I 

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. 

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 ‘‘Nancy Gardner Sewell 

5 Medicare Multi-Cancer Early Detection Screening Cov6 erage Act’’. 

7 SEC. 2. FINDINGS; PURPOSE. 

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


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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 4 times greater survival rate compared 

5 to cancers found after metastasis has occurred. Ex6 isting Medicare-covered early detection tests, such as 

7 mammograms and colonoscopies, have led to a sub8 stantial reduction in age-adjusted mortality. 

9 (2) Diagnosing and treating cancer earlier often 

10 results in less invasive treatments for patients, 

11 which are also less expensive. According to peer re12 viewed literature, treatment of early stage cancer is 

13 half the cost of metastatic cancer. 

14 (3) Driving national strategies to broadly detect 

15 cancer earlier will help reduce pervasive health dis16 parities since racial, ethnic, and geographic groups 

17 experience later stages of diagnosis, along with high18 er cancer incidence and mortality. 

19 (4) The benefits of early cancer detection to 

20 Medicare beneficiaries have been limited to five can21 cers. According to the National Cancer Institute’s 

22 Surveillance, Epidemiology, and End Results pro23 gram, 71 percent of the 600,000 cancer deaths each 

24 year are from types of cancer without a Medicare25 covered early detection test. 


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

2 placing Medicare beneficiaries at elevated risk. 

3 About 1,000,000 Medicare beneficiaries will be diag4 nosed with cancer this year, as the median age for 

5 cancer diagnosis is 66 years of age. 

6 (6) Several innovative private and academic ef7 forts are engaged in research, including advanced 

8 clinical trials to develop multi-cancer early detection 

9 blood-based tests. Published data indicate that these 

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

11 including rare cancers, with one example currently 

12 able to screen for more than 50 cancers. 

13 (7) Multi-cancer early detection tests can com14 plement the covered early detection tests enacted by 

15 Congress and extend the benefits of early detection 

16 to more cancers and more Americans. Medicare cov17 erage of comprehensive multi-cancer early detection 

18 screening tests could substantially transform cancer 

19 care for Americans, and the Medicare law needs 

20 modernizing to provide timely coverage and keep 

21 pace with medical innovation. 

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

23 a covered benefit for multi-cancer early detection screen24 ing tests to ensure Medicare beneficiary access to these 


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1 tests without unnecessary delay once approved under the 

2 Federal Food, Drug, and Cosmetic Act. 

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

4 DETECTION SCREENING TESTS. 

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

6 Act (42 U.S.C. 1395x) is amended— 

7 (1) in subsection (s)(2)— 

8 (A) by striking the semicolon at the end of 

9 subparagraph (JJ) and inserting ‘‘; and’’; and 

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

11 subparagraph: 

12 ‘‘(KK) multi-cancer early detection screen13 ing tests (as defined in subsection (nnn));’’; and 

14 (2) by adding at the end the following new sub15 section: 

16 ‘‘(nnn) MULTI-CANCER EARLY DETECTION SCREEN17 ING TESTS.—The term ‘multi-cancer early detection 

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

19 or cleared by the Food and Drug Administration, insofar 

20 as the Secretary determines coverage of such tests is ap21 propriate, furnished to an individual for the purpose of 

22 earlier detection of cancer across many cancer types (such 

23 as described in the National Cancer Institute’s Annual Re24 port to the Nation on the Status of Cancer): 


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1 ‘‘(2) A genomic sequencing blood or blood prod2 uct test that includes the analysis of cell-free nucleic 

3 acids. 

4 ‘‘(3) Such other equivalent tests (which are 

5 based on blood, blood products, urine or other sam6 ple of biological material) as the Secretary deter7 mines appropriate in providing results comparable to 

8 those obtained with a test described in paragraph 

9 (1).’’. 

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 

17 1861(nnn), 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(nnn)) for an individual 

23 if such a test was furnished to the individual during 

24 the previous 11 months.’’. 


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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 of title XVIII of the SoVerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407

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1 cial Security Act for other cancer screening tests 

2 covered under such title, such as screening tests for 

3 breast, cervical, colorectal, lung, or prostate cancer; 

4 or 

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

6 another cancer screening test, to affect coverage 

7 under such part for a multi-cancer early detection 

8 screening test or the use of such a test as a diag9 nostic or confirmatory test for a result of the other 

10 cancer screening test. 

Æ 


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