← Back to Bills
H.R. 9321House117th Congress (2021-2023)In Committee

Independent Drug Value Assessment Act

Sponsored by Jackie SpeierRep. Jackie Speier (D-CA)
Introduced November 16, 2022

AI-Generated Summary

Updated February 8, 2026 at 6:21 PM UTC

The Independent Drug Value Assessment Act would amend the Public Health Service Act to require the creation and public posting of independent economic assessments for newly approved drugs or new uses of existing drugs. The Secretary of Health and Human Services, through the Assistant Secretary for Planning and Evaluation, must contract eligible nonprofit or academic entities to produce these assessments within 90 days of approval. The law also mandates assessments for at least 25 high‑cost or breakthrough drugs approved before the law, to be completed within five years.

Key Provisions

  • Requires an independent value assessment for every drug approved or licensed after one year from the law’s enactment, and for any new indication of such drugs.
  • Assessments must be finished within 90 days of the drug’s approval or licensure date.
  • Within five years, the Secretary must assess at least 25 previously approved drugs, prioritizing the top 35% of spending drugs and those with breakthrough, fast‑track, or accelerated approval status.
  • Assessments are to be published on the HHS website, with redactions only for confidential or proprietary information.
  • Contracts for assessments can only go to nonprofit organizations, universities, federally funded research centers, or similarly qualified entities that are not involved in drug manufacturing, payer activities, or PBMs, and must be independent of such entities.
  • Contractors must receive all necessary data from HHS and drug manufacturers, and the public—including patient advocates and experts—may submit additional information for consideration.
  • Assessments must include economic analysis of direct and indirect benefits and propose a price or value‑based payment arrangement, and they may not use quality‑adjusted life‑year (QALY) metrics or any analysis that values life years differently based on age, severity, or disability.

Legislative Activity

Stay on top of the latest movement without scrolling through every action

2 earlier actions
HouseCommittee Latest Action

Referred to the Subcommittee on Health.

Health Subcommittee

November 17, 2022

View full timeline
HouseIntro Referral

Introduced in House

November 16, 2022

HouseIntro Referral

Referred to the House Committee on Energy and Commerce.

Energy and Commerce Committee

November 16, 2022

HouseCommittee

Referred to the Subcommittee on Health.

Health Subcommittee

November 17, 2022

Bill Text

Latest available legislative text

Reading Mode
Latest
Raw Text PDF XML
Introduced in HouseIssued November 16, 2022

I

117th CONGRESS

2d Session

H. R. 9321

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.

1.

Short title

This Act may be cited as the Independent Drug Value Assessment Act.

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:

XIII

Independent value assessments for drugs

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.

.