Medicare Multi-Cancer Early Detection Screening Coverage Act
This bill allows 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.
[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2085 Introduced in Senate (IS)]
<DOC>
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.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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