Medicare Multi-Cancer Early Detection Screening Coverage Act

II 118TH CONGRESS 1ST SESSION S. 2085 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 JUNE 21, 2023 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’’. 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 01:18 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S2085.IS S2085 kjohnson on DSK79L0C42PROD with BILLS 2 •S 2085 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 the semicolon at the end of 8 subparagraph (JJ) and inserting ‘‘; and’’; and 9 (B) by adding at the end the following new 10 subparagraph: 11 ‘‘(KK) multi-cancer early detection screening 12 tests (as defined in subsection (nnn));’’; and 13 (2) by adding at the end the following new sub- 14 section: 15 ‘‘(nnn) MULTI-CANCER EARLY DETECTION SCREEN- 16 ING TESTS.—The term ‘multi-cancer early detection 17 screening test’ means any of the following tests, approved 18 or cleared by the Food and Drug Administration, insofar 19 as the Secretary determines coverage of such tests is ap- 20 propriate, furnished to an individual for the purpose of 21 earlier detection of cancer across many cancer types (such 22 as described in the National Cancer Institute’s Annual Re- 23 port to the Nation on the Status of Cancer): 24 VerDate Sep 11 2014 01:18 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2085.IS S2085 kjohnson on DSK79L0C42PROD with BILLS 3 •S 2085 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 blood, blood products, urine, or other sam- 5 ple of biological material) as the Secretary deter- 6 mines appropriate in providing results comparable to 7 those obtained with a test described in paragraph 8 (1).’’. 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 16 1861(nnn), 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(nnn)) for an individual 22 if such a test was furnished to the individual during 23 the previous 11 months.’’. 24 VerDate Sep 11 2014 01:18 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S2085.IS S2085 kjohnson on DSK79L0C42PROD with BILLS 4 •S 2085 IS (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 a multi-cancer early detec- 12 tion screening test (as defined in section 13 1861(nnn)), which is performed more frequently 14 than is covered under section 1833(h)(10);’’; and 15 (B) in paragraph (7), by striking ‘‘or (P)’’ 16 and inserting ‘‘(P), or (Q)’’. 17 (c) RULE OF CONSTRUCTION RELATING TO OTHER 18 CANCER SCREENING TESTS.—Nothing in this section, in- 19 cluding the amendments made by this section, shall be 20 construed— 21 (1) in the case of an individual who undergoes 22 a multi-cancer early detection screening test, to af- 23 fect coverage under part B of title XVIII of the So- 24 cial Security Act for other cancer screening tests 25 VerDate Sep 11 2014 01:18 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S2085.IS S2085 kjohnson on DSK79L0C42PROD with BILLS 5 •S 2085 IS covered under such title, such as screening tests for 1 breast, cervical, colorectal, lung, or prostate cancer; 2 or 3 (2) in the case of an individual who undergoes 4 another cancer screening test, to affect coverage 5 under such part for a multi-cancer early detection 6 screening test or the use of such a test as a diag- 7 nostic or confirmatory test for a result of the other 8 cancer screening test. 9 Æ VerDate Sep 11 2014 01:18 Jul 14, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6301 E:\BILLS\S2085.IS S2085 kjohnson on DSK79L0C42PROD with BILLS