[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6977 Introduced in House (IH)]

<DOC>






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.''.
                                 <all>