I 
117TH CONGRESS 
1ST SESSION H. R. 1946 
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 16, 2021 
Ms. SEWELL (for herself, Mr. ARRINGTON, Mr. RUIZ, Mr. HUDSON, Ms. 
BLUNT ROCHESTER, Mr. WENSTRUP, Ms. JACKSON LEE, Mr. FER-
GUSON, Mr. KIND, Mr. DANNY K. DAVIS of Illinois, and Mr. CRENSHAW) 
introduced the following bill; which was referred to the Committee on En-
ergy 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 jurisdic-
tion 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 Representa-
tives 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. FINDINGS; PURPOSE. 
(a) FINDINGS.—Congress finds the following: 
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(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 5-year cancer specific survival of ap-
proximately 90 percent compared with approximately 
20 percent for 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 mor-
tality. 
(2) Diagnosing and treating cancer earlier often 
results in less invasive treatments for patients, 
which are also less expensive. According to peer re-
viewed literature, treatment of metastatic cancer is 
two times more costly than treatment of cancer be-
fore it metastasizes. 
(3) Driving national strategies to broadly detect 
cancer earlier will help reduce pervasive health dis-
parities since racial, ethnic, and geographic groups 
experience later stages of diagnosis, along with high-
er cancer incidence and mortality. 
(4) The benefits of early cancer detection to 
Medicare beneficiaries has been limited to five can-
cers. According to the National Cancer Institute’s 
Surveillance, Epidemiology, and End Results pro-
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gram, 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. 
Americans who are 65 years of age and older are 
more than 7 times as likely as Americans who are 
under 65 years of age to be diagnosed with cancer. 
(6) Several innovative private and academic ef-
forts 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 com-
plement the covered early detection tests enacted by 
Congress and extend the benefits of early detection 
to more cancers and more Americans. Medicare cov-
erage 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. 
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(b) PURPOSE.—The purpose of this Act is to create 
a covered benefit for multi-cancer early detection screen-
ing 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 sub-
paragraph (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 sub-
section: 
‘‘(lll) MULTI-CANCER EARLY DETECTION SCREEN-
ING
TESTS.—The term ‘multi-cancer early detection 
screening test’ means any of the following tests, approved 
or cleared by the Food and Drug Administration, fur-
nished to an individual for the purpose of early detection 
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