I 
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 Representa-
tives 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: 
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‘‘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 inde-
pendent value assessment for any drug— 
‘‘(1) that is approved under section 505(c) of 
the Federal Food, Drug, and Cosmetic Act, or li-
censed 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 ap-
proved 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 Sec-
retary shall— 
‘‘(1) not later than 5 years after the date of en-
actment 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 
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‘‘(2) in selecting drugs for assessment under 
paragraph (1), prioritize— 
‘‘(A) drugs in the top 35 percent of ex-
penditures 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 sub-
section (a) or (c) on the public website of the Department 
of Health and Human Services without modification, ex-
cept 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 as-
sessment under this section. 
‘‘(2) ELIGIBLE
ENTITIES.—To be eligible to 
prepare an independent value assessment under this 
section, an entity— 
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‘‘(A) shall be a nonprofit organization, a 
university, a federally funded research and de-
velopment center, or another type of organiza-
tion 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-in-
sured health plans, pharmaceutical benefit 
managers, or other entities that pay for 
drugs; and 
‘‘(C) shall be, as determined by the Sec-
retary, independent of any other entity de-
scribed in subparagraph (B). 
‘‘(3) INFORMATION.— 
‘‘(A) INFORMATION
IN
POSSESSION
OF 
HHS.—The Secretary shall ensure that any or-
ganization under contract to develop an inde-
pendent value assessment under this section has 
access to all of the information in the posses-
sion of the Department of Health and Human 
Services that is necessary to complete the as-
sessment. 
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equally for all patients no matter their severity of ill-
ness, 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 ca-
pacity of the patient; 
‘‘(II) benefits to family members, 
employers, and caregivers of the pa-
tient; and 
‘‘(III) benefits to the health care 
system, including savings to public- 
and private-sector payers resulting 
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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 ar-
rangement for the particular drug that is com-
mensurate 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 arrange-
ment’— 
‘‘(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 provi-
sion to vary the amount of the payment based 
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on the effectiveness of the drug for an indi-
vidual or a population, as the case may be.’’. 
Æ 
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