Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Medicare Multi-Cancer 4 Early Detection Screening Coverage Act of 2021’’. 5 SEC. 2. FINDINGS; PURPOSE. 6 (a) FINDINGS.—Congress finds the following: 7 VerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1946.IH H1946 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 1946 IH (1) Detecting cancer early, before it has spread 1 throughout the body, saves lives. Cancers detected 2 when still localized can be treated more effectively 3 and have a 5-year cancer specific survival of ap- 4 proximately 90 percent compared with approximately 5 20 percent for cancers found after metastasis has 6 occurred. Existing Medicare-covered early detection 7 tests such as mammograms and colonoscopies, have 8 led to a substantial reduction in age-adjusted mor- 9 tality. 10 (2) Diagnosing and treating cancer earlier often 11 results in less invasive treatments for patients, 12 which are also less expensive. According to peer re- 13 viewed literature, treatment of metastatic cancer is 14 two times more costly than treatment of cancer be- 15 fore it metastasizes. 16 (3) Driving national strategies to broadly detect 17 cancer earlier will help reduce pervasive health dis- 18 parities since racial, ethnic, and geographic groups 19 experience later stages of diagnosis, along with high- 20 er cancer incidence and mortality. 21 (4) The benefits of early cancer detection to 22 Medicare beneficiaries has been limited to five can- 23 cers. According to the National Cancer Institute’s 24 Surveillance, Epidemiology, and End Results pro- 25 VerDate 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 gram, 71 percent of the 600,000 cancer deaths each 1 year are from types of cancer without a Medicare- 2 covered early detection test. 3 (5) Age is the leading risk factor for cancer, 4 placing Medicare beneficiaries at elevated risk. 5 Americans who are 65 years of age and older are 6 more than 7 times as likely as Americans who are 7 under 65 years of age to be diagnosed with cancer. 8 (6) Several innovative private and academic ef- 9 forts are engaged in research, including advanced 10 clinical trials to develop multi-cancer early detection 11 blood-based tests. Published data indicate that these 12 tests can screen for many cancers at the same time, 13 including rare cancers, with one example currently 14 able to screen for more than 50 cancers. 15 (7) Multi-cancer early detection tests can com- 16 plement the covered early detection tests enacted by 17 Congress and extend the benefits of early detection 18 to more cancers and more Americans. Medicare cov- 19 erage of comprehensive multi-cancer early detection 20 screening tests could substantially transform cancer 21 care for Americans, and the Medicare law needs 22 modernizing to provide timely coverage and keep 23 pace with medical innovation. 24 VerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1946.IH H1946 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 1946 IH (b) PURPOSE.—The purpose of this Act is to create 1 a covered benefit for multi-cancer early detection screen- 2 ing tests to ensure Medicare beneficiary access to these 3 tests without unnecessary delay once approved under the 4 Federal Food, Drug, and Cosmetic Act. 5 SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY 6 DETECTION SCREENING TESTS. 7 (a) COVERAGE.—Section 1861 of the Social Security 8 Act (42 U.S.C. 1395x) is amended— 9 (1) in subsection (s)(2)— 10 (A) by striking ‘‘and’’ at the end of sub- 11 paragraph (GG); 12 (B) by striking the period at the end of 13 subparagraph (HH) and inserting ‘‘; and’’; and 14 (C) by adding at the end the following new 15 subparagraph: 16 ‘‘(II) multi-cancer early detection screening 17 tests (as defined in subsection (lll));’’; and 18 (2) by adding at the end the following new sub- 19 section: 20 ‘‘(lll) MULTI-CANCER EARLY DETECTION SCREEN- 21 ING TESTS.—The term ‘multi-cancer early detection 22 screening test’ means any of the following tests, approved 23 or cleared by the Food and Drug Administration, fur- 24 nished to an individual for the purpose of early detection 25 VerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1946.IH H1946 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 1946 IH of cancer across many cancer types (as categorized in the 1 Annual Report to the Nation on the Status of Cancer 2 issued by the National Cancer Institute): 3 ‘‘(1) A genomic sequencing blood or blood prod- 4 uct test that includes the analysis of cell-free nucleic 5 acids. 6 ‘‘(2) Such other equivalent tests (which are 7 based on urine or other sample of biological mate- 8 rial) as the Secretary determines appropriate.’’. 9 (b) PAYMENT AND FREQUENCY LIMIT.— 10 (1) PAYMENT UNDER FEE SCHEDULE.—Section 11 1833(h) of the Social Security Act (42 U.S.C. 12 1395l(h)) is amended— 13 (A) in paragraph (1)(A), by inserting after 14 ‘‘(including’’ the following: ‘‘multi-cancer early 15 detection screening tests under section 1861(lll) 16 and including’’; and 17 (B) by adding at the end the following new 18 paragraph: 19 ‘‘(10) No payment may be made under this 20 part for a multi-cancer early detection screening test 21 (as defined in section 1861(lll)) for an individual if 22 such a test was furnished to the individual during 23 the previous 11 months.’’. 24 VerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1946.IH H1946 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 1946 IH (2) CONFORMING AMENDMENT.—Section 1 1862(a) of the Social Security Act (42 U.S.C. 2 1395y(a)) is amended— 3 (A) in paragraph (1)— 4 (i) in subparagraph (O), by striking 5 ‘‘and’’ at the end; 6 (ii) in subparagraph (P), by striking 7 the semicolon at the end and inserting ‘‘, 8 and’’; and 9 (iii) by adding at the end the fol- 10 lowing new subparagraph: 11 ‘‘(Q) in the case of multi-cancer early de- 12 tection screening tests (as defined in section 13 1861(lll)), which are performed more frequently 14 than is covered under section 1833(h)(10);’’; 15 and 16 (B) in paragraph (7), by striking ‘‘or (P)’’ 17 and inserting ‘‘(P), or (Q)’’. 18 (c) RULE OF CONSTRUCTION RELATING TO OTHER 19 CANCER SCREENING TESTS.—Nothing in this section, in- 20 cluding the amendments made by this section, shall be 21 construed— 22 (1) in the case of an individual who undergoes 23 a multi-cancer early detection screening test, to af- 24 fect coverage under part B for other cancer screen- 25 VerDate 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 ing tests covered under this title, such as screening 1 tests for breast, cervical, colorectal, lung, or prostate 2 cancer; or 3 (2) in the case of an individual who undergoes 4 another cancer screening test, to affect coverage for 5 a multi-cancer early detection screening test or the 6 use of such a test as a diagnostic or confirmatory 7 test for a result of the other cancer screening test. 8 Æ VerDate Sep 11 2014 23:22 May 11, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H1946.IH H1946 pamtmann on DSKBC07HB2PROD with BILLS