Title: Cancer Patient Equity Act of 2021
Policy area: Health

Summary:
Cancer Patient Equity Act of 2021
This bill provides for coverage of certain cancer diagnostic and laboratory tests under Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). Specifically, the bill provides for coverage of microarray analysis, DNA and RNA sequencing, whole-exome sequencing, and other next-generation sequencing for individuals diagnosed with cancer.
Additionally, the Department of Health and Human Services must establish an education and awareness program for physicians and the public about genomic testing and the role of genetic counselors.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5377 Introduced in House (IH)]

<DOC>






117th CONGRESS
  1st Session
                                H. R. 5377

To facilitate the development of treatments for cancers, and for other 
                               purposes.


_______________________________________________________________________


                    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.

    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 ``Cancer Patient Equity Act of 2021''.

SEC. 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)).''.

SEC. 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.
                                 <all>