[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 5051 Introduced in Senate (IS)]

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116th CONGRESS
  2d Session
                                S. 5051

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

                           December 17, 2020

 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 2020''.

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 (kkk));''; and
            (2) by adding at the end the following new subsection:
    ``(kkk) 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(kkk) 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(kkk)) 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(kkk)), 
                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 for other cancer screening tests covered under this 
        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.
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