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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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