I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Independent Drug 

5 Value Assessment Act of 2024’’. 


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1 SEC. 2. DEMONSTRATION PROJECT FOR INDEPENDENT 

2 VALUE ASSESSMENTS FOR DRUGS. 

3 Part D of title III of the Public Health Service Act 

4 (21 U.S.C. 254b et seq.) is amended by adding at the end 

5 the following: 

6 ‘‘Subpart XIII—Demonstration Project for 

7 Independent Value Assessments for Drugs 

8 ‘‘SEC. 340J. INDEPENDENT VALUE ASSESSMENTS. 

9 ‘‘(a) NEWLY APPROVED DRUGS.— 

10 ‘‘(1) IN GENERAL.—The Secretary, acting 

11 through the Assistant Secretary for Planning and 

12 Evaluation, shall complete, by contract under sub13 section (d), an independent value assessment for 

14 every drug— 

15 ‘‘(A) that is approved under section 505(c) 

16 of the Federal Food, Drug, and Cosmetic Act, 

17 or licensed under section 351(a) of the Public 

18 Health Service Act; or 

19 ‘‘(B) for which a new indication or use is 

20 approved or licensed under such section 505(c) 

21 or 351(a). 

22 ‘‘(2) TIMELINE.—The Secretary shall ensure 

23 that an independent value assessment required by 

24 paragraph (1) is completed not later than 90 days 

25 after the effective date of the approval or licensure 

26 involved. 


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1 ‘‘(b) PREVIOUSLY APPROVED DRUGS.—The Sec2 retary shall— 

3 ‘‘(1) not later than the end of fiscal year 2028, 

4 complete, by contract under subsection (d), for each 

5 of fiscal years 2024, 2025, 2026, 2027, and 2028, 

6 an independent value assessment for no fewer than 

7 5 drugs not described in subsection (a); and 

8 ‘‘(2) in selecting drugs for assessment under 

9 paragraph (1)— 

10 ‘‘(A) prioritize— 

11 ‘‘(i) drugs in the top 35 percent of ex12 penditures for particular drugs under part 

13 B or D of title XVIII of the Social Secu14 rity Act; and 

15 ‘‘(ii) drugs approved as a break16 through therapy pursuant to section 

17 506(a), as a fast track product pursuant to 

18 section 506(b), or pursuant to accelerated 

19 approval under section 506(c); and 

20 ‘‘(B) exclude any drug (including any bio21 logical product) that is a selected drug (as re22 ferred to in section 1192(c) of the Social Secu23 rity Act), with respect to a price applicability 

24 period (as defined in section 1191(b)(2) of such 

25 Act). 


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1 ‘‘(c) PUBLICATION.—The Secretary shall publish 

2 each independent value assessment prepared under sub3 section (a) or (b) on the public website of the Department 

4 of Health and Human Services without modification, ex5 cept that the Secretary may redact any confidential or 

6 proprietary information in accordance with applicable law. 

7 ‘‘(d) CONTRACTS.— 

8 ‘‘(1) IN GENERAL.—To the extent and in the 

9 amounts made available in advance in appropriations 

10 Acts, the Secretary shall enter into a contract with 

11 an eligible entity to develop independent value as12 sessments under this section. 

13 ‘‘(2) ELIGIBLE ENTITIES.—To be eligible to 

14 prepare an independent value assessment under this 

15 section, an entity— 

16 ‘‘(A) shall be a nonprofit organization, a 

17 university, a federally funded research and de18 velopment center, or another type of organiza19 tion that is determined by the Secretary to be 

20 capable of developing such an independent value 

21 assessment; 

22 ‘‘(B) shall not be an entity that— 

23 ‘‘(i) is involved in the manufacturing, 

24 research, and development of drugs; or 


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1 ‘‘(ii) operates fully insured or self-in2 sured health plans, pharmaceutical benefit 

3 managers, or other entities that pay for 

4 drugs; and 

5 ‘‘(C) shall be, as determined by the Sec6 retary, independent of any other entity de7 scribed in subparagraph (B). 

8 ‘‘(3) INFORMATION.— 

9 ‘‘(A) INFORMATION IN POSSESSION OF

10 HHS.—The Secretary shall ensure that the enti11 ty under contract to develop an independent 

12 value assessment under this section has access 

13 to all of the information in the possession of the 

14 Department of Health and Human Services 

15 that is necessary to complete the assessment. 

16 ‘‘(B) INFORMATION IN POSSESSION OF

17 MANUFACTURER.—The manufacturer of any 

18 drug for which an independent value assess19 ment is being developed under this section shall, 

20 at the request of the Secretary or the entity 

21 under contract to develop the independent value 

22 assessment, provide to the Secretary or entity, 

23 as applicable, information in the possession of 

24 the manufacturer that is necessary to complete 

25 the assessment. 


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1 ‘‘(C) PATIENT INPUT.—The Secretary 

2 shall ensure that any organization under con3 tract to develop an independent value assess4 ment under this section for a drug solicits from 

5 and takes into consideration the impact on pa6 tients who use the drug. 

7 ‘‘(D) ADDITIONAL INFORMATION.—An en8 tity under contract to develop an independent 

9 value assessment under this section for a drug 

10 shall offer manufacturers, patients, patient ad11 vocates, clinical experts, and members of the 

12 public an opportunity to submit additional in13 formation and analyses for consideration before 

14 the independent value assessment is complete. 

15 ‘‘(e) PROHIBITIONS.—The Secretary shall prohibit 

16 the use in any independent value assessment under this 

17 section of— 

18 ‘‘(1) any analysis based on the quality-adjusted 

19 life year; and 

20 ‘‘(2) any research findings that do not weigh 

21 the value of each year of life gained from treatment 

22 equally for all patients no matter their severity of ill23 ness, age, or pre-existing disability. 

24 ‘‘(f) DEFINITIONS.—In this section: 


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1 ‘‘(1) The term ‘independent value assessment’ 

2 means an economic analysis that— 

3 ‘‘(A) analyzes the benefits of a particular 

4 drug for the average patient and for various 

5 subgroups of patients, as determined by the 

6 Secretary, and the benefits of the drug on a 

7 standalone basis and in comparison with other 

8 approved treatments, including— 

9 ‘‘(i) an economic analysis of direct 

10 benefits to the patient, including to the 

11 quality and duration of life of the patient; 

12 and 

13 ‘‘(ii) an economic analysis of indirect 

14 benefits, including— 

15 ‘‘(I) benefits to family members, 

16 employers, and caregivers of the pa17 tient; and 

18 ‘‘(II) benefits to the health care 

19 system, including savings to public20 and private-sector payers resulting 

21 from potential use of health services 

22 that is avoided due to the benefits of 

23 the particular drug; and 

24 ‘‘(B) includes, for the current year and 

25 each of the next 4 years, an estimate of a price, 


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1 price range, or a proposed value-based payment 

2 arrangement for the particular drug that is 

3 commensurate with the economic benefits of the 

4 particular drug, including a list and explanation 

5 of the factors that support the estimated price, 

6 price range, or proposed value-based payment 

7 arrangement. 

8 ‘‘(C) includes— 

9 ‘‘(i) an estimate of a price, price 

10 range, or a proposed value-based payment 

11 arrangement for the particular drug that— 

12 ‘‘(I) is tied to the Consumer 

13 Price Index for medical services start14 ing with the year the drug was ap15 proved or licensed; and 

16 ‘‘(II) is commensurate with the 

17 economic benefits of the particular 

18 drug; and 

19 ‘‘(ii) a list and explanation of the fac20 tors that support the estimated price, price 

21 range, or proposed value-based payment 

22 arrangement 

23 ‘‘(2) The term ‘value-based payment arrange24 ment’— 


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1 ‘‘(A) means a form of payment for a drug, 

2 other than a fixed payment per dose or other 

3 standard administration of the drug, that takes 

4 into consideration the effectiveness of the drug; 

5 and 

6 ‘‘(B) may include an overall payment for a 

7 course of treatment with the drug, an overall 

8 payment to cover all indicated uses of the drug 

9 for a particular population, or another approach 

10 to payment, any of which may include a provi11 sion to vary the amount of the payment based 

12 on the effectiveness of the drug for an indi13 vidual or a population, as the case may be.’’. 

Æ 


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