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. FERGUSON, Mr. KIND, Mr. DANNY K. DAVIS of Illinois, and Mr. CRENSHAW) 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medicare Multi-Cancer 

5 Early Detection Screening Coverage Act of 2021’’. 

6 SEC. 2. FINDINGS; PURPOSE. 

7 (a) FINDINGS.—Congress finds the following: 


pamtmann on DSKBC07HB2PROD with BILLS
2 

•HR 1946 IH

1 (1) Detecting cancer early, before it has spread 

2 throughout the body, saves lives. Cancers detected 

3 when still localized can be treated more effectively 

4 and have a 5-year cancer specific survival of ap5 proximately 90 percent compared with approximately 

6 20 percent for cancers found after metastasis has 

7 occurred. Existing Medicare-covered early detection 

8 tests such as mammograms and colonoscopies, have 

9 led to a substantial reduction in age-adjusted mor10 tality. 

11 (2) Diagnosing and treating cancer earlier often 

12 results in less invasive treatments for patients, 

13 which are also less expensive. According to peer re14 viewed literature, treatment of metastatic cancer is 

15 two times more costly than treatment of cancer be16 fore it metastasizes. 

17 (3) Driving national strategies to broadly detect 

18 cancer earlier will help reduce pervasive health dis19 parities since racial, ethnic, and geographic groups 

20 experience later stages of diagnosis, along with high21 er cancer incidence and mortality. 

22 (4) The benefits of early cancer detection to 

23 Medicare beneficiaries has been limited to five can24 cers. According to the National Cancer Institute’s 

25 Surveillance, Epidemiology, and End Results proVerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1946.IH H1946

pamtmann on DSKBC07HB2PROD with BILLS
3 

•HR 1946 IH

1 gram, 71 percent of the 600,000 cancer deaths each 

2 year are from types of cancer without a Medicare3 covered early detection test. 

4 (5) Age is the leading risk factor for cancer, 

5 placing Medicare beneficiaries at elevated risk. 

6 Americans who are 65 years of age and older are 

7 more than 7 times as likely as Americans who are 

8 under 65 years of age to be diagnosed with cancer. 

9 (6) Several innovative private and academic ef10 forts are engaged in research, including advanced 

11 clinical trials to develop multi-cancer early detection 

12 blood-based tests. Published data indicate that these 

13 tests can screen for many cancers at the same time, 

14 including rare cancers, with one example currently 

15 able to screen for more than 50 cancers. 

16 (7) Multi-cancer early detection tests can com17 plement the covered early detection tests enacted by 

18 Congress and extend the benefits of early detection 

19 to more cancers and more Americans. Medicare cov20 erage of comprehensive multi-cancer early detection 

21 screening tests could substantially transform cancer 

22 care for Americans, and the Medicare law needs 

23 modernizing to provide timely coverage and keep 

24 pace with medical innovation. 


pamtmann on DSKBC07HB2PROD with BILLS
4 

•HR 1946 IH

1 (b) PURPOSE.—The purpose of this Act is to create 

2 a covered benefit for multi-cancer early detection screen3 ing tests to ensure Medicare beneficiary access to these 

4 tests without unnecessary delay once approved under the 

5 Federal Food, Drug, and Cosmetic Act. 

6 SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY 

7 DETECTION SCREENING TESTS. 

8 (a) COVERAGE.—Section 1861 of the Social Security 

9 Act (42 U.S.C. 1395x) is amended— 

10 (1) in subsection (s)(2)— 

11 (A) by striking ‘‘and’’ at the end of sub12 paragraph (GG); 

13 (B) by striking the period at the end of 

14 subparagraph (HH) and inserting ‘‘; and’’; and 

15 (C) by adding at the end the following new 

16 subparagraph: 

17 ‘‘(II) multi-cancer early detection screening 

18 tests (as defined in subsection (lll));’’; and 

19 (2) by adding at the end the following new sub20 section: 

21 ‘‘(lll) MULTI-CANCER EARLY DETECTION SCREEN22 ING TESTS.—The term ‘multi-cancer early detection 

23 screening test’ means any of the following tests, approved 

24 or cleared by the Food and Drug Administration, fur25 nished to an individual for the purpose of early detection 


pamtmann on DSKBC07HB2PROD with BILLS
5 

•HR 1946 IH

1 of cancer across many cancer types (as categorized in the 

2 Annual Report to the Nation on the Status of Cancer 

3 issued by the National Cancer Institute): 

4 ‘‘(1) A genomic sequencing blood or blood prod5 uct test that includes the analysis of cell-free nucleic 

6 acids. 

7 ‘‘(2) Such other equivalent tests (which are 

8 based on urine or other sample of biological mate9 rial) as the Secretary determines appropriate.’’. 

10 (b) PAYMENT AND FREQUENCY LIMIT.— 

11 (1) PAYMENT UNDER FEE SCHEDULE.—Section 

12 1833(h) of the Social Security Act (42 U.S.C. 

13 1395l(h)) is amended— 

14 (A) in paragraph (1)(A), by inserting after 

15 ‘‘(including’’ the following: ‘‘multi-cancer early 

16 detection screening tests under section 1861(lll) 

17 and including’’; and 

18 (B) by adding at the end the following new 

19 paragraph: 

20 ‘‘(10) No payment may be made under this 

21 part for a multi-cancer early detection screening test 

22 (as defined in section 1861(lll)) for an individual if 

23 such a test was furnished to the individual during 

24 the previous 11 months.’’. 


pamtmann on DSKBC07HB2PROD with BILLS
6 

•HR 1946 IH

1 (2) CONFORMING AMENDMENT.—Section 

2 1862(a) of the Social Security Act (42 U.S.C. 

3 1395y(a)) is amended— 

4 (A) in paragraph (1)— 

5 (i) in subparagraph (O), by striking 

6 ‘‘and’’ at the end; 

7 (ii) in subparagraph (P), by striking 

8 the semicolon at the end and inserting ‘‘, 

9 and’’; and 

10 (iii) by adding at the end the fol11 lowing new subparagraph: 

12 ‘‘(Q) in the case of multi-cancer early de13 tection screening tests (as defined in section 

14 1861(lll)), which are performed more frequently 

15 than is covered under section 1833(h)(10);’’; 

16 and 

17 (B) in paragraph (7), by striking ‘‘or (P)’’ 

18 and inserting ‘‘(P), or (Q)’’. 

19 (c) RULE OF CONSTRUCTION RELATING TO OTHER

20 CANCER SCREENING TESTS.—Nothing in this section, in21 cluding the amendments made by this section, shall be 

22 construed— 

23 (1) in the case of an individual who undergoes 

24 a multi-cancer early detection screening test, to af25 fect coverage under part B for other cancer screenVerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H1946.IH H1946

pamtmann on DSKBC07HB2PROD with BILLS
7 

•HR 1946 IH

1 ing tests covered under this title, such as screening 

2 tests for breast, cervical, colorectal, lung, or prostate 

3 cancer; or 

4 (2) in the case of an individual who undergoes 

5 another cancer screening test, to affect coverage for 

6 a multi-cancer early detection screening test or the 

7 use of such a test as a diagnostic or confirmatory 

8 test for a result of the other cancer screening test. 

Æ 


pamtmann on DSKBC07HB2PROD with BILLS