Bill Details
S.339 - 119th Congress
Status
Latest action
2025-01-30 - Read twice and referred to the Committee on Finance.
Introduced Date
2025-01-30
Policy Area
Health
Committees
View committees (1)
Sponsors
Cosponsors
View cosponsors (20)
- Sen. Bennet, Michael F. [D-Colorado]
- Sen. Scott, Tim [R-South Carolina]
- Sen. Wyden, Ron [D-Oregon]
- Sen. Lankford, James [R-Oklahoma]
- Sen. Rounds, Mike [R-South Dakota]
- Sen. Tillis, Thomas [R-North Carolina]
- Sen. Budd, Ted [R-North Carolina]
- Sen. Klobuchar, Amy [D-Minnesota]
- Sen. Marshall, Roger [R-Kansas]
- Sen. Ossoff, Jon [D-Georgia]
- Sen. Risch, James E. [R-Idaho]
- Sen. Merkley, Jeff [D-Oregon]
- Sen. Barrasso, John [R-Wyoming]
- Sen. Kelly, Mark [D-Arizona]
- Sen. Capito, Shelley Moore [R-West Virginia]
- Sen. Rosen, Jacky [D-Nevada]
- Sen. Coons, Christopher A. [D-Delaware]
- Sen. Fetterman, John [D-Pennsylvania]
- Sen. Blumenthal, Richard [D-Connecticut]
- Sen. Reed, Jack [D-Rhode Island]
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AI Summary This summary was generated by AI from the bill text. AI can get information wrong.
This bill would make Medicare cover certain new blood or sample-based tests that can look for several kinds of cancer at once, starting in 2028. The goal is to help find cancer earlier, before it spreads. The tests would have to be approved or cleared by the FDA and judged by Medicare officials to be medically useful and appropriate for people with Medicare. The bill also sets how Medicare would pay for these tests and puts limits on how often they can be used and who can receive them each year.
- Medicare would cover multi-cancer early detection screening tests if they are approved by the FDA and Medicare decides they are reasonable and needed for early detection.
- The bill says Medicare must use its national coverage review process when deciding whether a new test should be covered.
- For payment, Medicare would initially pay the same amount it pays for certain stool-based DNA cancer screening tests, at least through the end of 2030. After that, payment would be the lower of that amount or a rate set under Medicare’s standard pricing rules.
- There are limits on use: Medicare would not pay for the test if the person had already had one in the previous 11 months, and the age limit would begin at 68 in 2028, then rise by one year each year after that.
- If the U.S. Preventive Services Task Force later gives one of these tests an A or B recommendation, those special limits and payment rules would no longer apply once coverage is in place under the usual Medicare rules.
- The bill also makes clear that this new coverage would not change Medicare coverage for other cancer screenings, such as breast, cervical, colorectal, lung, or prostate cancer tests.
Official Summaries
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.
Current Full Text
[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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