I 
118TH CONGRESS 
1ST SESSION H. R. 5647 
To amend title XXVII of the Public Health Service Act to require out- 
of-network coverage for qualified individuals diagnosed with a rare pedi-
atric disease participating in approved clinical trials, and for other pur-
poses. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 21, 2023 
Mr. MCCAUL (for himself, Mr. BERA, and Mr. KELLY of Pennsylvania) intro-
duced 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 amend title XXVII of the Public Health Service Act 
to require out-of-network coverage for qualified individ-
uals diagnosed with a rare pediatric disease participating 
in approved clinical trials, 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 ‘‘Childhood Cancer Clin-
ical Trials Act’’. 
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SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDI-
VIDUAL AND GROUP MARKET AND UNDER 
MEDICARE PROGRAM FOR QUALIFIED INDI-
VIDUALS DIAGNOSED WITH A RARE PEDI-
ATRIC 
DISEASE 
PARTICIPATING 
IN 
AP-
PROVED CLINICAL TRIALS. 
(a) INDIVIDUAL AND GROUP MARKET.— 
(1) REQUIRING
OUT-OF-NETWORK
COVERAGE 
OF ROUTINE PATIENT COSTS.—Section 2709 of the 
Public Health Service Act (42 U.S.C. 300gg–8) is 
amended— 
(A) in subsection (a)(2)— 
(i) in subparagraph (A), by inserting 
‘‘and subsection (c)(2)’’ after ‘‘(1)(B)’’; 
and 
(ii) in subparagraph (B), by inserting 
‘‘and subsection (c)(2)’’ after ‘‘(1)(B)’’; 
(B) by amending subsection (c) to read as 
follows: 
‘‘(c) TREATMENT
OF
NON-PARTICIPATING
PRO-
VIDERS.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
this section shall not be construed to require a group 
health plan, or a health insurance issuer offering 
group or individual health insurance coverage, to 
provide benefits for routine patient care services pro-
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vided outside of the plan’s (or coverage’s) health 
care provider network unless out-of-network benefits 
are otherwise provided under the plan (or coverage). 
‘‘(2) 
QUALIFIED
INDIVIDUALS
DIAGNOSED 
WITH A RARE PEDIATRIC DISEASE.—In the case of 
a qualified individual diagnosed with a rare pediatric 
disease, with respect to routine patient costs for 
items and services furnished to such individual in 
connection with participation in an approved clinical 
trial by a nonparticipating provider, a group health 
plan or health insurance issuer offering group or in-
dividual health insurance coverage that provides cov-
erage to such individual— 
‘‘(A) shall impose the same cost-sharing 
requirement (expressed as a copayment amount 
or coinsurance rate) that would apply if such 
item or service was furnished by a participating 
provider; and 
‘‘(B) shall pay to such nonparticipating 
provider the amount by which the recognized 
amount for such item or service exceeds the 
cost-sharing amount for such item or service 
(as determined in accordance with subpara-
graph (A)).’’; and 
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(C) by adding at the end the following new 
subsection: 
‘‘(i) OTHER DEFINITIONS.— 
‘‘(1) NONPARTICIPATING
PROVIDER; PARTICI-
PATING
PROVIDER; 
RECOGNIZED
AMOUNT.—For 
purposes of this section, the terms ‘nonparticipating 
provider’, ‘participating provider’, and ‘recognized 
amount’ have the meaning given such terms in sec-
tion 2799A–1(a)(3). 
‘‘(2) RARE
PEDIATRIC
DISEASE.—The term 
‘rare pediatric disease’ has the meaning given such 
term in section 529(a)(3) of the Federal Food, 
Drug, and Cosmetic Act.’’. 
(2) AMENDMENT RELATING TO DEFINITION OF 
ROUTINE
PATIENT
COSTS.—Section 2709(a)(2)(A) 
of the Public Health Service Act (42 U.S.C. 300gg– 
8(a)(2)(A)) is amended— 
(A) by striking ‘‘include all items and serv-
ices’’ and inserting ‘‘include— 
‘‘(i) all items and services’’; and 
(B) by striking the period at the end and 
inserting ‘‘; and 
‘‘(ii) consultation and referral services 
relating to approved clinical trials fur-
nished to qualified individuals.’’. 
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(3) AMENDMENT RELATING TO DEFINITION OF 
APPROVED CLINICAL TRIAL.—Section 2709(d)(1)(A) 
of the Public Health Service Act (42 U.S.C. 300gg– 
8(d)(1)(A)) is amended by adding at the end the fol-
lowing new clause: 
‘‘(viii) The Patient-Centered Out-
comes Research Institute.’’. 
(4) TECHNICAL
AND
CONFORMING
AMEND-
MENTS.—Section 2709 of the Public Health Service 
Act (42 U.S.C. 300gg–8), as amended by the pre-
ceding paragraphs, is further amended— 
(A) in subsection (a)— 
(i) in paragraph (1)(A), by inserting 
before ‘‘clinical trial referred to in sub-
section (b)(2)’’ the following: ‘‘approved’’; 
(ii) in paragraph (2)(A), by striking 
‘‘a clinical trial’’ and inserting ‘‘an ap-
proved clinical trial’’; 
(iii) in paragraph (3)— 
(I) by striking ‘‘IN-NETWORK 
PROVIDERS’’ and inserting ‘‘PARTICI-
PATING PROVIDERS’’; and 
(II) by striking ‘‘a clinical trial’’ 
and inserting ‘‘an approved clinical 
trial’’; and 
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(iv) in paragraph (4), by striking 
‘‘OUT-OF-NETWORK’’ and inserting ‘‘NON-
PARTICIPATING PROVIDERS’’; 
(B) in subsection (b)(2)(A), by striking 
‘‘participating health care provider’’ and insert-
ing ‘‘participating provider’’; and 
(C) in subsection (d)(1)(A)(v), by striking 
‘‘cooperative group’’ and inserting ‘‘A coopera-
tive group’’. 
(5) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply with respect to plan 
years beginning on or after January 1, 2024. 
(b) MEDICARE.— 
(1) AMENDMENT RELATING TO DEFINITION OF 
ROUTINE COSTS OF CARE.—Section 1862(m) of the 
Social Security Act (42 U.S.C. 1395y(m)) is amend-
ed— 
(A) in paragraph (1), by inserting before 
‘‘as defined by the Secretary’’ the following: 
‘‘subject to paragraph (3),’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(3) ROUTINE
COSTS
OF
CARE.—In defining 
‘routine costs of care’ for purposes of paragraph (1), 
the Secretary shall define such term in a manner 
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that provides for coverage of consultation and refer-
ral services furnished to an individual in the course 
of participation in a category A clinical trial.’’. 
(2) AMENDMENT RELATING TO DEFINITION OF 
CATEGORY A CLINICAL TRIAL.—Section 1862(m)(2) 
of the Social Security Act (42 U.S.C. 1395y(m)(2)) 
is amended by inserting after ‘‘means a trial’’ the 
following: ‘‘(including a trial funded by the Patient- 
Centered Outcomes Research Institute)’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection shall apply with respect to items 
and services furnished on or after January 1, 2024. 
SEC. 3. VOLUNTARY NETWORK OF PARTICIPATING PRO-
VIDERS. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services may issue a request for information from 
group health plans, and health insurance issuers offering 
group or individual health coverage to identify an interest 
in establishing a voluntary network of participating pro-
viders administered by a third-party administrator (as 
designated by the Secretary) for purposes of complying 
with coverage requirements for clinical trials under section 
2709 of the Public Health Service Act (42 U.S.C. 300gg– 
8). 
(b) DEFINITIONS.—In this section: 
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