What This Bill Does
This bill requires Medicare, Medicaid and the Children's Health Insurance Program (CHIP) to cover certain cancer genetic tests. The tests covered include microarray analysis, DNA sequencing, RNA sequencing, whole-exome sequencing and other next-generation sequencing (advanced ways to read genetic information) along with explanations of those results. The bill also requires the Secretary of Health and Human Services to run an education program about genomic testing (the study of a person's complete genetic material) for doctors and the public.
Who It Affects
People covered by Medicare (health insurance for people 65 and older and some younger people with disabilities), Medicaid (health insurance for low-income people), and CHIP (health insurance for children and pregnant women in low-income families). Doctors and physicians. Clinical laboratories (facilities that perform medical tests). The National Human Genome Research Institute.
Key Provisions
• Medicare will pay 80 percent of the cost for cancer diagnostic and laboratory tests, or 100 percent if the doctor accepts assignment (agrees to accept Medicare's payment as full payment) (Sec. 2(a)(2)).
• People on Medicare will not have to pay a deductible (an upfront amount patients pay before insurance kicks in) for these cancer tests (Sec. 2(a)(2)).
• Cancer diagnostic and laboratory tests can only be done once when cancer is first diagnosed, once if the cancer comes back, and as needed to plan treatment or monitor how the cancer responds to treatment (Sec. 2(a)(1)).
• Medicaid must cover cancer diagnostic and laboratory tests for all eligible people starting January 1, 2025 (Sec. 2(b)(1), (2)).
• CHIP must cover cancer diagnostic and laboratory tests for children and pregnant women starting January 1, 2025 (Sec. 2(c)).
• The Secretary of Health and Human Services and the Director of the National Human Genome Research Institute must create an education program teaching doctors and the public about genomic testing and the role of genetic counselors (doctors who help people understand genetic information) (Sec. 3(a)).
What Changes
If this bill becomes law, Medicare will start paying for cancer genetic tests six months after the law is signed. Medicaid and CHIP will start covering these tests on January 1, 2025. Patients on these programs will have reduced or no out-of-pocket costs for these tests. Doctors and medical students will receive education about using genetic testing to find cancer mutations (harmful changes in DNA).
Important Definitions
Cancer diagnostic and laboratory tests: microarray analysis (a test that checks many genes at once), DNA sequencing (reading the order of genetic material), RNA sequencing (reading genetic instructions that tell cells what to do), whole-exome sequencing (reading the protein-coding parts of all genes), and other next-generation sequencing performed by a clinical laboratory, plus explanation and interpretation of these results, for people diagnosed with cancer.
Effective Date
Medicare coverage begins six months after the law is signed (Sec. 2(a)(1)). Medicaid and CHIP coverage begins January 1, 2025 (Sec. 2(b)(5)(A), (c)).
II
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 Representa-
1
tives of the United States of America in Congress assembled,
2
SECTION 1. SHORT TITLE.
3
This Act may be cited as the ‘‘Finn Sawyer Access
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to Cancer Testing Act’’.
5
SEC. 2. COVERAGE OF CANCER DIAGNOSTIC AND LABORA-
6
TORY TESTS.
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(a) MEDICARE.—
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(1) COVERAGE.—Section 1861 of the Social Se-
9
curity Act (42 U.S.C. 1395x) is amended—
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(A) in subsection (s)(2)—
1
(i) in subparagraph (II), by striking
2
‘‘and’’ at the end;
3
(ii) in subparagraph (JJ), by adding
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‘‘and’’ at the end; and
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(iii) by adding at the end the fol-
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lowing 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
22
Health Service Act); and
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‘‘(B) explanation and interpretation of any
1
analysis or sequencing described in subpara-
2
graph (A);
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furnished to an individual diagnosed with cancer.
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‘‘(2) FREQUENCY.—When an individual test as
5
described in paragraph (1) reports out the same ge-
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netic content, it may only be furnished with respect
7
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
11
cancer; and
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‘‘(C) as necessary for purposes of planning
13
treatment or monitoring the progression of such
14
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
24
defined in section 1861(nnn)), the amount
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•S 642 IS
paid shall be an amount equal to 80 per-
1
cent (or 100 percent, in the case of such
2
tests for which payment is made on an as-
3
signment-related basis) of the lesser of the
4
actual charge for the test or the amount
5
that would have been determined for such
6
test under section 1834A had such test
7
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-
13
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
16
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.
19
1395y(a)(1)) is amended—
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(A) in subparagraph (O), by striking
21
‘‘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
1
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
5
under such section;’’.
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(b) MEDICAID.—
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(1) INCLUSION AS MEDICAL ASSISTANCE.—Sec-
8
tion 1905(a) of the Social Security Act (42 U.S.C.
9
1396d(a)) is amended—
10
(A) in paragraph (30), by striking ‘‘and’’
11
at the end;
12
(B) by redesignating paragraph (31) as
13
paragraph (32); and
14
(C) by inserting after paragraph (30) the
15
following new paragraph:
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‘‘(31) cancer diagnostic and laboratory tests (as
17
defined in section 1861(nnn)); and’’.
18
(2)
MANDATORY
COVERAGE.—Section
19
1902(a)(10)(A) of such Act is amended, in the mat-
20
ter preceding clause (i), by striking ‘‘and (30)’’ and
21
inserting ‘‘(30), and (31)’’.
22
(3) INCLUSION
IN
BENCHMARK
COVERAGE.—
23
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
2
1861(nnn))’’.
3
(4) CONFORMING AMENDMENTS.—Title XIX of
4
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
7
‘‘paragraph (30) of section 1905(a)’’ and in-
8
serting ‘‘the last numbered paragraph of the
9
first sentence of section 1905(a)’’; and
10
(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
‘‘the last numbered paragraph’’.
15
(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,
19
2025.
20
(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
3
respective plan shall not be regarded as failing
4
to comply with the requirements of such title
5
solely on the basis of its failure to meet such
6
an additional requirement before the first day
7
of the first calendar quarter beginning after the
8
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-
11
vious sentence, in the case of a State that has
12
a 2-year legislative session, each year of the ses-
13
sion shall be considered to be a separate regular
14
session of the State legislature.
15
(c) CHIP.—Section 2103(c) of the Social Security
16
Act (42 U.S.C. 1397cc(c)), as amended by section
17
11405(b)(1) of Public Law 117–169, is amended by add-
18
ing at the end the following new paragraph:
19
‘‘(13) COVERAGE OF CANCER DIAGNOSTIC AND
20
LABORATORY TESTS.—Regardless of the type of cov-
21
erage elected by a State under subsection (a), begin-
22
ning January 1, 2025, child health assistance pro-
23
vided under such coverage for targeted low-income
24
children and, in the case that the State elects to pro-
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•S 642 IS
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
4
coverage of cancer diagnostic and laboratory tests
5
(as defined in section 1861(nnn)).’’.
6
SEC.
3.
EDUCATION
AND
AWARENESS
PROGRAM
ON
7
GENOMIC TESTING.
8
(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)
16
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.
21
Æ
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