[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2407 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 2407
To amend title XVIII of the Social Security Act to provide for Medicare
coverage of multi-cancer early detection screening tests.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 30, 2023
Mr. Arrington (for himself, Ms. Sewell, Mr. Hudson, and Mr. Ruiz)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on Ways and
Means, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the
jurisdiction of the committee concerned
_______________________________________________________________________
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. FINDINGS; PURPOSE.
(a) Findings.--Congress finds the following:
(1) Detecting cancer early, before it has spread throughout
the body, saves lives. Cancers detected when still localized
can be treated more effectively and have a 4 times greater
survival rate compared to cancers found after metastasis has
occurred. Existing Medicare-covered early detection tests, such
as mammograms and colonoscopies, have led to a substantial
reduction in age-adjusted mortality.
(2) Diagnosing and treating cancer earlier often results in
less invasive treatments for patients, which are also less
expensive. According to peer reviewed literature, treatment of
early stage cancer is half the cost of metastatic cancer.
(3) Driving national strategies to broadly detect cancer
earlier will help reduce pervasive health disparities since
racial, ethnic, and geographic groups experience later stages
of diagnosis, along with higher cancer incidence and mortality.
(4) The benefits of early cancer detection to Medicare
beneficiaries have been limited to five cancers. According to
the National Cancer Institute's Surveillance, Epidemiology, and
End Results program, 71 percent of the 600,000 cancer deaths
each year are from types of cancer without a Medicare-covered
early detection test.
(5) Age is the leading risk factor for cancer, placing
Medicare beneficiaries at elevated risk. About 1,000,000
Medicare beneficiaries will be diagnosed with cancer this year,
as the median age for cancer diagnosis is 66 years of age.
(6) Several innovative private and academic efforts are
engaged in research, including advanced clinical trials to
develop multi-cancer early detection blood-based tests.
Published data indicate that these tests can screen for many
cancers at the same time, including rare cancers, with one
example currently able to screen for more than 50 cancers.
(7) Multi-cancer early detection tests can complement the
covered early detection tests enacted by Congress and extend
the benefits of early detection to more cancers and more
Americans. Medicare coverage of comprehensive multi-cancer
early detection screening tests could substantially transform
cancer care for Americans, and the Medicare law needs
modernizing to provide timely coverage and keep pace with
medical innovation.
(b) 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):
``(2) A genomic sequencing blood or blood product test that
includes the analysis of cell-free nucleic acids.
``(3) 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 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 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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