Title: Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
Policy area: Health

Summary:
Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
This bill provides for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types. The Government Accountability Office must report on the resulting utilization and effectiveness of such tests.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1873 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 1873

To amend title XVIII of the Social Security Act to provide for Medicare 
       coverage of multi-cancer early detection screening tests.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 27, 2021

 Mr. Crapo (for himself, Mr. Bennet, Mr. Scott of South Carolina, and 
  Mr. Cardin) introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide for Medicare 
       coverage of multi-cancer early detection screening tests.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Multi-Cancer Early 
Detection Screening Coverage Act of 2021''.

SEC. 2. PURPOSE.

    The purpose of this Act is to create a covered benefit for multi-
cancer early detection screening tests to ensure Medicare beneficiary 
access to these tests without unnecessary delay once approved under the 
Federal Food, Drug, and Cosmetic Act.

SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY DETECTION SCREENING 
              TESTS.

    (a) Coverage.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) by striking ``and'' at the end of subparagraph 
                (GG);
                    (B) by striking the period at the end of 
                subparagraph (HH) and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
            ``(II) multi-cancer early detection screening tests (as 
        defined in subsection (lll));''; and
            (2) by adding at the end the following new subsection:
    ``(lll) Multi-Cancer Early Detection Screening Tests.--The term 
`multi-cancer early detection screening test' means any of the 
following tests, approved or cleared by the Food and Drug 
Administration, furnished to an individual for the purpose of early 
detection of cancer across many cancer types (as categorized in the 
Annual Report to the Nation on the Status of Cancer issued by the 
National Cancer Institute):
            ``(1) A genomic sequencing blood or blood product test that 
        includes the analysis of cell-free nucleic acids.
            ``(2) Such other equivalent tests (which are based on urine 
        or other sample of biological material) as the Secretary 
        determines appropriate.''.
    (b) Payment and Frequency Limit.--
            (1) Payment under fee schedule.--Section 1833(h) of the 
        Social Security Act (42 U.S.C. 1395l(h)) is amended--
                    (A) in paragraph (1)(A), by inserting after 
                ``(including'' the following: ``multi-cancer early 
                detection screening tests under section 1861(lll) and 
                including''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(10) No payment may be made under this part for a multi-
        cancer early detection screening test (as defined in section 
        1861(lll)) for an individual if such a test was furnished to 
        the individual during the previous 11 months.''.
            (2) Conforming amendment.--Section 1862(a) of the Social 
        Security Act (42 U.S.C. 1395y(a)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (O), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (P), by striking the 
                        semicolon at the end and inserting ``, and''; 
                        and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(Q) in the case of multi-cancer early detection screening 
        tests (as defined in section 1861(lll)), which are performed 
        more frequently than is covered under section 1833(h)(10);''; 
        and
                    (B) in paragraph (7), by striking ``or (P)'' and 
                inserting ``(P), or (Q)''.
    (c) Rule of Construction Relating to Other Cancer Screening 
Tests.--Nothing in this section, including the amendments made by this 
section, shall be construed--
            (1) in the case of an individual who undergoes a multi-
        cancer early detection screening test, to affect coverage under 
        part B of title XVIII of the Social Security Act (42 U.S.C. 
        1395j et seq.) for other cancer screening tests covered under 
        such title, such as screening tests for breast, cervical, 
        colorectal, lung, or prostate cancer; or
            (2) in the case of an individual who undergoes another 
        cancer screening test, to affect coverage for a multi-cancer 
        early detection screening test or the use of such a test as a 
        diagnostic or confirmatory test for a result of the other 
        cancer screening test.
    (d) Implementation.--The Secretary of Health and Human Services 
shall provide for the implementation of coverage of multi-cancer early 
detection screening tests under the amendments made by this section 
through the applicable Medicare coverage process under title XVIII of 
the Social Security Act (42 U.S.C. 1395 et seq.).
    (e) GAO Study and Report on Multi-Cancer Early Detection Screening 
Tests.--
            (1) Study.--The Comptroller General of the United States 
        shall conduct a study on the utilization of multi-cancer early 
        detection tests under title XVIII of the Social Security Act 
        (42 U.S.C. 1395 et seq.). Such study shall include an analysis 
        of aggregate data on--
                    (A) the utilization of such tests by sex, race, 
                ethnicity, geography, and socioeconomic status; and
                    (B) the number of cancers detected through 
                screening in Medicare beneficiaries and improvements in 
                health outcomes.
            (2) Report.--Not later than three years after the start of 
        coverage of such tests under such title, the Comptroller 
        General shall submit to Congress a report containing the 
        results of the study conducted under paragraph (1), including 
        recommendations for increasing access and utilization in 
        underserved areas and other recommendations as the Comptroller 
        General determines appropriate.
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