Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act
This bill allows, beginning in 2028, 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, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate. Coverage is limited to those under a certain age (age 68 in 2028, increased by one year every year thereafter) and to one test every 11 months.
[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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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