What This Bill Does
This bill requires Medicare, Medicaid and the Children's Health Insurance Program (CHIP) to cover cancer diagnostic and laboratory tests. These tests include genetic analysis methods used to identify cancer mutations (genetic changes in cells). The bill also directs the Secretary of Health and Human Services to run an education program about genetic testing for doctors and the public.
Who It Affects
Medicare beneficiaries (people age 65 and older or with certain disabilities), Medicaid recipients (low-income individuals and families), CHIP beneficiaries (targeted low-income children and pregnant women), physicians, and the general public.
Key Provisions
• Medicare must cover cancer diagnostic and laboratory tests starting 6 months after the bill becomes law, paying 80 percent of the cost or 100 percent if the provider accepts the Medicare-approved amount (Sec. 2(a)(1))
• Cancer diagnostic and laboratory tests are defined as microarray analysis, DNA sequencing, RNA sequencing, whole-exome sequencing and other next-generation sequencing (a method of reading genetic information) provided by a clinical laboratory, along with explanation and interpretation of these tests (Sec. 2(a)(1))
• These tests may only be covered once at cancer diagnosis, once at cancer recurrence, and as needed for treatment planning or monitoring cancer response (Sec. 2(a)(1))
• Medicaid must cover cancer diagnostic and laboratory tests starting January 1, 2025 (Sec. 2(b)(5)(A))
• CHIP must cover cancer diagnostic and laboratory tests for low-income children and pregnant women starting January 1, 2025 (Sec. 2(c))
• The Secretary of Health and Human Services, working with the National Human Genome Research Institute, must create an education program for doctors and the public about what genetic testing is, how it works and the role of genetic counselors (Sec. 3(a))
What Changes
Medicare will begin covering genetic tests used to diagnose and monitor cancer, with beneficiaries responsible for 20 percent of the cost. Medicaid programs and CHIP programs across all states will be required to cover these same genetic tests. Doctors will receive education and training on using molecular diagnostics (testing that identifies genetic mutations) when cancer is first diagnosed and when it recurs.
Important Definitions
Cancer diagnostic and laboratory tests: microarray analysis, DNA sequencing, RNA sequencing, whole-exome sequencing and other next-generation sequencing furnished by a clinical laboratory, plus explanation and interpretation of these tests, provided to someone diagnosed with cancer.
Effective Date
Medicare coverage begins 6 months after the bill becomes law (Sec. 2(a)(1)). Medicaid and CHIP coverage begin January 1, 2025 (Sec. 2(b)(5)(A) and Sec. 2(c)).
I
118TH CONGRESS
1ST SESSION H. R. 1780
To facilitate the development of treatments for cancer, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 24, 2023
Mr. BILIRAKIS (for himself and Ms. MATSUI) 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 subse-
quently 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 cancer, and
for other purposes.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Finn Sawyer Access
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to Cancer Testing Act’’.
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SEC. 2. COVERAGE OF CANCER DIAGNOSTIC AND LABORA-
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TORY TESTS.
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(a) MEDICARE.—
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(1) COVERAGE.—Section 1861 of the Social Se-
1
curity Act (42 U.S.C. 1395x) is amended—
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(A) in subsection (s)(2)—
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(i) in subparagraph (JJ), by adding
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‘‘and’’ at the end; and
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(ii) by adding at the end the following
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new subparagraph:
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‘‘(KK) cancer diagnostic and laboratory tests
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(as defined in subsection (nnn)) furnished on or
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after the date that is 6 months after the date of the
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enactment of this subparagraph.’’; and
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(B) by adding at the end the following new
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subsection:
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‘‘(nnn) CANCER
DIAGNOSTIC
AND
LABORATORY
14
TESTS.—
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‘‘(1) IN
GENERAL.—The term ‘cancer diag-
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nostic and laboratory tests’ means—
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‘‘(A) microarray analysis, DNA sequenc-
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ing, RNA sequencing, whole-exome sequencing,
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and other forms of next-generation sequencing
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furnished and reported by a clinical laboratory
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(as defined in section 353(a) of the Public
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Health Service Act); and
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‘‘(B) explanation and interpretation of any
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analysis or sequencing described in subpara-
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graph (A);
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furnished to an individual diagnosed with cancer.
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‘‘(2) FREQUENCY.—When an individual test as
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described in paragraph (1) reports out the same ge-
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netic content, it may only be furnished with respect
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to an individual diagnosed with a cancer—
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‘‘(A) once upon the diagnosis of such can-
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cer;
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‘‘(B) once upon any recurrence of such
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cancer; and
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‘‘(C) as necessary for purposes of planning
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treatment or monitoring the progression of such
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cancer or the response of such cancer to treat-
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ment.’’.
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(2) PAYMENT.—Section 1833 of the Social Se-
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curity Act (42 U.S.C. 1395l) is amended—
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(A) in subsection (a)(1)—
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(i) by striking ‘‘and’’ before ‘‘(HH)’’;
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and
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(ii) by inserting the following before
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the semicolon: ‘‘, and (II) with respect to
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cancer diagnostic and laboratory tests (as
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defined in section 1861(nnn)), the amount
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paid shall be an amount equal to 80 per-
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cent (or 100 percent, in the case of such
2
tests for which payment is made on an as-
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signment-related basis) of the lesser of the
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actual charge for the test or the amount
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that would have been determined for such
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test under section 1834A had such test
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been a clinical diagnostic laboratory test;’’;
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and
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(B) in subsection (b)—
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(i) by striking ‘‘, and (13)’’ and in-
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serting ‘‘(13)’’; and
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(ii) by striking ‘‘1861(n).’’ and insert-
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ing ‘‘section 1861(n), and (14) such de-
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ductible shall not apply with respect to
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cancer diagnostic and laboratory tests (as
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defined in section 1861(nnn))’’.
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(3)
EXCLUSION
MODIFICATION.—Section
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1862(a)(1) of the Social Security Act (42 U.S.C.
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1395y(a)(1)) is amended—
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(A) in subparagraph (O), by striking
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‘‘and’’ at the end;
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(B) in subparagraph (P), by striking the
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semicolon and inserting ‘‘, and’’; and
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(C) by adding at the end the following new
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subparagraph:
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‘‘(Q) in the case of cancer diagnostic and lab-
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oratory tests (as defined in section 1861(nnn)),
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which are performed more frequently than is covered
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under such section;’’.
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(b) MEDICAID.—
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(1) INCLUSION AS MEDICAL ASSISTANCE.—Sec-
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tion 1905(a) of the Social Security Act (42 U.S.C.
9
1396d(a)) is amended—
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(A) in paragraph (30), by striking ‘‘and’’
11
at the end;
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(B) by redesignating paragraph (31) as
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paragraph (32); and
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(C) by inserting after paragraph (30) the
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following new paragraph:
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‘‘(31) cancer diagnostic and laboratory tests (as
17
defined in section 1861(nnn)); and’’.
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(2)
MANDATORY
COVERAGE.—Section
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1902(a)(10)(A) of such Act is amended, in the mat-
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ter preceding clause (i), by striking ‘‘and (30)’’ and
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inserting ‘‘(30), and (31)’’.
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(3) INCLUSION
IN
BENCHMARK
COVERAGE.—
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Section 1937(b)(5) of such Act is amended by in-
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serting before the period at the end the following: ‘‘,
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and beginning January 1, 2025, coverage of cancer
1
diagnostic and laboratory tests (as defined in section
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1861(nnn))’’.
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(4) CONFORMING AMENDMENTS.—Title XIX of
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the Social Security Act (42 U.S.C. 1396 et seq.) is
5
amended—
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(A) in section 1902(nn)(3), by striking
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‘‘paragraph (31) of section 1905(a)’’ and in-
8
serting ‘‘paragraph (32) of section 1905(a)’’;
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and
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(B) in section 1905(a), in the 4th sentence
11
in the flush matter following the last numbered
12
paragraph of the first sentence of such section,
13
by striking ‘‘paragraph (30)’’ and inserting
14
‘‘paragraph (32)’’.
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(5) EFFECTIVE DATE.—
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(A) IN GENERAL.—The amendments made
17
by this section shall apply with respect to items
18
and services furnished on or after January 1,
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2025.
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(B) EXEMPTION
FOR
STATE
LEGISLA-
21
TION.—In the case of a State plan under title
22
XIX of the Social Security Act (42 U.S.C. 1396
23
et seq.), or waiver of such plan, that the Sec-
24
retary of Health and Human Services deter-
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mines requires State legislation in order for the
1
respective plan to meet any requirement im-
2
posed by amendments made by this section, the
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respective plan shall not be regarded as failing
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to comply with the requirements of such title
5
solely on the basis of its failure to meet such
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an additional requirement before the first day
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of the first calendar quarter beginning after the
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close of the first regular session of the State
9
legislature that begins after the date of the en-
10
actment of this Act. For purposes of the pre-
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vious sentence, in the case of a State that has
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a 2-year legislative session, each year of the ses-
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sion shall be considered to be a separate regular
14
session of the State legislature.
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(c) CHIP.—Section 2103(c) of the Social Security
16
Act (42 U.S.C. 1397cc(c)), as amended by section
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11405(b)(1) of Public Law 117–169, is amended by add-
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ing at the end the following new paragraph:
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‘‘(13) COVERAGE OF CANCER DIAGNOSTIC AND
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LABORATORY TESTS.—Regardless of the type of cov-
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erage elected by a State under subsection (a), begin-
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ning January 1, 2025, child health assistance pro-
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vided under such coverage for targeted low-income
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children and, in the case that the State elects to pro-
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vide pregnancy-related assistance under such cov-
1
erage pursuant to section 2112, such pregnancy-re-
2
lated assistance for targeted low-income pregnant
3
women (as defined in section 2112(d)), shall include
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coverage of cancer diagnostic and laboratory tests
5
(as defined in section 1861(nnn)).’’.
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SEC.
3.
EDUCATION
AND
AWARENESS
PROGRAM
ON
7
GENOMIC TESTING.
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(a) IN GENERAL.—The Secretary of Health and
9
Human Services, in coordination with the Director of the
10
National Human Genome Research Institute, shall carry
11
out an education and awareness program for physicians
12
and the general public on what genomic testing is, how
13
can be used, and the role of genetic counselors.
14
(b) CANCER AND MOLECULAR DIAGNOSTICS.—The
15
education and awareness program under subsection (a)
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shall encourage the inclusion in graduate medical edu-
17
cation and continuing medical education (including for
18
specialty oncology services) of education and training on
19
the importance of molecular diagnostics at diagnosis and
20
reoccurrence of cancer to detect mutations.
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Æ
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