (as
described in section
1861(r)(1)) who has a primary
specialty designation of family
medicine, internal medicine,
geriatric medicine, or
pediatric medicine; or
(II) is a nurse practitioner,
clinical nurse specialist, or
physician assistant (as those
terms are defined in section
1861(aa)(5)); and
(ii) for whom primary care services
accounted for at least 60 percent of
the allowed charges under this part for
such physician or practitioner in a
prior period as determined appropriate
by the Secretary.
(B) Primary care services.--The term
``primary care services'' means services
identified, as of January 1, 2009, by the
following HCPCS codes (and as subsequently
modified by the Secretary):
(i) 99201 through 99215.
(ii) 99304 through 99340.
(iii) 99341 through 99350.
(3) Coordination with other payments.--The amount of
the additional payment for a service under this
subsection and subsection (m) shall be determined
without regard to any additional payment for the
service under subsection (m) and this subsection,
respectively. The amount of the additional payment for
a service under this subsection and subsection (z)
shall be determined without regard to any additional
payment for the service under subsection (z) and this
subsection, respectively.
(4) Limitation on review.--There shall be no
administrative or judicial review under section 1869,
1878, or otherwise, respecting the identification of
primary care practitioners under this subsection.
(y) Incentive Payments for Major Surgical Procedures
Furnished in Health Professional Shortage Areas.--
(1) In general.--In the case of major surgical
procedures furnished on or after January 1, 2011, and
before January 1, 2016, by a general surgeon in an area
that is designated (under section 332(a)(1)(A) of the
Public Health Service Act) as a health professional
shortage area as identified by the Secretary prior to
the beginning of the year involved, in addition to the
amount of payment that would otherwise be made for such
services under this part, there also shall be paid (on
a monthly or quarterly basis) an amount equal to 10
percent of the payment amount for the service under
this part.
(2) Definitions.--In this subsection:
(A) General surgeon.--In this subsection, the
term ``general surgeon'' means a physician (as
described in section 1861(r)(1)) who has
designated CMS specialty code 02-General
Surgery as their primary specialty code in the
physician's enrollment under section 1866(j).
(B) Major surgical procedures.--The term
``major surgical procedures'' means physicians'
services which are surgical procedures for
which a 10-day or 90-day global period is used
for payment under the fee schedule under
section 1848(b).
(3) Coordination with other payments.--The amount of
the additional payment for a service under this
subsection and subsection (m) shall be determined
without regard to any additional payment for the
service under subsection (m) and this subsection,
respectively. The amount of the additional payment for
a service under this subsection and subsection (z)
shall be determined without regard to any additional
payment for the service under subsection (z) and this
subsection, respectively.
(4) Application.--The provisions of paragraph (2) and
(4) of subsection (m) shall apply to the determination
of additional payments under this subsection in the
same manner as such provisions apply to the
determination of additional payments under subsection
(m).
(z) Incentive Payments for Participation in Eligible
Alternative Payment Models.--
(1) Payment incentive.--
(A) In general.--In the case of covered
professional services furnished by an eligible
professional during a year that is in the
period beginning with 2019 and ending with 2024
and for which the professional is a qualifying
APM participant with respect to such year, in
addition to the amount of payment that would
otherwise be made for such covered professional
services under this part for such year, there
also shall be paid to such professional an
amount equal to 5 percent of the estimated
aggregate payment amounts for such covered
professional services under this part for the
preceding year. For purposes of the previous
sentence, the payment amount for the preceding
year may be an estimation for the full
preceding year based on a period of such
preceding year that is less than the full year.
The Secretary shall establish policies to
implement this subparagraph in cases in which
payment for covered professional services
furnished by a qualifying APM participant in an
alternative payment model--
(i) is made to an eligible
alternative payment entity rather than
directly to the qualifying APM
participant; or
(ii) is made on a basis other than a
fee-for-service basis (such as payment
on a capitated basis).
(B) Form of payment.--Payments under this
subsection shall be made in a lump sum, on an
annual basis, as soon as practicable.
(C) Treatment of payment incentive.--Payments
under this subsection shall not be taken into
account for purposes of determining actual
expenditures under an alternative payment model
and for purposes of determining or rebasing any
benchmarks used under the alternative payment
model.
(D) Coordination.--The amount of the
additional payment under this subsection or
subsection (m) shall be determined without
regard to any additional payment under
subsection (m) and this subsection,
respectively. The amount of the additional
payment under this subsection or subsection (x)
shall be determined without regard to any
additional payment under subsection (x) and
this subsection, respectively. The amount of
the additional payment under this subsection or
subsection (y) shall be determined without
regard to any additional payment under
subsection (y) and this subsection,
respectively.
(2) Qualifying apm participant.--For purposes of this
subsection, the term ``qualifying APM participant''
means the following:
(A) 2019 and 2020.--With respect to 2019 and
2020, an eligible professional for whom the
Secretary determines that at least 25 percent
of payments under this part for covered
professional services furnished by such
professional during the most recent period for
which data are available (which may be less
than a year) were attributable to such services
furnished under this part through an eligible
alternative payment entity.
(B) 2021 and 2022.--With respect to 2021 and
2022, an eligible professional described in
either of the following clauses:
(i) Medicare payment threshold
option.--An eligible professional for
whom the Secretary determines that at
least 50 percent of payments under this
part for covered professional services
furnished by such professional during
the most recent period for which data
are available (which may be less than a
year) were attributable to such
services furnished under this part
through an eligible alternative payment
entity.
(ii) Combination all-payer and
medicare payment threshold option.--An
eligible professional--
(I) for whom the Secretary
determines, with respect to
items and services furnished by
such professional during the
most recent period for which
data are available (which may
be less than a year), that at
least 50 percent of the sum
of--
(aa) payments
described in clause
(i); and
(bb) all other
payments, regardless of
payer (other than
payments made by the
Secretary of Defense or
the Secretary of
Veterans Affairs and
other than payments
made under title XIX in
a State in which no
medical home or
alternative payment
model is available
under the State program
under that title),
meet the requirement described
in clause (iii)(I) with respect
to payments described in item
(aa) and meet the requirement
described in clause (iii)(II)
with respect to payments
described in item (bb);
(II) for whom the Secretary
determines at least 25 percent
of payments under this part for
covered professional services
furnished by such professional
during the most recent period
for which data are available
(which may be less than a year)
were attributable to such
services furnished under this
part through an eligible
alternative payment entity; and
(III) who provides to the
Secretary such information as
is necessary for the Secretary
to make a determination under
subclause (I), with respect to
such professional.
(iii) Requirement.--For purposes of
clause (ii)(I)--
(I) the requirement described
in this subclause, with respect
to payments described in item
(aa) of such clause, is that
such payments are made to an
eligible alternative payment
entity; and
(II) the requirement
described in this subclause,
with respect to payments
described in item (bb) of such
clause, is that such payments
are made under arrangements in
which--
(aa) quality measures
comparable to measures
under the performance
category described in
section
1848(q)(2)(B)(i) apply;
(bb) certified EHR
technology is used; and
(cc) the eligible
professional
participates in an
entity that--
(AA) bears
more than
nominal
financial risk
if actual
aggregate
expenditures
exceeds
expected
aggregate
expenditures;
or
(BB) with
respect to
beneficiaries
under title
XIX, is a
medical home
that meets
criteria
comparable to
medical homes
expanded under
section
1115A(c).
(C) Beginning in 2023.--With respect to 2023
and each subsequent year, an eligible
professional described in either of the
following clauses:
(i) Medicare payment threshold
option.--An eligible professional for
whom the Secretary determines that at
least 75 percent of payments under this
part for covered professional services
furnished by such professional during
the most recent period for which data
are available (which may be less than a
year) were attributable to such
services furnished under this part
through an eligible alternative payment
entity.
(ii) Combination all-payer and
medicare payment threshold option.--An
eligible professional--
(I) for whom the Secretary
determines, with respect to
items and services furnished by
such professional during the
most recent period for which
data are available (which may
be less than a year), that at
least 75 percent of the sum
of--
(aa) payments
described in clause
(i); and
(bb) all other
payments, regardless of
payer (other than
payments made by the
Secretary of Defense or
the Secretary of
Veterans Affairs and
other than payments
made under title XIX in
a State in which no
medical home or
alternative payment
model is available
under the State program
under that title),
meet the requirement described
in clause (iii)(I) with respect
to payments described in item
(aa) and meet the requirement
described in clause (iii)(II)
with respect to payments
described in item (bb);
(II) for whom the Secretary
determines at least 25 percent
of payments under this part for
covered professional services
furnished by such professional
during the most recent period
for which data are available
(which may be less than a year)
were attributable to such
services furnished under this
part through an eligible
alternative payment entity; and
(III) who provides to the
Secretary such information as
is necessary for the Secretary
to make a determination under
subclause (I), with respect to
such professional.
(iii) Requirement.--For purposes of
clause (ii)(I)--
(I) the requirement described
in this subclause, with respect
to payments described in item
(aa) of such clause, is that
such payments are made to an
eligible alternative payment
entity; and
(II) the requirement
described in this subclause,
with respect to payments
described in item (bb) of such
clause, is that such payments
are made under arrangements in
which--
(aa) quality measures
comparable to measures
under the performance
category described in
section
1848(q)(2)(B)(i) apply;
(bb) certified EHR
technology is used; and
(cc) the eligible
professional
participates in an
entity that--
(AA) bears
more than
nominal
financial risk
if actual
aggregate
expenditures
exceeds
expected
aggregate
expenditures;
or
(BB) with
respect to
beneficiaries
under title
XIX, is a
medical home
that meets
criteria
comparable to
medical homes
expanded under
section
1115A(c).
(D) Use of patient approach.--The Secretary
may base the determination of whether an
eligible professional is a qualifying APM
participant under this subsection and the
determination of whether an eligible
professional is a partial qualifying APM
participant under section 1848(q)(1)(C)(iii) by
using counts of patients in lieu of using
payments and using the same or similar
percentage criteria (as specified in this
subsection and such section, respectively), as
the Secretary determines appropriate.
(3) Additional definitions.--In this subsection:
(A) Covered professional services.--The term
``covered professional services'' has the
meaning given that term in section
1848(k)(3)(A).
(B) Eligible professional.--The term
``eligible professional'' has the meaning given
that term in section 1848(k)(3)(B) and includes
a group that includes such professionals.
(C) Alternative payment model (apm).--The
term ``alternative payment model'' means, other
than for purposes of subparagraphs
(B)(ii)(I)(bb) and (C)(ii)(I)(bb) of paragraph
(2), any of the following:
(i) A model under section 1115A
(other than a health care innovation
award).
(ii) The shared savings program under
section 1899.
(iii) A demonstration under section
1866C.
(iv) A demonstration required by
Federal law.
(D) Eligible alternative payment entity.--The
term ``eligible alternative payment entity''
means, with respect to a year, an entity that--
(i) participates in an alternative
payment model that--
(I) requires participants in
such model to use certified EHR
technology (as defined in
subsection (o)(4)); and
(II) provides for payment for
covered professional services
based on quality measures
comparable to measures under
the performance category
described in section
1848(q)(2)(B)(i); and
(ii)(I) bears financial risk for
monetary losses under such alternative
payment model that are in excess of a
nominal amount; or
(II) is a medical home expanded under
section 1115A(c).
(4) Limitation.--There shall be no administrative or
judicial review under section 1869, 1878, or otherwise,
of the following:
(A) The determination that an eligible
professional is a qualifying APM participant
under paragraph (2) and the determination that
an entity is an eligible alternative payment
entity under paragraph (3)(D).
(B) The determination of the amount of the 5
percent payment incentive under paragraph
(1)(A), including any estimation as part of
such determination.
[(z)] (aa) Medical Review of Spinal Subluxation Services.--
(1) In general.--The Secretary shall implement a
process for the medical review (as described in
paragraph (2)) of treatment by a chiropractor described
in section 1861(r)(5) by means of manual manipulation
of the spine to correct a subluxation (as described in
such section) of an individual who is enrolled under
this part and apply such process to such services
furnished on or after January 1, 2017, focusing on
services such as--
(A) services furnished by a such a
chiropractor whose pattern of billing is
aberrant compared to peers; and
(B) services furnished by such a chiropractor
who, in a prior period, has a services denial
percentage in the 85th percentile or greater,
taking into consideration the extent that
service denials are overturned on appeal.
(2) Medical review.--
(A) Prior authorization medical review.--
(i) In general.--Subject to clause
(ii), the Secretary shall use prior
authorization medical review for
services described in paragraph (1)
that are furnished to an individual by
a chiropractor described in section
1861(r)(5) that are part of an episode
of treatment that includes more than 12
services. For purposes of the preceding
sentence, an episode of treatment shall
be determined by the underlying cause
that justifies the need for services,
such as a diagnosis code.
(ii) Ending application of prior
authorization medical review.--The
Secretary shall end the application of
prior authorization medical review
under clause (i) to services described
in paragraph (1) by such a chiropractor
if the Secretary determines that the
chiropractor has a low denial rate
under such prior authorization medical
review. The Secretary may subsequently
reapply prior authorization medical
review to such chiropractor if the
Secretary determines it to be
appropriate and the chiropractor has,
in the time period subsequent to the
determination by the Secretary of a low
denial rate with respect to the
chiropractor, furnished such services
described in paragraph (1).
(iii) Early request for prior
authorization review permitted.--
Nothing in this subsection shall be
construed to prevent such a
chiropractor from requesting prior
authorization for services described in
paragraph (1) that are to be furnished
to an individual before the
chiropractor furnishes the twelfth such
service to such individual for an
episode of treatment.
(B) Type of review.--The Secretary may use
pre-payment review or post-payment review of
services described in section 1861(r)(5) that
are not subject to prior authorization medical
review under subparagraph (A).
(C) Relationship to law enforcement
activities.--The Secretary may determine that
medical review under this subsection does not
apply in the case where potential fraud may be
involved.
(3) No payment without prior authorization.--With
respect to a service described in paragraph (1) for
which prior authorization medical review under this
subsection applies, the following shall apply:
(A) Prior authorization determination.--The
Secretary shall make a determination, prior to
the service being furnished, of whether the
service would or would not meet the applicable
requirements of section 1862(a)(1)(A).
(B) Denial of payment.--Subject to paragraph
(5), no payment may be made under this part for
the service unless the Secretary determines
pursuant to subparagraph (A) that the service
would meet the applicable requirements of such
section 1862(a)(1)(A).
(4) Submission of information.--A chiropractor
described in section 1861(r)(5) may submit the
information necessary for medical review by fax, by
mail, or by electronic means. The Secretary shall make
available the electronic means described in the
preceding sentence as soon as practicable.
(5) Timeliness.--If the Secretary does not make a
prior authorization determination under paragraph
(3)(A) within 14 business days of the date of the
receipt of medical documentation needed to make such
determination, paragraph (3)(B) shall not apply.
(6) Application of limitation on beneficiary
liability.--Where payment may not be made as a result
of the application of paragraph (2)(B), section 1879
shall apply in the same manner as such section applies
to a denial that is made by reason of section
1862(a)(1).
(7) Review by contractors.--The medical review
described in paragraph (2) may be conducted by medicare
administrative contractors pursuant to section
1874A(a)(4)(G) or by any other contractor determined
appropriate by the Secretary that is not a recovery
audit contractor.
(8) Multiple services.--The Secretary shall, where
practicable, apply the medical review under this
subsection in a manner so as to allow an individual
described in paragraph (1) to obtain, at a single time
rather than on a service-by-service basis, an
authorization in accordance with paragraph (3)(A) for
multiple services.
(9) Construction.--With respect to a service
described in paragraph (1) that has been affirmed by
medical review under this subsection, nothing in this
subsection shall be construed to preclude the
subsequent denial of a claim for such service that does
not meet other applicable requirements under this Act.
(10) Implementation.--
(A) Authority.--The Secretary may implement
the provisions of this subsection by interim
final rule with comment period.
(B) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to medical
review under this subsection.
(bb) Additional Payments for Certain Rural Health Clinics
With Physicians or Practitioners Receiving DATA 2000 Waivers.--
(1) In general.--In the case of a rural health clinic
with respect to which, beginning on or after January 1,
2019, rural health clinic services (as defined in
section 1861(aa)(1)) are furnished for the treatment of
opioid use disorder by a physician or practitioner who
meets the requirements described in paragraph (3), the
Secretary shall, subject to availability of funds under
paragraph (4), make a payment (at such time and in such
manner as specified by the Secretary) to such rural
health clinic after receiving and approving an
application described in paragraph (2). Such payment
shall be in an amount determined by the Secretary,
based on an estimate of the average costs of training
for purposes of receiving a waiver described in
paragraph (3)(B). Such payment may be made only one
time with respect to each such physician or
practitioner.
(2) Application.--In order to receive a payment
described in paragraph (1), a rural health clinic shall
submit to the Secretary an application for such a
payment at such time, in such manner, and containing
such information as specified by the Secretary. A rural
health clinic may apply for such a payment for each
physician or practitioner described in paragraph (1)
furnishing services described in such paragraph at such
clinic.
(3) Requirements.--For purposes of paragraph (1), the
requirements described in this paragraph, with respect
to a physician or practitioner, are the following:
(A) The physician or practitioner is employed
by or working under contract with a rural
health clinic described in paragraph (1) that
submits an application under paragraph (2).
(B) The physician or practitioner first
receives a waiver under section 303(g) of the
Controlled Substances Acton or after January 1,
2019.
(4) Funding.--For purposes of making payments under
this subsection, there are appropriated, out of amounts
in the Treasury not otherwise appropriated, $2,000,000,
which shall remain available until expended.
SPECIAL PAYMENT RULES FOR PARTICULAR ITEMS AND SERVICES
Sec. 1834. (a) Payment for Durable Medical Equipment.--
(1) General rule for payment.--
(A) In general.--With respect to a covered
item (as defined in paragraph (13)) for which
payment is determined under this subsection,
payment shall be made in the frequency
specified in paragraphs (2) through (7) and in
an amount equal to 80 percent of the payment
basis described in subparagraph (B).
(B) Payment basis.--Subject to subparagraph
(F)(i), the payment basis described in this
subparagraph is the lesser of--
(i) the actual charge for the item,
or
(ii) the payment amount recognized
under paragraphs (2) through (7) of
this subsection for the item;
except that clause (i) shall not apply if the
covered item is furnished by a public home
health agency (or by another home health agency
which demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
(C) Exclusive payment rule.--Subject to
subparagraph (F)(ii), this subsection shall
constitute the exclusive provision of this
title for payment for covered items under this
part or under part A to a home health agency.
(D) Reduction in fee schedules for certain
items.--With respect to a seat-lift chair or
transcutaneous electrical nerve stimulator
furnished on or after April 1, 1990, the
Secretary shall reduce the payment amount
applied under subparagraph (B)(ii) for such an
item by 15 percent, and, in the case of a
transcutaneous electrical nerve stimulator
furnished on or after January 1, 1991, the
Secretary shall further reduce such payment
amount (as previously reduced) by 45 percent.
(E) Clinical conditions for coverage.--
(i) In general.--The Secretary shall
establish standards for clinical
conditions for payment for covered
items under this subsection.
(ii) Requirements.--The standards
established under clause (i) shall
include the specification of types or
classes of covered items that require,
as a condition of payment under this
subsection, a face-to-face examination
of the individual by a physician (as
defined in section 1861(r)), a
physician assistant, nurse
practitioner, or a clinical nurse
specialist (as those terms are defined
in section 1861(aa)(5)) and a
prescription for the item.
(iii) Priority of establishment of
standards.--In establishing the
standards under this subparagraph, the
Secretary shall first establish
standards for those covered items for
which the Secretary determines there
has been a proliferation of use,
consistent findings of charges for
covered items that are not delivered,
or consistent findings of falsification
of documentation to provide for payment
of such covered items under this part.
(iv) Standards for power
wheelchairs.--Effective on the date of
the enactment of this subparagraph, in
the case of a covered item consisting
of a motorized or power wheelchair for
an individual, payment may not be made
for such covered item unless a
physician (as defined in section
1861(r)(1)), a physician assistant,
nurse practitioner, or a clinical nurse
specialist (as those terms are defined
in section 1861(aa)(5)) has conducted a
face-to-face examination of the
individual and written a prescription
for the item.
(v) Limitation on payment for covered
items.--Payment may not be made for a
covered item under this subsection
unless the item meets any standards
established under this subparagraph for
clinical condition of coverage.
(F) Application of competitive acquisition;
limitation of inherent reasonableness
authority.--In the case of covered items
furnished on or after January 1, 2011, subject
to subparagraphs (G) and (H), that are included
in a competitive acquisition program in a
competitive acquisition area under section
1847(a)--
(i) the payment basis under this
subsection for such items and services
furnished in such area shall be the
payment basis determined under such
competitive acquisition program;
(ii) the Secretary may (and, in the
case of covered items furnished on or
after January 1, 2016, subject to
clause (iii), shall) use information on
the payment determined under such
competitive acquisition programs to
adjust the payment amount otherwise
recognized under subparagraph (B)(ii)
for an area that is not a competitive
acquisition area under section 1847 and
in the case of such adjustment,
paragraph (10)(B) shall not be applied;
and
(iii) in the case of covered items
furnished on or after January 1, 2016,
the Secretary shall continue to make
such adjustments described in clause
(ii) as, under such competitive
acquisition programs, additional
covered items are phased in or
information is updated as contracts
under section 1847 are recompeted in
accordance with section 1847(b)(3)(B).
(G) Use of information on competitive bid
rates.--The Secretary shall specify by
regulation the methodology to be used in
applying the provisions of subparagraph (F)(ii)
and subsection (h)(1)(H)(ii). In promulgating
such regulation, the Secretary shall consider
the costs of items and services in areas in
which such provisions would be applied compared
to the payment rates for such items and
services in competitive acquisition areas.In
the case of items and services furnished on or
after January 1, 2019, in making any
adjustments under clause (ii) or (iii) of
subparagraph (F), under subsection
(h)(1)(H)(ii), or under section 1842(s)(3)(B),
the Secretary shall--
(i) solicit and take into account
stakeholder input; and
(ii) take into account the highest
amount bid by a winning supplier in a
competitive acquisition area and a
comparison of each of the following
with respect to non-competitive
acquisition areas and competitive
acquisition areas:
(I) The average travel
distance and cost associated
with furnishing items and
services in the area.
(II) The average volume of
items and services furnished by
suppliers in the area.
(III) The number of suppliers
in the area.
(H) Diabetic supplies.--
(i) In general.--On or after the date
described in clause (ii), the payment
amount under this part for diabetic
supplies, including testing strips,
that are non-mail order items (as
defined by the Secretary) shall be
equal to the single payment amounts
established under the national mail
order competition for diabetic supplies
under section 1847.
(ii) Date described.--The date
described in this clause is the date of
the implementation of the single
payment amounts under the national mail
order competition for diabetic supplies
under section 1847.
(I) Treatment of vacuum erection systems.--
Effective for items and services furnished on
and after July 1, 2015, vacuum erection systems
described as prosthetic devices described in
section 1861(s)(8) shall be treated in the same
manner as erectile dysfunction drugs are
treated for purposes of section 1860D-
2(e)(2)(A).
(2) Payment for inexpensive and other routinely
purchased durable medical equipment.--
(A) In general.--Payment for an item of
durable medical equipment (as defined in
paragraph (13))--
(i) the purchase price of which does
not exceed $150,
(ii) which the Secretary determines
is acquired at least 75 percent of the
time by purchase,
(iii) which is an accessory used in
conjunction with a nebulizer,
aspirator, or a ventilator excluded
under paragraph (3)(A), or
(iv) in the case of devices furnished
on or after October 1, 2015, which
serves as a speech generating device or
which is an accessory that is needed
for the individual to effectively
utilize such a device,
shall be made on a rental basis or in a lump-
sum amount for the purchase of the item. The
payment amount recognized for purchase or
rental of such equipment is the amount
specified in subparagraph (B) for purchase or
rental, except that the total amount of
payments with respect to an item may not exceed
the payment amount specified in subparagraph
(B) with respect to the purchase of the item.
(B) Payment amount.--For purposes of
subparagraph (A), the amount specified in this
subparagraph, with respect to the purchase or
rental of an item furnished in a carrier
service area--
(i) in 1989 and in 1990 is the
average reasonable charge in the area
for the purchase or rental,
respectively, of the item for the 12-
month period ending on June 30, 1987,
increased by the percentage increase in
the consumer price index for all urban
consumers (U.S. city average) for the
6-month period ending with December
1987;
(ii) in 1991 is the sum of (I) 67
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(I) for 1991, and
(II) 33 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1991;
(iii) in 1992 is the sum of (I) 33
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(II) for 1992, and
(II) 67 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1992; and
(iv) in 1993 and each subsequent year
is the national limited payment amount
for the item or device computed under
subparagraph (C)(ii) for that year
(reduced by 10 percent, in the case of
a blood glucose testing strip furnished
after 1997 for an individual with
diabetes).
(C) Computation of local payment amount and
national limited payment amount.--For purposes
of subparagraph (B)--
(i) the local payment amount for an
item or device for a year is equal to--
(I) for 1991, the amount
specified in subparagraph
(B)(i) for 1990 increased by
the covered item update for
1991, and
(II) for 1992, 1993, and 1994
the amount determined under
this clause for the preceding
year increased by the covered
item update for the year; and
(ii) the national limited payment
amount for an item or device for a year
is equal to--
(I) for 1991, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the weighted
average of all local payment
amounts determined under such
clause for such item for that
year and may not be less than
85 percent of the weighted
average of all local payment
amounts determined under such
clause for such item,
(II) for 1992 and 1993, the
amount determined under this
clause for the preceding year
increased by the covered item
update for such subsequent
year,
(III) for 1994, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the median of
all local payment amounts
determined under such clause
for such item for that year and
may not be less than 85 percent
of the median of all local
payment amounts determined
under such clause for such item
or device for that year, and
(IV) for each subsequent
year, the amount determined
under this clause for the
preceding year increased by the
covered item update for such
subsequent year.
(3) Payment for items requiring frequent and
substantial servicing.--
(A) In general.--Payment for a covered item
(such as IPPB machines and ventilators,
excluding ventilators that are either
continuous airway pressure devices or
intermittent assist devices with continuous
airway pressure devices) for which there must
be frequent and substantial servicing in order
to avoid risk to the patient's health shall be
made on a monthly basis for the rental of the
item and the amount recognized is the amount
specified in subparagraph (B).
(B) Payment amount.--For purposes of
subparagraph (A), the amount specified in this
subparagraph, with respect to an item or device
furnished in a carrier service area--
(i) in 1989 and in 1990 is the
average reasonable charge in the area
for the rental of the item or device
for the 12-month period ending with
June 1987, increased by the percentage
increase in the consumer price index
for all urban consumers (U.S. city
average) for the 6-month period ending
with December 1987;
(ii) in 1991 is the sum of (I) 67
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(I) for 1991, and
(II) 33 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1991;
(iii) in 1992 is the sum of (I) 33
percent of the local payment amount for
the item or device computed under
subparagraph (C)(i)(II) for 1992, and
(II) 67 percent of the national limited
payment amount for the item or device
computed under subparagraph (C)(ii) for
1992; and
(iv) in 1993 and each subsequent year
is the national limited payment amount
for the item or device computed under
subparagraph (C)(ii) for that year.
(C) Computation of local payment amount and
national limited payment amount.--For purposes
of subparagraph (B)--
(i) the local payment amount for an
item or device for a year is equal to--
(I) for 1991, the amount
specified in subparagraph
(B)(i) for 1990 increased by
the covered item update for
1991, and
(II) for 1992, 1993, and 1994
the amount determined under
this clause for the preceding
year increased by the covered
item update for the year; and
(ii) the national limited payment
amount for an item or device for a year
is equal to--
(I) for 1991, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the weighted
average of all local payment
amounts determined under such
clause for such item for that
year and may not be less than
85 percent of the weighted
average of all local payment
amounts determined under such
clause for such item,
(II) for 1992 and 1993, the
amount determined under this
clause for the preceding year
increased by the covered item
update for such subsequent
year,
(III) for 1994, the local
payment amount determined under
clause (i) for such item or
device for that year, except
that the national limited
payment amount may not exceed
100 percent of the median of
all local payment amounts
determined under such clause
for such item for that year and
may not be less than 85 percent
of the median of all local
payment amounts determined
under such clause for such item
or device for that year, and
(IV) for each subsequent
year, the amount determined
under this clause for the
preceding year increased by the
covered item update for such
subsequent year.
(4) Payment for certain customized items.--Payment
with respect to a covered item that is uniquely
constructed or substantially modified to meet the
specific needs of an individual patient, and for that
reason cannot be grouped with similar items for
purposes of payment under this title, shall be made in
a lump-sum amount (A) for the purchase of the item in a
payment amount based upon the carrier's individual
consideration for that item, and (B) for the reasonable
and necessary maintenance and servicing for parts and
labor not covered by the supplier's or manufacturer's
warranty, when necessary during the period of medical
need, and the amount recognized for such maintenance
and servicing shall be paid on a lump-sum, as needed
basis based upon the carrier's individual consideration
for that item. In the case of a wheelchair furnished on
or after January 1, 1992, the wheelchair shall be
treated as a customized item for purposes of this
paragraph if the wheelchair has been measured, fitted,
or adapted in consideration of the patient's body size,
disability, period of need, or intended use, and has
been assembled by a supplier or ordered from a
manufacturer who makes available customized features,
modifications, or components for wheelchairs that are
intended for an individual patient's use in accordance
with instructions from the patient's physician.
(5) Payment for oxygen and oxygen equipment.--
(A) In general.--Payment for oxygen and
oxygen equipment shall be made on a monthly
basis in the monthly payment amount recognized
under paragraph (9) for oxygen and oxygen
equipment (other than portable oxygen
equipment), subject to subparagraphs (B), (C),
(E), and (F).
(B) Add-on for portable oxygen equipment.--
When portable oxygen equipment is used, but
subject to subparagraph (D), the payment amount
recognized under subparagraph (A) shall be
increased by the monthly payment amount
recognized under paragraph (9) for portable
oxygen equipment.
(C) Volume adjustment.--When the attending
physician prescribes an oxygen flow rate--
(i) exceeding 4 liters per minute,
the payment amount recognized under
subparagraph (A), subject to
subparagraph (D), shall be increased by
50 percent, or
(ii) of less than 1 liter per minute,
the payment amount recognized under
subparagraph (A) shall be decreased by
50 percent.
(D) Limit on adjustment.--When portable
oxygen equipment is used and the attending
physician prescribes an oxygen flow rate
exceeding 4 liters per minute, there shall only
be an increase under either subparagraph (B) or
(C), whichever increase is larger, and not
under both such subparagraphs.
(E) Recertification for patients receiving
home oxygen therapy.--In the case of a patient
receiving home oxygen therapy services who, at
the time such services are initiated, has an
initial arterial blood gas value at or above a
partial pressure of 56 or an arterial oxygen
saturation at or above 89 percent (or such
other values, pressures, or criteria as the
Secretary may specify) no payment may be made
under this part for such services after the
expiration of the 90-day period that begins on
the date the patient first receives such
services unless the patient's attending
physician certifies that, on the basis of a
follow-up test of the patient's arterial blood
gas value or arterial oxygen saturation
conducted during the final 30 days of such 90-
day period, there is a medical need for the
patient to continue to receive such services.
(F) Rental Cap.--
(i) In general.--Payment for oxygen
equipment (including portable oxygen
equipment) under this paragraph may not
extend over a period of continuous use
(as determined by the Secretary) of
longer than 36 months.
(ii) Payments and rules after rental
cap.--After the 36th continuous month
during which payment is made for the
equipment under this paragraph--
(I) the supplier furnishing
such equipment under this
subsection shall continue to
furnish the equipment during
any period of medical need for
the remainder of the reasonable
useful lifetime of the
equipment, as determined by the
Secretary;
(II) payments for oxygen
shall continue to be made in
the amount recognized for
oxygen under paragraph (9) for
the period of medical need; and
(III) maintenance and
servicing payments shall, if
the Secretary determines such
payments are reasonable and
necessary, be made (for parts
and labor not covered by the
supplier's or manufacturer's
warranty, as determined by the
Secretary to be appropriate for
the equipment), and such
payments shall be in an amount
determined to be appropriate by
the Secretary.
(6) Payment for other covered items (other than
durable medical equipment).--Payment for other covered
items (other than durable medical equipment and other
covered items described in paragraph (3), (4), or (5))
shall be made in a lump-sum amount for the purchase of
the item in the amount of the purchase price recognized
under paragraph (8).
(7) Payment for other items of durable medical
equipment.--
(A) Payment.--In the case of an item of
durable medical equipment not described in
paragraphs (2) through (6), the following rules
shall apply:
(i) Rental.--
(I) In general.--Except as
provided in clause (iii),
payment for the item shall be
made on a monthly basis for the
rental of the item during the
period of medical need (but
payments under this clause may
not extend over a period of
continuous use (as determined
by the Secretary) of longer
than 13 months).
(II) Payment amount.--Subject
to subclause (III) and
subparagraph (B), the amount
recognized for the item, for
each of the first 3 months of
such period, is 10 percent of
the purchase price recognized
under paragraph (8) with
respect to the item, and, for
each of the remaining months of
such period, is 7.5 percent of
such purchase price.
(III) Special rule for power-
driven wheelchairs.--For
purposes of payment for power-
driven wheelchairs, subclause
(II) shall be applied by
substituting ``15 percent'' and
``6 percent'' for ``10
percent'' and ``7.5 percent'',
respectively.
(ii) Ownership after rental.--On the
first day that begins after the 13th
continuous month during which payment
is made for the rental of an item under
clause (i), the supplier of the item
shall transfer title to the item to the
individual.
(iii) Purchase agreement option for
complex, rehabilitative power-driven
wheelchairs.--In the case of a complex,
rehabilitative power-driven wheelchair,
at the time the supplier furnishes the
item, the supplier shall offer the
individual the option to purchase the
item, and payment for such item shall
be made on a lump-sum basis if the
individual exercises such option.
(iv) Maintenance and servicing.--
After the supplier transfers title to
the item under clause (ii) or in the
case of a power-driven wheelchair for
which a purchase agreement has been
entered into under clause (iii),
maintenance and servicing payments
shall, if the Secretary determines such
payments are reasonable and necessary,
be made (for parts and labor not
covered by the supplier's or
manufacturer's warranty, as determined
by the Secretary to be appropriate for
the particular type of durable medical
equipment), and such payments shall be
in an amount determined to be
appropriate by the Secretary.
(B) Range for rental amounts.--
(i) For 1989.--For items furnished
during 1989, the payment amount
recognized under subparagraph (A)(i)
shall not be more than 115 percent, and
shall not be less than 85 percent, of
the prevailing charge established for
rental of the item in January 1987,
increased by the percentage increase in
the consumer price index for all urban
consumers (U.S. city average) for the
6-month period ending with December
1987.
(ii) For 1990.--For items furnished
during 1990, clause (i) shall apply in
the same manner as it applies to items
furnished during 1989.
(C) Replacement of items.--
(i) Establishment of reasonable
useful lifetime.--In accordance with
clause (iii), the Secretary shall
determine and establish a reasonable
useful lifetime for items of durable
medical equipment for which payment may
be made under this paragraph.
(ii) Payment for replacement items.--
If the reasonable lifetime of such an
item, as so established, has been
reached during a continuous period of
medical need, or the carrier determines
that the item is lost or irreparably
damaged, the patient may elect to have
payment for an item serving as a
replacement for such item made--
(I) on a monthly basis for
the rental of the replacement
item in accordance with
subparagraph (A); or
(II) in the case of an item
for which a purchase agreement
has been entered into under
subparagraph (A)(iii), in a
lump-sum amount for the
purchase of the item.
(iii) Length of reasonable useful
lifetime.--The reasonable useful
lifetime of an item of durable medical
equipment under this subparagraph shall
be equal to 5 years, except that, if
the Secretary determines that, on the
basis of prior experience in making
payments for such an item under this
title, a reasonable useful lifetime of
5 years is not appropriate with respect
to a particular item, the Secretary
shall establish an alternative
reasonable lifetime for such item.
(8) Purchase price recognized for miscellaneous
devices and items.--For purposes of paragraphs (6) and
(7), the amount that is recognized under this paragraph
as the purchase price for a covered item is the amount
described in subparagraph (C) of this paragraph,
determined as follows:
(A) Computation of local purchase price.--
Each carrier under section 1842 shall compute a
base local purchase price for the item as
follows:
(i) The carrier shall compute a base
local purchase price, for each item
described--
(I) in paragraph (6) equal to
the average reasonable charge
in the locality for the
purchase of the item for the
12-month period ending with
June 1987, or
(II) in paragraph (7) equal
to the average of the purchase
prices on the claims submitted
on an assignment-related basis
for the unused item supplied
during the 6-month period
ending with December 1986.
(ii) The carrier shall compute a
local purchase price, with respect to
the furnishing of each particular
item--
(I) in 1989 and 1990, equal
to the base local purchase
price computed under clause (i)
increased by the percentage
increase in the consumer price
index for all urban consumers
(U.S. city average) for the 6-
month period ending with
December 1987,
(II) in 1991, equal to the
local purchase price computed
under this clause for the
previous year, increased by the
covered item update for 1991,
and decreased by the percentage
by which the average of the
reasonable charges for claims
paid for all items described in
paragraph (7) is lower than the
average of the purchase prices
submitted for such items during
the final 9 months of 1988; or
(III) in 1992, 1993, and 1994
equal to the local purchase
price computed under this
clause for the previous year
increased by the covered item
update for the year.
(B) Computation of national limited purchase
price.--With respect to the furnishing of a
particular item in a year, the Secretary shall
compute a national limited purchase price--
(i) for 1991, equal to the local
purchase price computed under
subparagraph (A)(ii) for the item for
the year, except that such national
limited purchase price may not exceed
100 percent of the weighted average of
all local purchase prices for the item
computed under such subparagraph for
the year, and may not be less than 85
percent of the weighted average of all
local purchase prices for the item
computed under such subparagraph for
the year;
(ii) for 1992 and 1993, the amount
determined under this subparagraph for
the preceding year increased by the
covered item update for such subsequent
year;
(iii) for 1994, the local purchase
price computed under subparagraph
(A)(ii) for the item for the year,
except that such national limited
purchase price may not exceed 100
percent of the median of all local
purchase prices computed for the item
under such subparagraph for the year
and may not be less than 85 percent of
the median of all local purchase prices
computed under such subparagraph for
the item for the year; and
(iv) for each subsequent year, equal
to the amount determined under this
subparagraph for the preceding year
increased by the covered item update
for such subsequent year.
(C) Purchase price recognized.--For purposes
of paragraphs (6) and (7), the amount that is
recognized under this paragraph as the purchase
price for each item furnished--
(i) in 1989 or 1990, is 100 percent
of the local purchase price computed
under subparagraph (A)(ii)(I);
(ii) in 1991, is the sum of (I) 67
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1991, and (II) 33 percent of the
national limited purchase price
computed under subparagraph (B) for
1991;
(iii) in 1992, is the sum of (I) 33
percent of the local purchase price
computed under subparagraph
(A)(ii)(III) for 1992, and (II) 67
percent of the national limited
purchase price computed under
subparagraph (B) for 1992; and
(iv) in 1993 or a subsequent year, is
the national limited purchase price
computed under subparagraph (B) for
that year.
(9) Monthly payment amount recognized with respect to
oxygen and oxygen equipment.--For purposes of paragraph
(5), the amount that is recognized under this paragraph
for payment for oxygen and oxygen equipment is the
monthly payment amount described in subparagraph (C) of
this paragraph. Such amount shall be computed
separately (i) for all items of oxygen and oxygen
equipment (other than portable oxygen equipment) and
(ii) for portable oxygen equipment (each such group
referred to in this paragraph as an ``item'').
(A) Computation of local monthly payment
rate.--Each carrier under this section shall
compute a base local payment rate for each item
as follows:
(i) The carrier shall compute a base
local average monthly payment rate per
beneficiary as an amount equal to (I)
the total reasonable charges for the
item during the 12-month period ending
with December 1986, divided by (II) the
total number of months for all
beneficiaries receiving the item in the
area during the 12-month period for
which the carrier made payment for the
item under this title.
(ii) The carrier shall compute a
local average monthly payment rate for
the item applicable--
(I) to 1989 and 1990, equal
to 95 percent of the base local
average monthly payment rate
computed under clause (i) for
the item increased by the
percentage increase in the
consumer price index for all
urban consumers (U.S. city
average) for the 6-month period
ending with December 1987, or
(II) to 1991, 1992, 1993, and
1994 equal to the local average
monthly payment rate computed
under this clause for the item
for the previous year increased
by the covered item increase
for the year.
(B) Computation of national limited monthly
payment rate.--With respect to the furnishing
of an item in a year, the Secretary shall
compute a national limited monthly payment rate
equal to--
(i) for 1991, the local monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for the year, except that such national
limited monthly payment rate may not
exceed 100 percent of the weighted
average of all local monthly payment
rates computed for the item under such
subparagraph for the year, and may not
be less than 85 percent of the weighted
average of all local monthly payment
rates computed for the item under such
subparagraph for the year;
(ii) for 1992 and 1993, the amount
determined under this subparagraph for
the preceding year increased by the
covered item update for such subsequent
year;
(iii) for 1994, the local monthly
payment rate computed under
subparagraph (A)(ii) for the item for
the year, except that such national
limited monthly payment rate may not
exceed 100 percent of the median of all
local monthly payment rates computed
for the item under such subparagraph
for the year and may not be less than
85 percent of the median of all local
monthly payment rates computed for the
item under such subparagraph for the
year;
(iv) for 1995, 1996, and 1997, equal
to the amount determined under this
subparagraph for the preceding year
increased by the covered item update
for such subsequent year;
(v) for 1998, 75 percent of the
amount determined under this
subparagraph for 1997; and
(vi) for 1999 and each subsequent
year, 70 percent of the amount
determined under this subparagraph for
1997.
(C) Monthly payment amount recognized.--For
purposes of paragraph (5), the amount that is
recognized under this paragraph as the base
monthly payment amount for each item
furnished--
(i) in 1989 and in 1990, is 100
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii) for the item;
(ii) in 1991, is the sum of (I) 67
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for 1991, and (II) 33 percent of the
national limited monthly payment rate
computed under subparagraph (B)(i) for
the item for 1991;
(iii) in 1992, is the sum of (I) 33
percent of the local average monthly
payment rate computed under
subparagraph (A)(ii)(II) for the item
for 1992, and (II) 67 percent of the
national limited monthly payment rate
computed under subparagraph (B)(ii) for
the item for 1992; and
(iv) in a subsequent year, is the
national limited monthly payment rate
computed under subparagraph (B) for the
item for that year.
(10) Exceptions and adjustments.--
(A) Areas outside continental united
states.--Exceptions to the amounts recognized
under the previous provisions of this
subsection shall be made to take into account
the unique circumstances of covered items
furnished in Alaska, Hawaii, or Puerto Rico.
(B) Adjustment for inherent reasonableness.--
The Secretary is authorized to apply the
provisions of paragraphs (8) and (9) of section
1842(b) to covered items and suppliers of such
items and payments under this subsection in an
area and with respect to covered items and
services for which the Secretary does not make
a payment amount adjustment under paragraph
(1)(F).
(C) Transcutaneous electrical nerve
stimulator (tens).--In order to permit an
attending physician time to determine whether
the purchase of a transcutaneous electrical
nerve stimulator is medically appropriate for a
particular patient, the Secretary may determine
an appropriate payment amount for the initial
rental of such item for a period of not more
than 2 months. If such item is subsequently
purchased, the payment amount with respect to
such purchase is the payment amount determined
under paragraph (2).
(11) Improper billing and requirement of physician
order.--
(A) Improper billing for certain rental
items.--Notwithstanding any other provision of
this title, a supplier of a covered item for
which payment is made under this subsection and
which is furnished on a rental basis shall
continue to supply the item without charge
(other than a charge provided under this
subsection for the maintenance and servicing of
the item) after rental payments may no longer
be made under this subsection. If a supplier
knowingly and willfully violates the previous
sentence, the Secretary may apply sanctions
against the supplier under section 1842(j)(2)
in the same manner such sanctions may apply
with respect to a physician.
(B) Requirement of physician order.--
(i) In general.--The Secretary is
authorized to require, for specified
covered items, that payment may be made
under this subsection with respect to
the item only if a physician enrolled
under section 1866(j) or an eligible
professional under section
1848(k)(3)(B) that is enrolled under
section 1866(j) has communicated to the
supplier, before delivery of the item,
a written order for the item.
(ii) Requirement for face to face
encounter.--The Secretary shall require
that such an order be written pursuant
to a physician, a physician assistant,
a nurse practitioner, or a clinical
nurse specialist (as those terms are
defined in section 1861(aa)(5))
documenting such physician, physician
assistant, practitioner, or specialist
has had a face-to-face encounter
(including through use of telehealth
under subsection (m) and other than
with respect to encounters that are
incident to services involved) with the
individual involved during the 6-month
period preceding such written order, or
other reasonable timeframe as
determined by the Secretary.
(12) Regional carriers.--The Secretary may designate,
by regulation under section 1842, one carrier for one
or more entire regions to process all claims within the
region for covered items under this section.
(13) Covered item.--In this subsection, the term
``covered item'' means durable medical equipment (as
defined in section 1861(n)), including such equipment
described in section 1861(m)(5), but not including
implantable items for which payment may be made under
section 1833(t).
(14) Covered item update.--In this subsection, the
term ``covered item update'' means, with respect to a
year--
(A) for 1991 and 1992, the percentage
increase in the consumer price index for all
urban consumers (U.S. city average) for the 12-
month period ending with June of the previous
year reduced by 1 percentage point;
(B) for 1993, 1994, 1995, 1996, and 1997, the
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year;
(C) for each of the years 1998 through 2000,
0 percentage points;
(D) for 2001, the percentage increase in the
consumer price index for all urban consumers
(U.S. city average) for the 12-month period
ending with June 2000;
(E) for 2002, 0 percentage points;
(F) for 2003, the percentage increase in the
consumer price index for all urban consumers
(U.S. urban average) for the 12-month period
ending with June of 2002;
(G) for 2004 through 2006--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage increase described in
subparagraph (B) for the year involved;
and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(H) for 2007--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage change determined by the
Secretary to be appropriate taking into
account recommendations contained in
the report of the Comptroller General
of the United States under section
302(c)(1)(B) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003; and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(I) for 2008--
(i) subject to clause (ii), in the
case of class III medical devices
described in section 513(a)(1)(C) of
the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360(c)(1)(C)), the
percentage increase described in
subparagraph (B) (as applied to the
payment amount for 2007 determined
after the application of the percentage
change under subparagraph (H)(i)); and
(ii) in the case of covered items not
described in clause (i), 0 percentage
points;
(J) for 2009--
(i) in the case of items and services
furnished in any geographic area, if
such items or services were selected
for competitive acquisition in any area
under the competitive acquisition
program under section
1847(a)(1)(B)(i)(I) before July 1,
2008, including related accessories but
only if furnished with such items and
services selected for such competition
and diabetic supplies but only if
furnished through mail order, - 9.5
percent; or
(ii) in the case of other items and
services, the percentage increase in
the consumer price index for all urban
consumers (U.S. urban average) for the
12-month period ending with June 2008;
(K) for 2010, the percentage increase in the
consumer price index for all urban consumers
(U.S. urban average) for the 12-month period
ending with June of the previous year; and
(L) for 2011 and each subsequent year--
(i) the percentage increase in the
consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the previous year, reduced by--
(ii) the productivity adjustment
described in section
1886(b)(3)(B)(xi)(II).
The application of subparagraph (L)(ii) may result in
the covered item update under this paragraph being less
than 0.0 for a year, and may result in payment rates
under this subsection for a year being less than such
payment rates for the preceding year.
(15) Advance determinations of coverage for certain
items.--
(A) Development of lists of items by
secretary.--The Secretary may develop and
periodically update a list of items for which
payment may be made under this subsection that
the Secretary determines, on the basis of prior
payment experience, are frequently subject to
unnecessary utilization throughout a carrier's
entire service area or a portion of such area.
(B) Development of lists of suppliers by
secretary.--The Secretary may develop and
periodically update a list of suppliers of
items for which payment may be made under this
subsection with respect to whom--
(i) the Secretary has found that a
substantial number of claims for
payment under this part for items
furnished by the supplier have been
denied on the basis of the application
of section 1862(a)(1); or
(ii) the Secretary has identified a
pattern of overutilization resulting
from the business practice of the
supplier.
(C) Determinations of coverage in advance.--A
carrier shall determine in advance of delivery
of an item whether payment for the item may not
be made because the item is not covered or
because of the application of section
1862(a)(1) if--
(i) the item is included on the list
developed by the Secretary under
subparagraph (A);
(ii) the item is furnished by a
supplier included on the list developed
by the Secretary under subparagraph
(B); or
(iii) the item is a customized item
(other than inexpensive items specified
by the Secretary) and the patient to
whom the item is to be furnished or the
supplier requests that such advance
determination be made.
(16) Disclosure of information and surety bond.--The
Secretary shall not provide for the issuance (or
renewal) of a provider number for a supplier of durable
medical equipment, for purposes of payment under this
part for durable medical equipment furnished by the
supplier, unless the supplier provides the Secretary on
a continuing basis--
(A) with--
(i) full and complete information as
to the identity of each person with an
ownership or control interest (as
defined in section 1124(a)(3)) in the
supplier or in any subcontractor (as
defined by the Secretary in
regulations) in which the supplier
directly or indirectly has a 5 percent
or more ownership interest; and
(ii) to the extent determined to be
feasible under regulations of the
Secretary, the name of any disclosing
entity (as defined in section
1124(a)(2)) with respect to which a
person with such an ownership or
control interest in the supplier is a
person with such an ownership or
control interest in the disclosing
entity; and
(B) with a surety bond in a form specified by
the Secretary and in an amount that is not less
than $50,000 that the Secretary determines is
commensurate with the volume of the billing of
the supplier.
The Secretary may waive the requirement of a bond under
subparagraph (B) in the case of a supplier that
provides a comparable surety bond under State law. The
Secretary, at the Secretary's discretion, may impose
the requirements of the first sentence with respect to
some or all providers of items or services under part A
or some or all suppliers or other persons (other than
physicians or other practitioners, as defined in
section 1842(b)(18)(C)) who furnish items or services
under this part.
(17) Prohibition against unsolicited telephone
contacts by suppliers.--
(A) In general.--A supplier of a covered item
under this subsection may not contact an
individual enrolled under this part by
telephone regarding the furnishing of a covered
item to the individual unless 1 of the
following applies:
(i) The individual has given written
permission to the supplier to make
contact by telephone regarding the
furnishing of a covered item.
(ii) The supplier has furnished a
covered item to the individual and the
supplier is contacting the individual
only regarding the furnishing of such
covered item.
(iii) If the contact is regarding the
furnishing of a covered item other than
a covered item already furnished to the
individual, the supplier has furnished
at least 1 covered item to the
individual during the 15-month period
preceding the date on which the
supplier makes such contact.
(B) Prohibiting payment for items furnished
subsequent to unsolicited contacts.--If a
supplier knowingly contacts an individual in
violation of subparagraph (A), no payment may
be made under this part for any item
subsequently furnished to the individual by the
supplier.
(C) Exclusion from program for suppliers
engaging in pattern of unsolicited contacts.--
If a supplier knowingly contacts individuals in
violation of subparagraph (A) to such an extent
that the supplier's conduct establishes a
pattern of contacts in violation of such
subparagraph, the Secretary shall exclude the
supplier from participation in the programs
under this Act, in accordance with the
procedures set forth in subsections (c), (f),
and (g) of section 1128.
(18) Refund of amounts collected for certain
disallowed items.--
(A) In general.--If a nonparticipating
supplier furnishes to an individual enrolled
under this part a covered item for which no
payment may be made under this part by reason
of paragraph (17)(B), the supplier shall refund
on a timely basis to the patient (and shall be
liable to the patient for) any amounts
collected from the patient for the item,
unless--
(i) the supplier establishes that the
supplier did not know and could not
reasonably have been expected to know
that payment may not be made for the
item by reason of paragraph (17)(B), or
(ii) before the item was furnished,
the patient was informed that payment
under this part may not be made for
that item and the patient has agreed to
pay for that item.
(B) Sanctions.--If a supplier knowingly and
willfully fails to make refunds in violation of
subparagraph (A), the Secretary may apply
sanctions against the supplier in accordance
with section 1842(j)(2).
(C) Notice.--Each carrier with a contract in
effect under this part with respect to
suppliers of covered items shall send any
notice of denial of payment for covered items
by reason of paragraph (17)(B) and for which
payment is not requested on an assignment-
related basis to the supplier and the patient
involved.
(D) Timely basis defined.--A refund under
subparagraph (A) is considered to be on a
timely basis only if--
(i) in the case of a supplier who
does not request reconsideration or
seek appeal on a timely basis, the
refund is made within 30 days after the
date the supplier receives a denial
notice under subparagraph (C), or
(ii) in the case in which such a
reconsideration or appeal is taken, the
refund is made within 15 days after the
date the supplier receives notice of an
adverse determination on
reconsideration or appeal.
(19) Certain upgraded items.--
(A) Individual's right to choose upgraded
item.--Notwithstanding any other provision of
this title, the Secretary may issue regulations
under which an individual may purchase or rent
from a supplier an item of upgraded durable
medical equipment for which payment would be
made under this subsection if the item were a
standard item.
(B) Payments to supplier.--In the case of the
purchase or rental of an upgraded item under
subparagraph (A)--
(i) the supplier shall receive
payment under this subsection with
respect to such item as if such item
were a standard item; and
(ii) the individual purchasing or
renting the item shall pay the supplier
an amount equal to the difference
between the supplier's charge and the
amount under clause (i).
In no event may the supplier's charge for an
upgraded item exceed the applicable fee
schedule amount (if any) for such item.
(C) Consumer protection safeguards.--Any
regulations under subparagraph (A) shall
provide for consumer protection standards with
respect to the furnishing of upgraded equipment
under subparagraph (A). Such regulations shall
provide for--
(i) determination of fair market
prices with respect to an upgraded
item;
(ii) full disclosure of the
availability and price of standard
items and proof of receipt of such
disclosure information by the
beneficiary before the furnishing of
the upgraded item;
(iii) conditions of participation for
suppliers in the billing arrangement;
(iv) sanctions of suppliers who are
determined to engage in coercive or
abusive practices, including exclusion;
and
(v) such other safeguards as the
Secretary determines are necessary.
(20) Identification of quality standards.--
(A) In general.--Subject to subparagraph (C),
the Secretary shall establish and implement
quality standards for suppliers of items and
services described in subparagraph (D) to be
applied by recognized independent accreditation
organizations (as designated under subparagraph
(B)) and with which such suppliers shall be
required to comply in order to--
(i) furnish any such item or service
for which payment is made under this
part; and
(ii) receive or retain a provider or
supplier number used to submit claims
for reimbursement for any such item or
service for which payment may be made
under this title.
(B) Designation of independent accreditation
organizations.--Not later than the date that is
1 year after the date on which the Secretary
implements the quality standards under
subparagraph (A), notwithstanding section
1865(a), the Secretary shall designate and
approve one or more independent accreditation
organizations for purposes of such
subparagraph.
(C) Quality standards.--The quality standards
described in subparagraph (A) may not be less
stringent than the quality standards that would
otherwise apply if this paragraph did not apply
and shall include consumer services standards.
(D) Items and services described.--The items
and services described in this subparagraph are
the following items and services, as the
Secretary determines appropriate:
(i) Covered items (as defined in
paragraph (13)) for which payment may
otherwise be made under this
subsection.
(ii) Prosthetic devices and orthotics
and prosthetics described in section
1834(h)(4).
(iii) Items and services described in
section 1842(s)(2).
(E) Implementation.--The Secretary may
establish by program instruction or otherwise
the quality standards under this paragraph,
including subparagraph (F), after consultation
with representatives of relevant parties. Such
standards shall be applied prospectively and
shall be published on the Internet website of
the Centers for Medicare & Medicaid Services.
(F) Application of accreditation
requirement.--In implementing quality standards
under this paragraph--
(i) subject to clause (ii) and
subparagraph (G), the Secretary shall
require suppliers furnishing items and
services described in subparagraph (D)
on or after October 1, 2009, directly
or as a subcontractor for another
entity, to have submitted to the
Secretary evidence of accreditation by
an accreditation organization
designated under subparagraph (B) as
meeting applicable quality standards,
except that the Secretary shall not
require under this clause pharmacies to
obtain such accreditation before
January 1, 2010, except that the
Secretary shall not require a pharmacy
to have submitted to the Secretary such
evidence of accreditation prior to
January 1, 2011; and
(ii) in applying such standards and
the accreditation requirement of clause
(i) with respect to eligible
professionals (as defined in section
1848(k)(3)(B)), and including such
other persons, such as orthotists and
prosthetists, as specified by the
Secretary, furnishing such items and
services--
(I) such standards and
accreditation requirement shall
not apply to such professionals
and persons unless the
Secretary determines that the
standards being applied are
designed specifically to be
applied to such professionals
and persons; and
(II) the Secretary may exempt
such professionals and persons
from such standards and
requirement if the Secretary
determines that licensing,
accreditation, or other
mandatory quality requirements
apply to such professionals and
persons with respect to the
furnishing of such items and
services.
(G) Application of accreditation requirement
to certain pharmacies.--
(i) In general.--With respect to
items and services furnished on or
after January 1, 2011, in implementing
quality standards under this
paragraph--
(I) subject to subclause
(II), in applying such
standards and the accreditation
requirement of subparagraph
(F)(i) with respect to
pharmacies described in clause
(ii) furnishing such items and
services, such standards and
accreditation requirement shall
not apply to such pharmacies;
and
(II) the Secretary may apply
to such pharmacies an
alternative accreditation
requirement established by the
Secretary if the Secretary
determines such alternative
accreditation requirement is
more appropriate for such
pharmacies.
(ii) Pharmacies described.--A
pharmacy described in this clause is a
pharmacy that meets each of the
following criteria:
(I) The total billings by the
pharmacy for such items and
services under this title are
less than 5 percent of total
pharmacy sales, as determined
based on the average total
pharmacy sales for the previous
3 calendar years, 3 fiscal
years, or other yearly period
specified by the Secretary.
(II) The pharmacy has been
enrolled under section 1866(j)
as a supplier of durable
medical equipment, prosthetics,
orthotics, and supplies, has
been issued (which may include
the renewal of) a provider
number for at least 5 years,
and for which a final adverse
action (as defined in section
424.57(a) of title 42, Code of
Federal Regulations) has not
been imposed in the past 5
years.
(III) The pharmacy submits to
the Secretary an attestation,
in a form and manner, and at a
time, specified by the
Secretary, that the pharmacy
meets the criteria described in
subclauses (I) and (II). Such
attestation shall be subject to
section 1001 of title 18,
United States Code.
(IV) The pharmacy agrees to
submit materials as requested
by the Secretary, or during the
course of an audit conducted on
a random sample of pharmacies
selected annually, to verify
that the pharmacy meets the
criteria described in
subclauses (I) and (II).
Materials submitted under the
preceding sentence shall
include a certification by an
accountant on behalf of the
pharmacy or the submission of
tax returns filed by the
pharmacy during the relevant
periods, as requested by the
Secretary.
(21) Special payment rule for specified items and
supplies.--
(A) In general.--Notwithstanding the
preceding provisions of this subsection, for
specified items and supplies (described in
subparagraph (B)) furnished during 2005, the
payment amount otherwise determined under this
subsection for such specified items and
supplies shall be reduced by the percentage
difference between--
(i) the amount of payment otherwise
determined for the specified item or
supply under this subsection for 2002,
and
(ii) the amount of payment for the
specified item or supply under chapter
89 of title 5, United States Code, as
identified in the column entitled
``Median FEHP Price'' in the table
entitled ``SUMMARY OF MEDICARE PRICES
COMPARED TO VA, MEDICAID, RETAIL, AND
FEHP PRICES FOR 16 ITEMS'' included in
the Testimony of the Inspector General
before the Senate Committee on
Appropriations, June 12, 2002, or any
subsequent report by the Inspector
General.
(B) Specified item or supply described.--For
purposes of subparagraph (A), a specified item
or supply means oxygen and oxygen equipment,
standard wheelchairs (including standard power
wheelchairs), nebulizers, diabetic supplies
consisting of lancets and testing strips,
hospital beds, and air mattresses, but only if
the HCPCS code for the item or supply is
identified in a table referred to in
subparagraph (A)(ii).
(C) Application of update to special payment
amount.--The covered item update under
paragraph (14) for specified items and supplies
for 2006 and each subsequent year shall be
applied to the payment amount under
subparagraph (A) unless payment is made for
such items and supplies under section 1847.
(22) Special payment rule for diabetic supplies.--
Notwithstanding the preceding provisions of this
subsection, for purposes of determining the payment
amount under this subsection for diabetic supplies
furnished on or after the first day of the calendar
quarter during 2013 that is at least 30 days after the
date of the enactment of this paragraph and before the
date described in paragraph (1)(H)(ii), the Secretary
shall recalculate and apply the covered item update
under paragraph (14) as if subparagraph (J)(i) of such
paragraph was amended by striking ``but only if
furnished through mail order''.
(b) Fee Schedules for Radiologist Services.--
(1) Development.--The Secretary shall develop--
(A) a relative value scale to serve as the
basis for the payment for radiologist services
under this part, and
(B) using such scale and appropriate
conversion factors and subject to subsection
(c)(1)(A), fee schedules (on a regional,
statewide, locality, or carrier service area
basis) for payment for radiologist services
under this part, to be implemented for such
services furnished during 1989.
(2) Consultation.--In carrying out paragraph (1), the
Secretary shall regularly consult closely with the
Physician Payment Review Commission, the American
College of Radiology, and other organizations
representing physicians or suppliers who furnish
radiologist services and shall share with them the data
and data analysis being used to make the determinations
under paragraph (1), including data on variations in
current medicare payments by geographic area, and by
service and physician specialty.
(3) Considerations.--In developing the relative value
scale and fee schedules under paragraph (1), the
Secretary--
(A) shall take into consideration variations
in the cost of furnishing such services among
geographic areas and among different sites
where services are furnished, and
(B) may also take into consideration such
other factors respecting the manner in which
physicians in different specialties furnish
such services as may be appropriate to assure
that payment amounts are equitable and designed
to promote effective and efficient provision of
radiologist services by physicians in the
different specialties.
(4) Savings.--
(A) Budget neutral fee schedules.--The
Secretary shall develop preliminary fee
schedules for 1989, which are designed to
result in the same amount of aggregate payments
(net of any coinsurance and deductibles under
sections 1833(a)(1)(J) and 1833(b)) for
radiologist services furnished in 1989 as would
have been made if this subsection had not been
enacted.
(B) Initial savings.--The fee schedules
established for payment purposes under this
subsection for services furnished in 1989 shall
be 97 percent of the amounts permitted under
these preliminary fee schedules developed under
subparagraph (A).
(C) 1990 fee schedules.--For radiologist
services (other than portable X-ray services)
furnished under this part during 1990, after
March 31 of such year, the conversion factors
used under this subsection shall be 96 percent
of the conversion factors that applied under
this subsection as of December 31, 1989.
(D) 1991 fee schedules.--For radiologist
services (other than portable X-ray services)
furnished under this part during 1991, the
conversion factors used in a locality under
this subsection shall, subject to clause (vii),
be reduced to the adjusted conversion factor
for the locality determined as follows:
(i) National weighted average
conversion factor.--The Secretary shall
estimate the national weighted average
of the conversion factors used under
this subsection for services furnished
during 1990 beginning on April 1, using
the best available data.
(ii) Reduced national weighted
average.--The national weighted average
estimated under clause (i) shall be
reduced by 13 percent.
(iii) Computation of 1990 locality
index relative to national average.--
The Secretary shall establish an index
which reflects, for each locality, the
ratio of the conversion factor used in
the locality under this subsection to
the national weighted average estimated
under clause (i).
(iv) Adjusted conversion factor.--The
adjusted conversion factor for the
professional or technical component of
a service in a locality is the sum of
\1/2\ of the locally-adjusted amount
determined under clause (v) and \1/2\
of the GPCI-adjusted amount determined
under clause (vi).
(v) Locally-adjusted amount.--For
purposes of clause (iv), the locally
adjusted amount determined under this
clause is the product of (I) the
national weighted average conversion
factor computed under clause (ii), and
(II) the index value established under
clause (iii) for the locality.
(vi) GPCI-adjusted amount.--For
purposes of clause (iv), the GPCI-
adjusted amount determined under this
clause is the sum of--
(I) the product of (a) the
portion of the reduced national
weighted average conversion
factor computed under clause
(ii) which is attributable to
physician work and (b) the
geographic work index value for
the locality (specified in
Addendum C to the Model Fee
Schedule for Physician Services
(published on September 4,
1990, 55 Federal Register pp.
36238-36243)); and
(II) the product of (a) the
remaining portion of the
reduced national weighted
average conversion factor
computed under clause (ii), and
(b) the geographic practice
cost index value specified in
section 1842(b)(14)(C)(iv) for
the locality.
In applying this clause with respect to
the professional component of a
service, 80 percent of the conversion
factor shall be considered to be
attributable to physician work and with
respect to the technical component of
the service, 0 percent shall be
considered to be attributable to
physician work.
(vii) Limits on conversion factor.--
The conversion factor to be applied to
a locality to the professional or
technical component of a service shall
not be reduced under this subparagraph
by more than 9.5 percent below the
conversion factor applied in the
locality under subparagraph (C) to such
component, but in no case shall the
conversion factor be less than 60
percent of the national weighted
average of the conversion factors
(computed under clause (i)).
(E) Rule for certain scanning services.--In
the case of the technical components of
magnetic resonance imaging (MRI) services and
computer assisted tomography (CAT) services
furnished after December 31, 1990, the amount
otherwise payable shall be reduced by 10
percent.
(F) Subsequent updating.--For radiologist
services furnished in subsequent years, the fee
schedules shall be the schedules for the
previous year updated by the percentage
increase in the MEI (as defined in section
1842(i)(3)) for the year.
(G) Nonparticipating physicians and
suppliers.--Each fee schedule so established
shall provide that the payment rate recognized
for nonparticipating physicians and suppliers
is equal to the appropriate percent (as defined
in section 1842(b)(4)(A)(iv)) of the payment
rate recognized for participating physicians
and suppliers.
(5) Limiting charges of nonparticipating physicians
and suppliers.--
(A) In general.--In the case of radiologist
services furnished after January 1, 1989, for
which payment is made under a fee schedule
under this subsection, if a nonparticipating
physician or supplier furnishes the service to
an individual entitled to benefits under this
part, the physician or supplier may not charge
the individual more than the limiting charge
(as defined in subparagraph (B)).
(B) Limiting charge defined.--In subparagraph
(A), the term ``limiting charge'' means, with
respect to a service furnished--
(i) in 1989, 125 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1),
(ii) in 1990, 120 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1), and
(iii) after 1990, 115 percent of the
amount specified for the service in the
appropriate fee schedule established
under paragraph (1).
(C) Enforcement.--If a physician or supplier
knowingly and willfully bills in violation of
subparagraph (A), the Secretary may apply
sanctions against such physician or supplier in
accordance with section 1842(j)(2) in the same
manner as such sanctions may apply to a
physician.
(6) Radiologist services defined.--For the purposes
of this subsection and section 1833(a)(1)(J), the term
``radiologist services'' only includes radiology
services performed by, or under the direction or
supervision of, a physician--
(A) who is certified, or eligible to be
certified, by the American Board of Radiology,
or
(B) for whom radiology services account for
at least 50 percent of the total amount of
charges made under this part.
(c) Payment and Standards for Screening Mammography.--
(1) In general.--With respect to expenses incurred
for screening mammography (as defined in section
1861(jj)), payment may be made only--
(A) for screening mammography conducted
consistent with the frequency permitted under
paragraph (2); and
(B) if the screening mammography is conducted
by a facility that has a certificate (or
provisional certificate) issued under section
354 of the Public Health Service Act.
(2) Frequency covered.--
(A) In general.--Subject to revision by the
Secretary under subparagraph (B)--
(i) no payment may be made under this
part for screening mammography
performed on a woman under 35 years of
age;
(ii) payment may be made under this
part for only one screening mammography
performed on a woman over 34 years of
age, but under 40 years of age; and
(iii) in the case of a woman over 39
years of age, payment may not be made
under this part for screening
mammography performed within 11 months
following the month in which a previous
screening mammography was performed.
(B) Revision of frequency.--
(i) Review.--The Secretary, in
consultation with the Director of the
National Cancer Institute, shall review
periodically the appropriate frequency
for performing screening mammography,
based on age and such other factors as
the Secretary believes to be pertinent.
(ii) Revision of frequency.--The
Secretary, taking into consideration
the review made under clause (i), may
revise from time to time the frequency
with which screening mammography may be
paid for under this subsection.
(d) Frequency Limits and Payment for Colorectal Cancer
Screening Tests.--
(1) Screening fecal-occult blood tests.--
(A) Payment amount.--The payment amount for
colorectal cancer screening tests consisting of
screening fecal-occult blood tests is equal to
the payment amount established for diagnostic
fecal-occult blood tests under section 1833(h).
(B) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening fecal-
occult blood test--
(i) if the individual is under 50
years of age; or
(ii) if the test is performed within
the 11 months after a previous
screening fecal-occult blood test.
(2) Screening flexible sigmoidoscopies.--
(A) Fee schedule.--With respect to colorectal
cancer screening tests consisting of screening
flexible sigmoidoscopies, payment under section
1848 shall be consistent with payment under
such section for similar or related services.
(B) Payment limit.--In the case of screening
flexible sigmoidoscopy services, payment under
this part shall not exceed such amount as the
Secretary specifies, based upon the rates
recognized for diagnostic flexible
sigmoidoscopy services.
(C) Facility payment limit.--
(i) In general.--Notwithstanding
subsections (i)(2)(A) and (t) of
section 1833, in the case of screening
flexible sigmoidoscopy services
furnished on or after January 1, 1999,
that--
(I) in accordance with
regulations, may be performed
in an ambulatory surgical
center and for which the
Secretary permits ambulatory
surgical center payments under
this part, and
(II) are performed in an
ambulatory surgical center or
hospital outpatient department,
payment under this part shall be based
on the lesser of the amount under the
fee schedule that would apply to such
services if they were performed in a
hospital outpatient department in an
area or the amount under the fee
schedule that would apply to such
services if they were performed in an
ambulatory surgical center in the same
area.
(ii) Limitation on coinsurance.--
Notwithstanding any other provision of
this title, in the case of a
beneficiary who receives the services
described in clause (i)--
(I) in computing the amount
of any applicable copayment,
the computation of such
coinsurance shall be based upon
the fee schedule under which
payment is made for the
services, and
(II) the amount of such
coinsurance is equal to 25
percent of the payment amount
under the fee schedule
described in subclause (I).
(D) Special rule for detected lesions.--If
during the course of such screening flexible
sigmoidoscopy, a lesion or growth is detected
which results in a biopsy or removal of the
lesion or growth, payment under this part shall
not be made for the screening flexible
sigmoidoscopy but shall be made for the
procedure classified as a flexible
sigmoidoscopy with such biopsy or removal.
(E) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening
flexible sigmoidoscopy--
(i) if the individual is under 50
years of age; or
(ii) if the procedure is performed
within the 47 months after a previous
screening flexible sigmoidoscopy or, in
the case of an individual who is not at
high risk for colorectal cancer, if the
procedure is performed within the 119
months after a previous screening
colonoscopy.
(3) Screening colonoscopy.--
(A) Fee schedule.--With respect to colorectal
cancer screening test consisting of a screening
colonoscopy, payment under section 1848 shall
be consistent with payment amounts under such
section for similar or related services.
(B) Payment limit.--In the case of screening
colonoscopy services, payment under this part
shall not exceed such amount as the Secretary
specifies, based upon the rates recognized for
diagnostic colonoscopy services.
(C) Facility payment limit.--
(i) In general.--Notwithstanding
subsections (i)(2)(A) and (t) of
section 1833, in the case of screening
colonoscopy services furnished on or
after January 1, 1999, that are
performed in an ambulatory surgical
center or a hospital outpatient
department, payment under this part
shall be based on the lesser of the
amount under the fee schedule that
would apply to such services if they
were performed in a hospital outpatient
department in an area or the amount
under the fee schedule that would apply
to such services if they were performed
in an ambulatory surgical center in the
same area.
(ii) Limitation on coinsurance.--
Notwithstanding any other provision of
this title, in the case of a
beneficiary who receives the services
described in clause (i)--
(I) in computing the amount
of any applicable coinsurance,
the computation of such
coinsurance shall be based upon
the fee schedule under which
payment is made for the
services, and
(II) the amount of such
coinsurance is equal to 25
percent of the payment amount
under the fee schedule
described in subclause (I).
(D) Special rule for detected lesions.--If
during the course of such screening
colonoscopy, a lesion or growth is detected
which results in a biopsy or removal of the
lesion or growth, payment under this part shall
not be made for the screening colonoscopy but
shall be made for the procedure classified as a
colonoscopy with such biopsy or removal.
(E) Frequency limit.--No payment may be made
under this part for a colorectal cancer
screening test consisting of a screening
colonoscopy for individuals at high risk for
colorectal cancer if the procedure is performed
within the 23 months after a previous screening
colonoscopy or for other individuals if the
procedure is performed within the 119 months
after a previous screening colonoscopy or
within 47 months after a previous screening
flexible sigmoidoscopy.
(e) Accreditation Requirement for Advanced Diagnostic Imaging
Services.--
(1) In general.--
(A) In general.--Beginning with January 1,
2012, with respect to the technical component
of advanced diagnostic imaging services for
which payment is made under the fee schedule
established under section 1848(b) and that are
furnished by a supplier, payment may only be
made if such supplier is accredited by an
accreditation organization designated by the
Secretary under paragraph (2)(B)(i).
(B) Advanced diagnostic imaging services
defined.--In this subsection, the term
``advanced diagnostic imaging services''
includes--
(i) diagnostic magnetic resonance
imaging, computed tomography, and
nuclear medicine (including positron
emission tomography); and
(ii) such other diagnostic imaging
services, including services described
in section 1848(b)(4)(B) (excluding X-
ray, ultrasound, and fluoroscopy), as
specified by the Secretary in
consultation with physician specialty
organizations and other stakeholders.
(C) Supplier defined.--In this subsection,
the term ``supplier'' has the meaning given
such term in section 1861(d).
(2) Accreditation organizations.--
(A) Factors for designation of accreditation
organizations.--The Secretary shall consider
the following factors in designating
accreditation organizations under subparagraph
(B)(i) and in reviewing and modifying the list
of accreditation organizations designated
pursuant to subparagraph (C):
(i) The ability of the organization
to conduct timely reviews of
accreditation applications.
(ii) Whether the organization has
established a process for the timely
integration of new advanced diagnostic
imaging services into the
organization's accreditation program.
(iii) Whether the organization uses
random site visits, site audits, or
other strategies for ensuring
accredited suppliers maintain adherence
to the criteria described in paragraph
(3).
(iv) The ability of the organization
to take into account the capacities of
suppliers located in a rural area (as
defined in section 1886(d)(2)(D)).
(v) Whether the organization has
established reasonable fees to be
charged to suppliers applying for
accreditation.
(vi) Such other factors as the
Secretary determines appropriate.
(B) Designation.--Not later than January 1,
2010, the Secretary shall designate
organizations to accredit suppliers furnishing
the technical component of advanced diagnostic
imaging services. The list of accreditation
organizations so designated may be modified
pursuant to subparagraph (C).
(C) Review and modification of list of
accreditation organizations.--
(i) In general.--The Secretary shall
review the list of accreditation
organizations designated under
subparagraph (B) taking into account
the factors under subparagraph (A).
Taking into account the results of such
review, the Secretary may, by
regulation, modify the list of
accreditation organizations designated
under subparagraph (B).
(ii) Special rule for accreditations
done prior to removal from list of
designated accreditation
organizations.--In the case where the
Secretary removes an organization from
the list of accreditation organizations
designated under subparagraph (B), any
supplier that is accredited by the
organization during the period
beginning on the date on which the
organization is designated as an
accreditation organization under
subparagraph (B) and ending on the date
on which the organization is removed
from such list shall be considered to
have been accredited by an organization
designated by the Secretary under
subparagraph (B) for the remaining
period such accreditation is in effect.
(3) Criteria for accreditation.--The Secretary shall
establish procedures to ensure that the criteria used
by an accreditation organization designated under
paragraph (2)(B) to evaluate a supplier that furnishes
the technical component of advanced diagnostic imaging
services for the purpose of accreditation of such
supplier is specific to each imaging modality. Such
criteria shall include--
(A) standards for qualifications of medical
personnel who are not physicians and who
furnish the technical component of advanced
diagnostic imaging services;
(B) standards for qualifications and
responsibilities of medical directors and
supervising physicians, including standards
that recognize the considerations described in
paragraph (4);
(C) procedures to ensure that equipment used
in furnishing the technical component of
advanced diagnostic imaging services meets
performance specifications;
(D) standards that require the supplier have
procedures in place to ensure the safety of
persons who furnish the technical component of
advanced diagnostic imaging services and
individuals to whom such services are
furnished;
(E) standards that require the establishment
and maintenance of a quality assurance and
quality control program by the supplier that is
adequate and appropriate to ensure the
reliability, clarity, and accuracy of the
technical quality of diagnostic images produced
by such supplier; and
(F) any other standards or procedures the
Secretary determines appropriate.
(4) Recognition in standards for the evaluation of
medical directors and supervising physicians.--The
standards described in paragraph (3)(B) shall recognize
whether a medical director or supervising physician--
(A) in a particular specialty receives
training in advanced diagnostic imaging
services in a residency program;
(B) has attained, through experience, the
necessary expertise to be a medical director or
a supervising physician;
(C) has completed any continuing medical
education courses relating to such services; or
(D) has met such other standards as the
Secretary determines appropriate.
(5) Rule for accreditations made prior to
designation.--In the case of a supplier that is
accredited before January 1, 2010, by an accreditation
organization designated by the Secretary under
paragraph (2)(B) as of January 1, 2010, such supplier
shall be considered to have been accredited by an
organization designated by the Secretary under such
paragraph as of January 1, 2012, for the remaining
period such accreditation is in effect.
(f) Reduction in Payments for Physician Pathology Services
During 1991.--
(1) In general.--For physician pathology services
furnished under this part during 1991, the prevailing
charges used in a locality under this part shall be 7
percent below the prevailing charges used in the
locality under this part in 1990 after March 31.
(2) Limitation.--The prevailing charge for the
technical and professional components of an physician
pathology service furnished by a physician through an
independent laboratory shall not be reduced pursuant to
paragraph (1) to the extent that such reduction would
reduce such prevailing charge below 115 percent of the
prevailing charge for the professional component of
such service when furnished by a hospital-based
physician in the same locality. For purposes of the
preceding sentence, an independent laboratory is a
laboratory that is independent of a hospital and
separate from the attending or consulting physicians'
office.
(g) Payment for Outpatient Critical Access Hospital
Services.--
(1) In general.--The amount of payment for outpatient
critical access hospital services of a critical access
hospital is equal to 101 percent of the reasonable
costs of the hospital in providing such services,
unless the hospital makes the election under paragraph
(2).
(2) Election of cost-based hospital outpatient
service payment plus fee schedule for professional
services.--A critical access hospital may elect to be
paid for outpatient critical access hospital services
amounts equal to the sum of the following, less the
amount that such hospital may charge as described in
section 1866(a)(2)(A):
(A) Facility fee.--With respect to facility
services, not including any services for which
payment may be made under subparagraph (B), 101
percent of the reasonable costs of the critical
access hospital in providing such services.
(B) Fee schedule for professional services.--
With respect to professional services otherwise
included within outpatient critical access
hospital services, 115 percent of such amounts
as would otherwise be paid under this part if
such services were not included in outpatient
critical access hospital services. Subsections
(x) and (y) of section 1833 shall not be taken
into account in determining the amounts that
would otherwise be paid pursuant to the
preceding sentence.
The Secretary may not require, as a condition for
applying subparagraph (B) with respect to a critical
access hospital, that each physician or other
practitioner providing professional services in the
hospital must assign billing rights with respect to
such services, except that such subparagraph shall not
apply to those physicians and practitioners who have
not assigned such billing rights.
(3) Disregarding charges.--The payment amounts under
this subsection shall be determined without regard to
the amount of the customary or other charge.
(4) Treatment of clinical diagnostic laboratory
services.--No coinsurance, deductible, copayment, or
other cost-sharing otherwise applicable under this part
shall apply with respect to clinical diagnostic
laboratory services furnished as an outpatient critical
access hospital service. Nothing in this title shall be
construed as providing for payment for clinical
diagnostic laboratory services furnished as part of
outpatient critical access hospital services, other
than on the basis described in this subsection. For
purposes of the preceding sentence and section
1861(mm)(3), clinical diagnostic laboratory services
furnished by a critical access hospital shall be
treated as being furnished as part of outpatient
critical access services without regard to whether the
individual with respect to whom such services are
furnished is physically present in the critical access
hospital, or in a skilled nursing facility or a clinic
(including a rural health clinic) that is operated by a
critical access hospital, at the time the specimen is
collected.
(5) Coverage of costs for certain emergency room on-
call providers.--In determining the reasonable costs of
outpatient critical access hospital services under
paragraphs (1) and (2)(A), the Secretary shall
recognize as allowable costs, amounts (as defined by
the Secretary) for reasonable compensation and related
costs for physicians, physician assistants, nurse
practitioners, and clinical nurse specialists who are
on-call (as defined by the Secretary) to provide
emergency services but who are not present on the
premises of the critical access hospital involved, and
are not otherwise furnishing services covered under
this title and are not on-call at any other provider or
facility.
(h) Payment for Prosthetic Devices and Orthotics and
Prosthetics.--
(1) General rule for payment.--
(A) In general.--Payment under this
subsection for prosthetic devices and orthotics
and prosthetics shall be made in a lump-sum
amount for the purchase of the item in an
amount equal to 80 percent of the payment basis
described in subparagraph (B).
(B) Payment basis.--Except as provided in
subparagraphs (C), (E), and (H)(i), the payment
basis described in this subparagraph is the
lesser of--
(i) the actual charge for the item;
or
(ii) the amount recognized under
paragraph (2) as the purchase price for
the item.
(C) Exception for certain public home health
agencies.--Subparagraph (B)(i) shall not apply
to an item furnished by a public home health
agency (or by another home health agency which
demonstrates to the satisfaction of the
Secretary that a significant portion of its
patients are low income) free of charge or at
nominal charges to the public.
(D) Exclusive payment rule.--Subject to
subparagraph (H)(ii), this subsection shall
constitute the exclusive provision of this
title for payment for prosthetic devices,
orthotics, and prosthetics under this part or
under part A to a home health agency.
(E) Exception for certain items.--Payment for
ostomy supplies, tracheostomy supplies, and
urologicals shall be made in accordance with
subparagraphs (B) and (C) of section
1834(a)(2).
(F) Special payment rules for certain
prosthetics and custom-fabricated orthotics.--
(i) In general.--No payment shall be
made under this subsection for an item
of custom-fabricated orthotics
described in clause (ii) or for an item
of prosthetics unless such item is--
(I) furnished by a qualified
practitioner; and
(II) fabricated by a
qualified practitioner or a
qualified supplier at a
facility that meets such
criteria as the Secretary
determines appropriate.
(ii) Description of custom-fabricated
item.--
(I) In general.--An item
described in this clause is an
item of custom-fabricated
orthotics that requires
education, training, and
experience to custom-fabricate
and that is included in a list
established by the Secretary in
subclause (II). Such an item
does not include shoes and shoe
inserts.
(II) List of items.--The
Secretary, in consultation with
appropriate experts in
orthotics (including national
organizations representing
manufacturers of orthotics),
shall establish and update as
appropriate a list of items to
which this subparagraph
applies. No item may be
included in such list unless
the item is individually
fabricated for the patient over
a positive model of the
patient.
(iii) Qualified practitioner
defined.--In this subparagraph, the
term ``qualified practitioner'' means a
physician or other individual who--
(I) is a qualified physical
therapist or a qualified
occupational therapist;
(II) in the case of a State
that provides for the licensing
of orthotics and prosthetics,
is licensed in orthotics or
prosthetics by the State in
which the item is supplied; or
(III) in the case of a State
that does not provide for the
licensing of orthotics and
prosthetics, is specifically
trained and educated to provide
or manage the provision of
prosthetics and custom-designed
or -fabricated orthotics, and
is certified by the American
Board for Certification in
Orthotics and Prosthetics, Inc.
or by the Board for Orthotist/
Prosthetist Certification, or
is credentialed and approved by
a program that the Secretary
determines, in consultation
with appropriate experts in
orthotics and prosthetics, has
training and education
standards that are necessary to
provide such prosthetics and
orthotics.
(iv) Qualified supplier defined.--In
this subparagraph, the term ``qualified
supplier'' means any entity that is
accredited by the American Board for
Certification in Orthotics and
Prosthetics, Inc. or by the Board for
Orthotist/Prosthetist Certification, or
accredited and approved by a program
that the Secretary determines has
accreditation and approval standards
that are essentially equivalent to
those of such Board.
(G) Replacement of prosthetic devices and
parts.--
(i) In general.--Payment shall be
made for the replacement of prosthetic
devices which are artificial limbs, or
for the replacement of any part of such
devices, without regard to continuous
use or useful lifetime restrictions if
an ordering physician determines that
the provision of a replacement device,
or a replacement part of such a device,
is necessary because of any of the
following:
(I) A change in the
physiological condition of the
patient.
(II) An irreparable change in
the condition of the device, or
in a part of the device.
(III) The condition of the
device, or the part of the
device, requires repairs and
the cost of such repairs would
be more than 60 percent of the
cost of a replacement device,
or, as the case may be, of the
part being replaced.
(ii) Confirmation may be required if
device or part being replaced is less
than 3 years old.--If a physician
determines that a replacement device,
or a replacement part, is necessary
pursuant to clause (i)--
(I) such determination shall
be controlling; and
(II) such replacement device
or part shall be deemed to be
reasonable and necessary for
purposes of section
1862(a)(1)(A);
except that if the device, or part,
being replaced is less than 3 years old
(calculated from the date on which the
beneficiary began to use the device or
part), the Secretary may also require
confirmation of necessity of the
replacement device or replacement part,
as the case may be.
(H) Application of competitive acquisition to
orthotics; limitation of inherent
reasonableness authority.--In the case of
orthotics described in paragraph (2)(C) of
section 1847(a) furnished on or after January
1, 2009, subject to subsection (a)(1)(G), that
are included in a competitive acquisition
program in a competitive acquisition area under
such section--
(i) the payment basis under this
subsection for such orthotics furnished
in such area shall be the payment basis
determined under such competitive
acquisition program; and
(ii) subject to subsection (a)(1)(G),
the Secretary may use information on
the payment determined under such
competitive acquisition programs to
adjust the payment amount otherwise
recognized under subparagraph (B)(ii)
for an area that is not a competitive
acquisition area under section 1847,
and in the case of such adjustment,
paragraphs (8) and (9) of section
1842(b) shall not be applied.
(2) Purchase price recognized.--For purposes of
paragraph (1), the amount that is recognized under this
paragraph as the purchase price for prosthetic devices,
orthotics, and prosthetics is the amount described in
subparagraph (C) of this paragraph, determined as
follows:
(A) Computation of local purchase price.--
Each carrier under section 1842 shall compute a
base local purchase price for the item as
follows:
(i) The carrier shall compute a base
local purchase price for each item
equal to the average reasonable charge
in the locality for the purchase of the
item for the 12-month period ending
with June 1987.
(ii) The carrier shall compute a
local purchase price, with respect to
the furnishing of each particular
item--
(I) in 1989 and 1990, equal
to the base local purchase
price computed under clause (i)
increased by the percentage
increase in the consumer price
index for all urban consumers
(United States city average)
for the 6-month period ending
with December 1987, or
(II) in 1991, 1992 or 1993,
equal to the local purchase
price computed under this
clause for the previous year
increased by the applicable
percentage increase for the
year.
(B) Computation of regional purchase price.--
With respect to the furnishing of a particular
item in each region (as defined by the
Secretary), the Secretary shall compute a
regional purchase price--
(i) for 1992, equal to the average
(weighted by relative volume of all
claims among carriers) of the local
purchase prices for the carriers in the
region computed under subparagraph
(A)(ii)(II) for the year, and
(ii) for each subsequent year, equal
to the regional purchase price computed
under this subparagraph for the
previous year increased by the
applicable percentage increase for the
year.
(C) Purchase price recognized.--For purposes
of paragraph (1) and subject to subparagraph
(D), the amount that is recognized under this
paragraph as the purchase price for each item
furnished--
(i) in 1989, 1990, or 1991, is 100
percent of the local purchase price
computed under subparagraph (A)(ii);
(ii) in 1992, is the sum of (I) 75
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1992, and (II) 25 percent of the
regional purchase price computed under
subparagraph (B) for 1992;
(iii) in 1993, is the sum of (I) 50
percent of the local purchase price
computed under subparagraph (A)(ii)(II)
for 1993, and (II) 50 percent of the
regional purchase price computed under
subparagraph (B) for 1993; and
(iv) in 1994 or a subsequent year, is
the regional purchase price computed
under subparagraph (B) for that year.
(D) Range on amount recognized.--The amount
that is recognized under subparagraph (C) as
the purchase price for an item furnished--
(i) in 1992, may not exceed 125
percent, and may not be lower than 85
percent, of the average of the purchase
prices recognized under such
subparagraph for all the carrier
service areas in the United States in
that year; and
(ii) in a subsequent year, may not
exceed 120 percent, and may not be
lower than 90 percent, of the average
of the purchase prices recognized under
such subparagraph for all the carrier
service areas in the United States in
that year.
(3) Applicability of certain provisions relating to
durable medical equipment.--Paragraphs (12) and (17)
and subparagraphs (A) and (B) of paragraph (10) and
paragraph (11) of subsection (a) shall apply to
prosthetic devices, orthotics, and prosthetics in the
same manner as such provisions apply to covered items
under such subsection.
(4) Definitions.--In this subsection--
(A) the term ``applicable percentage
increase'' means--
(i) for 1991, 0 percent;
(ii) for 1992 and 1993, the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the
12-month period ending with June of the
previous year;
(iii) for 1994 and 1995, 0 percent;
(iv) for 1996 and 1997, the
percentage increase in the consumer
price index for all urban consumers
(United States city average) for the
12-month period ending with June of the
previous year;
(v) for each of the years 1998
through 2000, 1 percent;
(vi) for 2001, the percentage
increase in the consumer price index
for all urban consumers (U.S. city
average) for the 12-month period ending
with June 2000;
(vii) for 2002, 1 percent;
(viii) for 2003, the percentage
increase in the consumer price index
for all urban consumers (United States
city average) for the 12-month period
ending with June of the previous year;
(ix) for 2004, 2005, and 2006, 0
percent;
(x) for for each of 2007 through
2010, the percentage increase in the
consumer price index for all urban
consumers (United States city average)
for the 12-month period ending with
June of the previous year; and
(xi) for 2011 and each subsequent
year--
(I) the percentage increase
in the consumer price index for
all urban consumers (United
States city average) for the
12-month period ending with
June of the previous year,
reduced by--
(II) the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II).
(B) the term ``prosthetic devices'' has the
meaning given such term in section 1861(s)(8),
except that such term does not include
parenteral and enteral nutrition nutrients,
supplies, and equipment and does not include an
implantable item for which payment may be made
under section 1833(t); and
(C) the term ``orthotics and prosthetics''
has the meaning given such term in section
1861(s)(9) (and includes shoes described in
section 1861(s)(12)), but does not include
intraocular lenses or medical supplies
(including catheters, catheter supplies, ostomy
bags, and supplies related to ostomy care)
furnished by a home health agency under section
1861(m)(5).
The application of subparagraph (A)(xi)(II) may result
in the applicable percentage increase under
subparagraph (A) being less than 0.0 for a year, and
may result in payment rates under this subsection for a
year being less than such payment rates for the
preceding year.
(5) Documentation created by orthotists and
prosthetists.--For purposes of determining the
reasonableness and medical necessity of orthotics and
prosthetics, documentation created by an orthotist or
prosthetist shall be considered part of the
individual's medical record to support documentation
created by eligible professionals described in section
1848(k)(3)(B).
(i) Payment for Surgical Dressings.--
(1) In general.--Payment under this subsection for
surgical dressings (described in section 1861(s)(5))
shall be made in a lump sum amount for the purchase of
the item in an amount equal to 80 percent of the lesser
of--
(A) the actual charge for the item; or
(B) a payment amount determined in accordance
with the methodology described in subparagraphs
(B) and (C) of subsection (a)(2) (except that
in applying such methodology, the national
limited payment amount referred to in such
subparagraphs shall be initially computed based
on local payment amounts using average
reasonable charges for the 12-month period
ending December 31, 1992, increased by the
covered item updates described in such
subsection for 1993 and 1994).
(2) Exceptions.--Paragraph (1) shall not apply to
surgical dressings that are--
(A) furnished as an incident to a physician's
professional service; or
(B) furnished by a home health agency.
(j) Requirements for Suppliers of Medical Equipment and
Supplies.--
(1) Issuance and renewal of supplier number.--
(A) Payment.--Except as provided in
subparagraph (C), no payment may be made under
this part after the date of the enactment of
the Social Security Act Amendments of 1994 for
items furnished by a supplier of medical
equipment and supplies unless such supplier
obtains (and renews at such intervals as the
Secretary may require) a supplier number.
(B) Standards for possessing a supplier
number.--A supplier may not obtain a supplier
number unless--
(i) for medical equipment and
supplies furnished on or after the date
of the enactment of the Social Security
Act Amendments of 1994 and before
January 1, 1996, the supplier meets
standards prescribed by the Secretary
in regulations issued on June 18, 1992;
and
(ii) for medical equipment and
supplies furnished on or after January
1, 1996, the supplier meets revised
standards prescribed by the Secretary
(in consultation with representatives
of suppliers of medical equipment and
supplies, carriers, and consumers) that
shall include requirements that the
supplier--
(I) comply with all
applicable State and Federal
licensure and regulatory
requirements;
(II) maintain a physical
facility on an appropriate
site;
(III) have proof of
appropriate liability
insurance; and
(IV) meet such other
requirements as the Secretary
may specify.
(C) Exception for items furnished as incident
to a physician's service.--Subparagraph (A)
shall not apply with respect to medical
equipment and supplies furnished incident to a
physician's service.
(D) Prohibition against multiple supplier
numbers.--The Secretary may not issue more than
one supplier number to any supplier of medical
equipment and supplies unless the issuance of
more than one number is appropriate to identify
subsidiary or regional entities under the
supplier's ownership or control.
(E) Prohibition against delegation of
supplier determinations.--The Secretary may not
delegate (other than by contract under section
1842) the responsibility to determine whether
suppliers meet the standards necessary to
obtain a supplier number.
(2) Certificates of medical necessity.--
(A) Limitation on information provided by
suppliers on certificates of medical
necessity.--
(i) In general.--Effective 60 days
after the date of the enactment of the
Social Security Act Amendments of 1994,
a supplier of medical equipment and
supplies may distribute to physicians,
or to individuals entitled to benefits
under this part, a certificate of
medical necessity for commercial
purposes which contains no more than
the following information completed by
the supplier:
(I) An identification of the
supplier and the beneficiary to
whom such medical equipment and
supplies are furnished.
(II) A description of such
medical equipment and supplies.
(III) Any product code
identifying such medical
equipment and supplies.
(IV) Any other administrative
information (other than
information relating to the
beneficiary's medical
condition) identified by the
Secretary.
(ii) Information on payment amount
and charges.--If a supplier distributes
a certificate of medical necessity
containing any of the information
permitted to be supplied under clause
(i), the supplier shall also list on
the certificate of medical necessity
the fee schedule amount and the
supplier's charge for the medical
equipment or supplies being furnished
prior to distribution of such
certificate to the physician.
(iii) Penalty.--Any supplier of
medical equipment and supplies who
knowingly and willfully distributes a
certificate of medical necessity in
violation of clause (i) or fails to
provide the information required under
clause (ii) is subject to a civil money
penalty in an amount not to exceed
$1,000 for each such certificate of
medical necessity so distributed. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to
civil money penalties under this
subparagraph in the same manner as they
apply to a penalty or proceeding under
section 1128A(a).
(B) Definition.--For purposes of this
paragraph, the term ``certificate of medical
necessity'' means a form or other document
containing information required by the carrier
to be submitted to show that an item is
reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve
the functioning of a malformed body member.
(3) Coverage and review criteria.--The Secretary
shall annually review the coverage and utilization of
items of medical equipment and supplies to determine
whether such items should be made subject to coverage
and utilization review criteria, and if appropriate,
shall develop and apply such criteria to such items.
(4) Limitation on patient liability.--If a supplier
of medical equipment and supplies (as defined in
paragraph (5))--
(A) furnishes an item or service to a
beneficiary for which no payment may be made by
reason of paragraph (1);
(B) furnishes an item or service to a
beneficiary for which payment is denied in
advance under subsection (a)(15); or
(C) furnishes an item or service to a
beneficiary for which payment is denied under
section 1862(a)(1);
any expenses incurred for items and services furnished
to an individual by such a supplier not on an assigned
basis shall be the responsibility of such supplier. The
individual shall have no financial responsibility for
such expenses and the supplier shall refund on a timely
basis to the individual (and shall be liable to the
individual for) any amounts collected from the
individual for such items or services. The provisions
of subsection (a)(18) shall apply to refunds required
under the previous sentence in the same manner as such
provisions apply to refunds under such subsection.
(5) Definition.--The term ``medical equipment and
supplies'' means--
(A) durable medical equipment (as defined in
section 1861(n));
(B) prosthetic devices (as described in
section 1861(s)(8));
(C) orthotics and prosthetics (as described
in section 1861(s)(9));
(D) surgical dressings (as described in
section 1861(s)(5));
(E) such other items as the Secretary may
determine; and
(F) for purposes of paragraphs (1) and (3)--
(i) home dialysis supplies and
equipment (as described in section
1861(s)(2)(F)),
(ii) immunosuppressive drugs (as
described in section 1861(s)(2)(J)),
(iii) therapeutic shoes for diabetics
(as described in section 1861(s)(12)),
(iv) oral drugs prescribed for use as
an anticancer therapeutic agent (as
described in section 1861(s)(2)(Q)),
and
(v) self-administered erythropoetin
(as described in section
1861(s)(2)(P)).
(k) Payment for Outpatient Therapy Services and Comprehensive
Outpatient Rehabilitation Services.--
(1) In general.--With respect to services described
in section 1833(a)(8) or 1833(a)(9) for which payment
is determined under this subsection, the payment basis
shall be--
(A) for services furnished during 1998, the
amount determined under paragraph (2); or
(B) for services furnished during a
subsequent year, 80 percent of the lesser of--
(i) the actual charge for the
services, or
(ii) the applicable fee schedule
amount (as defined in paragraph (3))
for the services.
(2) Payment in 1998 based upon adjusted reasonable
costs.--The amount under this paragraph for services is
the lesser of--
(A) the charges imposed for the services, or
(B) the adjusted reasonable costs (as defined
in paragraph (4)) for the services,
less 20 percent of the amount of the charges imposed
for such services.
(3) Applicable fee schedule amount.--In this
subsection, the term ``applicable fee schedule amount''
means, with respect to services furnished in a year,
the amount determined under the fee schedule
established under section 1848 for such services
furnished during the year or, if there is no such fee
schedule established for such services, the amount
determined under the fee schedule established for such
comparable services as the Secretary specifies.
(4) Adjusted reasonable costs.--In paragraph (2), the
term ``adjusted reasonable costs'' means, with respect
to any services, reasonable costs determined for such
services, reduced by 10 percent. The 10-percent
reduction shall not apply to services described in
section 1833(a)(8)(B) (relating to services provided by
hospitals).
(5) Uniform coding.--For claims for services
submitted on or after April 1, 1998, for which the
amount of payment is determined under this subsection,
the claim shall include a code (or codes) under a
uniform coding system specified by the Secretary that
identifies the services furnished.
(6) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall
apply to therapy services for which payment is made
under this subsection in the same manner as they apply
to services provided by a practitioner described in
section 1842(b)(18)(C).
(7) Adjustment in discount for certain multiple
therapy services.--In the case of therapy services
furnished on or after April 1, 2013, and for which
payment is made under this subsection pursuant to the
applicable fee schedule amount (as defined in paragraph
(3)), instead of the 25 percent multiple procedure
payment reduction specified in the final rule published
by the Secretary in the Federal Register on November
29, 2010, the reduction percentage shall be 50 percent.
(l) Establishment of Fee Schedule for Ambulance Services.--
(1) In general.--The Secretary shall establish a fee
schedule for payment for ambulance services whether
provided directly by a supplier or provider or under
arrangement with a provider under this part through a
negotiated rulemaking process described in title 5,
United States Code, and in accordance with the
requirements of this subsection.
(2) Considerations.--In establishing such fee
schedule, the Secretary shall--
(A) establish mechanisms to control increases
in expenditures for ambulance services under
this part;
(B) establish definitions for ambulance
services which link payments to the type of
services provided;
(C) consider appropriate regional and
operational differences;
(D) consider adjustments to payment rates to
account for inflation and other relevant
factors; and
(E) phase in the application of the payment
rates under the fee schedule in an efficient
and fair manner consistent with paragraph (11),
except that such phase-in shall provide for
full payment of any national mileage rate for
ambulance services provided by suppliers that
are paid by carriers in any of the 50 States
where payment by a carrier for such services
for all such suppliers in such State did not,
prior to the implementation of the fee
schedule, include a separate amount for all
mileage within the county from which the
beneficiary is transported.
(3) Savings.--In establishing such fee schedule, the
Secretary shall--
(A) ensure that the aggregate amount of
payments made for ambulance services under this
part during 2000 does not exceed the aggregate
amount of payments which would have been made
for such services under this part during such
year if the amendments made by section 4531(a)
of the Balanced Budget Act of 1997 continued in
effect, except that in making such
determination the Secretary shall assume an
update in such payments for 2002 equal to
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year reduced in the case of 2002 by
1.0 percentage points;
(B) set the payment amounts provided under
the fee schedule for services furnished in 2001
and each subsequent year at amounts equal to
the payment amounts under the fee schedule for
services furnished during the previous year,
increased, subject to subparagraph (C) and the
succeeding sentence of this paragraph, by the
percentage increase in the consumer price index
for all urban consumers (U.S. city average) for
the 12-month period ending with June of the
previous year reduced in the case of 2002 by
1.0 percentage points; and
(C) for 2011 and each subsequent year, after
determining the percentage increase under
subparagraph (B) for the year, reduce such
percentage increase by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II).
The application of subparagraph (C) may result in the
percentage increase under subparagraph (B) being less
than 0.0 for a year, and may result in payment rates
under the fee schedule under this subsection for a year
being less than such payment rates for the preceding
year.
(4) Consultation.--In establishing the fee schedule
for ambulance services under this subsection, the
Secretary shall consult with various national
organizations representing individuals and entities who
furnish and regulate ambulance services and share with
such organizations relevant data in establishing such
schedule.
(5) Limitation on review.--There shall be no
administrative or judicial review under section 1869 or
otherwise of the amounts established under the fee
schedule for ambulance services under this subsection,
including matters described in paragraph (2).
(6) Restraint on billing.--The provisions of
subparagraphs (A) and (B) of section 1842(b)(18) shall
apply to ambulance services for which payment is made
under this subsection in the same manner as they apply
to services provided by a practitioner described in
section 1842(b)(18)(C).
(7) Coding system.--The Secretary may require the
claim for any services for which the amount of payment
is determined under this subsection to include a code
(or codes) under a uniform coding system specified by
the Secretary that identifies the services furnished.
(8) Services furnished by critical access
hospitals.--Notwithstanding any other provision of this
subsection, the Secretary shall pay 101 percent of the
reasonable costs incurred in furnishing ambulance
services if such services are furnished--
(A) by a critical access hospital (as defined
in section 1861(mm)(1)), or
(B) by an entity that is owned and operated
by a critical access hospital,
but only if the critical access hospital or entity is
the only provider or supplier of ambulance services
that is located within a 35-mile drive of such critical
access hospital.
(9) Transitional assistance for rural providers.--In
the case of ground ambulance services furnished on or
after July 1, 2001, and before January 1, 2004, for
which the transportation originates in a rural area (as
defined in section 1886(d)(2)(D)) or in a rural census
tract of a metropolitan statistical area (as determined
under the most recent modification of the Goldsmith
Modification, originally published in the Federal
Register on February 27, 1992 (57 Fed. Reg. 6725)), the
fee schedule established under this subsection shall
provide that, with respect to the payment rate for
mileage for a trip above 17 miles, and up to 50 miles,
the rate otherwise established shall be increased by
not less than \1/2\ of the additional payment per mile
established for the first 17 miles of such a trip
originating in a rural area.
(10) Phase-in providing floor using blend of fee
schedule and regional fee schedules.--In carrying out
the phase-in under paragraph (2)(E) for each level of
ground service furnished in a year, the portion of the
payment amount that is based on the fee schedule shall
be the greater of the amount determined under such fee
schedule (without regard to this paragraph) or the
following blended rate of the fee schedule under
paragraph (1) and of a regional fee schedule for the
region involved:
(A) For 2004 (for services furnished on or
after July 1, 2004), the blended rate shall be
based 20 percent on the fee schedule under
paragraph (1) and 80 percent on the regional
fee schedule.
(B) For 2005, the blended rate shall be based
40 percent on the fee schedule under paragraph
(1) and 60 percent on the regional fee
schedule.
(C) For 2006, the blended rate shall be based
60 percent on the fee schedule under paragraph
(1) and 40 percent on the regional fee
schedule.
(D) For 2007, 2008, and 2009, the blended
rate shall be based 80 percent on the fee
schedule under paragraph (1) and 20 percent on
the regional fee schedule.
(E) For 2010 and each succeeding year, the
blended rate shall be based 100 percent on the
fee schedule under paragraph (1).
For purposes of this paragraph, the Secretary shall
establish a regional fee schedule for each of the nine
census divisions (referred to in section 1886(d)(2))
using the methodology (used in establishing the fee
schedule under paragraph (1)) to calculate a regional
conversion factor and a regional mileage payment rate
and using the same payment adjustments and the same
relative value units as used in the fee schedule under
such paragraph.
(11) Adjustment in payment for certain long trips.--
In the case of ground ambulance services furnished on
or after July 1, 2004, and before January 1, 2009,
regardless of where the transportation originates, the
fee schedule established under this subsection shall
provide that, with respect to the payment rate for
mileage for a trip above 50 miles the per mile rate
otherwise established shall be increased by \1/4\ of
the payment per mile otherwise applicable to miles in
excess of 50 miles in such trip.
(12) Assistance for rural providers furnishing
services in low population density areas.--
(A) In general.--In the case of ground
ambulance services furnished on or after July
1, 2004, and before January 1, 2023, for which
the transportation originates in a qualified
rural area (identified under subparagraph
(B)(iii)), the Secretary shall provide for a
percent increase in the base rate of the fee
schedule for a trip established under this
subsection. In establishing such percent
increase, the Secretary shall estimate the
average cost per trip for such services (not
taking into account mileage) in the lowest
quartile as compared to the average cost per
trip for such services (not taking into account
mileage) in the highest quartile of all rural
county populations.
(B) Identification of qualified rural
areas.--
(i) Determination of population
density in area.--Based upon data from
the United States decennial census for
the year 2000, the Secretary shall
determine, for each rural area, the
population density for that area.
(ii) Ranking of areas.--The Secretary
shall rank each such area based on such
population density.
(iii) Identification of qualified
rural areas.--The Secretary shall
identify those areas (in subparagraph
(A) referred to as ``qualified rural
areas'') with the lowest population
densities that represent, if each such
area were weighted by the population of
such area (as used in computing such
population densities), an aggregate
total of 25 percent of the total of the
population of all such areas.
(iv) Rural area.--For purposes of
this paragraph, the term ``rural area''
has the meaning given such term in
section 1886(d)(2)(D). If feasible, the
Secretary shall treat a rural census
tract of a metropolitan statistical
area (as determined under the most
recent modification of the Goldsmith
Modification, originally published in
the Federal Register on February 27,
1992 (57 Fed. Reg. 6725) as a rural
area for purposes of this paragraph.
(v) Judicial review.--There shall be
no administrative or judicial review
under section 1869, 1878, or otherwise,
respecting the identification of an
area under this subparagraph.
(13) Temporary increase for ground ambulance
services.--
(A) In general.--After computing the rates
with respect to ground ambulance services under
the other applicable provisions of this
subsection, in the case of such services
furnished on or after July 1, 2004, and before
January 1, 2007, and for such services
furnished on or after July 1, 2008, and before
January 1, 2023, for which the transportation
originates in--
(i) a rural area described in
paragraph (9) or in a rural census
tract described in such paragraph, the
fee schedule established under this
section shall provide that the rate for
the service otherwise established,
after the application of any increase
under paragraphs (11) and (12), shall
be increased by 2 percent (or 3 percent
if such service is furnished on or
after July 1, 2008, and before January
1, 2023); and
(ii) an area not described in clause
(i), the fee schedule established under
this subsection shall provide that the
rate for the service otherwise
established, after the application of
any increase under paragraph (11),
shall be increased by 1 percent (or 2
percent if such service is furnished on
or after July 1, 2008, and before
January 1, 2023).
(B) Application of increased payments after
applicable period.--The increased payments
under subparagraph (A) shall not be taken into
account in calculating payments for services
furnished after the applicable period specified
in such subparagraph.
(14) Providing appropriate coverage of rural air
ambulance services.--
(A) In general.--The regulations described in
section 1861(s)(7) shall provide, to the extent
that any ambulance services (whether ground or
air) may be covered under such section, that a
rural air ambulance service (as defined in
subparagraph (C)) is reimbursed under this
subsection at the air ambulance rate if the air
ambulance service--
(i) is reasonable and necessary based
on the health condition of the
individual being transported at or
immediately prior to the time of the
transport; and
(ii) complies with equipment and crew
requirements established by the
Secretary.
(B) Satisfaction of requirement of medically
necessary.--The requirement of subparagraph
(A)(i) is deemed to be met for a rural air
ambulance service if--
(i) subject to subparagraph (D), such
service is requested by a physician or
other qualified medical personnel (as
specified by the Secretary) who
certifies or reasonably determines that
the individual's condition is such that
the time needed to transport the
individual by land or the instability
of transportation by land poses a
threat to the individual's survival or
seriously endangers the individual's
health; or
(ii) such service is furnished
pursuant to a protocol that is
established by a State or regional
emergency medical service (EMS) agency
and recognized or approved by the
Secretary under which the use of an air
ambulance is recommended, if such
agency does not have an ownership
interest in the entity furnishing such
service.
(C) Rural air ambulance service defined.--For
purposes of this paragraph, the term ``rural
air ambulance service'' means fixed wing and
rotary wing air ambulance service in which the
point of pick up of the individual occurs in a
rural area (as defined in section
1886(d)(2)(D)) or in a rural census tract of a
metropolitan statistical area (as determined
under the most recent modification of the
Goldsmith Modification, originally published in
the Federal Register on February 27, 1992 (57
Fed. Reg. 6725)).
(D) Limitation.--
(i) In general.--Subparagraph (B)(i)
shall not apply if there is a financial
or employment relationship between the
person requesting the rural air
ambulance service and the entity
furnishing the ambulance service, or an
entity under common ownership with the
entity furnishing the air ambulance
service, or a financial relationship
between an immediate family member of
such requester and such an entity.
(ii) Exception.--Where a hospital and
the entity furnishing rural air
ambulance services are under common
ownership, clause (i) shall not apply
to remuneration (through employment or
other relationship) by the hospital of
the requester or immediate family
member if the remuneration is for
provider-based physician services
furnished in a hospital (as described
in section 1887) which are reimbursed
under part A and the amount of the
remuneration is unrelated directly or
indirectly to the provision of rural
air ambulance services.
(15) Payment adjustment for non-emergency ambulance
transports for esrd beneficiaries.--The fee schedule
amount otherwise applicable under the preceding
provisions of this subsection shall be reduced by 10
percent for ambulance services furnished during the
period beginning on October 1, 2013, and ending on
September 30, 2018, and by 23 percent for such services
furnished on or after October 1, 2018, consisting of
non-emergency basic life support services involving
transport of an individual with end-stage renal disease
for renal dialysis services (as described in section
1881(b)(14)(B)) furnished other than on an emergency
basis by a provider of services or a renal dialysis
facility.
(16) Prior authorization for repetitive scheduled
non-emergent ambulance transports.--
(A) In general.--Beginning January 1, 2017,
if the expansion to all States of the model of
prior authorization described in paragraph (2)
of section 515(a) of the Medicare Access and
CHIP Reauthorization Act of 2015 meets the
requirements described in paragraphs (1)
through (3) of section 1115A(c), then the
Secretary shall expand such model to all
States.
(B) Funding.--The Secretary shall use funds
made available under section 1893(h)(10) to
carry out this paragraph.
(C) Clarification regarding budget
neutrality.--Nothing in this paragraph may be
construed to limit or modify the application of
section 1115A(b)(3)(B) to models described in
such section, including with respect to the
model described in subparagraph (A) and
expanded beginning on January 1, 2017, under
such subparagraph.
(17) Submission of cost and other information.--
(A) Development of data collection system.--
The Secretary shall develop a data collection
system (which may include use of a cost survey)
to collect cost, revenue, utilization, and
other information determined appropriate by the
Secretary with respect to providers of services
(in this paragraph referred to as
``providers'') and suppliers of ground
ambulance services. Such system shall be
designed to collect information--
(i) needed to evaluate the extent to
which reported costs relate to payment
rates under this subsection;
(ii) on the utilization of capital
equipment and ambulance capacity,
including information consistent with
the type of information described in
section 1121(a); and
(iii) on different types of ground
ambulance services furnished in
different geographic locations,
including rural areas and low
population density areas described in
paragraph (12).
(B) Specification of data collection
system.--
(i) In general.--The Secretary
shall--
(I) not later than December
31, 2019, specify the data
collection system under
subparagraph (A); and
(II) identify the providers
and suppliers of ground
ambulance services that would
be required to submit
information under such data
collection system, including
the representative sample
described in clause (ii).
(ii) Determination of representative
sample.--
(I) In general.--Not later
than December 31, 2019, with
respect to the data collection
for the first year under such
system, and for each subsequent
year through 2024, the
Secretary shall determine a
representative sample to submit
information under the data
collection system.
(II) Requirements.--The
sample under subclause (I)
shall be representative of the
different types of providers
and suppliers of ground
ambulance services (such as
those providers and suppliers
that are part of an emergency
service or part of a government
organization) and the
geographic locations in which
ground ambulance services are
furnished (such as urban,
rural, and low population
density areas).
(III) Limitation.--The
Secretary shall not include an
individual provider or supplier
of ground ambulance services in
the sample under subclause (I)
in 2 consecutive years, to the
extent practicable.
(C) Reporting of cost information.--For each
year, a provider or supplier of ground
ambulance services identified by the Secretary
under subparagraph (B)(i)(II) as being required
to submit information under the data collection
system with respect to a period for the year
shall submit to the Secretary information
specified under the system. Such information
shall be submitted in a form and manner, and at
a time, specified by the Secretary for purposes
of this subparagraph.
(D) Payment reduction for failure to
report.--
(i) In general.--Beginning January 1,
2022, subject to clause (ii), a 10
percent reduction to payments under
this subsection shall be made for the
applicable period (as defined in clause
(ii)) to a provider or supplier of
ground ambulance services that--
(I) is required to submit
information under the data
collection system with respect
to a period under subparagraph
(C); and
(II) does not sufficiently
submit such information, as
determined by the Secretary.
(ii) Applicable period defined.--For
purposes of clause (i), the term
``applicable period'' means, with
respect to a provider or supplier of
ground ambulance services, a year
specified by the Secretary not more
than 2 years after the end of the
period with respect to which the
Secretary has made a determination
under clause (i)(II) that the provider
or supplier of ground ambulance
services failed to sufficiently submit
information under the data collection
system.
(iii) Hardship exemption.--The
Secretary may exempt a provider or
supplier from the payment reduction
under clause (i) with respect to an
applicable period in the event of
significant hardship, such as a natural
disaster, bankruptcy, or other similar
situation that the Secretary determines
interfered with the ability of the
provider or supplier of ground
ambulance services to submit such
information in a timely manner for the
specified period.
(iv) Informal review.--The Secretary
shall establish a process under which a
provider or supplier of ground
ambulance services may seek an informal
review of a determination that the
provider or supplier is subject to the
payment reduction under clause (i).
(E) Ongoing data collection.--
(i) Revision of data collection
system.--The Secretary may, as the
Secretary determines appropriate and,
if available, taking into consideration
the report (or reports) under
subparagraph (F), revise the data
collection system under subparagraph
(A).
(ii) Subsequent data collection.--In
order to continue to evaluate the
extent to which reported costs relate
to payment rates under this subsection
and for other purposes the Secretary
deems appropriate, the Secretary shall
require providers and suppliers of
ground ambulance services to submit
information for years after 2024 as the
Secretary determines appropriate, but
in no case less often than once every 3
years.
(F) Ground ambulance data collection system
study.--
(i) In general.--Not later than March
15, 2023, and as determined necessary
by the Medicare Payment Advisory
Commission thereafter, such Commission
shall assess, and submit to Congress a
report on, information submitted by
providers and suppliers of ground
ambulance services through the data
collection system under subparagraph
(A), the adequacy of payments for
ground ambulance services under this
subsection, and geographic variations
in the cost of furnishing such
services.
(ii) Contents.--A report under clause
(i) shall contain the following:
(I) An analysis of
information submitted through
the data collection system.
(II) An analysis of any
burden on providers and
suppliers of ground ambulance
services associated with the
data collection system.
(III) A recommendation as to
whether information should
continue to be submitted
through such data collection
system or if such system should
be revised under subparagraph
(E)(i).
(IV) Other information
determined appropriate by the
Commission.
(G) Public availability.--The Secretary shall
post information on the results of the data
collection under this paragraph on the Internet
website of the Centers for Medicare & Medicaid
Services, as determined appropriate by the
Secretary.
(H) Implementation.--The Secretary shall
implement this paragraph through notice and
comment rulemaking.
(I) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to the
collection of information required under this
subsection.
(J) Limitations on review.--There shall be no
administrative or judicial review under section
1869, section 1878, or otherwise of the data
collection system or identification of
respondents under this paragraph.
(K) Funding for implementation.--For purposes
of carrying out subparagraph (A), the Secretary
shall provide for the transfer, from the
Federal Supplementary Medical Insurance Trust
Fund under section 1841, of $15,000,000 to the
Centers for Medicare & Medicaid Services
Program Management Account for fiscal year
2018. Amounts transferred under this
subparagraph shall remain available until
expended.
(m) Payment for Telehealth Services.--
(1) In general.--The Secretary shall pay for
telehealth services that are furnished via a
telecommunications system by a physician (as defined in
section 1861(r)) or a practitioner (described in
section 1842(b)(18)(C)) to an eligible telehealth
individual enrolled under this part notwithstanding
that the individual physician or practitioner providing
the telehealth service is not at the same location as
the beneficiary. For purposes of the preceding
sentence, in the case of any Federal telemedicine
demonstration program conducted in Alaska or Hawaii,
the term ``telecommunications system'' includes store-
and-forward technologies that provide for the
asynchronous transmission of health care information in
single or multimedia formats.
(2) Payment amount.--
(A) Distant site.--The Secretary shall pay to
a physician or practitioner located at a
distant site that furnishes a telehealth
service to an eligible telehealth individual an
amount equal to the amount that such physician
or practitioner would have been paid under this
title had such service been furnished without
the use of a telecommunications system.
(B) Facility fee for originating site.--
(i) In general.--Subject to clause
(ii), with respect to a telehealth
service, subject to section
1833(a)(1)(U), there shall be paid to
the originating site a facility fee
equal to--
(I) for the period beginning
on October 1, 2001, and ending
on December 31, 2001, and for
2002, $20; and
(II) for a subsequent year,
the facility fee specified in
subclause (I) or this subclause
for the preceding year
increased by the percentage
increase in the MEI (as defined
in section 1842(i)(3)) for such
subsequent year.
(ii) No facility fee if originating
site for home dialysis therapy is the
home.--No facility fee shall be paid
under this subparagraph to an
originating site described in paragraph
(4)(C)(ii)(X).
(C) Telepresenter not required.--Nothing in
this subsection shall be construed as requiring
an eligible telehealth individual to be
presented by a physician or practitioner at the
originating site for the furnishing of a
service via a telecommunications system, unless
it is medically necessary (as determined by the
physician or practitioner at the distant site).
(3) Limitation on beneficiary charges.--
(A) Physician and practitioner.--The
provisions of section 1848(g) and subparagraphs
(A) and (B) of section 1842(b)(18) shall apply
to a physician or practitioner receiving
payment under this subsection in the same
manner as they apply to physicians or
practitioners under such sections.
(B) Originating site.--The provisions of
section 1842(b)(18) shall apply to originating
sites receiving a facility fee in the same
manner as they apply to practitioners under
such section.
(4) Definitions.--For purposes of this subsection:
(A) Distant site.--The term ``distant site''
means the site at which the physician or
practitioner is located at the time the service
is provided via a telecommunications system.
(B) Eligible telehealth individual.--The term
``eligible telehealth individual'' means an
individual enrolled under this part who
receives a telehealth service furnished at an
originating site.
(C) Originating site.--
(i) In general.--Except as provided
in paragraph (6), the term``originating
site'' means only those sites described
in clause (ii) at which the eligible
telehealth individual is located at the
time the service is furnished via a
telecommunications system and only if
such site is located--
(I) in an area that is
designated as a rural health
professional shortage area
under section 332(a)(1)(A) of
the Public Health Service Act
(42 U.S.C. 254e(a)(1)(A));
(II) in a county that is not
included in a Metropolitan
Statistical Area; or
(III) from an entity that
participates in a Federal
telemedicine demonstration
project that has been approved
by (or receives funding from)
the Secretary of Health and
Human Services as of December
31, 2000.
(ii) Sites described.--The sites
referred to in clause (i) are the
following sites:
(I) The office of a physician
or practitioner.
(II) A critical access
hospital (as defined in section
1861(mm)(1)).
(III) A rural health clinic
(as defined in section
1861(aa)(2)).
(IV) A Federally qualified
health center (as defined in
section 1861(aa)(4)).
(V) A hospital (as defined in
section 1861(e)).
(VI) A hospital-based or
critical access hospital-based
renal dialysis center
(including satellites).
(VII) A skilled nursing
facility (as defined in section
1819(a)).
(VIII) A community mental
health center (as defined in
section 1861(ff)(3)(B)).
(IX) A renal dialysis
facility, but only for purposes
of section 1881(b)(3)(B).
(X) The home of an
individual, but only for
purposes of section
1881(b)(3)(B).
(D) Physician.--The term ``physician'' has
the meaning given that term in section 1861(r).
(E) Practitioner.--The term ``practitioner''
has the meaning given that term in section
1842(b)(18)(C).
(F) Telehealth service.--
(i) In general.--The term
``telehealth service'' means
professional consultations, office
visits, and office psychiatry services
(identified as of July 1, 2000, by
HCPCS codes 99241-99275, 99201-99215,
90804-90809, and 90862 (and as
subsequently modified by the
Secretary)), and any additional service
specified by the Secretary.
(ii) Yearly update.--The Secretary
shall establish a process that
provides, on an annual basis, for the
addition or deletion of services (and
HCPCS codes), as appropriate, to those
specified in clause (i) for authorized
payment under paragraph (1).
(5) Treatment of home dialysis monthly esrd-related
visit.--The geographic requirements described in
paragraph (4)(C)(i) shall not apply with respect to
telehealth services furnished on or after January 1,
2019, for purposes of section 1881(b)(3)(B), at an
originating site described in subclause (VI), (IX), or
(X) of paragraph (4)(C)(ii).
(6) Treatment of stroke telehealth services.--
(A) Non-application of originating site
requirements.--The requirements described in
paragraph (4)(C) shall not apply with respect
to telehealth services furnished on or after
January 1, 2019, for purposes of diagnosis,
evaluation, or treatment of symptoms of an
acute stroke, as determined by the Secretary.
(B) Inclusion of certain sites.--With respect
to telehealth services described in
subparagraph (A), the term ``originating site''
shall include any hospital (as defined in
section 1861(e)) or critical access hospital
(as defined in section 1861(mm)(1)), any mobile
stroke unit (as defined by the Secretary), or
any other site determined appropriate by the
Secretary, at which the eligible telehealth
individual is located at the time the service
is furnished via a telecommunications system.
(C) No originating site facility fee for new
sites.--No facility fee shall be paid under
paragraph (2)(B) to an originating site with
respect to a telehealth service described in
subparagraph (A) if the originating site does
not otherwise meet the requirements for an
originating site under paragraph (4)(C).
(n) Authority To Modify or Eliminate Coverage of Certain
Preventive Services.--Notwithstanding any other provision of
this title, effective beginning on January 1, 2010, if the
Secretary determines appropriate, the Secretary may--
(1) modify--
(A) the coverage of any preventive service
described in subparagraph (A) of section
1861(ddd)(3) to the extent that such
modification is consistent with the
recommendations of the United States Preventive
Services Task Force; and
(B) the services included in the initial
preventive physical examination described in
subparagraph (B) of such section; and
(2) provide that no payment shall be made under this
title for a preventive service described in
subparagraph (A) of such section that has not received
a grade of A, B, C, or I by such Task Force.
(o) Development and Implementation of Prospective Payment
System.--
(1) Development.--
(A) In general.--The Secretary shall develop
a prospective payment system for payment for
Federally qualified health center services
furnished by Federally qualified health centers
under this title. Such system shall include a
process for appropriately describing the
services furnished by Federally qualified
health centers and shall establish payment
rates for specific payment codes based on such
appropriate descriptions of services. Such
system shall be established to take into
account the type, intensity, and duration of
services furnished by Federally qualified
health centers. Such system may include
adjustments, including geographic adjustments,
determined appropriate by the Secretary.
(B) Collection of data and evaluation.--By
not later than January 1, 2011, the Secretary
shall require Federally qualified health
centers to submit to the Secretary such
information as the Secretary may require in
order to develop and implement the prospective
payment system under this subsection, including
the reporting of services using HCPCS codes.
(2) Implementation.--
(A) In general.--Notwithstanding section
1833(a)(3)(A), the Secretary shall provide, for
cost reporting periods beginning on or after
October 1, 2014, for payments of prospective
payment rates for Federally qualified health
center services furnished by Federally
qualified health centers under this title in
accordance with the prospective payment system
developed by the Secretary under paragraph (1).
(B) Payments.--
(i) Initial payments.--The Secretary
shall implement such prospective
payment system so that the estimated
aggregate amount of prospective payment
rates (determined prior to the
application of section 1833(a)(1)(Z))
under this title for Federally
qualified health center services in the
first year that such system is
implemented is equal to 100 percent of
the estimated amount of reasonable
costs (determined without the
application of a per visit payment
limit or productivity screen and prior
to the application of section
1866(a)(2)(A)(ii)) that would have
occurred for such services under this
title in such year if the system had
not been implemented.
(ii) Payments in subsequent years.--
Payment rates in years after the year
of implementation of such system shall
be the payment rates in the previous
year increased--
(I) in the first year after
implementation of such system,
by the percentage increase in
the MEI (as defined in section
1842(i)(3)) for the year
involved; and
(II) in subsequent years, by
the percentage increase in a
market basket of Federally
qualified health center goods
and services as promulgated
through regulations, or if such
an index is not available, by
the percentage increase in the
MEI (as defined in section
1842(i)(3)) for the year
involved.
(C) Preparation for pps implementation.--
Notwithstanding any other provision of law, the
Secretary may establish and implement by
program instruction or otherwise the payment
codes to be used under the prospective payment
system under this section.
(3) Additional payments for certain fqhcs with
physicians or other practitioners receiving data 2000
waivers.--
(A) In general.--In the case of a Federally
qualified health center with respect to which,
beginning on or after January 1, 2019,
Federally-qualified health center services (as
defined in section 1861(aa)(3)) are furnished
for the treatment of opioid use disorder by a
physician or practitioner who meets the
requirements described in subparagraph (C) the
Secretary shall, subject to availability of
funds under subparagraph (D), make a payment
(at such time and in such manner as specified
by the Secretary) to such Federally qualified
health center after receiving and approving an
application submitted by such Federally
qualified health center under subparagraph (B).
Such a payment shall be in an amount determined
by the Secretary, based on an estimate of the
average costs of training for purposes of
receiving a waiver described in subparagraph
(C)(ii). Such a payment may be made only one
time with respect to each such physician or
practitioner.
(B) Application.--In order to receive a
payment described in subparagraph (A), a
Federally-qualified health center shall submit
to the Secretary an application for such a
payment at such time, in such manner, and
containing such information as specified by the
Secretary. A Federally-qualified health center
may apply for such a payment for each physician
or practitioner described in subparagraph (A)
furnishing services described in such
subparagraph at such center.
(C) Requirements.--For purposes of
subparagraph (A), the requirements described in
this subparagraph, with respect to a physician
or practitioner, are the following:
(i) The physician or practitioner is
employed by or working under contract
with a Federally qualified health
center described in subparagraph (A)
that submits an application under
subparagraph (B).
(ii) The physician or practitioner
first receives a waiver under section
303(g) of the Controlled Substances
Acton or after January 1, 2019.
(D) Funding.--For purposes of making payments
under this paragraph, there are appropriated,
out of amounts in the Treasury not otherwise
appropriated, $6,000,000, which shall remain
available until expended.
(p) Quality Incentives To Promote Patient Safety and Public
Health in Computed Tomography.--
(1) Quality incentives.--In the case of an applicable
computed tomography service (as defined in paragraph
(2)) for which payment is made under an applicable
payment system (as defined in paragraph (3)) and that
is furnished on or after January 1, 2016, using
equipment that is not consistent with the CT equipment
standard (described in paragraph (4)), the payment
amount for such service shall be reduced by the
applicable percentage (as defined in paragraph (5)).
(2) Applicable computed tomography services
defined.--In this subsection, the term ``applicable
computed tomography service'' means a service billed
using diagnostic radiological imaging codes for
computed tomography (identified as of January 1, 2014,
by HCPCS codes 70450-70498, 71250-71275, 72125-72133,
72191-72194, 73200-73206, 73700-73706, 74150-74178,
74261-74263, and 75571-75574 (and any succeeding
codes).
(3) Applicable payment system defined.--In this
subsection, the term ``applicable payment system''
means the following:
(A) The technical component and the technical
component of the global fee under the fee
schedule established under section 1848(b).
(B) The prospective payment system for
hospital outpatient department services under
section 1833(t).
(4) Consistency with ct equipment standard.--In this
subsection, the term ``not consistent with the CT
equipment standard'' means, with respect to an
applicable computed tomography service, that the
service was furnished using equipment that does not
meet each of the attributes of the National Electrical
Manufacturers Association (NEMA) Standard XR-29-2013,
entitled ``Standard Attributes on CT Equipment Related
to Dose Optimization and Management''. Through
rulemaking, the Secretary may apply successor
standards.
(5) Applicable percentage defined.--In this
subsection, the term ``applicable percentage'' means--
(A) for 2016, 5 percent; and
(B) for 2017 and subsequent years, 15
percent.
(6) Implementation.--
(A) Information.--The Secretary shall require
that information be provided and attested to by
a supplier and a hospital outpatient department
that indicates whether an applicable computed
tomography service was furnished that was not
consistent with the CT equipment standard
(described in paragraph (4)). Such information
may be included on a claim and may be a
modifier. Such information shall be verified,
as appropriate, as part of the periodic
accreditation of suppliers under section
1834(e) and hospitals under section 1865(a).
(B) Administration.--Chapter 35 of title 44,
United States Code, shall not apply to
information described in subparagraph (A).
(q) Recognizing Appropriate Use Criteria for Certain Imaging
Services.--
(1) Program established.--
(A) In general.--The Secretary shall
establish a program to promote the use of
appropriate use criteria (as defined in
subparagraph (B)) for applicable imaging
services (as defined in subparagraph (C))
furnished in an applicable setting (as defined
in subparagraph (D)) by ordering professionals
and furnishing professionals (as defined in
subparagraphs (E) and (F), respectively).
(B) Appropriate use criteria defined.--In
this subsection, the term ``appropriate use
criteria'' means criteria, only developed or
endorsed by national professional medical
specialty societies or other provider-led
entities, to assist ordering professionals and
furnishing professionals in making the most
appropriate treatment decision for a specific
clinical condition for an individual. To the
extent feasible, such criteria shall be
evidence-based.
(C) Applicable imaging service defined.--In
this subsection, the term ``applicable imaging
service'' means an advanced diagnostic imaging
service (as defined in subsection (e)(1)(B))
for which the Secretary determines--
(i) one or more applicable
appropriate use criteria specified
under paragraph (2) apply;
(ii) there are one or more qualified
clinical decision support mechanisms
listed under paragraph (3)(C); and
(iii) one or more of such mechanisms
is available free of charge.
(D) Applicable setting defined.--In this
subsection, the term ``applicable setting''
means a physician's office, a hospital
outpatient department (including an emergency
department), an ambulatory surgical center, and
any other provider-led outpatient setting
determined appropriate by the Secretary.
(E) Ordering professional defined.--In this
subsection, the term ``ordering professional''
means a physician (as defined in section
1861(r)) or a practitioner described in section
1842(b)(18)(C) who orders an applicable imaging
service.
(F) Furnishing professional defined.--In this
subsection, the term ``furnishing
professional'' means a physician (as defined in
section 1861(r)) or a practitioner described in
section 1842(b)(18)(C) who furnishes an
applicable imaging service.
(2) Establishment of applicable appropriate use
criteria.--
(A) In general.--Not later than November 15,
2015, the Secretary shall through rulemaking,
and in consultation with physicians,
practitioners, and other stakeholders, specify
applicable appropriate use criteria for
applicable imaging services only from among
appropriate use criteria developed or endorsed
by national professional medical specialty
societies or other provider-led entities.
(B) Considerations.--In specifying applicable
appropriate use criteria under subparagraph
(A), the Secretary shall take into account
whether the criteria--
(i) have stakeholder consensus;
(ii) are scientifically valid and
evidence based; and
(iii) are based on studies that are
published and reviewable by
stakeholders.
(C) Revisions.--The Secretary shall review,
on an annual basis, the specified applicable
appropriate use criteria to determine if there
is a need to update or revise (as appropriate)
such specification of applicable appropriate
use criteria and make such updates or revisions
through rulemaking.
(D) Treatment of multiple applicable
appropriate use criteria.--In the case where
the Secretary determines that more than one
appropriate use criterion applies with respect
to an applicable imaging service, the Secretary
shall apply one or more applicable appropriate
use criteria under this paragraph for the
service.
(3) Mechanisms for consultation with applicable
appropriate use criteria.--
(A) Identification of mechanisms to consult
with applicable appropriate use criteria.--
(i) In general.--The Secretary shall
specify qualified clinical decision
support mechanisms that could be used
by ordering professionals to consult
with applicable appropriate use
criteria for applicable imaging
services.
(ii) Consultation.--The Secretary
shall consult with physicians,
practitioners, health care technology
experts, and other stakeholders in
specifying mechanisms under this
paragraph.
(iii) Inclusion of certain
mechanisms.--Mechanisms specified under
this paragraph may include any or all
of the following that meet the
requirements described in subparagraph
(B)(ii):
(I) Use of clinical decision
support modules in certified
EHR technology (as defined in
section 1848(o)(4)).
(II) Use of private sector
clinical decision support
mechanisms that are independent
from certified EHR technology,
which may include use of
clinical decision support
mechanisms available from
medical specialty
organizations.
(III) Use of a clinical
decision support mechanism
established by the Secretary.
(B) Qualified clinical decision support
mechanisms.--
(i) In general.--For purposes of this
subsection, a qualified clinical
decision support mechanism is a
mechanism that the Secretary determines
meets the requirements described in
clause (ii).
(ii) Requirements.--The requirements
described in this clause are the
following:
(I) The mechanism makes
available to the ordering
professional applicable
appropriate use criteria
specified under paragraph (2)
and the supporting
documentation for the
applicable imaging service
ordered.
(II) In the case where there
is more than one applicable
appropriate use criterion
specified under such paragraph
for an applicable imaging
service, the mechanism
indicates the criteria that it
uses for the service.
(III) The mechanism
determines the extent to which
an applicable imaging service
ordered is consistent with the
applicable appropriate use
criteria so specified.
(IV) The mechanism generates
and provides to the ordering
professional a certification or
documentation that documents
that the qualified clinical
decision support mechanism was
consulted by the ordering
professional.
(V) The mechanism is updated
on a timely basis to reflect
revisions to the specification
of applicable appropriate use
criteria under such paragraph.
(VI) The mechanism meets
privacy and security standards
under applicable provisions of
law.
(VII) The mechanism performs
such other functions as
specified by the Secretary,
which may include a requirement
to provide aggregate feedback
to the ordering professional.
(C) List of mechanisms for consultation with
applicable appropriate use criteria.--
(i) Initial list.--Not later than
April 1, 2016, the Secretary shall
publish a list of mechanisms specified
under this paragraph.
(ii) Periodic updating of list.--The
Secretary shall identify on an annual
basis the list of qualified clinical
decision support mechanisms specified
under this paragraph.
(4) Consultation with applicable appropriate use
criteria.--
(A) Consultation by ordering professional.--
Beginning with January 1, 2017, subject to
subparagraph (C), with respect to an applicable
imaging service ordered by an ordering
professional that would be furnished in an
applicable setting and paid for under an
applicable payment system (as defined in
subparagraph (D)), an ordering professional
shall--
(i) consult with a qualified decision
support mechanism listed under
paragraph (3)(C); and
(ii) provide to the furnishing
professional the information described
in clauses (i) through (iii) of
subparagraph (B).
(B) Reporting by furnishing professional.--
Beginning with January 1, 2017, subject to
subparagraph (C), with respect to an applicable
imaging service furnished in an applicable
setting and paid for under an applicable
payment system (as defined in subparagraph
(D)), payment for such service may only be made
if the claim for the service includes the
following:
(i) Information about which qualified
clinical decision support mechanism was
consulted by the ordering professional
for the service.
(ii) Information regarding--
(I) whether the service
ordered would adhere to the
applicable appropriate use
criteria specified under
paragraph (2);
(II) whether the service
ordered would not adhere to
such criteria; or
(III) whether such criteria
was not applicable to the
service ordered.
(iii) The national provider
identifier of the ordering professional
(if different from the furnishing
professional).
(C) Exceptions.--The provisions of
subparagraphs (A) and (B) and paragraph (6)(A)
shall not apply to the following:
(i) Emergency services.--An
applicable imaging service ordered for
an individual with an emergency medical
condition (as defined in section
1867(e)(1)).
(ii) Inpatient services.--An
applicable imaging service ordered for
an inpatient and for which payment is
made under part A.
(iii) Significant hardship.--An
applicable imaging service ordered by
an ordering professional who the
Secretary may, on a case-by-case basis,
exempt from the application of such
provisions if the Secretary determines,
subject to annual renewal, that
consultation with applicable
appropriate use criteria would result
in a significant hardship, such as in
the case of a professional who
practices in a rural area without
sufficient Internet access.
(D) Applicable payment system defined.--In
this subsection, the term ``applicable payment
system'' means the following:
(i) The physician fee schedule
established under section 1848(b).
(ii) The prospective payment system
for hospital outpatient department
services under section 1833(t).
(iii) The ambulatory surgical center
payment systems under section 1833(i).
(5) Identification of outlier ordering
professionals.--
(A) In general.--With respect to applicable
imaging services furnished beginning with 2017,
the Secretary shall determine, on an annual
basis, no more than five percent of the total
number of ordering professionals who are
outlier ordering professionals.
(B) Outlier ordering professionals.--The
determination of an outlier ordering
professional shall--
(i) be based on low adherence to
applicable appropriate use criteria
specified under paragraph (2), which
may be based on comparison to other
ordering professionals; and
(ii) include data for ordering
professionals for whom prior
authorization under paragraph (6)(A)
applies.
(C) Use of two years of data.--The Secretary
shall use two years of data to identify outlier
ordering professionals under this paragraph.
(D) Process.--The Secretary shall establish a
process for determining when an outlier
ordering professional is no longer an outlier
ordering professional.
(E) Consultation with stakeholders.--The
Secretary shall consult with physicians,
practitioners and other stakeholders in
developing methods to identify outlier ordering
professionals under this paragraph.
(6) Prior authorization for ordering professionals
who are outliers.--
(A) In general.--Beginning January 1, 2020,
subject to paragraph (4)(C), with respect to
services furnished during a year, the Secretary
shall, for a period determined appropriate by
the Secretary, apply prior authorization for
applicable imaging services that are ordered by
an outlier ordering professional identified
under paragraph (5).
(B) Appropriate use criteria in prior
authorization.--In applying prior authorization
under subparagraph (A), the Secretary shall
utilize only the applicable appropriate use
criteria specified under this subsection.
(C) Funding.--For purposes of carrying out
this paragraph, the Secretary shall provide for
the transfer, from the Federal Supplementary
Medical Insurance Trust Fund under section
1841, of $5,000,000 to the Centers for Medicare
& Medicaid Services Program Management Account
for each of fiscal years 2019 through 2021.
Amounts transferred under the preceding
sentence shall remain available until expended.
(7) Construction.--Nothing in this subsection shall
be construed as granting the Secretary the authority to
develop or initiate the development of clinical
practice guidelines or appropriate use criteria.
(r) Payment for Renal Dialysis Services for Individuals With
Acute Kidney Injury.--
(1) Payment rate.--In the case of renal dialysis
services (as defined in subparagraph (B) of section
1881(b)(14)) furnished under this part by a renal
dialysis facility or provider of services paid under
such section during a year (beginning with 2017) to an
individual with acute kidney injury (as defined in
paragraph (2)), the amount of payment under this part
for such services shall be the base rate for renal
dialysis services determined for such year under such
section, as adjusted by any applicable geographic
adjustment factor applied under subparagraph
(D)(iv)(II) of such section and may be adjusted by the
Secretary (on a budget neutral basis for payments under
this paragraph) by any other adjustment factor under
subparagraph (D) of such section.
(2) Individual with acute kidney injury defined.--In
this subsection, the term ``individual with acute
kidney injury'' means an individual who has acute loss
of renal function and does not receive renal dialysis
services for which payment is made under section
1881(b)(14).
(s) Payment for Applicable Disposable Devices.--
(1) Separate payment.--The Secretary shall make a
payment (separate from the payments otherwise made
under section 1895) in the amount established under
paragraph (3) to a home health agency for an applicable
disposable device (as defined in paragraph (2)) when
furnished on or after January 1, 2017, to an individual
who receives home health services for which payment is
made under section 1895(b).
(2) Applicable disposable device.--In this
subsection, the term applicable disposable device means
a disposable device that, as determined by the
Secretary, is--
(A) a disposable negative pressure wound
therapy device that is an integrated system
comprised of a non-manual vacuum pump, a
receptacle for collecting exudate, and
dressings for the purposes of wound therapy;
and
(B) a substitute for, and used in lieu of, a
negative pressure wound therapy durable medical
equipment item that is an integrated system of
a negative pressure vacuum pump, a separate
exudate collection canister, and dressings that
would otherwise be covered for individuals for
such wound therapy.
(3) Payment amount.--The separate payment amount
established under this paragraph for an applicable
disposable device for a year shall be equal to the
amount of the payment that would be made under section
1833(t) (relating to payment for covered OPD services)
for the year for the Level I Healthcare Common
Procedure Coding System (HCPCS) code for which the
description for a professional service includes the
furnishing of such device.
(t) Site-of-Service Price Transparency.--
(1) In general.--In order to facilitate price
transparency with respect to items and services for
which payment may be made either to a hospital
outpatient department or to an ambulatory surgical
center under this title, the Secretary shall, for 2018
and each year thereafter, make available to the public
via a searchable Internet website, with respect to an
appropriate number of such items and services--
(A) the estimated payment amount for the item
or service under the outpatient department fee
schedule under subsection (t) of section 1833
and the ambulatory surgical center payment
system under subsection (i) of such section;
and
(B) the estimated amount of beneficiary
liability applicable to the item or service.
(2) Calculation of estimated beneficiary liability.--
For purposes of paragraph (1)(B), the estimated amount
of beneficiary liability, with respect to an item or
service, is the amount for such item or service for
which an individual who does not have coverage under a
Medicare supplemental policy certified under section
1882 or any other supplemental insurance coverage is
responsible.
(3) Implementation.--In carrying out this subsection,
the Secretary--
(A) shall include in the notice described in
section 1804(a) a notification of the
availability of the estimated amounts made
available under paragraph (1); and
(B) may utilize mechanisms in existence on
the date of enactment of this subsection, such
as the portion of the Internet website of the
Centers for Medicare & Medicaid Services on
which information comparing physician
performance is posted (commonly referred to as
the Physician Compare Internet website), to
make available such estimated amounts under
such paragraph.
(4) Funding.--For purposes of implementing this
subsection, the Secretary shall provide for the
transfer, from the Federal Supplementary Medical
Insurance Trust Fund under section 1841 to the Centers
for Medicare & Medicaid Services Program Management
Account, of $6,000,000 for fiscal year 2017, to remain
available until expended.
(u) Payment and Related Requirements for Home Infusion
Therapy.--
(1) Payment.--
(A) Single payment.--
(i) In general.--Subject to clause
(iii) and subparagraphs (B) and (C),
the Secretary shall implement a payment
system under which a single payment is
made under this title to a qualified
home infusion therapy supplier for
items and services described in
subparagraphs (A) and (B) of section
1861(iii)(2)) furnished by a qualified
home infusion therapy supplier (as
defined in section 1861(iii)(3)(D)) in
coordination with the furnishing of
home infusion drugs (as defined in
section 1861(iii)(3)(C)) under this
part.
(ii) Unit of single payment.--A unit
of single payment under the payment
system implemented under this
subparagraph is for each infusion drug
administration calendar day in the
individual's home. The Secretary shall,
as appropriate, establish single
payment amounts for types of infusion
therapy, including to take into account
variation in utilization of nursing
services by therapy type.
(iii) Limitation.--The single payment
amount determined under this
subparagraph after application of
subparagraph (B) and paragraph (3)
shall not exceed the amount determined
under the fee schedule under section
1848 for infusion therapy services
furnished in a calendar day if
furnished in a physician office
setting, except such single payment
shall not reflect more than 5 hours of
infusion for a particular therapy in a
calendar day.
(B) Required adjustments.--The Secretary
shall adjust the single payment amount
determined under subparagraph (A) for home
infusion therapy services under section
1861(iii)(1) to reflect other factors such as--
(i) a geographic wage index and other
costs that may vary by region; and
(ii) patient acuity and complexity of
drug administration.
(C) Discretionary adjustments.--
(i) In general.--Subject to clause
(ii), the Secretary may adjust the
single payment amount determined under
subparagraph (A) (after application of
subparagraph (B)) to reflect outlier
situations and other factors as the
Secretary determines appropriate.
(ii) Requirement of budget
neutrality.--Any adjustment under this
subparagraph shall be made in a budget
neutral manner.
(2) Considerations.--In developing the payment system
under this subsection, the Secretary may consider the
costs of furnishing infusion therapy in the home,
consult with home infusion therapy suppliers, consider
payment amounts for similar items and services under
this part and part A, and consider payment amounts
established by Medicare Advantage plans under part C
and in the private insurance market for home infusion
therapy (including average per treatment day payment
amounts by type of home infusion therapy).
(3) Annual updates.--
(A) In general.--Subject to subparagraph (B),
the Secretary shall update the single payment
amount under this subsection from year to year
beginning in 2022 by increasing the single
payment amount from the prior year by the
percentage increase in the Consumer Price Index
for all urban consumers (United States city
average) for the 12-month period ending with
June of the preceding year.
(B) Adjustment.--For each year, the Secretary
shall reduce the percentage increase described
in subparagraph (A) by the productivity
adjustment described in section
1886(b)(3)(B)(xi)(II). The application of the
preceding sentence may result in a percentage
being less than 0.0 for a year, and may result
in payment being less than such payment rates
for the preceding year.
(4) Authority to apply prior authorization.--The
Secretary may, as determined appropriate by the
Secretary, apply prior authorization for home infusion
therapy services under section 1861(iii)(1).
(5) Accreditation of qualified home infusion therapy
suppliers.--
(A) Factors for designation of accreditation
organizations.--The Secretary shall consider
the following factors in designating
accreditation organizations under subparagraph
(B) and in reviewing and modifying the list of
accreditation organizations designated pursuant
to subparagraph (C):
(i) The ability of the organization
to conduct timely reviews of
accreditation applications.
(ii) The ability of the organization
to take into account the capacities of
suppliers located in a rural area (as
defined in section 1886(d)(2)(D)).
(iii) Whether the organization has
established reasonable fees to be
charged to suppliers applying for
accreditation.
(iv) Such other factors as the
Secretary determines appropriate.
(B) Designation.--Not later than January 1,
2021, the Secretary shall designate
organizations to accredit suppliers furnishing
home infusion therapy. The list of
accreditation organizations so designated may
be modified pursuant to subparagraph (C).
(C) Review and modification of list of
accreditation organizations.--
(i) In general.--The Secretary shall
review the list of accreditation
organizations designated under
subparagraph (B) taking into account
the factors under subparagraph (A).
Taking into account the results of such
review, the Secretary may, by
regulation, modify the list of
accreditation organizations designated
under subparagraph (B).
(ii) Special rule for accreditations
done prior to removal from list of
designated accreditation
organizations.--In the case where the
Secretary removes an organization from
the list of accreditation organizations
designated under subparagraph (B), any
supplier that is accredited by the
organization during the period
beginning on the date on which the
organization is designated as an
accreditation organization under
subparagraph (B) and ending on the date
on which the organization is removed
from such list shall be considered to
have been accredited by an organization
designated by the Secretary under
subparagraph (B) for the remaining
period such accreditation is in effect.
(D) Rule for accreditations made prior to
designation.--In the case of a supplier that is
accredited before January 1, 2021, by an
accreditation organization designated by the
Secretary under subparagraph (B) as of January
1, 2019, such supplier shall be considered to
have been accredited by an organization
designated by the Secretary under such
paragraph as of January 1, 2023, for the
remaining period such accreditation is in
effect.
(6) Notification of infusion therapy options
available prior to furnishing home infusion therapy.--
Prior to the furnishing of home infusion therapy to an
individual, the physician who establishes the plan
described in section 1861(iii)(1) for the individual
shall provide notification (in a form, manner, and
frequency determined appropriate by the Secretary) of
the options available (such as home, physician's
office, hospital outpatient department) for the
furnishing of infusion therapy under this part.
(7) Home infusion therapy services temporary
transitional payment.--
(A) Temporary transitional payment.--
(i) In general.--The Secretary shall,
in accordance with the payment
methodology described in subparagraph
(B) and subject to the provisions of
this paragraph, provide a home infusion
therapy services temporary transitional
payment under this part to an eligible
home infusion supplier (as defined in
subparagraph (F)) for items and
services described in subparagraphs (A)
and (B) of section 1861(iii)(2))
furnished during the period specified
in clause (ii) by such supplier in
coordination with the furnishing of
transitional home infusion drugs (as
defined in clause (iii)).
(ii) Period specified.--For purposes
of clause (i), the period specified in
this clause is the period beginning on
January 1, 2019, and ending on the day
before the date of the implementation
of the payment system under paragraph
(1)(A).
(iii) Transitional home infusion drug
defined.--For purposes of this
paragraph, the term ``transitional home
infusion drug'' has the meaning given
to the term ``home infusion drug''
under section 1861(iii)(3)(C)), except
that clause (ii) of such section shall
not apply if a drug described in such
clause is identified in clauses (i),
(ii), (iii) or (iv) of subparagraph (C)
as of the date of the enactment of this
paragraph.
(B) Payment methodology.--For purposes of
this paragraph, the Secretary shall establish a
payment methodology, with respect to items and
services described in subparagraph (A)(i).
Under such payment methodology the Secretary
shall--
(i) create the three payment
categories described in clauses (i),
(ii), and (iii) of subparagraph (C);
(ii) assign drugs to such categories,
in accordance with such clauses;
(iii) assign appropriate Healthcare
Common Procedure Coding System (HCPCS)
codes to each payment category; and
(iv) establish a single payment
amount for each such payment category,
in accordance with subparagraph (D),
for each infusion drug administration
calendar day in the individual's home
for drugs assigned to such category.
(C) Payment categories.--
(i) Payment category 1.--The
Secretary shall create a payment
category 1 and assign to such category
drugs which are covered under the Local
Coverage Determination on External
Infusion Pumps (LCD number L33794) and
billed with the following HCPCS codes
(as identified as of January 1, 2018,
and as subsequently modified by the
Secretary): J0133, J0285, J0287, J0288,
J0289, J0895, J1170, J1250, J1265,
J1325, J1455, J1457, J1570, J2175,
J2260, J2270, J2274, J2278, J3010, or
J3285.
(ii) Payment category 2.--The
Secretary shall create a payment
category 2 and assign to such category
drugs which are covered under such
local coverage determination and billed
with the following HCPCS codes (as
identified as of January 1, 2018, and
as subsequently modified by the
Secretary): J1555 JB, J1559 JB, J1561
JB, J1562 JB, J1569 JB, or J1575 JB.
(iii) Payment category 3.--The
Secretary shall create a payment
category 3 and assign to such category
drugs which are covered under such
local coverage determination and billed
with the following HCPCS codes (as
identified as of January 1, 2018, and
as subsequently modified by the
Secretary): J9000, J9039, J9040, J9065,
J9100, J9190, J9200, J9360, or J9370.
(iv) Infusion drugs not otherwise
included.--With respect to drugs that
are not included in payment category 1,
2, or 3 under clause (i), (ii), or
(iii), respectively, the Secretary
shall assign to the most appropriate of
such categories, as determined by the
Secretary, drugs which are--
(I) covered under such local
coverage determination and
billed under HCPCS codes J7799
or J7999 (as identified as of
July 1, 2017, and as
subsequently modified by the
Secretary); or
(II) billed under any code
that is implemented after the
date of the enactment of this
paragraph and included in such
local coverage determination or
included in subregulatory
guidance as a home infusion
drug described in subparagraph
(A)(i).
(D) Payment amounts.--
(i) In general.--Under the payment
methodology, the Secretary shall pay
eligible home infusion suppliers, with
respect to items and services described
in subparagraph (A)(i) furnished during
the period described in subparagraph
(A)(ii) by such supplier to an
individual, at amounts equal to the
amounts determined under the physician
fee schedule established under section
1848 for services furnished during the
year for codes and units of such codes
described in clauses (ii), (iii), and
(iv) with respect to drugs included in
the payment category under subparagraph
(C) specified in the respective clause,
determined without application of the
geographic adjustment under subsection
(e) of such section.
(ii) Payment amount for category 1.--
For purposes of clause (i), the codes
and units described in this clause,
with respect to drugs included in
payment category 1 described in
subparagraph (C)(i), are one unit of
HCPCS code 96365 plus three units of
HCPCS code 96366 (as identified as of
January 1, 2018, and as subsequently
modified by the Secretary).
(iii) Payment amount for category
2.--For purposes of clause (i), the
codes and units described in this
clause, with respect to drugs included
in payment category 2 described in
subparagraph (C)(i), are one unit of
HCPCS code 96369 plus three units of
HCPCS code 96370 (as identified as of
January 1, 2018, and as subsequently
modified by the Secretary).
(iv) Payment amount for category 3.--
For purposes of clause (i), the codes
and units described in this clause,
with respect to drugs included in
payment category 3 described in
subparagraph (C)(i), are one unit of
HCPCS code 96413 plus three units of
HCPCS code 96415 (as identified as of
January 1, 2018, and as subsequently
modified by the Secretary).
(E) Clarifications.--
(i) Infusion drug administration
day.--For purposes of this subsection,
with respect to the furnishing of
transitional home infusion drugs or
home infusion drugs to an individual by
an eligible home infusion supplier or a
qualified home infusion therapy
supplier, a reference to payment to
such supplier for an infusion drug
administration calendar day in the
individual's home shall refer to
payment only for the date on which
professional services (as described in
section 1861(iii)(2)(A)) were furnished
to administer such drugs to such
individual. For purposes of the
previous sentence, an infusion drug
administration calendar day shall
include all such drugs administered to
such individual on such day.
(ii) Treatment of multiple drugs
administered on same infusion drug
administration day.--In the case that
an eligible home infusion supplier,
with respect to an infusion drug
administration calendar day in an
individual's home, furnishes to such
individual transitional home infusion
drugs which are not all assigned to the
same payment category under
subparagraph (C), payment to such
supplier for such infusion drug
administration calendar day in the
individual's home shall be a single
payment equal to the amount of payment
under this paragraph for the drug,
among all such drugs so furnished to
such individual during such calendar
day, for which the highest payment
would be made under this paragraph.
(F) Eligible home infusion suppliers.--In
this paragraph, the term ``eligible home
infusion supplier'' means a supplier that is
enrolled under this part as a pharmacy that
provides external infusion pumps and external
infusion pump supplies and that maintains all
pharmacy licensure requirements in the State in
which the applicable infusion drugs are
administered.
(G) Implementation.--Notwithstanding any
other provision of law, the Secretary may
implement this paragraph by program instruction
or otherwise.
(v) Payment for Outpatient Physical Therapy Services and
Outpatient Occupational Therapy Services Furnished by a Therapy
Assistant.--
(1) In general.--In the case of an outpatient
physical therapy service or outpatient occupational
therapy service furnished on or after January 1, 2022,
for which payment is made under section 1848 or
subsection (k), that is furnished in whole or in part
by a therapy assistant (as defined by the Secretary),
the amount of payment for such service shall be an
amount equal to 85 percent of the amount of payment
otherwise applicable for the service under this part.
Nothing in the preceding sentence shall be construed to
change applicable requirements with respect to such
services.
(2) Use of modifier.--
(A) Establishment.--Not later than January 1,
2019, the Secretary shall establish a modifier
to indicate (in a form and manner specified by
the Secretary), in the case of an outpatient
physical therapy service or outpatient
occupational therapy service furnished in whole
or in part by a therapy assistant (as so
defined), that the service was furnished by a
therapy assistant.
(B) Required use.--Each request for payment,
or bill submitted, for an outpatient physical
therapy service or outpatient occupational
therapy service furnished in whole or in part
by a therapy assistant (as so defined) on or
after January 1, 2020, shall include the
modifier established under subparagraph (A) for
each such service.
(3) Implementation.--The Secretary shall implement
this subsection through notice and comment rulemaking.
(w) Opioid Use Disorder Treatment Services.--
(1) In general.--The Secretary shall pay to an opioid
treatment program (as defined in paragraph (2) of
section 1861(jjj)) an amount that is equal to 100
percent of a bundled payment under this part for opioid
use disorder treatment services (as defined in
paragraph (1) of such section) that are furnished by
such program to an individual during an episode of care
(as defined by the Secretary) beginning on or after
January 1, 2020. The Secretary shall ensure, as
determined appropriate by the Secretary, that no
duplicative payments are made under this part or part D
for items and services furnished by an opioid treatment
program.
(2) Considerations.--The Secretary may implement this
subsection through one or more bundles based on the
type of medication provided (such as buprenorphine,
methadone, naltrexone, or a new innovative drug), the
frequency of services, the scope of services furnished,
characteristics of the individuals furnished such
services, or other factors as the Secretary determine
appropriate. In developing such bundles, the Secretary
may consider payment rates paid to opioid treatment
programs for comparable services under State plans
under title XIX or under the TRICARE program under
chapter 55 of title 10 of the United States Code.
(3) Annual updates.--The Secretary shall provide an
update each year to the bundled payment amounts under
this subsection.
* * * * * * *
Part E--Miscellaneous Provisions
definitions of services, institutions, etc.
Sec. 1861. For purposes of this title--
Spell of Illness
(a) The term ``spell of illness'' with respect to any
individual means a period of consecutive days--
(1) beginning with the first day (not included in a
previous spell of illness) (A) on which such individual
is furnished inpatient hospital services, inpatient
critical access hospital services or extended care
services, and (B) which occurs in a month for which he
is entitled to benefits under part A, and
(2) ending with the close of the first period of 60
consecutive days thereafter on each of which he is
neither an inpatient of a hospital or critical access
hospital nor an inpatient of a facility described in
section 1819(a)(1) or subsection (y)(1).
Inpatient Hospital Services
(b) The term ``inpatient hospital services'' means the
following items and services furnished to an inpatient of a
hospital and (except as provided in paragraph (3)) by the
hospital--
(1) bed and board;
(2) such nursing services and other related services,
such use of hospital facilities, and such medical
social services as are ordinarily furnished by the
hospital for the care and treatment of inpatients, and
such drugs, biologicals, supplies, appliances, and
equipment, for use in the hospital, as are ordinarily
furnished by such hospital for the care and treatment
of inpatients; and
(3) such other diagnostic or therapeutic items or
services, furnished by the hospital or by others under
arrangements with them made by the hospital, as are
ordinarily furnished to inpatients either by such
hospital or by others under such arrangements;
excluding, however--
(4) medical or surgical services provided by a
physician, resident, or intern, services described by
subsection (s)(2)(K), certified nurse-midwife services,
qualified psychologist services, and services of a
certified registered nurse anesthetist; and
(5) the services of a private-duty nurse or other
private-duty attendant.
Paragraph (4) shall not apply to services provided in a
hospital by--
(6) an intern or a resident-in-training under a
teaching program approved by the Council on Medical
Education of the American Medical Association or, in
the case of an osteopathic hospital, approved by the
Committee on Hospitals of the Bureau of Professional
Education of the American Osteopathic Association, or,
in the case of services in a hospital or osteopathic
hospital by an intern or resident-in-training in the
field of dentistry, approved by the Council on Dental
Education of the American Dental Association, or in the
case of services in a hospital or osteopathic hospital
by an intern or resident-in-training in the field of
podiatry, approved by the Council on Podiatric Medical
Education of the American Podiatric Medical
Association; or
(7) a physician where the hospital has a teaching
program approved as specified in paragraph (6), if (A)
the hospital elects to receive any payment due under
this title for reasonable costs of such services, and
(B) all physicians in such hospital agree not to bill
charges for professional services rendered in such
hospital to individuals covered under the insurance
program established by this title.
Inpatient Psychiatric Hospital Services
(c) The term ``inpatient psychiatric hospital services''
means inpatient hospital services furnished to an inpatient of
a psychiatric hospital.
Supplier
(d) The term ``supplier'' means, unless the context otherwise
requires, a physician or other practitioner, a facility, or
other entity (other than a provider of services) that furnishes
items or services under this title.
Hospital
(e) The term ``hospital'' (except for purposes of sections
1814(d), 1814(f), and 1835(b), subsection (a)(2) of this
section, paragraph (7) of this subsection, and subsection (i)
of this section) means an institution which--
(1) is primarily engaged in providing, by or under
the supervision of physicians, to inpatients (A)
diagnostic services and therapeutic services for
medical diagnosis, treatment, and care of injured,
disabled, or sick persons, or (B) rehabilitation
services for the rehabilitation of injured, disabled,
or sick persons;
(2) maintains clinical records on all patients;
(3) has bylaws in effect with respect to its staff of
physicians;
(4) has a requirement that every patient with respect
to whom payment may be made under this title must be
under the care of a physician, except that a patient
receiving qualified psychologist services (as defined
in subsection (ii)) may be under the care of a clinical
psychologist with respect to such services to the
extent permitted under State law;
(5) provides 24-hour nursing service rendered or
supervised by a registered professional nurse, and has
a licensed practical nurse or registered professional
nurse on duty at all times; except that until January
1, 1979, the Secretary is authorized to waive the
requirement of this paragraph for any one-year period
with respect to any institution, insofar as such
requirement relates to the provision of twenty-four-
hour nursing service rendered or supervised by a
registered professional nurse (except that in any event
a registered professional nurse must be present on the
premises to render or supervise the nursing service
provided, during at least the regular daytime shift),
where immediately preceding such one-year period he
finds that--
(A) such institution is located in a rural
area and the supply of hospital services in
such area is not sufficient to meet the needs
of individuals residing therein,
(B) the failure of such institution to
qualify as a hospital would seriously reduce
the availability of such services to such
individuals, and
(C) such institution has made and continues
to make a good faith effort to comply with this
paragraph, but such compliance is impeded by
the lack of qualified nursing personnel in such
area;
(6)(A) has in effect a hospital utilization review
plan which meets the requirements of subsection (k) and
(B) has in place a discharge planning process that
meets the requirements of subsection (ee);
(7) in the case of an institution in any State in
which State or applicable local law provides for the
licensing of hospitals, (A) is licensed pursuant to
such law or (B) is approved, by the agency of such
State or locality responsible for licensing hospitals,
as meeting the standards established for such
licensing;
(8) has in effect an overall plan and budget that
meets the requirements of subsection (z); and
(9) meets such other requirements as the Secretary
finds necessary in the interest of the health and
safety of individuals who are furnished services in the
institution.
For purposes of subsection (a)(2), such term includes any
institution which meets the requirements of paragraph (1) of
this subsection. For purposes of sections 1814(d) and 1835(b)
(including determination of whether an individual received
inpatient hospital services or diagnostic services for purposes
of such sections), section 1814(f)(2), and subsection (i) of
this section, such term includes any institution which (i)
meets the requirements of paragraphs (5) and (7) of this
subsection, (ii) is not primarily engaged in providing the
services described in section 1861(j)(1)(A) and (iii) is
primarily engaged in providing, by or under the supervision of
individuals referred to in paragraph (1) of section 1861(r), to
inpatients diagnostic services and therapeutic services for
medical diagnosis, treatment, and care of injured, disabled, or
sick persons, or rehabilitation services for the rehabilitation
of injured, disabled, or sick persons. For purposes of section
1814(f)(1), such term includes an institution which (i) is a
hospital for purposes of sections 1814(d), 1814(f)(2), and
1835(b) and (ii) is accredited by a national accreditation body
recognized by the Secretary under section 1865(a), or is
accredited by or approved by a program of the country in which
such institution is located if the Secretary finds the
accreditation or comparable approval standards of such program
to be essentially equivalent to those of such a national
accreditation body.. Notwithstanding the preceding provisions
of this subsection, such term shall not, except for purposes of
subsection (a)(2), include any institution which is primarily
for the care and treatment of mental diseases unless it is a
psychiatric hospital (as defined in subsection (f)). The term
``hospital'' also includes a religious nonmedical health care
institution (as defined in subsection (ss)(1)), but only with
respect to items and services ordinarily furnished by such
institution to inpatients, and payment may be made with respect
to services provided by or in such an institution only to such
extent and under such conditions, limitations, and requirements
(in addition to or in lieu of the conditions, limitations, and
requirements otherwise applicable) as may be provided in
regulations consistent with section 1821. For provisions
deeming certain requirements of this subsection to be met in
the case of accredited institutions, see section 1865. The term
``hospital'' also includes a facility of fifty beds or less
which is located in an area determined by the Secretary to meet
the definition relating to a rural area described in
subparagraph (A) of paragraph (5) of this subsection and which
meets the other requirements of this subsection, except that--
(A) with respect to the requirements for nursing
services applicable after December 31, 1978, such
requirements shall provide for temporary waiver of the
requirements, for such period as the Secretary deems
appropriate, where (i) the facility's failure to fully
comply with the requirements is attributable to a
temporary shortage of qualified nursing personnel in
the area in which the facility is located, (ii) a
registered professional nurse is present on the
premises to render or supervise the nursing service
provided during at least the regular daytime shift, and
(iii) the Secretary determines that the employment of
such nursing personnel as are available to the facility
during such temporary period will not adversely affect
the health and safety of patients;
(B) with respect to the health and safety
requirements promulgated under paragraph (9), such
requirements shall be applied by the Secretary to a
facility herein defined in such manner as to assure
that personnel requirements take into account the
availability of technical personnel and the educational
opportunities for technical personnel in the area in
which such facility is located, and the scope of
services rendered by such facility; and the Secretary,
by regulations, shall provide for the continued
participation of such a facility where such personnel
requirements are not fully met, for such period as the
Secretary determines that (i) the facility is making
good faith efforts to fully comply with the personnel
requirements, (ii) the employment by the facility of
such personnel as are available to the facility will
not adversely affect the health and safety of patients,
and (iii) if the Secretary has determined that because
of the facility's waiver under this subparagraph the
facility should limit its scope of services in order
not to adversely affect the health and safety of the
facility's patients, the facility is so limiting the
scope of services it provides; and
(C) with respect to the fire and safety requirements
promulgated under paragraph (9), the Secretary (i) may
waive, for such period as he deems appropriate,
specific provisions of such requirements which if
rigidly applied would result in unreasonable hardship
for such a facility and which, if not applied, would
not jeopardize the health and safety of patients, and
(ii) may accept a facility's compliance with all
applicable State codes relating to fire and safety in
lieu of compliance with the fire and safety
requirements promulgated under paragraph (9), if he
determines that such State has in effect fire and
safety codes, imposed by State law, which adequately
protect patients.
The term ``hospital'' does not include, unless the context
otherwise requires, a critical access hospital (as defined in
section 1861(mm)(1)).
Psychiatric Hospital
(f) The term ``psychiatric hospital'' means an institution
which--
(1) is primarily engaged in providing, by or under
the supervision of a physician, psychiatric services
for the diagnosis and treatment of mentally ill
persons;
(2) satisfies the requirements of paragraphs (3)
through (9) of subsection (e);
(3) maintains clinical records on all patients and
maintains such records as the Secretary finds to be
necessary to determine the degree and intensity of the
treatment provided to individuals entitled to hospital
insurance benefits under part A; and
(4) meets such staffing requirements as the Secretary
finds necessary for the institution to carry out an
active program of treatment for individuals who are
furnished services in the institution.
In the case of an institution which satisfies paragraphs (1)
and (2) of the preceding sentence and which contains a distinct
part which also satisfies paragraphs (3) and (4) of such
sentence, such distinct part shall be considered to be a
``psychiatric hospital''.
Outpatient Occupational Therapy Services
(g) The term ``outpatient occupational therapy services'' has
the meaning given the term ``outpatient physical therapy
services'' in subsection (p), except that ``occupational''
shall be substituted for ``physical'' each place it appears
therein.
Extended Care Services
(h) The term ``extended care services'' means the following
items and services furnished to an inpatient of a skilled
nursing facility and (except as provided in paragraphs (3), (6)
and (7)) by such skilled nursing facility--
(1) nursing care provided by or under the supervision
of a registered professional nurse;
(2) bed and board in connection with the furnishing
of such nursing care;
(3) physical or occupational therapy or speech-
language pathology services furnished by the skilled
nursing facility or by others under arrangements with
them made by the facility;
(4) medical social services;
(5) such drugs, biologicals, supplies, appliances,
and equipment, furnished for use in the skilled nursing
facility, as are ordinarily furnished by such facility
for the care and treatment of inpatients;
(6) medical services provided by an intern or
resident-in- training of a hospital with which the
facility has in effect a transfer agreement (meeting
the requirements of subsection (l)), under a teaching
program of such hospital approved as provided in the
last sentence of subsection (b), and other diagnostic
or therapeutic services provided by a hospital with
which the facility has such an agreement in effect; and
(7) such other services necessary to the health of
the patients as are generally provided by skilled
nursing facilities, or by others under arrangements
with them made by the facility;
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital.
Post-Hospital Extended Care Services
(i) The term ``post-hospital extended care services'' means
extended care services furnished an individual after transfer
from a hospital in which he was an inpatient for not less than
3 consecutive days before his discharge from the hospital in
connection with such transfer. For purposes of the preceding
sentence, items and services shall be deemed to have been
furnished to an individual after transfer from a hospital, and
he shall be deemed to have been an inpatient in the hospital
immediately before transfer therefrom, if he is admitted to the
skilled nursing facility (A) within 30 days after discharge
from such hospital, or (B) within such time as it would be
medically appropriate to begin an active course of treatment,
in the case of an individual whose condition is such that
skilled nursing facility care would not be medically
appropriate within 30 days after discharge from a hospital; and
an individual shall be deemed not to have been discharged from
a skilled nursing facility if, within 30 days after discharge
therefrom, he is admitted to such facility or any other skilled
nursing facility.
Skilled Nursing Facility
(j) The term ``skilled nursing facility'' has the meaning
given such term in section 1819(a).
Utilization Review
(k) A utilization review plan of a hospital or skilled
nursing facility shall be considered sufficient if it is
applicable to services furnished by the institution to
individuals entitled to insurance benefits under this title and
if it provides--
(1) for the review, on a sample or other basis, of
admissions to the institution, the duration of stays
therein, and the professional services (including drugs
and biologicals) furnished, (A) with respect to the
medical necessity of the services, and (B) for the
purpose of promoting the most efficient use of
available health facilities and services;
(2) for such review to be made by either (A) a staff
committee of the institution composed of two or more
physicians (of which at least two must be physicians
described in subsection (r)(1) of this section), with
or without participation of other professional
personnel, or (B) a group outside the institution which
is similarly composed and (i) which is established by
the local medical society and some or all of the
hospitals and skilled nursing facilities in the
locality, or (ii) if (and for as long as) there has not
been established such a group which serves such
institution, which is established in such other manner
as may be approved by the Secretary;
(3) for such review, in each case of inpatient
hospital services or extended care services furnished
to such an individual during a continuous period of
extended duration, as of such days of such period
(which may differ for different classes of cases) as
may be specified in regulations, with such review to be
made as promptly as possible, after each day so
specified, and in no event later than one week
following such day; and
(4) for prompt notification to the institution, the
individual, and his attending physician of any finding
(made after opportunity for consultation to such
attending physician) by the physician members of such
committee or group that any further stay in the
institution is not medically necessary.
The review committee must be composed as provided in clause (B)
of paragraph (2) rather than as provided in clause (A) of such
paragraph in the case of any hospital or skilled nursing
facility where, because of the small size of the institution,
or (in the case of a skilled nursing facility) because of lack
of an organized medical staff, or for such other reason or
reasons as may be included in regulations, it is impracticable
for the institution to have a properly functioning staff
committee for the purposes of this subsection. If the Secretary
determines that the utilization review procedures established
pursuant to title XIX are superior in their effectiveness to
the procedures required under this section, he may, to the
extent that he deems it appropriate, require for purposes of
this title that the procedures established pursuant to title
XIX be utilized instead of the procedures required by this
section.
Agreements for Transfer Between Skilled Nursing Facilities and
Hospitals
(l) A hospital and a skilled nursing facility shall be
considered to have a transfer agreement in effect if, by reason
of a written agreement between them or (in case the two
institutions are under common control) by reason of a written
undertaking by the person or body which controls them, there is
reasonable assurance that--
(1) transfer of patients will be effected between the
hospital and the skilled nursing facility whenever such
transfer is medically appropriate as determined by the
attending physician; and
(2) there will be interchange of medical and other
information necessary or useful in the care and
treatment of individuals transferred between the
institutions, or in determining whether such
individuals can be adequately cared for otherwise than
in either of such institutions.
Any skilled nursing facility which does not have such an
agreement in effect, but which is found by a State agency (of
the State in which such facility is situated) with which an
agreement under section 1864 is in effect (or, in the case of a
State in which no such agency has an agreement under section
1864, by the Secretary) to have attempted in good faith to
enter into such an agreement with a hospital sufficiently close
to the facility to make feasible the transfer between them of
patients and the information referred to in paragraph (2),
shall be considered to have such an agreement in effect if and
for so long as such agency (or the Secretary, as the case may
be) finds that to do so is in the public interest and essential
to assuring extended care services for persons in the community
who are eligible for payments with respect to such services
under this title.
Home Health Services
(m) The term ``home health services'' means the following
items and services furnished to an individual, who is under the
care of a physician, by a home health agency or by others under
arrangements with them made by such agency, under a plan (for
furnishing such items and services to such individual)
established and periodically reviewed by a physician, which
items and services are, except as provided in paragraph (7),
provided on a visiting basis in a place of residence used as
such individual's home--
(1) part-time or intermittent nursing care provided
by or under the supervision of a registered
professional nurse;
(2) physical or occupational therapy or speech-
language pathology services;
(3) medical social services under the direction of a
physician;
(4) to the extent permitted in regulations, part-time
or intermittent services of a home health aide who has
successfully completed a training program approved by
the Secretary;
(5) medical supplies (including catheters, catheter
supplies, ostomy bags, and supplies related to ostomy
care, and a covered osteoporosis drug (as defined in
subsection (kk)), but excluding other drugs and
biologicals) and durable medical equipment and
applicable disposable devices (as defined in section
1834(s)(2)) while under such a plan;
(6) in the case of a home health agency which is
affiliated or under common control with a hospital,
medical services provided by an intern or resident-in-
training of such hospital, under a teaching program of
such hospital approved as provided in the last sentence
of subsection (b); and
(7) any of the foregoing items and services which are
provided on an outpatient basis, under arrangements
made by the home health agency, at a hospital or
skilled nursing facility, or at a rehabilitation center
which meets such standards as may be prescribed in
regulations, and--
(A) the furnishing of which involves the use
of equipment of such a nature that the items
and services cannot readily be made available
to the individual in such place of residence,
or
(B) which are furnished at such facility
while he is there to receive any such item or
service described in clause (A),
but not including transportation of the individual in
connection with any such item or service;
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital and home infusion therapy (as defined in subsection
(iii)(i)). For purposes of paragraphs (1) and (4), the term
``part-time or intermittent services'' means skilled nursing
and home health aide services furnished any number of days per
week as long as they are furnished (combined) less than 8 hours
each day and 28 or fewer hours each week (or, subject to review
on a case-by-case basis as to the need for care, less than 8
hours each day and 35 or fewer hours per week). For purposes of
sections 1814(a)(2)(C) and 1835(a)(2)(A), ``intermittent''
means skilled nursing care that is either provided or needed on
fewer than 7 days each week, or less than 8 hours of each day
for periods of 21 days or less (with extensions in exceptional
circumstances when the need for additional care is finite and
predictable).
Durable Medical Equipment
(n) The term ``durable medical equipment'' includes iron
lungs, oxygen tents, hospital beds, and wheelchairs (which may
include a power-operated vehicle that may be appropriately used
as a wheelchair, but only where the use of such a vehicle is
determined to be necessary on the basis of the individual's
medical and physical condition and the vehicle meets such
safety requirements as the Secretary may prescribe) used in the
patient's home (including an institution used as his home other
than an institution that meets the requirements of subsection
(e)(1) of this section or section 1819(a)(1)), whether
furnished on a rental basis or purchased, and includes blood-
testing strips and blood glucose monitors for individuals with
diabetes without regard to whether the individual has Type I or
Type II diabetes or to the individual's use of insulin (as
determined under standards established by the Secretary in
consultation with the appropriate organizations) and eye
tracking and gaze interaction accessories for speech generating
devices furnished to individuals with a demonstrated medical
need for such accessories; except that such term does not
include such equipment furnished by a supplier who has used,
for the demonstration and use of specific equipment, an
individual who has not met such minimum training standards as
the Secretary may establish with respect to the demonstration
and use of such specific equipment. With respect to a seat-lift
chair, such term includes only the seat-lift mechanism and does
not include the chair.
Home Health Agency
(o) The term ``home health agency'' means a public agency or
private organization, or a subdivision of such an agency or
organization, which--
(1) is primarily engaged in providing skilled nursing
services and other therapeutic services;
(2) has policies, established by a group of
professional personnel (associated with the agency or
organization), including one or more physicians and one
or more registered professional nurses, to govern the
services (referred to in paragraph (1)) which it
provides, and provides for supervision of such services
by a physician or registered professional nurse;
(3) maintains clinical records on all patients;
(4) in the case of an agency or organization in any
State in which State or applicable local law provides
for the licensing of agencies or organizations of this
nature, (A) is licensed pursuant to such law, or (B) is
approved, by the agency of such State or locality
responsible for licensing agencies or organizations of
this nature, as meeting the standards established for
such licensing;
(5) has in effect an overall plan and budget that
meets the requirements of subsection (z);
(6) meets the conditions of participation specified
in section 1891(a) and such other conditions of
participation as the Secretary may find necessary in
the interest of the health and safety of individuals
who are furnished services by such agency or
organization;
(7) provides the Secretary with a surety bond--
(A) in a form specified by the Secretary and
in an amount that is not less than the minimum
of $50,000; and
(B) that the Secretary determines is
commensurate with the volume of payments to the
home health agency; and
(8) meets such additional requirements (including
conditions relating to bonding or establishing of
escrow accounts as the Secretary finds necessary for
the financial security of the program) as the Secretary
finds necessary for the effective and efficient
operation of the program;
except that for purposes of part A such term shall not include
any agency or organization which is primarily for the care and
treatment of mental diseases. The Secretary may waive the
requirement of a surety bond under paragraph (7) in the case of
an agency or organization that provides a comparable surety
bond under State law.
Outpatient Physical Therapy Services
(p) The term ``outpatient physical therapy services'' means
physical therapy services furnished by a provider of services,
a clinic, rehabilitation agency, or a public health agency, or
by others under an arrangement with, and under the supervision
of, such provider, clinic, rehabilitation agency, or public
health agency to an individual as an outpatient--
(1) who is under the care of a physician (as defined
in paragraph (1), (3), or (4) of section 1861(r)), and
(2) with respect to whom a plan prescribing the type,
amount, and duration of physical therapy services that
are to be furnished such individual has been
established by a physician (as so defined) or by a
qualified physical therapist and is periodically
reviewed by a physician (as so defined);
excluding, however--
(3) any item or service if it would not be included
under subsection (b) if furnished to an inpatient of a
hospital; and
(4) any such service--
(A) if furnished by a clinic or
rehabilitation agency, or by others under
arrangements with such clinic or agency, unless
such clinic or rehabilitation agency--
(i) provides an adequate program of
physical therapy services for
outpatients and has the facilities and
personnel required for such program or
required for the supervision of such a
program, in accordance with such
requirements as the Secretary may
specify,
(ii) has policies, established by a
group of professional personnel,
including one or more physicians
(associated with the clinic or
rehabilitation agency) and one or more
qualified physical therapists, to
govern the services (referred to in
clause (i)) it provides,
(iii) maintains clinical records on
all patients,
(iv) if such clinic or agency is
situated in a State in which State or
applicable local law provides for the
licensing of institutions of this
nature, (I) is licensed pursuant to
such law, or (II) is approved by the
agency of such State or locality
responsible for licensing institutions
of this nature, as meeting the
standards established for such
licensing; and
(v) meets such other conditions
relating to the health and safety of
individuals who are furnished services
by such clinic or agency on an
outpatient basis, as the Secretary may
find necessary, and provides the
Secretary on a continuing basis with a
surety bond in a form specified by the
Secretary and in an amount that is not
less than $50,000, or
(B) if furnished by a public health agency,
unless such agency meets such other conditions
relating to health and safety of individuals
who are furnished services by such agency on an
outpatient basis, as the Secretary may find
necessary.
The term ``outpatient physical therapy services'' also includes
physical therapy services furnished an individual by a physical
therapist (in his office or in such individual's home) who
meets licensing and other standards prescribed by the Secretary
in regulations, otherwise than under an arrangement with and
under the supervision of a provider of services, clinic,
rehabilitation agency, or public health agency, if the
furnishing of such services meets such conditions relating to
health and safety as the Secretary may find necessary. In
addition, such term includes physical therapy services which
meet the requirements of the first sentence of this subsection
except that they are furnished to an individual as an inpatient
of a hospital or extended care facility. Nothing in this
subsection shall be construed as requiring, with respect to
outpatients who are not entitled to benefits under this title,
a physical therapist to provide outpatient physical therapy
services only to outpatients who are under the care of a
physician or pursuant to a plan of care established by a
physician. The Secretary may waive the requirement of a surety
bond under paragraph (4)(A)(v) in the case of a clinic or
agency that provides a comparable surety bond under State law.
Physicians' Services
(q) The term ``physicians' services'' means professional
services performed by physicians, including surgery,
consultation, and home, office, and institutional calls (but
not including services described in subsection (b)(6)).
Physician
(r) The term ``physician'', when used in connection with the
performance of any function or action, means (1) a doctor of
medicine or osteopathy legally authorized to practice medicine
and surgery by the State in which he performs such function or
action (including a physician within the meaning of section
1101(a)(7)), (2) a doctor of dental surgery or of dental
medicine who is legally authorized to practice dentistry by the
State in which he performs such function and who is acting
within the scope of his license when he performs such
functions, (3) a doctor of podiatric medicine for the purposes
of subsections (k), (m), (p)(1), and (s) of this section and
sections 1814(a), 1832(a)(2)(F)(ii), and 1835 but only with
respect to functions which he is legally authorized to perform
as such by the State in which he performs them, (4) a doctor of
optometry, but only for purposes of subsection (p)(1) and with
respect to the provision of items or services described in
subsection (s) which he is legally authorized to perform as a
doctor of optometry by the State in which he performs them, or
(5) a chiropractor who is licensed as such by the State (or in
a State which does not license chiropractors as such, is
legally authorized to perform the services of a chiropractor in
the jurisdiction in which he performs such services), and who
meets uniform minimum standards promulgated by the Secretary,
but only for the purpose of sections 1861(s)(1) and
1861(s)(2)(A) and only with respect to treatment by means of
manual manipulation of the spine (to correct a subluxation)
which he is legally authorized to perform by the State or
jurisdiction in which such treatment is provided. For the
purposes of section 1862(a)(4) and subject to the limitations
and conditions provided in the previous sentence, such term
includes a doctor of one of the arts, specified in such
previous sentence, legally authorized to practice such art in
the country in which the inpatient hospital services (referred
to in such section 1862(a)(4)) are furnished.
Medical and Other Health Services
(s) The term ``medical and other health services'' means any
of the following items or services:
(1) physicians' services;
(2)(A) services and supplies (including drugs and
biologicals which are not usually self-administered by
the patient) furnished as an incident to a physician's
professional service, of kinds which are commonly
furnished in physicians' offices and are commonly
either rendered without charge or included in the
physicians' bills (or would have been so included but
for the application of section 1847B);
(B) hospital services (including drugs and
biologicals which are not usually self-administered by
the patient) incident to physicians' services rendered
to outpatients and partial hospitalization services
incident to such services;
(C) diagnostic services which are--
(i) furnished to an individual as an
outpatient by a hospital or by others under
arrangements with them made by a hospital, and
(ii) ordinarily furnished by such hospital
(or by others under such arrangements) to its
outpatients for the purpose of diagnostic
study;
(D) outpatient physical therapy services, outpatient
speech-language pathology services, and outpatient
occupational therapy services;
(E) rural health clinic services and Federally
qualified health center services;
(F) home dialysis supplies and equipment, self-care
home dialysis support services, and institutional
dialysis services and supplies, and, for items and
services furnished on or after January 1, 2011, renal
dialysis services (as defined in section
1881(b)(14)(B)), including such renal dialysis services
furnished on or after January 1, 2017, by a renal
dialysis facility or provider of services paid under
section 1881(b)(14) to an individual with acute kidney
injury (as defined in section 1834(r)(2));
(G) antigens (subject to quantity limitations
prescribed in regulations by the Secretary) prepared by
a physician, as defined in section 1861(r)(1), for a
particular patient, including antigens so prepared
which are forwarded to another qualified person
(including a rural health clinic) for administration to
such patient, from time to time, by or under the
supervision of another such physician;
(H)(i) services furnished pursuant to a contract
under section 1876 to a member of an eligible
organization by a physician assistant or by a nurse
practitioner (as defined in subsection (aa)(5)) and
such services and supplies furnished as an incident to
his service to such a member as would otherwise be
covered under this part if furnished by a physician or
as an incident to a physician's service; and
(ii) services furnished pursuant to a risk-sharing
contract under section 1876(g) to a member of an
eligible organization by a clinical psychologist (as
defined by the Secretary) or by a clinical social
worker (as defined in subsection (hh)(2)), and such
services and supplies furnished as an incident to such
clinical psychologist's services or clinical social
worker's services to such a member as would otherwise
be covered under this part if furnished by a physician
or as an incident to a physician's service;
(I) blood clotting factors, for hemophilia patients
competent to use such factors to control bleeding
without medical or other supervision, and items related
to the administration of such factors, subject to
utilization controls deemed necessary by the Secretary
for the efficient use of such factors;
(J) prescription drugs used in immunosuppressive
therapy furnished, to an individual who receives an
organ transplant for which payment is made under this
title;
(K)(i) services which would be physicians' services
and services described in subsections (ww)(1) and (hhh)
if furnished by a physician (as defined in subsection
(r)(1)) and which are performed by a physician
assistant (as defined in subsection (aa)(5)) under the
supervision of a physician (as so defined) and which
the physician assistant is legally authorized to
perform by the State in which the services are
performed, and such services and supplies furnished as
incident to such services as would be covered under
subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other
provider charges or is paid any amounts with respect to
the furnishing of such services,
(ii) services which would be physicians' services and
services described in subsections (ww)(1) and (hhh) if
furnished by a physician (as defined in subsection
(r)(1)) and which are performed by a nurse practitioner
or clinical nurse specialist (as defined in subsection
(aa)(5)) working in collaboration (as defined in
subsection (aa)(6)) with a physician (as defined in
subsection (r)(1)) which the nurse practitioner or
clinical nurse specialist is legally authorized to
perform by the State in which the services are
performed, and such services and supplies furnished as
an incident to such services as would be covered under
subparagraph (A) if furnished incident to a physician's
professional service, but only if no facility or other
provider charges or is paid any amounts with respect to
the furnishing of such services;
(L) certified nurse-midwife services;
(M) qualified psychologist services;
(N) clinical social worker services (as defined in
subsection (hh)(2));
(O) erythropoietin for dialysis patients competent to
use such drug without medical or other supervision with
respect to the administration of such drug, subject to
methods and standards established by the Secretary by
regulation for the safe and effective use of such drug,
and items related to the administration of such drug;
(P) prostate cancer screening tests (as defined in
subsection (oo));
(Q) an oral drug (which is approved by the Federal
Food and Drug Administration) prescribed for use as an
anticancer chemotherapeutic agent for a given
indication, and containing an active ingredient (or
ingredients), which is the same indication and active
ingredient (or ingredients) as a drug which the carrier
determines would be covered pursuant to subparagraph
(A) or (B) if the drug could not be self-administered;
(R) colorectal cancer screening tests (as defined in
subsection (pp));
(S) diabetes outpatient self-management training
services (as defined in subsection (qq));
(T) an oral drug (which is approved by the Federal
Food and Drug Administration) prescribed for use as an
acute anti-emetic used as part of an anticancer
chemotherapeutic regimen if the drug is administered by
a physician (or as prescribed by a physician)--
(i) for use immediately before, at, or within
48 hours after the time of the administration
of the anticancer chemotherapeutic agent; and
(ii) as a full replacement for the anti-
emetic therapy which would otherwise be
administered intravenously;
(U) screening for glaucoma (as defined in subsection
(uu)) for individuals determined to be at high risk for
glaucoma, individuals with a family history of glaucoma
and individuals with diabetes;
(V) medical nutrition therapy services (as defined in
subsection (vv)(1)) in the case of a beneficiary with
diabetes or a renal disease who--
(i) has not received diabetes outpatient
self-management training services within a time
period determined by the Secretary;
(ii) is not receiving maintenance dialysis
for which payment is made under section 1881;
and
(iii) meets such other criteria determined by
the Secretary after consideration of protocols
established by dietitian or nutrition
professional organizations;
(W) an initial preventive physical examination (as
defined in subsection (ww));
(X) cardiovascular screening blood tests (as defined
in subsection (xx)(1));
(Y) diabetes screening tests (as defined in
subsection (yy));
(Z) intravenous immune globulin for the treatment of
primary immune deficiency diseases in the home (as
defined in subsection (zz));
(AA) ultrasound screening for abdominal aortic
aneurysm (as defined in subsection (bbb)) for an
individual--
(i) who receives a referral for such an
ultrasound screening as a result of an initial
preventive physical examination (as defined in
section 1861(ww)(1));
(ii) who has not been previously furnished
such an ultrasound screening under this title;
and
(iii) who--
(I) has a family history of abdominal
aortic aneurysm; or
(II) manifests risk factors included
in a beneficiary category recommended
for screening by the United States
Preventive Services Task Force
regarding abdominal aortic aneurysms;
(BB) additional preventive services (described in
subsection (ddd)(1));
(CC) items and services furnished under a
cardiac rehabilitation program (as defined in
subsection (eee)(1)) or under a pulmonary
rehabilitation program (as defined in
subsection (fff)(1));
(DD) items and services furnished under an
intensive cardiac rehabilitation program (as
defined in subsection (eee)(4));
(EE) kidney disease education services (as defined in
subsection (ggg));
(FF) personalized prevention plan services (as
defined in subsection (hhh)); [and]
(GG) home infusion therapy (as defined in subsection
(iii)(1)); and
(HH) opioid use disorder treatment services (as
defined in subsection (jjj)).
(3) diagnostic X-ray tests (including tests under the
supervision of a physician, furnished in a place of
residence used as the patient's home, if the
performance of such tests meets such conditions
relating to health and safety as the Secretary may find
necessary and including diagnostic mammography if
conducted by a facility that has a certificate (or
provisional certificate) issued under section 354 of
the Public Health Service Act), diagnostic laboratory
tests, and other diagnostic tests;
(4) X-ray, radium, and radioactive isotope therapy,
including materials and services of technicians;
(5) surgical dressings, and splints, casts, and other
devices used for reduction of fractures and
dislocations;
(6) durable medical equipment;
(7) ambulance service where the use of other methods
of transportation is contraindicated by the
individual's condition, but, subject to section
1834(l)(14), only to the extent provided in
regulations;
(8) prosthetic devices (other than dental) which
replace all or part of an internal body organ
(including colostomy bags and supplies directly related
to colostomy care), including replacement of such
devices, and including one pair of conventional
eyeglasses or contact lenses furnished subsequent to
each cataract surgery with insertion of an intraocular
lens;
(9) leg, arm, back, and neck braces, and artificial
legs, arms, and eyes, including replacements if
required because of a change in the patient's physical
condition;
(10)(A) pneumococcal vaccine and its administration
and, subject to section 4071(b) of the Omnibus Budget
Reconciliation Act of 1987, influenza vaccine and its
administration; and
(B) hepatitis B vaccine and its administration,
furnished to an individual who is at high or
intermediate risk of contracting hepatitis B (as
determined by the Secretary under regulations);
(11) services of a certified registered nurse
anesthetist (as defined in subsection (bb));
(12) subject to section 4072(e) of the Omnibus Budget
Reconciliation Act of 1987, extra-depth shoes with
inserts or custom molded shoes with inserts for an
individual with diabetes, if--
(A) the physician who is managing the
individual's diabetic condition (i) documents
that the individual has peripheral neuropathy
with evidence of callus formation, a history of
pre-ulcerative calluses, a history of previous
ulceration, foot deformity, or previous
amputation, or poor circulation, and (ii)
certifies that the individual needs such shoes
under a comprehensive plan of care related to
the individual's diabetic condition;
(B) the particular type of shoes are
prescribed by a podiatrist or other qualified
physician (as established by the Secretary);
and
(C) the shoes are fitted and furnished by a
podiatrist or other qualified individual (such
as a pedorthist or orthotist, as established by
the Secretary) who is not the physician
described in subparagraph (A) (unless the
Secretary finds that the physician is the only
such qualified individual in the area);
(13) screening mammography (as defined in subsection
(jj));
(14) screening pap smear and screening pelvic exam;
and
(15) bone mass measurement (as defined in subsection
(rr)).
No diagnostic tests performed in any laboratory, including a
laboratory that is part of a rural health clinic, or a hospital
(which, for purposes of this sentence, means an institution
considered a hospital for purposes of section 1814(d)) shall be
included within paragraph (3) unless such laboratory--
(16) if situated in any State in which State or
applicable local law provides for licensing of
establishments of this nature, (A) is licensed pursuant
to such law, or (B) is approved, by the agency of such
State or locality responsible for licensing
establishments of this nature, as meeting the standards
established for such licensing; and
(17)(A) meets the certification requirements under
section 353 of the Public Health Service Act; and
(B) meets such other conditions relating to the
health and safety of individuals with respect to whom
such tests are performed as the Secretary may find
necessary.
There shall be excluded from the diagnostic services specified
in paragraph (2)(C) any item or service (except services
referred to in paragraph (1)) which would not be included under
subsection (b) if it were furnished to an inpatient of a
hospital. None of the items and services referred to in the
preceding paragraphs (other than paragraphs (1) and (2)(A)) of
this subsection which are furnished to a patient of an
institution which meets the definition of a hospital for
purposes of section 1814(d) shall be included unless such other
conditions are met as the Secretary may find necessary relating
to health and safety of individuals with respect to whom such
items and services are furnished.
Drugs and Biologicals
(t)(1) The term ``drugs'' and the term ``biologicals'',
except for purposes of subsection (m)(5) and paragraph (2),
include only such drugs (including contrast agents) and
biologicals, respectively, as are included (or approved for
inclusion) in the United States Pharmacopoeia, the National
Formulary, or the United States Homeopathic Pharmacopoeia, or
in New Drugs or Accepted Dental Remedies (except for any drugs
and biologicals unfavorably evaluated therein), or as are
approved by the pharmacy and drug therapeutics committee (or
equivalent committee) of the medical staff of the hospital
furnishing such drugs and biologicals for use in such hospital.
(2)(A) For purposes of paragraph (1), the term ``drugs'' also
includes any drugs or biologicals used in an anticancer
chemotherapeutic regimen for a medically accepted indication
(as described in subparagraph (B)).
(B) In subparagraph (A), the term ``medically accepted
indication'', with respect to the use of a drug, includes any
use which has been approved by the Food and Drug Administration
for the drug, and includes another use of the drug if--
(i) the drug has been approved by the Food and Drug
Administration; and
(ii)(I) such use is supported by one or more
citations which are included (or approved for
inclusion) in one or more of the following compendia:
the American Hospital Formulary Service-Drug
Information, the American Medical Association Drug
Evaluations, the United States Pharmacopoeia-Drug
Information (or its successor publications), and other
authoritative compendia as identified by the Secretary,
unless the Secretary has determined that the use is not
medically appropriate or the use is identified as not
indicated in one or more such compendia, or
(II) the carrier involved determines, based upon
guidance provided by the Secretary to carriers for
determining accepted uses of drugs, that such use is
medically accepted based on supportive clinical
evidence in peer reviewed medical literature appearing
in publications which have been identified for purposes
of this subclause by the Secretary.
The Secretary may revise the list of compendia in clause
(ii)(I) as is appropriate for identifying medically accepted
indications for drugs. On and after January 1, 2010, no
compendia may be included on the list of compendia under this
subparagraph unless the compendia has a publicly transparent
process for evaluating therapies and for identifying potential
conflicts of interests.
Provider of Services
(u) The term ``provider of services'' means a hospital,
critical access hospital, skilled nursing facility,
comprehensive outpatient rehabilitation facility, home health
agency, hospice program, or, for purposes of section 1814(g)
and section 1835(e), a fund.
Reasonable Cost
(v)(1)(A) The reasonable cost of any services shall be the
cost actually incurred, excluding therefrom any part of
incurred cost found to be unnecessary in the efficient delivery
of needed health services, and shall be determined in
accordance with regulations establishing the method or methods
to be used, and the items to be included, in determining such
costs for various types or classes of institutions, agencies,
and services; except that in any case to which paragraph (2) or
(3) applies, the amount of the payment determined under such
paragraph with respect to the services involved shall be
considered the reasonable cost of such services. In prescribing
the regulations referred to in the preceding sentence, the
Secretary shall consider, among other things, the principles
generally applied by national organizations or established
prepayment organizations (which have developed such principles)
in computing the amount of payment, to be made by persons other
than the recipients of services, to providers of services on
account of services furnished to such recipients by such
providers. Such regulations may provide for determination of
the costs of services on a per diem, per unit, per capita, or
other basis, may provide for using different methods in
different circumstances, may provide for the use of estimates
of costs of particular items or services, may provide for the
establishment of limits on the direct or indirect overall
incurred costs or incurred costs of specific items or services
or groups of items or services to be recognized as reasonable
based on estimates of the costs necessary in the efficient
delivery of needed health services to individuals covered by
the insurance programs established under this title, and may
provide for the use of charges or a percentage of charges where
this method reasonably reflects the costs. Such regulations
shall (i) take into account both direct and indirect costs of
providers of services (excluding therefrom any such costs,
including standby costs, which are determined in accordance
with regulations to be unnecessary in the efficient delivery of
services covered by the insurance programs established under
this title) in order that, under the methods of determining
costs, the necessary costs of efficiently delivering covered
services to individuals covered by the insurance programs
established by this title will not be borne by individuals not
so covered, and the costs with respect to individuals not so
covered will not be borne by such insurance programs, and (ii)
provide for the making of suitable retroactive corrective
adjustments where, for a provider of services for any fiscal
period, the aggregate reimbursement produced by the methods of
determining costs proves to be either inadequate or excessive.
(B) In the case of extended care services, the regulations
under subparagraph (A) shall not include provision for specific
recognition of a return on equity capital.
(C) Where a hospital has an arrangement with a medical school
under which the faculty of such school provides services at
such hospital, an amount not in excess of the reasonable cost
of such services to the medical school shall be included in
determining the reasonable cost to the hospital of furnishing
services--
(i) for which payment may be made under part A, but
only if--
(I) payment for such services as furnished
under such arrangement would be made under part
A to the hospital had such services been
furnished by the hospital, and
(II) such hospital pays to the medical school
at least the reasonable cost of such services
to the medical school, or
(ii) for which payment may be made under part B, but
only if such hospital pays to the medical school at
least the reasonable cost of such services to the
medical school.
(D) Where (i) physicians furnish services which are either
inpatient hospital services (including services in conjunction
with the teaching programs of such hospital) by reason of
paragraph (7) of subsection (b) or for which entitlement exists
by reason of clause (II) of section 1832(a)(2)(B)(i), and (ii)
such hospital (or medical school under arrangement with such
hospital) incurs no actual cost in the furnishing of such
services, the reasonable cost of such services shall (under
regulations of the Secretary) be deemed to be the cost such
hospital or medical school would have incurred had it paid a
salary to such physicians rendering such services approximately
equivalent to the average salary paid to all physicians
employed by such hospital (or if such employment does not
exist, or is minimal in such hospital, by similar hospitals in
a geographic area of sufficient size to assure reasonable
inclusion of sufficient physicians in development of such
average salary).
(E) Such regulations may, in the case of skilled nursing
facilities in any State, provide for the use of rates,
developed by the State in which such facilities are located,
for the payment of the cost of skilled nursing facility
services furnished under the State's plan approved under title
XIX (and such rates may be increased by the Secretary on a
class or size of institution or on a geographical basis by a
percentage factor not in excess of 10 percent to take into
account determinable items or services or other requirements
under this title not otherwise included in the computation of
such State rates), if the Secretary finds that such rates are
reasonably related to (but not necessarily limited to) analyses
undertaken by such State of costs of care in comparable
facilities in such State. Notwithstanding the previous
sentence, such regulations with respect to skilled nursing
facilities shall take into account (in a manner consistent with
subparagraph (A) and based on patient-days of services
furnished) the costs (including the costs of services required
to attain or maintain the highest practicable physical, mental,
and psychosocial well-being of each resident eligible for
benefits under this title) of such facilities complying with
the requirements of subsections (b), (c), and (d) of section
1819 (including the costs of conducting nurse aide training and
competency evaluation programs and competency evaluation
programs).
(F) Such regulations shall require each provider of services
(other than a fund) to make reports to the Secretary of
information described in section 1121(a) in accordance with the
uniform reporting system (established under such section) for
that type of provider.
(G)(i) In any case in which a hospital provides inpatient
services to an individual that would constitute post-hospital
extended care services if provided by a skilled nursing
facility and a quality improvement organization (or, in the
absence of such a qualified organization, the Secretary or such
agent as the Secretary may designate) determines that inpatient
hospital services for the individual are not medically
necessary but post-hospital extended care services for the
individual are medically necessary and such extended care
services are not otherwise available to the individual (as
determined in accordance with criteria established by the
Secretary) at the time of such determination, payment for such
services provided to the individual shall continue to be made
under this title at the payment rate described in clause (ii)
during the period in which--
(I) such post-hospital extended care services for the
individual are medically necessary and not otherwise
available to the individual (as so determined),
(II) inpatient hospital services for the individual
are not medically necessary, and
(III) the individual is entitled to have payment made
for post-hospital extended care services under this
title,
except that if the Secretary determines that there is not an
excess of hospital beds in such hospital and (subject to clause
(iv)) there is not an excess of hospital beds in the area of
such hospital, such payment shall be made (during such period)
on the basis of the amount otherwise payable under part A with
respect to inpatient hospital services.
(ii)(I) Except as provided in subclause (II), the payment
rate referred to in clause (i) is a rate equal to the estimated
adjusted State-wide average rate per patient-day paid for
services provided in skilled nursing facilities under the State
plan approved under title XIX for the State in which such
hospital is located, or, if the State in which the hospital is
located does not have a State plan approved under title XIX,
the estimated adjusted State-wide average allowable costs per
patient-day for extended care services under this title in that
State.
(II) If a hospital has a unit which is a skilled nursing
facility, the payment rate referred to in clause (i) for the
hospital is a rate equal to the lesser of the rate described in
subclause (I) or the allowable costs in effect under this title
for extended care services provided to patients of such unit.
(iii) Any day on which an individual receives inpatient
services for which payment is made under this subparagraph
shall, for purposes of this Act (other than this subparagraph),
be deemed to be a day on which the individual received
inpatient hospital services.
(iv) In determining under clause (i), in the case of a public
hospital, whether or not there is an excess of hospital beds in
the area of such hospital, such determination shall be made on
the basis of only the public hospitals (including the hospital)
which are in the area of the hospital and which are under
common ownership with that hospital.
(H) In determining such reasonable cost with respect to home
health agencies, the Secretary may not include--
(i) any costs incurred in connection with bonding or
establishing an escrow account by any such agency as a
result of the surety bond requirement described in
subsection (o)(7) and the financial security
requirement described in subsection (o)(8);
(ii) in the case of home health agencies to which the
surety bond requirement described in subsection (o)(7)
and the financial security requirement described in
subsection (o)(8) apply, any costs attributed to
interest charged such an agency in connection with
amounts borrowed by the agency to repay overpayments
made under this title to the agency, except that such
costs may be included in reasonable cost if the
Secretary determines that the agency was acting in good
faith in borrowing the amounts;
(iii) in the case of contracts entered into by a home
health agency after the date of the enactment of this
subparagraph for the purpose of having services
furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract
which is entered into for a period exceeding five
years; and
(iv) in the case of contracts entered into by a home
health agency before the date of the enactment of this
subparagraph for the purpose of having services
furnished for or on behalf of such agency, any cost
incurred by such agency pursuant to any such contract,
which determines the amount payable by the home health
agency on the basis of a percentage of the agency's
reimbursement or claim for reimbursement for services
furnished by the agency, to the extent that such cost
exceeds the reasonable value of the services furnished
on behalf of such agency.
(I) In determining such reasonable cost, the Secretary may
not include any costs incurred by a provider with respect to
any services furnished in connection with matters for which
payment may be made under this title and furnished pursuant to
a contract between the provider and any of its subcontractors
which is entered into after the date of the enactment of this
subparagraph and the value or cost of which is $10,000 or more
over a twelve-month period unless the contract contains a
clause to the effect that--
(i) until the expiration of four years after the
furnishing of such services pursuant to such contract,
the subcontractor shall make available, upon written
request by the Secretary, or upon request by the
Comptroller General, or any of their duly authorized
representatives, the contract, and books, documents and
records of such subcontractor that are necessary to
certify the nature and extent of such costs, and
(ii) if the subcontractor carries out any of the
duties of the contract through a subcontract, with a
value or cost of $10,000 or more over a twelve-month
period, with a related organization, such subcontract
shall contain a clause to the effect that until the
expiration of four years after the furnishing of such
services pursuant to such subcontract, the related
organization shall make available, upon written request
by the Secretary, or upon request by the Comptroller
General, or any of their duly authorized
representatives, the subcontract, and books, documents
and records of such organization that are necessary to
verify the nature and extent of such costs.
The Secretary shall prescribe in regulation criteria and
procedures which the Secretary shall use in obtaining access to
books, documents, and records under clauses required in
contracts and subcontracts under this subparagraph.
(J) Such regulations may not provide for any inpatient
routine salary cost differential as a reimbursable cost for
hospitals and skilled nursing facilities.
(K)(i) The Secretary shall issue regulations that provide, to
the extent feasible, for the establishment of limitations on
the amount of any costs or charges that shall be considered
reasonable with respect to services provided on an outpatient
basis by hospitals (other than bona fide emergency services as
defined in clause (ii)) or clinics (other than rural health
clinics), which are reimbursed on a cost basis or on the basis
of cost related charges, and by physicians utilizing such
outpatient facilities. Such limitations shall be reasonably
related to the charges in the same area for similar services
provided in physicians' offices. Such regulations shall provide
for exceptions to such limitations in cases where similar
services are not generally available in physicians' offices in
the area to individuals entitled to benefits under this title.
(ii) For purposes of clause (i), the term ``bona fide
emergency services'' means services provided in a hospital
emergency room after the sudden onset of a medical condition
manifesting itself by acute symptoms of sufficient severity
(including severe pain) such that the absence of immediate
medical attention could reasonably be expected to result in--
(I) placing the patient's health in serious jeopardy;
(II) serious impairment to bodily functions; or
(III) serious dysfunction of any bodily organ or
part.
(L)(i) The Secretary, in determining the amount of the
payments that may be made under this title with respect to
services furnished by home health agencies, may not recognize
as reasonable (in the efficient delivery of such services)
costs for the provision of such services by an agency to the
extent these costs exceed (on the aggregate for the agency) for
cost reporting periods beginning on or after--
(I) July 1, 1985, and before July 1, 1986, 120
percent of the mean of the labor-related and nonlabor
per visit costs for freestanding home health agencies,
(II) July 1, 1986, and before July 1, 1987, 115
percent of such mean,
(III) July 1, 1987, and before October 1, 1997, 112
percent of such mean,
(IV) October 1, 1997, and before October 1, 1998, 105
percent of the median of the labor-related and nonlabor
per visit costs for freestanding home health agencies,
or
(V) October 1, 1998, 106 percent of such median.
(ii) Effective for cost reporting periods beginning on or
after July 1, 1986, such limitations shall be applied on an
aggregate basis for the agency, rather than on a discipline
specific basis. The Secretary may provide for such exemptions
and exceptions to such limitation as he deems appropriate.
(iii) Not later than July 1, 1991, and annually thereafter
(but not for cost reporting periods beginning on or after July
1, 1994, and before July 1, 1996, or on or after July 1, 1997,
and before October 1, 1997), the Secretary shall establish
limits under this subparagraph for cost reporting periods
beginning on or after such date by utilizing the area wage
index applicable under section 1886(d)(3)(E) and determined
using the survey of the most recent available wages and wage-
related costs of hospitals located in the geographic area in
which the home health service is furnished (determined without
regard to whether such hospitals have been reclassified to a
new geographic area pursuant to section 1886(d)(8)(B), a
decision of the Medicare Geographic Classification Review Board
under section 1886(d)(10), or a decision of the Secretary).
(iv) In establishing limits under this subparagraph for cost
reporting periods beginning after September 30, 1997, the
Secretary shall not take into account any changes in the home
health market basket, as determined by the Secretary, with
respect to cost reporting periods which began on or after July
1, 1994, and before July 1, 1996.
(v) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997,
subject to clause (viii)(I), the Secretary shall provide for an
interim system of limits. Payment shall not exceed the costs
determined under the preceding provisions of this subparagraph
or, if lower, the product of--
(I) an agency-specific per beneficiary annual
limitation calculated based 75 percent on 98 percent of
the reasonable costs (including nonroutine medical
supplies) for the agency's 12-month cost reporting
period ending during fiscal year 1994, and based 25
percent on 98 percent of the standardized regional
average of such costs for the agency's census division,
as applied to such agency, for cost reporting periods
ending during fiscal year 1994, such costs updated by
the home health market basket index; and
(II) the agency's unduplicated census count of
patients (entitled to benefits under this title) for
the cost reporting period subject to the limitation.
(vi) For services furnished by home health agencies for cost
reporting periods beginning on or after October 1, 1997, the
following rules apply:
(I) For new providers and those providers without a
12-month cost reporting period ending in fiscal year
1994 subject to clauses (viii)(II) and (viii)(III), the
per beneficiary limitation shall be equal to the median
of these limits (or the Secretary's best estimates
thereof) applied to other home health agencies as
determined by the Secretary. A home health agency that
has altered its corporate structure or name shall not
be considered a new provider for this purpose.
(II) For beneficiaries who use services furnished by
more than one home health agency, the per beneficiary
limitations shall be prorated among the agencies.
(vii)(I) Not later than January 1, 1998, the Secretary shall
establish per visit limits applicable for fiscal year 1998, and
not later than April 1, 1998, the Secretary shall establish per
beneficiary limits under clause (v)(I) for fiscal year 1998.
(II) Not later than August 1 of each year (beginning in 1998)
the Secretary shall establish the limits applicable under this
subparagraph for services furnished during the fiscal year
beginning October 1 of the year.
(viii)(I) In the case of a provider with a 12-month cost
reporting period ending in fiscal year 1994, if the limit
imposed under clause (v) (determined without regard to this
subclause) for a cost reporting period beginning during or
after fiscal year 1999 is less than the median described in
clause (vi)(I) (but determined as if any reference in clause
(v) to ``98 percent'' were a reference to ``100 percent''), the
limit otherwise imposed under clause (v) for such provider and
period shall be increased by \1/3\ of such difference.
(II) Subject to subclause (IV), for new providers and those
providers without a 12-month cost reporting period ending in
fiscal year 1994, but for which the first cost reporting period
begins before fiscal year 1999, for cost reporting periods
beginning during or after fiscal year 1999, the per beneficiary
limitation described in clause (vi)(I) shall be equal to the
median described in such clause (determined as if any reference
in clause (v) to ``98 percent'' were a reference to ``100
percent'').
(III) Subject to subclause (IV), in the case of a new
provider for which the first cost reporting period begins
during or after fiscal year 1999, the limitation applied under
clause (vi)(I) (but only with respect to such provider) shall
be equal to 75 percent of the median described in clause
(vi)(I).
(IV) In the case of a new provider or a provider without a
12-month cost reporting period ending in fiscal year 1994,
subclause (II) shall apply, instead of subclause (III), to a
home health agency which filed an application for home health
agency provider status under this title before September 15,
1998, or which was approved as a branch of its parent agency
before such date and becomes a subunit of the parent agency or
a separate agency on or after such date.
(V) Each of the amounts specified in subclauses (I) through
(III) are such amounts as adjusted under clause (iii) to
reflect variations in wages among different areas.
(ix) Notwithstanding the per beneficiary limit under clause
(viii), if the limit imposed under clause (v) (determined
without regard to this clause) for a cost reporting period
beginning during or after fiscal year 2000 is less than the
median described in clause (vi)(I) (but determined as if any
reference in clause (v) to ``98 percent'' were a reference to
``100 percent''), the limit otherwise imposed under clause (v)
for such provider and period shall be increased by 2 percent.
(x) Notwithstanding any other provision of this subparagraph,
in updating any limit under this subparagraph by a home health
market basket index for cost reporting periods beginning during
each of fiscal years 2000, 2002, and 2003, the update otherwise
provided shall be reduced by 1.1 percentage points. With
respect to cost reporting periods beginning during fiscal year
2001, the update to any limit under this subparagraph shall be
the home health market basket index.
(M) Such regulations shall provide that costs respecting care
provided by a provider of services, pursuant to an assurance
under title VI or XVI of the Public Health Service Act that the
provider will make available a reasonable volume of services to
persons unable to pay therefor, shall not be allowable as
reasonable costs.
(N) In determining such reasonable costs, costs incurred for
activities directly related to influencing employees respecting
unionization may not be included.
(O)(i) In establishing an appropriate allowance for
depreciation and for interest on capital indebtedness with
respect to an asset of a provider of services which has
undergone a change of ownership, such regulations shall
provide, except as provided in clause (iii), that the valuation
of the asset after such change of ownership shall be the
historical cost of the asset, as recognized under this title,
less depreciation allowed, to the owner of record as of the
date of enactment of the Balanced Budget Act of 1997 (or, in
the case of an asset not in existence as of that date, the
first owner of record of the asset after that date).
(ii) Such regulations shall not recognize, as reasonable in
the provision of health care services, costs (including legal
fees, accounting and administrative costs, travel costs, and
the costs of feasibility studies) attributable to the
negotiation or settlement of the sale or purchase of any
capital asset (by acquisition or merger) for which any payment
has previously been made under this title.
(iii) In the case of the transfer of a hospital from
ownership by a State to ownership by a nonprofit corporation
without monetary consideration, the basis for capital
allowances to the new owner shall be the book value of the
hospital to the State at the time of the transfer.
(P) If such regulations provide for the payment for a return
on equity capital (other than with respect to costs of
inpatient hospital services), the rate of return to be
recognized, for determining the reasonable cost of services
furnished in a cost reporting period, shall be equal to the
average of the rates of interest, for each of the months any
part of which is included in the period, on obligations issued
for purchase by the Federal Hospital Insurance Trust Fund.
(Q) Except as otherwise explicitly authorized, the Secretary
is not authorized to limit the rate of increase on allowable
costs of approved medical educational activities.
(R) In determining such reasonable cost, costs incurred by a
provider of services representing a beneficiary in an
unsuccessful appeal of a determination described in section
1869(b) shall not be allowable as reasonable costs.
(S)(i) Such regulations shall not include provision for
specific recognition of any return on equity capital with
respect to hospital outpatient departments.
(ii)(I) Such regulations shall provide that, in determining
the amount of the payments that may be made under this title
with respect to all the capital-related costs of outpatient
hospital services, the Secretary shall reduce the amounts of
such payments otherwise established under this title by 15
percent for payments attributable to portions of cost reporting
periods occurring during fiscal year 1990, by 15 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal year 1991, and by 10 percent for
payments attributable to portions of cost reporting periods
occurring during fiscal years 1992 through 1999 and until the
first date that the prospective payment system under section
1833(t) is implemented.
(II) The Secretary shall reduce the reasonable cost of
outpatient hospital services (other than the capital-related
costs of such services) otherwise determined pursuant to
section 1833(a)(2)(B)(i)(I) by 5.8 percent for payments
attributable to portions of cost reporting periods occurring
during fiscal years 1991 through 1999 and until the first date
that the prospective payment system under section 1833(t) is
implemented.
(III) Subclauses (I) and (II) shall not apply to payments
with respect to the costs of hospital outpatient services
provided by any hospital that is a sole community hospital (as
defined in section 1886(d)(5)(D)(iii)) or a critical access
hospital (as defined in section 1861(mm)(1)).
(IV) In applying subclauses (I) and (II) to services for
which payment is made on the basis of a blend amount under
section 1833(i)(3)(A)(ii) or 1833(n)(1)(A)(ii), the costs
reflected in the amounts described in sections
1833(i)(3)(B)(i)(I) and 1833(n)(1)(B)(i)(I), respectively,
shall be reduced in accordance with such subclause.
(T) In determining such reasonable costs for hospitals, no
reduction in copayments under section 1833(t)(8)(B) shall be
treated as a bad debt and the amount of bad debts otherwise
treated as allowable costs which are attributable to the
deductibles and coinsurance amounts under this title shall be
reduced--
(i) for cost reporting periods beginning during
fiscal year 1998, by 25 percent of such amount
otherwise allowable,
(ii) for cost reporting periods beginning during
fiscal year 1999, by 40 percent of such amount
otherwise allowable,
(iii) for cost reporting periods beginning during
fiscal year 2000, by 45 percent of such amount
otherwise allowable,
(iv) for cost reporting periods beginning during
fiscal years 2001 through 2012, by 30 percent of such
amount otherwise allowable, and
(v) for cost reporting periods beginning during
fiscal year 2013 or a subsequent fiscal year, by 35
percent of such amount otherwise allowable.
(U) In determining the reasonable cost of ambulance services
(as described in subsection (s)(7)) provided during fiscal year
1998, during fiscal year 1999, and during so much of fiscal
year 2000 as precedes January 1, 2000, the Secretary shall not
recognize the costs per trip in excess of costs recognized as
reasonable for ambulance services provided on a per trip basis
during the previous fiscal year (after application of this
subparagraph), increased by the percentage increase in the
consumer price index for all urban consumers (U.S. city
average) as estimated by the Secretary for the 12-month period
ending with the midpoint of the fiscal year involved reduced by
1.0 percentage point. For ambulance services provided after
June 30, 1998, the Secretary may provide that claims for such
services must include a code (or codes) under a uniform coding
system specified by the Secretary that identifies the services
furnished.
(V) In determining such reasonable costs for skilled nursing
facilities and (beginning with respect to cost reporting
periods beginning during fiscal year 2013) for covered skilled
nursing services described in section 1888(e)(2)(A) furnished
by hospital providers of extended care services (as described
in section 1883), the amount of bad debts otherwise treated as
allowed costs which are attributable to the coinsurance amounts
under this title for individuals who are entitled to benefits
under part A and--
(i) are not described in section 1935(c)(6)(A)(ii)
shall be reduced by--
(I) for cost reporting periods beginning on or after
October 1, 2005, but before fiscal year 2013, 30
percent of such amount otherwise allowable; and
(II) for cost reporting periods beginning during
fiscal year 2013 or a subsequent fiscal year, by 35
percent of such amount otherwise allowable.
(ii) are described in such section--
(I) for cost reporting periods beginning on or after
October 1, 2005, but before fiscal year 2013, shall not
be reduced;
(II) for cost reporting periods beginning during
fiscal year 2013, shall be reduced by 12 percent of
such amount otherwise allowable;
(III) for cost reporting periods beginning during
fiscal year 2014, shall be reduced by 24 percent of
such amount otherwise allowable; and
(IV) for cost reporting periods beginning during a
subsequent fiscal year, shall be reduced by 35 percent
of such amount otherwise allowable.
(W)(i) In determining such reasonable costs for providers
described in clause (ii), the amount of bad debts otherwise
treated as allowable costs which are attributable to
deductibles and coinsurance amounts under this title shall be
reduced--
(I) for cost reporting periods beginning during
fiscal year 2013, by 12 percent of such amount
otherwise allowable;
(II) for cost reporting periods beginning during
fiscal year 2014, by 24 percent of such amount
otherwise allowable; and
(III) for cost reporting periods beginning during a
subsequent fiscal year, by 35 percent of such amount
otherwise allowable.
(ii) A provider described in this clause is a provider of
services not described in subparagraph (T) or (V), a supplier,
or any other type of entity that receives payment for bad debts
under the authority under subparagraph (A).
(2)(A) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations more
expensive than semi-private accommodations, the amount taken
into account for purposes of payment under this title with
respect to such services may not exceed the amount that would
be taken into account with respect to such services if
furnished in such semi-private accommodations unless the more
expensive accommodations were required for medical reasons.
(B) Where a provider of services which has an agreement in
effect under this title furnishes to an individual items or
services which are in excess of or more expensive than the
items or services with respect to which payment may be made
under part A or part B, as the case may be, the Secretary shall
take into account for purposes of payment to such provider of
services only the items or services with respect to which such
payment may be made.
(3) If the bed and board furnished as part of inpatient
hospital services (including inpatient tuberculosis hospital
services and inpatient psychiatric hospital services) or post-
hospital extended care services is in accommodations other
than, but not more expensive than, semi-private accommodations
and the use of such other accommodations rather than semi-
private accommodations was neither at the request of the
patient nor for a reason which the Secretary determines is
consistent with the purposes of this title, the amount of the
payment with respect to such bed and board under part A shall
be the amount otherwise payable under this title for such bed
and board furnished in semi-private accommodations minus the
difference between the charge customarily made by the hospital
or skilled nursing facility for bed and board in semi-private
accommodations and the charge customarily made by it for bed
and board in the accommodations furnished.
(4) If a provider of services furnishes items or services to
an individual which are in excess of or more expensive than the
items or services determined to be necessary in the efficient
delivery of needed health services and charges are imposed for
such more expensive items or services under the authority
granted in section 1866(a)(2)(B)(ii), the amount of payment
with respect to such items or services otherwise due such
provider in any fiscal period shall be reduced to the extent
that such payment plus such charges exceed the cost actually
incurred for such items or services in the fiscal period in
which such charges are imposed.
(5)(A) Where physical therapy services, occupational therapy
services, speech therapy services, or other therapy services or
services of other health-related personnel (other than
physicians) are furnished under an arrangement with a provider
of services or other organization, specified in the first
sentence of subsection (p) (including through the operation of
subsection (g)) the amount included in any payment to such
provider or other organization under this title as the
reasonable cost of such services (as furnished under such
arrangements) shall not exceed an amount equal to the salary
which would reasonably have been paid for such services
(together with any additional costs that would have been
incurred by the provider or other organization) to the person
performing them if they had been performed in an employment
relationship with such provider or other organization (rather
than under such arrangement) plus the cost of such other
expenses (including a reasonable allowance for traveltime and
other reasonable types of expense related to any differences in
acceptable methods of organization for the provision of such
therapy) incurred by such person, as the Secretary may in
regulations determine to be appropriate.
(B) Notwithstanding the provisions of subparagraph (A), if a
provider of services or other organization specified in the
first sentence of section 1861(p) requires the services of a
therapist on a limited part-time basis, or only to perform
intermittent services, the Secretary may make payment on the
basis of a reasonable rate per unit of service, even though
such rate is greater per unit of time than salary related
amounts, where he finds that such greater payment is, in the
aggregate, less than the amount that would have been paid if
such organization had employed a therapist on a full- or part-
time salary basis.
(6) For purposes of this subsection, the term ``semi-private
accommodations'' means two-bed, three-bed, or four-bed
accommodations.
(7)(A) For limitation on Federal participation for capital
expenditures which are out of conformity with a comprehensive
plan of a State or areawide planning agency, see section 1122.
(B) For further limitations on reasonable cost and
determination of payment amounts for operating costs of
inpatient hospital services and waivers for certain States, see
section 1886.
(C) For provisions restricting payment for provider-based
physicians' services and for payments under certain percentage
arrangements, see section 1887.
(D) For further limitations on reasonable cost and
determination of payment amounts for routine service costs of
skilled nursing facilities, see subsections (a) through (c) of
section 1888.
(8) Items unrelated to patient care.--Reasonable costs do not
include costs for the following--
(i) entertainment, including tickets to sporting and
other entertainment events;
(ii) gifts or donations;
(iii) personal use of motor vehicles;
(iv) costs for fines and penalties resulting from
violations of Federal, State, or local laws; and
(v) education expenses for spouses or other
dependents of providers of services, their employees or
contractors.
Arrangements for Certain Services
(w)(1) The term ``arrangements'' is limited to arrangements
under which receipt of payment by the hospital, critical access
hospital, skilled nursing facility, home health agency, or
hospice program (whether in its own right or as agent), with
respect to services for which an individual is entitled to have
payment made under this title, discharges the liability of such
individual or any other person to pay for the services.
(2) Utilization review activities conducted, in accordance
with the requirements of the program established under part B
of title XI of the Social Security Act with respect to services
furnished by a hospital or critical access hospital to patients
insured under part A of this title or entitled to have payment
made for such services under part B of this title or under a
State plan approved under title XIX, by a quality improvement
organization designated for the area in which such hospital or
critical access hospital is located shall be deemed to have
been conducted pursuant to arrangements between such hospital
or critical access hospital and such organization under which
such hospital or critical access hospital is obligated to pay
to such organization, as a condition of receiving payment for
hospital or critical access hospital services so furnished
under this part or under such a State plan, such amount as is
reasonably incurred and requested (as determined under
regulations of the Secretary) by such organization in
conducting such review activities with respect to services
furnished by such hospital or critical access hospital to such
patients.
State and United States
(x) The terms ``State'' and ``United States'' have the
meaning given to them by subsections (h) and (i), respectively,
of section 210.
Extended Care in Religious Nonmedical Health Care Institutions
(y)(1) The term ``skilled nursing facility'' also includes a
religious nonmedical health care institution (as defined in
subsection (ss)(1)), but only (except for purposes of
subsection (a)(2)) with respect to items and services
ordinarily furnished by such an institution to inpatients, and
payment may be made with respect to services provided by or in
such an institution only to such extent and under such
conditions, limitations, and requirements (in addition to or in
lieu of the conditions, limitations, and requirements otherwise
applicable) as may be provided in regulations consistent with
section 1821.
(2) Notwithstanding any other provision of this title,
payment under part A may not be made for services furnished an
individual in a skilled nursing facility to which paragraph (1)
applies unless such individual elects, in accordance with
regulations, for a spell of illness to have such services
treated as post-hospital extended care services for purposes of
such part; and payment under part A may not be made for post-
hospital extended care services--
(A) furnished an individual during such spell of
illness in a skilled nursing facility to which
paragraph (1) applies after--
(i) such services have been furnished to him
in such a facility for 30 days during such
spell, or
(ii) such services have been furnished to him
during such spell in a skilled nursing facility
to which such paragraph does not apply; or
(B) furnished an individual during such spell of
illness in a skilled nursing facility to which
paragraph (1) does not apply after such services have
been furnished to him during such spell in a skilled
nursing facility to which such paragraph applies.
(3) The amount payable under part A for post-hospital
extended care services furnished an individual during any spell
of illness in a skilled nursing facility to which paragraph (1)
applies shall be reduced by a coinsurance amount equal to one-
eighth of the inpatient hospital deductible for each day before
the 31st day on which he is furnished such services in such a
facility during such spell (and the reduction under this
paragraph shall be in lieu of any reduction under section
1813(a)(3)).
(4) For purposes of subsection (i), the determination of
whether services furnished by or in an institution described in
paragraph (1) constitute post-hospital extended care services
shall be made in accordance with and subject to such
conditions, limitations, and requirements as may be provided in
regulations.
Institutional Planning
(z) An overall plan and budget of a hospital, skilled nursing
facility, comprehensive outpatient rehabilitation facility, or
home health agency shall be considered sufficient if it--
(1) provides for an annual operating budget which
includes all anticipated income and expenses related to
items which would, under generally accepted accounting
principles, be considered income and expense items
(except that nothing in this paragraph shall require
that there be prepared, in connection with any budget,
an item-by-item identification of the components of
each type of anticipated expenditure or income);
(2)(A) provides for a capital expenditures plan for
at least a 3-year period (including the year to which
the operating budget described in paragraph (1) is
applicable) which includes and identifies in detail the
anticipated sources of financing for, and the
objectives of, each anticipated expenditure in excess
of $600,000 (or such lesser amount as may be
established by the State under section 1122(g)(1) in
which the hospital is located) related to the
acquisition of land, the improvement of land,
buildings, and equipment, and the replacement,
modernization, and expansion of the buildings and
equipment which would, under generally accepted
accounting principles, be considered capital items;
(B) provides that such plan is submitted to the
agency designated under section 1122(b), or if no such
agency is designated, to the appropriate health
planning agency in the State (but this subparagraph
shall not apply in the case of a facility exempt from
review under section 1122 by reason of section
1122(j));
(3) provides for review and updating at least
annually; and
(4) is prepared, under the direction of the governing
body of the institution or agency, by a committee
consisting of representatives of the governing body,
the administrative staff, and the medical staff (if
any) of the institution or agency.
Rural Health Clinic Services and Federally Qualified Health Center
Services
(aa)(1) The term ``rural health clinic services'' means --
(A) physicians' services and such services and
supplies as are covered under section 1861(s)(2)(A) if
furnished as an incident to a physician's professional
service and items and services described in section
1861(s)(10),
(B) such services furnished by a physician assistant
or a nurse practitioner (as defined in paragraph (5)),
by a clinical psychologist (as defined by the
Secretary) or by a clinical social worker (as defined
in subsection (hh)(1)), and such services and supplies
furnished as an incident to his service as would
otherwise be covered if furnished by a physician or as
an incident to a physician's service, and
(C) in the case of a rural health clinic located in
an area in which there exists a shortage of home health
agencies, part-time or intermittent nursing care and
related medical supplies (other than drugs and
biologicals) furnished by a registered professional
nurse or licensed practical nurse to a homebound
individual under a written plan of treatment (i)
established and periodically reviewed by a physician
described in paragraph (2)(B), or (ii) established by a
nurse practitioner or physician assistant and
periodically reviewed and approved by a physician
described in paragraph (2)(B),
when furnished to an individual as an outpatient of a rural
health clinic.
(2) The term ``rural health clinic'' means a facility which
--
(A) is primarily engaged in furnishing to outpatients
services described in subparagraphs (A) and (B) of
paragraph (1);
(B) in the case of a facility which is not a
physician-directed clinic, has an arrangement
(consistent with the provisions of State and local law
relative to the practice, performance, and delivery of
health services) with one or more physicians (as
defined in subsection (r)(1)) under which provision is
made for the periodic review by such physicians of
covered services furnished by physician assistants and
nurse practitioners, the supervision and guidance by
such physicians of physician assistants and nurse
practitioners, the preparation by such physicians of
such medical orders for care and treatment of clinic
patients as may be necessary, and the availability of
such physicians for such referral of and consultation
for patients as is necessary and for advice and
assistance in the management of medical emergencies;
and, in the case of a physician-directed clinic, has
one or more of its staff physicians perform the
activities accomplished through such an arrangement;
(C) maintains clinical records on all patients;
(D) has arrangements with one or more hospitals,
having agreements in effect under section 1866, for the
referral and admission of patients requiring inpatient
services or such diagnostic or other specialized
services as are not available at the clinic;
(E) has written policies, which are developed with
the advice of (and with provision for review of such
policies from time to time by) a group of professional
personnel, including one or more physicians and one or
more physician assistants or nurse practitioners, to
govern those services described in paragraph (1) which
it furnishes;
(F) has a physician, physician assistant, or nurse
practitioner responsible for the execution of policies
described in subparagraph (E) and relating to the
provision of the clinic's services;
(G) directly provides routine diagnostic services,
including clinical laboratory services, as prescribed
in regulations by the Secretary, and has prompt access
to additional diagnostic services from facilities
meeting requirements under this title;
(H) in compliance with State and Federal law, has
available for administering to patients of the clinic
at least such drugs and biologicals as are determined
by the Secretary to be necessary for the treatment of
emergency cases (as defined in regulations) and has
appropriate procedures or arrangements for storing,
administering, and dispensing any drugs and
biologicals;
(I) has a quality assessment and performance
improvement program, and appropriate procedures for
review of utilization of clinic services, as the
Secretary may specify;
(J) has a nurse practitioner, a physician assistant,
or a certified nurse-midwife (as defined in subsection
(gg)) available to furnish patient care services not
less than 50 percent of the time the clinic operates;
and
(K) meets such other requirements as the Secretary
may find necessary in the interest of the health and
safety of the individuals who are furnished services by
the clinic.
For the purposes of this title, such term includes only a
facility which (i) is located in an area that is not an
urbanized area (as defined by the Bureau of the Census) and in
which there are insufficient numbers of needed health care
practitioners (as determined by the Secretary), and that,
within the previous 4-year period, has been designated by the
chief executive officer of the State and certified by the
Secretary as an area with a shortage of personal health
services or designated by the Secretary either (I) as an area
with a shortage of personal health services under section
330(b)(3) or 1302(7) of the Public Health Service Act, (II) as
a health professional shortage area described in section
332(a)(1)(A) of that Act because of its shortage of primary
medical care manpower, (III) as a high impact area described in
section 329(a)(5) of that Act, of (IV) as an area which
includes a population group which the Secretary determines has
a health manpower shortage under section 332(a)(1)(B) of that
Act, (ii) has filed an agreement with the Secretary by which it
agrees not to charge any individual or other person for items
or services for which such individual is entitled to have
payment made under this title, except for the amount of any
deductible or coinsurance amount imposed with respect to such
items or services (not in excess of the amount customarily
charged for such items and services by such clinic), pursuant
to subsections (a) and (b) of section 1833, (iii) employs a
physician assistant or nurse practitioner, and (iv) is not a
rehabilitation agency or a facility which is primarily for the
care and treatment of mental diseases. A facility that is in
operation and qualifies as a rural health clinic under this
title or title XIX and that subsequently fails to satisfy the
requirement of clause (i) shall be considered, for purposes of
this title and title XIX, as still satisfying the requirement
of such clause if it is determined, in accordance with criteria
established by the Secretary in regulations, to be essential to
the delivery of primary care services that would otherwise be
unavailable in the geographic area served by the clinic. If a
State agency has determined under section 1864(a) that a
facility is a rural health clinic and the facility has applied
to the Secretary for approval as such a clinic, the Secretary
shall notify the facility of the Secretary's approval or
disapproval not later than 60 days after the date of the State
agency determination or the application (whichever is later).
(3) The term ``Federally qualified health center services''
means--
(A) services of the type described in subparagraphs
(A) through (C) of paragraph (1) and preventive
services (as defined in section 1861(ddd)(3)); and
(B) preventive primary health services that a center
is required to provide under section 330 of the Public
Health Service Act,
when furnished to an individual as an outpatient of a Federally
qualified health center by the center or by a health care
professional under contract with the center and, for this
purpose, any reference to a rural health clinic or a physician
described in paragraph (2)(B) is deemed a reference to a
Federally qualified health center or a physician at the center,
respectively.
(4) The term ``Federally qualified health center'' means an
entity which--
(A)(i) is receiving a grant under section 330 of the
Public Health Service Act, or
(ii)(I) is receiving funding from such a grant under
a contract with the recipient of such a grant, and (II)
meets the requirements to receive a grant under section
330 of such Act;
(B) based on the recommendation of the Health
Resources and Services Administration within the Public
Health Service, is determined by the Secretary to meet
the requirements for receiving such a grant;
(C) was treated by the Secretary, for purposes of
part B, as a comprehensive Federally funded health
center as of January 1, 1990; or
(D) is an outpatient health program or facility
operated by a tribe or tribal organization under the
Indian Self-Determination Act or by an urban Indian
organization receiving funds under title V of the
Indian Health Care Improvement Act.
(5)(A) The term ``physician assistant'' and the term ``nurse
practitioner'' mean, for purposes of this title, a physician
assistant or nurse practitioner who performs such services as
such individual is legally authorized to perform (in the State
in which the individual performs such services) in accordance
with State law (or the State regulatory mechanism provided by
State law), and who meets such training, education, and
experience requirements (or any combination thereof) as the
Secretary may prescribe in regulations.
(B) The term ``clinical nurse specialist'' means, for
purposes of this title, an individual who--
(i) is a registered nurse and is licensed to practice
nursing in the State in which the clinical nurse
specialist services are performed; and
(ii) holds a master's degree in a defined clinical
area of nursing from an accredited educational
institution.
(6) The term ``collaboration'' means a process in which a
nurse practitioner works with a physician to deliver health
care services within the scope of the practitioner's
professional expertise, with medical direction and appropriate
supervision as provided for in jointly developed guidelines or
other mechanisms as defined by the law of the State in which
the services are performed.
(7)(A) The Secretary shall waive for a 1-year period the
requirements of paragraph (2) that a rural health clinic employ
a physician assistant, nurse practitioner or certified nurse
midwife or that such clinic require such providers to furnish
services at least 50 percent of the time that the clinic
operates for any facility that requests such waiver if the
facility demonstrates that the facility has been unable,
despite reasonable efforts, to hire a physician assistant,
nurse practitioner, or certified nurse-midwife in the previous
90-day period.
(B) The Secretary may not grant such a waiver under
subparagraph (A) to a facility if the request for the waiver is
made less than 6 months after the date of the expiration of any
previous such waiver for the facility, or if the facility has
not yet been determined to meet the requirements (including
subparagraph (J) of the first sentence of paragraph (2)) of a
rural health clinic.
(C) A waiver which is requested under this paragraph shall be
deemed granted unless such request is denied by the Secretary
within 60 days after the date such request is received.
Services of a Certified Registered Nurse Anesthetist
(bb)(1) The term ``services of a certified registered nurse
anesthetist'' means anesthesia services and related care
furnished by a certified registered nurse anesthetist (as
defined in paragraph (2)) which the nurse anesthetist is
legally authorized to perform as such by the State in which the
services are furnished.
(2) The term ``certified registered nurse anesthetist'' means
a certified registered nurse anesthetist licensed by the State
who meets such education, training, and other requirements
relating to anesthesia services and related care as the
Secretary may prescribe. In prescribing such requirements the
Secretary may use the same requirements as those established by
a national organization for the certification of nurse
anesthetists. Such term also includes, as prescribed by the
Secretary, an anesthesiologist assistant.
Comprehensive Outpatient Rehabilitation Facility Services
(cc)(1) The term ``comprehensive outpatient rehabilitation
facility services'' means the following items and services
furnished by a physician or other qualified professional
personnel (as defined in regulations by the Secretary) to an
individual who is an outpatient of a comprehensive outpatient
rehabilitation facility under a plan (for furnishing such items
and services to such individual) established and periodically
reviewed by a physician--
(A) physicians' services;
(B) physical therapy, occupational therapy, speech-
language pathology services, and respiratory therapy;
(C) prosthetic and orthotic devices, including
testing, fitting, or training in the use of prosthetic
and orthotic devices;
(D) social and psychological services;
(E) nursing care provided by or under the supervision
of a registered professional nurse;
(F) drugs and biologicals which cannot, as determined
in accordance with regulations, be self-administered;
(G) supplies and durable medical equipment; and
(H) such other items and services as are medically
necessary for the rehabilitation of the patient and are
ordinarily furnished by comprehensive outpatient
rehabilitation facilities,
excluding, however, any item or service if it would not be
included under subsection (b) if furnished to an inpatient of a
hospital. In the case of physical therapy, occupational
therapy, and speech pathology services, there shall be no
requirement that the item or service be furnished at any single
fixed location if the item or service is furnished pursuant to
such plan and payments are not otherwise made for the item or
service under this title.
(2) The term ``comprehensive outpatient rehabilitation
facility'' means a facility which--
(A) is primarily engaged in providing (by or under
the supervision of physicians) diagnostic, therapeutic,
and restorative services to outpatients for the
rehabilitation of injured, disabled, or sick persons;
(B) provides at least the following comprehensive
outpatient rehabilitation services: (i) physicians'
services (rendered by physicians, as defined in section
1861(r)(1), who are available at the facility on a
full- or part-time basis); (ii) physical therapy; and
(iii) social or psychological services;
(C) maintains clinical records on all patients;
(D) has policies established by a group of
professional personnel (associated with the facility),
including one or more physicians defined in subsection
(r)(1) to govern the comprehensive outpatient
rehabilitation services it furnishes, and provides for
the carrying out of such policies by a full- or part-
time physician referred to in subparagraph (B)(i);
(E) has a requirement that every patient must be
under the care of a physician;
(F) in the case of a facility in any State in which
State or applicable local law provides for the
licensing of facilities of this nature (i) is licensed
pursuant to such law, or (ii) is approved by the agency
of such State or locality, responsible for licensing
facilities of this nature, as meeting the standards
established for such licensing;
(G) has in effect a utilization review plan in
accordance with regulations prescribed by the
Secretary;
(H) has in effect an overall plan and budget that
meets the requirements of subsection (z);
(I) provides the Secretary on a continuing basis with
a surety bond in a form specified by the Secretary and
in an amount that is not less than $50,000; and
(J) meets such other conditions of participation as
the Secretary may find necessary in the interest of the
health and safety of individuals who are furnished
services by such facility, including conditions
concerning qualifications of personnel in these
facilities.
The Secretary may waive the requirement of a surety bond under
subparagraph (I) in the case of a facility that provides a
comparable surety bond under State law.
Hospice Care; Hospice Program
(dd)(1) The term ``hospice care'' means the following items
and services provided to a terminally ill individual by, or by
others under arrangements made by, a hospice program under a
written plan (for providing such care to such individual)
established and periodically reviewed by the individual's
attending physician and by the medical director (and by the
interdisciplinary group described in paragraph (2)(B)) of the
program--
(A) nursing care provided by or under the supervision
of a registered professional nurse,
(B) physical or occupational therapy, or speech-
language pathology services,
(C) medical social services under the direction of a
physician,
(D)(i) services of a home health aide who has
successfully completed a training program approved by
the Secretary and (ii) homemaker services,
(E) medical supplies (including drugs and
biologicals) and the use of medical appliances, while
under such a plan,
(F) physicians' services,
(G) short-term inpatient care (including both respite
care and procedures necessary for pain control and
acute and chronic symptom management) in an inpatient
facility meeting such conditions as the Secretary
determines to be appropriate to provide such care, but
such respite care may be provided only on an
intermittent, nonroutine, and occasional basis and may
not be provided consecutively over longer than five
days,
(H) counseling (including dietary counseling) with
respect to care of the terminally ill individual and
adjustment to his death, and
(I) any other item or service which is specified in
the plan and for which payment may otherwise be made
under this title.
The care and services described in subparagraphs (A) and (D)
may be provided on a 24-hour, continuous basis only during
periods of crisis (meeting criteria established by the
Secretary) and only as necessary to maintain the terminally ill
individual at home.
(2) The term ``hospice program'' means a public agency or
private organization (or a subdivision thereof) which--
(A)(i) is primarily engaged in providing the care and
services described in paragraph (1) and makes such
services available (as needed) on a 24-hour basis and
which also provides bereavement counseling for the
immediate family of terminally ill individuals and
services described in section 1812(a)(5),
(ii) provides for such care and services in
individuals' homes, on an outpatient basis, and on a
short-term inpatient basis, directly or under
arrangements made by the agency or organization, except
that--
(I) the agency or organization must routinely
provide directly substantially all of each of
the services described in subparagraphs (A),
(C), and (H) of paragraph (1), except as
otherwise provided in paragraph (5), and
(II) in the case of other services described
in paragraph (1) which are not provided
directly by the agency or organization, the
agency or organization must maintain
professional management responsibility for all
such services furnished to an individual,
regardless of the location or facility in which
such services are furnished; and
(iii) provides assurances satisfactory to the
Secretary that the aggregate number of days of
inpatient care described in paragraph (1)(G) provided
in any 12-month period to individuals who have an
election in effect under section 1812(d) with respect
to that agency or organization does not exceed 20
percent of the aggregate number of days during that
period on which such elections for such individuals are
in effect;
(B) has an interdisciplinary group of personnel
which--
(i) includes at least--
(I) one physician (as defined in
subsection (r)(1)),
(II) one registered professional
nurse, and
(III) one social worker,
employed by or, in the case of a physician described in
subclause (I), under contract with the agency or
organization, and also includes at least one pastoral
or other counselor,
(ii) provides (or supervises the provision
of) the care and services described in
paragraph (1), and
(iii) establishes the policies governing the
provision of such care and services;
(C) maintains central clinical records on all
patients;
(D) does not discontinue the hospice care it provides
with respect to a patient because of the inability of
the patient to pay for such care;
(E)(i) utilizes volunteers in its provision of care
and services in accordance with standards set by the
Secretary, which standards shall ensure a continuing
level of effort to utilize such volunteers, and (ii)
maintains records on the use of these volunteers and
the cost savings and expansion of care and services
achieved through the use of these volunteers;
(F) in the case of an agency or organization in any
State in which State or applicable local law provides
for the licensing of agencies or organizations of this
nature, is licensed pursuant to such law; and
(G) meets such other requirements as the Secretary
may find necessary in the interest of the health and
safety of the individuals who are provided care and
services by such agency or organization.
(3)(A) An individual is considered to be ``terminally ill''
if the individual has a medical prognosis that the individual's
life expectancy is 6 months or less.
(B) The term ``attending physician'' means, with respect to
an individual, the physician (as defined in subsection (r)(1)),
the nurse practitioner (as defined in subsection (aa)(5)), or
the physician assistant (as defined in such subsection), who
may be employed by a hospice program, whom the individual
identifies as having the most significant role in the
determination and delivery of medical care to the individual at
the time the individual makes an election to receive hospice
care.
(4)(A) An entity which is certified as a provider of services
other than a hospice program shall be considered, for purposes
of certification as a hospice program, to have met any
requirements under paragraph (2) which are also the same
requirements for certification as such other type of provider.
The Secretary shall coordinate surveys for determining
certification under this title so as to provide, to the extent
feasible, for simultaneous surveys of an entity which seeks to
be certified as a hospice program and as a provider of services
of another type.
(B) Any entity which is certified as a hospice program and as
a provider of another type shall have separate provider
agreements under section 1866 and shall file separate cost
reports with respect to costs incurred in providing hospice
care and in providing other services and items under this
title.
(C) Any entity that is certified as a hospice program shall
be subject to a standard survey by an appropriate State or
local survey agency, or an approved accreditation agency, as
determined by the Secretary, not less frequently than once
every 36 months beginning 6 months after the date of the
enactment of this subparagraph and ending September 30, 2025.
(5)(A) The Secretary may waive the requirements of paragraph
(2)(A)(ii)(I) for an agency or organization with respect to all
or part of the nursing care described in paragraph (1)(A) if
such agency or organization--
(i) is located in an area which is not an urbanized
area (as defined by the Bureau of the Census);
(ii) was in operation on or before January 1, 1983;
and
(iii) has demonstrated a good faith effort (as
determined by the Secretary) to hire a sufficient
number of nurses to provide such nursing care directly.
(B) Any waiver, which is in such form and containing such
information as the Secretary may require and which is requested
by an agency or organization under subparagraph (A) or (C),
shall be deemed to be granted unless such request is denied by
the Secretary within 60 days after the date such request is
received by the Secretary. The granting of a waiver under
subparagraph (A) or (C) shall not preclude the granting of any
subsequent waiver request should such a waiver again become
necessary.
(C) The Secretary may waive the requirements of paragraph
(2)(A)(i) and (2)(A)(ii) for an agency or organization with
respect to the services described in paragraph (1)(B) and, with
respect to dietary counseling, paragraph (1)(H), if such agency
or organization--
(i) is located in an area which is not an urbanized
area (as defined by the Bureau of Census), and
(ii) demonstrates to the satisfaction of the
Secretary that the agency or organization has been
unable, despite diligent efforts, to recruit
appropriate personnel.
(D) In extraordinary, exigent, or other non-routine
circumstances, such as unanticipated periods of high patient
loads, staffing shortages due to illness or other events, or
temporary travel of a patient outside a hospice program's
service area, a hospice program may enter into arrangements
with another hospice program for the provision by that other
program of services described in paragraph (2)(A)(ii)(I). The
provisions of paragraph (2)(A)(ii)(II) shall apply with respect
to the services provided under such arrangements.
(E) A hospice program may provide services described in
paragraph (1)(A) other than directly by the program if the
services are highly specialized services of a registered
professional nurse and are provided non-routinely and so
infrequently so that the provision of such services directly
would be impracticable and prohibitively expensive.
Discharge Planning Process
(ee)(1) A discharge planning process of a hospital shall be
considered sufficient if it is applicable to services furnished
by the hospital to individuals entitled to benefits under this
title and if it meets the guidelines and standards established
by the Secretary under paragraph (2).
(2) The Secretary shall develop guidelines and standards for
the discharge planning process in order to ensure a timely and
smooth transition to the most appropriate type of and setting
for post-hospital or rehabilitative care. The guidelines and
standards shall include the following:
(A) The hospital must identify, at an early stage of
hospitalization, those patients who are likely to
suffer adverse health consequences upon discharge in
the absence of adequate discharge planning.
(B) Hospitals must provide a discharge planning
evaluation for patients identified under subparagraph
(A) and for other patients upon the request of the
patient, patient's representative, or patient's
physician.
(C) Any discharge planning evaluation must be made on
a timely basis to ensure that appropriate arrangements
for post-hospital care will be made before discharge
and to avoid unnecessary delays in discharge.
(D) A discharge planning evaluation must include an
evaluation of a patient's likely need for appropriate
post-hospital services, including hospice care and
post-hospital extended care services, and the
availability of those services, including the
availability of home health services through
individuals and entities that participate in the
program under this title and that serve the area in
which the patient resides and that request to be listed
by the hospital as available and, in the case of
individuals who are likely to need post-hospital
extended care services, the availability of such
services through facilities that participate in the
program under this title and that serve the area in
which the patient resides.
(E) The discharge planning evaluation must be
included in the patient's medical record for use in
establishing an appropriate discharge plan and the
results of the evaluation must be discussed with the
patient (or the patient's representative).
(F) Upon the request of a patient's physician, the
hospital must arrange for the development and initial
implementation of a discharge plan for the patient.
(G) Any discharge planning evaluation or discharge
plan required under this paragraph must be developed
by, or under the supervision of, a registered
professional nurse, social worker, or other
appropriately qualified personnel.
(H) Consistent with section 1802, the discharge plan
shall--
(i) not specify or otherwise limit the
qualified provider which may provide post-
hospital home health services, and
(ii) identify (in a form and manner specified
by the Secretary) any entity to whom the
individual is referred in which the hospital
has a disclosable financial interest (as
specified by the Secretary consistent with
section 1866(a)(1)(S)) or which has such an
interest in the hospital.
(3) With respect to a discharge plan for an individual who is
enrolled with a Medicare+Choice organization under a
Medicare+Choice plan and is furnished inpatient hospital
services by a hospital under a contract with the organization--
(A) the discharge planning evaluation under paragraph
(2)(D) is not required to include information on the
availability of home health services through
individuals and entities which do not have a contract
with the organization; and
(B) notwithstanding subparagraph (H)(i), the plan may
specify or limit the provider (or providers) of post-
hospital home health services or other post-hospital
services under the plan.
Partial Hospitalization Services
(ff)(1) The term ``partial hospitalization services'' means
the items and services described in paragraph (2) prescribed by
a physician and provided under a program described in paragraph
(3) under the supervision of a physician pursuant to an
individualized, written plan of treatment established and
periodically reviewed by a physician (in consultation with
appropriate staff participating in such program), which plan
sets forth the physician's diagnosis, the type, amount,
frequency, and duration of the items and services provided
under the plan, and the goals for treatment under the plan.
(2) The items and services described in this paragraph are--
(A) individual and group therapy with physicians or
psychologists (or other mental health professionals to
the extent authorized under State law),
(B) occupational therapy requiring the skills of a
qualified occupational therapist,
(C) services of social workers, trained psychiatric
nurses, and other staff trained to work with
psychiatric patients,
(D) drugs and biologicals furnished for therapeutic
purposes (which cannot, as determined in accordance
with regulations, be self-administered),
(E) individualized activity therapies that are not
primarily recreational or diversionary,
(F) family counseling (the primary purpose of which
is treatment of the individual's condition),
(G) patient training and education (to the extent
that training and educational activities are closely
and clearly related to individual's care and
treatment),
(H) diagnostic services, and
(I) such other items and services as the Secretary
may provide (but in no event to include meals and
transportation);
that are reasonable and necessary for the diagnosis or active
treatment of the individual's condition, reasonably expected to
improve or maintain the individual's condition and functional
level and to prevent relapse or hospitalization, and furnished
pursuant to such guidelines relating to frequency and duration
of services as the Secretary shall by regulation establish
(taking into account accepted norms of medical practice and the
reasonable expectation of patient improvement).
(3)(A) A program described in this paragraph is a program
which is furnished by a hospital to its outpatients or by a
community mental health center (as defined in subparagraph
(B)), and which is a distinct and organized intensive
ambulatory treatment service offering less than 24-hour-daily
care other than in an individual's home or in an inpatient or
residential setting.
(B) For purposes of subparagraph (A), the term ``community
mental health center'' means an entity that--
(i)(I) provides the mental health services described
in section 1913(c)(1) of the Public Health Service Act;
or
(II) in the case of an entity operating in a State
that by law precludes the entity from providing itself
the service described in subparagraph (E) of such
section, provides for such service by contract with an
approved organization or entity (as determined by the
Secretary);
(ii) meets applicable licensing or certification
requirements for community mental health centers in the
State in which it is located;
(iii) provides at least 40 percent of its services to
individuals who are not eligible for benefits under
this title; and
(iv) meets such additional conditions as the
Secretary shall specify to ensure (I) the health and
safety of individuals being furnished such services,
(II) the effective and efficient furnishing of such
services, and (III) the compliance of such entity with
the criteria described in section 1931(c)(1) of the
Public Health Service Act.
Certified Nurse-Midwife Services
(gg)(1) The term ``certified nurse-midwife services'' means
such services furnished by a certified nurse-midwife (as
defined in paragraph (2)) and such services and supplies
furnished as an incident to the nurse-midwife's service which
the certified nurse-midwife is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law) as would otherwise be covered if furnished by a
physician or as an incident to a physicians' service.
(2) The term ``certified nurse-midwife'' means a registered
nurse who has successfully completed a program of study and
clinical experience meeting guidelines prescribed by the
Secretary, or has been certified by an organization recognized
by the Secretary.
Clinical Social Worker; Clinical Social Worker Services
(hh)(1) The term ``clinical social worker'' means an
individual who--
(A) possesses a master's or doctor's degree in social
work;
(B) after obtaining such degree has performed at
least 2 years of supervised clinical social work; and
(C)(i) is licensed or certified as a clinical social
worker by the State in which the services are
performed, or
(ii) in the case of an individual in a State which
does not provide for licensure or certification--
(I) has completed at least 2 years or 3,000
hours of post-master's degree supervised
clinical social work practice under the
supervision of a master's level social worker
in an appropriate setting (as determined by the
Secretary), and
(II) meets such other criteria as the
Secretary establishes.
(2) The term ``clinical social worker services'' means
services performed by a clinical social worker (as defined in
paragraph (1)) for the diagnosis and treatment of mental
illnesses (other than services furnished to an inpatient of a
hospital and other than services furnished to an inpatient of a
skilled nursing facility which the facility is required to
provide as a requirement for participation) which the clinical
social worker is legally authorized to perform under State law
(or the State regulatory mechanism provided by State law) of
the State in which such services are performed as would
otherwise be covered if furnished by a physician or as an
incident to a physician's professional service.
Qualified Psychologist Services
(ii) The term ``qualified psychologist services'' means such
services and such services and supplies furnished as an
incident to his service furnished by a clinical psychologist
(as defined by the Secretary) which the psychologist is legally
authorized to perform under State law (or the State regulatory
mechanism provided by State law) as would otherwise be covered
if furnished by a physician or as an incident to a physician's
service.
Screening Mammography
(jj) The term ``screening mammography'' means a radiologic
procedure provided to a woman for the purpose of early
detection of breast cancer and includes a physician's
interpretation of the results of the procedure.
Covered Osteoporosis Drug
(kk) The term ``covered osteoporosis drug'' means an
injectable drug approved for the treatment of post-menopausal
osteoporosis provided to an individual by a home health agency
if, in accordance with regulations promulgated by the
Secretary--
(1) the individual's attending physician certifies
that the individual has suffered a bone fracture
related to post-menopausal osteoporosis and that the
individual is unable to learn the skills needed to
self-administer such drug or is otherwise physically or
mentally incapable of self-administering such drug; and
(2) the individual is confined to the individual's
home (except when receiving items and services referred
to in subsection (m)(7)).
Speech-Language Pathology Services; Audiology Services
(ll)(1) The term ``speech-language pathology services'' means
such speech, language, and related function assessment and
rehabilitation services furnished by a qualified speech-
language pathologist as the speech-language pathologist is
legally authorized to perform under State law (or the State
regulatory mechanism provided by State law) as would otherwise
be covered if furnished by a physician.
(2) The term ``outpatient speech-language pathology
services'' has the meaning given the term ``outpatient physical
therapy services'' in subsection (p), except that in applying
such subsection--
(A) ``speech-language pathology'' shall be
substituted for ``physical therapy'' each place it
appears; and
(B) ``speech-language pathologist'' shall be
substituted for ``physical therapist'' each place it
appears.
(3) The term ``audiology services'' means such hearing and
balance assessment services furnished by a qualified
audiologist as the audiologist is legally authorized to perform
under State law (or the State regulatory mechanism provided by
State law), as would otherwise be covered if furnished by a
physician.
(4) In this subsection:
(A) The term ``qualified speech-language
pathologist'' means an individual with a master's or
doctoral degree in speech-language pathology who--
(i) is licensed as a speech-language
pathologist by the State in which the
individual furnishes such services, or
(ii) in the case of an individual who
furnishes services in a State which does not
license speech-language pathologists, has
successfully completed 350 clock hours of
supervised clinical practicum (or is in the
process of accumulating such supervised
clinical experience), performed not less than 9
months of supervised full-time speech-language
pathology services after obtaining a master's
or doctoral degree in speech-language pathology
or a related field, and successfully completed
a national examination in speech-language
pathology approved by the Secretary.
(B) The term ``qualified audiologist'' means an
individual with a master's or doctoral degree in
audiology who--
(i) is licensed as an audiologist by the
State in which the individual furnishes such
services, or
(ii) in the case of an individual who
furnishes services in a State which does not
license audiologists, has successfully
completed 350 clock hours of supervised
clinical practicum (or is in the process of
accumulating such supervised clinical
experience), performed not less than 9 months
of supervised full-time audiology services
after obtaining a master's or doctoral degree
in audiology or a related field, and
successfully completed a national examination
in audiology approved by the Secretary.
Critical Access Hospital; Critical Access Hospital Services
(mm)(1) The term ``critical access hospital'' means a
facility certified by the Secretary as a critical access
hospital under section 1820(e).
(2) The term ``inpatient critical access hospital services''
means items and services, furnished to an inpatient of a
critical access hospital by such facility, that would be
inpatient hospital services if furnished to an inpatient of a
hospital by a hospital.
(3) The term ``outpatient critical access hospital services''
means medical and other health services furnished by a critical
access hospital on an outpatient basis.
Screening Pap Smear; Screening Pelvic Exam
(nn)(1) The term ``screening pap smear'' means a diagnostic
laboratory test consisting of a routine exfoliative cytology
test (Papanicolaou test) provided to a woman for the purpose of
early detection of cervical or vaginal cancer and includes a
physician's interpretation of the results of the test, if the
individual involved has not had such a test during the
preceding 2 years, or during the preceding year in the case of
a woman described in paragraph (3).
(2) The term ``screening pelvic exam'' means a pelvic
examination provided to a woman if the woman involved has not
had such an examination during the preceding 2 years, or during
the preceding year in the case of a woman described in
paragraph (3), and includes a clinical breast examination.
(3) A woman described in this paragraph is a woman who--
(A) is of childbearing age and has had a test
described in this subsection during any of the
preceding 3 years that indicated the presence of
cervical or vaginal cancer or other abnormality; or
(B) is at high risk of developing cervical or vaginal
cancer (as determined pursuant to factors identified by
the Secretary).
Prostate Cancer Screening Tests
(oo)(1) The term ``prostate cancer screening test'' means a
test that consists of any (or all) of the procedures described
in paragraph (2) provided for the purpose of early detection of
prostate cancer to a man over 50 years of age who has not had
such a test during the preceding year.
(2) The procedures described in this paragraph are as
follows:
(A) A digital rectal examination.
(B) A prostate-specific antigen blood test.
(C) For years beginning after 2002, such other
procedures as the Secretary finds appropriate for the
purpose of early detection of prostate cancer, taking
into account changes in technology and standards of
medical practice, availability, effectiveness, costs,
and such other factors as the Secretary considers
appropriate.
Colorectal Cancer Screening Tests
(pp)(1) The term ``colorectal cancer screening test'' means
any of the following procedures furnished to an individual for
the purpose of early detection of colorectal cancer:
(A) Screening fecal-occult blood test.
(B) Screening flexible sigmoidoscopy.
(C) Screening colonoscopy.
(D) Such other tests or procedures, and modifications
to tests and procedures under this subsection, with
such frequency and payment limits, as the Secretary
determines appropriate, in consultation with
appropriate organizations.
(2) An ``individual at high risk for colorectal cancer'' is
an individual who, because of family history, prior experience
of cancer or precursor neoplastic polyps, a history of chronic
digestive disease condition (including inflammatory bowel
disease, Crohn's Disease, or ulcerative colitis), the presence
of any appropriate recognized gene markers for colorectal
cancer, or other predisposing factors, faces a high risk for
colorectal cancer.
Diabetes Outpatient Self-Management Training Services
(qq)(1) The term ``diabetes outpatient self-management
training services'' means educational and training services
furnished (at such times as the Secretary determines
appropriate) to an individual with diabetes by a certified
provider (as described in paragraph (2)(A)) in an outpatient
setting by an individual or entity who meets the quality
standards described in paragraph (2)(B), but only if the
physician who is managing the individual's diabetic condition
certifies that such services are needed under a comprehensive
plan of care related to the individual's diabetic condition to
ensure therapy compliance or to provide the individual with
necessary skills and knowledge (including skills related to the
self-administration of injectable drugs) to participate in the
management of the individual's condition.
(2) In paragraph (1)--
(A) a ``certified provider'' is a physician, or other
individual or entity designated by the Secretary, that,
in addition to providing diabetes outpatient self-
management training services, provides other items or
services for which payment may be made under this
title; and
(B) a physician, or such other individual or entity,
meets the quality standards described in this paragraph
if the physician, or individual or entity, meets
quality standards established by the Secretary, except
that the physician or other individual or entity shall
be deemed to have met such standards if the physician
or other individual or entity meets applicable
standards originally established by the National
Diabetes Advisory Board and subsequently revised by
organizations who participated in the establishment of
standards by such Board, or is recognized by an
organization that represents individuals (including
individuals under this title) with diabetes as meeting
standards for furnishing the services.
Bone Mass Measurement
(rr)(1) The term ``bone mass measurement'' means a radiologic
or radioisotopic procedure or other procedure approved by the
Food and Drug Administration performed on a qualified
individual (as defined in paragraph (2)) for the purpose of
identifying bone mass or detecting bone loss or determining
bone quality, and includes a physician's interpretation of the
results of the procedure.
(2) For purposes of this subsection, the term ``qualified
individual'' means an individual who is (in accordance with
regulations prescribed by the Secretary)--
(A) an estrogen-deficient woman at clinical risk for
osteoporosis;
(B) an individual with vertebral abnormalities;
(C) an individual receiving long-term glucocorticoid
steroid therapy;
(D) an individual with primary hyperparathyroidism;
or
(E) an individual being monitored to assess the
response to or efficacy of an approved osteoporosis
drug therapy.
(3) The Secretary shall establish such standards regarding
the frequency with which a qualified individual shall be
eligible to be provided benefits for bone mass measurement
under this title.
Religious Nonmedical Health Care Institution
(ss)(1) The term ``religious nonmedical health care
institution'' means an institution that--
(A) is described in subsection (c)(3) of
section 501 of the Internal Revenue Code of
1986 and is exempt from taxes under subsection
(a) of such section;
(B) is lawfully operated under all applicable
Federal, State, and local laws and regulations;
(C) provides only nonmedical nursing items
and services exclusively to patients who choose
to rely solely upon a religious method of
healing and for whom the acceptance of medical
health services would be inconsistent with
their religious beliefs;
(D) provides such nonmedical items and
services exclusively through nonmedical nursing
personnel who are experienced in caring for the
physical needs of such patients;
(E) provides such nonmedical items and
services to inpatients on a 24-hour basis;
(F) on the basis of its religious beliefs,
does not provide through its personnel or
otherwise medical items and services (including
any medical screening, examination, diagnosis,
prognosis, treatment, or the administration of
drugs) for its patients;
(G)(i) is not owned by, under common
ownership with, or has an ownership interest
in, a provider of medical treatment or
services;
(ii) is not affiliated with--
(I) a provider of medical treatment
or services, or
(II) an individual who has an
ownership interest in a provider of
medical treatment or services;
(H) has in effect a utilization review plan
which--
(i) provides for the review of
admissions to the institution, of the
duration of stays therein, of cases of
continuous extended duration, and of
the items and services furnished by the
institution,
(ii) requires that such reviews be
made by an appropriate committee of the
institution that includes the
individuals responsible for overall
administration and for supervision of
nursing personnel at the institution,
(iii) provides that records be
maintained of the meetings, decisions,
and actions of such committee, and
(iv) meets such other requirements as
the Secretary finds necessary to
establish an effective utilization
review plan;
(I) provides the Secretary with such
information as the Secretary may require to
implement section 1821, including information
relating to quality of care and coverage
determinations; and
(J) meets such other requirements as the
Secretary finds necessary in the interest of
the health and safety of individuals who are
furnished services in the institution.
(2) To the extent that the Secretary finds that the
accreditation of an institution by a State, regional, or
national agency or association provides reasonable assurances
that any or all of the requirements of paragraph (1) are met or
exceeded, the Secretary may treat such institution as meeting
the condition or conditions with respect to which the Secretary
made such finding.
(3)(A)(i) In administering this subsection and section 1821,
the Secretary shall not require any patient of a religious
nonmedical health care institution to undergo medical
screening, examination, diagnosis, prognosis, or treatment or
to accept any other medical health care service, if such
patient (or legal representative of the patient) objects
thereto on religious grounds.
(ii) Clause (i) shall not be construed as preventing the
Secretary from requiring under section 1821(a)(2) the provision
of sufficient information regarding an individual's condition
as a condition for receipt of benefits under part A for
services provided in such an institution.
(B)(i) In administering this subsection and section 1821, the
Secretary shall not subject a religious nonmedical health care
institution or its personnel to any medical supervision,
regulation, or control, insofar as such supervision,
regulation, or control would be contrary to the religious
beliefs observed by the institution or such personnel.
(ii) Clause (i) shall not be construed as preventing the
Secretary from reviewing items and services billed by the
institution to the extent the Secretary determines such review
to be necessary to determine whether such items and services
were not covered under part A, are excessive, or are
fraudulent.
(4)(A) For purposes of paragraph (1)(G)(i), an ownership
interest of less than 5 percent shall not be taken into
account.
(B) For purposes of paragraph (1)(G)(ii), none of the
following shall be considered to create an affiliation:
(i) An individual serving as an uncompensated
director, trustee, officer, or other member of the
governing body of a religious nonmedical health care
institution.
(ii) An individual who is a director, trustee,
officer, employee, or staff member of a religious
nonmedical health care institution having a family
relationship with an individual who is affiliated with
(or has an ownership interest in) a provider of medical
treatment or services.
(iii) An individual or entity furnishing goods or
services as a vendor to both providers of medical
treatment or services and religious nonmedical health
care institutions.
Post-Institutional Home Health Services; Home Health Spell of Illness
(tt)(1) The term ``post-institutional home health services''
means home health services furnished to an individual--
(A) after discharge from a hospital or critical
access hospital in which the individual was an
inpatient for not less than 3 consecutive days before
such discharge if such home health services were
initiated within 14 days after the date of such
discharge; or
(B) after discharge from a skilled nursing facility
in which the individual was provided post-hospital
extended care services if such home health services
were initiated within 14 days after the date of such
discharge.
(2) The term ``home health spell of illness'' with respect to
any individual means a period of consecutive days--
(A) beginning with the first day (not included in a
previous home health spell of illness) (i) on which
such individual is furnished post-institutional home
health services, and (ii) which occurs in a month for
which the individual is entitled to benefits under part
A, and
(B) ending with the close of the first period of 60
consecutive days thereafter on each of which the
individual is neither an inpatient of a hospital or
critical access hospital nor an inpatient of a facility
described in section 1819(a)(1) or subsection (y)(1)
nor provided home health services.
Screening for Glaucoma
(uu) The term ``screening for glaucoma'' means a dilated eye
examination with an intraocular pressure measurement, and a
direct ophthalmoscopy or a slit-lamp biomicroscopic examination
for the early detection of glaucoma which is furnished by or
under the direct supervision of an optometrist or
ophthalmologist who is legally authorized to furnish such
services under State law (or the State regulatory mechanism
provided by State law) of the State in which the services are
furnished, as would otherwise be covered if furnished by a
physician or as an incident to a physician's professional
service, if the individual involved has not had such an
examination in the preceding year.
Medical Nutrition Therapy Services; Registered Dietitian or Nutrition
Professional
(vv)(1) The term ``medical nutrition therapy services'' means
nutritional diagnostic, therapy, and counseling services for
the purpose of disease management which are furnished by a
registered dietitian or nutrition professional (as defined in
paragraph (2)) pursuant to a referral by a physician (as
defined in subsection (r)(1)).
(2) Subject to paragraph (3), the term ``registered dietitian
or nutrition professional'' means an individual who--
(A) holds a baccalaureate or higher degree granted by
a regionally accredited college or university in the
United States (or an equivalent foreign degree) with
completion of the academic requirements of a program in
nutrition or dietetics, as accredited by an appropriate
national accreditation organization recognized by the
Secretary for this purpose;
(B) has completed at least 900 hours of supervised
dietetics practice under the supervision of a
registered dietitian or nutrition professional; and
(C)(i) is licensed or certified as a dietitian or
nutrition professional by the State in which the
services are performed; or
(ii) in the case of an individual in a State that
does not provide for such licensure or certification,
meets such other criteria as the Secretary establishes.
(3) Subparagraphs (A) and (B) of paragraph (2) shall not
apply in the case of an individual who, as of the date of the
enactment of this subsection, is licensed or certified as a
dietitian or nutrition professional by the State in which
medical nutrition therapy services are performed.
Initial Preventive Physical Examination
(ww)(1) The term ``initial preventive physical examination''
means physicians' services consisting of a physical examination
(including measurement of height, weight body mass index,, and
blood pressure) with the goal of health promotion and disease
detection and includes education, counseling, and referral with
respect to screening and other preventive services described in
paragraph (2) and end-of-life planning (as defined in paragraph
(3)) upon the agreement with the individual, but does not
include clinical laboratory tests.
(2) The screening and other preventive services described in
this paragraph include the following:
(A) Pneumococcal, influenza, and hepatitis B vaccine
and administration under subsection (s)(10).
(B) Screening mammography as defined in subsection
(jj).
(C) Screening pap smear and screening pelvic exam as
defined in subsection (nn).
(D) Prostate cancer screening tests as defined in
subsection (oo).
(E) Colorectal cancer screening tests as defined in
subsection (pp).
(F) Diabetes outpatient self-management training
services as defined in subsection (qq)(1).
(G) Bone mass measurement as defined in subsection
(rr).
(H) Screening for glaucoma as defined in subsection
(uu).
(I) Medical nutrition therapy services as defined in
subsection (vv).
(J) Cardiovascular screening blood tests as defined
in subsection (xx)(1).
(K) Diabetes screening tests as defined in subsection
(yy).
(L) Ultrasound screening for abdominal aortic
aneurysm as defined in section 1861(bbb).
(M) An electrocardiogram.
(N) Additional preventive services (as defined in
subsection (ddd)(1)).
(3) For purposes of paragraph (1), the term ``end-of-life
planning'' means verbal or written information regarding--
(A) an individual's ability to prepare an advance
directive in the case that an injury or illness causes
the individual to be unable to make health care
decisions; and
(B) whether or not the physician is willing to follow
the individual's wishes as expressed in an advance
directive.
Cardiovascular Screening Blood Test
(xx)(1) The term ``cardiovascular screening blood test''
means a blood test for the early detection of cardiovascular
disease (or abnormalities associated with an elevated risk of
cardiovascular disease) that tests for the following:
(A) Cholesterol levels and other lipid or
triglyceride levels.
(B) Such other indications associated with the
presence of, or an elevated risk for, cardiovascular
disease as the Secretary may approve for all
individuals (or for some individuals determined by the
Secretary to be at risk for cardiovascular disease),
including indications measured by noninvasive testing.
The Secretary may not approve an indication under subparagraph
(B) for any individual unless a blood test for such is
recommended by the United States Preventive Services Task
Force.
(2) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency for
each type of cardiovascular screening blood tests, except that
such frequency may not be more often than once every 2 years.
Diabetes Screening Tests
(yy)(1) The term ``diabetes screening tests'' means testing
furnished to an individual at risk for diabetes (as defined in
paragraph (2)) for the purpose of early detection of diabetes,
including--
(A) a fasting plasma glucose test; and
(B) such other tests, and modifications to tests, as
the Secretary determines appropriate, in consultation
with appropriate organizations.
(2) For purposes of paragraph (1), the term ``individual at
risk for diabetes'' means an individual who has any of the
following risk factors for diabetes:
(A) Hypertension.
(B) Dyslipidemia.
(C) Obesity, defined as a body mass index greater
than or equal to 30 kg/m2.
(D) Previous identification of an elevated impaired
fasting glucose.
(E) Previous identification of impaired glucose
tolerance.
(F) A risk factor consisting of at least 2 of the
following characteristics:
(i) Overweight, defined as a body mass index
greater than 25, but less than 30, kg/
m2.
(ii) A family history of diabetes.
(iii) A history of gestational diabetes
mellitus or delivery of a baby weighing greater
than 9 pounds.
(iv) 65 years of age or older.
(3) The Secretary shall establish standards, in consultation
with appropriate organizations, regarding the frequency of
diabetes screening tests, except that such frequency may not be
more often than twice within the 12-month period following the
date of the most recent diabetes screening test of that
individual.
Intravenous Immune Globulin
(zz) The term ``intravenous immune globulin'' means an
approved pooled plasma derivative for the treatment in the
patient's home of a patient with a diagnosed primary immune
deficiency disease, but not including items or services related
to the administration of the derivative, if a physician
determines administration of the derivative in the patient's
home is medically appropriate.
Extended Care in Religious Nonmedical Health Care Institutions
(aaa)(1) The term ``home health agency'' also includes a
religious nonmedical health care institution (as defined in
subsection (ss)(1)), but only with respect to items and
services ordinarily furnished by such an institution to
individuals in their homes, and that are comparable to items
and services furnished to individuals by a home health agency
that is not religious nonmedical health care institution.
(2)(A) Subject to subparagraphs (B), payment may be made with
respect to services provided by such an institution only to
such extent and under such conditions, limitations, and
requirements (in addition to or in lieu of the conditions,
limitations, and requirements otherwise applicable) as may be
provided in regulations consistent with section 1821.
(B) Notwithstanding any other provision of this title,
payment may not be made under subparagraph (A)--
(i) in a year insofar as such payments exceed
$700,000; and
(ii) after December 31, 2006.
Ultrasound Screening for Abdominal Aortic Aneurysm
(bbb) The term ``ultrasound screening for abdominal aortic
aneurysm'' means--
(1) a procedure using sound waves (or such other
procedures using alternative technologies, of
commensurate accuracy and cost, that the Secretary may
specify) provided for the early detection of abdominal
aortic aneurysm; and
(2) includes a physician's interpretation of the
results of the procedure.
Long-Term Care Hospital
(ccc) The term ``long-term care hospital'' means a hospital
which--
(1) is primarily engaged in providing inpatient
services, by or under the supervision of a physician,
to Medicare beneficiaries whose medically complex
conditions require a long hospital stay and programs of
care provided by a long-term care hospital;
(2) has an average inpatient length of stay (as
determined by the Secretary) of greater than 25 days,
or meets the requirements of clause (II) of section
1886(d)(1)(B)(iv);
(3) satisfies the requirements of subsection (e); and
(4) meets the following facility criteria:
(A) the institution has a patient review
process, documented in the patient medical
record, that screens patients prior to
admission for appropriateness of admission to a
long-term care hospital, validates within 48
hours of admission that patients meet admission
criteria for long-term care hospitals,
regularly evaluates patients throughout their
stay for continuation of care in a long-term
care hospital, and assesses the available
discharge options when patients no longer meet
such continued stay criteria;
(B) the institution has active physician
involvement with patients during their
treatment through an organized medical staff,
physician-directed treatment with physician on-
site availability on a daily basis to review
patient progress, and consulting physicians on
call and capable of being at the patient's side
within a moderate period of time, as determined
by the Secretary; and
(C) the institution has interdisciplinary
team treatment for patients, requiring
interdisciplinary teams of health care
professionals, including physicians, to prepare
and carry out an individualized treatment plan
for each patient.
Additional Preventive Services; Preventive Services
(ddd)(1) The term ``additional preventive services'' means
services not described in subparagraph (A) or (C) of paragraph
(3) that identify medical conditions or risk factors and that
the Secretary determines are--
(A) reasonable and necessary for the prevention or
early detection of an illness or disability;
(B) recommended with a grade of A or B by the United
States Preventive Services Task Force; and
(C) appropriate for individuals entitled to benefits
under part A or enrolled under part B.
(2) In making determinations under paragraph (1) regarding
the coverage of a new service, the Secretary shall use the
process for making national coverage determinations (as defined
in section 1869(f)(1)(B)) under this title. As part of the use
of such process, the Secretary may conduct an assessment of the
relation between predicted outcomes and the expenditures for
such service and may take into account the results of such
assessment in making such determination.
(3) The term ``preventive services'' means the following:
(A) The screening and preventive services described
in subsection (ww)(2) (other than the service described
in subparagraph (M) of such subsection).
(B) An initial preventive physical examination (as
defined in subsection (ww)).
(C) Personalized prevention plan services (as defined
in subsection (hhh)(1)).
Cardiac Rehabilitation Program; Intensive Cardiac Rehabilitation
Program
(eee)(1) The term ``cardiac rehabilitation program'' means a
program (as described in paragraph (2)) that furnishes the
items and services described in paragraph (3) under the
supervision of a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical nurse
specialist (as those terms are defined in subsection (aa)(5)).
(2) A program described in this paragraph is a program under
which--
(A) items and services under the program are
delivered--
(i) in a physician's office;
(ii) in a hospital on an outpatient basis; or
(iii) in other settings determined
appropriate by the Secretary;
(B) a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical
nurse specialist (as those terms are defined in
subsection (aa)(5)) is immediately available and
accessible for medical consultation and medical
emergencies at all times items and services are being
furnished under the program, except that, in the case
of items and services furnished under such a program in
a hospital, such availability shall be presumed; and
(C) individualized treatment is furnished under a
written plan established, reviewed, and signed by a
physician every 30 days that describes--
(i) the individual's diagnosis;
(ii) the type, amount, frequency, and
duration of the items and services furnished
under the plan; and
(iii) the goals set for the individual under
the plan.
(3) The items and services described in this paragraph are--
(A) physician-prescribed exercise;
(B) cardiac risk factor modification, including
education, counseling, and behavioral intervention (to
the extent such education, counseling, and behavioral
intervention is closely related to the individual's
care and treatment and is tailored to the individual's
needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary
may determine, but only if such items and services
are--
(i) reasonable and necessary for the
diagnosis or active treatment of the
individual's condition;
(ii) reasonably expected to improve or
maintain the individual's condition and
functional level; and
(iii) furnished under such guidelines
relating to the frequency and duration of such
items and services as the Secretary shall
establish, taking into account accepted norms
of medical practice and the reasonable
expectation of improvement of the individual.
(4)(A) The term ``intensive cardiac rehabilitation program''
means a program (as described in paragraph (2)) that furnishes
the items and services described in paragraph (3) under the
supervision of a physician (as defined in subsection (r)(1)) or
a physician assistant, nurse practitioner, or clinical nurse
specialist (as those terms are defined in subsection (aa)(5))
and has shown, in peer-reviewed published research, that it
accomplished--
(i) one or more of the following:
(I) positively affected the progression of
coronary heart disease; or
(II) reduced the need for coronary bypass
surgery; or
(III) reduced the need for percutaneous
coronary interventions; and
(ii) a statistically significant reduction in 5 or
more of the following measures from their level before
receipt of cardiac rehabilitation services to their
level after receipt of such services:
(I) low density lipoprotein;
(II) triglycerides;
(III) body mass index;
(IV) systolic blood pressure;
(V) diastolic blood pressure; or
(VI) the need for cholesterol, blood
pressure, and diabetes medications.
(B) To be eligible for an intensive cardiac rehabilitation
program, an individual must have--
(i) had an acute myocardial infarction within the
preceding 12 months;
(ii) had coronary bypass surgery;
(iii) stable angina pectoris;
(iv) had heart valve repair or replacement;
(v) had percutaneous transluminal coronary
angioplasty (PTCA) or coronary stenting;
(vi) had a heart or heart-lung transplant;
(vii) stable, chronic heart failure (defined
as patients with left ventricular ejection
fraction of 35 percent or less and New York
Heart Association (NYHA) class II to IV
symptoms despite being on optimal heart failure
therapy for at least 6 weeks); or
(viii) any additional condition for which the
Secretary has determined that a cardiac
rehabilitation program shall be covered, unless
the Secretary determines, using the same
process used to determine that the condition is
covered for a cardiac rehabilitation program,
that such coverage is not supported by the
clinical evidence.
(C) An intensive cardiac rehabilitation program may be
provided in a series of 72 one-hour sessions (as defined in
section 1848(b)(5)), up to 6 sessions per day, over a period of
up to 18 weeks.
(5) The Secretary shall establish standards to ensure that a
physician with expertise in the management of individuals with
cardiac pathophysiology who is licensed to practice medicine in
the State in which a cardiac rehabilitation program (or the
intensive cardiac rehabilitation program, as the case may be)
is offered--
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is
involved substantially in directing the progress of
individual in the program.
Pulmonary Rehabilitation Program
(fff)(1) The term ``pulmonary rehabilitation program'' means
a program (as described in subsection (eee)(2) with respect to
a program under this subsection) that furnishes the items and
services described in paragraph (2) under the supervision of a
physician (as defined in subsection (r)(1)) or a physician
assistant, nurse practitioner, or clinical nurse specialist (as
those terms are defined in subsection (aa)(5)).
(2) The items and services described in this paragraph are--
(A) physician-prescribed exercise;
(B) education or training (to the extent the
education or training is closely and clearly related to
the individual's care and treatment and is tailored to
such individual's needs);
(C) psychosocial assessment;
(D) outcomes assessment; and
(E) such other items and services as the Secretary
may determine, but only if such items and services
are--
(i) reasonable and necessary for the
diagnosis or active treatment of the
individual's condition;
(ii) reasonably expected to improve or
maintain the individual's condition and
functional level; and
(iii) furnished under such guidelines
relating to the frequency and duration of such
items and services as the Secretary shall
establish, taking into account accepted norms
of medical practice and the reasonable
expectation of improvement of the individual.
(3) The Secretary shall establish standards to ensure that a
physician with expertise in the management of individuals with
respiratory pathophysiology who is licensed to practice
medicine in the State in which a pulmonary rehabilitation
program is offered--
(A) is responsible for such program; and
(B) in consultation with appropriate staff, is
involved substantially in directing the progress of
individual in the program.
Kidney Disease Education Services
(ggg)(1) The term ``kidney disease education services'' means
educational services that are--
(A) furnished to an individual with stage IV chronic
kidney disease who, according to accepted clinical
guidelines identified by the Secretary, will require
dialysis or a kidney transplant;
(B) furnished, upon the referral of the physician
managing the individual's kidney condition, by a
qualified person (as defined in paragraph (2)); and
(C) designed--
(i) to provide comprehensive information
(consistent with the standards set under
paragraph (3)) regarding--
(I) the management of comorbidities,
including for purposes of delaying the
need for dialysis;
(II) the prevention of uremic
complications; and
(III) each option for renal
replacement therapy (including
hemodialysis and peritoneal dialysis at
home and in-center as well as vascular
access options and transplantation);
(ii) to ensure that the individual has the
opportunity to actively participate in the
choice of therapy; and
(iii) to be tailored to meet the needs of the
individual involved.
(2)(A) The term ``qualified person'' means--
(i) a physician (as defined in section 1861(r)(1)) or
a physician assistant, nurse practitioner, or clinical
nurse specialist (as defined in section 1861(aa)(5)),
who furnishes services for which payment may be made
under the fee schedule established under section 1848;
and
(ii) a provider of services located in a rural area
(as defined in section 1886(d)(2)(D)).
(B) Such term does not include a provider of services (other
than a provider of services described in subparagraph (A)(ii))
or a renal dialysis facility.
(3) The Secretary shall set standards for the content of such
information to be provided under paragraph (1)(C)(i) after
consulting with physicians, other health professionals, health
educators, professional organizations, accrediting
organizations, kidney patient organizations, dialysis
facilities, transplant centers, network organizations described
in section 1881(c)(2), and other knowledgeable persons. To the
extent possible the Secretary shall consult with persons or
entities described in the previous sentence, other than a
dialysis facility, that has not received industry funding from
a drug or biological manufacturer or dialysis facility.
(4) No individual shall be furnished more than 6 sessions of
kidney disease education services under this title.
Annual Wellness Visit
(hhh)(1) The term ``personalized prevention plan services''
means the creation of a plan for an individual--
(A) that includes a health risk assessment (that
meets the guidelines established by the Secretary under
paragraph (4)(A)) of the individual that is completed
prior to or as part of the same visit with a health
professional described in paragraph (3); and
(B) that--
(i) takes into account the results of the
health risk assessment; and
(ii) may contain the elements described in
paragraph (2).
(2) Subject to paragraph (4)(H), the elements described in
this paragraph are the following:
(A) The establishment of, or an update to, the
individual's medical and family history.
(B) A list of current providers and suppliers that
are regularly involved in providing medical care to the
individual (including a list of all prescribed
medications).
(C) A measurement of height, weight, body mass index
(or waist circumference, if appropriate), blood
pressure, and other routine measurements.
(D) Detection of any cognitive impairment.
(E) The establishment of, or an update to, the
following:
(i) A screening schedule for the next 5 to 10
years, as appropriate, based on recommendations
of the United States Preventive Services Task
Force and the Advisory Committee on
Immunization Practices, and the individual's
health status, screening history, and age-
appropriate preventive services covered under
this title.
(ii) A list of risk factors and conditions
for which primary, secondary, or tertiary
prevention interventions are recommended or are
underway, including any mental health
conditions or any such risk factors or
conditions that have been identified through an
initial preventive physical examination (as
described under subsection (ww)(1)), and a list
of treatment options and their associated risks
and benefits.
(F) The furnishing of personalized health advice and
a referral, as appropriate, to health education or
preventive counseling services or programs aimed at
reducing identified risk factors and improving self-
management, or community-based lifestyle interventions
to reduce health risks and promote self-management and
wellness, including weight loss, physical activity,
smoking cessation, fall prevention, and nutrition.
(G) Any other element determined appropriate by the
Secretary.
(3) A health professional described in this paragraph is--
(A) a physician;
(B) a practitioner described in clause (i) of section
1842(b)(18)(C); or
(C) a medical professional (including a health
educator, registered dietitian, or nutrition
professional) or a team of medical professionals, as
determined appropriate by the Secretary, under the
supervision of a physician.
(4)(A) For purposes of paragraph (1)(A), the Secretary, not
later than 1 year after the date of enactment of this
subsection, shall establish publicly available guidelines for
health risk assessments. Such guidelines shall be developed in
consultation with relevant groups and entities and shall
provide that a health risk assessment--
(i) identify chronic diseases, injury risks,
modifiable risk factors, and urgent health needs of the
individual; and
(ii) may be furnished--
(I) through an interactive telephonic or web-
based program that meets the standards
established under subparagraph (B);
(II) during an encounter with a health care
professional;
(III) through community-based prevention
programs; or
(IV) through any other means the Secretary
determines appropriate to maximize
accessibility and ease of use by beneficiaries,
while ensuring the privacy of such
beneficiaries.
(B) Not later than 1 year after the date of enactment of this
subsection, the Secretary shall establish standards for
interactive telephonic or web-based programs used to furnish
health risk assessments under subparagraph (A)(ii)(I). The
Secretary may utilize any health risk assessment developed
under section 4004(f) of the Patient Protection and Affordable
Care Act as part of the requirement to develop a personalized
prevention plan to comply with this subparagraph.
(C)(i) Not later than 18 months after the date of enactment
of this subsection, the Secretary shall develop and make
available to the public a health risk assessment model. Such
model shall meet the guidelines under subparagraph (A) and may
be used to meet the requirement under paragraph (1)(A).
(ii) Any health risk assessment that meets the guidelines
under subparagraph (A) and is approved by the Secretary may be
used to meet the requirement under paragraph (1)(A).
(D) The Secretary may coordinate with community-based
entities (including State Health Insurance Programs, Area
Agencies on Aging, Aging and Disability Resource Centers, and
the Administration on Aging) to--
(i) ensure that health risk assessments are
accessible to beneficiaries; and
(ii) provide appropriate support for the completion
of health risk assessments by beneficiaries.
(E) The Secretary shall establish procedures to make
beneficiaries and providers aware of the requirement that a
beneficiary complete a health risk assessment prior to or at
the same time as receiving personalized prevention plan
services.
(F) To the extent practicable, the Secretary shall encourage
the use of, integration with, and coordination of health
information technology (including use of technology that is
compatible with electronic medical records and personal health
records) and may experiment with the use of personalized
technology to aid in the development of self-management skills
and management of and adherence to provider recommendations in
order to improve the health status of beneficiaries.
(G) A beneficiary shall be eligible to receive only an
initial preventive physical examination (as defined under
subsection (ww)(1)) during the 12-month period after the date
that the beneficiary's coverage begins under part B and shall
be eligible to receive personalized prevention plan services
under this subsection each year thereafter provided that the
beneficiary has not received either an initial preventive
physical examination or personalized prevention plan services
within the preceding 12-month period.
(H) The Secretary shall issue guidance that--
(i) identifies elements under paragraph (2) that are
required to be provided to a beneficiary as part of
their first visit for personalized prevention plan
services; and
(ii) establishes a yearly schedule for appropriate
provision of such elements thereafter.
(iii) Home Infusion Therapy.--(1) The term ``home infusion
therapy'' means the items and services described in paragraph
(2) furnished by a qualified home infusion therapy supplier (as
defined in paragraph (3)(D)) which are furnished in the
individual's home (as defined in paragraph (3)(B)) to an
individual--
(A) who is under the care of an applicable provider
(as defined in paragraph (3)(A)); and
(B) with respect to whom a plan prescribing the type,
amount, and duration of infusion therapy services that
are to be furnished such individual has been
established by a physician (as defined in subsection
(r)(1)) and is periodically reviewed by a physician (as
so defined) in coordination with the furnishing of home
infusion drugs (as defined in paragraph (3)(C)) under
part B.
(2) The items and services described in this paragraph are
the following:
(A) Professional services, including nursing
services, furnished in accordance with the plan.
(B) Training and education (not otherwise paid for as
durable medical equipment (as defined in subsection
(n)), remote monitoring, and monitoring services for
the provision of home infusion therapy and home
infusion drugs furnished by a qualified home infusion
therapy supplier.
(3) For purposes of this subsection:
(A) The term ``applicable provider'' means--
(i) a physician;
(ii) a nurse practitioner; and
(iii) a physician assistant.
(B) The term ``home'' means a place of residence used
as the home of an individual (as defined for purposes
of subsection (n)).
(C) The term ``home infusion drug'' means a
parenteral drug or biological administered
intravenously, or subcutaneously for an administration
period of 15 minutes or more, in the home of an
individual through a pump that is an item of durable
medical equipment (as defined in subsection (n)). Such
term does not include the following:
(i) Insulin pump systems.
(ii) A self-administered drug or biological
on a self-administered drug exclusion list.
(D)(i) The term ``qualified home infusion therapy
supplier'' means a pharmacy, physician, or other
provider of services or supplier licensed by the State
in which the pharmacy, physician, or provider or
services or supplier furnishes items or services and
that--
(I) furnishes infusion therapy to individuals
with acute or chronic conditions requiring
administration of home infusion drugs;
(II) ensures the safe and effective provision
and administration of home infusion therapy on
a 7-day-a-week, 24-hour-a-day basis;
(III) is accredited by an organization
designated by the Secretary pursuant to section
1834(u)(5); and
(IV) meets such other requirements as the
Secretary determines appropriate, taking into
account the standards of care for home infusion
therapy established by Medicare Advantage plans
under part C and in the private sector.
(ii) A qualified home infusion therapy supplier may
subcontract with a pharmacy, physician, provider of
services, or supplier to meet the requirements of this
subparagraph.
(jjj) Opioid Use Disorder Treatment Services; Opioid
Treatment Program.--
(1) Opioid use disorder treatment services.--The term
``opioid use disorder treatment services'' means items
and services that are furnished by an opioid treatment
program for the treatment of opioid use disorder,
including--
(A) opioid agonist and antagonist treatment
medications (including oral, injected, or
implanted versions) that are approved by the
Food and Drug Administration under section 505
of the Federal Food, Drug and Cosmetic Act for
use in the treatment of opioid use disorder;
(B) dispensing and administration of such
medications, if applicable;
(C) substance use counseling by a
professional to the extent authorized under
State law to furnish such services;
(D) individual and group therapy with a
physician or psychologist (or other mental
health professional to the extent authorized
under State law);
(E) toxicology testing, and
(F) other items and services that the
Secretary determines are appropriate (other
than meals or transportation).
(2) Opioid treatment program.--The term ``opioid
treatment program'' means an entity that is opioid
treatment program (as defined in section 8.2 of title
42 of the Code of Federal Regulations, or any successor
regulation) that--
(A) is enrolled under section 1866(j);
(B) has in effect a certification by the
Substance Abuse and Mental Health Services
Administration for such a program;
(C) is accredited by an accrediting body
approved by the Substance Abuse and Mental
Health Services Administration; and
(D) meets such additional conditions as the
Secretary may find necessary to ensure--
(i) the health and safety of
individuals being furnished services
under such program; and
(ii) the effective and efficient
furnishing of such services.
* * * * * * *
agreements with providers of services; enrollment processes
Sec. 1866. (a)(1) Any provider of services (except a fund
designated for purposes of section 1814(g) and section 1835(e))
shall be qualified to participate under this title and shall be
eligible for payments under this title if it files with the
Secretary an agreement--
(A)(i) not to charge, except as provided in paragraph
(2), any individual or any other person for items or
services for which such individual is entitled to have
payment made under this title (or for which he would be
so entitled if such provider of services had complied
with the procedural and other requirements under or
pursuant to this title or for which such provider is
paid pursuant to the provisions of section 1814(e)),
and (ii) not to impose any charge that is prohibited
under section 1902(n)(3),
(B) not to charge any individual or any other person
for items or services for which such individual is not
entitled to have payment made under this title because
payment for expenses incurred for such items or
services may not be made by reason of the provisions of
paragraph (1) or (9) of section 1862(a), but only if
(i) such individual was without fault in incurring such
expenses and (ii) the Secretary's determination that
such payment may not be made for such items and
services was made after the third year following the
year in which notice of such payment was sent to such
individual; except that the Secretary may reduce such
three-year period to not less than one year if he finds
such reduction is consistent with the objectives of
this title,
(C) to make adequate provision for return (or other
disposition, in accordance with regulations) of any
moneys incorrectly collected from such individual or
other person,
(D) to promptly notify the Secretary of its
employment of an individual who, at any time during the
year preceding such employment, was employed in a
managerial, accounting, auditing, or similar capacity
(as determined by the Secretary by regulation) by an
agency or organization which serves as a fiscal
intermediary or carrier (for purposes of part A or part
B, or both, of this title) with respect to the
provider,
(E) to release data with respect to patients of such
provider upon request to an organization having a
contract with the Secretary under part B of title XI as
may be necessary (i) to allow such organization to
carry out its functions under such contract, or (ii) to
allow such organization to carry out similar review
functions under any contract the organization may have
with a private or public agency paying for health care
in the same area with respect to patients who authorize
release of such data for such purposes,
(F)(i) in the case of hospitals which provide
inpatient hospital services for which payment may be
made under subsection (b), (c), or (d) of section 1886,
to maintain an agreement with a professional standards
review organization (if there is such an organization
in existence in the area in which the hospital is
located) or with a quality improvement organization
which has a contract with the Secretary under part B of
title XI for the area in which the hospital is located,
under which the organization will perform functions
under that part with respect to the review of the
validity of diagnostic information provided by such
hospital, the completeness, adequacy, and quality of
care provided, the appropriateness of admissions and
discharges, and the appropriateness of care provided
for which additional payments are sought under section
1886(d)(5), with respect to inpatient hospital services
for which payment may be made under part A of this
title (and for purposes of payment under this title,
the cost of such agreement to the hospital shall be
considered a cost incurred by such hospital in
providing inpatient services under part A, and (I)
shall be paid directly by the Secretary to such
organization on behalf of such hospital in accordance
with a rate per review established by the Secretary,
(II) shall be transferred from the Federal Hospital
Insurance Trust Fund, without regard to amounts
appropriated in advance in appropriation Acts, in the
same manner as transfers are made for payment for
services provided directly to beneficiaries, and (III)
shall not be less in the aggregate for a fiscal year
than the aggregate amount expended in fiscal year 1988
for direct and administrative costs (adjusted for
inflation and for any direct or administrative costs
incurred as a result of review functions added with
respect to a subsequent fiscal year) of such reviews),
(ii) in the case of hospitals, critical access
hospitals, skilled nursing facilities, and home health
agencies, to maintain an agreement with a quality
improvement organization (which has a contract with the
Secretary under part B of title XI for the area in
which the hospital, facility, or agency is located) to
perform the functions described in paragraph (3)(A),
(G) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
subsection (b) or (d) of section 1886, not to charge
any individual or any other person for inpatient
hospital services for which such individual would be
entitled to have payment made under part A but for a
denial or reduction of payments under section
1886(f)(2),
(H)(i) in the case of hospitals which provide
services for which payment may be made under this title
and in the case of critical access hospitals which
provide critical access hospital services, to have all
items and services (other than physicians' services as
defined in regulations for purposes of section
1862(a)(14), and other than services described by
section 1861(s)(2)(K), certified nurse-midwife
services, qualified psychologist services, and services
of a certified registered nurse anesthetist) (I) that
are furnished to an individual who is a patient of the
hospital, and (II) for which the individual is entitled
to have payment made under this title, furnished by the
hospital or otherwise under arrangements (as defined in
section 1861(w)(1)) made by the hospital,
(ii) in the case of skilled nursing facilities which
provide covered skilled nursing facility services--
(I) that are furnished to an individual who
is a resident of the skilled nursing facility
during a period in which the resident is
provided covered post-hospital extended care
services (or, for services described in section
1861(s)(2)(D), that are furnished to such an
individual without regard to such period), and
(II) for which the individual is entitled to
have payment made under this title,
to have items and services (other than services
described in section 1888(e)(2)(A)(ii)) furnished by
the skilled nursing facility or otherwise under
arrangements (as defined in section 1861(w)(1)) made by
the skilled nursing facility,
(I) in the case of a hospital or critical access
hospital--
(i) to adopt and enforce a policy to ensure
compliance with the requirements of section
1867 and to meet the requirements of such
section,
(ii) to maintain medical and other records
related to individuals transferred to or from
the hospital for a period of five years from
the date of the transfer, and
(iii) to maintain a list of physicians who
are on call for duty after the initial
examination to provide treatment necessary to
stabilize an individual with an emergency
medical condition,
(J) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care under any health plan contracted for under section
1079 or 1086 of title 10, or under section 613 of title
38, United States Code, in accordance with admission
practices, payment methodology, and amounts as
prescribed under joint regulations issued by the
Secretary and by the Secretaries of Defense and
Transportation, in implementation of sections 1079 and
1086 of title 10, United States Code,
(K) not to charge any individual or any other person
for items or services for which payment under this
title is denied under section 1154(a)(2) by reason of a
determination under section 1154(a)(1)(B),
(L) in the case of hospitals which provide inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care under section 603 of title 38, United States Code,
in accordance with such admission practices, and such
payment methodology and amounts, as are prescribed
under joint regulations issued by the Secretary and by
the Secretary of Veterans Affairs in implementation of
such section,
(M) in the case of hospitals, to provide to each
individual who is entitled to benefits under part A (or
to a person acting on the individual's behalf), at or
about the time of the individual's admission as an
inpatient to the hospital, a written statement
(containing such language as the Secretary prescribes
consistent with this paragraph) which explains--
(i) the individual's rights to benefits for
inpatient hospital services and for post-
hospital services under this title,
(ii) the circumstances under which such an
individual will and will not be liable for
charges for continued stay in the hospital,
(iii) the individual's right to appeal
denials of benefits for continued inpatient
hospital services, including the practical
steps to initiate such an appeal, and
(iv) the individual's liability for payment
for services if such a denial of benefits is
upheld on appeal,--and which provides such
additional information as the Secretary may
specify,
(N) in the case of hospitals and critical access
hospitals--
(i) to make available to its patients the
directory or directories of participating
physicians (published under section 1842(h)(4))
for the area served by the hospital or critical
access hospital,
(ii) if hospital personnel (including staff
of any emergency or outpatient department)
refer a patient to a nonparticipating physician
for further medical care on an outpatient
basis, the personnel must inform the patient
that the physician is a nonparticipating
physician and, whenever practicable, must
identify at least one qualified participating
physician who is listed in such a directory and
from whom the patient may receive the necessary
services,
(iii) to post conspicuously in any emergency
department a sign (in a form specified by the
Secretary) specifying rights of individuals
under section 1867 with respect to examination
and treatment for emergency medical conditions
and women in labor, and
(iv) to post conspicuously (in a form
specified by the Secretary) information
indicating whether or not the hospital
participates in the medicaid program under a
State plan approved under title XIX,
(O) to accept as payment in full for services that
are covered under this title and are furnished to any
individual enrolled with a Medicare+Choice organization
under part C, with a PACE provider under section 1894
or 1934, or with an eligible organization with a risk-
sharing contract under section 1876, under section
1876(i)(2)(A) (as in effect before February 1, 1985),
under section 402(a) of the Social Security Amendments
of 1967, or under section 222(a) of the Social Security
Amendments of 1972, which does not have a contract (or,
in the case of a PACE provider, contract or other
agreement) establishing payment amounts for services
furnished to members of the organization or PACE
program eligible individuals enrolled with the PACE
provider, the amounts that would be made as a payment
in full under this title (less any payments under
sections 1886(d)(11) and 1886(h)(3)(D)) if the
individuals were not so enrolled,
(P) in the case of home health agencies which provide
home health services to individuals entitled to
benefits under this title who require catheters,
catheter supplies, ostomy bags, and supplies related to
ostomy car (described in section 1861(m)(5)), to offer
to furnish such supplies to such an individual as part
of their furnishing of home health services,
(Q) in the case of hospitals, skilled nursing
facilities, home health agencies, and hospice programs,
to comply with the requirement of subsection (f)
(relating to maintaining written policies and
procedures respecting advance directives),
(R) to contract only with a health care clearinghouse
(as defined in section 1171) that meets each standard
and implementation specification adopted or established
under part C of title XI on or after the date on which
the health care clearinghouse is required to comply
with the standard or specification,
(S) in the case of a hospital that has a financial
interest (as specified by the Secretary in regulations)
in an entity to which individuals are referred as
described in section 1861(ee)(2)(H)(ii), or in which
such an entity has such a financial interest, or in
which another entity has such a financial interest
(directly or indirectly) with such hospital and such an
entity, to maintain and disclose to the Secretary (in a
form and manner specified by the Secretary) information
on--
(i) the nature of such financial interest,
(ii) the number of individuals who were
discharged from the hospital and who were
identified as requiring home health services,
and
(iii) the percentage of such individuals who
received such services from such provider (or
another such provider),
(T) in the case of hospitals and critical access
hospitals, to furnish to the Secretary such data as the
Secretary determines appropriate pursuant to
subparagraph (E) of section 1886(d)(12) to carry out
such section,
(U) in the case of hospitals which furnish inpatient
hospital services for which payment may be made under
this title, to be a participating provider of medical
care both--
(i) under the contract health services
program funded by the Indian Health Service and
operated by the Indian Health Service, an
Indian tribe, or tribal organization (as those
terms are defined in section 4 of the Indian
Health Care Improvement Act), with respect to
items and services that are covered under such
program and furnished to an individual eligible
for such items and services under such program;
and
(ii) under any program funded by the Indian
Health Service and operated by an urban Indian
organization with respect to the purchase of
items and services for an eligible urban Indian
(as those terms are defined in such section 4),
in accordance with regulations promulgated by the
Secretary regarding admission practices, payment
methodology, and rates of payment (including the
acceptance of no more than such payment rate as payment
in full for such items and services,
(V) in the case of hospitals that are not otherwise
subject to the Occupational Safety and Health Act of
1970 (or a State occupational safety and health plan
that is approved under 18(b) of such Act), to comply
with the Bloodborne Pathogens standard under section
1910.1030 of title 29 of the Code of Federal
Regulations (or as subsequently redesignated),
(W) in the case of a hospital described in
section 1886(d)(1)(B)(v), to report quality
data to the Secretary in accordance with
subsection (k),
(X) maintain and, upon request of the
Secretary, provide access to documentation
relating to written orders or requests for
payment for durable medical equipment,
certifications for home health services, or
referrals for other items or services written
or ordered by the provider under this title, as
specified by the Secretary, and
(Y) beginning 12 months after the date of the
enactment of this subparagraph, in the case of a
hospital or critical access hospital, with respect to
each individual who receives observation services as an
outpatient at such hospital or critical access hospital
for more than 24 hours, to provide to such individual
not later than 36 hours after the time such individual
begins receiving such services (or, if sooner, upon
release)--
(i) such oral explanation of the written
notification described in clause (ii), and such
documentation of the provision of such
explanation, as the Secretary determines to be
appropriate;
(ii) a written notification (as specified by
the Secretary pursuant to rulemaking and
containing such language as the Secretary
prescribes consistent with this paragraph)
which--
(I) explains the status of the
individual as an outpatient receiving
observation services and not as an
inpatient of the hospital or critical
access hospital and the reasons for
such status of such individual;
(II) explains the implications of
such status on services furnished by
the hospital or critical access
hospital (including services furnished
on an inpatient basis), such as
implications for cost-sharing
requirements under this title and for
subsequent eligibility for coverage
under this title for services furnished
by a skilled nursing facility;
(III) includes such additional
information as the Secretary determines
appropriate;
(IV) either--
(aa) is signed by such
individual or a person acting
on such individual's behalf to
acknowledge receipt of such
notification; or
(bb) if such individual or
person refuses to provide the
signature described in item
(aa), is signed by the staff
member of the hospital or
critical access hospital who
presented the written
notification and includes the
name and title of such staff
member, a certification that
the notification was presented,
and the date and time the
notification was presented; and
(V) is written and formatted using
plain language and is made available in
appropriate languages as determined by
the Secretary.
In the case of a hospital which has an agreement in effect with
an organization described in subparagraph (F), which
organization's contract with the Secretary under part B of
title XI is terminated on or after October 1, 1984, the
hospital shall not be determined to be out of compliance with
the requirement of such subparagraph during the six month
period beginning on the date of the termination of that
contract.
(2)(A) A provider of services may charge such individual or
other person (i) the amount of any deduction or coinsurance
amount imposed pursuant to section 1813(a)(1), (a)(3), or
(a)(4), section 1833(b), or section 1861(y)(3) with respect to
such items and services (not in excess of the amount
customarily charged for such items and services by such
provider), and (ii) an amount equal to 20 per centum of the
reasonable charges for such items and services (not in excess
of 20 per centum of the amount customarily charged for such
items and services by such provider) for which payment is made
under part B or which are durable medical equipment furnished
as home health services (but in the case of items and services
furnished to individuals with end-stage renal disease, an
amount equal to 20 percent of the estimated amounts for such
items and services calculated on the basis established by the
Secretary). In the case of items and services described in
section 1833(c), clause (ii) of the preceding sentence shall be
applied by substituting for 20 percent the proportion which is
appropriate under such section. A provider of services may not
impose a charge under clause (ii) of the first sentence of this
subparagraph with respect to items and services described in
section 1861(s)(10)(A) and with respect to clinical diagnostic
laboratory tests for which payment is made under part B.
Notwithstanding the first sentence of this subparagraph, a home
health agency may charge such an individual or person, with
respect to covered items subject to payment under section
1834(a), the amount of any deduction imposed under section
1833(b) and 20 percent of the payment basis described in
section 1834(a)(1)(B). In the case of items and services for
which payment is made under part B under the prospective
payment system established under section 1833(t), clause (ii)
of the first sentence shall be applied by substituting for 20
percent of the reasonable charge, the applicable copayment
amount established under section 1833(t)(5). In the case of
services described in section 1833(a)(8) or section 1833(a)(9)
for which payment is made under part B under section 1834(k),
clause (ii) of the first sentence shall be applied by
substituting for 20 percent of the reasonable charge for such
services 20 percent of the lesser of the actual charge or the
applicable fee schedule amount (as defined in such section) for
such services.
(B) Where a provider of services has furnished, at the
request of such individual, items or services which are in
excess of or more expensive than the items or services with
respect to which payment may be made under this title, such
provider of services may also charge such individual or other
person for such more expensive items or services to the extent
that the amount customarily charged by it for the items or
services furnished at such request exceeds the amount
customarily charged by it for the items or services with
respect to which payment may be made under this title.
(C) A provider of services may in accordance with its
customary practice also appropriately charge any such
individual for any whole blood (or equivalent quantities of
packed red blood cells, as defined under regulations) furnished
him with respect to which a deductible is imposed under section
1813(a)(2), except that (i) any excess of such charge over the
cost to such provider for the blood (or equivalent quantities
of packed red blood cells, as so defined) shall be deducted
from any payment to such provider under this title, (ii) no
such charge may be imposed for the cost of administration of
such blood (or equivalent quantities of packed red blood cells,
as so defined), and (iii) such charge may not be made to the
extent such blood (or equivalent quantities of packed red blood
cells, as so defined) has been replaced on behalf of such
individual or arrangements have been made for its replacement
on his behalf. For purposes of subparagraph (C), whole blood
(or equivalent quantities of packed red blood cells, as so
defined) furnished an individual shall be deemed replaced when
the provider of services is given one pint of blood for each
pint of blood (or equivalent quantities of packed red blood
cells, as so defined) furnished such individual with respect to
which a deduction is imposed under section 1813(a)(2).
(D) Where a provider of services customarily furnishes items
or services which are in excess of or more expensive than the
items or services with respect to which payment may be made
under this title, such provider, notwithstanding the preceding
provisions of this paragraph, may not, under the authority of
section 1866(a)(2)(B)(ii), charge any individual or other
person any amount for such items or services in excess of the
amount of the payment which may otherwise be made for such
items or services under this title if the admitting physician
has a direct or indirect financial interest in such provider.
(3)(A) Under the agreement required under paragraph
(1)(F)(ii), the quality improvement organization must perform
functions (other than those covered under an agreement under
paragraph (1)(F)(i)) under the third sentence of section
1154(a)(4)(A) and under section 1154(a)(14) with respect to
services, furnished by the hospital, critical access hospital,
facility, or agency involved, for which payment may be made
under this title.
(B) For purposes of payment under this title, the cost of
such an agreement to the hospital, critical access hospital,
facility, or agency shall be considered a cost incurred by such
hospital, critical access hospital, facility, or agency in
providing covered services under this title and shall be paid
directly by the Secretary to the quality improvement
organization on behalf of such hospital, critical access
hospital, facility, or agency in accordance with a schedule
established by the Secretary.
(C) Such payments--
(i) shall be transferred in appropriate proportions
from the Federal Hospital Insurance Trust Fund and from
the Federal Supplementary Medical Insurance Trust Fund,
without regard to amounts appropriated in advance in
appropriation Acts, in the same manner as transfers are
made for payment for services provided directly to
beneficiaries, and
(ii) shall not be less in the aggregate for a fiscal
year--
(I) in the case of hospitals, than the amount
specified in paragraph (1)(F)(i)(III), and
(II) in the case of facilities, critical
access hospitals, and agencies, than the
amounts the Secretary determines to be
sufficient to cover the costs of such
organizations' conducting the activities
described in subparagraph (A) with respect to
such facilities, critical access hospitals, or
agencies under part B of title XI.
(b)(1) A provider of services may terminate an agreement with
the Secretary under this section at such time and upon such
notice to the Secretary and the public as may be provided in
regulations, except that notice of more than six months shall
not be required.
(2) The Secretary may refuse to enter into an agreement under
this section or, upon such reasonable notice to the provider
and the public as may be specified in regulations, may refuse
to renew or may terminate such an agreement after the
Secretary--
(A) has determined that the provider fails to comply
substantially with the provisions of the agreement,
with the provisions of this title and regulations
thereunder, or with a corrective action required under
section 1886(f)(2)(B),
(B) has determined that the provider fails
substantially to meet the applicable provisions of
section 1861,
(C) has excluded the provider from participation in a
program under this title pursuant to section 1128 or
section 1128A, or
(D) has ascertained that the provider has been
convicted of a felony under Federal or State law for an
offense which the Secretary determines is detrimental
to the best interests of the program or program
beneficiaries.
(3) A termination of an agreement or a refusal to renew an
agreement under this subsection shall become effective on the
same date and in the same manner as an exclusion from
participation under the programs under this title becomes
effective under section 1128(c).
(4)(A) A hospital that fails to comply with the requirement
of subsection (a)(1)(V) (relating to the Bloodborne Pathogens
standard) is subject to a civil money penalty in an amount
described in subparagraph (B), but is not subject to
termination of an agreement under this section.
(B) The amount referred to in subparagraph (A) is an amount
that is similar to the amount of civil penalties that may be
imposed under section 17 of the Occupational Safety and Health
Act of 1970 for a violation of the Bloodborne Pathogens
standard referred to in subsection (a)(1)(U) by a hospital that
is subject to the provisions of such Act.
(C) A civil money penalty under this paragraph shall be
imposed and collected in the same manner as civil money
penalties under subsection (a) of section 1128A are imposed and
collected under that section.
(c)(1) Where the Secretary has terminated or has refused to
renew an agreement under this title with a provider of
services, such provider may not file another agreement under
this title unless the Secretary finds that the reason for the
termination or nonrenewal has been removed and that there is
reasonable assurance that it will not recur.
(2) Where the Secretary has terminated or has refused to
renew an agreement under this title with a provider of
services, the Secretary shall promptly notify each State agency
which administers or supervises the administration of a State
plan approved under title XIX of such termination or
nonrenewal.
(d) If the Secretary finds that there is a substantial
failure to make timely review in accordance with section
1861(k) of long-stay cases in a hospital, he may, in lieu of
terminating his agreement with such hospital, decide that, with
respect to any individual admitted to such hospital after a
subsequent date specified by him, no payment shall be made
under this title for inpatient hospital services (including
inpatient psychiatric hospital services) after the 20th day of
a continuous period of such services. Such decision may be made
effective only after such notice to the hospital and to the
public, as may be prescribed by regulations, and its
effectiveness shall terminate when the Secretary finds that the
reason therefor has been removed and that there is reasonable
assurance that it will not recur. The Secretary shall not make
any such decision except after reasonable notice and
opportunity for hearing to the institution or agency affected
thereby.
(e) For purposes of this section, the term ``provider of
services'' shall include--
(1) a clinic, rehabilitation agency, or public health
agency if, in the case of a clinic or rehabilitation
agency, such clinic or agency meets the requirements of
section 1861(p)(4)(A) (or meets the requirements of
such section through the operation of subsection (g) or
(ll)(2) of section 1861), or if, in the case of a
public health agency, such agency meets the
requirements of section 1861(p)(4)(B) (or meets the
requirements of such section through the operation of
subsection (g) or (ll)(2) of section 1861), but only
with respect to the furnishing of outpatient physical
therapy services (as therein defined), (through the
operation of section 1861(g)) with respect to the
furnishing of outpatient occupational therapy services,
or (through the operation of section 1861(ll)(2)) with
respect to the furnishing of outpatient speech-language
pathology; [and]
(2) a community mental health center (as defined in
section 1861(ff)(3)(B)), but only with respect to the
furnishing of partial hospitalization services (as
described in section 1861(ff)(1))[.]; and
(3) opioid treatment programs (as defined in
paragraph (2) of section 1861(jjj)), but only with
respect to the furnishing of opioid use disorder
treatment services (as defined in paragraph (1) of such
section).
(f)(1) For purposes of subsection (a)(1)(Q) and sections
1819(c)(2)(E), 1833(s), 1855(i), 1876(c)(8), and 1891(a)(6),
the requirement of this subsection is that a provider of
services, Medicare+Choice organization, or prepaid or eligible
organization (as the case may be) maintain written policies and
procedures with respect to all adult individuals receiving
medical care by or through the provider or organization--
(A) to provide written information to each such
individual concerning--
(i) an individual's rights under State law
(whether statutory or as recognized by the
courts of the State) to make decisions
concerning such medical care, including the
right to accept or refuse medical or surgical
treatment and the right to formulate advance
directives (as defined in paragraph (3)), and
(ii) the written policies of the provider or
organization respecting the implementation of
such rights;
(B) to document in a prominent part of the
individual's current medical record whether or not the
individual has executed an advance directive;
(C) not to condition the provision of care or
otherwise discriminate against an individual based on
whether or not the individual has executed an advance
directive;
(D) to ensure compliance with requirements of State
law (whether statutory or as recognized by the courts
of the State) respecting advance directives at
facilities of the provider or organization; and
(E) to provide (individually or with others) for
education for staff and the community on issues
concerning advance directives.
Subparagraph (C) shall not be construed as requiring the
provision of care which conflicts with an advance directive.
(2) The written information described in paragraph (1)(A)
shall be provided to an adult individual--
(A) in the case of a hospital, at the time of the
individual's admission as an inpatient,
(B) in the case of a skilled nursing facility, at the
time of the individual's admission as a resident,
(C) in the case of a home health agency, in advance
of the individual coming under the care of the agency,
(D) in the case of a hospice program, at the time of
initial receipt of hospice care by the individual from
the program, and
(E) in the case of an eligible organization (as
defined in section 1876(b)) or an organization provided
payments under section 1833(a)(1)(A) or a
Medicare+Choice organization, at the time of enrollment
of the individual with the organization.
(3) In this subsection, the term ``advance directive'' means
a written instruction, such as a living will or durable power
of attorney for health care, recognized under State law
(whether statutory or as recognized by the courts of the State)
and relating to the provision of such care when the individual
is incapacitated.
(4) For construction relating to this subsection, see section
7 of the Assisted Suicide Funding Restriction Act of 1997
(relating to clarification respecting assisted suicide,
euthanasia, and mercy killing).
(g) Except as permitted under subsection (a)(2), any person
who knowingly and willfully presents, or causes to be
presented, a bill or request for payment inconsistent with an
arrangement under subsection (a)(1)(H) or in violation of the
requirement for such an arrangement, is subject to a civil
money penalty of not to exceed $2,000. The provisions of
section 1128A (other than subsections (a) and (b)) shall apply
to a civil money penalty under the previous sentence in the
same manner as such provisions apply to a penalty or proceeding
under section 1128A(a).
(h)(1)(A) Except as provided in paragraph (2), an institution
or agency dissatisfied with a determination by the Secretary
that it is not a provider of services or with a determination
described in subsection (b)(2) shall be entitled to a hearing
thereon by the Secretary (after reasonable notice) to the same
extent as is provided in section 205(b), and to judicial review
of the Secretary's final decision after such hearing as is
provided in section 205(g), except that, in so applying such
sections and in applying section 205(l) thereto, any reference
therein to the Commissioner of Social Security or the Social
Security Administration shall be considered a reference to the
Secretary or the Department of Health and Human Services,
respectively.
(B) An institution or agency described in subparagraph (A)
that has filed for a hearing under subparagraph (A) shall have
expedited access to judicial review under this subparagraph in
the same manner as providers of services, suppliers, and
individuals entitled to benefits under part A or enrolled under
part B, or both, may obtain expedited access to judicial review
under the process established under section 1869(b)(2). Nothing
in this subparagraph shall be construed to affect the
application of any remedy imposed under section 1819 during the
pendency of an appeal under this subparagraph.
(C)(i) The Secretary shall develop and implement a process to
expedite proceedings under this subsection in which--
(I) the remedy of termination of participation has
been imposed;
(II) a remedy described in clause (i) or (iii) of
section 1819(h)(2)(B) has been imposed, but only if
such remedy has been imposed on an immediate basis; or
(III) a determination has been made as to a finding
of substandard quality of care that results in the loss
of approval of a skilled nursing facility's nurse aide
training program.
(ii) Under such process under clause (i), priority shall be
provided in cases of termination described in clause (i)(I).
(iii) Nothing in this subparagraph shall be construed to
affect the application of any remedy imposed under section 1819
during the pendency of an appeal under this subparagraph.
(2) An institution or agency is not entitled to separate
notice and opportunity for a hearing under both section 1128
and this section with respect to a determination or
determinations based on the same underlying facts and issues.
(i)(1) If the Secretary determines that a psychiatric
hospital which has an agreement in effect under this section no
longer meets the requirements for a psychiatric hospital under
this title and further finds that the hospital's deficiencies--
(A) immediately jeopardize the health and safety of
its patients, the Secretary shall terminate such
agreement; or
(B) do not immediately jeopardize the health and
safety of its patients, the Secretary may terminate
such agreement, or provide that no payment will be made
under this title with respect to any individual
admitted to such hospital after the effective date of
the finding, or both.
(2) If a psychiatric hospital, found to have deficiencies
described in paragraph (1)(B), has not complied with the
requirements of this title--
(A) within 3 months after the date the hospital is
found to be out of compliance with such requirements,
the Secretary shall provide that no payment will be
made under this title with respect to any individual
admitted to such hospital after the end of such 3-month
period, or
(B) within 6 months after the date the hospital is
found to be out of compliance with such requirements,
no payment may be made under this title with respect to
any individual in the hospital until the Secretary
finds that the hospital is in compliance with the
requirements of this title.
(j) Enrollment Process for Providers of Services and
Suppliers.--
(1) Enrollment process.--
(A) In general.--The Secretary shall
establish by regulation a process for the
enrollment of providers of services and
suppliers under this title. Such process shall
include screening of providers and suppliers in
accordance with paragraph (2), a provisional
period of enhanced oversight in accordance with
paragraph (3), disclosure requirements in
accordance with paragraph (5), the imposition
of temporary enrollment moratoria in accordance
with paragraph (7), and the establishment of
compliance programs in accordance with
paragraph (9).
(B) Deadlines.--The Secretary shall establish
by regulation procedures under which there are
deadlines for actions on applications for
enrollment (and, if applicable, renewal of
enrollment). The Secretary shall monitor the
performance of medicare administrative
contractors in meeting the deadlines
established under this subparagraph.
(C) Consultation before changing provider
enrollment forms.--The Secretary shall consult
with providers of services and suppliers before
making changes in the provider enrollment forms
required of such providers and suppliers to be
eligible to submit claims for which payment may
be made under this title.
(2) Provider screening.--
(A) Procedures.--Not later than 180 days
after the date of enactment of this paragraph,
the Secretary, in consultation with the
Inspector General of the Department of Health
and Human Services, shall establish procedures
under which screening is conducted with respect
to providers of medical or other items or
services and suppliers under the program under
this title, the Medicaid program under title
XIX, and the CHIP program under title XXI.
(B) Level of screening.--The Secretary shall
determine the level of screening conducted
under this paragraph according to the risk of
fraud, waste, and abuse, as determined by the
Secretary, with respect to the category of
provider of medical or other items or services
or supplier. Such screening--
(i) shall include a licensure check,
which may include such checks across
States; and
(ii) may, as the Secretary determines
appropriate based on the risk of fraud,
waste, and abuse described in the
preceding sentence, include--
(I) a criminal background
check;
(II) fingerprinting;
(III) unscheduled and
unannounced site visits,
including preenrollment site
visits;
(IV) database checks
(including such checks across
States); and
(V) such other screening as
the Secretary determines
appropriate.
(C) Application fees.--
(i) Institutional providers.--Except
as provided in clause (ii), the
Secretary shall impose a fee on each
institutional provider of medical or
other items or services or supplier
(such as a hospital or skilled nursing
facility) with respect to which
screening is conducted under this
paragraph in an amount equal to--
(I) for 2010, $500; and
(II) for 2011 and each
subsequent year, the amount
determined under this clause
for the preceding year,
adjusted by the percentage
change in the consumer price
index for all urban consumers
(all items; United States city
average) for the 12-month
period ending with June of the
previous year.
(ii) Hardship exception; waiver for
certain medicaid providers.--The
Secretary may, on a case-by-case basis,
exempt a provider of medical or other
items or services or supplier from the
imposition of an application fee under
this subparagraph if the Secretary
determines that the imposition of the
application fee would result in a
hardship. The Secretary may waive the
application fee under this subparagraph
for providers enrolled in a State
Medicaid program for whom the State
demonstrates that imposition of the fee
would impede beneficiary access to
care.
(iii) Use of funds.--Amounts
collected as a result of the imposition
of a fee under this subparagraph shall
be used by the Secretary for program
integrity efforts, including to cover
the costs of conducting screening under
this paragraph and to carry out this
subsection and section 1128J.
(D) Application and enforcement.--
(i) New providers of services and
suppliers.--The screening under this
paragraph shall apply, in the case of a
provider of medical or other items or
services or supplier who is not
enrolled in the program under this
title, title XIX, or title XXI as of
the date of enactment of this
paragraph, on or after the date that is
1 year after such date of enactment.
(ii) Current providers of services
and suppliers.--The screening under
this paragraph shall apply, in the case
of a provider of medical or other items
or services or supplier who is enrolled
in the program under this title, title
XIX, or title XXI as of such date of
enactment, on or after the date that is
2 years after such date of enactment.
(iii) Revalidation of enrollment.--
Effective beginning on the date that is
180 days after such date of enactment,
the screening under this paragraph
shall apply with respect to the
revalidation of enrollment of a
provider of medical or other items or
services or supplier in the program
under this title, title XIX, or title
XXI.
(iv) Limitation on enrollment and
revalidation of enrollment.--In no case
may a provider of medical or other
items or services or supplier who has
not been screened under this paragraph
be initially enrolled or reenrolled in
the program under this title, title
XIX, or title XXI on or after the date
that is 3 years after such date of
enactment.
(E) Use of information from the department of
treasury concerning tax debts.--In reviewing
the application of a provider of services or
supplier to enroll or reenroll under the
program under this title, the Secretary shall
take into account the information supplied by
the Secretary of the Treasury pursuant to
section 6103(l)(22) of the Internal Revenue
Code of 1986, in determining whether to deny
such application or to apply enhanced oversight
to such provider of services or supplier
pursuant to paragraph (3) if the Secretary
determines such provider of services or
supplier owes such a debt.
(F) Expedited rulemaking.--The Secretary may
promulgate an interim final rule to carry out
this paragraph.
(3) Provisional period of enhanced oversight for new
providers of services and suppliers.--
(A) In general.--The Secretary shall
establish procedures to provide for a
provisional period of not less than 30 days and
not more than 1 year during which new providers
of medical or other items or services and
suppliers, as the Secretary determines
appropriate, including categories of providers
or suppliers, would be subject to enhanced
oversight, such as prepayment review and
payment caps, under the program under this
title, the Medicaid program under title XIX.
and the CHIP program under title XXI.
(B) Implementation.--The Secretary may
establish by program instruction or otherwise
the procedures under this paragraph.
(4) 90-day period of enhanced oversight for initial
claims of dme suppliers.--For periods beginning after
January 1, 2011, if the Secretary determines that there
is a significant risk of fraudulent activity among
suppliers of durable medical equipment, in the case of
a supplier of durable medical equipment who is within a
category or geographic area under title XVIII
identified pursuant to such determination and who is
initially enrolling under such title, the Secretary
shall, notwithstanding sections 1816(c), 1842(c), and
1869(a)(2), withhold payment under such title with
respect to durable medical equipment furnished by such
supplier during the 90-day period beginning on the date
of the first submission of a claim under such title for
durable medical equipment furnished by such supplier.
(5) Increased disclosure requirements.--
(A) Disclosure.--A provider of medical or
other items or services or supplier who submits
an application for enrollment or revalidation
of enrollment in the program under this title,
title XIX, or title XXI on or after the date
that is 1 year after the date of enactment of
this paragraph shall disclose (in a form and
manner and at such time as determined by the
Secretary) any current or previous affiliation
(directly or indirectly) with a provider of
medical or other items or services or supplier
that has uncollected debt, has been or is
subject to a payment suspension under a Federal
health care program (as defined in section
1128B(f)), has been excluded from participation
under the program under this title, the
Medicaid program under title XIX, or the CHIP
program under title XXI, or has had its billing
privileges denied or revoked.
(B) Authority to deny enrollment.--If the
Secretary determines that such previous
affiliation poses an undue risk of fraud,
waste, or abuse, the Secretary may deny such
application. Such a denial shall be subject to
appeal in accordance with paragraph (7).
(6) Authority to adjust payments of providers of
services and suppliers with the same tax identification
number for medicare obligations.--
(A) In general.--Notwithstanding any other
provision of this title, in the case of an
applicable provider of services or supplier,
the Secretary may make any necessary
adjustments to payments to the applicable
provider of services or supplier under the
program under this title in order to satisfy
any amount described in subparagraph (B)(ii)
due from such obligated provider of services or
supplier.
(B) Definitions.--In this paragraph:
(i) In general.--The term
``applicable provider of services or
supplier'' means a provider of services
or supplier that has the same taxpayer
identification number assigned under
section 6109 of the Internal Revenue
Code of 1986 as is assigned to the
obligated provider of services or
supplier under such section, regardless
of whether the applicable provider of
services or supplier is assigned a
different billing number or national
provider identification number under
the program under this title than is
assigned to the obligated provider of
services or supplier.
(ii) Obligated provider of services
or supplier.--The term ``obligated
provider of services or supplier''
means a provider of services or
supplier that owes an amount that is
more than the amount required to be
paid under the program under this title
(as determined by the Secretary).
(7) Temporary moratorium on enrollment of new
providers; nonpayment.--
(A) In general.--The Secretary may impose a
temporary moratorium on the enrollment of new
providers of services and suppliers, including
categories of providers of services and
suppliers, in the program under this title,
under the Medicaid program under title XIX, or
under the CHIP program under title XXI if the
Secretary determines such moratorium is
necessary to prevent or combat fraud, waste, or
abuse under either such program.
(B) Limitation on review.--There shall be no
judicial review under section 1869, section
1878, or otherwise, of a temporary moratorium
imposed under subparagraph (A).
(C) Nonpayment.--
(i) In general.--No payment may be
made under this title or under a
program described in subparagraph (A)
with respect to an item or service
described in clause (ii) furnished on
or after October 1, 2017.
(ii) Item or service described.--An
item or service described in this
clause is an item or service
furnished--
(I) within a geographic area
with respect to which a
temporary moratorium imposed
under subparagraph (A) is in
effect; and
(II) by a provider of
services or supplier that meets
the requirements of clause
(iii).
(iii) Requirements.--For purposes of
clause (ii), the requirements of this
clause are that a provider of services
or supplier--
(I) enrolls under this title
on or after the effective date
of such temporary moratorium;
and
(II) is within a category of
providers of services and
suppliers (as described in
subparagraph (A)) subject to
such temporary moratorium.
(iv) Prohibition on charges for
specified items or services.--In no
case shall a provider of services or
supplier described in clause (ii)(II)
charge an individual or other person
for an item or service described in
clause (ii) furnished on or after
October 1, 2017, to an individual
entitled to benefits under part A or
enrolled under part B or an individual
under a program specified in
subparagraph (A).
(8) Compliance programs.--
(A) In general.--On or after the date of
implementation determined by the Secretary
under subparagraph (C), a provider of medical
or other items or services or supplier within a
particular industry sector or category shall,
as a condition of enrollment in the program
under this title, title XIX, or title XXI,
establish a compliance program that contains
the core elements established under
subparagraph (B) with respect to that provider
or supplier and industry or category.
(B) Establishment of core elements.--The
Secretary, in consultation with the Inspector
General of the Department of Health and Human
Services, shall establish core elements for a
compliance program under subparagraph (A) for
providers or suppliers within a particular
industry or category.
(C) Timeline for implementation.--The
Secretary shall determine the timeline for the
establishment of the core elements under
subparagraph (B) and the date of the
implementation of subparagraph (A) for
providers or suppliers within a particular
industry or category. The Secretary shall, in
determining such date of implementation,
consider the extent to which the adoption of
compliance programs by a provider of medical or
other items or services or supplier is
widespread in a particular industry sector or
with respect to a particular provider or
supplier category.
(9) Hearing rights in cases of denial or non-
renewal.--A provider of services or supplier whose
application to enroll (or, if applicable, to renew
enrollment) under this title is denied may have a
hearing and judicial review of such denial under the
procedures that apply under subsection (h)(1)(A) to a
provider of services that is dissatisfied with a
determination by the Secretary.
(k) Quality Reporting by Cancer Hospitals.--
(1) In general.--For purposes of fiscal year 2014 and
each subsequent fiscal year, a hospital described in
section 1886(d)(1)(B)(v) shall submit data to the
Secretary in accordance with paragraph (2) with respect
to such a fiscal year.
(2) Submission of quality data.--For fiscal year 2014
and each subsequent fiscal year, each hospital
described in such section shall submit to the Secretary
data on quality measures specified under paragraph (3).
Such data shall be submitted in a form and manner, and
at a time, specified by the Secretary for purposes of
this subparagraph.
(3) Quality measures.--
(A) In general.--Subject to subparagraph (B),
any measure specified by the Secretary under
this paragraph must have been endorsed by the
entity with a contract under section 1890(a).
(B) Exception.--In the case of a specified
area or medical topic determined appropriate by
the Secretary for which a feasible and
practical measure has not been endorsed by the
entity with a contract under section 1890(a),
the Secretary may specify a measure that is not
so endorsed as long as due consideration is
given to measures that have been endorsed or
adopted by a consensus organization identified
by the Secretary.
(C) Time frame.--Not later than October 1,
2012, the Secretary shall publish the measures
selected under this paragraph that will be
applicable with respect to fiscal year 2014.
(4) Public availability of data submitted.--The
Secretary shall establish procedures for making data
submitted under paragraph (4) available to the public.
Such procedures shall ensure that a hospital described
in section 1886(d)(1)(B)(v) has the opportunity to
review the data that is to be made public with respect
to the hospital prior to such data being made public.
The Secretary shall report quality measures of process,
structure, outcome, patients' perspective on care,
efficiency, and costs of care that relate to services
furnished in such hospitals on the Internet website of
the Centers for Medicare & Medicaid Services.
* * * * * * *
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
[all]
