Clinical Trial Coverage Act of 2022
This bill requires health insurance plans (including Medicare) to cover out-of-network routine care for clinical trial participants at the in-network rate when an in-network provider is not available.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8546 Introduced in House (IH)]
<DOC>
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 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 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 ``Clinical Trial Coverage Act of
2022''.
SEC. 2. AMENDMENTS RELATING TO COVERAGE IN INDIVIDUAL AND GROUP MARKET
AND UNDER MEDICARE PROGRAM FOR QUALIFIED INDIVIDUALS
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
subsection (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-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
``(ii) 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 clause (i));
and'';
(B) by striking subsection (c);
(C) by redesignating subsections (d) through (h) as
subsections (c) through (g), respectively; and
(D) by adding at the end the following new
subsection:
``(h) Other Definitions.--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) 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(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 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)).
<all>
Introduced in House
Introduced in House
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.
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.
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