[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6977 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 6977
To amend the Public Health Service Act to provide for a demonstration
project for the development and publication of independent value
assessments for drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 11, 2024
Mr. Nadler (for himself and Ms. Porter) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to provide for a demonstration
project for the development and publication of independent value
assessments for drugs, 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 ``Independent Drug Value Assessment
Act of 2024''.
SEC. 2. DEMONSTRATION PROJECT FOR INDEPENDENT VALUE ASSESSMENTS FOR
DRUGS.
Part D of title III of the Public Health Service Act (21 U.S.C.
254b et seq.) is amended by adding at the end the following:
``Subpart XIII--Demonstration Project for Independent Value Assessments
for Drugs
``SEC. 340J. INDEPENDENT VALUE ASSESSMENTS.
``(a) Newly Approved Drugs.--
``(1) In general.--The Secretary, acting through the
Assistant Secretary for Planning and Evaluation, shall
complete, by contract under subsection (d), an independent
value assessment for every drug--
``(A) that is approved under section 505(c) of the
Federal Food, Drug, and Cosmetic Act, or licensed under
section 351(a) of the Public Health Service Act; or
``(B) for which a new indication or use is approved
or licensed under such section 505(c) or 351(a).
``(2) Timeline.--The Secretary shall ensure that an
independent value assessment required by paragraph (1) is
completed not later than 90 days after the effective date of
the approval or licensure involved.
``(b) Previously Approved Drugs.--The Secretary shall--
``(1) not later than the end of fiscal year 2028, complete,
by contract under subsection (d), for each of fiscal years
2024, 2025, 2026, 2027, and 2028, an independent value
assessment for no fewer than 5 drugs not described in
subsection (a); and
``(2) in selecting drugs for assessment under paragraph
(1)--
``(A) prioritize--
``(i) drugs in the top 35 percent of
expenditures for particular drugs under part B
or D of title XVIII of the Social Security Act;
and
``(ii) drugs approved as a breakthrough
therapy pursuant to section 506(a), as a fast
track product pursuant to section 506(b), or
pursuant to accelerated approval under section
506(c); and
``(B) exclude any drug (including any biological
product) that is a selected drug (as referred to in
section 1192(c) of the Social Security Act), with
respect to a price applicability period (as defined in
section 1191(b)(2) of such Act).
``(c) Publication.--The Secretary shall publish each independent
value assessment prepared under subsection (a) or (b) on the public
website of the Department of Health and Human Services without
modification, except that the Secretary may redact any confidential or
proprietary information in accordance with applicable law.
``(d) Contracts.--
``(1) In general.--To the extent and in the amounts made
available in advance in appropriations Acts, the Secretary
shall enter into a contract with an eligible entity to develop
independent value assessments under this section.
``(2) Eligible entities.--To be eligible to prepare an
independent value assessment under this section, an entity--
``(A) shall be a nonprofit organization, a
university, a federally funded research and development
center, or another type of organization that is
determined by the Secretary to be capable of developing
such an independent value assessment;
``(B) shall not be an entity that--
``(i) is involved in the manufacturing,
research, and development of drugs; or
``(ii) operates fully insured or self-
insured health plans, pharmaceutical benefit
managers, or other entities that pay for drugs;
and
``(C) shall be, as determined by the Secretary,
independent of any other entity described in
subparagraph (B).
``(3) Information.--
``(A) Information in possession of hhs.--The
Secretary shall ensure that the entity under contract
to develop an independent value assessment under this
section has access to all of the information in the
possession of the Department of Health and Human
Services that is necessary to complete the assessment.
``(B) Information in possession of manufacturer.--
The manufacturer of any drug for which an independent
value assessment is being developed under this section
shall, at the request of the Secretary or the entity
under contract to develop the independent value
assessment, provide to the Secretary or entity, as
applicable, information in the possession of the
manufacturer that is necessary to complete the
assessment.
``(C) Patient input.--The Secretary shall ensure
that any organization under contract to develop an
independent value assessment under this section for a
drug solicits from and takes into consideration the
impact on patients who use the drug.
``(D) Additional information.--An entity under
contract to develop an independent value assessment
under this section for a drug shall offer
manufacturers, patients, patient advocates, clinical
experts, and members of the public an opportunity to
submit additional information and analyses for
consideration before the independent value assessment
is complete.
``(e) Prohibitions.--The Secretary shall prohibit the use in any
independent value assessment under this section of--
``(1) any analysis based on the quality-adjusted life year;
and
``(2) any research findings that do not weigh the value of
each year of life gained from treatment equally for all
patients no matter their severity of illness, age, or pre-
existing disability.
``(f) Definitions.--In this section:
``(1) The term `independent value assessment' means an
economic analysis that--
``(A) analyzes the benefits of a particular drug
for the average patient and for various subgroups of
patients, as determined by the Secretary, and the
benefits of the drug on a standalone basis and in
comparison with other approved treatments, including--
``(i) an economic analysis of direct
benefits to the patient, including to the
quality and duration of life of the patient;
and
``(ii) an economic analysis of indirect
benefits, including--
``(I) benefits to family members,
employers, and caregivers of the
patient; and
``(II) benefits to the health care
system, including savings to public-
and private-sector payers resulting
from potential use of health services
that is avoided due to the benefits of
the particular drug; and
``(B) includes, for the current year and each of
the next 4 years, an estimate of a price, price range,
or a proposed value-based payment arrangement for the
particular drug that is commensurate with the economic
benefits of the particular drug, including a list and
explanation of the factors that support the estimated
price, price range, or proposed value-based payment
arrangement.
``(C) includes--
``(i) an estimate of a price, price range,
or a proposed value-based payment arrangement
for the particular drug that--
``(I) is tied to the Consumer Price
Index for medical services starting
with the year the drug was approved or
licensed; and
``(II) is commensurate with the
economic benefits of the particular
drug; and
``(ii) a list and explanation of the
factors that support the estimated price, price
range, or proposed value-based payment
arrangement
``(2) The term `value-based payment arrangement'--
``(A) means a form of payment for a drug, other
than a fixed payment per dose or other standard
administration of the drug, that takes into
consideration the effectiveness of the drug; and
``(B) may include an overall payment for a course
of treatment with the drug, an overall payment to cover
all indicated uses of the drug for a particular
population, or another approach to payment, any of
which may include a provision to vary the amount of the
payment based on the effectiveness of the drug for an
individual or a population, as the case may be.''.
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