Finn Sawyer Access to Cancer Testing Act

Subjects: Health, Cancer, Health care costs and insurance, Health care coverage and access, Health promotion and preventive care, Medicaid, Medical tests and diagnostic methods, Medicare, Poverty and welfare assistance, State and local government operations

Summary:  <p><b>Finn Sawyer Access to Cancer Testing Act</b></p> <p>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.</p> <p>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.</p>

<html><body><pre>[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 642 Introduced in Senate (IS)]

&lt;DOC&gt;






118th CONGRESS
  1st Session
                                 S. 642

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 2, 2023

  Ms. Klobuchar (for herself and Mr. Wicker) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 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 ``Finn Sawyer Access to Cancer Testing 
Act''.

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 (II), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (JJ), by adding 
                        ``and'' at the end; and
                            (iii) by adding at the end the following 
                        new subparagraph:
            ``(KK) cancer diagnostic and laboratory tests (as defined 
        in subsection (nnn)) 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:
    ``(nnn) 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.--When an individual test as described in 
        paragraph (1) reports out the same genetic content, it 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 planning 
                treatment or 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'' before ``(HH)''; 
                        and
                            (ii) by inserting the following before the 
                        semicolon: ``, and (II) with respect to cancer 
                        diagnostic and laboratory tests (as defined in 
                        section 1861(nnn)), 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 (13)'' and 
                        inserting ``(13)''; and
                            (ii) by striking ``1861(n).'' and inserting 
                        ``section 1861(n), and (14) such deductible 
                        shall not apply with respect to cancer 
                        diagnostic and laboratory tests (as defined in 
                        section 1861(nnn))''.
            (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(nnn)), 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(nnn)); 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, 2025, coverage of 
        cancer diagnostic and laboratory tests (as defined in section 
        1861(nnn))''.
            (4) Conforming amendments.--Title XIX of the Social 
        Security Act (42 U.S.C. 1396 et seq.) is amended--
                    (A) in section 1902(nn)(3), by striking ``paragraph 
                (30) of section 1905(a)'' and inserting ``the last 
                numbered paragraph of the first sentence of section 
                1905(a)''; and
                    (B) in section 1905(a), in the 4th sentence in the 
                flush matter following the last numbered paragraph of 
                the first sentence of such section, by striking 
                ``paragraph (30)'' and inserting ``the last numbered 
                paragraph''.
            (5) 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, 2025.
                    (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)), as amended by section 11405(b)(1) of Public Law 117-169, is 
amended by adding at the end the following new paragraph:
            ``(13) Coverage of cancer diagnostic and laboratory 
        tests.--Regardless of the type of coverage elected by a State 
        under subsection (a), beginning January 1, 2025, 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(nnn)).''.

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.
                                 &lt;all&gt;
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