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115th Congress } { Rept. 115-449
HOUSE OF REPRESENTATIVES
1st Session } { Part 1
======================================================================
PROSTATE CANCER MISDIAGNOSIS ELIMINATION ACT OF 2017
_______
December 6, 2017.--Committed to the Comittee 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. 2557]
[Including cost estimate of the Congressional Budget Office]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 2557) to amend title XVIII of the Social
Security Act to provide for coverage under the Medicare program
of certain DNA Specimen Provenance Assay clinical diagnostic
laboratory tests, having considered the same, report favorably
thereon with an amendment and recommend that the bill as
amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 3
Committee Action................................................. 3
Committee Votes.................................................. 4
Oversight Findings and Recommendations........................... 4
New Budget Authority, Entitlement Authority, and Tax Expenditures 4
Congressional Budget Office Estimate............................. 4
Federal Mandates Statement....................................... 6
Statement of General Performance Goals and Objectives............ 7
Duplication of Federal Programs.................................. 7
Committee Cost Estimate.......................................... 7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 7
Disclosure of Directed Rule Makings.............................. 7
Advisory Committee Statement..................................... 7
Applicability to Legislative Branch.............................. 7
Section-by-Section Analysis of the Legislation................... 7
Changes in Existing Law Made by the Bill, as Reported............ 8
Exchange of Letters with Additional Committees of Referral....... 40
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Prostate Cancer Misdiagnosis
Elimination Act of 2017''.
SEC. 2. COVERAGE OF CERTAIN DNA SPECIMEN PROVENANCE ASSAY CLINICAL
DIAGNOSTIC LABORATORY TESTS UNDER MEDICARE.
(a) Coverage.--Section 1862(a)(1) of the Social Security Act (42
U.S.C. 1395y(a)(1)) is amended--
(1) in subparagraph (O), by striking ``and'' at the end;
(2) in subparagraph (P), by striking the semicolon at the end
and inserting ``, and''; and
(3) by adding at the end the following new subparagraph:
``(Q) in the case of a DNA Specimen Provenance Assay clinical
diagnostic laboratory test (DSPA test) furnished on or after
the date specified in section 1834A(j)(4), unless the DSPA test
is furnished to an individual enrolled under part B who has had
a prostate cancer biopsy the results of which are positive, the
DSPA test is furnished with respect to such biopsy, and the
DSPA test is ordered by the physician who furnished the
prostate cancer biopsy that obtained the specimen tested;''.
(b) Temporary Payment Amount for Certain Tests Furnished Before 2028
and Related Requirements.--Section 1834A of the Social Security Act (42
U.S.C. 1395m-1) is amended--
(1) in subsection (b)(1)(A), by striking ``and (d)'' and
inserting ``, (d), and (j)''; and
(2) by adding at the end the following new subsection:
``(j) DNA Specimen Provenance Assay Clinical Diagnostic Laboratory
Tests.--
``(1) Temporary payment amount for certain tests furnished
before 2028.--With respect to a DNA Specimen Provenance Assay
clinical diagnostic laboratory test furnished on or after the
date specified in paragraph (4) and before January 1, 2028, the
payment amount under this section for such test shall be equal
to $200.
``(2) HCPCS code and modifier assignment.--
``(A) In general.--The Secretary shall assign one or
more HCPCS codes to the DNA Specimen Provenance Assay
clinical diagnostic laboratory test and may use a
modifier to facilitate making payment under this
section with respect to such test.
``(B) Identification of dna match on claim.--The
Secretary shall require an indication on a claim for a
DNA Specimen Provenance Assay clinical diagnostic
laboratory test of whether the DNA of the prostate
biopsy specimen for such test matches the DNA of the
individual with respect to whom the test was ordered.
Such indication may be made through use of a HCPCS
code, a modifier, or other means, as determined
appropriate by the Secretary.
``(3) DNA match review.--
``(A) In general.--The Secretary shall review at
least three years of claims under part B for DNA
Specimen Provenance Assay clinical diagnostic
laboratory tests to identify whether the DNA of the
prostate biopsy specimens for such tests matched the
DNA of the individuals with respect to whom such tests
were ordered.
``(B) Posting on internet website.--Not later than
July 1, 2024, the Secretary shall post on the Internet
website of the Centers for Medicare & Medicaid Services
the findings of the review conducted under subparagraph
(A).
``(4) Date specified.--For purposes of paragraph (1) and
section 1862(a)(1)(Q), the date specified in this paragraph is
the first day of the second calendar quarter that begins at
least 180 days after the date of the enactment of this
subsection.''.
Purpose and Summary
H.R. 2557 was introduced on May 19, 2017, by Rep. Larry
Bucshon (R-IN). H.R. 2557 would provide Medicare coverage of
DNA Specimen Provenance Assay (DPSA) testing for positive
prostate biopsy tests to ensure that there are no specimen
provenance complications. DPSA is a diagnostic tool that can
address the chances of a false diagnosis, with the potential to
prevent unnecessary and costly treatment protocols. DPSA
compares the DNA of the patient to the DNA of the tissue sample
tested for cancer. Currently, this test is not covered under
the Medicare payment program due to its classification as
``quality assurance'' rather than a diagnostic test.
Background and Need for Legislation
Prostate cancer affects the lives of one in seven American
men. The current method to diagnose prostate cancer is via
needle biopsy of the prostate. Prostate cancer is diagnosed
with a 10 to 12 samples needle biopsy to detect for cancerous
cells, a protocol that became the clinical standard in 2010 and
improved the detection rates of prostate cancer.\1\ Over
800,000 prostate biopsies are performed on men each year. The
Committee received testimony that the transposition of one
patient's prostate biopsy specimen with another patient occurs
at a higher rate than other testing due to the number of
specimens collected at biopsy. Despite the most rigorous
protocols for obtaining and handling specimens, peer-reviewed
medical literature shows that about 2.5 percent of prostate
biopsies are subject to specimen provenance complications,
where a specimen from one patient is transposed with or
contaminated by that of another patient.
This leads to patients receiving false-negatives, and
losing the opportunity to treat their cancer at its earliest
possible stage, but also patients receiving false-positives--an
estimated 1.28 percent, according to peer-reviewed literature--
are erroneously told they have prostate cancer when they do
not. This can result in unnecessary, expensive, and invasive
procedures, including radical prostatectomy and radiation
therapy. An April 2016 report by Milliman projects that $539
million will be spent by Medicare on prostate cancer treatment
over the next 10 years for the 1.28 percent of beneficiaries
who are erroneously told they have prostate cancer due to
specimen provenance complications.
DSPA testing matches each patient's unique genetic profile
to that of the diagnostic tissue read by a pathologist in order
to rule out the presence of undetected provenance complications
prior to treatment. This ensures the proper patient is matched
to his specimen. Medicare currently does not provide coverage
of these tests. H.R. 2557 would provide coverage in conjunction
with a positive biopsy.
Committee Action
On July 20, 2017, the Subcommittee on Health held a hearing
on H.R. 2557. The hearing was entitled ``Examining Bipartisan
Legislation to Improve the Medicare Program.'' The Subcommittee
received testimony from:
Christel Aprigliano, CEO, Diabetes Patient
Advocacy Coalition;
Lisa Bardach, Speech-Language Pathologist,
ALS of Michigan;
K. Eric De Jonge, President-Elect, American
Academy of Home Care Medicine (AAHCM);
Cletis Earle, Chairman-Elect, CHIME Board of
Trustees;
Mary Grealy, President, Healthcare
Leadership Council;
Deepak A. Kapoor, Chairman and CEO,
Integrated Medical Professionals;
Brett Kissela, Chair, Department of
Neurology and Rehabilitation Medicine, University of
Cincinnati Gardner Neuroscience Institute, on behalf of
American Academy of Neurology;
Justin Moore, CEO, American Physical Therapy
Association;
Alan E. Morrison, Chair, Diagnostic Services
Committee, National Association for the Support of Long
Term Care (NASL);
Varner Richards, Board Chair, National Home
Infusion Association; and
Stacy Sanders, Federal Policy Director,
Medicare Rights Center.
On September 13, 2017, the Subcommittee on Health met in
open markup session and forwarded H.R. 2557, without amendment,
to the full Committee by a voice vote. On October 4, 2017, the
full Committee on Energy and Commerce met in open markup
session and ordered H.R. 2557, as amended, favorably reported
to the House by a voice vote.
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. 2557 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. 2557 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, October 24, 2017.
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 cost estimate for H.R. 2557, the Prostate
Cancer Misdiagnosis Elimination Act of 2017.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contacts are Lara
Robillard and Rebecca Yip.
Sincerely,
Keith Hall,
Director.
Enclosure.
H.R. 2557--Prostate Cancer Misdiagnosis Elimination Act of 2017
Summary: H.R. 2557 would require the Medicare program to
cover a certain type of laboratory test for beneficiaries who
test positive for prostate cancer. CBO estimates that H.R. 2557
would, on net, decrease direct spending by $7 million over the
2018-2027 period.
Enacting H.R. 2557 would affect direct spending; therefore,
pay-as-you-go procedures apply. The legislation would not
affect revenues.
CBO estimates that enacting H.R. 2557 would not increase
net direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2028.
H.R. 2557 contains no intergovernmental or private-sector
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
Estimated cost to the Federal Government: The estimated
budgetary effect of H.R. 2557 is shown in the following table.
The costs of this legislation fall within budget function 570
(Medicare).
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2018-2022 2018-2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
INCREASES OR DECREASES (-) IN DIRECT SPENDING
Estimated Budget Authority.................................. 0 1 1 0 0 -1 -1 -2 -2 -3 2 -7
Estimated Outlays........................................... 0 1 1 0 0 -1 -1 -2 -2 -3 2 -7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Basis of estimate: For this estimate, CBO assumes that H.R.
2557 will be enacted early in fiscal year 2018.
H.R. 2557 would establish Medicare coverage of and payment
for the DNA specimen provenance assay (DSPA) laboratory test.
The DSPA tests genetic material in a prostate cancer biopsy
specimen to ensure that the sample came from the beneficiary to
whom it is attributed.
CBO analyzed Medicare utilization data and estimates that
Medicare paid for about 148,000 prostate biopsies in 2016.
Based on discussions with stakeholders and a review of clinical
literature, CBO estimates that about 40 percent of biopsies are
positive. CBO expects that it would take some time for
clinicians to adopt the DSPA technology. By the end of the
2018-2027 period, CBO estimates that about half of all positive
biopsies would lead to a DSPA test. H.R. 2557 would set the
Medicare payment for DSPA at $200 until January 1, 2028, after
which it would be paid under the Medicare's fee schedule for
clinical laboratory tests. CBO estimates that Medicare would
spend $46 million over the 2018-2028 period on DSPA tests.
When men are diagnosed with prostate cancer, they can
choose either active treatment (including surgery, radiation,
and chemotherapy) or they can choose active surveillance, also
called watchful waiting. CBO estimates that the average annual
cost of prostate cancer treatment, accounting for both active
treatment and active surveillance, is about $13,000. Clinical
data indicate that some prostate biopsies yield false
positives, resulting in treatment for men who do not actually
have the disease. CBO expects that Medicare coverage would lead
to more DSPA testing, which would reduce the number of false
positives and thus fewer men would be treated for prostate
cancer they do not have. Based on clinical information and
discussions with stakeholders, CBO estimates that about 1.5
percent of these tests would reveal a false positive and
prevent some men from receiving unnecessary treatment. CBO
estimates the number of men who are not treated because of DSPA
results would rise from about 60 in 2019 to 450 in 2027. Over
the 2018-2027 period, CBO expects that Medicare coverage of
DSPA would reduce treatment costs associated with false
positive tests by about $51 million.
On net, taking into account both increased spending for the
DSPA test and averted treatment costs, CBO estimates that H.R.
2557 would decrease Medicare spending for patients in the fee-
for-service sector by $5 million. After taking into account
interactions with the Part B premium and payments to Medicare
Advantage plans, CBO estimates that the legislation would
reduce net direct spending by $7 million over the 2018-2027
period.
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. The net changes in outlays that are subject to those
pay-as-you-go procedures are shown in the following table.
CBO ESTIMATE OF PAY-AS-YOU-GO EFFECTS FOR H.R. 2557, AS ORDERED REPORTED BY THE HOUSE COMMITTEE ON ENERGY AND COMMERCE ON OCTOBER 4, 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
By fiscal year, in millions of dollars--
-------------------------------------------------------------------------------------------
2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2018-2022 2018-2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
NET INCREASE OR DECREASE (-) IN THE DEFICIT
Statutory Pay-As-You-Go Impact.............................. 0 1 1 0 0 -1 -1 -2 -2 -3 2 -7
--------------------------------------------------------------------------------------------------------------------------------------------------------
Increase in long-term direct spending and deficits: CBO
estimates that enacting the legislation would not increase net
direct spending or on-budget deficits in any of the four
consecutive 10-year periods beginning in 2028.
Intergovernmental and private-sector impact: H.R. 2557
contains no intergovernmental or private-sector mandates as
defined in UMRA.
Estimate prepared by: Federal costs: Lara Robillard and
Rebecca Yip; Impact on state, local, and tribal governments and
the private sector: Amy Petz.
Estimate approved by: Theresa 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 to provide
Medicare coverage of DPSA testing for positive prostate biopsy
tests to ensure that there are no specimen provenance
complications.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 2557 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. 2557 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. 2557 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
Section 1 provides that the Act may be cited as the
``Prostate Cancer Misdiagnosis Elimination Act.''
Section 2. Coverage of certain DNA specimen provenance assay clinical
diagnostic laboratory tests under medicare
Section 2 provides for coverage of DNA Specimen Provenance
Assay (DPSA) testing beginning January 1, 2018, setting the
payment rate for the test and mandating the assignment of an
HCPCS code to the test. This section also allows the use of a
modifier to facilitate payment. Finally, the section mandates a
post-payment review, which is to be made public on the Centers
for Medicare and Medicaid Services website no later than July
1, 2019.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italic, and existing law in which no
change is proposed is shown in roman):
SOCIAL SECURITY ACT
* * * * * * *
TITLE XVIII--HEALTH INSURANCE FOR THE AGED AND DISABLED
* * * * * * *
Part B--Supplementary Medical Insurance Benefits for the Aged and
Disabled
* * * * * * *
SEC. 1834A. IMPROVING POLICIES FOR CLINICAL DIAGNOSTIC LABORATORY
TESTS.
(a) Reporting of Private Sector Payment Rates for
Establishment of Medicare Payment Rates.--
(1) In general.--Beginning January 1, 2016, and every
3 years thereafter (or, annually, in the case of
reporting with respect to an advanced diagnostic
laboratory test, as defined in subsection (d)(5)), an
applicable laboratory (as defined in paragraph (2))
shall report to the Secretary, at a time specified by
the Secretary, applicable information (as defined in
paragraph (3)) for a data collection period (as defined
in paragraph (4)) for each clinical diagnostic
laboratory test that the laboratory furnishes during
such period for which payment is made under this part.
(2) Definition of applicable laboratory.--In this
section, the term ``applicable laboratory'' means a
laboratory that, with respect to its revenues under
this title, a majority of such revenues are from this
section, section 1833(h), or section 1848. The
Secretary may establish a low volume or low expenditure
threshold for excluding a laboratory from the
definition of applicable laboratory under this
paragraph, as the Secretary determines appropriate.
(3) Applicable information defined.--
(A) In general.--In this section, subject to
subparagraph (B), the term ``applicable
information'' means, with respect to a
laboratory test for a data collection period,
the following:
(i) The payment rate (as determined
in accordance with paragraph (5)) that
was paid by each private payor for the
test during the period.
(ii) The volume of such tests for
each such payor for the period.
(B) Exception for certain contractual
arrangements.--Such term shall not include
information with respect to a laboratory test
for which payment is made on a capitated basis
or other similar payment basis during the data
collection period.
(4) Data collection period defined.--In this section,
the term ``data collection period'' means a period of
time, such as a previous 12 month period, specified by
the Secretary.
(5) Treatment of discounts.--The payment rate
reported by a laboratory under this subsection shall
reflect all discounts, rebates, coupons, and other
price concessions, including those described in section
1847A(c)(3).
(6) Ensuring complete reporting.--In the case where
an applicable laboratory has more than one payment rate
for the same payor for the same test or more than one
payment rate for different payors for the same test,
the applicable laboratory shall report each such
payment rate and the volume for the test at each such
rate under this subsection. Beginning with January 1,
2019, the Secretary may establish rules to aggregate
reporting with respect to the situations described in
the preceding sentence.
(7) Certification.--An officer of the laboratory
shall certify the accuracy and completeness of the
information reported under this subsection.
(8) Private payor defined.--In this section, the term
``private payor'' means the following:
(A) A health insurance issuer and a group
health plan (as such terms are defined in
section 2791 of the Public Health Service Act).
(B) A Medicare Advantage plan under part C.
(C) A medicaid managed care organization (as
defined in section 1903(m)).
(9) Civil money penalty.--
(A) In general.--If the Secretary determines
that an applicable laboratory has failed to
report or made a misrepresentation or omission
in reporting information under this subsection
with respect to a clinical diagnostic
laboratory test, the Secretary may apply a
civil money penalty in an amount of up to
$10,000 per day for each failure to report or
each such misrepresentation or omission.
(B) Application.--The provisions of section
1128A (other than subsections (a) and (b))
shall apply to a civil money penalty under this
paragraph in the same manner as they apply to a
civil money penalty or proceeding under section
1128A(a).
(10) Confidentiality of information.--Notwithstanding
any other provision of law, information disclosed by a
laboratory under this subsection is confidential and
shall not be disclosed by the Secretary or a Medicare
contractor in a form that discloses the identity of a
specific payor or laboratory, or prices charged or
payments made to any such laboratory, except--
(A) as the Secretary determines to be
necessary to carry out this section;
(B) to permit the Comptroller General to
review the information provided;
(C) to permit the Director of the
Congressional Budget Office to review the
information provided; and
(D) to permit the Medicare Payment Advisory
Commission to review the information provided.
(11) Protection from public disclosure.--A payor
shall not be identified on information reported under
this subsection. The name of an applicable laboratory
under this subsection shall be exempt from disclosure
under section 552(b)(3) of title 5, United States Code.
(12) Regulations.--Not later than June 30, 2015, the
Secretary shall establish through notice and comment
rulemaking parameters for data collection under this
subsection.
(b) Payment for Clinical Diagnostic Laboratory Tests.--
(1) Use of private payor rate information to
determine medicare payment rates.--
(A) In general.--Subject to paragraph (3) and
subsections (c) [and (d)], (d), and (j), in the
case of a clinical diagnostic laboratory test
furnished on or after January 1, 2017, the
payment amount under this section shall be
equal to the weighted median determined for the
test under paragraph (2) for the most recent
data collection period.
(B) Application of payment amounts to
hospital laboratories.--The payment amounts
established under this section shall apply to a
clinical diagnostic laboratory test furnished
by a hospital laboratory if such test is paid
for separately, and not as part of a bundled
payment under section 1833(t).
(2) Calculation of weighted median.--For each
laboratory test with respect to which information is
reported under subsection (a) for a data collection
period, the Secretary shall calculate a weighted median
for the test for the period, by arraying the
distribution of all payment rates reported for the
period for each test weighted by volume for each payor
and each laboratory.
(3) Phase-in of reductions from private payor rate
implementation.--
(A) In general.--Payment amounts determined
under this subsection for a clinical diagnostic
laboratory test for each of 2017 through 2022
shall not result in a reduction in payments for
a clinical diagnostic laboratory test for the
year of greater than the applicable percent (as
defined in subparagraph (B)) of the amount of
payment for the test for the preceding year.
(B) Applicable percent defined.--In this
paragraph, the term ``applicable percent''
means--
(i) for each of 2017 through 2019, 10
percent; and
(ii) for each of 2020 through 2022,
15 percent.
(C) No application to new tests.--This
paragraph shall not apply to payment amounts
determined under this section for either of the
following.
(i) A new test under subsection (c).
(ii) A new advanced diagnostic test
(as defined in subsection (d)(5)) under
subsection (d).
(4) Application of market rates.--
(A) In general.--Subject to paragraph (3),
once established for a year following a data
collection period, the payment amounts under
this subsection shall continue to apply until
the year following the next data collection
period.
(B) Other adjustments not applicable.--The
payment amounts under this section shall not be
subject to any adjustment (including any
geographic adjustment, budget neutrality
adjustment, annual update, or other
adjustment).
(5) Sample collection fee.--In the case of a sample
collected from an individual in a skilled nursing
facility or by a laboratory on behalf of a home health
agency, the nominal fee that would otherwise apply
under section 1833(h)(3)(A) shall be increased by $2.
(c) Payment for New Tests that are not Advanced Diagnostic
Laboratory Tests.--
(1) Payment during initial period.--In the case of a
clinical diagnostic laboratory test that is assigned a
new or substantially revised HCPCS code on or after the
date of enactment of this section, and which is not an
advanced diagnostic laboratory test (as defined in
subsection (d)(5)), during an initial period until
payment rates under subsection (b) are established for
the test, payment for the test shall be determined--
(A) using cross-walking (as described in
section 414.508(a) of title 42, Code of Federal
Regulations, or any successor regulation) to
the most appropriate existing test under the
fee schedule under this section during that
period; or
(B) if no existing test is comparable to the
new test, according to the gapfilling process
described in paragraph (2).
(2) Gapfilling process described.--The gapfilling
process described in this paragraph shall take into
account the following sources of information to
determine gapfill amounts, if available:
(A) Charges for the test and routine
discounts to charges.
(B) Resources required to perform the test.
(C) Payment amounts determined by other
payors.
(D) Charges, payment amounts, and resources
required for other tests that may be comparable
or otherwise relevant.
(E) Other criteria the Secretary determines
appropriate.
(3) Additional consideration.--In determining the
payment amount under crosswalking or gapfilling
processes under this subsection, the Secretary shall
consider recommendations from the panel established
under subsection (f)(1).
(4) Explanation of payment rates.--In the case of a
clinical diagnostic laboratory test for which payment
is made under this subsection, the Secretary shall make
available to the public an explanation of the payment
rate for the test, including an explanation of how the
criteria described in paragraph (2) and paragraph (3)
are applied.
(d) Payment for New Advanced Diagnostic Laboratory Tests.--
(1) Payment during initial period.--
(A) In general.--In the case of an advanced
diagnostic laboratory test for which payment
has not been made under the fee schedule under
section 1833(h) prior to the date of enactment
of this section, during an initial period of
three quarters, the payment amount for the test
for such period shall be based on the actual
list charge for the laboratory test.
(B) Actual list charge.--For purposes of
subparagraph (A), the term ``actual list
charge'', with respect to a laboratory test
furnished during such period, means the
publicly available rate on the first day at
which the test is available for purchase by a
private payor.
(2) Special rule for timing of initial reporting.--
With respect to an advanced diagnostic laboratory test
described in paragraph (1)(A), an applicable laboratory
shall initially be required to report under subsection
(a) not later than the last day of the second quarter
of the initial period under such paragraph.
(3) Application of market rates after initial
period.--Subject to paragraph (4), data reported under
paragraph (2) shall be used to establish the payment
amount for an advanced diagnostic laboratory test after
the initial period under paragraph (1)(A) using the
methodology described in subsection (b). Such payment
amount shall continue to apply until the year following
the next data collection period.
(4) Recoupment if actual list charge exceeds market
rate.--With respect to the initial period described in
paragraph (1)(A), if, after such period, the Secretary
determines that the payment amount for an advanced
diagnostic laboratory test under paragraph (1)(A) that
was applicable during the period was greater than 130
percent of the payment amount for the test established
using the methodology described in subsection (b) that
is applicable after such period, the Secretary shall
recoup the difference between such payment amounts for
tests furnished during such period.
(5) Advanced diagnostic laboratory test defined.--In
this subsection, the term ``advanced diagnostic
laboratory test'' means a clinical diagnostic
laboratory test covered under this part that is offered
and furnished only by a single laboratory and not sold
for use by a laboratory other than the original
developing laboratory (or a successor owner) and meets
one of the following criteria:
(A) The test is an analysis of multiple
biomarkers of DNA, RNA, or proteins combined
with a unique algorithm to yield a single
patient-specific result.
(B) The test is cleared or approved by the
Food and Drug Administration.
(C) The test meets other similar criteria
established by the Secretary.
(e) Coding.--
(1) Temporary codes for certain new tests.--
(A) In general.--The Secretary shall adopt
temporary HCPCS codes to identify new advanced
diagnostic laboratory tests (as defined in
subsection (d)(5)) and new laboratory tests
that are cleared or approved by the Food and
Drug Administration.
(B) Duration.--
(i) In general.--Subject to clause
(ii), the temporary code shall be
effective until a permanent HCPCS code
is established (but not to exceed 2
years).
(ii) Exception.--The Secretary may
extend the temporary code or establish
a permanent HCPCS code, as the
Secretary determines appropriate.
(2) Existing tests.--Not later than January 1, 2016,
for each existing advanced diagnostic laboratory test
(as so defined) and each existing clinical diagnostic
laboratory test that is cleared or approved by the Food
and Drug Administration for which payment is made under
this part as of the date of enactment of this section,
if such test has not already been assigned a unique
HCPCS code, the Secretary shall--
(A) assign a unique HCPCS code for the test;
and
(B) publicly report the payment rate for the
test.
(3) Establishment of unique identifier for certain
tests.--For purposes of tracking and monitoring, if a
laboratory or a manufacturer requests a unique
identifier for an advanced diagnostic laboratory test
(as so defined) or a laboratory test that is cleared or
approved by the Food and Drug Administration, the
Secretary shall utilize a means to uniquely track such
test through a mechanism such as a HCPCS code or
modifier.
(f) Input From Clinicians and Technical Experts.--
(1) In general.--The Secretary shall consult with an
expert outside advisory panel, established by the
Secretary not later than July 1, 2015, composed of an
appropriate selection of individuals with expertise,
which may include molecular pathologists, researchers,
and individuals with expertise in laboratory science or
health economics, in issues related to clinical
diagnostic laboratory tests, which may include the
development, validation, performance, and application
of such tests, to provide--
(A) input on--
(i) the establishment of payment
rates under this section for new
clinical diagnostic laboratory tests,
including whether to use crosswalking
or gapfilling processes to determine
payment for a specific new test; and
(ii) the factors used in determining
coverage and payment processes for new
clinical diagnostic laboratory tests;
and
(B) recommendations to the Secretary under
this section.
(2) Compliance with faca.--The panel shall be subject
to the Federal Advisory Committee Act (5 U.S.C. App.).
(3) Continuation of annual meeting.--The Secretary
shall continue to convene the annual meeting described
in section 1833(h)(8)(B)(iii) after the implementation
of this section for purposes of receiving comments and
recommendations (and data on which the recommendations
are based) as described in such section on the
establishment of payment amounts under this section.
(g) Coverage.--
(1) Issuance of coverage policies.--
(A) In general.--A medicare administrative
contractor shall only issue a coverage policy
with respect to a clinical diagnostic
laboratory test in accordance with the process
for making a local coverage determination (as
defined in section 1869(f)(2)(B)), including
the appeals and review process for local
coverage determinations under part 426 of title
42, Code of Federal Regulations (or successor
regulations).
(B) No effect on national coverage
determination process.--This paragraph shall
not apply to the national coverage
determination process (as defined in section
1869(f)(1)(B)).
(C) Effective date.--This paragraph shall
apply to coverage policies issued on or after
January 1, 2015.
(2) Designation of one or more medicare
administrative contractors for clinical diagnostic
laboratory tests.--The Secretary may designate one or
more (not to exceed 4) medicare administrative
contractors to either establish coverage policies or
establish coverage policies and process claims for
payment for clinical diagnostic laboratory tests, as
determined appropriate by the Secretary.
(h) Implementation.--
(1) Implementation.--There shall be no administrative
or judicial review under section 1869, section 1878, or
otherwise, of the establishment of payment amounts
under this section.
(2) Administration.--Chapter 35 of title 44, United
States Code, shall not apply to information collected
under this section.
(3) Funding.--For purposes of implementing this
section, the Secretary shall provide for the transfer,
from the Federal Supplementary Medical Insurance Trust
Fund under section 1841, to the Centers for Medicare &
Medicaid Services Program Management Account, for each
of fiscal years 2014 through 2018, $4,000,000, and for
each of fiscal years 2019 through 2023, $3,000,000.
Amounts transferred under the preceding sentence shall
remain available until expended.
(i) Transitional Rule.--During the period beginning on the
date of enactment of this section and ending on December 31,
2016, with respect to advanced diagnostic laboratory tests
under this part, the Secretary shall use the methodologies for
pricing, coding, and coverage in effect on the day before such
date of enactment, which may include cross-walking or
gapfilling methods.
(j) DNA Specimen Provenance Assay Clinical Diagnostic
Laboratory Tests.--
(1) Temporary payment amount for certain tests
furnished before 2028.--With respect to a DNA Specimen
Provenance Assay clinical diagnostic laboratory test
furnished on or after the date specified in paragraph
(4) and before January 1, 2028, the payment amount
under this section for such test shall be equal to
$200.
(2) HCPCS code and modifier assignment.--
(A) In general.--The Secretary shall assign
one or more HCPCS codes to the DNA Specimen
Provenance Assay clinical diagnostic laboratory
test and may use a modifier to facilitate
making payment under this section with respect
to such test.
(B) Identification of dna match on claim.--
The Secretary shall require an indication on a
claim for a DNA Specimen Provenance Assay
clinical diagnostic laboratory test of whether
the DNA of the prostate biopsy specimen for
such test matches the DNA of the individual
with respect to whom the test was ordered. Such
indication may be made through use of a HCPCS
code, a modifier, or other means, as determined
appropriate by the Secretary.
(3) DNA match review.--
(A) In general.--The Secretary shall review
at least three years of claims under part B for
DNA Specimen Provenance Assay clinical
diagnostic laboratory tests to identify whether
the DNA of the prostate biopsy specimens for
such tests matched the DNA of the individuals
with respect to whom such tests were ordered.
(B) Posting on internet website.--Not later
than July 1, 2024, the Secretary shall post on
the Internet website of the Centers for
Medicare & Medicaid Services the findings of
the review conducted under subparagraph (A).
(4) Date specified.--For purposes of paragraph (1)
and section 1862(a)(1)(Q), the date specified in this
paragraph is the first day of the second calendar
quarter that begins at least 180 days after the date of
the enactment of this subsection.
* * * * * * *
Part E--Miscellaneous Provisions
* * * * * * *
exclusions from coverage and medicare as secondary payer
Sec. 1862. (a) Notwithstanding any other provision of this
title, no payment may be made under part A or part B for any
expenses incurred for items or services--
(1)(A) which, except for items and services described
in a succeeding subparagraph or additional preventive
services (as described in section 1861(ddd)(1)), are
not reasonable and necessary for the diagnosis or
treatment of illness or injury or to improve the
functioning of a malformed body member,
(B) in the case of items and services described in
section 1861(s)(10), which are not reasonable and
necessary for the prevention of illness,
(C) in the case of hospice care, which are not
reasonable and necessary for the palliation or
management of terminal illness,
(D) in the case of clinical care items and services
provided with the concurrence of the Secretary and with
respect to research and experimentation conducted by,
or under contract with, the Medicare Payment Advisory
Commission or the Secretary, which are not reasonable
and necessary to carry out the purposes of section
1886(e)(6),
(E) in the case of research conducted pursuant to
section 1142, which is not reasonable and necessary to
carry out the purposes of that section,
(F) in the case of screening mammography, which is
performed more frequently than is covered under section
1834(c)(2) or which is not conducted by a facility
described in section 1834(c)(1)(B), in the case of
screening pap smear and screening pelvic exam, which is
performed more frequently than is provided under
section 1861(nn), and, in the case of screening for
glaucoma, which is performed more frequently than is
provided under section 1861(uu),
(G) in the case of prostate cancer screening tests
(as defined in section 1861(oo)), which are performed
more frequently than is covered under such section,
(H) in the case of colorectal cancer screening tests,
which are performed more frequently than is covered
under section 1834(d),
(I) the frequency and duration of home health
services which are in excess of normative guidelines
that the Secretary shall establish by regulation,
(J) in the case of a drug or biological specified in
section 1847A(c)(6)(C) for which payment is made under
part B that is furnished in a competitive area under
section 1847B, that is not furnished by an entity under
a contract under such section,
(K) in the case of an initial preventive physical
examination, which is performed more than 1 year after
the date the individual's first coverage period begins
under part B,
(L) in the case of cardiovascular screening blood
tests (as defined in section 1861(xx)(1)), which are
performed more frequently than is covered under section
1861(xx)(2),
(M) in the case of a diabetes screening test (as
defined in section 1861(yy)(1)), which is performed
more frequently than is covered under section
1861(yy)(3),
(N) in the case of ultrasound screening for abdominal
aortic aneurysm which is performed more frequently than
is provided for under section 1861(s)(2)(AA),
(O) in the case of kidney disease education services
(as defined in paragraph (1) of section 1861(ggg)),
which are furnished in excess of the number of sessions
covered under paragraph (4) of such section, [and]
(P) in the case of personalized prevention plan
services (as defined in section 1861(hhh)(1)), which
are performed more frequently than is covered under
such section[;], and
(Q) in the case of a DNA Specimen Provenance Assay
clinical diagnostic laboratory test (DSPA test)
furnished on or after the date specified in section
1834A(j)(4), unless the DSPA test is furnished to an
individual enrolled under part B who has had a prostate
cancer biopsy the results of which are positive, the
DSPA test is furnished with respect to such biopsy, and
the DSPA test is ordered by the physician who furnished
the prostate cancer biopsy that obtained the specimen
tested;
(2) for which the individual furnished such items or
services has no legal obligation to pay, and which no
other person (by reason of such individual's membership
in a prepayment plan or otherwise) has a legal
obligation to provide or pay for, except in the case of
Federally qualified health center services;
(3) which are paid for directly or indirectly by a
governmental entity (other than under this Act and
other than under a health benefits or insurance plan
established for employees of such an entity), except in
the case of rural health clinic services, as defined in
section 1861(aa)(1), in the case of Federally qualified
health center services, as defined in section
1861(aa)(3), in the case of services for which payment
may be made under section 1880(e), and in such other
cases as the Secretary may specify;
(4) which are not provided within the United States
(except for inpatient hospital services furnished
outside the United States under the conditions
described in section 1814(f) and, subject to such
conditions, limitations, and requirements as are
provided under or pursuant to this title, physicians'
services and ambulance services furnished an individual
in conjunction with such inpatient hospital services
but only for the period during which such inpatient
hospital services were furnished);
(5) which are required as a result of war, or of an
act of war, occurring after the effective date of such
individual's current coverage under such part;
(6) which constitute personal comfort items (except,
in the case of hospice care, as is otherwise permitted
under paragraph (1)(C));
(7) where such expenses are for routine physical
checkups, eyeglasses (other than eyewear described in
section 1861(s)(8)) or eye examinations for the purpose
of prescribing, fitting, or changing eyeglasses,
procedures performed (during the course of any eye
examination) to determine the refractive state of the
eyes, hearing aids or examinations therefor, or
immunizations (except as otherwise allowed under
section 1861(s)(10) and subparagraph (B), (F), (G),
(H), (K), or (P) of paragraph (1));
(8) where such expenses are for orthopedic shoes or
other supportive devices for the feet, other than shoes
furnished pursuant to section 1861(s)(12);
(9) where such expenses are for custodial care
(except, in the case of hospice care, as is otherwise
permitted under paragraph (1)(C));
(10) where such expenses are for cosmetic surgery or
are incurred in connection therewith, except as
required for the prompt repair of accidental injury or
for improvement of the functioning of a malformed body
member;
(11) where such expenses constitute charges imposed
by immediate relatives of such individual or members of
his household;
(12) where such expenses are for services in
connection with the care, treatment, filling, removal,
or replacement of teeth or structures directly
supporting teeth, except that payment may be made under
part A in the case of inpatient hospital services in
connection with the provision of such dental services
if the individual, because of his underlying medical
condition and clinical status or because of the
severity of the dental procedure, requires
hospitalization in connection with the provision of
such services;
(13) where such expenses are for--
(A) the treatment of flat foot conditions and
the prescription of supportive devices
therefor,
(B) the treatment of subluxations of the
foot, or
(C) routine foot care (including the cutting
or removal of corns or calluses, the trimming
of nails, and other routine hygienic care);
(14) which are other than physicians' services (as
defined in regulations promulgated specifically for
purposes of this paragraph), services described by
section 1861(s)(2)(K), certified nurse-midwife
services, qualified psychologist services, and services
of a certified registered nurse anesthetist, and which
are furnished to an individual who is a patient of a
hospital or critical access hospital by an entity other
than the hospital or critical access hospital, unless
the services are furnished under arrangements (as
defined in section 1861(w)(1)) with the entity made by
the hospital or critical access hospital;
(15)(A) which are for services of an assistant at
surgery in a cataract operation (including subsequent
insertion of an intraocular lens) unless, before the
surgery is performed, the appropriate quality
improvement organization (under part B of title XI) or
a carrier under section 1842 has approved of the use of
such an assistant in the surgical procedure based on
the existence of a complicating medical condition, or
(B) which are for services of an assistant at surgery
to which section 1848(i)(2)(B) applies;
(16) in the case in which funds may not be used for
such items and services under the Assisted Suicide
Funding Restriction Act of 1997;
(17) where the expenses are for an item or service
furnished in a competitive acquisition area (as
established by the Secretary under section 1847(a)) by
an entity other than an entity with which the Secretary
has entered into a contract under section 1847(b) for
the furnishing of such an item or service in that area,
unless the Secretary finds that the expenses were
incurred in a case of urgent need, or in other
circumstances specified by the Secretary;
(18) which are covered skilled nursing facility
services described in section 1888(e)(2)(A)(i) and
which are furnished to an individual who is a resident
of a skilled nursing facility during a period in which
the resident is provided covered post-hospital extended
care services (or, for services described in section
1861(s)(2)(D), which are furnished to such an
individual without regard to such period), by an entity
other than the skilled nursing facility, unless the
services are furnished under arrangements (as defined
in section 1861(w)(1)) with the entity made by the
skilled nursing facility;
(19) which are for items or services which are
furnished pursuant to a private contract described in
section 1802(b);
(20) in the case of outpatient physical therapy
services, outpatient speech-language pathology
services, or outpatient occupational therapy services
furnished as an incident to a physician's professional
services (as described in section 1861(s)(2)(A)), that
do not meet the standards and conditions (other than
any licensing requirement specified by the Secretary)
under the second sentence of section 1861(p) (or under
such sentence through the operation of subsection (g)
or (ll)(2) of section 1861) as such standards and
conditions would apply to such therapy services if
furnished by a therapist;
(21) where such expenses are for home health services
(including medical supplies described in section
1861(m)(5), but excluding durable medical equipment to
the extent provided for in such section) furnished to
an individual who is under a plan of care of the home
health agency if the claim for payment for such
services is not submitted by the agency;
(22) subject to subsection (h), for which a claim is
submitted other than in an electronic form specified by
the Secretary;
(23) which are the technical component of advanced
diagnostic imaging services described in section
1834(e)(1)(B) for which payment is made under the fee
schedule established under section 1848(b) and that are
furnished by a supplier (as defined in section
1861(d)), if such supplier is not accredited by an
accreditation organization designated by the Secretary
under section 1834(e)(2)(B);
(24) where such expenses are for renal dialysis
services (as defined in subparagraph (B) of section
1881(b)(14)) for which payment is made under such
section unless such payment is made under such section
to a provider of services or a renal dialysis facility
for such services; or
(25) not later than January 1, 2014, for which the
payment is other than by electronic funds transfer
(EFT) or an electronic remittance in a form as
specified in ASC X12 835 Health Care Payment and
Remittance Advice or subsequent standard.
Paragraph (7) shall not apply to Federally qualified health
center services described in section 1861(aa)(3)(B). In making
a national coverage determination (as defined in paragraph
(1)(B) of section 1869(f)) the Secretary shall ensure
consistent with subsection (l) that the public is afforded
notice and opportunity to comment prior to implementation by
the Secretary of the determination; meetings of advisory
committees with respect to the determination are made on the
record; in making the determination, the Secretary has
considered applicable information (including clinical
experience and medical, technical, and scientific evidence)
with respect to the subject matter of the determination; and in
the determination, provide a clear statement of the basis for
the determination (including responses to comments received
from the public), the assumptions underlying that basis, and
make available to the public the data (other than proprietary
data) considered in making the determination.
(b) Medicare as Secondary Payer.--
(1) Requirements of group health plans.--
(A) Working aged under group health plans.--
(i) In general.--A group health
plan--
(I) may not take into account
that an individual (or the
individual's spouse) who is
covered under the plan by
virtue of the individual's
current employment status with
an employer is entitled to
benefits under this title under
section 226(a), and
(II) shall provide that any
individual age 65 or older (and
the spouse age 65 or older of
any individual) who has current
employment status with an
employer shall be entitled to
the same benefits under the
plan under the same conditions
as any such individual (or
spouse) under age 65.
(ii) Exclusion of group health plan
of a small employer.--Clause (i) shall
not apply to a group health plan unless
the plan is a plan of, or contributed
to by, an employer that has 20 or more
employees for each working day in each
of 20 or more calendar weeks in the
current calendar year or the preceding
calendar year.
(iii) Exception for small employers
in multiemployer or multiple employer
group health plans.--Clause (i) also
shall not apply with respect to
individuals enrolled in a multiemployer
or multiple employer group health plan
if the coverage of the individuals
under the plan is by virtue of current
employment status with an employer that
does not have 20 or more individuals in
current employment status for each
working day in each of 20 or more
calendar weeks in the current calendar
year and the preceding calendar year;
except that the exception provided in
this clause shall only apply if the
plan elects treatment under this
clause.
(iv) Exception for individuals with
end stage renal disease.--Subparagraph
(C) shall apply instead of clause (i)
to an item or service furnished in a
month to an individual if for the month
the individual is, or (without regard
to entitlement under section 226) would
upon application be, entitled to
benefits under section 226A.
(v) Group health plan defined.--In
this subparagraph, and subparagraph
(C), the term ``group health plan'' has
the meaning given such term in section
5000(b)(1) of the Internal Revenue Code
of 1986, without regard to section
5000(d) of such Code
(B) Disabled individuals in large group
health plans.--
(i) In general.--A large group health
plan (as defined in clause (iii)) may
not take into account that an
individual (or a member of the
individual's family) who is covered
under the plan by virtue of the
individual's current employment status
with an employer is entitled to
benefits under this title under section
226(b).
(ii) Exception for individuals with
end stage renal disease.--Subparagraph
(C) shall apply instead of clause (i)
to an item or service furnished in a
month to an individual if for the month
the individual is, or (without regard
to entitlement under section 226) would
upon application be, entitled to
benefits under section 226A.
(iii) Large Group Health Plan
Defined.--In this subparagraph, the
term ``large group health plan'' has
the meaning given such term in section
5000(b)(2) of the Internal Revenue Code
of 1986, without regard to section
5000(d) of such Code.
(C) Individuals with end stage renal
disease.--A group health plan (as defined in
subparagraph (A)(v))--
(i) may not take into account that an
individual is entitled to or eligible
for benefits under this title under
section 226A during the 12-month period
which begins with the first month in
which the individual becomes entitled
to benefits under part A under the
provisions of section 226A, or, if
earlier, the first month in which the
individual would have been entitled to
benefits under such part under the
provisions of section 226A if the
individual had filed an application for
such benefits; and
(ii) may not differentiate in the
benefits it provides between
individuals having end stage renal
disease and other individuals covered
by such plan on the basis of the
existence of end stage renal disease,
the need for renal dialysis, or in any
other manner;
except that clause (ii) shall not prohibit a
plan from paying benefits secondary to this
title when an individual is entitled to or
eligible for benefits under this title under
section 226A after the end of the 12-month
period described in clause (i). Effective for
items and services furnished on or after
February 1, 1991, and before the date of
enactment of the Balanced Budget Act of 1997
(with respect to periods beginning on or after
February 1, 1990), this subparagraph shall be
applied by substituting ``18- month'' for ``12-
month'' each place it appears. Effective for
items and services furnished on or after the
date of enactment of the Balanced Budget Act of
1997, (with respect to periods beginning on or
after the date that is 18 months prior to such
date), clauses (i) and (ii) shall be applied by
substituting ``30-month'' for ``12-month'' each
place it appears.
(D) Treatment of certain members of religious
orders.--In this subsection, an individual
shall not be considered to be employed, or an
employee, with respect to the performance of
services as a member of a religious order which
are considered employment only by virtue of an
election made by the religious order under
section 3121(r) of the Internal Revenue Code of
1986.
(E) General Provisions.--For purposes of this
subsection:
(i) Aggregation Rules.--
(I) All employers treated as
a single employer under
subsection (a) or (b) of
section 52 of the Internal
Revenue Code of 1986 shall be
treated as a single employer.
(II) All employees of the
members of an affiliated
service group (as defined in
section 414(m) of such Code)
shall be treated as employed by
a single employer.
(III) Leased employees (as
defined in section 414(n)(2) of
such Code) shall be treated as
employees of the person for
whom they perform services to
the extent they are so treated
under section 414(n) of such
Code.
In applying sections of the Internal
Revenue Code of 1986 under this clause,
the Secretary shall rely upon
regulations and decisions of the
Secretary of the Treasury respecting
such sections.
(ii) Current employment status
defined.--An individual has ``current
employment status'' with an employer if
the individual is an employee, is the
employer, or is associated with the
employer in a business relationship.
(iii) Treatment of self-employed
persons as employers.--The term
``employer'' includes a self-employed
person.
(F) Limitation on beneficiary liability.--An
individual who is entitled to benefits under
this title and is furnished an item or service
for which such benefits are incorrectly paid is
not liable for repayment of such benefits under
this paragraph unless payment of such benefits
was made to the individual.
(2) Medicare secondary payer.--
(A) In general.--Payment under this title may
not be made, except as provided in subparagraph
(B), with respect to any item or service to the
extent that--
(i) payment has been made, or can
reasonably be expected to be made, with
respect to the item or service as
required under paragraph (1), or
(ii) payment has been made or can
reasonably be expected to be made under
a workmen's compensation law or plan of
the United States or a State or under
an automobile or liability insurance
policy or plan (including a self-
insured plan) or under no fault
insurance.
In the subsection, the term ``primary plan''
means a group health plan or large group health
plan, to the extent that clause (i) applies,
and a workmen's compensation law or plan, an
automobile or liability insurance policy or
plan (including a self-insured plan) or no
fault insurance, to the extent that clause (ii)
applies. An entity that engages in a business,
trade, or profession shall be deemed to have a
self-insured plan if it carries its own risk
(whether by a failure to obtain insurance, or
otherwise) in whole or in part.
(B) Conditional payment.--
(i) Authority to make conditional
payment.--The Secretary may make
payment under this title with respect
to an item or service if a primary plan
described in subparagraph (A)(ii) has
not made or cannot reasonably be
expected to make payment with respect
to such item or service promptly (as
determined in accordance with
regulations). Any such payment by the
Secretary shall be conditioned on
reimbursement to the appropriate Trust
Fund in accordance with the succeeding
provisions of this subsection.
(ii) Repayment required.--Subject to
paragraph (9), a primary plan, and an
entity that receives payment from a
primary plan, shall reimburse the
appropriate Trust Fund for any payment
made by the Secretary under this title
with respect to an item or service if
it is demonstrated that such primary
plan has or had a responsibility to
make payment with respect to such item
or service. A primary plan's
responsibility for such payment may be
demonstrated by a judgment, a payment
conditioned upon the recipient's
compromise, waiver, or release (whether
or not there is a determination or
admission of liability) of payment for
items or services included in a claim
against the primary plan or the primary
plan's insured, or by other means. If
reimbursement is not made to the
appropriate Trust Fund before the
expiration of the 60-day period that
begins on the date notice of, or
information related to, a primary
plan's responsibility for such payment
or other information is received, the
Secretary may charge interest
(beginning with the date on which the
notice or other information is
received) on the amount of the
reimbursement until reimbursement is
made (at a rate determined by the
Secretary in accordance with
regulations of the Secretary of the
Treasury applicable to charges for late
payments).
(iii) Action by united states.--In
order to recover payment made under
this title for an item or service, the
United States may bring an action
against any or all entities that are or
were required or responsible (directly,
as an insurer or self-insurer, as a
third-party administrator, as an
employer that sponsors or contributes
to a group health plan, or large group
health plan, or otherwise) to make
payment with respect to the same item
or service (or any portion thereof)
under a primary plan. The United States
may, in accordance with paragraph
(3)(A) collect double damages against
any such entity. In addition, the
United States may recover under this
clause from any entity that has
received payment from a primary plan or
from the proceeds of a primary plan's
payment to any entity. The United
States may not recover from a third-
party administrator under this clause
in cases where the third-party
administrator would not be able to
recover the amount at issue from the
employer or group health plan and is
not employed by or under contract with
the employer or group health plan at
the time the action for recovery is
initiated by the United States or for
whom it provides administrative
services due to the insolvency or
bankruptcy of the employer or plan. An
action may not be brought by the United
States under this clause with respect
to payment owed unless the complaint is
filed not later than 3 years after the
date of the receipt of notice of a
settlement, judgment, award, or other
payment made pursuant to paragraph (8)
relating to such payment owed.
(iv) Subrogation rights.--The United
States shall be subrogated (to the
extent of payment made under this title
for such an item or service) to any
right under this subsection of an
individual or any other entity to
payment with respect to such item or
service under a primary plan.
(v) Waiver of rights.--The Secretary
may waive (in whole or in part) the
provisions of this subparagraph in the
case of an individual claim if the
Secretary determines that the waiver is
in the best interests of the program
established under this title.
(vi) Claims-filing period.--
Notwithstanding any other time limits
that may exist for filing a claim under
an employer group health plan, the
United States may seek to recover
conditional payments in accordance with
this subparagraph where the request for
payment is submitted to the entity
required or responsible under this
subsection to pay with respect to the
item or service (or any portion
thereof) under a primary plan within
the 3-year period beginning on the date
on which the item or service was
furnished.
(vii) Use of website to determine
final conditional reimbursement
amount.--
(I) Notice to secretary of
expected date of a settlement,
judgment, etc.--In the case of
a payment made by the Secretary
pursuant to clause (i) for
items and services provided to
the claimant, the claimant or
applicable plan (as defined in
paragraph (8)(F)) may at any
time beginning 120 days before
the reasonably expected date of
a settlement, judgment, award,
or other payment, notify the
Secretary that a payment is
reasonably expected and the
expected date of such payment.
(II) Secretarial providing
access to claims information
through a website.--The
Secretary shall maintain and
make available to individuals
to whom items and services are
furnished under this title (and
to authorized family or other
representatives recognized
under regulations and to an
applicable plan which has
obtained the consent of the
individual) access to
information on the claims for
such items and services
(including payment amounts for
such claims), including those
claims that relate to a
potential settlement, judgment,
award, or other payment. Such
access shall be provided to an
individual, representative, or
plan through a website that
requires a password to gain
access to the information. The
Secretary shall update the
information on claims and
payments on such website in as
timely a manner as possible but
not later than 15 days after
the date that payment is made.
Information related to claims
and payments subject to the
notice under subclause (I)
shall be maintained and made
available consistent with the
following:
(aa) The information
shall be as complete as
possible and shall
include provider or
supplier name,
diagnosis codes (if
any), dates of service,
and conditional payment
amounts.
(bb) The information
accurately identifies
those claims and
payments that are
related to a potential
settlement, judgment,
award, or other payment
to which the provisions
of this subsection
apply.
(cc) The website
provides a method for
the receipt of secure
electronic
communications with the
individual,
representative, or plan
involved.
(dd) The website
provides that
information is
transmitted from the
website in a form that
includes an official
time and date that the
information is
transmitted.
(ee) The website
shall permit the
individual,
representative, or plan
to download a statement
of reimbursement
amounts (in this clause
referred to as a
``statement of
reimbursement amount'')
on payments for claims
under this title
relating to a potential
settlement, judgment,
award, or other
payment.
(III) Use of timely web
download as basis for final
conditional amount.--If an
individual (or other claimant
or applicable plan with the
consent of the individual)
obtains a statement of
reimbursement amount from the
website during the protected
period as defined in subclause
(V) and the related settlement,
judgment, award or other
payment is made during such
period, then the last statement
of reimbursement amount that is
downloaded during such period
and within 3 business days
before the date of the
settlement, judgment, award, or
other payment shall constitute
the final conditional amount
subject to recovery under
clause (ii) related to such
settlement, judgment, award, or
other payment.
(IV) Resolution of
discrepancies.--If the
individual (or authorized
representative) believes there
is a discrepancy with the
statement of reimbursement
amount, the Secretary shall
provide a timely process to
resolve the discrepancy. Under
such process the individual (or
representative) must provide
documentation explaining the
discrepancy and a proposal to
resolve such discrepancy.
Within 11 business days after
the date of receipt of such
documentation, the Secretary
shall determine whether there
is a reasonable basis to
include or remove claims on the
statement of reimbursement. If
the Secretary does not make
such determination within the
11 business-day period, then
the proposal to resolve the
discrepancy shall be accepted.
If the Secretary determines
within such period that there
is not a reasonable basis to
include or remove claims on the
statement of reimbursement, the
proposal shall be rejected. If
the Secretary determines within
such period that there is a
reasonable basis to conclude
there is a discrepancy, the
Secretary must respond in a
timely manner by agreeing to
the proposal to resolve the
discrepancy or by providing
documentation showing with good
cause why the Secretary is not
agreeing to such proposal and
establishing an alternate
discrepancy resolution. In no
case shall the process under
this subclause be treated as an
appeals process or as
establishing a right of appeal
for a statement of
reimbursement amount and there
shall be no administrative or
judicial review of the
Secretary's determinations
under this subclause.
(V) Protected period.--In
subclause (III), the term
``protected period'' means,
with respect to a settlement,
judgment, award or other
payment relating to an injury
or incident, the portion (if
any) of the period beginning on
the date of notice under
subclause (I) with respect to
such settlement, judgment,
award, or other payment that is
after the end of a Secretarial
response period beginning on
the date of such notice to the
Secretary. Such Secretarial
response period shall be a
period of 65 days, except that
such period may be extended by
the Secretary for a period of
an additional 30 days if the
Secretary determines that
additional time is required to
address claims for which
payment has been made. Such
Secretarial response period
shall be extended and shall not
include any days for any part
of which the Secretary
determines (in accordance with
regulations) that there was a
failure in the claims and
payment posting system and the
failure was justified due to
exceptional circumstances (as
defined in such regulations).
Such regulations shall define
exceptional circumstances in a
manner so that not more than 1
percent of the repayment
obligations under this
subclause would qualify as
exceptional circumstances.
(VI) Effective date.--The
Secretary shall promulgate
final regulations to carry out
this clause not later than 9
months after the date of the
enactment of this clause.
(VII) Website including
successor technology.--In this
clause, the term ``website''
includes any successor
technology.
(viii) Right of appeal for secondary
payer determinations relating to
liability insurance (including self-
insurance), no fault insurance, and
workers' compensation laws and plans.--
The Secretary shall promulgate
regulations establishing a right of
appeal and appeals process, with
respect to any determination under this
subsection for a payment made under
this title for an item or service for
which the Secretary is seeking to
recover conditional payments from an
applicable plan (as defined in
paragraph (8)(F)) that is a primary
plan under subsection (A)(ii), under
which the applicable plan involved, or
an attorney, agent, or third party
administrator on behalf of such plan,
may appeal such determination. The
individual furnished such an item or
service shall be notified of the plan's
intent to appeal such determination
(C) Treatment of questionnaires.--The
Secretary may not fail to make payment under
subparagraph (A) solely on the ground that an
individual failed to complete a questionnaire
concerning the existence of a primary plan.
(3) Enforcement.--
(A) Private cause of action.--There is
established a private cause of action for
damages (which shall be in an amount double the
amount otherwise provided) in the case of a
primary plan which fails to provide for primary
payment (or appropriate reimbursement) in
accordance with paragraphs (1) and (2)(A).
(B) Reference to excise tax with respect to
nonconforming group health plans.--For
provision imposing an excise tax with respect
to nonconforming group health plans, see
section 5000 of the Internal Revenue Code of
1986.
(C) Prohibition of financial incentives not
to enroll in a group health plan or a large
group health plan.--It is unlawful for an
employer or other entity to offer any financial
or other incentive for an individual entitled
to benefits under this title not to enroll (or
to terminate enrollment) under a group health
plan or a large group health plan which would
(in the case of such enrollment) be a primary
plan (as defined in paragraph (2)(A)). Any
entity that violates the previous sentence is
subject to a civil money penalty of not to
exceed $5,000 for each such violation. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to a civil
money penalty under the previous sentence in
the same manner as such provisions apply to a
penalty or proceeding under section 1128A(a).
(4) Coordination of benefits.--Where payment for an
item or service by a primary plan is less than the
amount of the charge for such item or service and is
not payment in full, payment may be made under this
title (without regard to deductibles and coinsurance
under this title) for the remainder of such charge,
but--
(A) payment under this title may not exceed
an amount which would be payable under this
title for such item or service if paragraph
(2)(A) did not apply; and
(B) payment under this title, when combined
with the amount payable under the primary plan,
may not exceed--
(i) in the case of an item or service
payment for which is determined under
this title on the basis of reasonable
cost (or other cost-related basis) or
under section 1886, the amount which
would be payable under this title on
such basis, and
(ii) in the case of an item or
service for which payment is authorized
under this title on another basis--
(I) the amount which would be
payable under the primary plan
(without regard to deductibles
and coinsurance under such
plan), or
(II) the reasonable charge or
other amount which would be
payable under this title
(without regard to deductibles
and coinsurance under this
title),
whichever is greater.
(5) Identification of secondary payer situations.--
(A) Requesting matching information.--
(i) Commissioner of social
security.--The Commissioner of Social
Security shall, not less often that
annually, transmit to the Secretary of
the Treasury a list of the names and
TINs of medicare beneficiaries (as
defined in section 6103(l)(12) of the
Internal Revenue Code of 1986) and
request that the Secretary disclose to
the Commissioner the information
described in subparagraph (A) of such
section.
(ii) Administrator.--The
Administrator of the Centers for
Medicare & Medicaid Services shall
request, not less often than annually,
the Commissioner of the Social Security
Administration to disclose to the
Administrator the information described
in subparagraph (B) of section
6103(l)(12) of the Internal Revenue
Code of 1986.
(B) Disclosure to fiscal intermediaries and
carriers.--In addition to any other information
provided under this title to fiscal
intermediaries and carriers, the Administrator
shall disclose to such intermediaries and
carriers (or to such a single intermediary or
carrier as the Secretary may designate) the
information received under subparagraph (A) for
purposes of carrying out this subsection.
(C) Contacting employers.--
(i) In general.--With respect to each
individual (in this subparagraph
referred to as an ``employee'') who was
furnished a written statement under
section 6051 of the Internal Revenue
Code of 1986 by a qualified employer
(as defined in section
6103(l)(12)(E)(iii) of such Code), as
disclosed under subparagraph (B), the
appropriate fiscal intermediary or
carrier shall contact the employer in
order to determine during what period
the employee or employee's spouse may
be (or have been) covered under a group
health plan of the employer and the
nature of the coverage that is or was
provided under the plan (including the
name, address, and identifying number
of the plan).
(ii) Employer response.--Within 30
days of the date of receipt of the
inquiry, the employer shall notify the
intermediary or carrier making the
inquiry as to the determinations
described in clause (i). An employer
(other than a Federal or other
governmental entity) who willfully or
repeatedly fails to provide timely and
accurate notice in accordance with the
previous sentence shall be subject to a
civil money penalty of not to exceed
$1,000 for each individual with respect
to which such an inquiry is made. The
provision of section 1128A (other than
subsections (a) and (b)) shall apply to
a civil money penalty under the
previous sentence in the same manner as
such provisions apply to a penalty or
proceeding under section 1128A(a).
(D) Obtaining information from
beneficiaries.--Before an individual applies
for benefits under part A or enrolls under part
B, the Administrator shall mail the individual
a questionnaire to obtain information on
whether the individual is covered under a
primary plan and the nature of the coverage
provided under the plan, including the name,
address, and identifying number of the plan.
(E) End date.--The provisions of this
paragraph shall not apply to information
required to be provided on or after July 1,
2016.
(6) Screening requirements for providers and
suppliers.--
(A) In general.--Notwithstanding any other
provision of this title, no payment may be made
for any item or service furnished under part B
unless the entity furnishing such item or
service completes (to the best of its knowledge
and on the basis of information obtained from
the individual to whom the item or service is
furnished) the portion of the claim form
relating to the availability of other health
benefit plans.
(B) Penalties.--An entity that knowingly,
willfully, and repeatedly fails to complete a
claim form in accordance with subparagraph (A)
or provides inaccurate information relating to
the availability of other health benefit plans
on a claim form under such subparagraph shall
be subject to a civil money penalty of not to
exceed $2,000 for each such incident. The
provisions of section 1128A (other than
subsections (a) and (b)) shall apply to a civil
money penalty under the previous sentence in
the same manner as such provisions apply to a
penalty or proceeding under section 1128A(a).
(7) Required submission of information by group
health plans.--
(A) Requirement.--On and after the first day
of the first calendar quarter beginning after
the date that is 1 year after the date of the
enactment of this paragraph, an entity serving
as an insurer or third party administrator for
a group health plan, as defined in paragraph
(1)(A)(v), and, in the case of a group health
plan that is self-insured and self-
administered, a plan administrator or
fiduciary, shall--
(i) secure from the plan sponsor and
plan participants such information as
the Secretary shall specify for the
purpose of identifying situations where
the group health plan is or has been a
primary plan to the program under this
title; and
(ii) submit such information to the
Secretary in a form and manner
(including frequency) specified by the
Secretary.
(B) Enforcement.--
(i) In general.--An entity, a plan
administrator, or a fiduciary described
in subparagraph (A) that fails to
comply with the requirements under such
subparagraph shall be subject to a
civil money penalty of $1,000 for each
day of noncompliance for each
individual for which the information
under such subparagraph should have
been submitted. The provisions of
subsections (e) and (k) of section
1128A shall apply to a civil money
penalty under the previous sentence in
the same manner as such provisions
apply to a penalty or proceeding under
section 1128A(a). A civil money penalty
under this clause shall be in addition
to any other penalties prescribed by
law and in addition to any Medicare
secondary payer claim under this title
with respect to an individual.
(ii) Deposit of amounts collected.--
Any amounts collected pursuant to
clause (i) shall be deposited in the
Federal Hospital Insurance Trust Fund
under section 1817.
(C) Sharing of information.--Notwithstanding
any other provision of law, under terms and
conditions established by the Secretary, the
Secretary--
(i) shall share information on
entitlement under Part A and enrollment
under Part B under this title with
entities, plan administrators, and
fiduciaries described in subparagraph
(A);
(ii) may share the entitlement and
enrollment information described in
clause (i) with entities and persons
not described in such clause; and
(iii) may share information collected
under this paragraph as necessary for
purposes of the proper coordination of
benefits.
(D) Implementation.--Notwithstanding any
other provision of law, the Secretary may
implement this paragraph by program instruction
or otherwise.
(8) Required submission of information by or on
behalf of liability insurance (including self-
insurance), no fault insurance, and workers'
compensation laws and plans.--
(A) Requirement.--On and after the first day
of the first calendar quarter beginning after
the date that is 18 months after the date of
the enactment of this paragraph, an applicable
plan shall--
(i) determine whether a claimant
(including an individual whose claim is
unresolved) is entitled to benefits
under the program under this title on
any basis; and
(ii) if the claimant is determined to
be so entitled, submit the information
described in subparagraph (B) with
respect to the claimant to the
Secretary in a form and manner
(including frequency) specified by the
Secretary.
(B) Required information.--The information
described in this subparagraph is--
(i) the identity of the claimant for
which the determination under
subparagraph (A) was made; and
(ii) such other information as the
Secretary shall specify in order to
enable the Secretary to make an
appropriate determination concerning
coordination of benefits, including any
applicable recovery claim.
Not later than 18 months after the date of
enactment of this sentence, the Secretary shall
modify the reporting requirements under this
paragraph so that an applicable plan in
complying with such requirements is permitted
but not required to access or report to the
Secretary beneficiary social security account
numbers or health identification claim numbers,
except that the deadline for such modification
shall be extended by one or more periods
(specified by the Secretary) of up to 1 year
each if the Secretary notifies the committees
of jurisdiction of the House of Representatives
and of the Senate that the prior deadline for
such modification, without such extension,
threatens patient privacy or the integrity of
the secondary payer program under this
subsection. Any such deadline extension notice
shall include information on the progress being
made in implementing such modification and the
anticipated implementation date for such
modification.
(C) Timing.--Information shall be submitted
under subparagraph (A)(ii) within a time
specified by the Secretary after the claim is
resolved through a settlement, judgment, award,
or other payment (regardless of whether or not
there is a determination or admission of
liability).
(D) Claimant.--For purposes of subparagraph
(A), the term ``claimant'' includes--
(i) an individual filing a claim
directly against the applicable plan;
and
(ii) an individual filing a claim
against an individual or entity insured
or covered by the applicable plan.
(E) Enforcement.--
(i) In general.--An applicable plan
that fails to comply with the
requirements under subparagraph (A)
with respect to any claimant may be
subject to a civil money penalty of up
to $1,000 for each day of noncompliance
with respect to each claimant. The
provisions of subsections (e) and (k)
of section 1128A shall apply to a civil
money penalty under the previous
sentence in the same manner as such
provisions apply to a penalty or
proceeding under section 1128A(a). A
civil money penalty under this clause
shall be in addition to any other
penalties prescribed by law and in
addition to any Medicare secondary
payer claim under this title with
respect to an individual.
(ii) Deposit of amounts collected.--
Any amounts collected pursuant to
clause (i) shall be deposited in the
Federal Hospital Insurance Trust Fund.
(F) Applicable plan.--In this paragraph, the
term ``applicable plan'' means the following
laws, plans, or other arrangements, including
the fiduciary or administrator for such law,
plan, or arrangement:
(i) Liability insurance (including
self-insurance).
(ii) No fault insurance.
(iii) Workers' compensation laws or
plans.
(G) Sharing of information.--The Secretary
may share information collected under this
paragraph as necessary for purposes of the
proper coordination of benefits.
(H) Implementation.--Notwithstanding any
other provision of law, the Secretary may
implement this paragraph by program instruction
or otherwise.
(I) Regulations.--Not later than 60 days
after the date of the enactment of this
subparagraph, the Secretary shall publish a
notice in the Federal Register soliciting
proposals, which will be accepted during a 60-
day period, for the specification of practices
for which sanctions will and will not be
imposed under subparagraph (E), including not
imposing sanctions for good faith efforts to
identify a beneficiary pursuant to this
paragraph under an applicable entity
responsible for reporting information. After
considering the proposals so submitted, the
Secretary, in consultation with the Attorney
General, shall publish in the Federal Register,
including a 60-day period for comment, proposed
specified practices for which such sanctions
will and will not be imposed. After considering
any public comments received during such
period, the Secretary shall issue final rules
specifying such practices.
(9) Exception.--
(A) In general.--Clause (ii) of paragraph
(2)(B) and any reporting required by paragraph
(8) shall not apply with respect to any
settlement, judgment, award, or other payment
by an applicable plan arising from liability
insurance (including self-insurance) and from
alleged physical trauma-based incidents
(excluding alleged ingestion, implantation, or
exposure cases) constituting a total payment
obligation to a claimant of not more than the
single threshold amount calculated by the
Secretary under subparagraph (B) for the year
involved.
(B) Annual computation of threshold.--
(i) In general.--Not later than
November 15 before each year, the
Secretary shall calculate and publish a
single threshold amount for
settlements, judgments, awards, or
other payments for obligations arising
from liability insurance (including
self-insurance) and for alleged
physical trauma-based incidents
(excluding alleged ingestion,
implantation, or exposure cases)
subject to this section for that year.
The annual single threshold amount for
a year shall be set such that the
estimated average amount to be credited
to the Medicare trust funds of
collections of conditional payments
from such settlements, judgments,
awards, or other payments arising from
liability insurance (including self-
insurance) and for such alleged
incidents subject to this section shall
equal the estimated cost of collection
incurred by the United States
(including payments made to
contractors) for a conditional payment
arising from liability insurance
(including self-insurance) and for such
alleged incidents subject to this
section for the year. At the time of
calculating, but before publishing, the
single threshold amount for 2014, the
Secretary shall inform, and seek review
of, the Comptroller General of the
United States with regard to such
amount.
(ii) Publication.--The Secretary
shall include, as part of such
publication for a year--
(I) the estimated cost of
collection incurred by the
United States (including
payments made to contractors)
for a conditional payment
arising from liability
insurance (including self-
insurance) and for such alleged
incidents; and
(II) a summary of the
methodology and data used by
the Secretary in computing such
threshold amount and such cost
of collection.
(C) Exclusion of ongoing expenses.--For
purposes of this paragraph and with respect to
a settlement, judgment, award, or other payment
not otherwise addressed in clause (ii) of
paragraph (2)(B) that includes ongoing
responsibility for medical payments (excluding
settlements, judgments, awards, or other
payments made by a workers' compensation law or
plan or no fault insurance), the amount
utilized for calculation of the threshold
described in subparagraph (A) shall include
only the cumulative value of the medical
payments made under this title.
(D) Report to congress.--Not later than
November 15 before each year, the Secretary
shall submit to the Congress a report on the
single threshold amount for settlements,
judgments, awards, or other payments for
conditional payment obligations arising from
liability insurance (including self-insurance)
and alleged incidents described in subparagraph
(A) for that year and on the establishment and
application of similar thresholds for such
payments for conditional payment obligations
arising from worker compensation cases and from
no fault insurance cases subject to this
section for the year. For each such report, the
Secretary shall--
(i) calculate the threshold amount by
using the methodology applicable to
certain liability claims described in
subparagraph (B); and
(ii) include a summary of the
methodology and data used in
calculating each threshold amount and
the amount of estimated savings under
this title achieved by the Secretary
implementing each such threshold.
(c) No payment may be made under part B for any expenses
incurred for--
(1) a drug product--
(A) which is described in section 107(c)(3)
of the Drug Amendments of 1962,
(B) which may be dispensed only upon
prescription,
(C) for which the Secretary has issued a
notice of an opportunity for a hearing under
subsection (e) of section 505 of the Federal
Food, Drug, and Cosmetic Act on a proposed
order of the Secretary to withdraw approval of
an application for such drug product under such
section because the Secretary has determined
that the drug is less than effective for all
conditions of use prescribed, recommended, or
suggested in its labeling, and
(D) for which the Secretary has not
determined there is a compelling justification
for its medical need; and
(2) any other drug product--
(A) which is identical, related, or similar
(as determined in accordance with section 310.6
of title 21 of the Code of Federal Regulations)
to a drug product described in paragraph (1),
and
(B) for which the Secretary has not
determined there is a compelling justification
for its medical need,
until such time as the Secretary withdraws such proposed order.
(d) For purposes of subsection (a)(1)(A), in the case of any
item or service that is required to be provided pursuant to
section 1867 to an individual who is entitled to benefits under
this title, determinations as to whether the item or service is
reasonable and necessary shall be made on the basis of the
information available to the treating physician or practitioner
(including the patient's presenting symptoms or complaint) at
the time the item or service was ordered or furnished by the
physician or practitioner (and not on the patient's principal
diagnosis). When making such determinations with respect to
such an item or service, the Secretary shall not consider the
frequency with which the item or service was provided to the
patient before or after the time of the admission or visit.
(e)(1) No payment may be made under this title with respect
to any item or service (other than an emergency item or
service, not including items or services furnished in an
emergency room of a hospital) furnished--
(A) by an individual or entity during the period when
such individual or entity is excluded pursuant to
section 1128, 1128A, 1156 or 1842(j)(2) from
participation in the program under this title; or
(B) at the medical direction or on the prescription
of a physician during the period when he is excluded
pursuant to section 1128, 1128A, 1156 or 1842(j)(2)
from participation in the program under this title and
when the person furnishing such item or service knew or
had reason to know of the exclusion (after a reasonable
time period after reasonable notice has been furnished
to the person).
(2) Where an individual eligible for benefits under this
title submits a claim for payment for items or services
furnished by an individual or entity excluded from
participation in the programs under this title, pursuant to
section 1128, 1128A, 1156, 1160 (as in effect on September 2,
1982), 1842(j)(2), 1862(d) (as in effect on the date of the
enactment of the Medicare and Medicaid Patient and Program
Protection Act of 1987), or l866, and such beneficiary did not
know or have reason to know that such individual or entity was
so excluded, then, to the extent permitted by this title, and
notwithstanding such exclusion, payment shall be made for such
items or services. In each such case the Secretary shall notify
the beneficiary of the exclusion of the individual or entity
furnishing the items or services. Payment shall not be made for
items or services furnished by an excluded individual or entity
to a beneficiary after a reasonable time (as determined by the
Secretary in regulations) after the Secretary has notified the
beneficiary of the exclusion of that individual or entity.
(f) The Secretary shall establish utilization guidelines for
the determination of whether or not payment may be made,
consistent with paragraph (1)(A) of subsection (a), under part
A or part B for expenses incurred with respect to the provision
of home health services, and shall provide for the
implementation of such guidelines through a process of
selective postpayment coverage review by intermediaries or
otherwise.
(g) The Secretary shall, in making the determinations under
paragraphs (1) and (9) of subsection (a), and for the purposes
of promoting the effective, efficient, and economical delivery
of health care services, and of promoting the quality of
services of the type for which payment may be made under this
title, enter into contracts with quality improvement
organizations pursuant to part B of title XI of this Act.
(h)(1) The Secretary--
(A) shall waive the application of subsection (a)(22)
in cases in which--
(i) there is no method available for the
submission of claims in an electronic form; or
(ii) the entity submitting the claim is a
small provider of services or supplier; and
(B) may waive the application of such subsection in
such unusual cases as the Secretary finds appropriate.
(2) For purposes of this subsection, the term ``small
provider of services or supplier'' means--
(A) a provider of services with fewer than 25 full-
time equivalent employees; or
(B) a physician, practitioner, facility, or supplier
(other than provider of services) with fewer than 10
full-time equivalent employees.
(i) In order to supplement the activities of the Medicare
Payment Advisory Commission under section 1886(e) in assessing
the safety, efficacy, and cost-effectiveness of new and
existing medical procedures, the Secretary may carry out, or
award grants or contracts for, original research and
experimentation of the type described in clause (ii) of section
1886(e)(6)(E) with respect to such a procedure if the Secretary
finds that--
(1) such procedure is not of sufficient commercial
value to justify research and experimentation by a
commercial organization;
(2) research and experimentation with respect to such
procedure is not of a type that may appropriately be
carried out by an institute, division, or bureau of the
National Institutes of Health; and
(3) such procedure has the potential to be more cost-
effective in the treatment of a condition than
procedures currently in use with respect to such
condition.
(j)(1) Any advisory committee appointed to advise the
Secretary on matters relating to the interpretation,
application, or implementation of subsection (a)(1) shall
assure the full participation of a nonvoting member in the
deliberations of the advisory committee, and shall provide such
nonvoting member access to all information and data made
available to voting members of the advisory committee, other
than information that--
(A) is exempt from disclosure pursuant to subsection
(a) of section 552 of title 5, United States Code, by
reason of subsection (b)(4) of such section (relating
to trade secrets); or
(B) the Secretary determines would present a conflict
of interest relating to such nonvoting member.
(2) If an advisory committee described in paragraph (1)
organizes into panels of experts according to types of items or
services considered by the advisory committee, any such panel
of experts may report any recommendation with respect to such
items or services directly to the Secretary without the prior
approval of the advisory committee or an executive committee
thereof.
(k)(1) Subject to paragraph (2), a group health plan (as
defined in subsection (a)(1)(A)(v)) providing supplemental or
secondary coverage to individuals also entitled to services
under this title shall not require a medicare claims
determination under this title for dental benefits specifically
excluded under subsection (a)(12) as a condition of making a
claims determination for such benefits under the group health
plan.
(2) A group health plan may require a claims determination
under this title in cases involving or appearing to involve
inpatient dental hospital services or dental services expressly
covered under this title pursuant to actions taken by the
Secretary.
(l) National and Local Coverage Determination Process.--
(1) Factors and evidence used in making national
coverage determinations.--The Secretary shall make
available to the public the factors considered in
making national coverage determinations of whether an
item or service is reasonable and necessary. The
Secretary shall develop guidance documents to carry out
this paragraph in a manner similar to the development
of guidance documents under section 701(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)).
(2) Timeframe for decisions on requests for national
coverage determinations.--In the case of a request for
a national coverage determination that--
(A) does not require a technology assessment
from an outside entity or deliberation from the
Medicare Coverage Advisory Committee, the
decision on the request shall be made not later
than 6 months after the date of the request; or
(B) requires such an assessment or
deliberation and in which a clinical trial is
not requested, the decision on the request
shall be made not later than 9 months after the
date of the request.
(3) Process for public comment in national coverage
determinations.--
(A) Period for proposed decision.--Not later
than the end of the 6-month period (or 9-month
period for requests described in paragraph
(2)(B)) that begins on the date a request for a
national coverage determination is made, the
Secretary shall make a draft of proposed
decision on the request available to the public
through the Internet website of the Centers for
Medicare & Medicaid Services or other
appropriate means.
(B) 30-day period for public comment.--
Beginning on the date the Secretary makes a
draft of the proposed decision available under
subparagraph (A), the Secretary shall provide a
30-day period for public comment on such draft.
(C) 60-day period for final decision.--Not
later than 60 days after the conclusion of the
30-day period referred to under subparagraph
(B), the Secretary shall--
(i) make a final decision on the
request;
(ii) include in such final decision
summaries of the public comments
received and responses to such
comments;
(iii) make available to the public
the clinical evidence and other data
used in making such a decision when the
decision differs from the
recommendations of the Medicare
Coverage Advisory Committee; and
(iv) in the case of a final decision
under clause (i) to grant the request
for the national coverage
determination, the Secretary shall
assign a temporary or permanent code
(whether existing or unclassified) and
implement the coding change.
(4) Consultation with outside experts in certain
national coverage determinations.--With respect to a
request for a national coverage determination for which
there is not a review by the Medicare Coverage Advisory
Committee, the Secretary shall consult with appropriate
outside clinical experts.
(5) Local coverage determination process.--
(A) Plan to promote consistency of coverage
determinations.--The Secretary shall develop a
plan to evaluate new local coverage
determinations to determine which
determinations should be adopted nationally and
to what extent greater consistency can be
achieved among local coverage determinations.
(B) Consultation.--The Secretary shall
require the fiscal intermediaries or carriers
providing services within the same area to
consult on all new local coverage
determinations within the area.
(C) Dissemination of information.--The
Secretary should serve as a center to
disseminate information on local coverage
determinations among fiscal intermediaries and
carriers to reduce duplication of effort.
(D) Local coverage determinations.--The
Secretary shall require each Medicare
administrative contractor that develops a local
coverage determination to make available on the
Internet website of such contractor and on the
Medicare Internet website, at least 45 days
before the effective date of such
determination, the following information:
(i) Such determination in its
entirety.
(ii) Where and when the proposed
determination was first made public.
(iii) Hyperlinks to the proposed
determination and a response to
comments submitted to the contractor
with respect to such proposed
determination.
(iv) A summary of evidence that was
considered by the contractor during the
development of such determination and a
list of the sources of such evidence.
(v) An explanation of the rationale
that supports such determination.
(6) National and local coverage determination
defined.--For purposes of this subsection--
(A) National coverage determination.--The
term ``national coverage determination'' means
a determination by the Secretary with respect
to whether or not a particular item or service
is covered nationally under this title.
(B) Local coverage determination.--The term
``local coverage determination'' has the
meaning given that in section 1869(f)(2)(B).
(m) Coverage of Routine Costs Associated With Certain
Clinical Trials of Category A Devices.--
(1) In general.--In the case of an individual
entitled to benefits under part A, or enrolled under
part B, or both who participates in a category A
clinical trial, the Secretary shall not exclude under
subsection (a)(1) payment for coverage of routine costs
of care (as defined by the Secretary) furnished to such
individual in the trial.
(2) Category a clinical trial.--For purposes of
paragraph (1), a ``category A clinical trial'' means a
trial of a medical device if--
(A) the trial is of an experimental/
investigational (category A) medical device (as
defined in regulations under section 405.201(b)
of title 42, Code of Federal Regulations (as in
effect as of September 1, 2003));
(B) the trial meets criteria established by
the Secretary to ensure that the trial conforms
to appropriate scientific and ethical
standards; and
(C) in the case of a trial initiated before
January 1, 2010, the device involved in the
trial has been determined by the Secretary to
be intended for use in the diagnosis,
monitoring, or treatment of an immediately
life-threatening disease or condition.
(n) Requirement of a Surety Bond for Certain Providers of
Services and Suppliers.--
(1) In general.--The Secretary may require a provider
of services or supplier described in paragraph (2) to
provide the Secretary on a continuing basis with a
surety bond in a form specified by the Secretary in an
amount (not less than $50,000) that the Secretary
determines is commensurate with the volume of the
billing of the provider of services or supplier. The
Secretary may waive the requirement of a bond under the
preceding sentence in the case of a provider of
services or supplier that provides a comparable surety
bond under State law.
(2) Provider of services or supplier described.--A
provider of services or supplier described in this
paragraph is a provider of services or supplier the
Secretary determines appropriate based on the level of
risk involved with respect to the provider of services
or supplier, and consistent with the surety bond
requirements under sections 1834(a)(16)(B) and
1861(o)(7)(C).
(o) Suspension of Payments Pending Investigation of Credible
Allegations of Fraud.--
(1) In general.--The Secretary may suspend payments
to a provider of services or supplier under this title
pending an investigation of a credible allegation of
fraud against the provider of services or supplier,
unless the Secretary determines there is good cause not
to suspend such payments.
(2) Consultation.--The Secretary shall consult with
the Inspector General of the Department of Health and
Human Services in determining whether there is a
credible allegation of fraud against a provider of
services or supplier.
(3) Promulgation of regulations.--The Secretary shall
promulgate regulations to carry out this subsection and
section 1903(i)(2)(C).
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