Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
This bill provides 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. The Government Accountability Office must report on the resulting utilization and effectiveness of such tests.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1873 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
1st Session
S. 1873
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
May 27, 2021
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 of 2021''.
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 ``and'' at the end of subparagraph
(GG);
(B) by striking the period at the end of
subparagraph (HH) and inserting ``; and''; and
(C) by adding at the end the following new
subparagraph:
``(II) multi-cancer early detection screening tests (as
defined in subsection (lll));''; and
(2) by adding at the end the following new subsection:
``(lll) 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, furnished to an individual for the purpose of early
detection of cancer across many cancer types (as categorized in the
Annual Report to the Nation on the Status of Cancer issued by the
National Cancer Institute):
``(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 urine
or other sample of biological material) as the Secretary
determines appropriate.''.
(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(lll) 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(lll)) 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 multi-cancer early detection screening
tests (as defined in section 1861(lll)), which are 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 (42 U.S.C.
1395j et seq.) 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 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.
(d) Implementation.--The Secretary of Health and Human Services
shall provide for the implementation of coverage of multi-cancer early
detection screening tests under the amendments made by this section
through the applicable Medicare coverage process under title XVIII of
the Social Security Act (42 U.S.C. 1395 et seq.).
(e) GAO Study and Report on Multi-Cancer Early Detection Screening
Tests.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the utilization of multi-cancer early
detection tests under title XVIII of the Social Security Act
(42 U.S.C. 1395 et seq.). Such study shall include an analysis
of aggregate data on--
(A) the utilization of such tests by sex, race,
ethnicity, geography, and socioeconomic status; and
(B) the number of cancers detected through
screening in Medicare beneficiaries and improvements in
health outcomes.
(2) Report.--Not later than three years after the start of
coverage of such tests under such title, the Comptroller
General shall submit to Congress a report containing the
results of the study conducted under paragraph (1), including
recommendations for increasing access and utilization in
underserved areas and other recommendations as the Comptroller
General determines appropriate.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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