Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act

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) in- troduced 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 ‘‘Nancy Gardner Sewell 4 Medicare Multi-Cancer Early Detection Screening Cov- 5 erage Act’’. 6 SEC. 2. FINDINGS; PURPOSE. 7 (a) FINDINGS.—Congress finds the following: 8 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB 2 •HR 2407 IH (1) Detecting cancer early, before it has spread 1 throughout the body, saves lives. Cancers detected 2 when still localized can be treated more effectively 3 and have a 4 times greater survival rate compared 4 to cancers found after metastasis has occurred. Ex- 5 isting Medicare-covered early detection tests, such as 6 mammograms and colonoscopies, have led to a sub- 7 stantial reduction in age-adjusted mortality. 8 (2) Diagnosing and treating cancer earlier often 9 results in less invasive treatments for patients, 10 which are also less expensive. According to peer re- 11 viewed literature, treatment of early stage cancer is 12 half the cost of metastatic cancer. 13 (3) Driving national strategies to broadly detect 14 cancer earlier will help reduce pervasive health dis- 15 parities since racial, ethnic, and geographic groups 16 experience later stages of diagnosis, along with high- 17 er cancer incidence and mortality. 18 (4) The benefits of early cancer detection to 19 Medicare beneficiaries have been limited to five can- 20 cers. According to the National Cancer Institute’s 21 Surveillance, Epidemiology, and End Results pro- 22 gram, 71 percent of the 600,000 cancer deaths each 23 year are from types of cancer without a Medicare- 24 covered early detection test. 25 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB 3 •HR 2407 IH (5) Age is the leading risk factor for cancer, 1 placing Medicare beneficiaries at elevated risk. 2 About 1,000,000 Medicare beneficiaries will be diag- 3 nosed with cancer this year, as the median age for 4 cancer diagnosis is 66 years of age. 5 (6) Several innovative private and academic ef- 6 forts are engaged in research, including advanced 7 clinical trials to develop multi-cancer early detection 8 blood-based tests. Published data indicate that these 9 tests can screen for many cancers at the same time, 10 including rare cancers, with one example currently 11 able to screen for more than 50 cancers. 12 (7) Multi-cancer early detection tests can com- 13 plement the covered early detection tests enacted by 14 Congress and extend the benefits of early detection 15 to more cancers and more Americans. Medicare cov- 16 erage of comprehensive multi-cancer early detection 17 screening tests could substantially transform cancer 18 care for Americans, and the Medicare law needs 19 modernizing to provide timely coverage and keep 20 pace with medical innovation. 21 (b) PURPOSE.—The purpose of this Act is to create 22 a covered benefit for multi-cancer early detection screen- 23 ing tests to ensure Medicare beneficiary access to these 24 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB 4 •HR 2407 IH tests without unnecessary delay once approved under the 1 Federal Food, Drug, and Cosmetic Act. 2 SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY 3 DETECTION SCREENING TESTS. 4 (a) COVERAGE.—Section 1861 of the Social Security 5 Act (42 U.S.C. 1395x) is amended— 6 (1) in subsection (s)(2)— 7 (A) by striking the semicolon at the end of 8 subparagraph (JJ) and inserting ‘‘; and’’; and 9 (B) by adding at the end the following new 10 subparagraph: 11 ‘‘(KK) multi-cancer early detection screen- 12 ing tests (as defined in subsection (nnn));’’; and 13 (2) by adding at the end the following new sub- 14 section: 15 ‘‘(nnn) MULTI-CANCER EARLY DETECTION SCREEN- 16 ING TESTS.—The term ‘multi-cancer early detection 17 screening test’ means any of the following tests, approved 18 or cleared by the Food and Drug Administration, insofar 19 as the Secretary determines coverage of such tests is ap- 20 propriate, furnished to an individual for the purpose of 21 earlier detection of cancer across many cancer types (such 22 as described in the National Cancer Institute’s Annual Re- 23 port to the Nation on the Status of Cancer): 24 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB 5 •HR 2407 IH ‘‘(2) A genomic sequencing blood or blood prod- 1 uct test that includes the analysis of cell-free nucleic 2 acids. 3 ‘‘(3) 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 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB 6 •HR 2407 IH (2) CONFORMING AMENDMENT.—Section 1 1862(a) of the Social Security Act (42 U.S.C. 2 1395y(a)) is amended— 3 (A) in paragraph (1)— 4 (i) in subparagraph (O), by striking 5 ‘‘and’’ at the end; 6 (ii) in subparagraph (P), by striking 7 the semicolon at the end and inserting ‘‘, 8 and’’; and 9 (iii) by adding at the end the fol- 10 lowing new subparagraph: 11 ‘‘(Q) in the case of multi-cancer early de- 12 tection screening tests (as defined in section 13 1861(lll)), which are performed more frequently 14 than is covered under section 1833(h)(10);’’; 15 and 16 (B) in paragraph (7), by striking ‘‘or (P)’’ 17 and inserting ‘‘(P), or (Q)’’. 18 (c) RULE OF CONSTRUCTION RELATING TO OTHER 19 CANCER SCREENING TESTS.—Nothing in this section, in- 20 cluding the amendments made by this section, shall be 21 construed— 22 (1) in the case of an individual who undergoes 23 a multi-cancer early detection screening test, to af- 24 fect coverage under part B of title XVIII of the So- 25 VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB 7 •HR 2407 IH cial Security Act for other cancer screening tests 1 covered under such title, such as screening tests for 2 breast, cervical, colorectal, lung, or prostate cancer; 3 or 4 (2) in the case of an individual who undergoes 5 another cancer screening test, to affect coverage 6 under such part for a multi-cancer early detection 7 screening test or the use of such a test as a diag- 8 nostic or confirmatory test for a result of the other 9 cancer screening test. 10 Æ VerDate Sep 11 2014 01:08 Apr 12, 2023 Jkt 039200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H2407.IH H2407 pbinns on DSKJLVW7X2PROD with $$_JOB