I 
117TH CONGRESS 
2D SESSION 
H. R. 8546 
To amend title XXVII of the Public Health Service Act to require out- 
of-network coverage for qualified individuals participating in approved 
clinical trials, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 27, 2022 
Ms. SPEIER (for herself and Mr. MCCAUL) 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 provi-
sions 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 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 ‘‘Clinical Trial Coverage 
Act of 2022’’. 
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SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDI-
VIDUAL AND GROUP MARKET AND UNDER 
MEDICARE PROGRAM FOR QUALIFIED INDI-
VIDUALS 
PARTICIPATING 
IN 
APPROVED 
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)(1)— 
(i) in subparagraph (B)— 
(I) by striking ‘‘subject to sub-
section (c),’’; and 
(II) by striking ‘‘and’’ at the end; 
(ii) by redesignating subparagraph 
(C) as subparagraph (D); and 
(iii) by inserting after subparagraph 
(B) the following new subparagraph: 
‘‘(C) in the case of routine patient costs 
for items or services furnished to the individual 
in connection with participation in the trial by 
a nonparticipating provider— 
‘‘(i) shall impose the same cost-shar-
ing requirement (expressed as a copayment 
amount or coinsurance rate) that would 
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apply if such item or service was furnished 
by a participating provider; and 
‘‘(ii) shall pay to such nonpartici-
pating 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 accord-
ance with clause (i)); and’’; 
(B) by striking subsection (c); 
(C) 
by 
redesignating 
subsections 
(d) 
through (h) as subsections (c) through (g), re-
spectively; and 
(D) by adding at the end the following new 
subsection: 
‘‘(h) OTHER DEFINITIONS.—For purposes of this 
section, the terms ‘nonparticipating provider’, ‘partici-
pating provider’, and ‘recognized amount’ have the mean-
ing given such terms in section 2799A–1(a)(3).’’. 
(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 
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(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.’’. 
(3) AMENDMENT RELATING TO DEFINITION OF 
APPROVED CLINICAL TRIAL.—Section 2709(c)(1)(A) 
of the Public Health Service Act (42 U.S.C. 300gg– 
8(c)(1)(A)), as redesignated by paragraph (1), is 
amended by adding at the end the following 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)— 
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(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 
(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— 
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(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 
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 
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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: 
(1) GROUP HEALTH PLAN.—The term ‘‘group 
health plan’’ has the meaning given such term in 
section 607(1) of the Employee Retirement Income 
Security Act of 1974 (29 U.S.C. 1167(1)). 
(2) HEALTH
INSURANCE
ISSUER.—The term 
‘‘health insurance issuer’’ has the meaning given 
such term in section 2791(b)(1) of the Public Health 
Service Act (42 U.S.C. 300gg–91(b)(1)). 
(3) 
PARTICIPATING
PROVIDER.—The 
term 
‘‘participating provider’’ has the meaning given such 
term in section 2799A–1(a)(3)(G)(ii) of the Public 
Health 
Service 
Act 
(42 
U.S.C. 
300gg– 
111(a)(3)(G)(ii)). 
Æ 
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