[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2085 Introduced in Senate (IS)]

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118th CONGRESS
  1st Session
                                S. 2085

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

                             June 21, 2023

 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''.

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 the semicolon at the end of 
                subparagraph (JJ) and inserting ``; and''; and
                    (B) by adding at the end the following new 
                subparagraph:
            ``(KK) multi-cancer early detection screening tests (as 
        defined in subsection (nnn));''; and
            (2) by adding at the end the following new subsection:
    ``(nnn) 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, insofar as the Secretary determines coverage of such 
tests is appropriate, furnished to an individual for the purpose of 
earlier detection of cancer across many cancer types (such as described 
in the National Cancer Institute's Annual Report to the Nation on the 
Status of Cancer):
            ``(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 
        blood, blood products, urine, or other sample of biological 
        material) as the Secretary determines appropriate in providing 
        results comparable to those obtained with a test described in 
        paragraph (1).''.
    (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(nnn), 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(nnn)) 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 a multi-cancer early detection 
        screening test (as defined in section 1861(nnn)), which is 
        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 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 under such part 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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