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>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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