[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9321 Introduced in House (IH)]

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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.''.
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