Medicare Multi-Cancer Early Detection Screening Coverage Act

To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests. 1. Short title This Act may be cited as the Medicare Multi-Cancer Early Detection Screening Coverage Act 2. Purpose The purpose of this Act is to create a covered benefit for multi-cancer early detection screening tests to ensure Medicare beneficiary access to these tests without unnecessary delay once approved under the Federal Food, Drug, and Cosmetic Act. 3. Medicare coverage of multi-cancer early detection screening tests (a) Coverage Section 1861 of the Social Security Act ( 42 U.S.C. 1395x (1) in subsection (s)(2)— (A) by striking the semicolon at the end of subparagraph (JJ) and inserting ; and (B) by adding at the end the following new subparagraph: (KK) multi-cancer early detection screening tests (as defined in subsection (nnn)); ; and (2) by adding at the end the following new subsection: (nnn) Multi-Cancer early detection screening tests The term multi-cancer early detection screening test (1) A genomic sequencing blood or blood product test that includes the analysis of cell-free nucleic acids. (2) Such other equivalent tests (which are based on blood, blood products, urine, or other sample of biological material) as the Secretary determines appropriate in providing results comparable to those obtained with a test described in paragraph (1). . (b) Payment and frequency limit (1) Payment under fee schedule Section 1833(h) of the Social Security Act ( 42 U.S.C. 1395l(h) (A) in paragraph (1)(A), by inserting after (including multi-cancer early detection screening tests under section 1861(nnn), and including (B) by adding at the end the following new paragraph: (10) No payment may be made under this part for a multi-cancer early detection screening test (as defined in section 1861(nnn)) for an individual if such a test was furnished to the individual during the previous 11 months. . (2) Conforming amendment Section 1862(a) of the Social Security Act ( 42 U.S.C. 1395y(a) (A) in paragraph (1)— (i) in subparagraph (O), by striking and (ii) in subparagraph (P), by striking the semicolon at the end and inserting , and (iii) by adding at the end the following new subparagraph: (Q) in the case of a multi-cancer early detection screening test (as defined in section 1861(nnn)), which is performed more frequently than is covered under section 1833(h)(10); ; and (B) in paragraph (7), by striking or (P) (P), or (Q) (c) Rule of construction relating to other cancer screening tests Nothing in this section, including the amendments made by this section, shall be construed— (1) in the case of an individual who undergoes a multi-cancer early detection screening test, to affect coverage under part B of title XVIII of the Social Security Act for other cancer screening tests covered under such title, such as screening tests for breast, cervical, colorectal, lung, or prostate cancer; or (2) in the case of an individual who undergoes another cancer screening test, to affect coverage under such part for a multi-cancer early detection screening test or the use of such a test as a diagnostic or confirmatory test for a result of the other cancer screening test.

Summary: Medicare Multi-Cancer Early Detection Screening Coverage Act This bill allows for Medicare coverage and payment for multi-cancer early detection screening tests that are approved by the Food and Drug Administration and that are used to screen for cancer across many cancer types, if the Centers for Medicare & Medicaid Services determines such coverage is appropriate.