[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5647 Introduced in House (IH)]
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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
pediatric disease participating in approved clinical trials, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 21, 2023
Mr. McCaul (for himself, Mr. Bera, and Mr. Kelly of Pennsylvania)
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 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 individuals diagnosed with a rare
pediatric disease participating in approved clinical trials, and for
other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Childhood Cancer Clinical Trials
Act''.
SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDIVIDUAL AND GROUP MARKET
AND UNDER MEDICARE PROGRAM FOR QUALIFIED INDIVIDUALS
DIAGNOSED WITH A RARE PEDIATRIC DISEASE 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)(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 Providers.--
``(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 provided 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 individual health insurance
coverage that provides coverage 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
subparagraph (A)).''; and
(C) by adding at the end the following new
subsection:
``(i) Other Definitions.--
``(1) Nonparticipating provider; participating provider;
recognized amount.--For purposes of this section, the terms
`nonparticipating provider', `participating provider', and
`recognized amount' have the meaning given such terms in
section 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 services''
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 furnished
to qualified individuals.''.
(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 following new clause:
``(viii) The Patient-Centered Outcomes
Research Institute.''.
(4) Technical and conforming amendments.--Section 2709 of
the Public Health Service Act (42 U.S.C. 300gg-8), as amended
by the preceding paragraphs, is further amended--
(A) in subsection (a)--
(i) in paragraph (1)(A), by inserting
before ``clinical trial referred to in
subsection (b)(2)'' the following:
``approved'';
(ii) in paragraph (2)(A), by striking ``a
clinical trial'' and inserting ``an approved
clinical trial'';
(iii) in paragraph (3)--
(I) by striking ``in-network
providers'' and inserting
``participating 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 ``nonparticipating
providers'';
(B) in subsection (b)(2)(A), by striking
``participating health care provider'' and inserting
``participating provider''; and
(C) in subsection (d)(1)(A)(v), by striking
``cooperative group'' and inserting ``A cooperative
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 amended--
(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 referral 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 PROVIDERS.
(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 providers 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)).
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