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115th Congress } { Rept. 115-739
HOUSE OF REPRESENTATIVES
2d Session } { Part 1
======================================================================
OPIOID SCREENING AND CHRONIC PAIN MANAGEMENT ALTERNATIVES FOR SENIORS
ACT
_______
June 12, 2018.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. Walden, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 5798]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 5798) to amend title XVIII of the Social
Security Act to require a review of current opioid
prescriptions for chronic pain and screening for opioid use
disorder to be included in the Welcome to Medicare initial
preventive physical examination, having considered the same,
report favorably thereon without amendment and recommend that
the bill do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Committee Action................................................. 2
Committee Votes.................................................. 3
Oversight Findings and Recommendations........................... 3
New Budget Authority, Entitlement Authority, and Tax Expenditures 3
Congressional Budget Office Estimate............................. 3
Federal Mandates Statement....................................... 25
Statement of General Performance Goals and Objectives............ 25
Duplication of Federal Programs.................................. 25
Committee Cost Estimate.......................................... 25
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 26
Disclosure of Directed Rule Makings.............................. 26
Advisory Committee Statement..................................... 26
Applicability to Legislative Branch.............................. 26
Section-by-Section Analysis of the Legislation................... 26
Changes in Existing Law Made by the Bill, as Reported............ 26
Exchange of Letters with Additional Committees of Referral....... 87
Purpose and Summary
H.R. 5798, Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act, was introduced on May 15, 2018,
by Rep. Larry Bucshon (R-IN), Rep. Debbie Dingell (D-MI), and
Rep. Erik Paulsen (R-MN) to add a review of current opioid
prescriptions, a pain assessment, and, as appropriate, a
screening for opioid use disorder as part of the Welcome to
Medicare initial examination.
Background and Need for Legislation
The Medicare program serves as the healthcare coverage
provider to over 58 million beneficiaries. This number is
projected to rise to over 80 million by 2030. In serving the
over age 65 population, Medicare accounts for a large share of
total opioid prescriptions. In 2016, one out of every three
beneficiaries was prescribed an opioid through Medicare Part D.
In total, this equates to almost 80 million prescriptions and
$4 billion in Medicare Part D spending. While many Medicare
beneficiaries with serious pain-related conditions are being
properly prescribed opioids, there is mounting evidence of
opioid misuse in the Medicare system. As more seniors and
individuals with disabilities come into the program, the
challenges of fraud, misuse, and abuse will only increase.
This bill seeks to increase screening and thus, early
detection of potential opioid use disorder is addressed upon
entry into the Medicare program. In the case of a beneficiary
with a current opioid prescription for chronic pain, the bill
requires qualified practitioners to review the beneficiary's
potential risk factors for opioid use disorder, evaluate the
beneficiary's level of pain, provide the beneficiary with
information regarding non-opioid treatment options, and provide
a referral for additional treatment, where appropriate.
Committee Action
On April 11 and 12, 2018, the Subcommittee on Health held a
hearing entitled ``Combating the Opioid Crisis: Improving the
Ability of Medicare and Medicaid to Provide Care for Patients''
to review legislation related to the opioid epidemic. The
Subcommittee received testimony from:
Kimberly Brandt, Principal Deputy
Administrator for Operations, Centers for Medicare and
Medicaid Services, U.S. Department of Health and Human
Services;
Michael Botticelli, Executive Director,
Grayken Center for Addiction, Boston Medical Center;
Toby Douglas, Senior Vice President,
Medicaid Solutions, Centene Corporation;
David Guth, CEO, Centerstone;
John Kravitz, CIO, Geisinger Health System;
and,
Sam Srivastava, CEO, Magellan Health.
On April 25, 2018, the Subcommittee on Health met in open
markup session and forwarded a discussion draft, entitled
``Welcome to Medicare,'' without amendment, to the full
Committee by a voice vote. On May 17, 2018, the full Committee
on Energy and Commerce met in open markup session and ordered
H.R. 5798, without amendment, reported to the House by a voice
vote. H.R. 5798 was similar to the discussion draft forwarded
by the Subcommittee.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. There were no record votes taken in connection with
ordering H.R. 5798 reported.
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 5798 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, the following is
the cost estimate provided by the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974:
U.S. Congress,
Congressional Budget Office,
Washington, DC, June 6, 2018.
Hon. Greg Walden,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed document with cost estimates for the
opioid-related legislation ordered to be reported on May 9 and
May 17, 2018.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Tom Bradley
and Chad Chirico.
Sincerely,
Mark P. Hadley
(For Keith Hall, Director).
Enclosure.
Opioid Legislation
Summary: On May 9 and May 17, 2018, the House Committee on
Energy and Commerce ordered 59 bills to be reported related to
the nation's response to the opioid epidemic. Generally, the
bills would:
Provide grants to facilities and providers
that treat people with substance use disorders,
Direct various agencies within the
Department of Health and Human Services (HHS) to
explore nonopioid approaches to treating pain and to
educate providers about those alternatives,
Modify requirements under Medicaid and
Medicare for prescribing controlled substances,
Expand Medicaid coverage for substance abuse
treatment, and
Direct the Food and Drug Administration
(FDA) to modify its oversight of opioid drugs and other
medications that are used to manage pain.
Because of the large number of related bills ordered
reported by the Committee, CBO is publishing a single
comprehensive document that includes estimates for each piece
of legislation.
CBO estimates that enacting 20 of the bills would affect
direct spending, and 2 of the bills would affect revenues;
therefore, pay-as-you-go procedures apply for those bills.
CBO estimates that enacting H.R. 4998, the Health Insurance
for Former Foster Youth Act, would increase net direct spending
by more than $2.5 billion and on-budget deficits by more than
$5 billion in at least one of the four consecutive 10-year
periods beginning in 2029. None of the remaining 58 bills
included in this estimate would increase net direct spending by
more than $2.5 billion or on-budget deficits by more than $5
billion in any of the four consecutive 10-year periods
beginning in 2029.
One of the bills reviewed for this document, H.R. 5795,
would impose both intergovernmental and private-sector mandates
as defined in the Unfunded Mandates Reform Act (UMRA). CBO
estimates that the costs of those mandates on public and
private entities would fall below the thresholds in UMRA ($80
million and $160 million, respectively, in 2018, adjusted
annually for inflation). Five bills, H.R. 5228, H.R. 5333, H.R.
5554, H.R. 5687, and H.R. 5811, would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of the bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would not exceed the UMRA threshold for private
entities. Because CBO is uncertain how federal agencies would
implement new authority granted in the other two bills, H.R.
5228 and H.R. 5687, CBO cannot determine whether the costs of
those mandates would exceed the UMRA threshold.
Estimated cost to the Federal Government: The estimates in
this document do not include the effects of interactions among
the bills. If all 59 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 any such differences would be small. The costs of
this legislation fall within budget functions 550 (health), 570
(Medicare), 750 (administration of justice), and 800 (general
government).
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 and revenues
Table 1 lists the 22 bills of the 59 ordered to be reported
that would affect direct spending or revenues.
TABLE 1.--ESTIMATED CHANGES IN MANDATORY SPENDING AND REVENUES
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
------------------------------------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2019-2023 2019-2028
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
Legislation Primarily Affecting
Medicaid:
H.R. 1925, At-Risk Youth 0 * 5 5 5 10 10 10 10 10 10 25 75
Medicaid Protection Act of
2017......................
H.R. 4998, Health Insurance 0 0 0 0 0 * 10 21 33 46 61 * 171
for Former Foster Youth
Act.......................
H.R. 5477, Rural 0 13 35 58 68 83 27 9 3 3 3 256 301
Development of Opioid
Capacity Services Act.....
H.R. 5583, a bill to amend 0 * * * * * * * * * * * *
title XI of the Social
Security Act to require
States to annually report
on certain adult health
quality measures, and for
other purposes............
H.R. 5797, IMD CARE Act.... 0 38 158 251 265 279 0 0 0 0 0 991 991
H.R. 5799, Medicaid DRUG 0 * * 1 1 1 1 1 1 1 1 2 5
Improvement Acta..........
H.R. 5801 Medicaid 0 * * * * * * * * * * * *
Providers Are Required To
Note Experiences in Record
Systems to Help In-Need
Patients (PARTNERSHIP)
Acta......................
H.R. 5808, Medicaid 0 * -1 -1 -1 -1 -2 -2 -2 -2 -2 -4 -13
Pharmaceutical Home Act of
2018a.....................
H.R. 5810, Medicaid Health 0 94 58 62 56 52 48 43 38 32 25 323 509
HOME Act..................
Legislation Primarily Affecting
Medicare:
H.R. 3528, Every 0 0 0 -24 -35 -33 -30 -33 -32 -31 -32 -92 -250
Prescription Conveyed
Securely Act..............
H.R. 4841, Standardizing 0 0 0 * * * * * * * * * *
Electronic Prior
Authorization for Safe
Prescribing Act of 2018...
H.R. 5603, Access to 0 2 * * * 1 1 1 2 2 2 3 11
Telehealth Services for
Opioid Use Disorders Act..
H.R. 5605, Advancing High 0 0 0 15 26 24 23 23 10 1 * 65 122
Quality Treatment for
Opioid Use Disorders in
Medicare Act..............
H.R. 5675, a bill to amend 0 0 0 -6 -7 -7 -7 -8 -9 -9 -11 -20 -64
title XVIII of the Social
Security Act to require
prescription drug plan
sponsors under the
Medicare program to
establish drug management
programs for at-risk
beneficiaries.............
H.R. 5684, Protecting 0 0 0 * * * * * * * * * *
Seniors From Opioid Abuse
Act.......................
H.R. 5796, Responsible 0 10 25 50 10 5 0 0 0 0 0 100 100
Education Achieves Care
and Healthy Outcomes for
Users' Treatment Act of
2018......................
H.R. 5798, Opioid Screening 0 0 * 1 1 1 1 1 1 1 1 2 5
and Chronic Pain
Management Alternatives
for Seniors Act...........
H.R. 5804, Post-Surgical 0 0 25 30 25 20 10 5 0 0 0 100 115
Injections as an Opioid
Alternative Acta..........
H.R. 5809, Postoperative 0 0 0 0 10 15 20 25 30 35 45 25 180
Opioid Prevention Act of
2018......................
Legislation Primarily Affecting
the Food and Drug
Administration:
H.R. 5333, Over-the-Counter 0 0 * * * * * * * * * * *
Monograph Safety,
Innovation, and Reform Act
of 2018a..................
INCREASES OR DECREASES (-) IN REVENUESb
H.R. 5752, Stop Illicit 0 * * * * * * * * * * * *
Drug Importation Act of
2018......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000. Budget authority is equivalent to outlays.
aThis bill also would affect spending subject to appropriation.
bOne additional bill, H.R. 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act, would have a negligible effect on revenues.
Legislation Primarily Affecting Medicaid. The following
nine bills would affect direct spending for the Medicaid
program.
H.R. 1925, the At-Risk Youth Medicaid Protection Act of
2017, would require states to suspend, rather than terminate,
Medicaid eligibility for juvenile enrollees (generally under 21
years of age) who become inmates of public correctional
institutions. States also would have to redetermine those
enrollees' Medicaid eligibility before their release and
restore their coverage upon release if they qualify for the
program. States would be required to process Medicaid
applications submitted by or on behalf of juveniles in public
correctional institutions who were not enrolled in Medicaid
before becoming inmates and ensure that Medicaid coverage is
provided when they are released if they are found to be
eligible. On the basis of an analysis of juvenile incarceration
trends and of the per enrollee spending for Medicaid foster
care children, who have a similar health profile to
incarcerated juveniles, CBO estimates that implementing the
bill would cost $75 million over the 2019-2028 period.
H.R. 4998, the Health Insurance for Former Foster Youth
Act, would require states to provide Medicaid coverage to
adults up to age 25 who had aged out of foster care in any
state. Under current law, such coverage is mandatory only if
the former foster care youth has aged out in the state in which
the individual applies for coverage. The policy also would
apply to former foster children who had been in foster care
upon turning 14 years of age but subsequently left foster care
to enter into a legal guardianship with a kinship caregiver.
The provisions would take effect respect for foster youth who
turn 18 on or after January 1, 2023. On the basis of spending
for Medicaid foster care children and data from the Census
Bureau regarding annual migration rates between states, CBO
estimates that implementing the bill would cost $171 million
over the 2019-2028 period.
H.R. 5477, the Rural Development of Opioid Capacity
Services Act, would direct the Secretary of HHS to conduct a
five-year demonstration to increase the number and ability of
providers participating in Medicaid to provide treatment for
substance use disorders. On the basis of an analysis of federal
and state spending for treatment of substance use disorders and
the prevalence of such disorders, CBO estimates that enacting
the bill would increase direct spending by $301 million over
the 2019-2028 period.
H.R. 5583, a bill to amend title XI of the Social Security
Act to require States to annually report on certain adult
health quality measures, and for other purposes, would require
states to include behavioral health indicators in their annual
reports on the quality of care under Medicaid. Although the
bill would add a requirement for states, CBO estimates that its
enactment would not have a significant budgetary effect because
most states have systems in place for reporting such measures
to the federal government.
H.R. 5797, the IMD CARE Act, would expand Medicaid coverage
for people with opioid use disorder who are in institutions for
mental disease (IMDs) for up to 30 days per year. Under a
current-law policy known as the IMD exclusion, the federal
government generally does not make matching payments to state
Medicaid programs for most services provided by IMDs to adults
between the ages of 21 and 64. Recent administrative changes
have made federal financing for IMDs available in limited
circumstances, but the statutory prohibition remains in place.
CBO analyzed several data sets, primarily those collected by
the Substance Abuse and Mental Health Services Administration
(SAMHSA), to estimate current federal spending under Medicaid
for IMD services and to estimate spending under H.R. 5797.
Using that analysis, CBO estimates that enacting H.R. 5797
would increase direct spending by $991 million over the 2019-
2028 period.
H.R. 5799, the Medicaid DRUG Improvement Act, would require
state Medicaid programs to implement additional reviews of
opioid prescriptions, monitor concurrent prescribing of opioids
and certain other drugs, and monitor use of antipsychotic drugs
by children. CBO estimates that the bill would increase direct
spending by $5 million over 2019-2028 period to cover the
administrative costs of complying with those requirements. On
the basis of stakeholder feedback, CBO expects that the bill
would not have a significant effect on Medicaid spending for
prescription drugs because many of the bill's requirements
would duplicate current efforts to curb opioid and
antipsychotic drug use. (If enacted, H.R. 5799 also would
affect spending subject to appropriation; CBO has not completed
an estimate of that amount.)
H.R. 5801, the Medicaid Providers Are Required To Note
Experiences in Record Systems to Help-In-Need Patients
(PARTNERSHIP) Act, would require providers who are permitted to
prescribe controlled substances and who participate in Medicaid
to query prescription drug monitoring programs (PDMPs) before
prescribing controlled substances to Medicaid patients. PDMPs
are statewide electronic databases that collect data on
controlled substances dispensed in the state. The bill also
would require PDMPs to comply with certain data and system
criteria, and it would provide additional federal matching
funds to certain states to help cover administrative costs. On
the basis of a literature review and stakeholder feedback, CBO
estimates that the net budgetary effect of enacting H.R. 5801
would be insignificant. Costs for states to come into
compliance with the systems and administrative requirements
would be roughly offset by savings from small reductions in the
number of controlled substances paid for by Medicaid under the
proposal. (If enacted, H.R. 5801 also would affect spending
subject to appropriation; CBO has not completed an estimate of
that amount.)
H.R. 5808, the Medicaid Pharmaceutical Home Act of 2018,
would require state Medicaid programs to operate pharmacy
programs that would identify people at high risk of abusing
controlled substances and require those patients to use a
limited number of providers and pharmacies. Although nearly all
state Medicaid programs currently meet such a requirement, a
small number of high-risk Medicaid beneficiaries are not now
monitored. Based on an analysis of information about similar
state and federal programs, CBO estimates that net Medicaid
spending under the bill would decrease by $13 million over the
2019-2028 period. That amount represents a small increase in
administrative costs and a small reduction in the number of
controlled substances paid for by Medicaid under the proposal.
(If enacted, H.R. 5808 also would affect spending subject to
appropriation; CBO has not completed an estimate of that
amount.)
H.R. 5810, the Medicaid Health HOME Act, would allow states
to receive six months of enhanced federal Medicaid funding for
programs that coordinate care for people with substance use
disorders. Based on enrollment and spending data from states
that currently participate in Medicaid's Health Homes program,
CBO estimates that the expansion would cost approximately $469
million over the 2019-2028 period. The bill also would require
states to cover all FDA-approved drugs used in medication-
assisted treatment for five years, although states could seek a
waiver from that requirement. (Medication-assisted treatment
combines behavioral therapy and pharmaceutical treatment for
substance use disorders.) Under current law, states already
cover most FDA-approved drugs used in such programs in some
capacity, although a few exclude methadone dispensed by opioid
treatment programs. CBO estimates that a small share of those
states would begin to cover methadone if this bill was enacted
at a federal cost of about $39 million over the 2019-2028
period. In sum, CBO estimates that the enacting H.R. 5810 would
increase direct spending by $509 million over the 2019-2028
period.
Legislation Primarily Affecting Medicare. The following ten
bills would affect direct spending for the Medicare program.
H.R. 3528, the Every Prescription Conveyed Securely Act,
would require prescriptions for controlled substances covered
under Medicare Part D to be transmitted electronically,
starting on January 1, 2021. Based on CBO's analysis of
prescription drug spending, spending for controlled substances
is a small share of total drug spending. CBO also assumes a
small share of those prescriptions would not be filled because
they are not converted to an electronic format. Therefore, CBO
expects that enacting H.R. 3528 would reduce the number of
prescriptions filled and estimates that Medicare spending would
be reduced by $250 million over the 2019-2028 period.
H.R. 4841, the Standardizing Electronic Prior Authorization
for Safe Prescribing 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 H.R. 4841 would not
significantly affect direct spending for Part D.
H.R. 5603, the Access to Telehealth Services for Opioid Use
Disorders Act, would permit the Secretary of HHS to lift
current geographic and other restrictions on coverage of
telehealth services under Medicare for treatment of substance
use disorders or co-occurring mental health disorders. Under
the bill, the Secretary of HHS would be directed to encourage
other payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on current use of Medicare
telehealth services for treatment of substance use disorders,
CBO estimates that expanding that coverage would increase
direct spending by $11 million over the 2019-2028 period.
H.R. 5605, the Advancing High Quality Treatment for Opioid
Use Disorders in Medicare Act, would establish a five-year
demonstration program to increase access to treatment for
opioid use disorder. The demonstration would provide incentive
payments and funding for care management services based on
criteria such as patient engagement, use of evidence-based
treatments, and treatment length and intensity. Under the bill,
the Secretary of HHS would be directed to encourage other
payers to coordinate payments for opioid use disorder
treatments and to evaluate the extent to which the
demonstration reduces hospitalizations, increases the use of
medication-assisted treatments, and improves the health
outcomes of individuals with opioid use disorders during and
after the demonstration. Based on historical utilization of
opioid use disorder treatments and projected spending on
incentive payments and care management fees, CBO estimates that
increased use of treatment services and the demonstration's
incentive payments would increase direct spending by $122
million over the 2019-2028 period.
H.R. 5675, a bill to amend title XVIII of the Social
Security Act to require prescription drug plan sponsors under
the Medicare program to establish drug management programs for
at-risk beneficiaries, 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. 5675 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.
H.R. 5684, the Protecting Seniors From Opioid Abuse Act,
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 bill, CBO estimates that its
enactment would not significantly affect direct spending for
Part D.
H.R. 5796, the Responsible Education Achieves Care and
Healthy Outcomes for Users' Treatment Act of 2018, would allow
the Secretary of HHS to award grants to certain organizations
that provide technical assistance and education to high-volume
prescribers of opioids. The bill would appropriate $100 million
for fiscal year 2019. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 5796
would cost $100 million over the 2019-2028 period.
H.R. 5798, the Opioid Screening and Chronic Pain Management
Alternatives for Seniors Act, would add an assessment of
current opioid prescriptions and screening for opioid use
disorder to the Welcome to Medicare Initial Preventive Physical
Examination. Based on historical use of the examinations and
pain management alternatives, CBO expects that enacting the
bill would increase use of pain management services and
estimates that direct spending would increase by $5 million
over the 2019-2028 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers (ASCs). (For injections identified by specific billing
codes, Medicare would pay the 2016 rate, which is higher than
the current rate, during the 2020-2024 period.) Based on
current utilization in the ASC setting, CBO estimates that
enacting the legislation would increase direct spending by
about $115 million over the 2019-2028 period. (If enacted, H.R.
5804 also would affect spending subject to appropriation; see
Table 3.)
H.R. 5809, the Postoperative Opioid Prevention Act of 2018,
would create an additional payment under Medicare for nonopioid
analgesics. Under current law, certain new drugs and devices
may receive an additional payment--separate from the bundled
payment for a surgical procedure--in outpatient hospital
departments and ambulatory surgical centers. The bill would
allow nonopioid analgesics to qualify for a five-year period of
additional payments. Based on its assessment of current
spending for analgesics and on the probability of new nonopioid
analgesics coming to market, CBO estimates that H.R. 5809 would
increase direct spending by about $180 million over the 2019-
2028 period.
Legislation Primarily Affecting the Food and Drug
Administration. One bill related to the FDA would affect direct
spending.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the way that
the FDA regulates the marketing of over-the-counter (OTC)
medicines, and it would authorize that agency to grant 18
months of exclusive market protection for certain qualifying
OTC drugs, thus delaying the entry of other versions of the
same qualifying OTC product. Medicaid currently provides some
coverage for OTC medicines, but only if a medicine is the least
costly alternative in its drug class. On the basis of
stakeholder feedback, CBO expects that delaying the
availability of additional OTC versions of a drug would not
significantly affect the average net price paid by Medicaid. As
a result, CBO estimates that enacting H.R. 5333 would have a
negligible effect on the federal budget. (If enacted, H.R. 5333
also would affect spending subject to appropriation; see Table
3.)
Legislation with Revenue Effects. Two bills would affect
revenues. However, CBO estimates that one bill, H.R. 5228, the
Stop Counterfeit Drugs by Regulating and Enhancing Enforcement
Now Act, would have only a negligible effect.
H.R. 5752, the Stop Illicit Drug Importation Act of 2018,
would amend the Federal, Food, Drug, and Cosmetic Act (FDCA) to
strengthen the FDA's seizure powers and enhance its authority
to detain, refuse, seize, or destroy illegal products offered
for import. The legislation would subject more people to
debarment under the FDCA and thus increase the potential for
violations, and subsequently, the assessment of civil
penalties, which are recorded in the budget as revenues. CBO
estimates that those collections would result in an
insignificant increase in revenues. Because H.R. 5752 would
prohibit the importation of drugs that are in the process of
being scheduled, it also could reduce amounts collected in
customs duties. CBO anticipates that the result would be a
negligible decrease in revenues. With those results taken
together, CBO estimates, enacting H.R. 5752 would generate an
insignificant net increase in revenues over the 2019-2028
period.
Spending subject to appropriation
For this document, CBO has grouped bills with spending that
would be subject to appropriation into four general categories:
Bills that would have no budgetary effect,
Bills with provisions that would authorize
specified amounts to be appropriated (see Table 2),
Bills with provisions for which CBO has
estimated an authorization of appropriations (see Table
3), 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 6 of the 59 bills
would have no effect on direct spending, revenues, or spending
subject to appropriation.
H.R. 3192, the CHIP Mental Health Parity Act, would require
all Children's Health Insurance Program (CHIP) plans to cover
mental health and substance abuse treatment. In addition,
states would not be allowed to impose financial or utilization
limits on mental health treatment that are lower than limits
placed on physical health treatment. Based on information from
the Centers for Medicare and Medicaid Services, CBO estimates
that enacting the bill would have no budgetary effect because
all CHIP enrollees are already in plans that meet those
requirements.
H.R. 3331, a bill to amend title XI of the Social Security
Act to promote testing of incentive payments for behavioral
health providers for adoption and use of certified electronic
health record technology, would give the Center for Medicare
and Medicaid Innovation (CMMI) explicit authorization to test a
program offering incentive payments to behavioral health
providers that adopt and use certified electronic health record
technology. Because it is already clear to CMMI that it has
that authority, CBO estimates that enacting the legislation
would not affect federal spending.
H.R. 5202, the Ensuring Patient Access to Substance Use
Disorder Treatments Act of 2018, would clarify permission for
pharmacists to deliver controlled substances to providers under
certain circumstances. Because this provision would codify
current practice, CBO estimates that H.R. 5202 would not affect
direct spending or revenues during the 2019-2028 period.
H.R. 5685, the Medicare Opioid Safety Education Act of
2018, would require the Secretary of HHS to include information
on opioid use, pain management, and nonopioid pain management
treatments in future editions of Medicare & You, the program's
handbook for beneficiaries, starting on January 1, 2019.
Because H.R. 5685 would add information to an existing
administrative document, CBO estimates that enacting the bill
would have no budgetary effect.
H.R. 5686, the Medicare Clear Health Options in Care for
Enrollees 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. CBO
estimates that enacting the bill would not affect direct
spending because the required activities would not impose
significant administrative costs.
H.R. 5716, the Commit to Opioid Medical Prescriber
Accountability and Safety for Seniors Act, 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.
Specified Authorizations. Table 2 lists the ten bills that
would authorize specified amounts to be appropriated over the
2019-2023 period. Spending from those authorized amounts would
be subject to appropriation.
TABLE 2.--ESTIMATED SPENDING SUBJECT TO APPROPRIATION FOR BILLS WITH SPECIFIED AUTHORIZATIONS
----------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
----------------------------------------------------------
2018 2019 2020 2021 2022 2023 2019-2023
----------------------------------------------------------------------------------------------------------------
INCREASES IN SPENDING SUBJECT TO APPROPRIATION
H.R. 4684, Ensuring Access to Quality Sober Living
Act:
Authorization Level.............................. 0 3 0 0 0 0 3
Estimated Outlays................................ 0 1 2 * * * 3
H.R. 5102, Substance Use Disorder Workforce Loan
Repayment Act of 2018:
Authorization Level.............................. 0 25 25 25 25 25 125
Estimated Outlays................................ 0 9 19 23 25 25 100
H.R. 5176, Preventing Overdoses While in Emergency
Rooms Act of 2018:
Authorization Level.............................. 0 50 0 0 0 0 50
Estimated Outlays................................ 0 16 26 6 2 1 50
H.R. 5197, Alternatives to Opioids (ALTO) in the
Emergency Department Act:
Authorization Level.............................. 0 10 10 10 0 0 30
Estimated Outlays................................ 0 3 8 10 7 2 30
H.R. 5261, Treatment, Education, and Community Help
to Combat Addiction Act of 2018:
Authorization Level.............................. 0 4 4 4 4 4 20
Estimated Outlays................................ 0 1 3 4 4 4 16
H.R. 5327, Comprehensive Opioid Recovery Centers Act
of 2018:
Authorization Level.............................. 0 10 10 10 10 10 50
Estimated Outlays................................ 0 3 8 10 10 10 41
H.R. 5329, Poison Center Network Enhancement Act of
2018:
Authorization Level.............................. 0 30 30 30 30 30 151
Estimated Outlays................................ 0 12 25 29 29 29 125
H.R. 5353, Eliminating Opioid-Related Infectious
Diseases Act of 2018:
Authorization Level.............................. 0 40 40 40 40 40 200
Estimated Outlays................................ 0 15 34 38 39 40 166
H.R. 5580, Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018:
Authorization Level.............................. 30 30 30 30 30 0 120
Estimated Outlays................................ 0 11 25 29 29 19 113
H.R. 5587, Peer Support Communities of Recovery Act:
Authorization Level.............................. 0 15 15 15 15 15 75
Estimated Outlays................................ 0 5 13 14 15 15 62
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between zero and $500,000.
H.R. 4684, the Ensuring Access to Quality Sober Living Act,
would direct the Secretary of HHS to develop and disseminate
best practices for organizations that operate housing designed
for people recovering from substance use disorders. The bill
would authorize a total of $3 million over the 2019-2021 period
for that purpose. Based on historical spending patterns for
similar activities, CBO estimates that implementing H.R. 4684
would cost $3 million over the 2019-2023 period.
H.R. 5102, the Substance Use Disorder Workforce Loan
Repayment Act of 2018, would establish a loan repayment program
for mental health professionals who practice in areas with few
mental health providers or with high rates of death from
overdose and would authorize $25 million per year over the
2019-2028 period for that purpose. Based on historical spending
patterns for similar activities, CBO estimates that
implementing H.R. 5102 would cost $100 million over the 2019-
2023 period; the remaining amounts would be spent in years
after 2023.
H.R. 5176, the Preventing Overdoses While in Emergency
Rooms Act of 2018, would require the Secretary of HHS to
develop protocols and a grant program for health care providers
to address the needs of people who survive a drug overdose, and
it would authorize $50 million in 2019 for that purpose. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5176 would cost $50 million
over the 2019-2023 period.
H.R. 5197, the Alternatives to Opioids (ALTO) in the
Emergency Department Act, would direct the Secretary of HHS to
carry out a demonstration program for hospitals and emergency
departments to develop alternative protocols for pain
management that limit the use of opioids and would authorize
$10 million annually in grants for fiscal years 2019 through
2021. Based on historical spending patterns for similar
programs, CBO estimates that implementing H.R. 5197 would cost
$30 million over the 2019-2023 period.
H.R. 5261, the Treatment, Education, and Community Help to
Combat Addiction Act of 2018, would direct the Secretary of
HHS to designate regional centers of excellence to improve the
training of health professionals who treat substance use
disorders. The bill would authorize $4 million annually for
grants to those programs over the 2019-2023 period. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5261 would cost $16 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5327, the Comprehensive Opioid Recovery Centers Act of
2018, would direct the Secretary of HHS to award grants to at
least 10 providers that offer treatment services for people
with opioid use disorder, and it would authorize $10 million
per year over the 2019-2023 period for that purpose. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5327 would cost $41 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5329, the Poison Center Network Enhancement Act of
2018, would reauthorize the poison control center toll-free
number, national media campaign, and grant program under the
Public Health Service Act. Among other actions, H.R. 5329 would
increase the share of poison control center funding that could
be provided by federal grants. The bill would authorize a total
of about $30 million per year over the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5329 would cost $125 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
H.R. 5353, the Eliminating Opioid Related Infectious
Diseases Act of 2018, would amend the Public Health Service Act
by broadening the focus of surveillance and education programs
from preventing and treating hepatitis C virus to preventing
and treating infections associated with injection drug use. It
would authorize $40 million per year over 2019-2023 period for
that purpose. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5353 would
cost $166 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5580, the Surveillance and Testing of Opioids to
Prevent Fentanyl Deaths Act of 2018, would establish a grant
program for public health laboratories that conduct testing for
fentanyl and other synthetic opioids. It also would direct the
Centers for Disease Control and Prevention to expand its drug
surveillance program, with a particular focus on collecting
data on fentanyl. The bill would authorize a total of $30
million per year over the 2018-2022 period for those
activities. Based on historical spending patterns for similar
activities, CBO estimates that implementing H.R. 5580 would
cost $113 million over the 2019-2023 period; the remaining
amounts would be spent in years after 2023.
H.R. 5587, Peer Support Communities of Recovery Act, would
direct the Secretary of HHS to award grants to nonprofit
organizations that support community-based, peer-delivered
support, including technical support for the establishment of
recovery community organizations, independent, nonprofit groups
led by people in recovery and their families. The bill would
authorize $15 million per year for the 2019-2023 period. Based
on historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5587 would cost $62 million
over the 2019-2023 period; the remaining amounts would be spent
in years after 2023.
Estimated Authorizations. Table 3 shows CBO's estimates of
the appropriations that would be necessary to implement 19 of
the bills. Spending would be subject to appropriation of those
amounts.
H.R. 449, the Synthetic Drug Awareness Act of 2018, would
require the Surgeon General to report to the Congress on the
health effects of synthetic psychoactive drugs on children
between the ages of 12 and 18. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 449
would cost approximately $1 million over the 2019-2023 period.
H.R. 4005, the Medicaid Reentry Act, would direct the
Secretary of HHS to convene a group of stakeholders to develop
and report to the Congress on best practices for addressing
issues related to health care faced by those returning from
incarceration to their communities. The bill also would require
the Secretary to issue a letter to state Medicaid directors
about relevant demonstration projects. Based on an analysis of
anticipated workload, CBO estimates that implementing H.R. 4005
would cost less than $500,000 over the 2018-2023 period.
H.R. 4275, the Empowering Pharmacists in the Fight Against
Opioid Abuse Act, would require the Secretary of HHS to develop
and disseminate materials for training pharmacists, health care
practitioners, and the public about the circumstances under
which a pharmacist may decline to fill a prescription. Based on
historical spending patterns for similar activities, CBO
estimates that costs to the federal government for the
development and distribution of those materials would not be
significant.
TABLE 3.--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. 449, Synthetic Drug Awareness Act of 2018:
Estimated Authorization Level................. 0 * * * 0 0 1
Estimated Outlays............................. 0 * * * 0 0 1
H.R. 4005, Medicaid Reentry Act:
Estimated Authorization Level................. * * 0 0 0 0 *
Estimated Outlays............................. * * 0 0 0 0 *
H.R. 4275, Empowering Pharmacists in the Fight
Against Opioid Abuse Act:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5009, Jessie's Law:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5041, Safe Disposal of Unused Medication Act:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5272, Reinforcing Evidence-Based Standards
Under Law in Treating Substance Abuse Act of
2018:
Estimated Authorization Level................. 0 1 1 1 1 1 4
Estimated Outlays............................. 0 1 1 1 1 1 4
H.R. 5333, Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018:a
Food and Drug Administration:
Collections from fees:
Estimated Authorization Level......... 0 -22 -22 -26 -35 -42 -147
Estimated Outlays..................... 0 -22 -22 -26 -35 -42 -147
Spending of fees:
Estimated Authorization Level......... 0 22 22 26 35 42 147
Estimated Outlays..................... 0 6 17 30 44 41 137
Net effect on FDA:
Estimated Authorization Level......... 0 0 0 0 0 0 0
Estimated Outlays..................... 0 -17 -6 4 9 * -10
Government Accountability Office:
Estimated Authorization Level............. 0 0 0 0 0 * *
Estimated Outlays......................... 0 0 0 0 0 * *
Total, H.R. 5333:
Estimated Authorization Level............. 0 0 0 0 0 * *
Estimated Outlays......................... 0 -17 -6 4 9 * -10
H.R. 5473, Better Pain Management Through Better
Data Act of 2018:
Estimated Authorization Level................. 0 * * * * 0 1
Estimated Outlays............................. 0 * * * * * 1
H.R. 5483, Special Registration for Telemedicine
Clarification Act of 2018:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5554, Animal Drug and Animal Generic Drug
User Fee Amendments of 2018:
Collections from fees:
Animal drug fees.......................... 0 -30 -31 -32 -33 -34 -159
Generic animal drug fees.................. 0 -18 -19 -19 -20 -21 -97
Total, Estimated Authorization Level.. 0 -49 -50 -51 -53 -55 -257
Total, Estimated Outlays.............. 0 -49 -50 -51 -53 -55 -257
Spending of fees:
Animal drug fees.......................... 0 30 31 32 33 34 159
Generic animal drug fees.................. 0 18 19 19 20 21 97
Total, Estimated Authorization Level.. 0 49 50 51 53 55 257
Total, Estimated Outlays.............. 0 39 47 51 52 54 243
Net changes in fees:
Estimated Authorization Level............. 0 0 0 0 0 0 0
Estimated Outlays......................... 0 -10 -3 * * * -14
Other effects:
Estimated Authorization Level............. 0 3 1 1 1 1 6
Estimated Outlays......................... 0 2 1 1 1 1 6
Total, H.R. 5554:
Estimated Authorization Level............. 0 3 1 1 1 1 6
Estimated Outlays......................... 0 -8 -2 1 * * -8
H.R. 5582, Abuse Deterrent Access Act of 2018:
Estimated Authorization Level................. 0 0 * 0 0 0 *
Estimated Outlays............................. 0 0 * 0 0 0 *
H.R. 5590, Opioid Addiction Action Plan Act:
Estimated Authorization Level................. * * * * * * 2
Estimated Outlays............................. * * * * * * 2
H.R. 5687, Securing Opioids and Unused Narcotics
with Deliberate Disposal and Packaging Act of
2018:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
H.R. 5715, Strengthening Partnerships to Prevent
Opioid Abuse Act:
Estimated Authorization Level................. 0 2 2 2 2 2 9
Estimated Outlays............................. 0 2 2 2 2 2 9
H.R. 5789, a bill to require the Secretary of
Health and Human Services to issue guidance to
improve care for infants with neonatal abstinence
syndrome and their mothers, and to require the
Comptroller General of the United States to
conduct a study on gaps in Medicaid coverage for
pregnant and postpartum women with substance use
disorder:
Estimated Authorization Level................. 0 2 0 0 0 0 2
Estimated Outlays............................. 0 2 0 0 0 0 2
H.R. 5795, Overdose Prevention and Patient Safety
Act:
Estimated Authorization Level................. 0 1 0 0 0 0 1
Estimated Outlays............................. 0 1 0 0 0 0 1
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act:
Estimated Authorization Level................. 0 1 0 0 0 0 1
Estimated Outlays............................. 0 * * 0 0 0 1
H.R. 5804, Post-Surgical Injections as an Opioid
Alternative Act:a
Estimated Authorization Level................. 0 0 0 0 1 1 1
Estimated Outlays............................. 0 0 0 0 1 1 1
H.R. 5811, a bill to amend the Federal Food, Drug,
and Cosmetic Act with respect to postapproval
study requirements for certain controlled
substances, and for other purposes:
Estimated Authorization Level................. 0 * * * * * *
Estimated Outlays............................. 0 * * * * * *
----------------------------------------------------------------------------------------------------------------
Annual amounts may not sum to totals because of rounding. * = between -$500,000 and $500,000.
aThis bill also would affect mandatory spending (see Table 1).
H.R. 5009, Jessie's Law, would require HHS, in
collaboration with outside experts, to develop best practices
for displaying information about opioid use disorder in a
patient's medical record. HHS also would be required to develop
and disseminate written materials annually to health care
providers about what disclosures could be made while still
complying with federal laws that govern health care privacy.
Based on spending patterns for similar activities, CBO
estimates that implementing H.R. 5009 would have an
insignificant effect on spending over the 2019-2023 period.
H.R. 5041, the Safe Disposal of Unused Medication Act,
would require hospice programs to have written policies and
procedures for the disposal of controlled substances after a
patient's death. Certain licensed employees of hospice programs
would be permitted to assist in the disposal of controlled
substances that were lawfully dispensed. Using information from
the Department of Justice (DOJ), CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5272, the Reinforcing Evidence-Based Standards Under
Law in Treating Substance Abuse Act of 2018, would require the
newly established National Mental Health and Substance Use
Policy Laboratory to issue guidance to applicants for SAMHSA
grants that support evidence-based practices. Using information
from HHS about the historical cost of similar activities, CBO
estimates that enacting this bill would cost approximately $4
million over the 2019-2023 period.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would change the FDA's
oversight of the commercial marketing of OTC medicines and
authorize the collection and spending of fees through 2023 to
cover the costs of expediting the FDA's administrative
procedures for certain regulatory activities relating to OTC
products. Under H.R. 5333, CBO estimates, the FDA would assess
about $147 million in fees over the 2019-2023 period that could
be collected and made available for obligation only to the
extent and in the amounts provided in advance in appropriation
acts. Because the FDA could spend those fees, CBO estimates
that the estimated budget authority for collections and
spending would offset each other exactly in each year, although
CBO expects that spending initially would lag behind
collections. Assuming appropriation action consistent with the
bill, CBO estimates that implementing H.R. 5333 would reduce
net discretionary outlays by $10 million over the 2019-2023
period, primarily because of that lag. The bill also would
require the Government Accountability Office to study exclusive
market protections for certain qualifying OTC drugs authorized
by the bill--a provision that CBO estimates would cost less
than $500,000. (If enacted, H.R. 5333 also would affect
mandatory spending; see Table 1.)
H.R. 5473, the Better Pain Management Through Better Data
Act of 2018, would require that the FDA conduct a public
meeting and issue guidance to industry addressing data
collection and labeling for medical products that reduce pain
while enabling the reduction, replacement, or avoidance of oral
opioids. Using information from the agency, CBO estimates that
implementing H.R. 5473 would cost about $1 million over the
2019-2023 period.
H.R. 5483, the Special Registration for Telemedicine
Clarification Act of 2018, would direct DOJ, within one year of
the bill's enactment, to issue regulations concerning the
practice of telemedicine (for remote diagnosis and treatment of
patients). Using information from DOJ, CBO estimates that
implementing the bill would cost less than $500,000 over the
2019-2023 period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would authorize the FDA to collect and
spend fees to cover the cost of expedited approval for the
development and marketing of certain drugs for use in animals.
The legislation would extend through fiscal year 2023, and make
several changes to, the FDA's existing approval processes and
fee programs for brand-name and generic veterinary drugs, which
expire at the end of fiscal year 2018. CBO estimates that
implementing H.R. 5554 would reduce net discretionary outlays
by $8 million over the 2019-2023 period, primarily because the
spending of fees lags somewhat behind their collection.
Fees authorized under the bill would supplement funds
appropriated to cover the FDA's cost of reviewing certain
applications and investigational submissions for brand-name and
generic drugs for use in animals. Those fees could be collected
and made available for obligation only to the extent and in the
amounts provided in advance in appropriation acts. Under H.R.
5554, CBO estimates, the FDA would assess about $257 million in
fees over the 2019-2023 period. Because the FDA could spend
those funds, CBO estimates that budget authority for
collections and spending would offset each other exactly in
each year. CBO estimates that the delay between collecting and
spending fees under the reauthorized programs would reduce net
discretionary outlays by $14 million over the 2019-2023 period,
assuming appropriation actions consistent with the bill.
Enacting H.R. 5554 would increase the FDA's workload
because the legislation would expand eligibility for
conditional approval for certain drugs. The agency's
administrative costs also would increase because of regulatory
activities required by a provision concerning petitions for
additives intended for use in animal food. H.R. 5554 also would
require the FDA to publish guidance or produce regulations on a
range of topics, transmit a report to the Congress, and hold
public meetings. CBO expects that the costs associated with
those activities would not be covered by fees, and it estimates
that implementing such provisions would cost $6 million over
the 2019-2023 period.
H.R. 5582, the Abuse Deterrent Access Act of 2018, would
require the Secretary of HHS to report to the Congress on
existing barriers to access to ``abuse-deterrent opioid
formulations'' by Medicare Part C and D beneficiaries. Such
formulations make the drugs more difficult to dissolve for
injection, for example, and thus can impede their abuse.
Assuming the availability of appropriated funds and based on
historical spending patterns for similar activities, CBO
estimates that implementing the legislation would cost less
than $500,000 over the 2019-2023 period.
H.R. 5590, the Opioid Addiction Action Plan Act, would
require the Secretary of HHS to develop an action plan by
January 1, 2019, for increasing access to medication-assisted
treatment among Medicare and Medicaid enrollees. The bill also
would require HHS to convene a stakeholder meeting and issue a
request for information within three months of enactment, and
to submit a report to the Congress by June 1, 2019. Based on
historical spending patterns for similar activities, CBO
estimates that implementing H.R. 5590 would cost approximately
$2 million over the 2019-2023 period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
FDA to require certain packaging and disposal technologies,
controls, or measures to mitigate the risk of abuse and misuse
of drugs. Based on information from the FDA, CBO estimates that
implementing H.R. 5687 would not significantly affect spending
over the 2019-2023 period. This bill would also require that
the GAO study the effectiveness and use of packaging
technologies for controlled substances--a provision that CBO
estimates would cost less than $500,000.
H.R. 5715, the Strengthening Partnerships to Prevent Opioid
Abuse Act, 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. 5715 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. 5715 would cost approximately
$9 million over the 2019-2023 period.
H.R. 5789, a bill to require the Secretary of Health and
Human Services to issue guidance to improve care for infants
with neonatal abstinence syndrome and their mothers, and to
require the Comptroller General of the United States to conduct
a study on gaps in Medicaid coverage for pregnant and
postpartum women with substance use disorder, would direct the
Secretary of HHS to issue guidance to states on best practices
under Medicaid and CHIP for treating infants with neonatal
abstinence syndrome. H.R. 5789 also would direct the Government
Accountability Office to study Medicaid coverage for pregnant
and postpartum women with substance use disorders. Based on
information from HHS and historical spending patterns for
similar activities, CBO estimates that enacting H.R. 5789 would
cost approximately $2 million over the 2019-2023 period.
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would amend the Public Health Service Act so that requirements
pertaining to the confidentiality and disclosure of medical
records relating to substance use disorders align with the
provisions of the Health Insurance Portability and
Accountability Act of 1996. The bill would require the Office
of the Secretary of HHS to issue regulations prohibiting
discrimination based on data disclosed from such medical
records, to issue regulations requiring covered entities to
provide written notice of privacy practices, and to develop
model training programs and materials for health care providers
and patients and their families. Based on spending patterns for
similar activities, CBO estimates that implementing H.R. 5795
would cost approximately $1 million over the 2019-2023 period.
H.R. 5800, Medicaid IMD ADDITIONAL INFO Act, would direct
the Medicaid and CHIP Payment and Access Commission to study
institutions for mental diseases in a representative sample of
states. Based on information from the commission about the cost
of similar work, CBO estimates that implementing H.R. 5800
would cost about $1 million over the 2019-2023 period.
H.R. 5804, the Post-Surgical Injections as an Opioid
Alternative Act, would freeze the Medicare payment rate for
certain analgesic injections provided in ambulatory surgical
centers. The bill also would mandate two studies of Medicare
coding and payments arising from enactment of this legislation.
Based on the cost of similar activities, CBO estimates that
those reports would cost $1 million over the 2019-2023 period.
(If enacted, H.R. 5804 also would affect mandatory spending;
see Table 1.)
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would allow the FDA to require that pharmaceutical
manufacturers study certain drugs after they are approved to
assess any potential reduction in those drugs' effectiveness
for the conditions of use prescribed, recommended, or suggested
in labeling. CBO anticipates that implementing H.R. 5811 would
not significantly affect the FDA's costs over the 2019-2023
period.
Other Authorizations. The following nine bills would
increase authorization levels, but CBO has not completed
estimates of amounts. All authorizations would be subject to
future appropriation action.
H.R. 4284, Indexing Narcotics, Fentanyl, and
Opioids Act of 2017
H.R. 5002, Advancing Cutting Edge Research
Act
H.R. 5228, Stop Counterfeit Drugs by
Regulating and Enhancing Enforcement Now Act (see Table
1 for an estimate of the revenue effects of H.R. 5228)
H.R. 5752, Stop Illicit Drug Importation Act
of 2018 (see Table 1 for an estimate of the revenue
effects of H.R. 5752)
H.R. 5799, Medicaid DRUG Improvement Act
(see Table 1 for an estimate of the direct spending
effects of H.R. 5799)
H.R. 5801, Medicaid Providers and
Pharmacists Are Required to Note Experiences in Record
Systems to Help In-Need Patients (PARTNERSHIP) Act (see
Table 1 for an estimate of the direct spending effects
of H.R. 5801)
H.R. 5806, 21st Century Tools for Pain and
Addiction Treatments Act
H.R. 5808, Medicaid Pharmaceutical Home Act
of 2018 (see Table 1 for an estimate of the direct
spending effects of H.R. 5808)
H.R. 5812, Creating Opportunities that
Necessitate New and Enhanced Connections That Improve
Opioid Navigation Strategies Act (CONNECTIONS) Act
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. Twenty-two of the bills discussed in this document
contain direct spending or revenues and are subject to pay-as-
you-go procedures. Details about the amount of direct spending
and revenues in those bills can be found in Table 1.
Increase in long-term direct spending and deficits: CBO
estimates that enacting H.R. 4998, the Health Insurance for
Former Foster Youth Act, would increase net direct spending by
more than $2.5 billion and on-budget deficits by more than $5
billion in at least one of the four consecutive 10-year periods
beginning in 2029.
CBO estimates that none of the remaining 58 bills included
in this estimate would increase net direct spending by more
than $2.5 billion or on-budget deficits by more than $5 billion
in any of the four consecutive 10-year periods beginning in
2029.
Mandates: One of the 59 bills included in this document,
H.R. 5795, would impose both intergovernmental and private-
sector mandates as defined in UMRA. CBO estimates that the
costs of that bill's mandates on public and private entities
would fall below UMRA's thresholds ($80 million and $160
million, respectively, for public- and private-sector entities
in 2018, adjusted annually for inflation).
In addition, five bills would impose private-sector
mandates as defined in UMRA. CBO estimates that the costs of
the mandates in three of those bills (H.R. 5333, H.R. 5554, and
H.R. 5811) would fall below the UMRA threshold. Because CBO
does not know how federal agencies would implement new
authority granted in the other two of those five bills, H.R.
5228 and 5687, CBO cannot determine whether the costs of their
mandates would exceed the threshold.
For large entitlement grant programs, including Medicaid
and CHIP, UMRA defines an increase in the stringency of
conditions on states or localities as an intergovernmental
mandate if the affected governments lack authority to offset
those costs while continuing to provide required services.
Because states possess significant flexibility to alter their
responsibilities within Medicaid and CHIP, the requirements
imposed by various bills in the markup on state administration
of those programs would not constitute mandates as defined in
UMRA.
Mandates Affecting Public and Private Entities
H.R. 5795, the Overdose Prevention and Patient Safety Act,
would impose intergovernmental and private-sector mandates by
requiring entities that provide treatment for substance use
disorders to notify patients of their privacy rights and also
to notify patients in the event that the confidentiality of
their records is breached. In certain circumstances, H.R. 5795
also would prohibit public and private entities from denying
entry to treatment on the basis of information in patient
health records. Those requirements would either supplant or
narrowly expand responsibilities under existing law, and
compliance with them would not impose significant additional
costs. CBO estimates that the costs of the mandates would fall
below the annual thresholds established in UMRA.
Mandates Affecting Private Entities
Five bills included in this document would impose private-
sector mandates:
H.R. 5228, the Stop Counterfeit Drugs by Regulating and
Enhancing Enforcement Now Act, would require drug distributors
to cease distributing any drug that the Secretary of HHS
determines might present an imminent or substantial hazard to
public health. CBO cannot determine what drugs could be subject
to such an order nor can it determine how private entities
would respond. Consequently, CBO cannot determine whether the
aggregate cost of the mandate would exceed the annual threshold
for private-sector mandates.
H.R. 5333, the Over-the-Counter Monograph Safety,
Innovation, and Reform Act of 2018, would require developers
and manufacturers of OTC drugs to pay certain fees to the FDA.
CBO estimates that about $30 million would be collected each
year, on average, for a total of $147 million over the 2019-
2023 period. Those amounts would not exceed the annual
threshold for private-sector mandates in any year during that
period.
H.R. 5554, the Animal Drug and Animal Generic Drug User Fee
Amendments of 2018, would require developers and manufacturers
of brand-name and generic veterinary drugs to pay application,
product, establishment, and sponsor fees to the FDA. CBO
estimates that about $51 million would be collected annually,
on average, for a total of $257 million over the 2019-2023
period. Those amounts would not exceed the annual threshold for
private-sector mandates in any year during that period.
H.R. 5687, the Securing Opioids and Unused Narcotics with
Deliberate Disposal and Packaging Act of 2018, would permit the
Secretary of HHS to require drug developers and manufacturers
to implement new packaging and disposal technology for certain
drugs. Based on information from the agency, CBO expects that
the Secretary would use the new regulatory authority provided
in the bill; however, it is uncertain how or when those
requirements would be implemented. Consequently, CBO cannot
determine whether the aggregate cost of the mandate would
exceed the annual threshold for private entities.
H.R. 5811, a bill to amend the Federal Food, Drug, and
Cosmetic Act with respect to postapproval study requirements
for certain controlled substances, and for other purposes,
would expand an existing mandate that requires drug developers
to conduct postapproval studies or clinical trials for certain
drugs. Under current law, in certain instances, the FDA can
require studies or clinical trials after a drug has been
approved. H.R. 5811 would permit the FDA to use that authority
if the reduction in a drug's effectiveness meant that its
benefits no longer outweighed its costs. CBO estimates that the
incremental cost of the mandate would fall below the annual
threshold established in UMRA because of the small number of
drugs affected and the narrow expansion of the authority that
exists under current law.
None of the remaining 53 bills included in this document
would impose an intergovernmental or private-sector mandate.
Previous CBO estimate: On June 6, 2018, CBO issued an
estimate for seven opioid-related bills ordered reported by the
House Committee on Ways and Means on May 16, 2018. Two of those
bills contain provisions that are identical or similar to the
legislation ordered reported by the Committee on Energy and
Commerce, and for those provisions, CBO's estimates are the
same.
In particular, five bills listed in this estimate contain
provisions that are identical or similar to those in several
sections of H.R. 5773, the Preventing Addiction for Susceptible
Seniors Act of 2018:
H.R. 5675, which would require prescription drug
plans to implement drug management programs, is identical to
section 2 of H.R. 5773.
H.R. 4841, regarding electronic prior
authorization for prescriptions under Medicare's Part D, is
similar to section 3 of H.R. 5773.
H.R. 5715, which would mandate the creation of a
new Internet portal to allow various stakeholders to exchange
information, is identical to section 4 of H.R. 5773.
H.R. 5684, which would expand medication therapy
management, is the same as section 5 of H.R. 5773.
H.R. 5716, regarding prescriber notification, is
identical to section 6 of H.R. 5773.
In addition, in this estimate, a provision related to
Medicare beneficiary education in H.R. 5686, the Medicare Clear
Health Options in Care for Enrollees Act of 2018, is the same
as a provision in section 2 of H.R. 5775, the Providing
Reliable Options for Patients and Educational Resources Act of
2018, in CBO's estimate for the Committee on Ways and Means.
Estimate prepared by: Federal Costs: Rebecca Yip (Centers
for Disease Control and Prevention), Mark Grabowicz (Drug
Enforcement Agency), Julia Christensen, Ellen Werble (Food and
Drug Administration), Emily King, Andrea Noda, Lisa Ramirez-
Branum, Robert Stewart (Medicaid and Children's Health
Insurance Program), Philippa Haven, Lara Robillard, Colin Yee,
Rebecca Yip (Medicare), Philippa Haven (National Institutes of
Health), Alice Burns, Andrea Noda (Office of the Secretary of
the Department of Health and Human Services), Philippa Haven,
Lori Housman, Emily King (Substance Abuse and Mental Health
Services Administration, Health Resources and Services
Administration); Federal Revenues: Jacob Fabian, Peter Huether,
and Cecilia Pastrone; Fact Checking: Zachary Byrum and Kate
Kelly; Mandates: Andrew Laughlin.
Estimate reviewed by: Tom Bradley, Chief, Health Systems
and Medicare Cost Estimates Unit; Chad M. Chirico, Chief, Low-
Income Health Programs and Prescription Drugs Cost Estimates
Unit; Sarah Masi, Special Assistant for Health; Susan Willie,
Chief, Mandates Unit; Leo Lex, Deputy Assistant Director for
Budget Analysis; Theresa A. Gullo, Assistant Director for
Budget Analysis.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is work with
eligible entities, including Quality Improvement Organizations,
to instruct Centers for Medicare and Medicaid Services (CMS) to
add a review of current opioid prescriptions and, as
appropriate, a screening for opioid use disorder as part of the
Welcome to Medicare initial examination.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 5798 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 5798 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Disclosure of Directed Rule Makings
Pursuant to section 3(i) of H. Res. 5, the Committee finds
that H.R. 3331 contains no directed rule makings.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
The section provides that the Act may be cited as the
``Opioid Screening and Chronic Management Alternatives for
Seniors Act.''
Section 2. Requiring a review of current opioid prescriptions for
chronic pain and screening for opioid use disorder to be
included in the Welcome to Medicare initial preventive physical
examination
Section 2 provides that an Initial Preventive Physical
Examination shall include a review of current opioid
prescriptions and screenings for opioid use disorder.
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 (new matter is
printed in italic and existing law in which no change is
proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
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));
(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, and a review of
current opioid prescriptions and screening for opioid use
disorder (as defined in paragraph (4)), 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.
(4)(A) For purposes of paragraph (1), the term ``a review of
current opioid prescriptions and screening for opioid use
disorder'' means, with respect to an individual--
(i) a review by a physician or qualified non-
physician practitioner of all current prescriptions of
the individual; and
(ii) in the case of an individual determined by the
review of a physician or qualified non-physician
practitioner under subparagraph (A) to have a current
prescription for opioids for chronic pain that has been
prescribed for a minimum period of time (as specified
by the Secretary)--
(I) a review by the physician or practitioner
of the potential risk factors to the individual
for opioid use disorder;
(II) an evaluation by the physician or
practitioner of pain of the individual;
(III) the provision of information regarding
non-opioid treatment options for the treatment
and management of any chronic pain of the
individual; and
(IV) if determined necessary by the physician
or practitioner based on the results of the
review and evaluation conducted as described in
this paragraph, an appropriate referral by the
physician or practitioner for additional
treatment.
(B) For purposes of this paragraph, the term ``qualified non-
physician practitioner'' means a physician assistant, nurse
practitioner, or certified clinical nurse specialist.
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.
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