I 117th CONGRESS 1st Session H. R. 5377 IN THE HOUSE OF REPRESENTATIVES September 27, 2021 Mr. Butterfield (for himself and Mr. Bilirakis ) 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 facilitate the development of treatments for cancers, and for other purposes.

1. Short title This Act may be cited as the Cancer Patient Equity Act of 2021 . 2. Coverage of cancer diagnostic and laboratory tests (a) Medicare (1) Coverage Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended— (A) in subsection (s)(2)— (i) in subparagraph (GG), by striking and at the end; (ii) in subparagraph (HH), by striking the period at the end and inserting ; and ; and (iii) by adding at the end the following new subparagraph: (II) cancer diagnostic and laboratory tests (as defined in subsection (lll)) furnished on or after the date that is 6 months after the date of the enactment of this subparagraph. ; and (B) by adding at the end the following new subsection: (lll) Cancer diagnostic and laboratory tests (1) In general The term cancer diagnostic and laboratory tests means— (A) microarray analysis, DNA sequencing, RNA sequencing, whole-exome sequencing, and other forms of next-generation sequencing furnished and reported by a clinical laboratory (as defined in section 353(a) of the Public Health Service Act); and (B) explanation and interpretation of any analysis or sequencing described in subparagraph (A); furnished to an individual diagnosed with cancer. (2) Frequency Tests described in paragraph (1) may only be furnished with respect to an individual diagnosed with a cancer— (A) once upon the diagnosis of such cancer; (B) once upon any recurrence of such cancer; and (C) as necessary for purposes of monitoring the progression of such cancer or the response of such cancer to treatment. . (2) Payment Section 1833 of the Social Security Act ( 42 U.S.C. 1395l ) is amended— (A) in subsection (a)(1)— (i) by striking and (DD) and inserting (DD) ; and (ii) by striking ,; and inserting , and (EE) with respect to cancer diagnostic and laboratory tests (as defined in section 1861(lll)), the amount paid shall be an amount equal to 80 percent (or 100 percent, in the case of such tests for which payment is made on an assignment-related basis) of the lesser of the actual charge for the test or the amount that would have been determined for such test under section 1834A had such test been a clinical diagnostic laboratory test; ; and (B) in subsection (b)— (i) by striking and (12) and inserting (12) ; and (ii) by striking section 1861(s)(10)(A). and inserting section 1861(s)(10)(A), and (13) such deductible shall not apply with respect to cancer diagnostic and laboratory tests (as defined in section 1861(lll)). . (3) Exclusion modification Section 1862(a)(1) of the Social Security Act ( 42 U.S.C. 1395y(a)(1) ) is amended— (A) in subparagraph (O), by striking and at the end; (B) in subparagraph (P), by striking the semicolon and inserting , and ; and (C) by adding at the end the following new subparagraph: (Q) in the case of cancer diagnostic and laboratory tests (as defined in section 1861(lll)), which are performed more frequently than is covered under such section; . (b) Medicaid (1) Inclusion as medical assistance Section 1905(a) of the Social Security Act ( 42 U.S.C. 1396d(a) ) is amended— (A) in paragraph (30), by striking and at the end; (B) by redesignating paragraph (31) as paragraph (32); and (C) by inserting after paragraph (30) the following new paragraph: (31) cancer diagnostic and laboratory tests (as defined in section 1861(lll)); and . (2) Mandatory coverage Section 1902(a)(10)(A) of such Act is amended, in the matter preceding clause (i), by striking and (30) and inserting (30), and (31) . (3) Inclusion in benchmark coverage Section 1937(b)(5) of such Act is amended by inserting before the period at the end the following: , and beginning January 1, 2022, coverage of cancer diagnostic and laboratory tests (as defined in section 1861(lll)) . (4) Effective date (A) In general The amendments made by this section shall apply with respect to items and services furnished on or after January 1, 2022. (B) Exemption for State legislation In the case of a State plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 et seq. ), or waiver of such plan, that the Secretary of Health and Human Services determines requires State legislation in order for the respective plan to meet any requirement imposed by amendments made by this section, the respective plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet such an additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the State legislature that begins after the date of the enactment of this Act. For purposes of the previous sentence, in the case of a State that has a 2-year legislative session, each year of the session shall be considered to be a separate regular session of the State legislature. (c) CHIP Section 2103(c) of the Social Security Act ( 42 U.S.C. 1397cc(c) ) is amended by adding at the end the following new paragraph: (11) Coverage of cancer diagnostic and laboratory tests Regardless of the type of coverage elected by a State under subsection (a), beginning January 1, 2022, child health assistance provided under such coverage for targeted low-income children and, in the case that the State elects to provide pregnancy-related assistance under such coverage pursuant to section 2112, such pregnancy-related assistance for targeted low-income pregnant women (as defined in section 2112(d)), shall include coverage of cancer diagnostic and laboratory tests (as defined in section 1861(lll)). . 3. Education and awareness program on genomic testing (a) In general The Secretary of Health and Human Services, in coordination with the Director of the National Human Genome Research Institute, shall carry out an education and awareness program for physicians and the general public on what genomic testing is, how can be used, and the role of genetic counselors. (b) Cancer and molecular diagnostics The education and awareness program under subsection (a) shall encourage the inclusion in graduate medical education and continuing medical education (including for specialty oncology services) of education and training on the importance of molecular diagnostics at diagnosis and reoccurrence of cancer to detect mutations.