Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
This bill provides 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.
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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medicare Multi-Cancer Early 
Detection Screening Coverage Act of 2021''.

SEC. 2. FINDINGS; PURPOSE.

    (a) Findings.--Congress finds the following:
            (1) Detecting cancer early, before it has spread throughout 
        the body, saves lives. Cancers detected when still localized 
        can be treated more effectively and have a 5-year cancer 
        specific survival of approximately 90 percent compared with 
        approximately 20 percent for cancers found after metastasis has 
        occurred. Existing Medicare-covered early detection tests such 
        as mammograms and colonoscopies, have led to a substantial 
        reduction in age-adjusted mortality.
            (2) Diagnosing and treating cancer earlier often results in 
        less invasive treatments for patients, which are also less 
        expensive. According to peer reviewed literature, treatment of 
        metastatic cancer is two times more costly than treatment of 
        cancer before it metastasizes.
            (3) Driving national strategies to broadly detect cancer 
        earlier will help reduce pervasive health disparities since 
        racial, ethnic, and geographic groups experience later stages 
        of diagnosis, along with higher cancer incidence and mortality.
            (4) The benefits of early cancer detection to Medicare 
        beneficiaries has been limited to five cancers. According to 
        the National Cancer Institute's Surveillance, Epidemiology, and 
        End Results program, 71 percent of the 600,000 cancer deaths 
        each year are from types of cancer without a Medicare-covered 
        early detection test.
            (5) Age is the leading risk factor for cancer, placing 
        Medicare beneficiaries at elevated risk. Americans who are 65 
        years of age and older are more than 7 times as likely as 
        Americans who are under 65 years of age to be diagnosed with 
        cancer.
            (6) Several innovative private and academic efforts are 
        engaged in research, including advanced clinical trials to 
        develop multi-cancer early detection blood-based tests. 
        Published data indicate that these tests can screen for many 
        cancers at the same time, including rare cancers, with one 
        example currently able to screen for more than 50 cancers.
            (7) Multi-cancer early detection tests can complement the 
        covered early detection tests enacted by Congress and extend 
        the benefits of early detection to more cancers and more 
        Americans. Medicare coverage of comprehensive multi-cancer 
        early detection screening tests could substantially transform 
        cancer care for Americans, and the Medicare law needs 
        modernizing to provide timely coverage and keep pace with 
        medical innovation.
    (b) 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.

SEC. 3. MEDICARE COVERAGE OF MULTI-CANCER EARLY DETECTION SCREENING 
              TESTS.

    (a) Coverage.--Section 1861 of the Social Security Act (42 U.S.C. 
1395x) is amended--
            (1) in subsection (s)(2)--
                    (A) by striking ``and'' at the end of subparagraph 
                (GG);
                    (B) by striking the period at the end of 
                subparagraph (HH) and inserting ``; and''; and
                    (C) by adding at the end the following new 
                subparagraph:
                    ``(II) multi-cancer early detection screening tests 
                (as defined in subsection (lll));''; and
            (2) by adding at the end the following new subsection:
    ``(lll) Multi-Cancer Early Detection Screening Tests.--The term 
`multi-cancer early detection screening test' means any of the 
following tests, approved or cleared by the Food and Drug 
Administration, furnished to an individual for the purpose of early 
detection of cancer across many cancer types (as categorized in the 
Annual Report to the Nation on the Status of Cancer issued by the 
National Cancer Institute):
            ``(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 urine 
        or other sample of biological material) as the Secretary 
        determines appropriate.''.
    (b) Payment and Frequency Limit.--
            (1) Payment under fee schedule.--Section 1833(h) of the 
        Social Security Act (42 U.S.C. 1395l(h)) is amended--
                    (A) in paragraph (1)(A), by inserting after 
                ``(including'' the following: ``multi-cancer early 
                detection screening tests under section 1861(lll) and 
                including''; and
                    (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(lll)) 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)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (O), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (P), by striking the 
                        semicolon at the end and inserting ``, and''; 
                        and
                            (iii) by adding at the end the following 
                        new subparagraph:
                    ``(Q) in the case of multi-cancer early detection 
                screening tests (as defined in section 1861(lll)), 
                which are performed more frequently than is covered 
                under section 1833(h)(10);''; and
                    (B) in paragraph (7), by striking ``or (P)'' and 
                inserting ``(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 for other cancer screening tests covered under this 
        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 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.
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Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
To amend title XVIII of the Social Security Act to provide for Medicare coverage of multi-cancer early detection screening tests.
Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021
Rep. Sewell, Terri A.