[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9321 Introduced in House (IH)]
<DOC>
117th CONGRESS
2d Session
H. R. 9321
To amend the Public Health Service Act to provide for the development
and publication of independent value assessments for drugs, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 16, 2022
Ms. Speier (for herself, Mr. Nadler, 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 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''.
SEC. 2. 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--Independent Value Assessments for Drugs
``SEC. 340J. INDEPENDENT VALUE ASSESSMENTS.
``(a) In General.--The Secretary, acting through the Assistant
Secretary for Planning and Evaluation, shall complete, by contract
under subsection (e), an independent value assessment for any drug--
``(1) 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, on or after the day that is 1
year after the date of enactment of this section; or
``(2) for which a new indication or use is approved or
licensed under such section 505(c) or 351(a) on or after such
day.
``(b) Timeline.--The Secretary shall ensure that an independent
value assessment required by subsection (a) is completed not later than
90 days after the effective date of the approval or licensure involved.
``(c) Previously Approved Drugs.--The Secretary shall--
``(1) not later than 5 years after the date of enactment of
this section, complete, by contract under subsection (e), an
independent value assessment for no fewer than 25 drugs not
described in subsection (a); and
``(2) in selecting drugs for assessment under paragraph
(1), prioritize--
``(A) 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
``(B) 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).
``(d) Publication.--The Secretary shall publish each independent
value assessment prepared under subsection (a) or (c) 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.
``(e) 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
an independent value assessment 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 and 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 any organization 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) Additional information.--An entity under
contract to develop an independent value assessment
under this section for a drug shall offer
manufacturers, 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.
``(f) 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.
``(g) 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 the earnings
capacity of the patient;
``(II) benefits to family members,
employers, and caregivers of the
patient; and
``(III) 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 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.
``(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.''.
<all>