I 
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 sub-
sequently 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 Representa-
tives 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 LABORA-
TORY TESTS. 
(a) MEDICARE.— 
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(1) COVERAGE.—Section 1861 of the Social Se-
curity 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 strik-
ing the period at the end and inserting ‘‘; 
and’’; and 
(iii) by adding at the end the fol-
lowing 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 enact-
ment 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 diag-
nostic and laboratory tests’ means— 
‘‘(A) microarray analysis, DNA sequenc-
ing, RNA sequencing, whole-exome sequencing, 
and other forms of next-generation sequencing 
furnished and reported by a clinical laboratory 
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(as defined in section 353(a) of the Public 
Health Service Act); and 
‘‘(B) explanation and interpretation of any 
analysis or sequencing described in subpara-
graph (A); 
furnished to an individual diagnosed with cancer. 
‘‘(2) FREQUENCY.—Tests described in para-
graph (1) may only be furnished with respect to an 
individual diagnosed with a cancer— 
‘‘(A) once upon the diagnosis of such can-
cer; 
‘‘(B) once upon any recurrence of such 
cancer; and 
‘‘(C) as necessary for purposes of moni-
toring the progression of such cancer or the re-
sponse of such cancer to treatment.’’. 
(2) PAYMENT.—Section 1833 of the Social Se-
curity Act (42 U.S.C. 1395l) is amended— 
(A) in subsection (a)(1)— 
(i) by striking ‘‘and (DD)’’ and in-
serting ‘‘(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 
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amount equal to 80 percent (or 100 per-
cent, 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 sec-
tion 1834A had such test been a clinical 
diagnostic laboratory test;’’; and 
(B) in subsection (b)— 
(i) by striking ‘‘and (12)’’ and insert-
ing ‘‘(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 diag-
nostic 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 
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(C) by adding at the end the following new 
subparagraph: 
‘‘(Q) in the case of cancer diagnostic and lab-
oratory 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.—Sec-
tion 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 mat-
ter 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 in-
serting before the period at the end the following: ‘‘, 
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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
LEGISLA-
TION.—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 Sec-
retary of Health and Human Services deter-
mines requires State legislation in order for the 
respective plan to meet any requirement im-
posed 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 en-
actment of this Act. For purposes of the pre-
vious sentence, in the case of a State that has 
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a 2-year legislative session, each year of the ses-
sion 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 cov-
erage elected by a State under subsection (a), begin-
ning January 1, 2022, child health assistance pro-
vided under such coverage for targeted low-income 
children and, in the case that the State elects to pro-
vide pregnancy-related assistance under such cov-
erage pursuant to section 2112, such pregnancy-re-
lated 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 
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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 edu-
cation 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. 
Æ 
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