Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1873 To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests. IN THE SENATE OF THE UNITED STATES MAY 27, 2021 Mr. CRAPO (for himself, Mr. BENNET, Mr. SCOTT of South Carolina, and Mr. CARDIN) introduced the following bill; which was read twice and referred to the Committee on Finance 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. PURPOSE. 6 The purpose of this Act is to create a covered benefit 7 for multi-cancer early detection screening tests to ensure 8 Medicare beneficiary access to these tests without unnec- 9 VerDate Sep 11 2014 00:26 Jun 19, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1873.IS S1873 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 1873 IS essary delay once approved under the Federal Food, Drug, 1 and Cosmetic Act. 2 SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY 3 DETECTION SCREENING TESTS. 4 (a) COVERAGE.—Section 1861 of the Social Security 5 Act (42 U.S.C. 1395x) is amended— 6 (1) in subsection (s)(2)— 7 (A) by striking ‘‘and’’ at the end of sub- 8 paragraph (GG); 9 (B) by striking the period at the end of 10 subparagraph (HH) and inserting ‘‘; and’’; and 11 (C) by adding at the end the following new 12 subparagraph: 13 ‘‘(II) multi-cancer early detection screening 14 tests (as defined in subsection (lll));’’; and 15 (2) by adding at the end the following new sub- 16 section: 17 ‘‘(lll) MULTI-CANCER EARLY DETECTION SCREEN- 18 ING TESTS.—The term ‘multi-cancer early detection 19 screening test’ means any of the following tests, approved 20 or cleared by the Food and Drug Administration, fur- 21 nished to an individual for the purpose of early detection 22 of cancer across many cancer types (as categorized in the 23 Annual Report to the Nation on the Status of Cancer 24 issued by the National Cancer Institute): 25 VerDate Sep 11 2014 00:26 Jun 19, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1873.IS S1873 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 1873 IS ‘‘(1) A genomic sequencing blood or blood prod- 1 uct test that includes the analysis of cell-free nucleic 2 acids. 3 ‘‘(2) Such other equivalent tests (which are 4 based on urine or other sample of biological mate- 5 rial) as the Secretary determines appropriate.’’. 6 (b) PAYMENT AND FREQUENCY LIMIT.— 7 (1) PAYMENT UNDER FEE SCHEDULE.—Section 8 1833(h) of the Social Security Act (42 U.S.C. 9 1395l(h)) is amended— 10 (A) in paragraph (1)(A), by inserting after 11 ‘‘(including’’ the following: ‘‘multi-cancer early 12 detection screening tests under section 1861(lll) 13 and including’’; and 14 (B) by adding at the end the following new 15 paragraph: 16 ‘‘(10) No payment may be made under this 17 part for a multi-cancer early detection screening test 18 (as defined in section 1861(lll)) for an individual if 19 such a test was furnished to the individual during 20 the previous 11 months.’’. 21 (2) CONFORMING AMENDMENT.—Section 22 1862(a) of the Social Security Act (42 U.S.C. 23 1395y(a)) is amended— 24 (A) in paragraph (1)— 25 VerDate Sep 11 2014 00:26 Jun 19, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1873.IS S1873 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 1873 IS (i) in subparagraph (O), by striking 1 ‘‘and’’ at the end; 2 (ii) in subparagraph (P), by striking 3 the semicolon at the end and inserting ‘‘, 4 and’’; and 5 (iii) by adding at the end the fol- 6 lowing new subparagraph: 7 ‘‘(Q) in the case of multi-cancer early detection 8 screening tests (as defined in section 1861(lll)), 9 which are performed more frequently than is covered 10 under section 1833(h)(10);’’; and 11 (B) in paragraph (7), by striking ‘‘or (P)’’ 12 and inserting ‘‘(P), or (Q)’’. 13 (c) RULE OF CONSTRUCTION RELATING TO OTHER 14 CANCER SCREENING TESTS.—Nothing in this section, in- 15 cluding the amendments made by this section, shall be 16 construed— 17 (1) in the case of an individual who undergoes 18 a multi-cancer early detection screening test, to af- 19 fect coverage under part B of title XVIII of the So- 20 cial Security Act (42 U.S.C. 1395j et seq.) for other 21 cancer screening tests covered under such title, such 22 as screening tests for breast, cervical, colorectal, 23 lung, or prostate cancer; or 24 VerDate Sep 11 2014 00:26 Jun 19, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1873.IS S1873 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 1873 IS (2) in the case of an individual who undergoes 1 another cancer screening test, to affect coverage for 2 a multi-cancer early detection screening test or the 3 use of such a test as a diagnostic or confirmatory 4 test for a result of the other cancer screening test. 5 (d) IMPLEMENTATION.—The Secretary of Health and 6 Human Services shall provide for the implementation of 7 coverage of multi-cancer early detection screening tests 8 under the amendments made by this section through the 9 applicable Medicare coverage process under title XVIII of 10 the Social Security Act (42 U.S.C. 1395 et seq.). 11 (e) GAO STUDY AND REPORT ON MULTI-CANCER 12 EARLY DETECTION SCREENING TESTS.— 13 (1) STUDY.—The Comptroller General of the 14 United States shall conduct a study on the utiliza- 15 tion of multi-cancer early detection tests under title 16 XVIII of the Social Security Act (42 U.S.C. 1395 et 17 seq.). Such study shall include an analysis of aggre- 18 gate data on— 19 (A) the utilization of such tests by sex, 20 race, ethnicity, geography, and socioeconomic 21 status; and 22 (B) the number of cancers detected 23 through screening in Medicare beneficiaries and 24 improvements in health outcomes. 25 VerDate Sep 11 2014 00:26 Jun 19, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1873.IS S1873 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 1873 IS (2) REPORT.—Not later than three years after 1 the start of coverage of such tests under such title, 2 the Comptroller General shall submit to Congress a 3 report containing the results of the study conducted 4 under paragraph (1), including recommendations for 5 increasing access and utilization in underserved 6 areas and other recommendations as the Comptroller 7 General determines appropriate. 8 Æ VerDate Sep 11 2014 00:26 Jun 19, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\S1873.IS S1873 pbinns on DSKJLVW7X2PROD with BILLS