119-s339

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 339 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 339

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

 January 30, 2025

 Mr. Crapo (for himself, Mr. Bennet, Mr. Scott of South Carolina, and 
 Mr. Wyden) 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 ``Nancy Gardner Sewell Medicare Multi-
Cancer Early Detection Screening Coverage Act''.

SEC. 2. 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.--
 ``

    (1) In general.--The term `multi-cancer early detection 
 screening test' means a test furnished to an individual for the 
 concurrent detection of multiple cancer types across multiple 
 organ sites on or after January 1, 2028, that--
 ``
        (A) is cleared under 

section 510

    (k) , classified 
 under 

section 513

    (f)

    (2) , or approved under 

section 515 
 of the Federal Food, Drug, and Cosmetic Act;
 ``
        (B) is--
 ``
            (i) a genomic sequencing blood or blood 
 product test that includes the analysis of 
 cell-free nucleic acids; or
 ``
            (ii) a test based on samples of 
 biological material that provides results 
 comparable to those obtained with a test 
 described in clause
            (i) , as determined by the 
 Secretary; and
 ``
            (C) the Secretary determines is--
 ``
            (i) reasonable and necessary for the 
 prevention or early detection of an illness or 
 disability; and
 ``
            (ii) appropriate for individuals entitled 
 to benefits under part A or enrolled under part 
 B.
 ``

    (2) NCD process.--In making determinations under 
 paragraph

    (1)
            (C) regarding the coverage of a new test, the 
 Secretary shall use the process for making national coverage 
 determinations (as defined in 

section 1869

    (f)

    (1)
        (B) ) under this 
 title.''.

    (b) Payment and Standards for Multi-Cancer Early Detection 
Screening Tests.--

    (1) In general.--

Section 1834 of the Social Security Act 
 (42 U.S.C. 1395m) is amended by adding at the end the following 
 new subsection:
 ``

    (aa) Payment and Standards for Multi-Cancer Early Detection 
Screening Tests.--
 ``

    (1) Payment amount.--The payment amount for a multi-
 cancer early detection screening test (as defined in 

section 1861

    (nnn) ) is--
 ``
        (A) with respect to such a test furnished before 
 January 1, 2031, equal to the payment amount in effect 
 on the date of the enactment of this subsection for a 
 multi-target stool screening DNA test covered pursuant 
 to 

section 1861

    (pp)

    (1)
            (D) ; and
 ``
        (B) with respect to such a test furnished on or 
 after January 1, 2031, equal to the lesser of--
 ``
            (i) the amount described in subparagraph
        (A) ; or
 ``
            (ii) the payment amount determined for 
 such test under 

section 1834A.
 ``

    (2) Limitations.--
 ``
        (A) In general.--No payment may be made under 
 this part for a multi-cancer early detection screening 
 test furnished during a year to an individual if--
 ``
            (i) as of January 1 of such year, such 
 individual has attained the age specified in 
 subparagraph
        (B) for such year; or
 ``
            (ii) such a test was furnished to the 
 individual during the previous 11 months.
 ``
        (B) Age specified.--For purposes of subparagraph
        (A)
            (i) , the age specified in this subparagraph is--
 ``
            (i) for 2028, 68 years of age; and
 ``
            (ii) for a succeeding year, the age 
 specified in this subparagraph for the 
 preceding year, increased by 1 year.
 ``

    (3) Standards following uspstf rating.--In the case of a 
 multi-cancer early detection screening test that is recommended 
 with a grade of A or B by the United States Preventive Services 
 Task Force, beginning on the date on which coverage for such 
 test is provided pursuant to 

section 1861
            (ddd) (1) , the 
 preceding provisions of this subsection shall not apply.''.

    (2) Conforming amendments.--
        (A) Section 1833 of the Social Security Act (42 
 U.S.C. 1395l) is amended--
            (i) in subsection

    (a) --
            (I) in paragraph

    (1)
            (D) 
            (i) 
            (I) , by 
 striking ``

section 1834
            (d) (1) '' and 
 inserting ``subsection
            (d) (1) or

    (aa) of 

section 1834''; and
            (II) in paragraph

    (2)
            (D) 
            (i) 
            (I) , by 
 striking ``

section 1834
            (d) (1) '' and 
 inserting ``subsection
            (d) (1) or

    (aa) of 

section 1834''; and
            (ii) in subsection

    (h) , by striking 
 ``

section 1834
            (d) (1) '' and inserting 
 ``subsections
            (d) (1) and

    (aa) of 

section 1834''.
        (B) Section 1862

    (a) of the Social Security Act (42 
 U.S.C. 1395y

    (a) ) is amended--
            (i) 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

    (nnn) ), which are not 
 reasonable and necessary for the concurrent detection of 
 multiple cancer types across multiple organ sites;''; and
            (ii) 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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