116TH CONGRESS 

1ST SESSION H. R. 3 

AN ACT 

To establish a fair price negotiation program, protect the 

Medicare program from excessive price increases, and 

establish an out-of-pocket maximum for Medicare part 

D enrollees, 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, 
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Elijah E. Cummings Lower Drug Costs Now Act’’. 

4 (b) TABLE OF CONTENTS.—The table of contents is 

5 as follows: 

Sec. 1. Short title; table of contents. 

TITLE I—LOWERING PRICES THROUGH FAIR DRUG PRICE 

NEGOTIATION 

Sec. 101. Providing for lower prices for certain high-priced single source drugs. 

Sec. 102. Selected drug manufacturer excise tax imposed during noncompliance 

periods. 

Sec. 103. Fair Price Negotiation Implementation Fund. 

TITLE II—MEDICARE PARTS B AND D PRESCRIPTION DRUG 

INFLATION REBATES 

Sec. 201. Medicare part B rebate by manufacturers. 

Sec. 202. Medicare part D rebate by manufacturers. 

Sec. 203. Provision regarding inflation rebates for group health plans and 

group health insurance coverage. 

Sec. 204. Annual report on drug costs in group health plans and group health 

insurance coverage. 

Sec. 205. Collection of data. 

TITLE III—PART D IMPROVEMENTS AND MAXIMUM OUT-OFPOCKET CAP FOR MEDICARE BENEFICIARIES 

Sec. 301. Medicare part D benefit redesign. 

Sec. 302. Allowing certain enrollees of prescription drugs plans and MA–PD 

plans under Medicare program to spread out cost-sharing 

under certain circumstances. 

Sec. 303. Establishment of pharmacy quality measures under Medicare part D. 

TITLE IV—DRUG PRICE TRANSPARENCY 

Sec. 401. Drug price transparency. 

TITLE V—PROGRAM IMPROVEMENTS FOR MEDICARE LOWINCOME BENEFICIARIES 

Sec. 501. Dissemination to Medicare part D subsidy eligible individuals of information comparing premiums of certain prescription drug 

plans. 

Sec. 502. Providing for intelligent assignment of certain subsidy eligible individuals auto-enrolled under Medicare prescription drug plans and 

MA–PD plans. 

Sec. 503. Expanding eligibility for low-income subsidies under part D of the 

Medicare program. 
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Sec. 504. Automatic eligibility of certain low-income territorial residents for 

premium and cost-sharing subsidies under the Medicare program; Sunset of enhanced allotment program. 

Sec. 505. Automatic qualification of certain Medicaid beneficiaries for premium 

and cost-sharing subsidies under part D of the Medicare program. 

Sec. 506. Providing for certain rules regarding the treatment of eligible retirement plans in determining the eligibility of individuals for premium and cost-sharing subsidies under part D of the Medicare 

program. 

Sec. 507. Reducing cost-sharing and other program improvements for low-income beneficiaries. 

TITLE VI—PROVIDING FOR DENTAL, VISION, AND HEARING 

COVERAGE UNDER THE MEDICARE PROGRAM 

Sec. 601. Dental and oral health care. 

Sec. 602. Providing coverage for hearing care under the Medicare program. 

Sec. 603. Providing coverage for vision care under the Medicare program. 

TITLE VII—NIH, FDA, AND OPIOIDS FUNDING 

Subtitle A—Biomedical Innovation Expansion 

Sec. 701. NIH Innovation Initiatives. 

Sec. 702. NIH clinical trial. 

Sec. 703. Innovation Network. 

Subtitle B—Investing in Safety and Innovation 

Sec. 711. Food and Drug Administration. 

Sec. 712. Study on high-risk, high-reward drugs. 

Subtitle C—Opioid Epidemic Response 

Sec. 721. Opioid Epidemic Response Fund. 

Sec. 722. Substance Abuse and Mental Health Services Administration. 

Sec. 723. Centers for Disease Control and Prevention. 

Sec. 724. Food and Drug Administration. 

Sec. 725. National Institutes of Health. 

Sec. 726. Health Resources and Services Administration. 

Sec. 727. Administration for Children and Families. 

Subtitle D—Reducing Administrative Costs and Burdens in Health Care 

Sec. 731. Reducing administrative costs and burdens in health care. 

TITLE VIII—MISCELLANEOUS 

Sec. 801. Guaranteed issue of certain Medigap policies. 

Sec. 802. Reporting requirements for PDP sponsors regarding point-of-sale rejections under Medicare part D. 

Sec. 803. Providing access to annual Medicare notifications in multiple languages. 

Sec. 804. Temporary increase in Medicare part B payment for certain biosimilar biological products. 

Sec. 805. Waiving medicare coinsurance for colorectal cancer screening tests. 
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Sec. 806. Medicare coverage of certain lymphedema compression treatment 

items. 

Sec. 807. Physician fee update. 

Sec. 808. Additional community health center funding. 

Sec. 809. Grants to improve trauma support services and mental health care 

for children and youth in educational settings. 

Sec. 810. Pathway to Health Careers Act. 

Sec. 811. Home Visiting to Reduce Maternal Mortality and Morbidity Act. 

Sec. 812. Addition of new measures based on access to biosimilar biological 

products to the 5-star rating system under medicare advantage. 

Sec. 813. Sense of Congress regarding the impact of the high cost of prescription drugs on communities of color and persons living in rural 

or sparsely populated areas of the United States. 

Sec. 814. Regulations requiring direct-to-consumer advertisements for prescription drugs and biological products to include truthful and not 

misleading pricing information. 

Sec. 815. Improving transparency and preventing the use of abusive spread 

pricing and related practices in Medicaid. 

Sec. 816. Graduate medical education improvements in rural and underserved 

communities. 

1 TITLE I—LOWERING PRICES 

2 THROUGH FAIR DRUG PRICE 

3 NEGOTIATION 

4 SEC. 101. PROVIDING FOR LOWER PRICES FOR CERTAIN 

5 HIGH-PRICED SINGLE SOURCE DRUGS. 

6 (a) PROGRAM TO LOWER PRICES FOR CERTAIN

7 HIGH-PRICED SINGLE SOURCE DRUGS.—Title XI of the 

8 Social Security Act (42 U.S.C. 1301 et seq.) is amended 

9 by adding at the end the following new part: 

10 ‘‘PART E—FAIR PRICE NEGOTIATION PROGRAM 

11 TO LOWER PRICES FOR CERTAIN HIGH12 PRICED SINGLE SOURCE DRUGS 

13 ‘‘SEC. 1191. ESTABLISHMENT OF PROGRAM. 

14 ‘‘(a) IN GENERAL.—The Secretary shall establish a 

15 Fair Price Negotiation Program (in this part referred to 
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1 as the ‘program’). Under the program, with respect to 

2 each price applicability period, the Secretary shall— 

3 ‘‘(1) publish a list of selected drugs in accord4 ance with section 1192; 

5 ‘‘(2) enter into agreements with manufacturers 

6 of selected drugs with respect to such period, in ac7 cordance with section 1193; 

8 ‘‘(3) negotiate and, if applicable, renegotiate 

9 maximum fair prices for such selected drugs, in ac10 cordance with section 1194; and 

11 ‘‘(4) carry out the administrative duties de12 scribed in section 1196. 

13 ‘‘(b) DEFINITIONS RELATING TO TIMING.—For pur14 poses of this part: 

15 ‘‘(1) INITIAL PRICE APPLICABILITY YEAR.—The 

16 term ‘initial price applicability year’ means a plan 

17 year (beginning with plan year 2023) or, if agreed 

18 to in an agreement under section 1193 by the Sec19 retary and manufacturer involved, a period of more 

20 than one plan year (beginning on or after January 

21 1, 2023). 

22 ‘‘(2) PRICE APPLICABILITY PERIOD.—The term 

23 ‘price applicability period’ means, with respect to a 

24 drug, the period beginning with the initial price ap25 plicability year with respect to which such drug is a 
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1 selected drug and ending with the last plan year 

2 during which the drug is a selected drug. 

3 ‘‘(3) SELECTED DRUG PUBLICATION DATE.— 

4 The term ‘selected drug publication date’ means, 

5 with respect to each initial price applicability year, 

6 April 15 of the plan year that begins 2 years prior 

7 to such year. 

8 ‘‘(4) VOLUNTARY NEGOTIATION PERIOD.—The 

9 term ‘voluntary negotiation period’ means, with re10 spect to an initial price applicability year with re11 spect to a selected drug, the period— 

12 ‘‘(A) beginning on the sooner of— 

13 ‘‘(i) the date on which the manufac14 turer of the drug and the Secretary enter 

15 into an agreement under section 1193 with 

16 respect to such drug; or 

17 ‘‘(ii) June 15 following the selected 

18 drug publication date with respect to such 

19 selected drug; and 

20 ‘‘(B) ending on March 31 of the year that 

21 begins one year prior to the initial price appli22 cability year. 

23 ‘‘(c) OTHER DEFINITIONS.—For purposes of this 

24 part: 
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1 ‘‘(1) FAIR PRICE ELIGIBLE INDIVIDUAL.—The 

2 term ‘fair price eligible individual’ means, with re3 spect to a selected drug— 

4 ‘‘(A) in the case such drug is furnished or 

5 dispensed to the individual at a pharmacy or by 

6 a mail order service— 

7 ‘‘(i) an individual who is enrolled 

8 under a prescription drug plan under part 

9 D of title XVIII or an MA–PD plan under 

10 part C of such title if coverage is provided 

11 under such plan for such selected drug; 

12 and 

13 ‘‘(ii) an individual who is enrolled 

14 under a group health plan or health insur15 ance coverage offered in the group or indi16 vidual market (as such terms are defined 

17 in section 2791 of the Public Health Serv18 ice Act) with respect to which there is in 

19 effect an agreement with the Secretary 

20 under section 1197 with respect to such se21 lected drug as so furnished or dispensed; 

22 and 

23 ‘‘(B) in the case such drug is furnished or 

24 administered to the individual by a hospital, 
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1 physician, or other provider of services or sup2 plier— 

3 ‘‘(i) an individual who is entitled to 

4 benefits under part A of title XVIII or en5 rolled under part B of such title if such se6 lected drug is covered under the respective 

7 part; and 

8 ‘‘(ii) an individual who is enrolled 

9 under a group health plan or health insur10 ance coverage offered in the group or indi11 vidual market (as such terms are defined 

12 in section 2791 of the Public Health Serv13 ice Act) with respect to which there is in 

14 effect an agreement with the Secretary 

15 under section 1197 with respect to such se16 lected drug as so furnished or adminis17 tered. 

18 ‘‘(2) MAXIMUM FAIR PRICE.—The term ‘max19 imum fair price’ means, with respect to a plan year 

20 during a price applicability period and with respect 

21 to a selected drug (as defined in section 1192(c)) 

22 with respect to such period, the price published pur23 suant to section 1195 in the Federal Register for 

24 such drug and year. 
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1 ‘‘(3) AVERAGE INTERNATIONAL MARKET PRICE

2 DEFINED.— 

3 ‘‘(A) IN GENERAL.—The terms ‘average 

4 international market price’ and ‘AIM price’ 

5 mean, with respect to a drug, the average price 

6 (which shall be the net average price, if prac7 ticable, and volume-weighted, if practicable) for 

8 a unit (as defined in paragraph (4)) of the drug 

9 for sales of such drug (calculated across dif10 ferent dosage forms and strengths of the drug 

11 and not based on the specific formulation or 

12 package size or package type), as computed (as 

13 of the date of publication of such drug as a se14 lected drug under section 1192(a)) in all coun15 tries described in clause (ii) of subparagraph 

16 (B) that are applicable countries (as described 

17 in clause (i) of such subparagraph) with respect 

18 to such drug. 

19 ‘‘(B) APPLICABLE COUNTRIES.— 

20 ‘‘(i) IN GENERAL.—For purposes of 

21 subparagraph (A), a country described in 

22 clause (ii) is an applicable country de23 scribed in this clause with respect to a 

24 drug if there is available an average price 
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1 for any unit for the drug for sales of such 

2 drug in such country. 

3 ‘‘(ii) COUNTRIES DESCRIBED.—For 

4 purposes of this paragraph, the following 

5 are countries described in this clause: 

6 ‘‘(I) Australia. 

7 ‘‘(II) Canada. 

8 ‘‘(III) France. 

9 ‘‘(IV) Germany. 

10 ‘‘(V) Japan. 

11 ‘‘(VI) The United Kingdom. 

12 ‘‘(4) UNIT.—The term ‘unit’ means, with re13 spect to a drug, the lowest identifiable quantity 

14 (such as a capsule or tablet, milligram of molecules, 

15 or grams) of the drug that is dispensed. 

16 ‘‘SEC. 1192. SELECTION OF NEGOTIATION-ELIGIBLE DRUGS 

17 AS SELECTED DRUGS. 

18 ‘‘(a) IN GENERAL.—Not later than the selected drug 

19 publication date with respect to an initial price applica20 bility year, subject to subsection (h), the Secretary shall 

21 select and publish in the Federal Register a list of— 

22 ‘‘(1)(A) with respect to an initial price applica23 bility year during 2023, at least 25 negotiation-eligi24 ble drugs described in subparagraphs (A) and (B), 

25 but not subparagraph (C), of subsection (d)(1) (or, 
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1 with respect to an initial price applicability year dur2 ing such period beginning after 2023, the maximum 

3 number (if such number is less than 25) of such ne4 gotiation-eligible drugs for the year) with respect to 

5 such year; and 

6 ‘‘(B) with respect to an initial price applica7 bility year during 2024 or a subsequent year, at 

8 least 50 negotiation-eligible drugs described in sub9 paragraphs (A) and (B), but not subparagraph (C), 

10 of subsection (d)(1) (or, with respect to an initial 

11 price applicability year during such period, the max12 imum number (if such number is less than 50) of 

13 such negotiation-eligible drugs for the year) with re14 spect to such year; 

15 ‘‘(2) all negotiation-eligible drugs described in 

16 subparagraph (C) of such subsection with respect to 

17 such year; and 

18 ‘‘(3) all new-entrant negotiation-eligible drugs 

19 (as defined in subsection (g)(1)) with respect to such 

20 year. 

21 Each drug published on the list pursuant to the previous 

22 sentence shall be subject to the negotiation process under 

23 section 1194 for the voluntary negotiation period with re24 spect to such initial price applicability year (and the re25 negotiation process under such section as applicable for 
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1 any subsequent year during the applicable price applica2 bility period). In applying this subsection, any negotiation3 eligible drug that is selected under this subsection for an 

4 initial price applicability year shall not count toward the 

5 required minimum amount of drugs to be selected under 

6 paragraph (1) for any subsequent year, including such a 

7 drug so selected that is subject to renegotiation under sec8 tion 1194. 

9 ‘‘(b) SELECTION OF DRUGS.—In carrying out sub10 section (a)(1) the Secretary shall select for inclusion on 

11 the published list described in subsection (a) with respect 

12 to a price applicability period, the negotiation-eligible 

13 drugs that the Secretary projects will result in the greatest 

14 savings to the Federal Government or fair price eligible 

15 individuals during the price applicability period. In making 

16 this projection of savings for drugs for which there is an 

17 AIM price for a price applicability period, the savings shall 

18 be projected across different dosage forms and strengths 

19 of the drugs and not based on the specific formulation or 

20 package size or package type of the drugs, taking into con21 sideration both the volume of drugs for which payment 

22 is made, to the extent such data is available, and the 

23 amount by which the net price for the drugs exceeds the 

24 AIM price for the drugs. 
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1 ‘‘(c) SELECTED DRUG.—For purposes of this part, 

2 each drug included on the list published under subsection 

3 (a) with respect to an initial price applicability year shall 

4 be referred to as a ‘selected drug’ with respect to such 

5 year and each subsequent plan year beginning before the 

6 first plan year beginning after the date on which the Sec7 retary determines two or more drug products— 

8 ‘‘(1) are approved or licensed (as applicable)— 

9 ‘‘(A) under section 505(j) of the Federal 

10 Food, Drug, and Cosmetic Act using such drug 

11 as the listed drug; or 

12 ‘‘(B) under section 351(k) of the Public 

13 Health Service Act using such drug as the ref14 erence product; and 

15 ‘‘(2) continue to be marketed. 

16 ‘‘(d) NEGOTIATION-ELIGIBLE DRUG.— 

17 ‘‘(1) IN GENERAL.—For purposes of this part, 

18 the term ‘negotiation-eligible drug’ means, with re19 spect to the selected drug publication date with re20 spect to an initial price applicability year, a quali21 fying single source drug, as defined in subsection 

22 (e), that meets any of the following criteria: 

23 ‘‘(A) COVERED PART D DRUGS.—The drug 

24 is among the 125 covered part D drugs (as de25 fined in section 1860D–2(e)) for which there 
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1 was an estimated greatest net spending under 

2 parts C and D of title XVIII, as determined by 

3 the Secretary, during the most recent plan year 

4 prior to such drug publication date for which 

5 data are available. 

6 ‘‘(B) OTHER DRUGS.—The drug is among 

7 the 125 drugs for which there was an estimated 

8 greatest net spending in the United States (in9 cluding the 50 States, the District of Columbia, 

10 and the territories of the United States), as de11 termined by the Secretary, during the most re12 cent plan year prior to such drug publication 

13 date for which data are available. 

14 ‘‘(C) INSULIN.—The drug is a qualifying 

15 single source drug described in subsection 

16 (e)(3). 

17 ‘‘(2) CLARIFICATION.—In determining whether 

18 a qualifying single source drug satisfies any of the 

19 criteria described in paragraph (1), the Secretary 

20 shall, to the extent practicable, use data that is ag21 gregated across dosage forms and strengths of the 

22 drug and not based on the specific formulation or 

23 package size or package type of the drug. 

24 ‘‘(3) PUBLICATION.—Not later than the se25 lected drug publication date with respect to an ini-
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1 tial price applicability year, the Secretary shall pub2 lish in the Federal Register a list of negotiation-eli3 gible drugs with respect to such selected drug publi4 cation date. 

5 ‘‘(e) QUALIFYING SINGLE SOURCE DRUG.—For pur6 poses of this part, the term ‘qualifying single source drug’ 

7 means any of the following: 

8 ‘‘(1) DRUG PRODUCTS.—A drug that— 

9 ‘‘(A) is approved under section 505(c) of 

10 the Federal Food, Drug, and Cosmetic Act and 

11 continues to be marketed pursuant to such ap12 proval; and 

13 ‘‘(B) is not the listed drug for any drug 

14 that is approved and continues to be marketed 

15 under section 505(j) of such Act. 

16 ‘‘(2) BIOLOGICAL PRODUCTS.—A biological 

17 product that— 

18 ‘‘(A) is licensed under section 351(a) of 

19 the Public Health Service Act, including any 

20 product that has been deemed to be licensed 

21 under section 351 of such Act pursuant to sec22 tion 7002(e)(4) of the Biologics Price Competi23 tion and Innovation Act of 2009, and continues 

24 to be marketed under section 351 of such Act; 

25 and 
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1 ‘‘(B) is not the reference product for any 

2 biological product that is licensed and continues 

3 to be marketed under section 351(k) of such 

4 Act. 

5 ‘‘(3) INSULIN PRODUCT.—Notwithstanding 

6 paragraphs (1) and (2), any insulin product that is 

7 approved under subsection (c) or (j) of section 505 

8 of the Federal Food, Drug, and Cosmetic Act or li9 censed under subsection (a) or (k) of section 351 of 

10 the Public Health Service Act and continues to be 

11 marketed under such section 505 or 351, including 

12 any insulin product that has been deemed to be li13 censed under section 351(a) of the Public Health 

14 Service Act pursuant to section 7002(e)(4) of the 

15 Biologics Price Competition and Innovation Act of 

16 2009 and continues to be marketed pursuant to such 

17 licensure. 

18 For purposes of applying paragraphs (1) and (2), a drug 

19 or biological product that is marketed by the same sponsor 

20 or manufacturer (or an affiliate thereof or a cross-licensed 

21 producer or distributor) as the listed drug or reference 

22 product described in such respective paragraph shall not 

23 be taken into consideration. 

24 ‘‘(f) INFORMATION ON INTERNATIONAL DRUG

25 PRICES.—For purposes of determining which negotiation- 
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1 eligible drugs to select under subsection (a) and, in the 

2 case of such drugs that are selected drugs, to determine 

3 the maximum fair price for such a drug and whether such 

4 maximum fair price should be renegotiated under section 

5 1194, the Secretary shall use data relating to the AIM 

6 price with respect to such drug as available or provided 

7 to the Secretary and shall on an ongoing basis request 

8 from manufacturers of selected drugs information on the 

9 AIM price of such a drug. 

10 ‘‘(g) NEW-ENTRANT NEGOTIATION-ELIGIBLE

11 DRUGS.— 

12 ‘‘(1) IN GENERAL.—For purposes of this part, 

13 the term ‘new-entrant negotiation-eligible drug’ 

14 means, with respect to the selected drug publication 

15 date with respect to an initial price applicability 

16 year, a qualifying single source drug— 

17 ‘‘(A) that is first approved or licensed, as 

18 described in paragraph (1), (2), or (3) of sub19 section (e), as applicable, during the year pre20 ceding such selected drug publication date; and 

21 ‘‘(B) that the Secretary determines under 

22 paragraph (2) is likely to be included as a nego23 tiation-eligible drug with respect to the subse24 quent selected drug publication date. 
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1 ‘‘(2) DETERMINATION.—In the case of a quali2 fying single source drug that meets the criteria de3 scribed in subparagraph (A) of paragraph (1), with 

4 respect to an initial price applicability year, if the 

5 wholesale acquisition cost at which such drug is first 

6 marketed in the United States is equal to or greater 

7 than the median household income (as determined 

8 according to the most recent data collected by the 

9 United States Census Bureau), the Secretary shall 

10 determine before the selected drug publication date 

11 with respect to the initial price applicability year, if 

12 the drug is likely to be included as a negotiation-eli13 gible drug with respect to the subsequent selected 

14 drug publication date, based on the projected spend15 ing under title XVIII or in the United States on 

16 such drug. For purposes of this paragraph the term 

17 ‘United States’ includes the 50 States, the District 

18 of Columbia, and the territories of the United 

19 States. 

20 ‘‘(h) CONFLICT OF INTEREST.— 

21 ‘‘(1) IN GENERAL.—In the case the Inspector 

22 General of the Department of Health and Human 

23 Services determines the Secretary has a conflict, 

24 with respect to a matter described in paragraph (2), 

25 the individual described in paragraph (3) shall carry 
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1 out the duties of the Secretary under this part, with 

2 respect to a negotiation-eligible drug, that would 

3 otherwise be such a conflict. 

4 ‘‘(2) MATTER DESCRIBED.—A matter described 

5 in this paragraph is— 

6 ‘‘(A) a financial interest (as described in 

7 section 2635.402 of title 5, Code of Federal 

8 Regulations (except for an interest described in 

9 subsection (b)(2)(iv) of such section)) on the 

10 date of the selected drug publication date, with 

11 respect the price applicability year (as applica12 ble); 

13 ‘‘(B) a personal or business relationship 

14 (as described in section 2635.502 of such title) 

15 on the date of the selected drug publication 

16 date, with respect the price applicability year; 

17 ‘‘(C) employment by a manufacturer of a 

18 negotiation-eligible drug during the preceding 

19 10-year period beginning on the date of the se20 lected drug publication date, with respect to 

21 each price applicability year; and 

22 ‘‘(D) any other matter the General Counsel 

23 determines appropriate. 

24 ‘‘(3) INDIVIDUAL DESCRIBED.—An individual 

25 described in this paragraph is— 
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1 ‘‘(A) the highest-ranking officer or em2 ployee of the Department of Health and 

3 Human Services (as determined by the organi4 zational chart of the Department) that does not 

5 have a conflict under this subsection; and 

6 ‘‘(B) is nominated by the President and 

7 confirmed by the Senate with respect to the po8 sition. 

9 ‘‘SEC. 1193. MANUFACTURER AGREEMENTS. 

10 ‘‘(a) IN GENERAL.—For purposes of section 

11 1191(a)(2), the Secretary shall enter into agreements with 

12 manufacturers of selected drugs with respect to a price 

13 applicability period, by not later than June 15 following 

14 the selected drug publication date with respect to such se15 lected drug, under which— 

16 ‘‘(1) during the voluntary negotiation period for 

17 the initial price applicability year for the selected 

18 drug, the Secretary and manufacturer, in accordance 

19 with section 1194, negotiate to determine (and, by 

20 not later than the last date of such period and in ac21 cordance with subsection (c), agree to) a maximum 

22 fair price for such selected drug of the manufacturer 

23 in order to provide access to such price— 

24 ‘‘(A) to fair price eligible individuals who 

25 with respect to such drug are described in sub-
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1 paragraph (A) of section 1191(c)(1) and are 

2 furnished or dispensed such drug during, sub3 ject to subparagraph (2), the price applicability 

4 period; and 

5 ‘‘(B) to hospitals, physicians, and other 

6 providers of services and suppliers with respect 

7 to fair price eligible individuals who with re8 spect to such drug are described in subpara9 graph (B) of such section and are furnished or 

10 administered such drug during, subject to sub11 paragraph (2), the price applicability period; 

12 ‘‘(2) the Secretary and the manufacturer shall, 

13 in accordance with a process and during a period 

14 specified by the Secretary pursuant to rulemaking, 

15 renegotiate (and, by not later than the last date of 

16 such period and in accordance with subsection (c), 

17 agree to) the maximum fair price for such drug if 

18 the Secretary determines that there is a material 

19 change in any of the factors described in section 

20 1194(d) relating to the drug, including changes in 

21 the AIM price for such drug, in order to provide ac22 cess to such maximum fair price (as so renegoti23 ated)— 

24 ‘‘(A) to fair price eligible individuals who 

25 with respect to such drug are described in sub-
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1 paragraph (A) of section 1191(c)(1) and are 

2 furnished or dispensed such drug during any 

3 year during the price applicability period (be4 ginning after such renegotiation) with respect 

5 to such selected drug; and 

6 ‘‘(B) to hospitals, physicians, and other 

7 providers of services and suppliers with respect 

8 to fair price eligible individuals who with re9 spect to such drug are described in subpara10 graph (B) of such section and are furnished or 

11 administered such drug during any year de12 scribed in subparagraph (A); 

13 ‘‘(3) the maximum fair price (including as re14 negotiated pursuant to paragraph (2)), with respect 

15 to such a selected drug, shall be provided to fair 

16 price eligible individuals, who with respect to such 

17 drug are described in subparagraph (A) of section 

18 1191(c)(1), at the pharmacy or by a mail order serv19 ice at the point-of-sale of such drug; 

20 ‘‘(4) the manufacturer, subject to subsection 

21 (d), submits to the Secretary, in a form and manner 

22 specified by the Secretary— 

23 ‘‘(A) for the voluntary negotiation period 

24 for the price applicability period (and, if appli25 cable, before any period of renegotiation speci-
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1 fied pursuant to paragraph (2)) with respect to 

2 such drug all information that the Secretary re3 quires to carry out the negotiation (or renegoti4 ation process) under this part, including infor5 mation described in section 1192(f) and section 

6 1194(d)(1); and 

7 ‘‘(B) on an ongoing basis, information on 

8 changes in prices for such drug that would af9 fect the AIM price for such drug or otherwise 

10 provide a basis for renegotiation of the max11 imum fair price for such drug pursuant to 

12 paragraph (2); 

13 ‘‘(5) the manufacturer agrees that in the case 

14 the selected drug of a manufacturer is a drug de15 scribed in subsection (c), the manufacturer will, in 

16 accordance with such subsection, make any payment 

17 required under such subsection with respect to such 

18 drug; and 

19 ‘‘(6) the manufacturer complies with require20 ments imposed by the Secretary for purposes of ad21 ministering the program, including with respect to 

22 the duties described in section 1196. 

23 ‘‘(b) AGREEMENT IN EFFECT UNTIL DRUG IS NO

24 LONGER A SELECTED DRUG.—An agreement entered into 

25 under this section shall be effective, with respect to a drug, 
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1 until such drug is no longer considered a selected drug 

2 under section 1192(c). 

3 ‘‘(c) SPECIAL RULE FOR CERTAIN SELECTED DRUGS

4 WITHOUT AIM PRICE.— 

5 ‘‘(1) IN GENERAL.—In the case of a selected 

6 drug for which there is no AIM price available with 

7 respect to the initial price applicability year for such 

8 drug and for which an AIM price becomes available 

9 beginning with respect to a subsequent plan year 

10 during the price applicability period for such drug, 

11 if the Secretary determines that the amount de12 scribed in paragraph (2)(A) for a unit of such drug 

13 is greater than the amount described in paragraph 

14 (2)(B) for a unit of such drug, then by not later 

15 than one year after the date of such determination, 

16 the manufacturer of such selected drug shall pay to 

17 the Treasury an amount equal to the product of— 

18 ‘‘(A) the difference between such amount 

19 described in paragraph (2)(A) for a unit of 

20 such drug and such amount described in para21 graph (2)(B) for a unit of such drug; and 

22 ‘‘(B) the number of units of such drug sold 

23 in the United States, including the 50 States, 

24 the District of Columbia, and the territories of 
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1 the United States, during the period described 

2 in paragraph (2)(B). 

3 ‘‘(2) AMOUNTS DESCRIBED.— 

4 ‘‘(A) WEIGHTED AVERAGE PRICE BEFORE

5 AIM PRICE AVAILABLE.—For purposes of para6 graph (1), the amount described in this sub7 paragraph for a selected drug described in such 

8 paragraph, is the amount equal to the weighted 

9 average manufacturer price (as defined in sec10 tion 1927(k)(1)) for such dosage strength and 

11 form for the drug during the period beginning 

12 with the first plan year for which the drug is 

13 included on the list of negotiation-eligible drugs 

14 published under section 1192(d) and ending 

15 with the last plan year during the price applica16 bility period for such drug with respect to which 

17 there is no AIM price available for such drug. 

18 ‘‘(B) AMOUNT MULTIPLIER AFTER AIM

19 PRICE AVAILABLE.—For purposes of paragraph 

20 (1), the amount described in this subparagraph 

21 for a selected drug described in such paragraph, 

22 is the amount equal to 200 percent of the AIM 

23 price for such drug with respect to the first 

24 plan year during the price applicability period 
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1 for such drug with respect to which there is an 

2 AIM price available for such drug. 

3 ‘‘(d) CONFIDENTIALITY OF INFORMATION.—Infor4 mation submitted to the Secretary under this part by a 

5 manufacturer of a selected drug that is proprietary infor6 mation of such manufacturer (as determined by the Sec7 retary) may be used only by the Secretary or disclosed 

8 to and used by the Comptroller General of the United 

9 States or the Medicare Payment Advisory Commission for 

10 purposes of carrying out this part. 

11 ‘‘(e) REGULATIONS.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall, pursu13 ant to rulemaking, specify, in accordance with para14 graph (2), the information that must be submitted 

15 under subsection (a)(4). 

16 ‘‘(2) INFORMATION SPECIFIED.—Information 

17 described in paragraph (1), with respect to a se18 lected drug, shall include information on sales of the 

19 drug (by the manufacturer of the drug or by another 

20 entity under license or other agreement with the 

21 manufacturer, with respect to the sales of such drug, 

22 regardless of the name under which the drug is sold) 

23 in any foreign country that is part of the AIM price. 

24 The Secretary shall verify, to the extent practicable, 
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1 such sales from appropriate officials of the govern2 ment of the foreign country involved. 

3 ‘‘(f) COMPLIANCE WITH REQUIREMENTS FOR AD4 MINISTRATION OF PROGRAM.—Each manufacturer with 

5 an agreement in effect under this section shall comply with 

6 requirements imposed by the Secretary or a third party 

7 with a contract under section 1196(c)(1), as applicable, 

8 for purposes of administering the program. 

9 ‘‘SEC. 1194. NEGOTIATION AND RENEGOTIATION PROCESS. 

10 ‘‘(a) IN GENERAL.—For purposes of this part, under 

11 an agreement under section 1193 between the Secretary 

12 and a manufacturer of a selected drug, with respect to 

13 the period for which such agreement is in effect and in 

14 accordance with subsections (b) and (c), the Secretary and 

15 the manufacturer— 

16 ‘‘(1) shall during the voluntary negotiation pe17 riod with respect to the initial price applicability 

18 year for such drug, in accordance with this section, 

19 negotiate a maximum fair price for such drug for 

20 the purpose described in section 1193(a)(1); and 

21 ‘‘(2) as applicable pursuant to section 

22 1193(a)(2) and in accordance with the process speci23 fied pursuant to such section, renegotiate such max24 imum fair price for such drug for the purpose de25 scribed in such section. 
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1 ‘‘(b) NEGOTIATING METHODOLOGY AND OBJEC2 TIVE.— 

3 ‘‘(1) IN GENERAL.—The Secretary shall develop 

4 and use a consistent methodology for negotiations 

5 under subsection (a) that, in accordance with para6 graph (2) and subject to paragraph (3), achieves the 

7 lowest maximum fair price for each selected drug 

8 while appropriately rewarding innovation. 

9 ‘‘(2) PRIORITIZING FACTORS.—In considering 

10 the factors described in subsection (d) in negotiating 

11 (and, as applicable, renegotiating) the maximum fair 

12 price for a selected drug, the Secretary shall, to the 

13 extent practicable, consider all of the available fac14 tors listed but shall prioritize the following factors: 

15 ‘‘(A) RESEARCH AND DEVELOPMENT

16 COSTS.—The factor described in paragraph 

17 (1)(A) of subsection (d). 

18 ‘‘(B) MARKET DATA.—The factor de19 scribed in paragraph (1)(B) of such subsection. 

20 ‘‘(C) UNIT COSTS OF PRODUCTION AND

21 DISTRIBUTION.—The factor described in para22 graph (1)(C) of such subsection. 

23 ‘‘(D) COMPARISON TO EXISTING THERA24 PEUTIC ALTERNATIVES.—The factor described 

25 in paragraph (2)(A) of such subsection. 
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1 ‘‘(3) REQUIREMENT.— 

2 ‘‘(A) IN GENERAL.—In negotiating the 

3 maximum fair price of a selected drug, with re4 spect to an initial price applicability year for 

5 the selected drug, and, as applicable, in renego6 tiating the maximum fair price for such drug, 

7 with respect to a subsequent year during the 

8 price applicability period for such drug, in the 

9 case that the manufacturer of the selected drug 

10 offers under the negotiation or renegotiation, as 

11 applicable, a price for such drug that is not 

12 more than the target price described in sub13 paragraph (B) for such drug for the respective 

14 year, the Secretary shall agree under such ne15 gotiation or renegotiation, respectively, to such 

16 offered price as the maximum fair price. 

17 ‘‘(B) TARGET PRICE.— 

18 ‘‘(i) IN GENERAL.—Subject to clause 

19 (ii), the target price described in this sub20 paragraph for a selected drug with respect 

21 to a year, is the average price (which shall 

22 be the net average price, if practicable, and 

23 volume-weighted, if practicable) for a unit 

24 of such drug for sales of such drug, as 

25 computed (across different dosage forms 
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1 and strengths of the drug and not based 

2 on the specific formulation or package size 

3 or package type of the drug) in the appli4 cable country described in section 

5 1191(c)(3)(B) with respect to such drug 

6 that, with respect to such year, has the 

7 lowest average price for such drug as com8 pared to the average prices (as so com9 puted) of such drug with respect to such 

10 year in the other applicable countries de11 scribed in such section with respect to such 

12 drug. 

13 ‘‘(ii) SELECTED DRUGS WITHOUT AIM

14 PRICE.—In applying this paragraph in the 

15 case of negotiating the maximum fair price 

16 of a selected drug for which there is no 

17 AIM price available with respect to the ini18 tial price applicability year for such drug, 

19 or, as applicable, renegotiating the max20 imum fair price for such drug with respect 

21 to a subsequent year during the price ap22 plicability period for such drug before the 

23 first plan year for which there is an AIM 

24 price available for such drug, the target 

25 price described in this subparagraph for 
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1 such drug and respective year is the 

2 amount that is 80 percent of the average 

3 manufacturer price (as defined in section 

4 1927(k)(1)) for such drug and year. 

5 ‘‘(4) ANNUAL REPORT.—After the completion 

6 of each voluntary negotiation period, the Secretary 

7 shall submit to Congress a report on the maximum 

8 fair prices negotiated (or, as applicable, renegoti9 ated) for such period. Such report shall include in10 formation on how such prices so negotiated (or re11 negotiated) meet the requirements of this part, in12 cluding the requirements of this subsection. 

13 ‘‘(c) LIMITATION.— 

14 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

15 the maximum fair price negotiated (including as re16 negotiated) under this section for a selected drug, 

17 with respect to each plan year during a price appli18 cability period for such drug, shall not exceed 120 

19 percent of the AIM price applicable to such drug 

20 with respect to such year. 

21 ‘‘(2) SELECTED DRUGS WITHOUT AIM PRICE.— 

22 In the case of a selected drug for which there is no 

23 AIM price available with respect to the initial price 

24 applicability year for such drug, for each plan year 

25 during the price applicability period before the first 
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1 plan year for which there is an AIM price available 

2 for such drug, the maximum fair price negotiated 

3 (including as renegotiated) under this section for the 

4 selected drug shall not exceed the amount equal to 

5 85 percent of the average manufacturer price for the 

6 drug with respect to such year. 

7 ‘‘(d) CONSIDERATIONS.—For purposes of negotiating 

8 and, as applicable, renegotiating (including for purposes 

9 of determining whether to renegotiate) the maximum fair 

10 price of a selected drug under this part with the manufac11 turer of the drug, the Secretary, consistent with sub12 section (b)(2), shall take into consideration the factors de13 scribed in paragraphs (1), (2), (3), and (5), and may take 

14 into consideration the factor described in paragraph (4): 

15 ‘‘(1) MANUFACTURER-SPECIFIC INFORMA16 TION.—The following information, including as sub17 mitted by the manufacturer: 

18 ‘‘(A) Research and development costs of 

19 the manufacturer for the drug and the extent to 

20 which the manufacturer has recouped research 

21 and development costs. 

22 ‘‘(B) Market data for the drug, including 

23 the distribution of sales across different pro24 grams and purchasers and projected future rev25 enues for the drug. 
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1 ‘‘(C) Unit costs of production and distribu2 tion of the drug. 

3 ‘‘(D) Prior Federal financial support for 

4 novel therapeutic discovery and development 

5 with respect to the drug. 

6 ‘‘(E) Data on patents and on existing and 

7 pending exclusivity for the drug. 

8 ‘‘(F) National sales data for the drug. 

9 ‘‘(G) Information on clinical trials for the 

10 drug in the United States or in applicable coun11 tries described in section 1191(c)(3)(B). 

12 ‘‘(2) INFORMATION ON ALTERNATIVE PROD13 UCTS.—The following information: 

14 ‘‘(A) The extent to which the drug rep15 resents a therapeutic advance as compared to 

16 existing therapeutic alternatives and, to the ex17 tent such information is available, the costs of 

18 such existing therapeutic alternatives. 

19 ‘‘(B) Information on approval by the Food 

20 and Drug Administration of alternative drug 

21 products. 

22 ‘‘(C) Information on comparative effective23 ness analysis for such products, taking into 

24 consideration the effects of such products on 

25 specific populations, such as individuals with 
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1 disabilities, the elderly, terminally ill, children, 

2 and other patient populations. 

3 In considering information described in subpara4 graph (C), the Secretary shall not use evidence or 

5 findings from comparative clinical effectiveness re6 search in a manner that treats extending the life of 

7 an elderly, disabled, or terminally ill individual as of 

8 lower value than extending the life of an individual 

9 who is younger, nondisabled, or not terminally ill. 

10 Nothing in the previous sentence shall affect the ap11 plication or consideration of an AIM price for a se12 lected drug. 

13 ‘‘(3) FOREIGN SALES INFORMATION.—To the 

14 extent available on a timely basis, including as pro15 vided by a manufacturer of the selected drug or oth16 erwise, information on sales of the selected drug in 

17 each of the countries described in section 

18 1191(c)(3)(B). 

19 ‘‘(4) VA DRUG PRICING INFORMATION.—Infor20 mation disclosed to the Secretary pursuant to sub21 section (f). 

22 ‘‘(5) ADDITIONAL INFORMATION.—Information 

23 submitted to the Secretary, in accordance with a 

24 process specified by the Secretary, by other parties 
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1 that are affected by the establishment of a maximum 

2 fair price for the selected drug. 

3 ‘‘(e) REQUEST FOR INFORMATION.—For purposes of 

4 negotiating and, as applicable, renegotiating (including for 

5 purposes of determining whether to renegotiate) the max6 imum fair price of a selected drug under this part with 

7 the manufacturer of the drug, with respect to a price ap8 plicability period, and other relevant data for purposes of 

9 this section— 

10 ‘‘(1) the Secretary shall, not later than the se11 lected drug publication date with respect to the ini12 tial price applicability year of such period, request 

13 drug pricing information from the manufacturer of 

14 such selected drug, including information described 

15 in subsection (d)(1); and 

16 ‘‘(2) by not later than October 1 following the 

17 selected drug publication date, the manufacturer of 

18 such selected drug shall submit to the Secretary 

19 such requested information in such form and man20 ner as the Secretary may require. 

21 The Secretary shall request, from the manufacturer or 

22 others, such additional information as may be needed to 

23 carry out the negotiation and renegotiation process under 

24 this section. 
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1 ‘‘(f) DISCLOSURE OF INFORMATION.—For purposes 

2 of this part, the Secretary of Veterans Affairs may disclose 

3 to the Secretary of Health and Human Services the price 

4 of any negotiation-eligible drug that is purchased pursuant 

5 to section 8126 of title 38, United States Code. 

6 ‘‘SEC. 1195. PUBLICATION OF MAXIMUM FAIR PRICES. 

7 ‘‘(a) IN GENERAL.—With respect to an initial price 

8 applicability year and selected drug with respect to such 

9 year, not later than April 1 of the plan year prior to such 

10 initial price applicability year, the Secretary shall publish 

11 in the Federal Register the maximum fair price for such 

12 drug negotiated under this part with the manufacturer of 

13 such drug. 

14 ‘‘(b) UPDATES.— 

15 ‘‘(1) SUBSEQUENT YEAR MAXIMUM FAIR

16 PRICES.—For a selected drug, for each plan year 

17 subsequent to the initial price applicability year for 

18 such drug with respect to which an agreement for 

19 such drug is in effect under section 1193, the Sec20 retary shall publish in the Federal Register— 

21 ‘‘(A) subject to subparagraph (B), the 

22 amount equal to the maximum fair price pub23 lished for such drug for the previous year, in24 creased by the annual percentage increase in 

25 the consumer price index for all urban con-
37 

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1 sumers (all items; U.S. city average) as of Sep2 tember of such previous year; or 

3 ‘‘(B) in the case the maximum fair price 

4 for such drug was renegotiated, for the first 

5 year for which such price as so renegotiated ap6 plies, such renegotiated maximum fair price. 

7 ‘‘(2) PRICES NEGOTIATED AFTER DEADLINE.— 

8 In the case of a selected drug with respect to an ini9 tial price applicability year for which the maximum 

10 fair price is determined under this part after the 

11 date of publication under this section, the Secretary 

12 shall publish such maximum fair price in the Fed13 eral Register by not later than 30 days after the 

14 date such maximum price is so determined. 

15 ‘‘SEC. 1196. ADMINISTRATIVE DUTIES; COORDINATION PRO16 VISIONS. 

17 ‘‘(a) ADMINISTRATIVE DUTIES.— 

18 ‘‘(1) IN GENERAL.—For purposes of section 

19 1191, the administrative duties described in this sec20 tion are the following: 

21 ‘‘(A) The establishment of procedures (in22 cluding through agreements with manufacturers 

23 under this part, contracts with prescription 

24 drug plans under part D of title XVIII and 

25 MA–PD plans under part C of such title, and 
38 

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1 agreements under section 1197 with group 

2 health plans and health insurance issuers of 

3 health insurance coverage offered in the indi4 vidual or group market) under which the max5 imum fair price for a selected drug is provided 

6 to fair price eligible individuals, who with re7 spect to such drug are described in subpara8 graph (A) of section 1191(c)(1), at pharmacies 

9 or by mail order service at the point-of-sale of 

10 the drug for the applicable price period for such 

11 drug and providing that such maximum fair 

12 price is used for determining cost-sharing under 

13 such plans or coverage for the selected drug. 

14 ‘‘(B) The establishment of procedures (in15 cluding through agreements with manufacturers 

16 under this part and contracts with hospitals, 

17 physicians, and other providers of services and 

18 suppliers and agreements under section 1197 

19 with group health plans and health insurance 

20 issuers of health insurance coverage offered in 

21 the individual or group market) under which, in 

22 the case of a selected drug furnished or admin23 istered by such a hospital, physician, or other 

24 provider of services or supplier to fair price eli25 gible individuals (who with respect to such drug 
39 

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1 are described in subparagraph (B) of section 

2 1191(c)(1)), the maximum fair price for the se3 lected drug is provided to such hospitals, physi4 cians, and other providers of services and sup5 pliers (as applicable) with respect to such indi6 viduals and providing that such maximum fair 

7 price is used for determining cost-sharing under 

8 the respective part, plan, or coverage for the se9 lected drug. 

10 ‘‘(C) The establishment of procedures (in11 cluding through agreements and contracts de12 scribed in subparagraphs (A) and (B)) to en13 sure that, not later than 90 days after the dis14 pensing of a selected drug to a fair price eligi15 ble individual by a pharmacy or mail order serv16 ice, the pharmacy or mail order service is reim17 bursed for an amount equal to the difference 

18 between— 

19 ‘‘(i) the lesser of— 

20 ‘‘(I) the wholesale acquisition 

21 cost of the drug; 

22 ‘‘(II) the national average drug 

23 acquisition cost of the drug; and 

24 ‘‘(III) any other similar deter25 mination of pharmacy acquisition 
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1 costs of the drug, as determined by 

2 the Secretary; and 

3 ‘‘(ii) the maximum fair price for the 

4 drug. 

5 ‘‘(D) The establishment of procedures to 

6 ensure that the maximum fair price for a se7 lected drug is applied before— 

8 ‘‘(i) any coverage or financial assist9 ance under other health benefit plans or 

10 programs that provide coverage or finan11 cial assistance for the purchase or provi12 sion of prescription drug coverage on be13 half of fair price eligible individuals as the 

14 Secretary may specify; and 

15 ‘‘(ii) any other discounts. 

16 ‘‘(E) The establishment of procedures to 

17 enter into appropriate agreements and protocols 

18 for the ongoing computation of AIM prices for 

19 selected drugs, including, to the extent possible, 

20 to compute the AIM price for selected drugs 

21 and including by providing that the manufac22 turer of such a selected drug should provide in23 formation for such computation not later than 

24 3 months after the first date of the voluntary 

25 negotiation period for such selected drug. 
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1 ‘‘(F) The establishment of procedures to 

2 compute and apply the maximum fair price 

3 across different strengths and dosage forms of 

4 a selected drug and not based on the specific 

5 formulation or package size or package type of 

6 the drug. 

7 ‘‘(G) The establishment of procedures to 

8 negotiate and apply the maximum fair price in 

9 a manner that does not include any dispensing 

10 or similar fee. 

11 ‘‘(H) The establishment of procedures to 

12 carry out the provisions of this part, as applica13 ble, with respect to— 

14 ‘‘(i) fair price eligible individuals who 

15 are enrolled under a prescription drug plan 

16 under part D of title XVIII or an MA–PD 

17 plan under part C of such title; 

18 ‘‘(ii) fair price eligible individuals who 

19 are enrolled under a group health plan or 

20 health insurance coverage offered by a 

21 health insurance issuer in the individual or 

22 group market with respect to which there 

23 is an agreement in effect under section 

24 1197; and 
42 

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1 ‘‘(iii) fair price eligible individuals who 

2 are entitled to benefits under part A of 

3 title XVIII or enrolled under part B of 

4 such title. 

5 ‘‘(I) The establishment of a negotiation 

6 process and renegotiation process in accordance 

7 with section 1194, including a process for ac8 quiring information described in subsection (d) 

9 of such section and determining amounts de10 scribed in subsection (b) of such section. 

11 ‘‘(J) The provision of a reasonable dispute 

12 resolution mechanism to resolve disagreements 

13 between manufacturers, fair price eligible indi14 viduals, and the third party with a contract 

15 under subsection (c)(1). 

16 ‘‘(2) MONITORING COMPLIANCE.— 

17 ‘‘(A) IN GENERAL.—The Secretary shall 

18 monitor compliance by a manufacturer with the 

19 terms of an agreement under section 1193, in20 cluding by establishing a mechanism through 

21 which violations of such terms may be reported. 

22 ‘‘(B) NOTIFICATION.—If a third party 

23 with a contract under subsection (c)(1) deter24 mines that the manufacturer is not in compli25 ance with such agreement, the third party shall 
43 

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1 notify the Secretary of such noncompliance for 

2 appropriate enforcement under section 4192 of 

3 the Internal Revenue Code of 1986 or section 

4 1198, as applicable. 

5 ‘‘(b) COLLECTION OF DATA.— 

6 ‘‘(1) FROM PRESCRIPTION DRUG PLANS AND

7 MA–PD PLANS.—The Secretary may collect appro8 priate data from prescription drug plans under part 

9 D of title XVIII and MA–PD plans under part C of 

10 such title in a timeframe that allows for maximum 

11 fair prices to be provided under this part for selected 

12 drugs. 

13 ‘‘(2) FROM HEALTH PLANS.—The Secretary 

14 may collect appropriate data from group health 

15 plans or health insurance issuers offering group or 

16 individual health insurance coverage in a timeframe 

17 that allows for maximum fair prices to be provided 

18 under this part for selected drugs. 

19 ‘‘(3) COORDINATION OF DATA COLLECTION.— 

20 To the extent feasible, as determined by the Sec21 retary, the Secretary shall ensure that data collected 

22 pursuant to this subsection is coordinated with, and 

23 not duplicative of, other Federal data collection ef24 forts. 

25 ‘‘(c) CONTRACT WITH THIRD PARTIES.— 
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1 ‘‘(1) IN GENERAL.—The Secretary may enter 

2 into a contract with 1 or more third parties to ad3 minister the requirements established by the Sec4 retary in order to carry out this part. At a min5 imum, the contract with a third party under the pre6 ceding sentence shall require that the third party— 

7 ‘‘(A) receive and transmit information be8 tween the Secretary, manufacturers, and other 

9 individuals or entities the Secretary determines 

10 appropriate; 

11 ‘‘(B) receive, distribute, or facilitate the 

12 distribution of funds of manufacturers to ap13 propriate individuals or entities in order to 

14 meet the obligations of manufacturers under 

15 agreements under this part; 

16 ‘‘(C) provide adequate and timely informa17 tion to manufacturers, consistent with the 

18 agreement with the manufacturer under this 

19 part, as necessary for the manufacturer to ful20 fill its obligations under this part; and 

21 ‘‘(D) permit manufacturers to conduct 

22 periodic audits, directly or through contracts, of 

23 the data and information used by the third 

24 party to determine discounts for applicable 

25 drugs of the manufacturer under the program. 
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1 ‘‘(2) PERFORMANCE REQUIREMENTS.—The 

2 Secretary shall establish performance requirements 

3 for a third party with a contract under paragraph 

4 (1) and safeguards to protect the independence and 

5 integrity of the activities carried out by the third 

6 party under the program under this part. 

7 ‘‘SEC. 1197. VOLUNTARY PARTICIPATION BY OTHER 

8 HEALTH PLANS. 

9 ‘‘(a) AGREEMENT TO PARTICIPATE UNDER PRO10 GRAM.— 

11 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

12 under the program under this part the Secretary 

13 shall be treated as having in effect an agreement 

14 with a group health plan or health insurance issuer 

15 offering group or individual health insurance cov16 erage (as such terms are defined in section 2791 of 

17 the Public Health Service Act), with respect to a 

18 price applicability period and a selected drug with 

19 respect to such period— 

20 ‘‘(A) with respect to such selected drug 

21 furnished or dispensed at a pharmacy or by 

22 mail order service if coverage is provided under 

23 such plan or coverage during such period for 

24 such selected drug as so furnished or dispensed; 

25 and 
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1 ‘‘(B) with respect to such selected drug 

2 furnished or administered by a hospital, physi3 cian, or other provider of services or supplier if 

4 coverage is provided under such plan or cov5 erage during such period for such selected drug 

6 as so furnished or administered. 

7 ‘‘(2) OPTING OUT OF AGREEMENT.—The Sec8 retary shall not be treated as having in effect an 

9 agreement under the program under this part with 

10 a group health plan or health insurance issuer offer11 ing group or individual health insurance coverage 

12 with respect to a price applicability period and a se13 lected drug with respect to such period if such a 

14 plan or issuer affirmatively elects, through a process 

15 specified by the Secretary, not to participate under 

16 the program with respect to such period and drug. 

17 ‘‘(b) PUBLICATION OF ELECTION.—With respect to 

18 each price applicability period and each selected drug with 

19 respect to such period, the Secretary and the Secretary 

20 of Labor and the Secretary of the Treasury, as applicable, 

21 shall make public a list of each group health plan and each 

22 health insurance issuer offering group or individual health 

23 insurance coverage, with respect to which coverage is pro24 vided under such plan or coverage for such drug, that has 
47 

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1 elected under subsection (a) not to participate under the 

2 program with respect to such period and drug. 

3 ‘‘SEC. 1198. CIVIL MONETARY PENALTY. 

4 ‘‘(a) VIOLATIONS RELATING TO OFFERING OF MAX5 IMUM FAIR PRICE.—Any manufacturer of a selected drug 

6 that has entered into an agreement under section 1193, 

7 with respect to a plan year during the price applicability 

8 period for such drug, that does not provide access to a 

9 price that is not more than the maximum fair price (or 

10 a lesser price) for such drug for such year— 

11 ‘‘(1) to a fair price eligible individual who with 

12 respect to such drug is described in subparagraph 

13 (A) of section 1191(c)(1) and who is furnished or 

14 dispensed such drug during such year; or 

15 ‘‘(2) to a hospital, physician, or other provider 

16 of services or supplier with respect to fair price eligi17 ble individuals who with respect to such drug is de18 scribed in subparagraph (B) of such section and is 

19 furnished or administered such drug by such hos20 pital, physician, or provider or supplier during such 

21 year; 

22 shall be subject to a civil monetary penalty equal to ten 

23 times the amount equal to the difference between the price 

24 for such drug made available for such year by such manu25 facturer with respect to such individual or hospital, physi-
48 

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1 cian, provider, or supplier and the maximum fair price for 

2 such drug for such year. 

3 ‘‘(b) VIOLATIONS OF CERTAIN TERMS OF AGREE4 MENT.—Any manufacturer of a selected drug that has en5 tered into an agreement under section 1193, with respect 

6 to a plan year during the price applicability period for 

7 such drug, that is in violation of a requirement imposed 

8 pursuant to section 1193(a)(6) shall be subject to a civil 

9 monetary penalty of not more than $1,000,000 for each 

10 such violation. 

11 ‘‘(c) APPLICATION.—The provisions of section 1128A 

12 (other than subsections (a) and (b)) shall apply to a civil 

13 monetary penalty under this section in the same manner 

14 as such provisions apply to a penalty or proceeding under 

15 section 1128A(a). 

16 ‘‘SEC. 1199. MISCELLANEOUS PROVISIONS. 

17 ‘‘(a) PAPERWORK REDUCTION ACT.—Chapter 35 of 

18 title 44, United States Code, shall not apply to data col19 lected under this part. 

20 ‘‘(b) NATIONAL ACADEMY OF MEDICINE STUDY.— 

21 Not later than December 31, 2025, the National Academy 

22 of Medicine shall conduct a study, and submit to Congress 

23 a report, on recommendations for improvements to the 

24 program under this part, including the determination of 

25 the limits applied under section 1194(c). 
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1 ‘‘(c) MEDPAC STUDY.—Not later than December 31, 

2 2025, the Medicare Payment Advisory Commission shall 

3 conduct a study, and submit to Congress a report, on the 

4 program under this part with respect to the Medicare pro5 gram under title XVIII, including with respect to the ef6 fect of the program on individuals entitled to benefits or 

7 enrolled under such title. 

8 ‘‘(d) LIMITATION ON JUDICIAL REVIEW.—The fol9 lowing shall not be subject to judicial review: 

10 ‘‘(1) The selection of drugs for publication 

11 under section 1192(a). 

12 ‘‘(2) The determination of whether a drug is a 

13 negotiation-eligible drug under section 1192(d). 

14 ‘‘(3) The determination of the maximum fair 

15 price of a selected drug under section 1194. 

16 ‘‘(4) The determination of units of a drug for 

17 purposes of section 1191(c)(3). 

18 ‘‘(e) COORDINATION.—In carrying out this part with 

19 respect to group health plans or health insurance coverage 

20 offered in the group market that are subject to oversight 

21 by the Secretary of Labor or the Secretary of the Treas22 ury, the Secretary of Health and Human Services shall 

23 coordinate with such respective Secretary. 

24 ‘‘(f) DATA SHARING.—The Secretary shall share with 

25 the Secretary of the Treasury such information as is nec-
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1 essary to determine the tax imposed by section 4192 of 

2 the Internal Revenue Code of 1986. 

3 ‘‘(g) GAO STUDY.—Not later than December 31, 

4 2025, the Comptroller General of the United States shall 

5 conduct a study of, and submit to Congress a report on, 

6 the implementation of the Fair Price Negotiation Program 

7 under this part.’’. 

8 (b) APPLICATION OF MAXIMUM FAIR PRICES AND

9 CONFORMING AMENDMENTS.— 

10 (1) UNDER MEDICARE.— 

11 (A) APPLICATION TO PAYMENTS UNDER

12 PART B.—Section 1847A(b)(1)(B) of the Social 

13 Security Act (42 U.S.C. 1395w–3a(b)(1)(B)) is 

14 amended by inserting ‘‘or in the case of such a 

15 drug or biological that is a selected drug (as de16 fined in section 1192(c)), with respect to a 

17 price applicability period (as defined in section 

18 1191(b)(2)), 106 percent of the maximum fair 

19 price (as defined in section 1191(c)(2) applica20 ble for such drug and a plan year during such 

21 period’’ after ‘‘paragraph (4)’’. 

22 (B) EXCEPTION TO PART D NON-INTER23 FERENCE.—Section 1860D–11(i) of the Social 

24 Security Act (42 U.S.C. 1395w–111(i)) is 
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1 amended by inserting ‘‘, except as provided 

2 under part E of title XI’’ after ‘‘the Secretary’’. 

3 (C) APPLICATION AS NEGOTIATED PRICE

4 UNDER PART D.—Section 1860D–2(d)(1) of the 

5 Social Security Act (42 U.S.C. 1395w– 

6 102(d)(1)) is amended— 

7 (i) in subparagraph (B), by inserting 

8 ‘‘, subject to subparagraph (D),’’ after 

9 ‘‘negotiated prices’’; and 

10 (ii) by adding at the end the following 

11 new subparagraph: 

12 ‘‘(D) APPLICATION OF MAXIMUM FAIR

13 PRICE FOR SELECTED DRUGS.—In applying this 

14 section, in the case of a covered part D drug 

15 that is a selected drug (as defined in section 

16 1192(c)), with respect to a price applicability 

17 period (as defined in section 1191(b)(2)), the 

18 negotiated prices used for payment (as de19 scribed in this subsection) shall be the max20 imum fair price (as defined in section 

21 1191(c)(2)) for such drug and for each plan 

22 year during such period.’’. 

23 (D) INFORMATION FROM PRESCRIPTION

24 DRUG PLANS AND MA–PD PLANS REQUIRED.— 
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1 (i) PRESCRIPTION DRUG PLANS.—Sec2 tion 1860D–12(b) of the Social Security 

3 Act (42 U.S.C. 1395w–112(b)) is amended 

4 by adding at the end the following new 

5 paragraph: 

6 ‘‘(8) PROVISION OF INFORMATION RELATED TO

7 MAXIMUM FAIR PRICES.—Each contract entered into 

8 with a PDP sponsor under this part with respect to 

9 a prescription drug plan offered by such sponsor 

10 shall require the sponsor to provide information to 

11 the Secretary as requested by the Secretary in ac12 cordance with section 1196(b).’’. 

13 (ii) MA–PD PLANS.—Section 

14 1857(f)(3) of the Social Security Act (42 

15 U.S.C. 1395w–27(f)(3)) is amended by 

16 adding at the end the following new sub17 paragraph: 

18 ‘‘(E) PROVISION OF INFORMATION RE19 LATED TO MAXIMUM FAIR PRICES.—Section 

20 1860D–12(b)(8).’’. 

21 (2) UNDER GROUP HEALTH PLANS AND

22 HEALTH INSURANCE COVERAGE.— 

23 (A) PHSA.—Part A of title XXVII of the 

24 Public Health Service Act is amended by insert-
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1 ing after section 2729 the following new sec2 tion: 

3 ‘‘SEC. 2729A. FAIR PRICE NEGOTIATION PROGRAM AND AP4 PLICATION OF MAXIMUM FAIR PRICES. 

5 ‘‘(a) IN GENERAL.—In the case of a group health 

6 plan or health insurance issuer offering group or indi7 vidual health insurance coverage that is treated under sec8 tion 1197 of the Social Security Act as having in effect 

9 an agreement with the Secretary under the Fair Price Ne10 gotiation Program under part E of title XI of such Act, 

11 with respect to a price applicability period (as defined in 

12 section 1191(b) of such Act) and a selected drug (as de13 fined in section 1192(c) of such Act) with respect to such 

14 period with respect to which coverage is provided under 

15 such plan or coverage— 

16 ‘‘(1) the provisions of such part shall apply— 

17 ‘‘(A) if coverage of such selected drug is 

18 provided under such plan or coverage if the 

19 drug is furnished or dispensed at a pharmacy 

20 or by a mail order service, to the plans or cov21 erage offered by such plan or issuer, and to the 

22 individuals enrolled under such plans or cov23 erage, during such period, with respect to such 

24 selected drug, in the same manner as such pro25 visions apply to prescription drug plans and 
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1 MA–PD plans, and to individuals enrolled 

2 under such prescription drug plans and MA– 

3 PD plans during such period; and 

4 ‘‘(B) if coverage of such selected drug is 

5 provided under such plan or coverage if the 

6 drug is furnished or administered by a hospital, 

7 physician, or other provider of services or sup8 plier, to the plans or coverage offered by such 

9 plan or issuers, to the individuals enrolled 

10 under such plans or coverage, and to hospitals, 

11 physicians, and other providers of services and 

12 suppliers during such period, with respect to 

13 such drug in the same manner as such provi14 sions apply to the Secretary, to individuals enti15 tled to benefits under part A of title XVIII or 

16 enrolled under part B of such title, and to hos17 pitals, physicians, and other providers and sup18 pliers participating under title XVIII during 

19 such period; 

20 ‘‘(2) the plan or issuer shall apply any cost21 sharing responsibilities under such plan or coverage, 

22 with respect to such selected drug, by substituting 

23 an amount not more than the maximum fair price 

24 negotiated under such part E of title XI for such 

25 drug in lieu of the drug price upon which the cost- 
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1 sharing would have otherwise applied, and such cost2 sharing responsibilities with respect to such selected 

3 drug may not exceed such maximum fair price; and 

4 ‘‘(3) the Secretary shall apply the provisions of 

5 such part E to such plan, issuer, and coverage, such 

6 individuals so enrolled in such plans and coverage, 

7 and such hospitals, physicians, and other providers 

8 and suppliers participating in such plans and cov9 erage. 

10 ‘‘(b) NOTIFICATION REGARDING NONPARTICIPATION

11 IN FAIR PRICE NEGOTIATION PROGRAM.—A group health 

12 plan or a health insurance issuer offering group or indi13 vidual health insurance coverage shall publicly disclose in 

14 a manner and in accordance with a process specified by 

15 the Secretary any election made under section 1197 of the 

16 Social Security Act by the plan or issuer to not participate 

17 in the Fair Price Negotiation Program under part E of 

18 title XI of such Act with respect to a selected drug (as 

19 defined in section 1192(c) of such Act) for which coverage 

20 is provided under such plan or coverage before the begin21 ning of the plan year for which such election was made.’’. 

22 (B) ERISA.— 

23 (i) IN GENERAL.—Subpart B of part 

24 7 of subtitle B of title I of the Employee 

25 Retirement Income Security Act of 1974 
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1 (29 U.S.C. 1181 et. seq.) is amended by 

2 adding at the end the following new sec3 tion: 

4 ‘‘SEC. 716. FAIR PRICE NEGOTIATION PROGRAM AND APPLI5 CATION OF MAXIMUM FAIR PRICES. 

6 ‘‘(a) IN GENERAL.—In the case of a group health 

7 plan or health insurance issuer offering group health in8 surance coverage that is treated under section 1197 of the 

9 Social Security Act as having in effect an agreement with 

10 the Secretary under the Fair Price Negotiation Program 

11 under part E of title XI of such Act, with respect to a 

12 price applicability period (as defined in section 1191(b) 

13 of such Act) and a selected drug (as defined in section 

14 1192(c) of such Act) with respect to such period with re15 spect to which coverage is provided under such plan or 

16 coverage— 

17 ‘‘(1) the provisions of such part shall apply, as 

18 applicable— 

19 ‘‘(A) if coverage of such selected drug is 

20 provided under such plan or coverage if the 

21 drug is furnished or dispensed at a pharmacy 

22 or by a mail order service, to the plans or cov23 erage offered by such plan or issuer, and to the 

24 individuals enrolled under such plans or cov25 erage, during such period, with respect to such 
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1 selected drug, in the same manner as such pro2 visions apply to prescription drug plans and 

3 MA–PD plans, and to individuals enrolled 

4 under such prescription drug plans and MA– 

5 PD plans during such period; and 

6 ‘‘(B) if coverage of such selected drug is 

7 provided under such plan or coverage if the 

8 drug is furnished or administered by a hospital, 

9 physician, or other provider of services or sup10 plier, to the plans or coverage offered by such 

11 plan or issuers, to the individuals enrolled 

12 under such plans or coverage, and to hospitals, 

13 physicians, and other providers of services and 

14 suppliers during such period, with respect to 

15 such drug in the same manner as such provi16 sions apply to the Secretary, to individuals enti17 tled to benefits under part A of title XVIII or 

18 enrolled under part B of such title, and to hos19 pitals, physicians, and other providers and sup20 pliers participating under title XVIII during 

21 such period; 

22 ‘‘(2) the plan or issuer shall apply any cost23 sharing responsibilities under such plan or coverage, 

24 with respect to such selected drug, by substituting 

25 an amount not more than the maximum fair price 
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1 negotiated under such part E of title XI for such 

2 drug in lieu of the drug price upon which the cost3 sharing would have otherwise applied, and such cost4 sharing responsibilities with respect to such selected 

5 drug may not exceed such maximum fair price; and 

6 ‘‘(3) the Secretary shall apply the provisions of 

7 such part E to such plan, issuer, and coverage, and 

8 such individuals so enrolled in such plans. 

9 ‘‘(b) NOTIFICATION REGARDING NONPARTICIPATION

10 IN FAIR PRICE NEGOTIATION PROGRAM.—A group health 

11 plan or a health insurance issuer offering group health in12 surance coverage shall publicly disclose in a manner and 

13 in accordance with a process specified by the Secretary 

14 any election made under section 1197 of the Social Secu15 rity Act by the plan or issuer to not participate in the 

16 Fair Price Negotiation Program under part E of title XI 

17 of such Act with respect to a selected drug (as defined 

18 in section 1192(c) of such Act) for which coverage is pro19 vided under such plan or coverage before the beginning 

20 of the plan year for which such election was made.’’. 

21 (ii) APPLICATION TO RETIREE AND

22 CERTAIN SMALL GROUP HEALTH PLANS.— 

23 Section 732(a) of the Employee Retire24 ment Income Security Act of 1974 (29 

25 U.S.C. 1191a(a)) is amended by striking 
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1 ‘‘section 711’’ and inserting ‘‘sections 711 

2 and 716’’. 

3 (iii) CLERICAL AMENDMENT.—The 

4 table of sections for subpart B of part 7 of 

5 subtitle B of title I of the Employee Re6 tirement Income Security Act of 1974 is 

7 amended by adding at the end the fol8 lowing: 

‘‘Sec. 716. Fair Price Negotiation Program and application of maximum fair 

prices.’’. 

9 (C) IRC.— 

10 (i) IN GENERAL.—Subchapter B of 

11 chapter 100 of the Internal Revenue Code 

12 of 1986 is amended by adding at the end 

13 the following new section: 

14 ‘‘SEC. 9816. FAIR PRICE NEGOTIATION PROGRAM AND AP15 PLICATION OF MAXIMUM FAIR PRICES. 

16 ‘‘(a) IN GENERAL.—In the case of a group health 

17 plan that is treated under section 1197 of the Social Secu18 rity Act as having in effect an agreement with the Sec19 retary under the Fair Price Negotiation Program under 

20 part E of title XI of such Act, with respect to a price 

21 applicability period (as defined in section 1191(b) of such 

22 Act) and a selected drug (as defined in section 1192(c) 

23 of such Act) with respect to such period with respect to 

24 which coverage is provided under such plan— 
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1 ‘‘(1) the provisions of such part shall apply, as 

2 applicable— 

3 ‘‘(A) if coverage of such selected drug is 

4 provided under such plan if the drug is fur5 nished or dispensed at a pharmacy or by a mail 

6 order service, to the plan, and to the individuals 

7 enrolled under such plan during such period, 

8 with respect to such selected drug, in the same 

9 manner as such provisions apply to prescription 

10 drug plans and MA–PD plans, and to individ11 uals enrolled under such prescription drug 

12 plans and MA–PD plans during such period; 

13 and 

14 ‘‘(B) if coverage of such selected drug is 

15 provided under such plan if the drug is fur16 nished or administered by a hospital, physician, 

17 or other provider of services or supplier, to the 

18 plan, to the individuals enrolled under such 

19 plan, and to hospitals, physicians, and other 

20 providers of services and suppliers during such 

21 period, with respect to such drug in the same 

22 manner as such provisions apply to the Sec23 retary, to individuals entitled to benefits under 

24 part A of title XVIII or enrolled under part B 

25 of such title, and to hospitals, physicians, and 
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1 other providers and suppliers participating 

2 under title XVIII during such period; 

3 ‘‘(2) the plan shall apply any cost-sharing re4 sponsibilities under such plan, with respect to such 

5 selected drug, by substituting an amount not more 

6 than the maximum fair price negotiated under such 

7 part E of title XI for such drug in lieu of the drug 

8 price upon which the cost-sharing would have other9 wise applied, and such cost-sharing responsibilities 

10 with respect to such selected drug may not exceed 

11 such maximum fair price; and 

12 ‘‘(3) the Secretary shall apply the provisions of 

13 such part E to such plan and such individuals so en14 rolled in such plan. 

15 ‘‘(b) NOTIFICATION REGARDING NONPARTICIPATION

16 IN FAIR PRICE NEGOTIATION PROGRAM.—A group health 

17 plan shall publicly disclose in a manner and in accordance 

18 with a process specified by the Secretary any election 

19 made under section 1197 of the Social Security Act by 

20 the plan to not participate in the Fair Price Negotiation 

21 Program under part E of title XI of such Act with respect 

22 to a selected drug (as defined in section 1192(c) of such 

23 Act) for which coverage is provided under such plan before 

24 the beginning of the plan year for which such election was 

25 made.’’. 
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1 (ii) APPLICATION TO RETIREE AND

2 CERTAIN SMALL GROUP HEALTH PLANS.— 

3 Section 9831(a)(2) of the Internal Revenue 

4 Code of 1986 is amended by inserting 

5 ‘‘other than with respect to section 9816,’’ 

6 before ‘‘any group health plan’’. 

7 (iii) CLERICAL AMENDMENT.—The 

8 table of sections for subchapter B of chap9 ter 100 of such Code is amended by add10 ing at the end the following new item: 

‘‘Sec. 9816. Fair Price Negotiation Program and application of maximum fair 

prices.’’. 

11 (3) FAIR PRICE NEGOTIATION PROGRAM PRICES

12 INCLUDED IN BEST PRICE AND AMP.—Section 1927 

13 of the Social Security Act (42 U.S.C. 1396r–8) is 

14 amended— 

15 (A) in subsection (c)(1)(C)(ii)— 

16 (i) in subclause (III), by striking at 

17 the end ‘‘; and’’; 

18 (ii) in subclause (IV), by striking at 

19 the end the period and inserting ‘‘; and’’; 

20 and 

21 (iii) by adding at the end the fol22 lowing new subclause: 

23 ‘‘(V) in the case of a rebate pe24 riod and a covered outpatient drug 
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1 that is a selected drug (as defined in 

2 section 1192(c)) during such rebate 

3 period, shall be inclusive of the price 

4 for such drug made available from the 

5 manufacturer during the rebate period 

6 by reason of application of part E of 

7 title XI to any wholesaler, retailer, 

8 provider, health maintenance organi9 zation, nonprofit entity, or govern10 mental entity within the United 

11 States.’’; and 

12 (B) in subsection (k)(1)(B), by adding at 

13 the end the following new clause: 

14 ‘‘(iii) CLARIFICATION.—Notwith15 standing clause (i), in the case of a rebate 

16 period and a covered outpatient drug that 

17 is a selected drug (as defined in section 

18 1192(c)) during such rebate period, any 

19 reduction in price paid during the rebate 

20 period to the manufacturer for the drug by 

21 a wholesaler or retail community pharmacy 

22 described in subparagraph (A) by reason of 

23 application of part E of title XI shall be 

24 included in the average manufacturer price 

25 for the covered outpatient drug.’’. 
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1 (4) FEHBP.—Section 8902 of title 5, United 

2 States Code, is amended by adding at the end the 

3 following: 

4 ‘‘(p) A contract may not be made or a plan approved 

5 under this chapter with any carrier that has affirmatively 

6 elected, pursuant to section 1197 of the Social Security 

7 Act, not to participate in the Fair Price Negotiation Pro8 gram established under section 1191 of such Act for any 

9 selected drug (as that term is defined in section 1192(c) 

10 of such Act).’’. 

11 (5) OPTION OF SECRETARY OF VETERANS AF12 FAIRS TO PURCHASE COVERED DRUGS AT MAXIMUM

13 FAIR PRICES.—Section 8126 of title 38, United 

14 States Code, is amended— 

15 (A) in subsection (a)(2), by inserting ‘‘, 

16 subject to subsection (j),’’ after ‘‘may not ex17 ceed’’; 

18 (B) in subsection (d), in the matter pre19 ceding paragraph (1), by inserting ‘‘, subject to 

20 subsection (j)’’ after ‘‘for the procurement of 

21 the drug’’; and 

22 (C) by adding at the end the following new 

23 subsection: 

24 ‘‘(j)(1) In the case of a covered drug that is a selected 

25 drug, for any year during the price applicability period for 
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1 such drug, if the Secretary determines that the maximum 

2 fair price of such drug for such year is less than the price 

3 for such drug otherwise in effect pursuant to this section 

4 (including after application of any reduction under sub5 section (a)(2) and any discount under subsection (c)), at 

6 the option of the Secretary, in lieu of the maximum price 

7 (determined after application of the reduction under sub8 section (a)(2) and any discount under subsection (c), as 

9 applicable) that would be permitted to be charged during 

10 such year for such drug pursuant to this section without 

11 application of this subsection, the maximum price per12 mitted to be charged during such year for such drug pur13 suant to this section shall be such maximum fair price for 

14 such drug and year. 

15 ‘‘(2) For purposes of this subsection: 

16 ‘‘(A) The term ‘maximum fair price’ means, 

17 with respect to a selected drug and year during the 

18 price applicability period for such drug, the max19 imum fair price (as defined in section 1191(c)(2) of 

20 the Social Security Act) for such drug and year. 

21 ‘‘(B) The term ‘negotiation eligible drug’ has 

22 the meaning given such term in section 1192(d)(1) 

23 of the Social Security Act. 
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1 ‘‘(C) The term ‘price applicability period’ has, 

2 with respect to a selected drug, the meaning given 

3 such term in section 1191(b)(2) of such Act. 

4 ‘‘(D) The term ‘selected drug’ means, with re5 spect to a year, a drug that is a selected drug under 

6 section 1192(c) of such Act for such year.’’. 

7 SEC. 102. SELECTED DRUG MANUFACTURER EXCISE TAX 

8 IMPOSED DURING NONCOMPLIANCE PERI9 ODS. 

10 (a) IN GENERAL.—Subchapter E of chapter 32 of the 

11 Internal Revenue Code of 1986 is amended by adding at 

12 the end the following new section: 

13 ‘‘SEC. 4192. SELECTED DRUGS DURING NONCOMPLIANCE 

14 PERIODS. 

15 ‘‘(a) IN GENERAL.—There is hereby imposed on the 

16 sale by the manufacturer, producer, or importer of any 

17 selected drug during a day described in subsection (b) a 

18 tax in an amount such that the applicable percentage is 

19 equal to the ratio of— 

20 ‘‘(1) such tax, divided by 

21 ‘‘(2) the sum of such tax and the price for 

22 which so sold. 

23 ‘‘(b) NONCOMPLIANCE PERIODS.—A day is described 

24 in this subsection with respect to a selected drug if it is 

25 a day during one of the following periods: 
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1 ‘‘(1) The period beginning on the June 16th 

2 immediately following the selected drug publication 

3 date and ending on the first date during which the 

4 manufacturer of the drug has in place an agreement 

5 described in subsection (a) of section 1193 of the 

6 Social Security Act with respect to such drug. 

7 ‘‘(2) The period beginning on the April 1st im8 mediately following the June 16th described in para9 graph (1) and ending on the first date during which 

10 the manufacturer of the drug has agreed to a max11 imum fair price under such agreement. 

12 ‘‘(3) In the case of a selected drug with respect 

13 to which the Secretary of Health and Human Serv14 ices has specified a renegotiation period under such 

15 agreement, the period beginning on the first date 

16 after the last date of such renegotiation period and 

17 ending on the first date during which the manufac18 turer of the drug has agreed to a renegotiated max19 imum fair price under such agreement. 

20 ‘‘(4) With respect to information that is re21 quired to be submitted to the Secretary of Health 

22 and Human Services under such agreement, the pe23 riod beginning on the date on which such Secretary 

24 certifies that such information is overdue and ending 

25 on the date that such information is so submitted. 
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1 ‘‘(5) In the case of a selected drug with respect 

2 to which a payment is due under subsection (c) of 

3 such section 1193, the period beginning on the date 

4 on which the Secretary of Health and Human Serv5 ices certifies that such payment is overdue and end6 ing on the date that such payment is made in full. 

7 ‘‘(c) APPLICABLE PERCENTAGE.—For purposes of 

8 this section, the term ‘applicable percentage’ means— 

9 ‘‘(1) in the case of sales of a selected drug dur10 ing the first 90 days described in subsection (b) with 

11 respect to such drug, 65 percent, 

12 ‘‘(2) in the case of sales of such drug during 

13 the 91st day through the 180th day described in 

14 subsection (b) with respect to such drug, 75 percent, 

15 ‘‘(3) in the case of sales of such drug during 

16 the 181st day through the 270th day described in 

17 subsection (b) with respect to such drug, 85 percent, 

18 and 

19 ‘‘(4) in the case of sales of such drug during 

20 any subsequent day, 95 percent. 

21 ‘‘(d) SELECTED DRUG.—For purposes of this sec22 tion— 

23 ‘‘(1) IN GENERAL.—The term ‘selected drug’ 

24 means any selected drug (within the meaning of sec25 tion 1192 of the Social Security Act) which is manu-
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1 factured or produced in the United States or entered 

2 into the United States for consumption, use, or 

3 warehousing. 

4 ‘‘(2) UNITED STATES.—The term ‘United 

5 States’ has the meaning given such term by section 

6 4612(a)(4). 

7 ‘‘(3) COORDINATION WITH RULES FOR POSSES8 SIONS OF THE UNITED STATES.—Rules similar to 

9 the rules of paragraphs (2) and (4) of section 

10 4132(c) shall apply for purposes of this section. 

11 ‘‘(e) OTHER DEFINITIONS.—For purposes of this 

12 section, the terms ‘selected drug publication date’ and 

13 ‘maximum fair price’ have the meaning given such terms 

14 in section 1191 of the Social Security Act. 

15 ‘‘(f) ANTI-ABUSE RULE.—In the case of a sale which 

16 was timed for the purpose of avoiding the tax imposed by 

17 this section, the Secretary may treat such sale as occur18 ring during a day described in subsection (b).’’. 

19 (b) NO DEDUCTION FOR EXCISE TAX PAYMENTS.— 

20 Section 275 of the Internal Revenue Code of 1986 is 

21 amended by adding ‘‘or by section 4192’’ before the period 

22 at the end of subsection (a)(6). 

23 (c) CONFORMING AMENDMENTS.— 
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1 (1) Section 4221(a) of the Internal Revenue 

2 Code of 1986 is amended by inserting ‘‘or 4192’’ 

3 after ‘‘section 4191’’. 

4 (2) Section 6416(b)(2) of such Code is amend5 ed by inserting ‘‘or 4192’’ after ‘‘section 4191’’. 

6 (d) CLERICAL AMENDMENTS.— 

7 (1) The heading of subchapter E of chapter 32 

8 of the Internal Revenue Code of 1986 is amended by 

9 striking ‘‘Medical Devices’’ and inserting 

10 ‘‘Other Medical Products’’. 

11 (2) The table of subchapters for chapter 32 of 

12 such Code is amended by striking the item relating 

13 to subchapter E and inserting the following new 

14 item: 

‘‘SUBCHAPTER E. OTHER MEDICAL PRODUCTS’’. 

15 (3) The table of sections for subchapter E of 

16 chapter 32 of such Code is amended by adding at 

17 the end the following new item: 

‘‘Sec. 4192. Selected drugs during noncompliance periods.’’. 

18 (e) EFFECTIVE DATE.—The amendments made by 

19 this section shall apply to sales after the date of the enact20 ment of this Act. 

21 SEC. 103. FAIR PRICE NEGOTIATION IMPLEMENTATION 

22 FUND. 

23 (a) IN GENERAL.—There is hereby established a Fair 

24 Price Negotiation Implementation Fund (referred to in 
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1 this section as the ‘‘Fund’’). The Secretary of Health and 

2 Human Services may obligate and expend amounts in the 

3 Fund to carry out this title and titles II and III (and the 

4 amendments made by such titles). 

5 (b) FUNDING.—There is authorized to be appro6 priated, and there is hereby appropriated, out of any mon7 ies in the Treasury not otherwise appropriated, to the 

8 Fund $3,000,000,000, to remain available until expended, 

9 of which— 

10 (1) $600,000,000 shall become available on the 

11 date of the enactment of this Act; 

12 (2) $600,000,000 shall become available on Oc13 tober 1, 2020; 

14 (3) $600,000,000 shall become available on Oc15 tober 1, 2021; 

16 (4) $600,000,000 shall become available on Oc17 tober 1, 2022; and 

18 (5) $600,000,000 shall become available on Oc19 tober 1, 2023. 

20 (c) SUPPLEMENT NOT SUPPLANT.—Any amounts 

21 appropriated pursuant to this section shall be in addition 

22 to any other amounts otherwise appropriated pursuant to 

23 any other provision of law. 
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1 TITLE II—MEDICARE PARTS B 

2 AND D PRESCRIPTION DRUG 

3 INFLATION REBATES 

4 SEC. 201. MEDICARE PART B REBATE BY MANUFACTURERS. 

5 (a) IN GENERAL.—Section 1834 of the Social Secu6 rity Act (42 U.S.C. 1395m) is amended by adding at the 

7 end the following new subsection: 

8 ‘‘(x) REBATE BY MANUFACTURERS FOR SINGLE

9 SOURCE DRUGS WITH PRICES INCREASING FASTER

10 THAN INFLATION.— 

11 ‘‘(1) REQUIREMENTS.— 

12 ‘‘(A) SECRETARIAL PROVISION OF INFOR13 MATION.—Not later than 6 months after the 

14 end of each calendar quarter beginning on or 

15 after July 1, 2021, the Secretary shall, for each 

16 part B rebatable drug, report to each manufac17 turer of such part B rebatable drug the fol18 lowing for such calendar quarter: 

19 ‘‘(i) Information on the total number 

20 of units of the billing and payment code 

21 described in subparagraph (A)(i) of para22 graph (3) with respect to such drug and 

23 calendar quarter. 

24 ‘‘(ii) Information on the amount (if 

25 any) of the excess average sales price in-
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1 crease described in subparagraph (A)(ii) of 

2 such paragraph for such drug and calendar 

3 quarter. 

4 ‘‘(iii) The rebate amount specified 

5 under such paragraph for such part B 

6 rebatable drug and calendar quarter. 

7 ‘‘(B) MANUFACTURER REQUIREMENT.— 

8 For each calendar quarter beginning on or after 

9 July 1, 2021, the manufacturer of a part B 

10 rebatable drug shall, for such drug, not later 

11 than 30 days after the date of receipt from the 

12 Secretary of the information described in sub13 paragraph (A) for such calendar quarter, pro14 vide to the Secretary a rebate that is equal to 

15 the amount specified in paragraph (3) for such 

16 drug for such calendar quarter. 

17 ‘‘(2) PART B REBATABLE DRUG DEFINED.— 

18 ‘‘(A) IN GENERAL.—In this subsection, the 

19 term ‘part B rebatable drug’ means a single 

20 source drug or biological (as defined in sub21 paragraph (D) of section 1847A(c)(6)), includ22 ing a biosimilar biological product (as defined 

23 in subparagraph (H) of such section), paid for 

24 under this part, except such term shall not in25 clude such a drug or biological— 
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1 ‘‘(i) if the average total allowed 

2 charges for a year per individual that uses 

3 such a drug or biological, as determined by 

4 the Secretary, are less than, subject to 

5 subparagraph (B), $100; or 

6 ‘‘(ii) that is a vaccine described in 

7 subparagraph (A) or (B) of section 

8 1861(s)(10). 

9 ‘‘(B) INCREASE.—The dollar amount ap10 plied under subparagraph (A)(i)— 

11 ‘‘(i) for 2022, shall be the dollar 

12 amount specified under such subparagraph 

13 for 2021, increased by the percentage in14 crease in the consumer price index for all 

15 urban consumers (United States city aver16 age) for the 12 month period ending with 

17 June of the previous year; and 

18 ‘‘(ii) for a subsequent year, shall be 

19 the dollar amount specified in this clause 

20 (or clause (i)) for the previous year, in21 creased by the percentage increase in the 

22 consumer price index for all urban con23 sumers (United States city average) for 

24 the 12 month period ending with June of 

25 the previous year. 
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1 Any dollar amount specified under this sub2 paragraph that is not a multiple of $10 shall be 

3 rounded to the nearest multiple of $10. 

4 ‘‘(3) REBATE AMOUNT.— 

5 ‘‘(A) IN GENERAL.—For purposes of para6 graph (1), the amount specified in this para7 graph for a part B rebatable drug assigned to 

8 a billing and payment code for a calendar quar9 ter is, subject to paragraph (4), the amount 

10 equal to the product of— 

11 ‘‘(i) subject to subparagraphs (B) and 

12 (G), the total number of units of the bill13 ing and payment code for such part B 

14 rebatable drug furnished under this part 

15 during the calendar quarter; and 

16 ‘‘(ii) the amount (if any) by which— 

17 ‘‘(I) the payment amount under 

18 subparagraph (B) or (C) of section 

19 1847A(b)(1), as applicable, for such 

20 part B rebatable drug during the cal21 endar quarter; exceeds 

22 ‘‘(II) the inflation-adjusted pay23 ment amount determined under sub24 paragraph (C) for such part B 
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1 rebatable drug during the calendar 

2 quarter. 

3 ‘‘(B) EXCLUDED UNITS.—For purposes of 

4 subparagraph (A)(i), the total number of units 

5 of the billing and payment code for each part 

6 B rebatable drug furnished during a calendar 

7 quarter shall not include— 

8 ‘‘(i) units packaged into the payment 

9 for a procedure or service under section 

10 1833(t) or under section 1833(i) (instead 

11 of separately payable under such respective 

12 section); 

13 ‘‘(ii) units included under the single 

14 payment system for renal dialysis services 

15 under section 1881(b)(14); or 

16 ‘‘(iii) units of a part B rebatable drug 

17 of a manufacturer furnished to an indi18 vidual, if such manufacturer, with respect 

19 to the furnishing of such units of such 

20 drug, provides for discounts under section 

21 340B of the Public Health Service Act or 

22 for rebates under section 1927. 

23 ‘‘(C) DETERMINATION OF INFLATION-AD24 JUSTED PAYMENT AMOUNT.—The inflation-ad25 justed payment amount determined under this 
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1 subparagraph for a part B rebatable drug for 

2 a calendar quarter is— 

3 ‘‘(i) the payment amount for the bill4 ing and payment code for such drug in the 

5 payment amount benchmark quarter (as 

6 defined in subparagraph (D)); increased by 

7 ‘‘(ii) the percentage by which the re8 bate period CPI–U (as defined in subpara9 graph (F)) for the calendar quarter ex10 ceeds the benchmark period CPI–U (as de11 fined in subparagraph (E)). 

12 ‘‘(D) PAYMENT AMOUNT BENCHMARK

13 QUARTER.—The term ‘payment amount bench14 mark quarter’ means the calendar quarter be15 ginning January 1, 2016. 

16 ‘‘(E) BENCHMARK PERIOD CPI–U.—The 

17 term ‘benchmark period CPI–U’ means the con18 sumer price index for all urban consumers 

19 (United States city average) for July 2015. 

20 ‘‘(F) REBATE PERIOD CPI–U.—The term 

21 ‘rebate period CPI–U’ means, with respect to a 

22 calendar quarter described in subparagraph 

23 (C), the greater of the benchmark period CPI– 

24 U and the consumer price index for all urban 

25 consumers (United States city average) for the 
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1 first month of the calendar quarter that is two 

2 calendar quarters prior to such described cal3 endar quarter. 

4 ‘‘(G) COUNTING UNITS.— 

5 ‘‘(i) CUT-OFF PERIOD TO COUNT

6 UNITS.—For purposes of subparagraph 

7 (A)(i), subject to clause (ii), to count the 

8 total number of billing units for a part B 

9 rebatable drug for a quarter, the Secretary 

10 may use a cut-off period in order to ex11 clude from such total number of billing 

12 units for such quarter claims for services 

13 furnished during such quarter that were 

14 not processed at an appropriate time prior 

15 to the end of the cut-off period. 

16 ‘‘(ii) COUNTING UNITS FOR CLAIMS

17 PROCESSED AFTER CUT-OFF PERIOD.—If 

18 the Secretary uses a cut-off period pursu19 ant to clause (i), in the case of units of a 

20 part B rebatable drug furnished during a 

21 quarter but pursuant to application of such 

22 cut-off period excluded for purposes of sub23 paragraph (A)(i) from the total number of 

24 billing units for the drug for such quarter, 

25 the Secretary shall count such units of 
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1 such drug so furnished in the total number 

2 of billing units for such drug for a subse3 quent quarter, as the Secretary determines 

4 appropriate. 

5 ‘‘(4) SPECIAL TREATMENT OF CERTAIN DRUGS

6 AND EXEMPTION.— 

7 ‘‘(A) SUBSEQUENTLY APPROVED DRUGS.— 

8 Subject to subparagraph (B), in the case of a 

9 part B rebatable drug first approved or licensed 

10 by the Food and Drug Administration after 

11 July 1, 2015, clause (i) of paragraph (3)(C) 

12 shall be applied as if the term ‘payment amount 

13 benchmark quarter’ were defined under para14 graph (3)(D) as the third full calendar quarter 

15 after the day on which the drug was first mar16 keted and clause (ii) of paragraph (3)(C) shall 

17 be applied as if the term ‘benchmark period 

18 CPI–U’ were defined under paragraph (3)(E) 

19 as if the reference to ‘July 2015’ under such 

20 paragraph were a reference to ‘the first month 

21 of the first full calendar quarter after the day 

22 on which the drug was first marketed’. 

23 ‘‘(B) TIMELINE FOR PROVISION OF RE24 BATES FOR SUBSEQUENTLY APPROVED

25 DRUGS.—In the case of a part B rebatable drug 
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1 first approved or licensed by the Food and 

2 Drug Administration after July 1, 2015, para3 graph (1)(B) shall be applied as if the reference 

4 to ‘July 1, 2021’ under such paragraph were a 

5 reference to the later of the 6th full calendar 

6 quarter after the day on which the drug was 

7 first marketed or July 1, 2021. 

8 ‘‘(C) EXEMPTION FOR SHORTAGES.—The 

9 Secretary may reduce or waive the rebate 

10 amount under paragraph (1)(B) with respect to 

11 a part B rebatable drug that is described as 

12 currently in shortage on the shortage list in ef13 fect under section 506E of the Federal Food, 

14 Drug, and Cosmetic Act or in the case of other 

15 exigent circumstances, as determined by the 

16 Secretary. 

17 ‘‘(D) SELECTED DRUGS.—In the case of a 

18 part B rebatable drug that is a selected drug 

19 (as defined in section 1192(c)) for a price appli20 cability period (as defined in section 

21 1191(b)(2))— 

22 ‘‘(i) for calendar quarters during such 

23 period for which a maximum fair price (as 

24 defined in section 1191(c)(2)) for such 

25 drug has been determined and is applied 
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1 under part E of title XI, the rebate 

2 amount under paragraph (1)(B) shall be 

3 waived; and 

4 ‘‘(ii) in the case such drug is deter5 mined (pursuant to such section 1192(c)) 

6 to no longer be a selected drug, for each 

7 applicable year beginning after the price 

8 applicability period with respect to such 

9 drug, clause (i) of paragraph (3)(C) shall 

10 be applied as if the term ‘payment amount 

11 benchmark quarter’ were defined under 

12 paragraph (3)(D) as the calendar quarter 

13 beginning January 1 of the last year be14 ginning during such price applicability pe15 riod with respect to such selected drug and 

16 clause (ii) of paragraph (3)(C) shall be ap17 plied as if the term ‘benchmark period 

18 CPI–U’ were defined under paragraph 

19 (3)(E) as if the reference to ‘July 2015’ 

20 under such paragraph were a reference to 

21 the July of the year preceding such last 

22 year. 

23 ‘‘(5) APPLICATION TO BENEFICIARY COINSUR24 ANCE.—In the case of a part B rebatable drug, if 
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1 the payment amount for a quarter exceeds the infla2 tion adjusted payment for such quarter— 

3 ‘‘(A) in computing the amount of any coin4 surance applicable under this title to an indi5 vidual with respect to such drug, the computa6 tion of such coinsurance shall be based on the 

7 inflation-adjusted payment amount determined 

8 under paragraph (3)(C) for such part B 

9 rebatable drug; and 

10 ‘‘(B) the amount of such coinsurance is 

11 equal to 20 percent of such inflation-adjusted 

12 payment amount so determined. 

13 ‘‘(6) REBATE DEPOSITS.—Amounts paid as re14 bates under paragraph (1)(B) shall be deposited into 

15 the Federal Supplementary Medical Insurance Trust 

16 Fund established under section 1841. 

17 ‘‘(7) CIVIL MONEY PENALTY.—If a manufac18 turer of a part B rebatable drug has failed to com19 ply with the requirements under paragraph (1)(B) 

20 for such drug for a calendar quarter, the manufac21 turer shall be subject to, in accordance with a proc22 ess established by the Secretary pursuant to regula23 tions, a civil money penalty in an amount equal to 

24 at least 125 percent of the amount specified in para25 graph (3) for such drug for such calendar quarter. 
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1 The provisions of section 1128A (other than sub2 sections (a) (with respect to amounts of penalties or 

3 additional assessments) and (b)) shall apply to a 

4 civil money penalty under this paragraph in the 

5 same manner as such provisions apply to a penalty 

6 or proceeding under section 1128A(a). 

7 ‘‘(8) STUDY AND REPORT.— 

8 ‘‘(A) STUDY.—The Secretary shall conduct 

9 a study of the feasibility of and operational 

10 issues involved with the following: 

11 ‘‘(i) Including multiple source drugs 

12 (as defined in section 1847A(c)(6)(C)) in 

13 the rebate system under this subsection. 

14 ‘‘(ii) Including drugs and biologicals 

15 paid for under MA plans under part C in 

16 the rebate system under this subsection. 

17 ‘‘(iii) Including drugs excluded under 

18 paragraph (2)(A) and units of the billing 

19 and payment code of the drugs excluded 

20 under paragraph (3)(B) in the rebate sys21 tem under this subsection. 

22 ‘‘(B) REPORT.—Not later than 3 years 

23 after the date of the enactment of this sub24 section, the Secretary shall submit to Congress 
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1 a report on the study conducted under subpara2 graph (A). 

3 ‘‘(9) APPLICATION TO MULTIPLE SOURCE

4 DRUGS.—The Secretary may, based on the report 

5 submitted under paragraph (8) and pursuant to 

6 rulemaking, apply the provisions of this subsection 

7 to multiple source drugs (as defined in section 

8 1847A(c)(6)(C)), including, for purposes of deter9 mining the rebate amount under paragraph (3), by 

10 calculating manufacturer-specific average sales 

11 prices for the benchmark period and the rebate pe12 riod.’’. 

13 (b) AMOUNTS PAYABLE; COST-SHARING.—Section 

14 1833 of the Social Security Act (42 U.S.C. 1395l) is 

15 amended— 

16 (1) in subsection (a)— 

17 (A) in paragraph (1)— 

18 (i) in subparagraph (S), by striking 

19 ‘‘with respect to’’ and inserting ‘‘subject to 

20 subparagraph (DD), with respect to’’; 

21 (ii) by striking ‘‘and (CC)’’ and in22 serting ‘‘(CC)’’; and 

23 (iii) by inserting before the semicolon 

24 at the end the following: ‘‘, and (DD) with 

25 respect to a part B rebatable drug (as de-
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1 fined in paragraph (2) of section 1834(x)) 

2 for which the payment amount for a cal3 endar quarter under paragraph 

4 (3)(A)(ii)(I) of such section for such quar5 ter exceeds the inflation-adjusted payment 

6 under paragraph (3)(A)(ii)(II) of such sec7 tion for such quarter, the amounts paid 

8 shall be the difference between (i) the pay9 ment amount under paragraph 

10 (3)(A)(ii)(I) of such section for such drug, 

11 and (ii) 20 percent of the inflation-ad12 justed payment amount under paragraph 

13 (3)(A)(ii)(II) of such section for such 

14 drug’’; 

15 (B) by adding at the end of the flush left 

16 matter following paragraph (9), the following: 

17 ‘‘For purposes of applying paragraph (1)(DD), sub18 sections (i)(9) and (t)(8)(F), and section 1834(x)(5), the 

19 Secretary shall make such estimates and use such data 

20 as the Secretary determines appropriate, and notwith21 standing any other provision of law, may do so by program 

22 instruction or otherwise.’’; 

23 (2) in subsection (i), by adding at the end the 

24 following new paragraph: 
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1 ‘‘(9) In the case of a part B rebatable drug (as de2 fined in paragraph (2) of section 1834(x)) for which pay3 ment under this subsection is not packaged into a payment 

4 for a covered OPD service (as defined in subsection 

5 (t)(1)(B)) (or group of services) furnished on or after July 

6 1, 2021, under the system under this subsection, in lieu 

7 of calculation of coinsurance and the amount of payment 

8 otherwise applicable under this subsection, the provisions 

9 of section 1834(x)(5), paragraph (1)(DD) of subsection 

10 (a), and the flush left matter following paragraph (9) of 

11 subsection (a), shall, as determined appropriate by the 

12 Secretary, apply under this subsection in the same manner 

13 as such provisions of section 1834(x)(5) and subsection 

14 (a) apply under such section and subsection.’’; and 

15 (3) in subsection (t)(8), by adding at the end 

16 the following new subparagraph: 

17 ‘‘(F) PART B REBATABLE DRUGS.—In the 

18 case of a part B rebatable drug (as defined in 

19 paragraph (2) of section 1834(x)) for which 

20 payment under this part is not packaged into a 

21 payment for a service furnished on or after July 

22 1, 2021, under the system under this sub23 section, in lieu of calculation of coinsurance and 

24 the amount of payment otherwise applicable 

25 under this subsection, the provisions of section 
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1 1834(x)(5), paragraph (1)(DD) of subsection 

2 (a), and the flush left matter following para3 graph (9) of subsection (a), shall, as determined 

4 appropriate by the Secretary, apply under this 

5 subsection in the same manner as such provi6 sions of section 1834(x)(5) and subsection (a) 

7 apply under such section and subsection.’’. 

8 (c) CONFORMING AMENDMENTS.— 

9 (1) TO PART B ASP CALCULATION.—Section 

10 1847A(c)(3) of the Social Security Act (42 U.S.C. 

11 1395w–3a(c)(3)) is amended by inserting ‘‘or section 

12 1834(x)’’ after ‘‘section 1927’’. 

13 (2) EXCLUDING PARTS B DRUG INFLATION RE14 BATE FROM BEST PRICE.—Section 

15 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 

16 U.S.C. 1396r–8(c)(1)(C)(ii)(I)) is amended by in17 serting ‘‘or section 1834(x)’’ after ‘‘this section’’. 

18 (3) COORDINATION WITH MEDICAID REBATE IN19 FORMATION DISCLOSURE.—Section 1927(b)(3)(D)(i) 

20 of the Social Security Act (42 U.S.C. 1396r– 

21 8(b)(3)(D)(i)) is amended by striking ‘‘or to carry 

22 out section 1847B’’ and inserting ‘‘to carry out sec23 tion 1847B or section 1834(x)’’. 
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1 SEC. 202. MEDICARE PART D REBATE BY MANUFACTURERS. 

2 (a) IN GENERAL.—Part D of title XVIII of the Social 

3 Security Act is amended by inserting after section 1860D– 

4 14A (42 U.S.C. 1395w–114a) the following new section: 

5 ‘‘SEC. 1860D–14B. MANUFACTURER REBATE FOR CERTAIN 

6 DRUGS WITH PRICES INCREASING FASTER 

7 THAN INFLATION. 

8 ‘‘(a) IN GENERAL.— 

9 ‘‘(1) IN GENERAL.—Subject to the provisions of 

10 this section, in order for coverage to be available 

11 under this part for a part D rebatable drug (as de12 fined in subsection (h)(1)) of a manufacturer (as de13 fined in section 1927(k)(5)) dispensed during an ap14 plicable year, the manufacturer must have entered 

15 into and have in effect an agreement described in 

16 subsection (b). 

17 ‘‘(2) AUTHORIZING COVERAGE FOR DRUGS NOT

18 COVERED UNDER AGREEMENTS.—Paragraph (1) 

19 shall not apply to the dispensing of a covered part 

20 D drug if— 

21 ‘‘(A) the Secretary has made a determina22 tion that the availability of the drug is essential 

23 to the health of beneficiaries under this part; or 

24 ‘‘(B) the Secretary determines that in the 

25 period beginning on January 1, 2022, and end-
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1 ing on December 31, 2022, there were extenu2 ating circumstances. 

3 ‘‘(3) APPLICABLE YEAR.—For purposes of this 

4 section the term ‘applicable year’ means a year be5 ginning with 2022. 

6 ‘‘(b) AGREEMENTS.— 

7 ‘‘(1) TERMS OF AGREEMENT.—An agreement 

8 described in this subsection, with respect to a manu9 facturer of a part D rebatable drug, is an agreement 

10 under which the following shall apply: 

11 ‘‘(A) SECRETARIAL PROVISION OF INFOR12 MATION.—Not later than 9 months after the 

13 end of each applicable year with respect to 

14 which the agreement is in effect, the Secretary, 

15 for each part D rebatable drug of the manufac16 turer, shall report to the manufacturer the fol17 lowing for such year: 

18 ‘‘(i) Information on the total number 

19 of units (as defined in subsection (h)(2)) 

20 for each dosage form and strength with re21 spect to such part D rebatable drug and 

22 year. 

23 ‘‘(ii) Information on the amount (if 

24 any) of the excess average manufacturer 

25 price increase described in subsection 
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1 (c)(1)(B) for each dosage form and 

2 strength with respect to such drug and 

3 year. 

4 ‘‘(iii) The rebate amount specified 

5 under subsection (c) for each dosage form 

6 and strength with respect to such drug and 

7 year. 

8 ‘‘(B) MANUFACTURER REQUIREMENTS.— 

9 For each applicable year with respect to which 

10 the agreement is in effect, the manufacturer of 

11 the part D rebatable drug, for each dosage 

12 form and strength with respect to such drug, 

13 not later than 30 days after the date of receipt 

14 from the Secretary of the information described 

15 in subparagraph (A) for such year, shall pro16 vide to the Secretary a rebate that is equal to 

17 the amount specified in subsection (c) for such 

18 dosage form and strength with respect to such 

19 drug for such year. 

20 ‘‘(2) LENGTH OF AGREEMENT.— 

21 ‘‘(A) IN GENERAL.—An agreement under 

22 this section, with respect to a part D rebatable 

23 drug, shall be effective for an initial period of 

24 not less than one year and shall be automati25 cally renewed for a period of not less than one 
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1 year unless terminated under subparagraph 

2 (B). 

3 ‘‘(B) TERMINATION.— 

4 ‘‘(i) BY SECRETARY.—The Secretary 

5 may provide for termination of an agree6 ment under this section for violation of the 

7 requirements of the agreement or other 

8 good cause shown. Such termination shall 

9 not be effective earlier than 30 days after 

10 the date of notice of such termination. The 

11 Secretary shall provide, upon request, a 

12 manufacturer with a hearing concerning 

13 such a termination, but such hearing shall 

14 not delay the effective date of the termi15 nation. 

16 ‘‘(ii) BY A MANUFACTURER.—A man17 ufacturer may terminate an agreement 

18 under this section for any reason. Any 

19 such termination shall be effective, with re20 spect to a plan year— 

21 ‘‘(I) if the termination occurs be22 fore January 30 of the plan year, as 

23 of the day after the end of the plan 

24 year; and 
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1 ‘‘(II) if the termination occurs on 

2 or after January 30 of the plan year, 

3 as of the day after the end of the suc4 ceeding plan year. 

5 ‘‘(C) EFFECTIVENESS OF TERMINATION.— 

6 Any termination under this paragraph shall not 

7 affect rebates due under the agreement under 

8 this section before the effective date of its ter9 mination. 

10 ‘‘(D) DELAY BEFORE REENTRY.—In the 

11 case of any agreement under this section with 

12 a manufacturer that is terminated in a plan 

13 year, the Secretary may not enter into another 

14 such agreement with the manufacturer (or a 

15 successor manufacturer) before the subsequent 

16 plan year, unless the Secretary finds good cause 

17 for an earlier reinstatement of such an agree18 ment. 

19 ‘‘(c) REBATE AMOUNT.— 

20 ‘‘(1) IN GENERAL.—For purposes of this sec21 tion, the amount specified in this subsection for a 

22 dosage form and strength with respect to a part D 

23 rebatable drug and applicable year is, subject to sub24 paragraphs (B) and (C) of paragraph (5), the 

25 amount equal to the product of— 
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1 ‘‘(A) the total number of units of such dos2 age form and strength with respect to such part 

3 D rebatable drug and year; and 

4 ‘‘(B) the amount (if any) by which— 

5 ‘‘(i) the annual manufacturer price 

6 (as determined in paragraph (2)) paid for 

7 such dosage form and strength with re8 spect to such part D rebatable drug for the 

9 year; exceeds 

10 ‘‘(ii) the inflation-adjusted payment 

11 amount determined under paragraph (3) 

12 for such dosage form and strength with re13 spect to such part D rebatable drug for the 

14 year. 

15 ‘‘(2) DETERMINATION OF ANNUAL MANUFAC16 TURER PRICE.—The annual manufacturer price de17 termined under this paragraph for a dosage form 

18 and strength, with respect to a part D rebatable 

19 drug and an applicable year, is the sum of the prod20 ucts of— 

21 ‘‘(A) the average manufacturer price (as 

22 defined in subsection (h)(6)) of such dosage 

23 form and strength, as calculated for a unit of 

24 such drug, with respect to each of the calendar 

25 quarters of such year; and 
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1 ‘‘(B) the ratio of— 

2 ‘‘(i) the total number of units of such 

3 dosage form and strength dispensed during 

4 each such calendar quarter of such year; to 

5 ‘‘(ii) the total number of units of such 

6 dosage form and strength dispensed during 

7 such year. 

8 ‘‘(3) DETERMINATION OF INFLATION-ADJUSTED

9 PAYMENT AMOUNT.—The inflation-adjusted payment 

10 amount determined under this paragraph for a dos11 age form and strength with respect to a part D 

12 rebatable drug for an applicable year, subject to sub13 paragraphs (A) and (D) of paragraph (5), is— 

14 ‘‘(A) the benchmark year manufacturer 

15 price determined under paragraph (4) for such 

16 dosage form and strength with respect to such 

17 drug and an applicable year; increased by 

18 ‘‘(B) the percentage by which the applica19 ble year CPI–U (as defined in subsection 

20 (h)(5)) for the applicable year exceeds the 

21 benchmark period CPI–U (as defined in sub22 section (h)(4)). 

23 ‘‘(4) DETERMINATION OF BENCHMARK YEAR

24 MANUFACTURER PRICE.—The benchmark year man25 ufacturer price determined under this paragraph for 
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1 a dosage form and strength, with respect to a part 

2 D rebatable drug and an applicable year, is the sum 

3 of the products of— 

4 ‘‘(A) the average manufacturer price (as 

5 defined in subsection (h)(6)) of such dosage 

6 form and strength, as calculated for a unit of 

7 such drug, with respect to each of the calendar 

8 quarters of the payment amount benchmark 

9 year (as defined in subsection (h)(3)); and 

10 ‘‘(B) the ratio of— 

11 ‘‘(i) the total number of units of such 

12 dosage form and strength dispensed during 

13 each such calendar quarter of such pay14 ment amount benchmark year; to 

15 ‘‘(ii) the total number of units of such 

16 dosage form and strength dispensed during 

17 such payment amount benchmark year. 

18 ‘‘(5) SPECIAL TREATMENT OF CERTAIN DRUGS

19 AND EXEMPTION.— 

20 ‘‘(A) SUBSEQUENTLY APPROVED DRUGS.— 

21 In the case of a part D rebatable drug first ap22 proved or licensed by the Food and Drug Ad23 ministration after January 1, 2016, subpara24 graphs (A) and (B) of paragraph (4) shall be 

25 applied as if the term ‘payment amount bench-
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1 mark year’ were defined under subsection 

2 (h)(3) as the first calendar year beginning after 

3 the day on which the drug was first marketed 

4 by any manufacturer and subparagraph (B) of 

5 paragraph (3) shall be applied as if the term 

6 ‘benchmark period CPI–U’ were defined under 

7 subsection (h)(4) as if the reference to ‘January 

8 2016’ under such subsection were a reference to 

9 ‘January of the first year beginning after the 

10 date on which the drug was first marketed by 

11 any manufacturer’. 

12 ‘‘(B) EXEMPTION FOR SHORTAGES.—The 

13 Secretary may reduce or waive the rebate under 

14 paragraph (1) with respect to a part D 

15 rebatable drug that is described as currently in 

16 shortage on the shortage list in effect under 

17 section 506E of the Federal Food, Drug, and 

18 Cosmetic Act or in the case of other exigent cir19 cumstances, as determined by the Secretary. 

20 ‘‘(C) TREATMENT OF NEW FORMULA21 TIONS.— 

22 ‘‘(i) IN GENERAL.—In the case of a 

23 part D rebatable drug that is a line exten24 sion of a part D rebatable drug that is an 

25 oral solid dosage form, the Secretary shall 
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1 establish a formula for determining the 

2 amount specified in this subsection with 

3 respect to such part D rebatable drug and 

4 an applicable year with consideration of 

5 the original part D rebatable drug. 

6 ‘‘(ii) LINE EXTENSION DEFINED.—In 

7 this subparagraph, the term ‘line exten8 sion’ means, with respect to a part D 

9 rebatable drug, a new formulation of the 

10 drug (as determined by the Secretary), 

11 such as an extended release formulation, 

12 but does not include an abuse-deterrent 

13 formulation of the drug (as determined by 

14 the Secretary), regardless of whether such 

15 abuse-deterrent formulation is an extended 

16 release formulation. 

17 ‘‘(D) SELECTED DRUGS.—In the case of a 

18 part D rebatable drug that is a selected drug 

19 (as defined in section 1192(c)) for a price appli20 cability period (as defined in section 

21 1191(b)(2))— 

22 ‘‘(i) for plan years during such period 

23 for which a maximum fair price (as defined 

24 in section 1191(c)(2)) for such drug has 

25 been determined and is applied under part 
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1 E of title XI, the rebate under subsection 

2 (b)(1)(B) shall be waived; and 

3 ‘‘(ii) in the case such drug is deter4 mined (pursuant to such section 1192(c)) 

5 to no longer be a selected drug, for each 

6 applicable year beginning after the price 

7 applicability period with respect to such 

8 drug, subparagraphs (A) and (B) of para9 graph (4) shall be applied as if the term 

10 ‘payment amount benchmark year’ were 

11 defined under subsection (h)(3) as the last 

12 year beginning during such price applica13 bility period with respect to such selected 

14 drug and subparagraph (B) of paragraph 

15 (3) shall be applied as if the term ‘bench16 mark period CPI–U’ were defined under 

17 subsection (h)(4) as if the reference to 

18 ‘January 2016’ under such subsection were 

19 a reference to January of the last year be20 ginning during such price applicability pe21 riod with respect to such drug. 

22 ‘‘(d) REBATE DEPOSITS.—Amounts paid as rebates 

23 under subsection (c) shall be deposited into the Medicare 

24 Prescription Drug Account in the Federal Supplementary 
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1 Medical Insurance Trust Fund established under section 

2 1841. 

3 ‘‘(e) INFORMATION.—For purposes of carrying out 

4 this section, the Secretary shall use information submitted 

5 by manufacturers under section 1927(b)(3). 

6 ‘‘(f) CIVIL MONEY PENALTY.—In the case of a man7 ufacturer of a part D rebatable drug with an agreement 

8 in effect under this section who has failed to comply with 

9 the terms of the agreement under subsection (b)(1)(B) 

10 with respect to such drug for an applicable year, the Sec11 retary may impose a civil money penalty on such manufac12 turer in an amount equal to 125 percent of the amount 

13 specified in subsection (c) for such drug for such year. 

14 The provisions of section 1128A (other than subsections 

15 (a) (with respect to amounts of penalties or additional as16 sessments) and (b)) shall apply to a civil money penalty 

17 under this subsection in the same manner as such provi18 sions apply to a penalty or proceeding under section 

19 1128A(a). 

20 ‘‘(g) JUDICIAL REVIEW.—There shall be no judicial 

21 review of the following: 

22 ‘‘(1) The determination of units under this sec23 tion. 

24 ‘‘(2) The determination of whether a drug is a 

25 part D rebatable drug under this section. 
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1 ‘‘(3) The calculation of the rebate amount 

2 under this section. 

3 ‘‘(h) DEFINITIONS.—In this section: 

4 ‘‘(1) PART D REBATABLE DRUG DEFINED.— 

5 ‘‘(A) IN GENERAL.—The term ‘part D 

6 rebatable drug’ means a drug or biological that 

7 would (without application of this section) be a 

8 covered part D drug, except such term shall, 

9 with respect to an applicable year, not include 

10 such a drug or biological if the average annual 

11 total cost under this part for such year per in12 dividual who uses such a drug or biological, as 

13 determined by the Secretary, is less than, sub14 ject to subparagraph (B), $100, as determined 

15 by the Secretary using the most recent data 

16 available or, if data is not available, as esti17 mated by the Secretary. 

18 ‘‘(B) INCREASE.—The dollar amount ap19 plied under subparagraph (A)— 

20 ‘‘(i) for 2023, shall be the dollar 

21 amount specified under such subparagraph 

22 for 2022, increased by the percentage in23 crease in the consumer price index for all 

24 urban consumers (United States city aver-
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1 age) for the 12-month period beginning 

2 with January of 2022; and 

3 ‘‘(ii) for a subsequent year, shall be 

4 the dollar amount specified in this sub5 paragraph for the previous year, increased 

6 by the percentage increase in the consumer 

7 price index for all urban consumers 

8 (United States city average) for the 12- 

9 month period beginning with January of 

10 the previous year. 

11 Any dollar amount specified under this sub12 paragraph that is not a multiple of $10 shall be 

13 rounded to the nearest multiple of $10. 

14 ‘‘(2) UNIT DEFINED.—The term ‘unit’ means, 

15 with respect to a part D rebatable drug, the lowest 

16 identifiable quantity (such as a capsule or tablet, 

17 milligram of molecules, or grams) of the part D 

18 rebatable drug that is dispensed to individuals under 

19 this part. 

20 ‘‘(3) PAYMENT AMOUNT BENCHMARK YEAR.— 

21 The term ‘payment amount benchmark year’ means 

22 the year beginning January 1, 2016. 

23 ‘‘(4) BENCHMARK PERIOD CPI–U.—The term 

24 ‘benchmark period CPI–U’ means the consumer 
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1 price index for all urban consumers (United States 

2 city average) for January 2016. 

3 ‘‘(5) APPLICABLE YEAR CPI–U.—The term ‘ap4 plicable year CPI–U’ means, with respect to an ap5 plicable year, the consumer price index for all urban 

6 consumers (United States city average) for January 

7 of such year. 

8 ‘‘(6) AVERAGE MANUFACTURER PRICE.—The 

9 term ‘average manufacturer price’ has the meaning, 

10 with respect to a part D rebatable drug of a manu11 facturer, given such term in section 1927(k)(1), with 

12 respect to a covered outpatient drug of a manufac13 turer for a rebate period under section 1927.’’. 

14 (b) CONFORMING AMENDMENTS.— 

15 (1) TO PART B ASP CALCULATION.—Section 

16 1847A(c)(3) of the Social Security Act (42 U.S.C. 

17 1395w–3a(c)(3)), as amended by section 201(c)(1), 

18 is further amended by striking ‘‘section 1927 or sec19 tion 1834(x)’’ and inserting ‘‘section 1927, section 

20 1834(x), or section 1860D–14B’’. 

21 (2) EXCLUDING PART D DRUG INFLATION RE22 BATE FROM BEST PRICE.—Section 

23 1927(c)(1)(C)(ii)(I) of the Social Security Act (42 

24 U.S.C. 1396r–8(c)(1)(C)(ii)(I)), as amended by sec25 tion 201(c)(2), is further amended by striking ‘‘or 
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1 section 1834(x)’’ and inserting ‘‘, section 1834(x), or 

2 section 1860D–14B’’. 

3 (3) COORDINATION WITH MEDICAID REBATE IN4 FORMATION DISCLOSURE.—Section 1927(b)(3)(D)(i) 

5 of the Social Security Act (42 U.S.C. 1396r– 

6 8(b)(3)(D)(i)), as amended by section 201(c)(3), is 

7 further amended by striking ‘‘or section 1834(x)’’ 

8 and inserting ‘‘, section 1834(x), or section 1860D– 

9 14B’’. 

10 SEC. 203. PROVISION REGARDING INFLATION REBATES 

11 FOR GROUP HEALTH PLANS AND GROUP 

12 HEALTH INSURANCE COVERAGE. 

13 (a) IN GENERAL.—Not later than December 31, 

14 2021, the Secretary of Labor, in consultation with the 

15 Secretary of Health and Human Services and the Sec16 retary of the Treasury, shall submit to Congress a report 

17 on— 

18 (1) potential models for an agreement process 

19 with manufacturers of prescription drugs under 

20 which such manufacturers provide for inflation re21 bates with respect to such drugs that are furnished 

22 or dispensed to participants and beneficiaries of 

23 group health plans and health insurance coverage of24 fered in the group market in a manner similar to 

25 how manufacturers provide for rebates under section 
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1 1834(x) of the Social Security Act, as added by sec2 tion 201, and section 1860D–14B of such Act, as 

3 added by section 202, with respect to prescription 

4 drugs that are furnished or dispensed under part B 

5 of title XVIII of such Act and part D of such title, 

6 respectively; and 

7 (2) potential models for enforcement mecha8 nisms with respect to such an agreement process 

9 that ensure that such inflation rebates are propor10 tionally distributed, with respect to costs, to group 

11 health plans and health insurance issuers offering 

12 health insurance coverage in the group market, to 

13 participants and beneficiaries of such plans and cov14 erage, or to both. 

15 (b) REGULATIONS.—Not later than December 31, 

16 2022, the Secretary of Labor shall, in consultation with 

17 the Secretary of Health and Human Services and the Sec18 retary of the Treasury, promulgate regulations to imple19 ment a model described in subsection (a)(1) and a model 

20 described in subsection (a)(2), if the Secretary determines 

21 that— 

22 (1) the prices of a sufficient number (as deter23 mined by the Secretary) of drugs described in sub24 section (a)(1) have increased over a period of time 

25 (as determined by the Secretary) at a percentage 
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1 that exceeds the percentage by which the consumer 

2 price index for all urban consumers (United States 

3 city average) has increased over such period; and 

4 (2) such model described in subsection (a)(1) 

5 and such model described in subsection (a)(2) are 

6 feasible. 

7 SEC. 204. ANNUAL REPORT ON DRUG COSTS IN GROUP 

8 HEALTH PLANS AND GROUP HEALTH INSUR9 ANCE COVERAGE. 

10 (a) INITIAL REPORT.—Not later than December 31, 

11 2021, the Secretary of Labor shall, in consultation with 

12 the Secretary of Health and Human Services and the Sec13 retary of the Treasury, submit to Congress a report, with 

14 respect to a period (as determined by the Secretary of 

15 Labor), on— 

16 (1) whether the prices of prescription drugs 

17 that are furnished or dispensed to participants and 

18 beneficiaries of group health plans and health insur19 ance coverage offered in the group market during 

20 such period have increased at a percentage that ex21 ceeds the percentage by which the consumer price 

22 index for all urban consumers (United States city 

23 average) increased for such period; and 

24 (2) whether there are mechanisms by which 

25 manufacturers of prescription drugs have attempted 
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1 to recover rebate payments required of such manu2 facturers under section 1834(x) of the Social Secu3 rity Act, as added by section 201, and section 

4 1860D–14B of such Act, as added by section 202, 

5 with respect to prescription drugs that are furnished 

6 or dispensed under part B of title XVIII of such Act 

7 and part D of such title, respectively, through in8 creased prices charged with respect to drugs that are 

9 furnished or dispensed to participants and bene10 ficiaries of group health plans and health insurance 

11 coverage offered in the group market during such 

12 period. 

13 (b) ANNUAL REPORT.—Not later than December 31 

14 of each year following 2021, the Secretary of Labor shall, 

15 in consultation with the Secretary of Health and Human 

16 Services and the Secretary of the Treasury, submit to 

17 Congress a report updating the information and analysis 

18 included in the report required under subsection (a), re19 flecting, in part, new price and cost information and data 

20 for the 12-month period after the period on which the 

21 prior year’s report was based. 

22 SEC. 205. COLLECTION OF DATA. 

23 (a) MANUFACTURERS OF PRESCRIPTION DRUGS.— 

24 Manufacturers of prescription drugs shall submit to the 

25 Secretary of Health and Human Services, Secretary of 
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1 Labor, and the Secretary of the Treasury appropriate data 

2 as necessary for the Secretaries to obtain information 

3 needed to provide the reports under sections 203 and 204. 

4 (b) GROUP HEALTH PLANS AND HEALTH INSUR5 ANCE ISSUERS OFFERING HEALTH INSURANCE COV6 ERAGE IN THE GROUP MARKET.—Group health plans and 

7 health insurance issuers offering health insurance cov8 erage in the group market shall submit to the Secretary 

9 of Health and Human Services, Secretary of Labor, and 

10 the Secretary of the Treasury appropriate data as nec11 essary for the Secretaries to obtain information needed to 

12 provide the reports under sections 203 and 204. 

13 TITLE III—PART D IMPROVE14 MENTS AND MAXIMUM OUT15 OF-POCKET CAP FOR MEDI16 CARE BENEFICIARIES 

17 SEC. 301. MEDICARE PART D BENEFIT REDESIGN. 

18 (a) BENEFIT STRUCTURE REDESIGN.—Section 

19 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w– 

20 102(b)) is amended— 

21 (1) in paragraph (2)— 

22 (A) in subparagraph (A), in the matter 

23 preceding clause (i), by inserting ‘‘for a year 

24 preceding 2022 and for costs above the annual 

25 deductible specified in paragraph (1) and up to 
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1 the annual out-of-pocket threshold specified in 

2 paragraph (4)(B) for 2022 and each subsequent 

3 year’’ after ‘‘paragraph (3)’’; 

4 (B) in subparagraph (C)— 

5 (i) in clause (i), in the matter pre6 ceding subclause (I), by inserting ‘‘for a 

7 year preceding 2022,’’ after ‘‘paragraph 

8 (4),’’; and 

9 (ii) in clause (ii)(III), by striking 

10 ‘‘and each subsequent year’’ and inserting 

11 ‘‘and 2021’’; and 

12 (C) in subparagraph (D)— 

13 (i) in clause (i)— 

14 (I) in the matter preceding sub15 clause (I), by inserting ‘‘for a year 

16 preceding 2022,’’ after ‘‘paragraph 

17 (4),’’; and 

18 (II) in subclause (I)(bb), by 

19 striking ‘‘a year after 2018’’ and in20 serting ‘‘each of years 2018 through 

21 2021’’; and 

22 (ii) in clause (ii)(V), by striking 

23 ‘‘2019 and each subsequent year’’ and in24 serting ‘‘each of years 2019 through 

25 2021’’; 
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1 (2) in paragraph (3)(A)— 

2 (A) in the matter preceding clause (i), by 

3 inserting ‘‘for a year preceding 2022,’’ after 

4 ‘‘and (4),’’; and 

5 (B) in clause (ii), by striking ‘‘for a subse6 quent year’’ and inserting ‘‘for each of years 

7 2007 through 2021’’; and 

8 (3) in paragraph (4)— 

9 (A) in subparagraph (A)— 

10 (i) in clause (i)— 

11 (I) by redesignating subclauses 

12 (I) and (II) as items (aa) and (bb), 

13 respectively, and moving the margin 

14 of each such redesignated item 2 ems 

15 to the right; 

16 (II) in the matter preceding item 

17 (aa), as redesignated by subclause (I), 

18 by striking ‘‘is equal to the greater 

19 of—’’ and inserting ‘‘is equal to— 

20 ‘‘(I) for a year preceding 2022, 

21 the greater of—’’; 

22 (III) by striking the period at the 

23 end of item (bb), as redesignated by 

24 subclause (I), and inserting ‘‘; and’’; 

25 and 
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1 (IV) by adding at the end the fol2 lowing: 

3 ‘‘(II) for 2022 and each suc4 ceeding year, $0.’’; and 

5 (ii) in clause (ii), by striking ‘‘clause 

6 (i)(I)’’ and inserting ‘‘clause (i)(I)(aa)’’; 

7 (B) in subparagraph (B)— 

8 (i) in clause (i)— 

9 (I) in subclause (V), by striking 

10 ‘‘or’’ at the end; 

11 (II) in subclause (VI)— 

12 (aa) by striking ‘‘for a sub13 sequent year’’ and inserting ‘‘for 

14 2021’’; and 

15 (bb) by striking the period 

16 at the end and inserting a semi17 colon; and 

18 (III) by adding at the end the 

19 following new subclauses: 

20 ‘‘(VII) for 2022, is equal to 

21 $2,000; or 

22 ‘‘(VIII) for a subsequent year, is 

23 equal to the amount specified in this 

24 subparagraph for the previous year, 

25 increased by the annual percentage in-
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1 crease described in paragraph (6) for 

2 the year involved.’’; and 

3 (ii) in clause (ii), by striking ‘‘clause 

4 (i)(II)’’ and inserting ‘‘clause (i)’’; 

5 (C) in subparagraph (C)(i), by striking 

6 ‘‘and for amounts’’ and inserting ‘‘and, for a 

7 year preceding 2022, for amounts’’; and 

8 (D) in subparagraph (E), by striking ‘‘In 

9 applying’’ and inserting ‘‘For each of years 

10 2011 through 2021, in applying’’. 

11 (b) DECREASING REINSURANCE PAYMENT

12 AMOUNT.—Section 1860D–15(b)(1) of the Social Security 

13 Act (42 U.S.C. 1395w–115(b)(1)) is amended by inserting 

14 after ‘‘80 percent’’ the following: ‘‘(or, with respect to a 

15 coverage year after 2021, 20 percent)’’. 

16 (c) MANUFACTURER DISCOUNT PROGRAM.— 

17 (1) IN GENERAL.—Part D of title XVIII of the 

18 Social Security Act (42 U.S.C. 1395w–101 et seq.), 

19 as amended by section 202, is further amended by 

20 inserting after section 1860D–14B the following new 

21 section: 

22 ‘‘SEC. 1860D–14C. MANUFACTURER DISCOUNT PROGRAM. 

23 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab24 lish a manufacturer discount program (in this section re25 ferred to as the ‘program’). Under the program, the Sec-
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1 retary shall enter into agreements described in subsection 

2 (b) with manufacturers and provide for the performance 

3 of the duties described in subsection (c). The Secretary 

4 shall establish a model agreement for use under the pro5 gram by not later than January 1, 2021, in consultation 

6 with manufacturers, and allow for comment on such model 

7 agreement. 

8 ‘‘(b) TERMS OF AGREEMENT.— 

9 ‘‘(1) IN GENERAL.— 

10 ‘‘(A) AGREEMENT.—An agreement under 

11 this section shall require the manufacturer to 

12 provide applicable beneficiaries access to dis13 counted prices for applicable drugs of the man14 ufacturer that are dispensed on or after Janu15 ary 1, 2022. 

16 ‘‘(B) PROVISION OF DISCOUNTED PRICES

17 AT THE POINT-OF-SALE.—The discounted prices 

18 described in subparagraph (A) shall be provided 

19 to the applicable beneficiary at the pharmacy or 

20 by the mail order service at the point-of-sale of 

21 an applicable drug. 

22 ‘‘(C) TIMING OF AGREEMENT.— 

23 ‘‘(i) SPECIAL RULE FOR 2022.—In 

24 order for an agreement with a manufac25 turer to be in effect under this section with 
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1 respect to the period beginning on January 

2 1, 2022, and ending on December 31, 

3 2022, the manufacturer shall enter into 

4 such agreement not later than 30 days 

5 after the date of the establishment of a 

6 model agreement under subsection (a). 

7 ‘‘(ii) 2023 AND SUBSEQUENT

8 YEARS.—In order for an agreement with a 

9 manufacturer to be in effect under this 

10 section with respect to plan year 2023 or 

11 a subsequent plan year, the manufacturer 

12 shall enter into such agreement (or such 

13 agreement shall be renewed under para14 graph (4)(A)) not later than January 30 of 

15 the preceding year. 

16 ‘‘(2) PROVISION OF APPROPRIATE DATA.—Each 

17 manufacturer with an agreement in effect under this 

18 section shall collect and have available appropriate 

19 data, as determined by the Secretary, to ensure that 

20 it can demonstrate to the Secretary compliance with 

21 the requirements under the program. 

22 ‘‘(3) COMPLIANCE WITH REQUIREMENTS FOR

23 ADMINISTRATION OF PROGRAM.—Each manufac24 turer with an agreement in effect under this section 

25 shall comply with requirements imposed by the Sec-
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1 retary or a third party with a contract under sub2 section (d)(3), as applicable, for purposes of admin3 istering the program, including any determination 

4 under subparagraph (A) of subsection (c)(1) or pro5 cedures established under such subsection (c)(1). 

6 ‘‘(4) LENGTH OF AGREEMENT.— 

7 ‘‘(A) IN GENERAL.—An agreement under 

8 this section shall be effective for an initial pe9 riod of not less than 12 months and shall be 

10 automatically renewed for a period of not less 

11 than 1 year unless terminated under subpara12 graph (B). 

13 ‘‘(B) TERMINATION.— 

14 ‘‘(i) BY THE SECRETARY.—The Sec15 retary may provide for termination of an 

16 agreement under this section for a knowing 

17 and willful violation of the requirements of 

18 the agreement or other good cause shown. 

19 Such termination shall not be effective ear20 lier than 30 days after the date of notice 

21 to the manufacturer of such termination. 

22 The Secretary shall provide, upon request, 

23 a manufacturer with a hearing concerning 

24 such a termination, and such hearing shall 

25 take place prior to the effective date of the 
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1 termination with sufficient time for such 

2 effective date to be repealed if the Sec3 retary determines appropriate. 

4 ‘‘(ii) BY A MANUFACTURER.—A man5 ufacturer may terminate an agreement 

6 under this section for any reason. Any 

7 such termination shall be effective, with re8 spect to a plan year— 

9 ‘‘(I) if the termination occurs be10 fore January 30 of a plan year, as of 

11 the day after the end of the plan year; 

12 and 

13 ‘‘(II) if the termination occurs on 

14 or after January 30 of a plan year, as 

15 of the day after the end of the suc16 ceeding plan year. 

17 ‘‘(iii) EFFECTIVENESS OF TERMI18 NATION.—Any termination under this sub19 paragraph shall not affect discounts for 

20 applicable drugs of the manufacturer that 

21 are due under the agreement before the ef22 fective date of its termination. 

23 ‘‘(iv) NOTICE TO THIRD PARTY.—The 

24 Secretary shall provide notice of such ter25 mination to a third party with a contract 
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1 under subsection (d)(3) within not less 

2 than 30 days before the effective date of 

3 such termination. 

4 ‘‘(c) DUTIES DESCRIBED.—The duties described in 

5 this subsection are the following: 

6 ‘‘(1) ADMINISTRATION OF PROGRAM.—Admin7 istering the program, including— 

8 ‘‘(A) the determination of the amount of 

9 the discounted price of an applicable drug of a 

10 manufacturer; 

11 ‘‘(B) the establishment of procedures 

12 under which discounted prices are provided to 

13 applicable beneficiaries at pharmacies or by 

14 mail order service at the point-of-sale of an ap15 plicable drug; 

16 ‘‘(C) the establishment of procedures to 

17 ensure that, not later than the applicable num18 ber of calendar days after the dispensing of an 

19 applicable drug by a pharmacy or mail order 

20 service, the pharmacy or mail order service is 

21 reimbursed for an amount equal to the dif22 ference between— 

23 ‘‘(i) the negotiated price of the appli24 cable drug; and 
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1 ‘‘(ii) the discounted price of the appli2 cable drug; 

3 ‘‘(D) the establishment of procedures to 

4 ensure that the discounted price for an applica5 ble drug under this section is applied before any 

6 coverage or financial assistance under other 

7 health benefit plans or programs that provide 

8 coverage or financial assistance for the pur9 chase or provision of prescription drug coverage 

10 on behalf of applicable beneficiaries as the Sec11 retary may specify; and 

12 ‘‘(E) providing a reasonable dispute resolu13 tion mechanism to resolve disagreements be14 tween manufacturers, applicable beneficiaries, 

15 and the third party with a contract under sub16 section (d)(3). 

17 ‘‘(2) MONITORING COMPLIANCE.— 

18 ‘‘(A) IN GENERAL.—The Secretary shall 

19 monitor compliance by a manufacturer with the 

20 terms of an agreement under this section. 

21 ‘‘(B) NOTIFICATION.—If a third party 

22 with a contract under subsection (d)(3) deter23 mines that the manufacturer is not in compli24 ance with such agreement, the third party shall 
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1 notify the Secretary of such noncompliance for 

2 appropriate enforcement under subsection (e). 

3 ‘‘(3) COLLECTION OF DATA FROM PRESCRIP4 TION DRUG PLANS AND MA–PD PLANS.—The Sec5 retary may collect appropriate data from prescrip6 tion drug plans and MA–PD plans in a timeframe 

7 that allows for discounted prices to be provided for 

8 applicable drugs under this section. 

9 ‘‘(d) ADMINISTRATION.— 

10 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

11 the Secretary shall provide for the implementation of 

12 this section, including the performance of the duties 

13 described in subsection (c). 

14 ‘‘(2) LIMITATION.—In providing for the imple15 mentation of this section, the Secretary shall not re16 ceive or distribute any funds of a manufacturer 

17 under the program. 

18 ‘‘(3) CONTRACT WITH THIRD PARTIES.—The 

19 Secretary shall enter into a contract with 1 or more 

20 third parties to administer the requirements estab21 lished by the Secretary in order to carry out this 

22 section. At a minimum, the contract with a third 

23 party under the preceding sentence shall require 

24 that the third party— 
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1 ‘‘(A) receive and transmit information be2 tween the Secretary, manufacturers, and other 

3 individuals or entities the Secretary determines 

4 appropriate; 

5 ‘‘(B) receive, distribute, or facilitate the 

6 distribution of funds of manufacturers to ap7 propriate individuals or entities in order to 

8 meet the obligations of manufacturers under 

9 agreements under this section; 

10 ‘‘(C) provide adequate and timely informa11 tion to manufacturers, consistent with the 

12 agreement with the manufacturer under this 

13 section, as necessary for the manufacturer to 

14 fulfill its obligations under this section; and 

15 ‘‘(D) permit manufacturers to conduct 

16 periodic audits, directly or through contracts, of 

17 the data and information used by the third 

18 party to determine discounts for applicable 

19 drugs of the manufacturer under the program. 

20 ‘‘(4) PERFORMANCE REQUIREMENTS.—The 

21 Secretary shall establish performance requirements 

22 for a third party with a contract under paragraph 

23 (3) and safeguards to protect the independence and 

24 integrity of the activities carried out by the third 

25 party under the program under this section. 
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1 ‘‘(5) IMPLEMENTATION.—Notwithstanding any 

2 other provision of law, the Secretary may implement 

3 the program under this section by program instruc4 tion or otherwise. 

5 ‘‘(6) ADMINISTRATION.—Chapter 35 of title 44, 

6 United States Code, shall not apply to the program 

7 under this section. 

8 ‘‘(e) ENFORCEMENT.— 

9 ‘‘(1) AUDITS.—Each manufacturer with an 

10 agreement in effect under this section shall be sub11 ject to periodic audit by the Secretary. 

12 ‘‘(2) CIVIL MONEY PENALTY.— 

13 ‘‘(A) IN GENERAL.—The Secretary may 

14 impose a civil money penalty on a manufacturer 

15 that fails to provide applicable beneficiaries dis16 counts for applicable drugs of the manufacturer 

17 in accordance with such agreement for each 

18 such failure in an amount the Secretary deter19 mines is equal to the sum of— 

20 ‘‘(i) the amount that the manufac21 turer would have paid with respect to such 

22 discounts under the agreement, which will 

23 then be used to pay the discounts which 

24 the manufacturer had failed to provide; 

25 and 
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1 ‘‘(ii) 25 percent of such amount. 

2 ‘‘(B) APPLICATION.—The provisions of 

3 section 1128A (other than subsections (a) and 

4 (b)) shall apply to a civil money penalty under 

5 this paragraph in the same manner as such 

6 provisions apply to a penalty or proceeding 

7 under section 1128A(a). 

8 ‘‘(f) CLARIFICATION REGARDING AVAILABILITY OF

9 OTHER COVERED PART D DRUGS.—Nothing in this sec10 tion shall prevent an applicable beneficiary from pur11 chasing a covered part D drug that is not an applicable 

12 drug (including a generic drug or a drug that is not on 

13 the formulary of the prescription drug plan or MA–PD 

14 plan that the applicable beneficiary is enrolled in). 

15 ‘‘(g) DEFINITIONS.—In this section: 

16 ‘‘(1) APPLICABLE BENEFICIARY.—The term 

17 ‘applicable beneficiary’ means an individual who, on 

18 the date of dispensing a covered part D drug— 

19 ‘‘(A) is enrolled in a prescription drug plan 

20 or an MA–PD plan; 

21 ‘‘(B) is not enrolled in a qualified retiree 

22 prescription drug plan; and 

23 ‘‘(C) has incurred costs, as determined in 

24 accordance with section 1860D–2(b)(4)(C), for 

25 covered part D drugs in the year that exceed 
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1 the annual deductible with respect to such indi2 vidual for such year, as specified in section 

3 1860D–2(b)(1), section 1860D–14(a)(1)(B), or 

4 section 1860D–14(a)(2)(B), as applicable. 

5 ‘‘(2) APPLICABLE DRUG.—The term ‘applicable 

6 drug’, with respect to an applicable beneficiary— 

7 ‘‘(A) means a covered part D drug— 

8 ‘‘(i) approved under a new drug appli9 cation under section 505(c) of the Federal 

10 Food, Drug, and Cosmetic Act or, in the 

11 case of a biologic product, licensed under 

12 section 351 of the Public Health Service 

13 Act; and 

14 ‘‘(ii)(I) if the PDP sponsor of the pre15 scription drug plan or the MA organization 

16 offering the MA–PD plan uses a for17 mulary, which is on the formulary of the 

18 prescription drug plan or MA–PD plan 

19 that the applicable beneficiary is enrolled 

20 in; 

21 ‘‘(II) if the PDP sponsor of the pre22 scription drug plan or the MA organization 

23 offering the MA–PD plan does not use a 

24 formulary, for which benefits are available 

25 under the prescription drug plan or MA– 
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1 PD plan that the applicable beneficiary is 

2 enrolled in; or 

3 ‘‘(III) is provided through an excep4 tion or appeal; and 

5 ‘‘(B) does not include a selected drug (as 

6 defined in section 1192(c)) during a price appli7 cability period (as defined in section 

8 1191(b)(2)) with respect to such drug. 

9 ‘‘(3) APPLICABLE NUMBER OF CALENDAR

10 DAYS.—The term ‘applicable number of calendar 

11 days’ means— 

12 ‘‘(A) with respect to claims for reimburse13 ment submitted electronically, 14 days; and 

14 ‘‘(B) with respect to claims for reimburse15 ment submitted otherwise, 30 days. 

16 ‘‘(4) DISCOUNTED PRICE.— 

17 ‘‘(A) IN GENERAL.—The term ‘discounted 

18 price’ means, with respect to an applicable drug 

19 of a manufacturer dispensed during a year to 

20 an applicable beneficiary— 

21 ‘‘(i) who has not incurred costs, as de22 termined in accordance with section 

23 1860D–2(b)(4)(C), for covered part D 

24 drugs in the year that are equal to or ex25 ceed the annual out-of-pocket threshold 
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1 specified in section 1860D–2(b)(4)(B)(i) 

2 for the year, 90 percent of the negotiated 

3 price of such drug; and 

4 ‘‘(ii) who has incurred such costs, as 

5 so determined, in the year that are equal 

6 to or exceed such threshold for the year, 

7 70 percent of the negotiated price of such 

8 drug. 

9 ‘‘(B) CLARIFICATION.—Nothing in this 

10 section shall be construed as affecting the re11 sponsibility of an applicable beneficiary for pay12 ment of a dispensing fee for an applicable drug. 

13 ‘‘(C) SPECIAL CASE FOR CERTAIN

14 CLAIMS.— 

15 ‘‘(i) CLAIMS SPANNING DEDUCT16 IBLE.—In the case where the entire 

17 amount of the negotiated price of an indi18 vidual claim for an applicable drug with re19 spect to an applicable beneficiary does not 

20 fall above the annual deductible specified 

21 in section 1860D–2(b)(1) for the year, the 

22 manufacturer of the applicable drug shall 

23 provide the discounted price under this 

24 section on only the portion of the nego-
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1 tiated price of the applicable drug that 

2 falls above such annual deductible. 

3 ‘‘(ii) CLAIMS SPANNING OUT-OF-POCK4 ET THRESHOLD.—In the case where the 

5 entire amount of the negotiated price of an 

6 individual claim for an applicable drug 

7 with respect to an applicable beneficiary 

8 does not fall entirely below or entirely 

9 above the annual out-of-pocket threshold 

10 specified in section 1860D–2(b)(4)(B)(i) 

11 for the year, the manufacturer of the ap12 plicable drug shall provide the discounted 

13 price— 

14 ‘‘(I) in accordance with subpara15 graph (A)(i) on the portion of the ne16 gotiated price of the applicable drug 

17 that falls below such threshold; and 

18 ‘‘(II) in accordance with subpara19 graph (A)(ii) on the portion of such 

20 price of such drug that falls at or 

21 above such threshold. 

22 ‘‘(5) MANUFACTURER.—The term ‘manufac23 turer’ means any entity which is engaged in the pro24 duction, preparation, propagation, compounding, 

25 conversion, or processing of prescription drug prod-
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1 ucts, either directly or indirectly by extraction from 

2 substances of natural origin, or independently by 

3 means of chemical synthesis, or by a combination of 

4 extraction and chemical synthesis. Such term does 

5 not include a wholesale distributor of drugs or a re6 tail pharmacy licensed under State law. 

7 ‘‘(6) NEGOTIATED PRICE.—The term ‘nego8 tiated price’ has the meaning given such term in sec9 tion 423.100 of title 42, Code of Federal Regula10 tions (or any successor regulation), except that, with 

11 respect to an applicable drug, such negotiated price 

12 shall not include any dispensing fee for the applica13 ble drug. 

14 ‘‘(7) QUALIFIED RETIREE PRESCRIPTION DRUG

15 PLAN.—The term ‘qualified retiree prescription drug 

16 plan’ has the meaning given such term in section 

17 1860D–22(a)(2).’’. 

18 (2) SUNSET OF MEDICARE COVERAGE GAP DIS19 COUNT PROGRAM.—Section 1860D–14A of the So20 cial Security Act (42 U.S.C. 1395–114a) is amend21 ed— 

22 (A) in subsection (a), in the first sentence, 

23 by striking ‘‘The Secretary’’ and inserting 

24 ‘‘Subject to subsection (h), the Secretary’’; and 
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1 (B) by adding at the end the following new 

2 subsection: 

3 ‘‘(h) SUNSET OF PROGRAM.— 

4 ‘‘(1) IN GENERAL.—The program shall not 

5 apply with respect to applicable drugs dispensed on 

6 or after January 1, 2022, and, subject to paragraph 

7 (2), agreements under this section shall be termi8 nated as of such date. 

9 ‘‘(2) CONTINUED APPLICATION FOR APPLICA10 BLE DRUGS DISPENSED PRIOR TO SUNSET.—The 

11 provisions of this section (including all responsibil12 ities and duties) shall continue to apply after Janu13 ary 1, 2022, with respect to applicable drugs dis14 pensed prior to such date.’’. 

15 (3) INCLUSION OF ACTUARIAL VALUE OF MANU16 FACTURER DISCOUNTS IN BIDS.—Section 1860D–11 

17 of the Social Security Act (42 U.S.C. 1395w–111) 

18 is amended— 

19 (A) in subsection (b)(2)(C)(iii)— 

20 (i) by striking ‘‘assumptions regarding 

21 the reinsurance’’ and inserting ‘‘assump22 tions regarding— 

23 ‘‘(I) the reinsurance’’; and 

24 (ii) by adding at the end the fol25 lowing: 
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1 ‘‘(II) for 2022 and each subse2 quent year, the manufacturer dis3 counts provided under section 1860D– 

4 14C subtracted from the actuarial 

5 value to produce such bid; and’’; and 

6 (B) in subsection (c)(1)(C)— 

7 (i) by striking ‘‘an actuarial valuation 

8 of the reinsurance’’ and inserting ‘‘an ac9 tuarial valuation of— 

10 ‘‘(i) the reinsurance’’; 

11 (ii) in clause (i), as inserted by clause 

12 (i) of this subparagraph, by adding ‘‘and’’ 

13 at the end; and 

14 (iii) by adding at the end the fol15 lowing: 

16 ‘‘(ii) for 2022 and each subsequent 

17 year, the manufacturer discounts provided 

18 under section 1860D–14C;’’. 

19 (d) CONFORMING AMENDMENTS.— 

20 (1) Section 1860D–2 of the Social Security Act 

21 (42 U.S.C. 1395w–102) is amended— 

22 (A) in subsection (a)(2)(A)(i)(I), by strik23 ing ‘‘, or an increase in the initial’’ and insert24 ing ‘‘or, for a year preceding 2022, an increase 

25 in the initial’’; 
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1 (B) in subsection (c)(1)(C)— 

2 (i) in the subparagraph heading, by 

3 striking ‘‘AT INITIAL COVERAGE LIMIT’’; 

4 and 

5 (ii) by inserting ‘‘for a year preceding 

6 2022 or the annual out-of-pocket threshold 

7 specified in subsection (b)(4)(B) for the 

8 year for 2022 and each subsequent year’’ 

9 after ‘‘subsection (b)(3) for the year’’ each 

10 place it appears; and 

11 (C) in subsection (d)(1)(A), by striking ‘‘or 

12 an initial’’ and inserting ‘‘or, for a year pre13 ceding 2022, an initial’’. 

14 (2) Section 1860D–4(a)(4)(B)(i) of the Social 

15 Security Act (42 U.S.C. 1395w–104(a)(4)(B)(i)) is 

16 amended by striking ‘‘the initial’’ and inserting ‘‘for 

17 a year preceding 2022, the initial’’. 

18 (3) Section 1860D–14(a) of the Social Security 

19 Act (42 U.S.C. 1395w–114(a)) is amended— 

20 (A) in paragraph (1)— 

21 (i) in subparagraph (C), by striking 

22 ‘‘The continuation’’ and inserting ‘‘For a 

23 year preceding 2022, the continuation’’; 
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1 (ii) in subparagraph (D)(iii), by strik2 ing ‘‘1860D–2(b)(4)(A)(i)(I)’’ and insert3 ing ‘‘1860D–2(b)(4)(A)(i)(I)(aa)’’; and 

4 (iii) in subparagraph (E), by striking 

5 ‘‘The elimination’’ and inserting ‘‘For a 

6 year preceding 2022, the elimination’’; and 

7 (B) in paragraph (2)— 

8 (i) in subparagraph (C), by striking 

9 ‘‘The continuation’’ and inserting ‘‘For a 

10 year preceding 2022, the continuation’’; 

11 and 

12 (ii) in subparagraph (E), by striking 

13 ‘‘1860D–2(b)(4)(A)(i)(I)’’ and inserting 

14 ‘‘1860D–2(b)(4)(A)(i)(I)(aa)’’. 

15 (4) Section 1860D–21(d)(7) of the Social Secu16 rity Act (42 U.S.C. 1395w–131(d)(7)) is amended 

17 by striking ‘‘section 1860D–2(b)(4)(B)(i)’’ and in18 serting ‘‘section 1860D–2(b)(4)(C)(i)’’. 

19 (5) Section 1860D–22(a)(2)(A) of the Social 

20 Security Act (42 U.S.C. 1395w–132(a)(2)(A)) is 

21 amended— 

22 (A) by striking ‘‘the value of any discount’’ 

23 and inserting the following: ‘‘the value of— 

24 ‘‘(i) for years prior to 2022, any dis25 count’’; 
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1 (B) in clause (i), as inserted by subpara2 graph (A) of this paragraph, by striking the pe3 riod at the end and inserting ‘‘; and’’; and 

4 (C) by adding at the end the following new 

5 clause: 

6 ‘‘(ii) for 2022 and each subsequent 

7 year, any discount provided pursuant to 

8 section 1860D–14C.’’. 

9 (6) Section 1860D–41(a)(6) of the Social Secu10 rity Act (42 U.S.C. 1395w–151(a)(6)) is amended— 

11 (A) by inserting ‘‘for a year before 2022’’ 

12 after ‘‘1860D–2(b)(3)’’; and 

13 (B) by inserting ‘‘for such year’’ before the 

14 period. 

15 (7) Section 1860D–43 of the Social Security 

16 Act (42 U.S.C. 1395w–153) is amended— 

17 (A) in subsection (a)— 

18 (i) by striking paragraph (1) and in19 serting the following: 

20 ‘‘(1) participate in— 

21 ‘‘(A) for 2011 through 2021, the Medicare 

22 coverage gap discount program under section 

23 1860D–14A; and 
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1 ‘‘(B) for 2022 and each subsequent year, 

2 the manufacturer discount program under sec3 tion 1860D–14C;’’; 

4 (ii) by striking paragraph (2) and in5 serting the following: 

6 ‘‘(2) have entered into and have in effect— 

7 ‘‘(A) for 2011 through 2021, an agreement 

8 described in subsection (b) of section 1860D– 

9 14A with the Secretary; and 

10 ‘‘(B) for 2022 and each subsequent year, 

11 an agreement described in subsection (b) of sec12 tion 1860D–14C with the Secretary; and’’; and 

13 (iii) by striking paragraph (3) and in14 serting the following: 

15 ‘‘(3) have entered into and have in effect, under 

16 terms and conditions specified by the Secretary— 

17 ‘‘(A) for 2011 through 2021, a contract 

18 with a third party that the Secretary has en19 tered into a contract with under subsection 

20 (d)(3) of section 1860D–14A; and 

21 ‘‘(B) for 2022 and each subsequent year, 

22 a contract with a third party that the Secretary 

23 has entered into a contract with under sub24 section (d)(3) of section 1860D–14C.’’; and 
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1 (B) by striking subsection (b) and insert2 ing the following: 

3 ‘‘(b) EFFECTIVE DATE.—Paragraphs (1)(A), (2)(A), 

4 and (3)(A) of subsection (a) shall apply to covered part 

5 D drugs dispensed under this part on or after January 

6 1, 2011, and before January 1, 2022, and paragraphs 

7 (1)(B), (2)(B), and (3)(B) of such subsection shall apply 

8 to covered part D drugs dispensed under this part on or 

9 after January 1, 2022.’’. 

10 (8) Section 1927 of the Social Security Act (42 

11 U.S.C. 1396r–8) is amended— 

12 (A) in subsection (c)(1)(C)(i)(VI), by in13 serting before the period at the end the fol14 lowing: ‘‘or under the manufacturer discount 

15 program under section 1860D–14C’’; and 

16 (B) in subsection (k)(1)(B)(i)(V), by in17 serting before the period at the end the fol18 lowing: ‘‘or under section 1860D–14C’’. 

19 (e) EFFECTIVE DATE.—The amendments made by 

20 this section shall apply with respect to plan year 2022 and 

21 subsequent plan years. 
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1 SEC. 302. ALLOWING CERTAIN ENROLLEES OF PRESCRIP2 TION DRUGS PLANS AND MA–PD PLANS 

3 UNDER MEDICARE PROGRAM TO SPREAD 

4 OUT COST-SHARING UNDER CERTAIN CIR5 CUMSTANCES. 

6 Section 1860D–2(b)(2) of the Social Security Act (42 

7 U.S.C. 1395w–102(b)(2)), as amended by section 301, is 

8 further amended— 

9 (1) in subparagraph (A), by striking ‘‘Subject 

10 to subparagraphs (C) and (D)’’ and inserting ‘‘Sub11 ject to subparagraphs (C), (D), and (E)’’; and 

12 (2) by adding at the end the following new sub13 paragraph: 

14 ‘‘(E) ENROLLEE OPTION REGARDING

15 SPREADING COST-SHARING.—The Secretary 

16 shall establish by regulation a process under 

17 which, with respect to plan year 2022 and sub18 sequent plan years, a prescription drug plan or 

19 an MA–PD plan shall, in the case of a part D 

20 eligible individual enrolled with such plan for 

21 such plan year who is not a subsidy eligible in22 dividual (as defined in section 1860D–14(a)(3)) 

23 and with respect to whom the plan projects that 

24 the dispensing of the first fill of a covered part 

25 D drug to such individual will result in the indi26 vidual incurring costs that are equal to or above 
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1 the annual out-of-pocket threshold specified in 

2 paragraph (4)(B) for such plan year, provide 

3 such individual with the option to make the co4 insurance payment required under subpara5 graph (A) (for the portion of such costs that 

6 are not above such annual out-of-pocket thresh7 old) in the form of periodic installments over 

8 the remainder of such plan year.’’. 

9 SEC. 303. ESTABLISHMENT OF PHARMACY QUALITY MEAS10 URES UNDER MEDICARE PART D. 

11 Section 1860D–4(c) of the Social Security Act (42 

12 U.S.C. 1395w–104(c)) is amended— 

13 (1) by redesignating the paragraph (6), as 

14 added by section 50354 of division E of the Bipar15 tisan Budget Act of 2018 (Public Law 115–123), as 

16 paragraph (7); and 

17 (2) by adding at the end the following new 

18 paragraph: 

19 ‘‘(8) APPLICATION OF PHARMACY QUALITY

20 MEASURES.— 

21 ‘‘(A) IN GENERAL.—A PDP sponsor that 

22 implements incentive payments to a pharmacy 

23 or price concessions paid by a pharmacy based 

24 on quality measures shall use measures estab25 lished or approved by the Secretary under sub-
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1 paragraph (B) with respect to payment for cov2 ered part D drugs dispensed by such pharmacy. 

3 ‘‘(B) STANDARD PHARMACY QUALITY

4 MEASURES.—The Secretary shall establish or 

5 approve standard quality measures from a con6 sensus and evidence-based organization for pay7 ments described in subparagraph (A). Such 

8 measures shall focus on patient health outcomes 

9 and be based on proven criteria measuring 

10 pharmacy performance. 

11 ‘‘(C) EFFECTIVE DATE.—The requirement 

12 under subparagraph (A) shall take effect for 

13 plan years beginning on or after January 1, 

14 2021, or such earlier date specified by the Sec15 retary if the Secretary determines there are suf16 ficient measures established or approved under 

17 subparagraph (B) to meet the requirement 

18 under subparagraph (A).’’. 

19 TITLE IV—DRUG PRICE 

20 TRANSPARENCY 

21 SEC. 401. DRUG PRICE TRANSPARENCY. 

22 Part A of title XI of the Social Security Act is 

23 amended by adding at the end the following new sections: 

24 ‘‘SEC. 1150C. REPORTING ON DRUG PRICES. 

25 ‘‘(a) DEFINITIONS.—In this section: 
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1 ‘‘(1) MANUFACTURER.—The term ‘manufac2 turer’ means the person— 

3 ‘‘(A) that holds the application for a drug 

4 approved under section 505 of the Federal 

5 Food, Drug, and Cosmetic Act or licensed 

6 under section 351 of the Public Health Service 

7 Act; or 

8 ‘‘(B) who is responsible for setting the 

9 wholesale acquisition cost for the drug. 

10 ‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 

11 drug’ means any drug that is approved under sub12 section (c) or (j) of section 505 of the Federal Food, 

13 Drug, and Cosmetic Act or licensed under subsection 

14 (a) or (k) of section 351 of the Public Health Serv15 ice Act— 

16 ‘‘(A) that has a wholesale acquisition cost 

17 of $100 or more, adjusted for inflation occur18 ring after the date of enactment of this section, 

19 for a month’s supply or a typical course of 

20 treatment that lasts less than a month, and 

21 is— 

22 ‘‘(i) subject to section 503(b)(1) of 

23 the Federal Food, Drug, and Cosmetic 

24 Act; and 

25 ‘‘(ii) not a preventative vaccine; and 
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1 ‘‘(B) for which, during the previous cal2 endar year, at least 1 dollar of the total amount 

3 of sales were for individuals enrolled under the 

4 Medicare program under title XVIII or under a 

5 State Medicaid plan under title XIX or under 

6 a waiver of such plan. 

7 ‘‘(3) WHOLESALE ACQUISITION COST.—The 

8 term ‘wholesale acquisition cost’ has the meaning 

9 given that term in section 1847A(c)(6)(B). 

10 ‘‘(b) REPORT.— 

11 ‘‘(1) REPORT REQUIRED.—The manufacturer of 

12 a qualifying drug shall submit a report to the Sec13 retary if, with respect to the qualifying drug— 

14 ‘‘(A) there is an increase in the price of 

15 the qualifying drug that results in an increase 

16 in the wholesale acquisition cost of that drug 

17 that is equal to— 

18 ‘‘(i) 10 percent or more within a 12- 

19 month period beginning on or after Janu20 ary 1, 2019; or 

21 ‘‘(ii) 25 percent or more within a 36- 

22 month period beginning on or after Janu23 ary 1, 2019; 

24 ‘‘(B) the estimated price of the qualifying 

25 drug or spending per individual or per user of 
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1 such drug (as estimated by the Secretary) for 

2 the applicable year (or per course of treatment 

3 in such applicable year as determined by the 

4 Secretary) is at least $26,000 beginning on or 

5 after January 1, 2021; or 

6 ‘‘(C) there was an increase in the price of 

7 the qualifying drug that resulted in an increase 

8 in the wholesale acquisition cost of that drug 

9 that is equal to— 

10 ‘‘(i) 10 percent or more within a 12- 

11 month period that begins and ends during 

12 the 5-year period preceding January 1, 

13 2021; or 

14 ‘‘(ii) 25 percent or more within a 36- 

15 month period that begins and ends during 

16 the 5-year period preceding January 1, 

17 2021. 

18 ‘‘(2) REPORT DEADLINE.—Each report de19 scribed in paragraph (1) shall be submitted to the 

20 Secretary— 

21 ‘‘(A) in the case of a report with respect 

22 to an increase in the price of a qualifying drug 

23 that occurs during the period beginning on Jan24 uary 1, 2019, and ending on the day that is 60 

25 days after the date of the enactment of this sec-
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1 tion, not later than 90 days after such date of 

2 enactment; 

3 ‘‘(B) in the case of a report with respect 

4 to an increase in the price of a qualifying drug 

5 that occurs after the period described in sub6 paragraph (A), not later than 30 days prior to 

7 the planned effective date of such price increase 

8 for such qualifying drug; 

9 ‘‘(C) in the case of a report with respect 

10 to a qualifying drug that meets the criteria 

11 under paragraph (1)(B), not later than 30 days 

12 after such drug meets such criteria; and 

13 ‘‘(D) in the case of a report with respect 

14 to an increase in the price of a qualifying drug 

15 that occurs during a 12-month or 36-month pe16 riod described in paragraph (1)(C), not later 

17 than April 1, 2021. 

18 ‘‘(c) CONTENTS.—A report under subsection (b), con19 sistent with the standard for disclosures described in sec20 tion 213.3(d) of title 12, Code of Federal Regulations (as 

21 in effect on the date of enactment of this section), shall, 

22 at a minimum, include— 

23 ‘‘(1) with respect to the qualifying drug— 

24 ‘‘(A) the percentage by which the manufac25 turer will raise the wholesale acquisition cost of 
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1 the drug within the 12-month period or 36- 

2 month period as described in subsection 

3 (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or 

4 (b)(1)(C)(ii), as applicable, and the effective 

5 date of such price increase or the cost associ6 ated with a qualifying drug if such drug meets 

7 the criteria under subsection (b)(1)(B) and the 

8 effective date at which such drug meets such 

9 criteria; 

10 ‘‘(B) an explanation for, and description 

11 of, each price increase for such drug that will 

12 occur during the 12-month period or the 36- 

13 month period described in subsection 

14 (b)(1)(A)(i), (b)(1)(A)(ii), (b)(1)(C)(i), or 

15 (b)(1)(C)(ii), as applicable; 

16 ‘‘(C) an explanation for, and description 

17 of, the cost associated with a qualifying drug if 

18 such drug meets the criteria under subsection 

19 (b)(1)(B), as applicable; 

20 ‘‘(D) if known and different from the man21 ufacturer of the qualifying drug, the identity 

22 of— 

23 ‘‘(i) the sponsor or sponsors of any in24 vestigational new drug applications under 

25 section 505(i) of the Federal Food, Drug, 
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1 and Cosmetic Act for clinical investigations 

2 with respect to such drug, for which the 

3 full reports are submitted as part of the 

4 application— 

5 ‘‘(I) for approval of the drug 

6 under section 505 of such Act; or 

7 ‘‘(II) for licensure of the drug 

8 under section 351 of the Pubic Health 

9 Service Act; and 

10 ‘‘(ii) the sponsor of an application for 

11 the drug approved under such section 505 

12 of the Federal Food, Drug, and Cosmetic 

13 Act or licensed under section 351 of the 

14 Public Health Service Act; 

15 ‘‘(E) a description of the history of the 

16 manufacturer’s price increases for the drug 

17 since the approval of the application for the 

18 drug under section 505 of the Federal Food, 

19 Drug, and Cosmetic Act or the issuance of the 

20 license for the drug under section 351 of the 

21 Public Health Service Act, or since the manu22 facturer acquired such approved application or 

23 license, if applicable; 

24 ‘‘(F) the current wholesale acquisition cost 

25 of the drug; 
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1 ‘‘(G) the total expenditures of the manu2 facturer on— 

3 ‘‘(i) materials and manufacturing for 

4 such drug; 

5 ‘‘(ii) acquiring patents and licensing 

6 for such drug; and 

7 ‘‘(iii) purchasing or acquiring such 

8 drug from another manufacturer, if appli9 cable; 

10 ‘‘(H) the percentage of total expenditures 

11 of the manufacturer on research and develop12 ment for such drug that was derived from Fed13 eral funds; 

14 ‘‘(I) the total expenditures of the manufac15 turer on research and development for such 

16 drug that is necessary to demonstrate that it 

17 meets applicable statutory standards for ap18 proval under section 505 of the Federal Food, 

19 Drug, and Cosmetic Act or licensure under sec20 tion 351 of the Public Health Service Act, as 

21 applicable; 

22 ‘‘(J) the total expenditures of the manufac23 turer on pursuing new or expanded indications 

24 or dosage changes for such drug under section 

25 505 of the Federal Food, Drug, and Cosmetic 
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1 Act or section 351 of the Public Health Service 

2 Act; 

3 ‘‘(K) the total expenditures of the manu4 facturer on carrying out postmarket require5 ments related to such drug, including under 

6 section 505(o)(3) of the Federal Food, Drug, 

7 and Cosmetic Act; 

8 ‘‘(L) the total revenue and the net profit 

9 generated from the qualifying drug for each cal10 endar year since the approval of the application 

11 for the drug under section 505 of the Federal 

12 Food, Drug, and Cosmetic Act or the issuance 

13 of the license for the drug under section 351 of 

14 the Public Health Service Act, or since the 

15 manufacturer acquired such approved applica16 tion or license; and 

17 ‘‘(M) the total costs associated with mar18 keting and advertising for the qualifying drug; 

19 ‘‘(2) with respect to the manufacturer— 

20 ‘‘(A) the total revenue and the net profit 

21 of the manufacturer for each of the 12-month 

22 period described in subsection (b)(1)(A)(i) or 

23 (b)(1)(C)(i) or the 36-month period described in 

24 subsection (b)(1)(A)(ii) or (b)(1)(C)(ii), as ap25 plicable; 
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1 ‘‘(B) all stock-based performance metrics 

2 used by the manufacturer to determine execu3 tive compensation for each of the 12-month pe4 riods described in subsection (b)(1)(A)(i) or 

5 (b)(1)(C)(i) or the 36-month periods described 

6 in subsection (b)(1)(A)(ii) or (b)(1)(C)(ii), as 

7 applicable; and 

8 ‘‘(C) any additional information the manu9 facturer chooses to provide related to drug pric10 ing decisions, such as total expenditures on— 

11 ‘‘(i) drug research and development; 

12 or 

13 ‘‘(ii) clinical trials, including on drugs 

14 that failed to receive approval by the Food 

15 and Drug Administration; and 

16 ‘‘(3) such other related information as the Sec17 retary considers appropriate and as specified by the 

18 Secretary. 

19 ‘‘(d) INFORMATION PROVIDED.—The manufacturer 

20 of a qualifying drug that is required to submit a report 

21 under subsection (b), shall ensure that such report and 

22 any explanation for, and description of, each price increase 

23 described in subsection (c)(1) shall be truthful, not mis24 leading, and accurate. 
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1 ‘‘(e) CIVIL MONETARY PENALTY.—Any manufac2 turer of a qualifying drug that fails to submit a report 

3 for the drug as required by this section, following notifica4 tion by the Secretary to the manufacturer that the manu5 facturer is not in compliance with this section, shall be 

6 subject to a civil monetary penalty of $75,000 for each 

7 day on which the violation continues. 

8 ‘‘(f) FALSE INFORMATION.—Any manufacturer that 

9 submits a report for a drug as required by this section 

10 that knowingly provides false information in such report 

11 is subject to a civil monetary penalty in an amount not 

12 to exceed $100,000 for each item of false information. 

13 ‘‘(g) PUBLIC POSTING.— 

14 ‘‘(1) IN GENERAL.—Subject to paragraph (4), 

15 the Secretary shall post each report submitted under 

16 subsection (b) on the public website of the Depart17 ment of Health and Human Services the day the 

18 price increase of a qualifying drug is scheduled to go 

19 into effect. 

20 ‘‘(2) FORMAT.—In developing the format in 

21 which reports will be publicly posted under para22 graph (1), the Secretary shall consult with stake23 holders, including beneficiary groups, and shall seek 

24 feedback from consumer advocates and readability 

25 experts on the format and presentation of the con-
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1 tent of such reports to ensure that such reports 

2 are— 

3 ‘‘(A) user-friendly to the public; and 

4 ‘‘(B) written in plain language that con5 sumers can readily understand. 

6 ‘‘(3) LIST.—In addition to the reports sub7 mitted under subsection (b), the Secretary shall also 

8 post a list of each qualifying drug with respect to 

9 which the manufacturer was required to submit such 

10 a report in the preceding year and whether such 

11 manufacturer was required to submit such report 

12 based on a qualifying price increase or whether such 

13 drug meets the criteria under subsection (b)(1)(B). 

14 ‘‘(4) PROTECTED INFORMATION.—In carrying 

15 out this section, the Secretary shall enforce applica16 ble law concerning the protection of confidential 

17 commercial information and trade secrets. 

18 ‘‘SEC. 1150D. ANNUAL REPORT TO CONGRESS. 

19 ‘‘(a) IN GENERAL.—Subject to subsection (b), the 

20 Secretary shall submit to the Committees on Energy and 

21 Commerce and Ways and Means of the House of Rep22 resentatives and the Committees on Health, Education, 

23 Labor, and Pensions and Finance of the Senate, and post 

24 on the public website of the Department of Health and 

25 Human Services in a way that is user-friendly to the pub-
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1 lic and written in plain language that consumers can read2 ily understand, an annual report— 

3 ‘‘(1) summarizing the information reported pur4 suant to section 1150C; 

5 ‘‘(2) including copies of the reports and sup6 porting detailed economic analyses submitted pursu7 ant to such section; 

8 ‘‘(3) detailing the costs and expenditures in9 curred by the Department of Health and Human 

10 Services in carrying out section 1150C; and 

11 ‘‘(4) explaining how the Department of Health 

12 and Human Services is improving consumer and 

13 provider information about drug value and drug 

14 price transparency. 

15 ‘‘(b) PROTECTED INFORMATION.—In carrying out 

16 this section, the Secretary shall enforce applicable law con17 cerning the protection of confidential commercial informa18 tion and trade secrets.’’. 
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1 TITLE V—PROGRAM IMPROVE2 MENTS FOR MEDICARE LOW3 INCOME BENEFICIARIES 

4 SEC. 501. DISSEMINATION TO MEDICARE PART D SUBSIDY 

5 ELIGIBLE INDIVIDUALS OF INFORMATION 

6 COMPARING PREMIUMS OF CERTAIN PRE7 SCRIPTION DRUG PLANS. 

8 Section 1860D–1(c)(3) of the Social Security Act (42 

9 U.S.C. 1395w–101(c)(3)) is amended by adding at the end 

10 the following new subparagraph: 

11 ‘‘(C) INFORMATION ON PREMIUMS FOR

12 SUBSIDY ELIGIBLE INDIVIDUALS.— 

13 ‘‘(i) IN GENERAL.—For plan year 

14 2022 and each subsequent plan year, the 

15 Secretary shall disseminate to each subsidy 

16 eligible individual (as defined in section 

17 1860D–14(a)(3)) information under this 

18 paragraph comparing premiums that would 

19 apply to such individual for prescription 

20 drug coverage under LIS benchmark plans, 

21 including, in the case of an individual en22 rolled in a prescription drug plan under 

23 this part, information that compares the 

24 premium that would apply if such indi25 vidual were to remain enrolled in such plan 
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1 to premiums that would apply if the indi2 vidual were to enroll in other LIS bench3 mark plans. 

4 ‘‘(ii) LIS BENCHMARK PLAN.—For 

5 purposes of clause (i), the term ‘LIS 

6 benchmark plan’ means, with respect to an 

7 individual, a prescription drug plan under 

8 this part that is offered in the region in 

9 which the individual resides and— 

10 ‘‘(I) that provides for a premium 

11 that is not more than the low-income 

12 benchmark premium amount (as de13 fined in section 1860D–14(b)(2)) for 

14 such region; or 

15 ‘‘(II) with respect to which the 

16 premium would be waived as de mini17 mis pursuant to section 1860D– 

18 14(a)(5) for such individual.’’. 

19 SEC. 502. PROVIDING FOR INTELLIGENT ASSIGNMENT OF 

20 CERTAIN SUBSIDY ELIGIBLE INDIVIDUALS 

21 AUTO-ENROLLED UNDER MEDICARE PRE22 SCRIPTION DRUG PLANS AND MA–PD PLANS. 

23 (a) IN GENERAL.—Section 1860D–1(b)(1) of the So24 cial Security Act (42 U.S.C. 1395w–101(b)(1)) is amend25 ed— 
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1 (1) in subparagraph (C)— 

2 (A) by inserting after ‘‘PDP region’’ the 

3 following: ‘‘or through use of an intelligent as4 signment process that is designed to maximize 

5 the access of such individual to necessary pre6 scription drugs while minimizing costs to such 

7 individual and to the program under this part 

8 to the greatest extent possible. In the case the 

9 Secretary enrolls such individuals through use 

10 of an intelligent assignment process, such proc11 ess shall take into account the extent to which 

12 prescription drugs necessary for the individual 

13 are covered in the case of a PDP sponsor of a 

14 prescription drug plan that uses a formulary, 

15 the use of prior authorization or other restric16 tions on access to coverage of such prescription 

17 drugs by such a sponsor, and the overall quality 

18 of a prescription drug plan as measured by 

19 quality ratings established by the Secretary’’; 

20 and 

21 (B) by striking ‘‘Nothing in the previous 

22 sentence’’ and inserting ‘‘Nothing in this sub23 paragraph’’; and 

24 (2) in subparagraph (D)— 
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1 (A) by inserting after ‘‘PDP region’’ the 

2 following: ‘‘or through use of an intelligent as3 signment process that is designed to maximize 

4 the access of such individual to necessary pre5 scription drugs while minimizing costs to such 

6 individual and to the program under this part 

7 to the greatest extent possible. In the case the 

8 Secretary enrolls such individuals through use 

9 of an intelligent assignment process, such proc10 ess shall take into account the extent to which 

11 prescription drugs necessary for the individual 

12 are covered in the case of a PDP sponsor of a 

13 prescription drug plan that uses a formulary, 

14 the use of prior authorization or other restric15 tions on access to coverage of such prescription 

16 drugs by such a sponsor, and the overall quality 

17 of a prescription drug plan as measured by 

18 quality ratings established by the Secretary’’; 

19 and 

20 (B) by striking ‘‘Nothing in the previous 

21 sentence’’ and inserting ‘‘Nothing in this sub22 paragraph’’. 

23 (b) EFFECTIVE DATE.—The amendments made by 

24 subsection (a) shall apply with respect to plan years begin25 ning with plan year 2022. 
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1 SEC. 503. EXPANDING ELIGIBILITY FOR LOW-INCOME SUB2 SIDIES UNDER PART D OF THE MEDICARE 

3 PROGRAM. 

4 Section 1860D–14(a) of the Social Security Act (42 

5 U.S.C. 1395w–114(a)), as amended by section 301(d), is 

6 further amended— 

7 (1) in the subsection heading, by striking ‘‘IN8 DIVIDUALS’’ and all that follows through ‘‘LINE’’ 

9 and inserting ‘‘CERTAIN INDIVIDUALS’’; 

10 (2) in paragraph (1)— 

11 (A) by striking the paragraph heading and 

12 inserting ‘‘INDIVIDUALS WITH CERTAIN LOW IN13 COMES’’; and 

14 (B) in the matter preceding subparagraph 

15 (A), by inserting ‘‘(or, with respect to a plan 

16 year beginning on or after January 1, 2022, 

17 150 percent)’’ after ‘‘135 percent’’; and 

18 (3) in paragraph (2)— 

19 (A) by striking the paragraph heading and 

20 inserting ‘‘OTHER LOW-INCOME INDIVIDUALS’’; 

21 and 

22 (B) in the matter preceding subparagraph 

23 (A), by striking ‘‘In the case of a subsidy’’ and 

24 inserting ‘‘With respect to a plan year begin25 ning before January 1, 2022, in the case of a 

26 subsidy’’. 
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1 SEC. 504. AUTOMATIC ELIGIBILITY OF CERTAIN LOW-IN2 COME TERRITORIAL RESIDENTS FOR PRE3 MIUM AND COST-SHARING SUBSIDIES UNDER 

4 THE MEDICARE PROGRAM; SUNSET OF EN5 HANCED ALLOTMENT PROGRAM. 

6 (a) AUTOMATIC ELIGIBILITY OF CERTAIN LOW-IN7 COME TERRITORIAL RESIDENTS FOR PREMIUM AND

8 COST-SHARING SUBSIDIES UNDER THE MEDICARE PRO9 GRAM.— 

10 (1) IN GENERAL.—Section 1860D–14(a)(3) of 

11 the Social Security Act (42 U.S.C. 1395w– 

12 114(a)(3)) is amended— 

13 (A) in subparagraph (B)(v)— 

14 (i) in subclause (I), by striking ‘‘and’’ 

15 at the end; 

16 (ii) in subclause (II), by striking the 

17 period and inserting ‘‘; and’’; and 

18 (iii) by inserting after subclause (II) 

19 the following new subclause: 

20 ‘‘(III) with respect to plan years 

21 beginning on or after January 1, 

22 2024, shall provide that any part D 

23 eligible individual who is enrolled for 

24 medical assistance under the State 

25 Medicaid plan of a territory (as de26 fined in section 1935(f)) under title 
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1 XIX (or a waiver of such a plan) shall 

2 be treated as a subsidy eligible indi3 vidual described in paragraph (1).’’; 

4 and 

5 (B) in subparagraph (F), by adding at the 

6 end the following new sentence: ‘‘The previous 

7 sentence shall not apply with respect to eligi8 bility determinations for premium and cost9 sharing subsidies under this section made on or 

10 after January 1, 2024.’’. 

11 (2) CONFORMING AMENDMENT.—Section 

12 1860D–31(j)(2)(D) of the Social Security Act (42 

13 U.S.C. 1395w–141(j)(2)(D)) is amended by adding 

14 at the end the following new sentence: ‘‘The previous 

15 sentence shall not apply with respect to amounts 

16 made available to a State under this paragraph on 

17 or after January 1, 2024.’’. 

18 (b) SUNSET OF ENHANCED ALLOTMENT PRO19 GRAM.— 

20 (1) IN GENERAL.—Section 1935(e) of the So21 cial Security Act (42 U.S.C. 1396u–5(e)) is amend22 ed— 

23 (A) in paragraph (1)(A), by inserting after 

24 ‘‘such State’’ the following: ‘‘before January 1, 

25 2021’’; and 
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1 (B) in paragraph (3)— 

2 (i) in subparagraph (A), in the matter 

3 preceding clause (i), by inserting after ‘‘a 

4 year’’ the following: ‘‘(before 2024)’’; and 

5 (ii) in subparagraph (B)(iii), by strik6 ing ‘‘a subsequent year’’ and inserting 

7 ‘‘each of fiscal years 2008 through 2023’’. 

8 (2) TERRITORY DEFINED.—Section 1935 of the 

9 Social Security Act (42 U.S.C. 1396u–5) is amended 

10 by adding at the end the following new subsection: 

11 ‘‘(f) TERRITORY DEFINED.—In this section, the term 

12 ‘territory’ means Puerto Rico, the Virgin Islands, Guam, 

13 the Northern Mariana Islands, and American Samoa.’’. 

14 SEC. 505. AUTOMATIC QUALIFICATION OF CERTAIN MED15 ICAID BENEFICIARIES FOR PREMIUM AND 

16 COST-SHARING SUBSIDIES UNDER PART D OF 

17 THE MEDICARE PROGRAM. 

18 Clause (v) of section 1860D–14(a)(3)(B) of the So19 cial Security Act (42 U.S.C. 1395w–114(a)(3)(B)), as 

20 amended by section 504, is further amended— 

21 (1) in subclause (II), by striking ‘‘and’’ at the 

22 end; 

23 (2) in subclause (III), by striking the period 

24 and inserting ‘‘; and’’; and 
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1 (3) by inserting after subclause (III) the fol2 lowing new subclause: 

3 ‘‘(IV) with respect to plan years 

4 beginning on or after January 1, 

5 2024, shall, notwithstanding the pre6 ceding clauses of this subparagraph, 

7 provide that any part D eligible indi8 vidual not described in subclause (I), 

9 (II), or (III) who is enrolled, as of the 

10 day before the date on which such in11 dividual attains the age of 65, for 

12 medical assistance under a State plan 

13 under title XIX (or a waiver of such 

14 plan) pursuant to clause (i)(VIII) or 

15 (ii)(XX) of section 1902(a)(10)(A), 

16 and who has income below 200 per17 cent of the poverty line applicable to 

18 a family of the size involved, shall be 

19 treated as a subsidy eligible individual 

20 described in paragraph (1) for a lim21 ited period of time, as specified by the 

22 Secretary.’’. 
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1 SEC. 506. PROVIDING FOR CERTAIN RULES REGARDING 

2 THE TREATMENT OF ELIGIBLE RETIREMENT 

3 PLANS IN DETERMINING THE ELIGIBILITY OF 

4 INDIVIDUALS FOR PREMIUM AND COST5 SHARING SUBSIDIES UNDER PART D OF THE 

6 MEDICARE PROGRAM. 

7 Section 1860D–14(a)(3)(C)(i) of the Social Security 

8 Act (42 U.S.C. 1395w–114(a)(3)(C)(i)) is amended, by 

9 striking ‘‘except that support and maintenance furnished 

10 in kind shall not be counted as income; and’’ and inserting 

11 ‘‘except that— 

12 ‘‘(I) support and maintenance 

13 furnished in kind shall not be counted 

14 as income; and 

15 ‘‘(II) for plan years beginning on 

16 or after January 1, 2024, any dis17 tribution or withdrawal from an eligi18 ble retirement plan (as defined in sub19 paragraph (B) of section 402(c)(8) of 

20 the Internal Revenue Code of 1986, 

21 but excluding any defined benefit plan 

22 described in clause (iv) or (v) of such 

23 subparagraph and any qualified trust 

24 (as defined in subparagraph (A) of 

25 such section) which is part of such a 
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1 defined benefit plan) shall be counted 

2 as income; and’’. 

3 SEC. 507. REDUCING COST-SHARING AND OTHER PROGRAM 

4 IMPROVEMENTS FOR LOW-INCOME BENE5 FICIARIES. 

6 (a) INCREASE IN INCOME ELIGIBILITY TO 150 PER7 CENT OF FPL FOR QUALIFIED MEDICARE BENE8 FICIARIES.— 

9 (1) IN GENERAL.—Section 1905(p)(2)(A) of the 

10 Social Security Act (42 U.S.C. 1396d(p)(2)(A)) is 

11 amended by striking ‘‘shall be at least the percent 

12 provided under subparagraph (B) (but not more 

13 than 100 percent) of the official poverty line’’ and 

14 all that follows through the period at the end and 

15 inserting the following: ‘‘shall be— 

16 ‘‘(i) before January 1, 2022, at least 

17 the percent provided under subparagraph 

18 (B) (but not more than 100 percent) of 

19 the official poverty line (as defined by the 

20 Office of Management and Budget, and re21 vised annually in accordance with section 

22 673(2) of the Omnibus Budget Reconcili23 ation Act of 1981) applicable to a family 

24 of the size involved; and 
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1 ‘‘(ii) on or after January 1, 2022, 

2 equal to 150 percent of the official poverty 

3 line (as so defined and revised) applicable 

4 to a family of the size involved.’’. 

5 (2) NOT COUNTING IN-KIND SUPPORT AND

6 MAINTENANCE AS INCOME.—Section 1905(p)(2)(D) 

7 of the Social Security Act (42 U.S.C. 

8 1396d(p)(2)(D)) is amended by adding at the end 

9 the following new clause: 

10 ‘‘(iii) In determining income under 

11 this subsection, support and maintenance 

12 furnished in kind, as described in section 

13 1612(a)(2)(A), shall not be counted as in14 come.’’. 

15 (3) CONFORMING AMENDMENTS.— 

16 (A) Section 1902(a)(10)(E) of the Social 

17 Security Act (42 U.S.C. 1396a(a)(10)(E)) is 

18 amended— 

19 (i) in clause (iii), by striking ‘‘for 

20 making medical’’ and inserting ‘‘before 

21 January 1, 2022, for making medical’’; 

22 and 

23 (ii) in clause (iv), by striking ‘‘subject 

24 to sections’’ and inserting ‘‘before January 

25 1, 2022, subject to sections’’. 
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1 (B) Section 1933 of the Social Security 

2 Act (42 U.S.C. 1396u–3) is amended— 

3 (i) in subsection (a), by striking ‘‘A 

4 State plan’’ and inserting ‘‘Subject to sub5 section (h), a State plan’’; and 

6 (ii) by adding at the end the following 

7 new subsection: 

8 ‘‘(h) SUNSET.—The provisions of this section shall 

9 have no force or effect after December 31, 2021.’’. 

10 (b) 100 PERCENT FMAP.—Section 1905 of the So11 cial Security Act (42 U.S.C. 1396d) is amended by adding 

12 at the end the following new subsection: 

13 ‘‘(gg) INCREASED FMAP FOR EXPANDED MEDICARE

14 COST-SHARING POPULATIONS.— 

15 ‘‘(1) IN GENERAL.—Notwithstanding subsection 

16 (b), with respect to expenditures described in para17 graph (2) the Federal medical assistance percentage 

18 shall be equal to 100 percent. 

19 ‘‘(2) EXPENDITURES DESCRIBED.—The expend20 itures described in this paragraph are expenditures 

21 made on or after January 1, 2022, for medical as22 sistance for medicare cost-sharing provided to any 

23 individual under clause (i) or (ii) of section 

24 1902(a)(10)(E) who would not have been eligible for 

25 medicare cost-sharing under any such clause under 
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1 the income or resource eligibility standards in effect 

2 on October 1, 2018.’’. 

3 TITLE VI—PROVIDING FOR DEN4 TAL, VISION, AND HEARING 

5 COVERAGE UNDER THE MEDI6 CARE PROGRAM 

7 SEC. 601. DENTAL AND ORAL HEALTH CARE. 

8 (a) COVERAGE.—Section 1861(s)(2) of the Social Se9 curity Act (42 U.S.C. 1395x(s)(2)) is amended— 

10 (1) in subparagraph (GG), by striking ‘‘and’’ 

11 after the semicolon at the end; 

12 (2) in subparagraph (HH), by striking the pe13 riod at the end and adding ‘‘; and’’; and 

14 (3) by adding at the end the following new sub15 paragraph: 

16 ‘‘(II) dental and oral health services (as defined 

17 in subsection (kkk));’’. 

18 (b) DENTAL AND ORAL HEALTH SERVICES DE19 FINED.—Section 1861 of the Social Security Act (42 

20 U.S.C. 1395x) is amended by adding at the end the fol21 lowing new subsection: 

22 ‘‘(kkk) DENTAL AND ORAL HEALTH SERVICES.— 

23 ‘‘(1) IN GENERAL.—The term ‘dental and oral 

24 health services’ means items and services (other 

25 than such items and services for which payment may 
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1 be made under part A as inpatient hospital services) 

2 that are furnished during 2025 or a subsequent 

3 year, for which coverage was not provided under 

4 part B as of the date of the enactment of this sub5 section, and that are— 

6 ‘‘(A) the preventive and screening services 

7 described in paragraph (2) furnished by a doc8 tor of dental surgery or of dental medicine (as 

9 described in subsection (r)(2)) or an oral health 

10 professional (as defined in paragraph (4)); or 

11 ‘‘(B) the basic treatments specified for 

12 such year by the Secretary pursuant to para13 graph (3)(A) and the major treatments speci14 fied for such year by the Secretary pursuant to 

15 paragraph (3)(B) furnished by such a doctor or 

16 such a professional. 

17 ‘‘(2) PREVENTIVE AND SCREENING SERV18 ICES.—The preventive and screening services de19 scribed in this paragraph are the following: 

20 ‘‘(A) Oral exams. 

21 ‘‘(B) Dental cleanings. 

22 ‘‘(C) Dental x-rays performed in the office 

23 of a doctor or professional described in para24 graph (1)(A). 

25 ‘‘(D) Fluoride treatments. 
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1 ‘‘(3) BASIC AND MAJOR TREATMENTS.—For 

2 2025 and each subsequent year, the Secretary shall 

3 specify— 

4 ‘‘(A) basic treatments (which may include 

5 basic tooth restorations, basic periodontic serv6 ices, tooth extractions, and oral disease man7 agement services); and 

8 ‘‘(B) major treatments (which may include 

9 major tooth restorations, major periodontic 

10 services, bridges, crowns, and root canals); 

11 that shall be included as dental and oral health serv12 ices for such year. 

13 ‘‘(4) ORAL HEALTH PROFESSIONAL.—The term 

14 ‘oral health professional’ means, with respect to den15 tal and oral health services, a health professional 

16 who is licensed to furnish such services, acting with17 in the scope of such license, by the State in which 

18 such services are furnished.’’. 

19 (c) PAYMENT; COINSURANCE; AND LIMITATIONS.— 

20 (1) IN GENERAL.—Section 1833(a)(1) of the 

21 Social Security Act (42 U.S.C. 1395l(a)(1)) is 

22 amended— 

23 (A) in subparagraph (N), by inserting 

24 ‘‘and dental and oral health services (as defined 
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1 in section 1861(kkk))’’ after ‘‘section 

2 1861(hhh)(1))’’; 

3 (B) by striking ‘‘and’’ before ‘‘(CC)’’; and 

4 (C) by inserting before the semicolon at 

5 the end the following: ‘‘, and (DD) with respect 

6 to dental and oral health services (as defined in 

7 section 1861(kkk)), the amount paid shall be 

8 the payment amount specified under section 

9 1834(x)’’. 

10 (2) PAYMENT AND LIMITS SPECIFIED.—Section 

11 1834 of the Social Security Act (42 U.S.C. 1395m) 

12 is amended by adding at the end the following new 

13 subsection: 

14 ‘‘(x) PAYMENT AND LIMITS FOR DENTAL AND ORAL

15 HEALTH SERVICES.— 

16 ‘‘(1) IN GENERAL.—The payment amount 

17 under this part for dental and oral health services 

18 (as defined in section 1861(kkk)) shall be, subject to 

19 paragraph (3), the applicable percent (specified in 

20 paragraph (2)) of the lesser of the actual charge for 

21 the services or the amount determined under the 

22 payment basis determined under section 1848. In 

23 determining such amounts determined under such 

24 payment basis, the Secretary shall consider payment 

25 rates paid to dentists for comparable services under 
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1 State plans under title XIX, under the TRICARE 

2 program under chapter 55 of title 10 of the United 

3 States Code, and by other health care payers, such 

4 as Medicare Advantage plans under part C. 

5 ‘‘(2) APPLICABLE PERCENT.—For purposes of 

6 paragraph (1), the applicable percent specified in 

7 this paragraph is, with respect to dental and oral 

8 health services (as defined in section 1861(kkk)) fur9 nished in a year— 

10 ‘‘(A) that are preventive and screening 

11 services described in paragraph (2) or basic 

12 treatments specified for such year pursuant to 

13 paragraph (3)(A) of such section, 80 percent; 

14 and 

15 ‘‘(B) that are major treatments specified 

16 for such year pursuant to paragraph (3)(B) of 

17 such section— 

18 ‘‘(i) in the case such services are fur19 nished during 2025, 10 percent; 

20 ‘‘(ii) in the case such services are fur21 nished during 2026 or a subsequent year 

22 before 2029, the applicable percent speci23 fied under this subparagraph for the pre24 vious year, increased by 10 percentage 

25 points; and 
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1 ‘‘(iii) in the case such services are fur2 nished during 2029 or a subsequent year, 

3 50 percent. 

4 ‘‘(3) LIMITATIONS.—With respect to dental and 

5 oral health services that are— 

6 ‘‘(A) preventive and screening oral exams, 

7 payment may be made under this part for not 

8 more than two such exams during a 12-month 

9 period; 

10 ‘‘(B) dental cleanings, payment may be 

11 made under this part for not more than two 

12 such cleanings during a 12-month period; and 

13 ‘‘(C) not described in subparagraph (A) or 

14 (B), payment may be made under this part only 

15 at such frequencies and under such cir16 cumstances determined appropriate by the Sec17 retary.’’. 

18 (d) PAYMENT UNDER PHYSICIAN FEE SCHEDULE.— 

19 (1) IN GENERAL.—Section 1848(j)(3) of the 

20 Social Security Act (42 U.S.C. 1395w–4(j)(3)) is 

21 amended by inserting ‘‘(2)(II),’’ before ‘‘(3)’’. 

22 (2) EXCLUSION FROM MIPS.—Section 

23 1848(q)(1)(C)(ii) of the Social Security Act (42 

24 U.S.C. 1395w–4(q)(1)(C)(ii)) is amended— 
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1 (A) in subclause (II), by striking ‘‘or’’ at 

2 the end; 

3 (B) in subclause (III), by striking the pe4 riod at the end and inserting ‘‘; or’’; and 

5 (C) by adding at the end the following new 

6 subclause: 

7 ‘‘(IV) with respect to 2025 and 

8 each subsequent year, is a doctor of 

9 dental surgery or of dental medicine 

10 (as described in section 1861(r)(2)) or 

11 is an oral health professional (as de12 fined in section 1861(kkk)(4)).’’. 

13 (3) INCLUSION OF ORAL HEALTH PROFES14 SIONALS AS CERTAIN PRACTITIONERS.—Section 

15 1842(b)(18)(C) of the Social Security Act (42 

16 U.S.C. 1395u(b)(18)(C)) is amended by adding at 

17 the end the following new clause: 

18 ‘‘(vii) With respect to 2025 and each subse19 quent year, an oral health professional (as defined in 

20 section 1861(kkk)(4)).’’. 

21 (e) DENTURES.— 

22 (1) IN GENERAL.—Section 1861(s)(8) of the 

23 Social Security Act (42 U.S.C. 1395x(s)(8)) is 

24 amended— 

25 (A) by striking ‘‘(other than dental)’’; and 
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1 (B) by inserting ‘‘and excluding dental, ex2 cept for a full or partial set of dentures fur3 nished on or after January 1, 2025’’ after ‘‘co4 lostomy care’’. 

5 (2) SPECIAL PAYMENT RULES.— 

6 (A) LIMITATIONS.—Section 1834(h) of the 

7 Social Security Act (42 U.S.C. 1395m(h)) is 

8 amended by adding at the end the following 

9 new paragraph: 

10 ‘‘(6) SPECIAL PAYMENT RULE FOR DEN11 TURES.—Payment may be made under this part 

12 with respect to an individual for dentures— 

13 ‘‘(A) not more than once during any 5-year 

14 period (except in the case that a doctor or pro15 fessional described in section 1861(kkk)(1)(A) 

16 determines such dentures do not fit the indi17 vidual); and 

18 ‘‘(B) only to the extent that such dentures 

19 are furnished pursuant to a written order of 

20 such a doctor or professional.’’. 

21 (B) APPLICATION OF COMPETITIVE ACQUI22 SITION.— 

23 (i) IN GENERAL.—Section 

24 1834(h)(1)(H) of the Social Security Act 

25 (42 U.S.C. 1395m(h)(1)(H)) is amended— 
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1 (I) in the subparagraph heading, 

2 by inserting ‘‘, DENTURES’’ after 

3 ‘‘ORTHOTICS’’; 

4 (II) by inserting ‘‘, of dentures 

5 described in paragraph (2)(D) of such 

6 section,’’ after ‘‘2011,’’; and 

7 (III) in clause (i), by inserting ‘‘, 

8 such dentures’’ after ‘‘orthotics’’. 

9 (ii) CONFORMING AMENDMENT.—Sec10 tion 1847(a)(2) of the Social Security Act 

11 (42 U.S.C. 1395w–3(a)(2)) is amended by 

12 adding at the end the following new sub13 paragraph: 

14 ‘‘(D) DENTURES.—Dentures described in 

15 section 1861(s)(8) for which payment would 

16 otherwise be made under section 1834(h).’’. 

17 (iii) EXEMPTION OF CERTAIN ITEMS

18 FROM COMPETITIVE ACQUISITION.—Sec19 tion 1847(a)(7) of the Social Security Act 

20 (42 U.S.C. 1395w–3(a)(7)) is amended by 

21 adding at the end the following new sub22 paragraph: 

23 ‘‘(C) CERTAIN DENTURES.—Those items 

24 and services described in paragraph (2)(D) if 

25 furnished by a physician or other practitioner 
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1 (as defined by the Secretary) to the physician’s 

2 or practitioner’s own patients as part of the 

3 physician’s or practitioner’s professional serv4 ice.’’. 

5 (f) EXCLUSION MODIFICATIONS.—Section 1862(a) of 

6 the Social Security Act (42 U.S.C. 1395y(a)) is amend7 ed— 

8 (1) in paragraph (1)— 

9 (A) in subparagraph (O), by striking 

10 ‘‘and’’ at the end; 

11 (B) in subparagraph (P), by striking the 

12 semicolon at the end and inserting ‘‘, and’’; and 

13 (C) by adding at the end the following new 

14 subparagraph: 

15 ‘‘(Q) in the case of dental and oral health serv16 ices (as defined in section 1861(kkk)) that are pre17 ventive and screening services described in para18 graph (2) of such section, which are furnished more 

19 frequently than provided under section 1834(x)(3) 

20 and under circumstances other than circumstances 

21 determined appropriate under such section;’’; and 

22 (2) in paragraph (12), by inserting before the 

23 semicolon at the end the following: ‘‘and except that 

24 payment may be made under part B for dental and 
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1 oral health services that are covered under section 

2 1861(s)(2)(II)’’. 

3 (g) CERTAIN NON-APPLICATION.— 

4 (1) IN GENERAL.—Paragraphs (1) and (4) of 

5 section 1839(a) of the Social Security Act (42 

6 U.S.C. 1395r(a)) are amended by adding at the end 

7 of each such paragraphs the following: ‘‘In applying 

8 this paragraph there shall not be taken into account 

9 benefits and administrative costs attributable to the 

10 amendments made by section 601 (other than sub11 section (g)) of the Elijah E. Cummings Lower Drug 

12 Costs Now Act and the Government contribution 

13 under section 1844(a)(4)’’. 

14 (2) PAYMENT.—Section 1844(a) of such Act 

15 (42 U.S.C. 1395w(a)) is amended— 

16 (A) in paragraph (3), by striking the pe17 riod at the end and inserting ‘‘; plus’’; and 

18 (B) by adding at the end the following new 

19 paragraph: 

20 ‘‘(4) a Government contribution equal to the 

21 amount that is estimated to be payable for benefits 

22 and related administrative costs incurred that are 

23 attributable to the amendments made by section 601 

24 (other than subsection (g)) of the Elijah E. Cum25 mings Lower Drug Costs Now Act.’’. 
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1 (h) IMPLEMENTATION FUNDING.— 

2 (1) IN GENERAL.—The Secretary of Health and 

3 Human Services (in this subsection referred to as 

4 the ‘‘Secretary’’) shall provide for the transfer from 

5 the Federal Supplementary Medical Insurance Trust 

6 Fund under section 1841 of the Social Security Act 

7 (42 U.S.C. 1395t) to the Centers for Medicare & 

8 Medicaid Services Program Management Account 

9 of— 

10 (A) $20,000,000 for each of fiscal years 

11 2020 through 2025 for purposes of imple12 menting the amendments made by this section; 

13 and 

14 (B) such sums as determined appropriate 

15 by the Secretary for each subsequent fiscal year 

16 for purposes of administering the provisions of 

17 such amendments. 

18 (2) AVAILABILITY AND ADDITIONAL USE OF

19 FUNDS.—Funds transferred pursuant to paragraph 

20 (1) shall remain available until expended and may be 

21 used, in addition to the purpose specified in para22 graph (1)(A), to implement the amendments made 

23 by sections 602 and 603. 
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1 SEC. 602. PROVIDING COVERAGE FOR HEARING CARE 

2 UNDER THE MEDICARE PROGRAM. 

3 (a) PROVISION OF AURAL REHABILITATION AND

4 TREATMENT SERVICES BY QUALIFIED AUDIOLOGISTS.— 

5 Section 1861(ll)(3) of the Social Security Act (42 U.S.C. 

6 1395x(ll)(3)) is amended by inserting ‘‘(and, beginning 

7 January 1, 2023, such aural rehabilitation and treatment 

8 services)’’ after ‘‘assessment services’’. 

9 (b) COVERAGE OF HEARING AIDS.— 

10 (1) INCLUSION OF HEARING AIDS AS PROS11 THETIC DEVICES.—Section 1861(s)(8) of the Social 

12 Security Act (42 U.S.C. 1395x(s)(8)) is amended by 

13 inserting ‘‘, and including hearing aids furnished on 

14 or after January 1, 2023, to individuals diagnosed 

15 with profound or severe hearing loss’’ before the 

16 semicolon at the end. 

17 (2) PAYMENT LIMITATIONS FOR HEARING

18 AIDS.—Section 1834(h) of the Social Security Act 

19 (42 U.S.C. 1395m(h)), as amended by section 

20 601(e)(2)(A), is further amended by adding at the 

21 end the following new paragraph: 

22 ‘‘(7) LIMITATIONS FOR HEARING AIDS.—Pay23 ment may be made under this part with respect to 

24 an individual, with respect to hearing aids furnished 

25 on or after January 1, 2023— 
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1 ‘‘(A) not more than once during a 5-year 

2 period; 

3 ‘‘(B) only for types of such hearing aids 

4 that are not over-the-counter hearing aids (as 

5 defined in section 520(q)(1) of the Federal 

6 Food, Drug, and Cosmetic Act) and that are 

7 determined appropriate by the Secretary; and 

8 ‘‘(C) only if furnished pursuant to a writ9 ten order of a physician or qualified audiologist 

10 (as defined in section 1861(ll)(4)(B)).’’. 

11 (3) APPLICATION OF COMPETITIVE ACQUISI12 TION.— 

13 (A) IN GENERAL.—Section 1834(h)(1)(H) 

14 of the Social Security Act (42 U.S.C. 

15 1395m(h)(1)(H)), as amended by section 

16 601(e)(2)(B)(i), is further amended— 

17 (i) in the header, by inserting ‘‘, 

18 HEARING AIDS’’ after ‘‘DENTURES’’; 

19 (ii) by inserting ‘‘, of hearing aids de20 scribed in paragraph (2)(E) of such sec21 tion,’’ after ‘‘paragraph (2)(D) of such sec22 tion’’; and 

23 (iii) in clause (i), by inserting ‘‘, such 

24 hearing aids’’ after ‘‘such dentures’’. 

25 (B) CONFORMING AMENDMENT.— 
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1 (i) IN GENERAL.—Section 1847(a)(2) 

2 of the Social Security Act (42 U.S.C. 

3 1395w–3(a)(2)), as amended by section 

4 601(e)(2)(B)(ii), is further amended by 

5 adding at the end the following new sub6 paragraph: 

7 ‘‘(E) HEARING AIDS.—Hearing aids de8 scribed in section 1861(s)(8) for which payment 

9 would otherwise be made under section 

10 1834(h).’’. 

11 (ii) EXEMPTION OF CERTAIN ITEMS

12 FROM COMPETITIVE ACQUISITION.—Sec13 tion 1847(a)(7) of the Social Security Act 

14 (42 U.S.C. 1395w–3(a)(7)), as amended 

15 by section 601(e)(2)(B)(iii), is further 

16 amended by adding at the end the fol17 lowing new subparagraph: 

18 ‘‘(D) CERTAIN HEARING AIDS.—Those 

19 items and services described in paragraph 

20 (2)(E) if furnished by a physician or other 

21 practitioner (as defined by the Secretary) to the 

22 physician’s or practitioner’s own patients as 

23 part of the physician’s or practitioner’s profes24 sional service.’’. 
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1 (4) INCLUSION OF AUDIOLOGISTS AS CERTAIN

2 PRACTITIONERS TO RECEIVE PAYMENT ON AN AS3 SIGNMENT-RELATED BASIS.—Section 

4 1842(b)(18)(C) of the Social Security Act (42 

5 U.S.C. 1395u(b)(18)(C)), as amended by section 

6 601(d)(4), is further amended by adding at the end 

7 the following new clause: 

8 ‘‘(viii) With respect to 2023 and each 

9 subsequent year, a qualified audiologist (as 

10 defined in section 1861(ll)(4)(B)).’’. 

11 (c) EXCLUSION MODIFICATION.—Section 1862(a)(7) 

12 of the Social Security Act (42 U.S.C. 1395y(a)(7)) is 

13 amended by inserting ‘‘(except such hearing aids or exami14 nations therefor as described in and otherwise allowed 

15 under section 1861(s)(8))’’ after ‘‘hearing aids or exami16 nations therefor’’. 

17 (d) CERTAIN NON-APPLICATION.— 

18 (1) IN GENERAL.—The last sentence of section 

19 1839(a)(1) of the Social Security Act (42 U.S.C. 

20 1395r(a)(1)), as added by section 601(g)(1), is 

21 amended by striking ‘‘section 601 (other than sub22 section (g))’’ and inserting ‘‘sections 601 (other than 

23 subsection (g)), 602 (other than subsection (d))’’. 

24 (2) PAYMENT.—Paragraph (4) of section 

25 1844(a) of such Act (42 U.S.C. 1395w(a)), as added 
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1 by section 601(g)(2), is amended by striking ‘‘sec2 tion 601 (other than subsection (g))’’ and inserting 

3 ‘‘sections 601 (other than subsection (g)), 602 

4 (other than subsection (d))’’. 

5 (e) REPORT; REGULATIONS.— 

6 (1) REPORT.—Not later than the date that is 

7 3 years after the date of the enactment of this Act, 

8 the Inspector General of the Department of Health 

9 and Human Services shall conduct a study to assess 

10 (and submit to the Secretary of Health and Human 

11 Services a report on) any program integrity or over12 utilization risks with respect to allowing qualified 

13 audiologists (as defined in paragraph (4)(B) of 

14 1861(ll) of the Social Security Act (42 U.S.C. 

15 1395x(ll))) to furnish audiology services (as defined 

16 in paragraph (3) of such section) to individuals enti17 tled to benefits under part A of title XVIII of such 

18 Act (42 U.S.C. 1395c et seq.) and enrolled for bene19 fits under part B of such title (42 U.S.C.1395j et 

20 seq.) without such individuals being referred by a 

21 physician (as defined in section 1861(r) of such Act 

22 (42 U.S.C. 1395x(r))) or practitioner (as described 

23 in section 602.32 of title 42, Code of Federal Regu24 lations) to such qualified audiologists. In conducting 

25 such study, the Inspector General may take into ac-
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1 count experiences with audiologists furnishing audi2 ology services to enrollees in other Federal pro3 grams, including in a health benefit plan under 

4 chapter 89 of title 5, United States Code or in 

5 health care benefits under the TRICARE program 

6 under chapter 55 of title 10 of the United States 

7 Code or under chapter 17 of title 38 of such Code. 

8 (2) REGULATIONS.—The Secretary of Health 

9 and Human Services may promulgate regulations to 

10 allow qualified audiologists (as so defined) to furnish 

11 audiology services (as so defined) without a referral 

12 from a physician or practitioner, consistent with the 

13 findings submitted to the Secretary pursuant to 

14 paragraph (1)(B). 

15 (f) IMPLEMENTATION FUNDING.— 

16 (1) IN GENERAL.—The Secretary of Health and 

17 Human Services (in this subsection referred to as 

18 the ‘‘Secretary’’) shall provide for the transfer from 

19 the Federal Supplementary Medical Insurance Trust 

20 Fund under section 1841 of the Social Security Act 

21 (42 U.S.C. 1395t) to the Centers for Medicare & 

22 Medicaid Services Program Management Account 

23 of— 

24 (A) $20,000,000 for each of fiscal years 

25 2020 through 2024 for purposes of imple-
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1 menting the amendments made by this section; 

2 and 

3 (B) such sums as determined appropriate 

4 by the Secretary for each subsequent fiscal year 

5 for purposes of administering the provisions of 

6 such amendments. 

7 (2) AVAILABILITY AND ADDITIONAL USE OF

8 FUNDS.—Funds transferred pursuant to paragraph 

9 (1) shall remain available until expended and may be 

10 used, in addition to the purpose specified in para11 graph (1)(A), to implement the amendments made 

12 by sections 601 and 603. 

13 SEC. 603. PROVIDING COVERAGE FOR VISION CARE UNDER 

14 THE MEDICARE PROGRAM. 

15 (a) COVERAGE.—Section 1861(s)(2) of the Social Se16 curity Act (42 U.S.C. 1395x(s)(2)), as amended by section 

17 601(a), is further amended— 

18 (1) in subparagraph (HH), by striking ‘‘and’’ 

19 after the semicolon at the end; 

20 (2) in subparagraph (II), by striking the period 

21 at the end and adding ‘‘; and’’; and 

22 (3) by adding at the end the following new sub23 paragraph: 

24 ‘‘(JJ) vision services (as defined in subsection 

25 (lll));’’. 
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1 (b) VISION SERVICES DEFINED.—Section 1861 of 

2 the Social Security Act (42 U.S.C. 1395x), as amended 

3 by section 601(b), is further amended by adding at the 

4 end the following new subsection: 

5 ‘‘(lll) VISION SERVICES.—The term ‘vision services’ 

6 means— 

7 ‘‘(1) routine eye examinations to determine the 

8 refractive state of the eyes, including procedures per9 formed during the course of such examination; and 

10 ‘‘(2) contact lens fitting services; 

11 furnished on or after January 1, 2023, by or under the 

12 direct supervision of an optometrist or ophthalmologist 

13 who is legally authorized to furnish such examinations, 

14 procedures, or fitting services (as applicable) under State 

15 law (or the State regulatory mechanism provided by State 

16 law) of the State in which the examinations, procedures, 

17 or fitting services are furnished.’’. 

18 (c) PAYMENT LIMITATIONS.—Section 1834 of the 

19 Social Security Act (42 U.S.C. 1395m), as amended by 

20 section 601(c)(2), is further amended by adding at the end 

21 the following new subsection: 

22 ‘‘(y) LIMITATION FOR VISION SERVICES.—With re23 spect to vision services (as defined in section 1861(lll)) 

24 and an individual, payment may be made under this part 

25 for only 1 routine eye examination described in paragraph 
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1 (1) of such section and 1 contact lens fitting service de2 scribed in paragraph (2) of such section during a 2-year 

3 period.’’. 

4 (d) PAYMENT UNDER PHYSICIAN FEE SCHEDULE.— 

5 Section 1848(j)(3) of the Social Security Act (42 U.S.C. 

6 1395w–4(j)(3)), as amended by section 601(d)(1), is fur7 ther amended by inserting ‘‘(2)(JJ),’’ before ‘‘(3)’’. 

8 (e) COVERAGE OF CONVENTIONAL EYEGLASSES AND

9 CONTACT LENSES.—Section 1861(s)(8) of the Social Se10 curity Act (42 U.S.C. 1395x(s)(8)), as amended by section 

11 602(b)(1), is further amended by striking ‘‘, and including 

12 one pair of conventional eyeglasses or contact lenses fur13 nished subsequent to each cataract surgery with insertion 

14 of an intraocular lens’’ and inserting ‘‘, including one pair 

15 of conventional eyeglasses or contact lenses furnished sub16 sequent to each cataract surgery with insertion of an 

17 intraocular lens, if furnished before January 1, 2023, in18 cluding conventional eyeglasses or contact lenses, whether 

19 or not furnished subsequent to such a surgery, if furnished 

20 on or after January 1, 2024’’. 

21 (f) SPECIAL PAYMENT RULES FOR EYEGLASSES AND

22 CONTACT LENSES.— 

23 (1) LIMITATIONS.—Section 1834(h) of the So24 cial Security Act (42 U.S.C. 1395m(h)), as amended 

25 by section 601(e)(2)(A) and section 602(b)(2), is 
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1 further amended by adding at the end the following 

2 new paragraph: 

3 ‘‘(8) PAYMENT LIMITATIONS FOR EYEGLASSES

4 AND CONTACT LENSES.— 

5 ‘‘(A) IN GENERAL.—With respect to eye6 glasses and contact lenses furnished to an indi7 vidual on or after January 1, 2023, subject to 

8 subparagraph (B), payment may be made under 

9 this part only— 

10 ‘‘(i) during a 2-year period, for either 

11 1 pair of eyeglasses (including lenses and 

12 frames) or not more than a 2-year supply 

13 of contact lenses that is provided in not 

14 more than 180-day increments; 

15 ‘‘(ii) with respect to amounts attrib16 utable to the lenses and frames of such a 

17 pair of eyeglasses or amounts attributable 

18 to such a 2-year supply of contact lenses, 

19 in an amount not greater than— 

20 ‘‘(I) for a pair of eyeglasses fur21 nished in, or a 2-year supply of con22 tact lenses beginning in, 2023— 

23 ‘‘(aa) $85 for the lenses of 

24 such pair of eyeglasses and $85 
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1 for the frames of such pair of 

2 eyeglasses; or 

3 ‘‘(bb) $85 for such 2-year 

4 supply of contact lenses; and 

5 ‘‘(II) for the lenses and frames of 

6 a pair of eyeglasses furnished in, or a 

7 2-year supply of contact lenses begin8 ning in, a subsequent year, the dollar 

9 amounts specified under this subpara10 graph for the previous year, increased 

11 by the percentage change in the con12 sumer price index for all urban con13 sumers (United States city average) 

14 for the 12-month period ending with 

15 June of the previous year; 

16 ‘‘(iii) for types of eyeglass lenses, and 

17 for types of contact lenses, as determined 

18 appropriate by the Secretary; 

19 ‘‘(iv) if furnished pursuant to a writ20 ten order of a physician described in sec21 tion 1861(lll); and 

22 ‘‘(v) if during the 2-year period de23 scribed in clause (i), the individual did not 

24 already receive (as described in subpara25 graph (B)) one pair of conventional eye-
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1 glasses or contact lenses subsequent to a 

2 cataract surgery with insertion of an intra3 ocular lens furnished during such period. 

4 ‘‘(B) EXCEPTION.—With respect to a 2- 

5 year period described in subparagraph (A)(i), in 

6 the case of an individual who receives cataract 

7 surgery with insertion of an intraocular lens, 

8 notwithstanding subparagraph (A), payment 

9 may be made under this part for one pair of 

10 conventional eyeglasses or contact lenses fur11 nished subsequent to such cataract surgery dur12 ing such period.’’. 

13 (2) APPLICATION OF COMPETITIVE ACQUISI14 TION.— 

15 (A) IN GENERAL.—Section 1834(h)(1)(H) 

16 of the Social Security Act (42 U.S.C. 

17 1395m(h)(1)(H)), as amended by section 

18 601(e)(2)(B)(i) and section 602(b)(3)(A), is 

19 further amended— 

20 (i) in the header by inserting ‘‘, EYE21 GLASSES, AND CONTACT LENSES’’ after 

22 ‘‘HEARING AIDS’’; 

23 (ii) by inserting ‘‘and of eyeglasses 

24 and contact lenses described in paragraph 
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1 (2)(F) of such section,’’ after ‘‘paragraph 

2 (2)(E) of such section,’’; and 

3 (iii) in clause (i), by inserting ‘‘, or 

4 such eyeglasses and contact lenses’’ after 

5 ‘‘such hearing aids’’. 

6 (B) CONFORMING AMENDMENT.— 

7 (i) IN GENERAL.—Section 1847(a)(2) 

8 of the Social Security Act (42 U.S.C. 

9 1395w–3(a)(2)), as amended by section 

10 601(e)(2)(B)(ii) and section 

11 602(b)(3)(B)(i), is further amended by 

12 adding at the end the following new sub13 paragraph: 

14 ‘‘(F) EYEGLASSES AND CONTACT

15 LENSES.—Eyeglasses and contact lenses de16 scribed in section 1861(s)(8) for which payment 

17 would otherwise be made under section 

18 1834(h).’’. 

19 (ii) EXEMPTION OF CERTAIN ITEMS

20 FROM COMPETITIVE ACQUISITION.—Sec21 tion 1847(a)(7) of the Social Security Act 

22 (42 U.S.C. 1395w–3(a)(7)), as amended 

23 by section 601(e)(2)(B)(iii) and section 

24 602(b)(3)(B)(ii), is further amended by 
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1 adding at the end the following new sub2 paragraph: 

3 ‘‘(E) CERTAIN EYEGLASSES AND CONTACT

4 LENSES.—Those items and services described in 

5 paragraph (2)(F) if furnished by a physician or 

6 other practitioner (as defined by the Secretary) 

7 to the physician’s or practitioner’s own patients 

8 as part of the physician’s or practitioner’s pro9 fessional service.’’. 

10 (g) EXCLUSION MODIFICATIONS.—Section 1862(a) 

11 of the Social Security Act (42 U.S.C. 1395y(a)), as 

12 amended by section 601(f), is further amended— 

13 (1) in paragraph (1)— 

14 (A) in subparagraph (P), by striking 

15 ‘‘and’’ at the end; 

16 (B) in subparagraph (Q), by striking the 

17 semicolon at the end and inserting ‘‘, and’’; and 

18 (C) by adding at the end the following new 

19 subparagraph: 

20 ‘‘(R) in the case of vision services (as defined 

21 in section 1861(lll)) that are routine eye examina22 tions and contact lens fitting services (as described 

23 in paragraph (1) or (2), respectively, of such sec24 tion), which are furnished more frequently than once 

25 during a 2-year period;’’; and 
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1 (2) in paragraph (7)— 

2 (A) by inserting ‘‘(other than such an ex3 amination that is a vision service that is cov4 ered under section 1861(s)(2)(JJ))’’ after ‘‘eye 

5 examinations’’; and 

6 (B) by inserting ‘‘(other than such a proce7 dure that is a vision service that is covered 

8 under section 1861(s)(2)(JJ))’’ after ‘‘refractive 

9 state of the eyes’’. 

10 (h) CERTAIN NON-APPLICATION.— 

11 (1) IN GENERAL.—The last sentence of section 

12 1839(a)(1) of the Social Security Act (42 U.S.C. 

13 1395r(a)(1)), as added by section 601(g)(1) and 

14 amended by section 602(d)(1), is further amended 

15 by inserting ‘‘, and 603 (other than subsection (h))’’ 

16 after ‘‘602 (other than subsection (d))’’. 

17 (2) PAYMENT.—Paragraph (4) of section 

18 1844(a) of such Act (42 U.S.C. 1395w(a)), as added 

19 by section 601(g)(2) and amended by section 

20 602(d)(2), is further amended by inserting ‘‘, and 

21 603 (other than subsection (h))’’ after ‘‘602 (other 

22 than subsection (d))’’. 

23 (i) IMPLEMENTATION FUNDING.— 

24 (1) IN GENERAL.—The Secretary of Health and 

25 Human Services (in this subsection referred to as 
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1 the ‘‘Secretary’’) shall provide for the transfer from 

2 the Federal Supplementary Medical Insurance Trust 

3 Fund under section 1841 of the Social Security Act 

4 (42 U.S.C. 1395t) to the Centers for Medicare & 

5 Medicaid Services Program Management Account 

6 of— 

7 (A) $20,000,000 for each of fiscal years 

8 2020 through 2024 for purposes of imple9 menting the amendments made by this section; 

10 and 

11 (B) such sums as determined appropriate 

12 by the Secretary for each subsequent fiscal year 

13 for purposes of administering the provisions of 

14 such amendments. 

15 (2) AVAILABILITY AND ADDITIONAL USE OF

16 FUNDS.—Funds transferred pursuant to paragraph 

17 (1) shall remain available until expended and may be 

18 used, in addition to the purpose specified in para19 graph (1)(A), to implement the amendments made 

20 by sections 601 and 602. 
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1 TITLE VII—NIH, FDA, AND 

2 OPIOIDS FUNDING 

3 Subtitle A—Biomedical Innovation 

4 Expansion 

5 SEC. 701. NIH INNOVATION INITIATIVES. 

6 (a) NIH INNOVATION ACCOUNT.— 

7 (1) IN GENERAL.—Section 1001(b) of the 21st 

8 Century Cures Act (Public Law 114–255) is amend9 ed by adding at the end the following: 

10 ‘‘(5) SUPPLEMENTAL FUNDING AND ADDI11 TIONAL ACTIVITIES.— 

12 ‘‘(A) IN GENERAL.—In addition to the 

13 funds made available under paragraph (2), 

14 there are authorized to be appropriated, and 

15 are hereby appropriated, to the Account, out of 

16 any monies in the Treasury not otherwise ap17 propriated, to be available until expended with18 out further appropriation, the following: 

19 ‘‘(i) For fiscal year 2021, 

20 $255,400,000. 

21 ‘‘(ii) For fiscal year 2022, 

22 $260,400,000. 

23 ‘‘(iii) For fiscal year 2023, 

24 $163,400,000. 
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1 ‘‘(iv) For fiscal year 2024, 

2 $547,000,000. 

3 ‘‘(v) For fiscal year 2025, 

4 $848,000,000. 

5 ‘‘(vi) For fiscal year 2026, 

6 $842,400,000. 

7 ‘‘(vii) For fiscal year 2027, 

8 $1,089,600,000. 

9 ‘‘(viii) For fiscal year 2028, 

10 $1,115,600,000. 

11 ‘‘(ix) For fiscal year 2029, 

12 $1,170,600,000. 

13 ‘‘(x) For fiscal year 2030, 

14 $1,207,600,000. 

15 ‘‘(B) SUPPLEMENTAL FUNDING FOR CER16 TAIN PROJECTS.—Of the total amounts made 

17 available under subparagraph (A) for each of 

18 fiscal years 2021 through 2030, a total amount 

19 not to exceed the following shall be made avail20 able for the following categories of NIH Innova21 tion Projects: 

22 ‘‘(i) For projects described in para23 graph (4)(A), an amount not to exceed a 

24 total of $2,070,600,000 as follows: 
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1 ‘‘(I) For each of fiscal years 

2 2021 and 2022, $50,000,000. 

3 ‘‘(II) For fiscal year 2024, 

4 $100,000,000. 

5 ‘‘(III) For each of fiscal years 

6 2025 and 2026, $300,000,000. 

7 ‘‘(IV) For each of fiscal years 

8 2027 through 2029, $317,000,000. 

9 ‘‘(V) For fiscal year 2030, 

10 $319,600,000. 

11 ‘‘(ii) For projects described in para12 graph (4)(B), an amount not to exceed a 

13 total of $2,041,900,000 as follows: 

14 ‘‘(I) For each of fiscal years 

15 2021 and 2022, $50,000,000. 

16 ‘‘(II) For fiscal year 2024, 

17 $128,000,000. 

18 ‘‘(III) For fiscal year 2025, 

19 $209,000,000. 

20 ‘‘(IV) For fiscal year 2026, 

21 $100,000,000. 

22 ‘‘(V) For fiscal year 2027, 

23 $325,000,000. 

24 ‘‘(VI) For fiscal year 2028, 

25 $350,000,000. 
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1 ‘‘(VII) For fiscal year 2029, 

2 $400,000,000. 

3 ‘‘(VIII) For fiscal year 2030, 

4 $429,900,000. 

5 ‘‘(iii) For projects described in para6 graph (4)(C), an amount not to exceed a 

7 total of $1,558,400,000 as follows: 

8 ‘‘(I) For each of fiscal years 

9 2024 and 2025, $151,200,000. 

10 ‘‘(II) For each of fiscal years 

11 2026 through 2030, $251,200,000. 

12 ‘‘(iv) For projects described in para13 graph (4)(D), an amount not to exceed 

14 $15,400,000 for each of fiscal years 2021 

15 through 2030. 

16 ‘‘(C) ADDITIONAL NIH INNOVATION

17 PROJECTS.—In addition to funding NIH Inno18 vation Projects pursuant to subparagraph (B), 

19 of the total amounts made available under sub20 paragraph (A), a total amount not to exceed 

21 the following shall be made available for the fol22 lowing categories of NIH Innovation Projects: 

23 ‘‘(i) To support research related to 

24 combating antimicrobial resistance and an25 tibiotic resistant bacteria, including re-
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1 search into new treatments, diagnostics, 

2 and vaccines, research, in consultation with 

3 the Centers for Disease Control and Pre4 vention, into stewardship, and the develop5 ment of strategies, in coordination with the 

6 Biomedical Advanced Research and Devel7 opment Authority under section 319L of 

8 the Public Health Service Act, to support 

9 commercialization of new antibiotics, not 

10 to exceed a total of 1,144,500,000, as fol11 lows: 

12 ‘‘(I) For each of fiscal years 

13 2021 through 2024, $100,000,000. 

14 ‘‘(II) For each of fiscal years 

15 2025 and 2026, $120,000,000. 

16 ‘‘(III) For each of fiscal years 

17 2027 through 2029, $125,000,000. 

18 ‘‘(IV) For fiscal year 2030, 

19 $129,500,000. 

20 ‘‘(ii) To support research and re21 search activities related to rare diseases or 

22 conditions, including studies or analyses 

23 that help to better understand the natural 

24 history of a rare disease or condition and 

25 translational studies related to rare dis-
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1 eases or conditions, not to exceed a total of 

2 $530,600,000, as follows: 

3 ‘‘(I) For fiscal year 2021, 

4 $40,000,000. 

5 ‘‘(II) For fiscal year 2022, 

6 $45,000,000. 

7 ‘‘(III) For fiscal year 2023, 

8 $48,000,000. 

9 ‘‘(IV) For each of fiscal years 

10 2024 and 2025, $52,400,000. 

11 ‘‘(V) For fiscal year 2026, 

12 $55,800,000. 

13 ‘‘(VI) For fiscal year 2027, 

14 $56,000,000. 

15 ‘‘(VII) For fiscal year 2028, 

16 $57,000,000. 

17 ‘‘(VIII) For each of fiscal years 

18 2029 and 2030, $62,000,000.’’. 

19 (2) CONFORMING AMENDMENTS.—Section 1001 

20 of the 21st Century Cures Act (Public Law 114– 

21 255) is amended— 

22 (A) in subsection (a), by striking ‘‘sub23 section (b)(4)’’ and inserting ‘‘subsections 

24 (b)(4) and (b)(5)’’; 
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1 (B) in subsection (b)(1), by striking ‘‘para2 graph (4)’’ and inserting ‘‘paragraphs (4) and 

3 (5)’’; and 

4 (C) in subsection (c)(2)(A)(ii), by inserting 

5 ‘‘or pursuant to subsection (b)(5)’’ after ‘‘sub6 section (b)(3)’’; and 

7 (D) in subsection (d), by inserting ‘‘or pur8 suant to subsection (b)(5)’’ after ‘‘subsection 

9 (b)(3)’’. 

10 (b) WORKPLAN.—Section 1001(c)(1) of the 21st 

11 Century Cures Act (Public Law 114–255) is amended by 

12 adding at the end the following: 

13 ‘‘(D) UPDATES.—The Director of NIH 

14 shall , after seeking recommendations in accord15 ance with the process described in subpara16 graph (C), update the work plan submitted 

17 under this subsection for each of fiscal years 

18 2021 through 2030 to reflect the amendments 

19 made to this section by the Elijah E. Cum20 mings Lower Drug Costs Now Act.’’. 

21 (c) ANNUAL REPORTS.—Section 1001(c)(2)(A) of the 

22 21st Century Cures Act (Public Law 114–255) is amend23 ed by striking ‘‘2027’’ and inserting ‘‘2030’’. 

24 (d) SUNSET.—Section 1001(e) of the 21st Century 

25 Cures Act (Public Law 114–255) is amended by striking 
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1 ‘‘September 30, 2026’’ and inserting ‘‘September 30, 

2 2030’’. 

3 SEC. 702. NIH CLINICAL TRIAL. 

4 Part A of title IV of the Public Health Service Act 

5 (42 U.S.C. 281 et seq.) is amended by adding at the end 

6 the following: 

7 ‘‘SEC. 404O. CLINICAL TRIAL ACCELERATION PILOT INITIA8 TIVE. 

9 ‘‘(a) ESTABLISHMENT OF PILOT PROGRAM.—The 

10 Secretary, acting through the Director of the National In11 stitutes of Health, shall, not later than 2 years after the 

12 date of enactment of this Act, establish and implement 

13 a pilot program to award multi-year contracts to eligible 

14 entities to support phase II clinical trials and phase III 

15 clinical trials— 

16 ‘‘(1) to promote innovation in treatments and 

17 technologies supporting the advanced research and 

18 development and production of high need cures; and 

19 ‘‘(2) to provide support for the development of 

20 medical products and therapies. 

21 ‘‘(b) ELIGIBLE ENTITIES.—To be eligible to receive 

22 assistance under the pilot program established under sub23 section (a), an entity shall— 
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1 ‘‘(1) be seeking to market a medical product or 

2 therapy that is the subject of clinical trial or trials 

3 to be supported using such assistance; 

4 ‘‘(2) be a public or private entity, which may 

5 include a private or public research institution, a 

6 contract research organization, an institution of 

7 higher education (as defined in section 101 of the 

8 Higher Education Act of 1965 (20 U.S.C. 1001)), a 

9 medical center, a biotechnology company, or an aca10 demic research institution; and 

11 ‘‘(3) comply with requirements of the Federal 

12 Food, Drug, and Cosmetic Act or section 351 of this 

13 Act at all stages of development, manufacturing, re14 view, approval, and safety surveillance of a medical 

15 product. 

16 ‘‘(c) DUTIES.—The Secretary, acting through the Di17 rector of National Institutes of Health, shall— 

18 ‘‘(1) in establishing the pilot program under 

19 subsection (a), consult with— 

20 ‘‘(A) the Director of the National Center 

21 for Advancing Translational Sciences and the 

22 other national research institutes in considering 

23 their requests for new or expanded clinical trial 

24 support efforts; and 
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1 ‘‘(B) the Commissioner of Food and Drugs 

2 and any other head of a Federal agency as the 

3 Secretary determines to be appropriate to en4 sure coordination and efficiently advance clin5 ical trial activities; 

6 ‘‘(2) in implementing the pilot program under 

7 subsection (a), consider consulting with patients and 

8 patient advocates; and 

9 ‘‘(3) in awarding contracts under the pilot pro10 gram under subsection (a), consider— 

11 ‘‘(A) the expected health impacts of the 

12 clinical trial or trials to be supported under the 

13 contract; and 

14 ‘‘(B) the degree to which the medical prod15 uct or therapy that is the subject of such clin16 ical trial or trials is a high need cure. 

17 ‘‘(d) EXCLUSION.—A contract may not be awarded 

18 under the pilot program under subsection (a) if the drug 

19 that is the subject of the clinical trial or trials to be sup20 ported under the contract is a drug designated under sec21 tion 526 of the Federal Food, Drug, and Cosmetic Act 

22 as a drug for a rare disease or condition. 

23 ‘‘(e) NIH CLINICAL TRIAL ACCELERATOR AC24 COUNT.— 
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1 ‘‘(1) ESTABLISHMENT.—There is established in 

2 the Treasury an account, to be known as the ‘NIH 

3 Clinical Trial Accelerator Account’ (referred to in 

4 this section as the ‘Account’), for purposes of car5 rying out this section. 

6 ‘‘(2) TRANSFER OF DIRECT SPENDING SAV7 INGS.—There shall be transferred to the Account 

8 from the general fund of the Treasury, 

9 $680,000,000 for each of fiscal years 2021 through 

10 2025, to be available until expended without further 

11 appropriation. 

12 ‘‘(3) WORK PLAN.—Not later than 180 days 

13 after the date of enactment of this Act, the Sec14 retary shall submit to the Committee on Energy and 

15 Commerce of the House of Representatives and the 

16 Committee on Health, Education, Labor and Pen17 sions of the Senate a work plan that includes the 

18 proposed implementation of this section and the pro19 posed allocation of funds in the Account. 

20 ‘‘(f) REPORTS TO CONGRESS.—Not later than Octo21 ber 1 of each fiscal year, the Secretary shall submit to 

22 the Committee on Energy and Commerce of the House 

23 of Representatives and the Committee on Health, Edu24 cation, Labor and Pensions of the Senate a report on— 

25 ‘‘(1) the implementation of this section; 
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1 ‘‘(2) any available results on phase II clinical 

2 trials and phase III clinical trials supported under 

3 this section during such fiscal year; and 

4 ‘‘(3) the extent to which Federal funds are obli5 gated to support such clinical trials, including the 

6 specific amount of such support and awards pursu7 ant to an allocation from the Account under sub8 section (e). 

9 ‘‘(g) DEFINITIONS.—In this section: 

10 ‘‘(1) PHASE II CLINICAL TRIAL.—The term 

11 ‘phase II clinical trial’ means a phase II clinical in12 vestigation, as described in section 312.21 of title 

13 21, Code of Federal Regulations (or any successor 

14 regulations). 

15 ‘‘(2) PHASE III CLINICAL TRIALS.—The term 

16 ‘phase III clinical trial’ means a phase III clinical 

17 investigation, as described in section 312.21 of title 

18 21, Code of Federal Regulations (or any successor 

19 regulations). 

20 ‘‘(3) HIGH NEED CURE.—The term ‘high need 

21 cure’ has the meaning given such term in section 

22 480(a)(3).’’. 
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1 SEC. 703. INNOVATION NETWORK. 

2 Part A of title IV of the Public Health Service Act 

3 (42 U.S.C. 281 et seq.), as amended by section 702, is 

4 further amended by adding at the end the following: 

5 ‘‘SEC. 404P. INNOVATION NETWORK. 

6 ‘‘(a) FUNDS.—The Director of NIH shall award 

7 grants or contracts to eligible entities to develop, expand, 

8 and enhance the commercialization of biomedical products. 

9 ‘‘(b) ELIGIBLE ENTITY.—In this section, the term 

10 ‘eligible entity’ means an entity receiving funding under— 

11 ‘‘(1) the Small Business Innovation Research 

12 program of the National Institutes of Health; or 

13 ‘‘(2) the Small Business Technology Transfer 

14 program of the National Institutes of Health. 

15 ‘‘(c) USE OF FUNDS.—An eligible entity shall use the 

16 funds received through such grant or contract to sup17 port— 

18 ‘‘(1) the Commercialization Readiness Pilot 

19 program of the National Institutes of Health; 

20 ‘‘(2) the Innovation Corps program of the Na21 tional Institutes of Health; 

22 ‘‘(3) the Commercialization Accelerator pro23 gram of the National Institutes of Health; 

24 ‘‘(4) the Commercialization Assistance program 

25 of the National Institutes of Health; and 
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1 ‘‘(5) such other programs and activities as the 

2 Director of NIH determines to be appropriate, to 

3 support the commercialization stage of research, 

4 later stage research and development, technology 

5 transfer, and commercialization technical assistance. 

6 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

7 are authorized to be appropriated to carry out this section 

8 $100,000,000 for each of fiscal years 2021 through 2025, 

9 to be available until expended.’’. 

10 Subtitle B—Investing in Safety and 

11 Innovation 

12 SEC. 711. FOOD AND DRUG ADMINISTRATION. 

13 (a) FDA INNOVATION ACCOUNT.— 

14 (1) IN GENERAL.—Section 1002(b) of the 21st 

15 Century Cures Act (Public Law 114–255) is amend16 ed— 

17 (A) in paragraph (1), by striking ‘‘para18 graph (4)’’ and inserting ‘‘paragraphs (4) and 

19 (5)’’; and 

20 (B) by adding at the end the following new 

21 paragraph: 

22 ‘‘(5) SUPPLEMENTAL FUNDING AND ADDI23 TIONAL ACTIVITIES.— 

24 ‘‘(A) IN GENERAL.—In addition to the 

25 funds made available under paragraph (2), 
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1 there are authorized to be appropriated, and 

2 are hereby appropriated, to the Account, out of 

3 any monies in the Treasury not otherwise ap4 propriated, to be available until expended with5 out further appropriation, the following: 

6 ‘‘(i) For fiscal year 2020, 

7 $417,500,000. 

8 ‘‘(ii) For each of fiscal years 2021 

9 and 2022, $157,500,000. 

10 ‘‘(iii) For each of fiscal years 2023 

11 through 2025, $152,500,000. 

12 ‘‘(iv) For each of fiscal years 2026 

13 through 2029, $202,500,000. 

14 ‘‘(B) SUPPLEMENTAL FUNDING FOR CER15 TAIN ACTIVITIES.—Of the total amounts made 

16 available under subparagraph (A) for each of 

17 fiscal years 2026 through 2029, a total amount 

18 not to exceed $50,000,000 for each such fiscal 

19 year, shall be made available for the activities 

20 under subtitles A through F (including the 

21 amendments made by such subtitles) of title III 

22 of this Act and section 1014 of the Federal 

23 Food, Drug, and Cosmetic Act, as added by 

24 section 3073 of this Act. 
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1 ‘‘(C) ADDITIONAL FDA ACTIVITIES.—In 

2 addition to funding activities pursuant to sub3 paragraph (B), of the total amounts made 

4 available under subparagraph (A), a total 

5 amount not to exceed the following shall be 

6 made available for the following categories of 

7 activities: 

8 ‘‘(i) For modernization of the tech9 nical infrastructure of the Food and Drug 

10 Administration, including enhancements 

11 such as interoperability across the agency, 

12 and additional capabilities to develop an 

13 advanced information technology infra14 structure to support the agency’s regu15 latory mission: 

16 ‘‘(I) For fiscal year 2020, 

17 $180,000,000. 

18 ‘‘(II) For each of fiscal years 

19 2021 through 2029, $60,000. 

20 ‘‘(ii) For support for continuous man21 ufacturing of drugs and biological prod22 ucts, including complex biological products 

23 such as regenerative medicine therapies, 

24 through grants to institutions of higher 

25 education and nonprofit organizations and 
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1 other appropriate mechanisms, for each of 

2 fiscal years 2020 through 2029, 

3 $20,000,000. 

4 ‘‘(iii) For support for the Commis5 sioner of Food and Drugs to engage ex6 perts, such as through the formation and 

7 operation of public-private partnerships or 

8 other appropriate collaborative efforts, to 

9 advance the development and delivery of 

10 individualized human gene therapy prod11 ucts: 

12 ‘‘(I) For fiscal year 2020, 

13 $50,000,000. 

14 ‘‘(II) For each of fiscal years 

15 2021 through 2029, $10,000,000. 

16 ‘‘(iv) For support for inspections, en17 forcement, and quality surveillance activi18 ties across the Food and Drug Administra19 tion, including foreign and domestic in20 spections across products, for each of fiscal 

21 years 2020 through 2029, $20,000,000. 

22 ‘‘(v) For support for activities of the 

23 Food and Drug Administration related to 

24 customs and border protection to provide 

25 improvements to technologies, inspection 
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1 capacity, and sites of import (including 

2 international mail facilities) in which the 

3 Food and Drug Administration operates, 

4 for each of fiscal years 2020 through 

5 2029, $10,000,000. 

6 ‘‘(vi) To further advance the develop7 ment of a coordinated postmarket surveil8 lance system for all medical products, in9 cluding drugs, biological products, and de10 vices, linked to electronic health records in 

11 furtherance of the Food and Drug Admin12 istration’s postmarket surveillance capabili13 ties: 

14 ‘‘(I) For fiscal year 2020, 

15 $112,500,000. 

16 ‘‘(II) For each of fiscal years 

17 2021 through 2029, $12,500,000. 

18 ‘‘(vii) For support for Food and Drug 

19 Administration activities to keep pace with 

20 the projected product development of re21 generative therapies, including cellular and 

22 somatic cell gene therapy products: 

23 ‘‘(I) For each of fiscal years 

24 2020 through 2022, $10,000,000. 
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1 ‘‘(II) For each of fiscal years 

2 2023 through 2029, $5,000,000. 

3 ‘‘(viii) For carrying out section 714A 

4 of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 379d–3a; relating to hiring 

6 authority for scientific, technical, and pro7 fessional personnel), for each of fiscal 

8 years 2020 through 2029, $2,500,000. 

9 ‘‘(ix) For the Food and Drug Admin10 istration to support improvements to the 

11 technological infrastructure for reporting 

12 and analysis of adverse events associated 

13 with the use of drugs and biological prod14 ucts, for each of fiscal years 2020 through 

15 2029, $12,500,000.’’. 

16 (2) CONFORMING AMENDMENTS.—Section 1002 

17 of the 21st Century Cures Act (Public Law 114– 

18 255) is amended— 

19 (A) in subsection (a), by inserting before 

20 the period at the end the following: ‘‘or pursu21 ant to subparagraph (A) of subsection (b)(5) to 

22 carry out the activities described in subpara23 graphs (B) and (C) of such subsection’’; and 

24 (B) in subsection (d)— 
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1 (i) by inserting ‘‘or pursuant to sub2 paragraph (A) of subsection (b)(5)’’ after 

3 ‘‘subsection (b)(3)’’; and 

4 (ii) by striking ‘‘subsection (b)(4)’’ 

5 and inserting ‘‘subsections (b)(4) and 

6 (b)(5)’’. 

7 (b) ANNUAL REPORT.—Section 1002(c)(2)(A) of the 

8 21st Century Cures Act (Public Law 114–255) is amend9 ed, in the matter preceding clause (i), by striking ‘‘2026’’ 

10 and inserting ‘‘2030’’. 

11 (c) SUNSET.—Section 1002(e) of the 21st Century 

12 Cures Act (Public Law 114–255) is amended by striking 

13 ‘‘September 30, 2025’’ and inserting ‘‘September 30, 

14 2030’’. 

15 SEC. 712. STUDY ON HIGH-RISK, HIGH-REWARD DRUGS. 

16 (a) IN GENERAL.—Not later than 180 days after the 

17 date of enactment of this Act, the Secretary of Health and 

18 Human Services shall conduct a study to identify— 

19 (1) diseases or conditions that lack a treatment 

20 approved by the Food and Drug Administration and 

21 instances in which development of a treatment for 

22 such diseases or conditions could fill an unmet med23 ical need for the treatment of a serious or life24 threatening disease or condition or a rare disease or 

25 condition; and 
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1 (2) appropriate incentives that would lead to 

2 the development, approval, and marketing of such 

3 treatments. 

4 (b) REPORT TO CONGRESS; RECOMMENDATIONS.— 

5 Not later than one year after the date of enactment of 

6 this Act, the Secretary shall submit to the Congress a re7 port that includes— 

8 (1) findings from the study under subsection 

9 (a); and 

10 (2) recommendations regarding legislation nec11 essary to create appropriate incentives identified 

12 pursuant to subsection (a)(2). 

13 Subtitle C—Opioid Epidemic 

14 Response 

15 SEC. 721. OPIOID EPIDEMIC RESPONSE FUND. 

16 (a) IN GENERAL.—The Secretary of Health and 

17 Human Services (referred to in this section as the ‘‘Sec18 retary’’) shall use any funds made available pursuant to 

19 subsection (b) to carry out the programs and activities de20 scribed in subsection (c) to address the opioid and sub21 stance use disorder epidemic. Such funds shall be in addi22 tion to any funds which are otherwise available to carry 

23 out such programs and activities. 

24 (b) OPIOID EPIDEMIC RESPONSE FUND.— 
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1 (1) ESTABLISHMENT OF ACCOUNT.—There is 

2 established in the Treasury an account, to be known 

3 as the Opioid Epidemic Response Fund (referred to 

4 in this section as the ‘‘Fund’’), for purposes of fund5 ing the programs and activities described in sub6 section (c). 

7 (2) FUNDING.—There is authorized to be ap8 propriated, and there is appropriated, to the Fund, 

9 out of any monies in the Treasury not otherwise ap10 propriated $1,980,000,000 for each of fiscal years 

11 2021 through 2025. 

12 (3) AVAILABILITY.—Amounts made available by 

13 paragraph (2) shall be made available to the agen14 cies specified in subsection (c) in accordance with 

15 such subsection. Amounts made available to an 

16 agency pursuant to the preceding sentence for a fis17 cal year shall remain available until expended. 

18 (c) PROGRAMS AND ACTIVITIES.—Of the total 

19 amount in the Fund for each of fiscal years 2021 through 

20 2025, such amount shall be allocated as follows: 

21 (1) SAMHSA.—For the Substance Abuse and 

22 Mental Health Services Administration to carry out 

23 programs and activities pursuant to section 722, 

24 $1,500,000,000 for each of fiscal years 2021 

25 through 2025. 
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1 (2) CDC.—For the Centers for Disease Control 

2 and Prevention to carry out programs and activities 

3 pursuant to section 723, $120,000,000 for each of 

4 fiscal years 2021 through 2025. 

5 (3) FDA.—For the Food and Drug Adminis6 tration to carry out programs and activities pursu7 ant to section 724, $10,000,000 for each of fiscal 

8 years 2021 through 2025. 

9 (4) NIH.—For the National Institutes of 

10 Health to carry out programs and activities pursu11 ant to section 725, $240,000,000 for each of fiscal 

12 years 2021 through 2025. 

13 (5) HRSA.—For the Health Resources and 

14 Services Administration to carry out programs and 

15 activities pursuant to section 726, $90,000,000 for 

16 each of fiscal years 2021 through 2025. 

17 (6) ACF.—For the Administration for Children 

18 and Families to carry out programs and activities 

19 pursuant to section 727, $20,000,000 for each of 

20 fiscal years 2021 through 2025. 

21 (d) ACCOUNTABILITY AND OVERSIGHT.— 

22 (1) WORK PLAN.— 

23 (A) IN GENERAL.—Not later than 180 

24 days after the date of enactment of this Act, 

25 the Secretary of Health and Human Services 
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1 shall submit to the Committee on Health, Edu2 cation, Labor, and Pensions and the Committee 

3 on Appropriations of the Senate and the Com4 mittee on Energy and Commerce, the Com5 mittee on Appropriations, and the Committee 

6 on Education and Labor of the House of Rep7 resentatives, a work plan including the proposed 

8 allocation of funds made available pursuant to 

9 subsection (b) for each of fiscal years 2021 

10 through 2025 and the contents described in 

11 subparagraph (B). 

12 (B) CONTENTS.—The work plan submitted 

13 under subparagraph (A) shall include— 

14 (i) the amount of money to be obli15 gated or expended out of the Fund in each 

16 fiscal year for each program and activity 

17 described in subsection (c); and 

18 (ii) a description and justification of 

19 each such program and activity. 

20 (2) ANNUAL REPORTS.—Not later than October 

21 1 of each of fiscal years 2022 through 2026, the 

22 Secretary of Health and Human Services shall sub23 mit to the Committee on Health, Education, Labor, 

24 and Pensions and the Committee on Appropriations 

25 of the Senate and the Committee on Energy and 
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1 Commerce, the Committee on Appropriations, and 

2 the Committee on Education and Labor of the 

3 House of Representatives, a report including— 

4 (A) the amount of money obligated or ex5 pended out of the Fund in the prior fiscal year 

6 for each program and activity described in sub7 section (c); 

8 (B) a description of all programs and ac9 tivities using funds made available pursuant to 

10 subsection (b); and 

11 (C) how the programs and activities are re12 sponding to the opioid and substance use dis13 order epidemic. 

14 (e) LIMITATIONS.—Notwithstanding any authority in 

15 this subtitle or any appropriations Act, any funds made 

16 available pursuant to subsection (b) may not be used for 

17 any purpose other than the programs and activities de18 scribed in subsection (c). 

19 SEC. 722. SUBSTANCE ABUSE AND MENTAL HEALTH SERV20 ICES ADMINISTRATION. 

21 (a) IN GENERAL.—The entirety of the funds made 

22 available pursuant to section 721(c)(1) shall be for the As23 sistant Secretary for Mental Health and Substance Use 

24 to continue to award the State Opioid Response Grants 

25 funded by the heading ‘‘Substance Abuse And Mental 
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1 Health Services Administration—Substance Abuse Treat2 ment’’ in title II of the Departments of Labor, Health and 

3 Human Services, and Education, and Related Agencies 

4 Appropriations Act, 2018 (Public Law 115–141). Subject 

5 to subsections (b) and (c), such grants shall be awarded 

6 in the same manner and subject to the same conditions 

7 as were applicable to such grants for fiscal year 2018. 

8 (b) REQUIREMENT THAT TREATMENT BE EVI9 DENCE-BASED.—As a condition on receipt of a grant pur10 suant to subsection (a), a grantee shall agree that— 

11 (1) treatments, practices, or interventions fund12 ed through the grant will be evidence-based; and 

13 (2) such treatments, practices, and interven14 tions will include medication-assisted treatment for 

15 individuals diagnosed with opioid use disorder, using 

16 drugs only if the drugs have been approved or li17 censed by the Food and Drug Administration under 

18 section 505 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 355) or section 351 of the 

20 Public Health Service Act (42 U.S.C. 262). 

21 (c) RESERVATIONS.—Of the amount made available 

22 pursuant to section 731(c)(1) for a fiscal year— 

23 (1) not less than $75,000,000 shall be reserved 

24 to make grants under subsection (a) to Indian 

25 Tribes or Tribal organizations; and 
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1 (2) not less than $50,000,000 shall be reserved 

2 to make grants under subsection (a) to political sub3 divisions of States, such as counties, cities, or towns. 

4 SEC. 723. CENTERS FOR DISEASE CONTROL AND PREVEN5 TION. 

6 (a) ADDRESSING OPIOID USE DISORDER.—The en7 tirety of the funds made available pursuant to section 

8 721(c)(2) shall be for the Director of the Centers for Dis9 ease Control and Prevention, pursuant to applicable au10 thorities in the Public Health Service Act (42 U.S.C. 201 

11 et seq.), to continue and expand programs of the Centers 

12 for Disease Control and Prevention to address opioid and 

13 substance use disorder, including by— 

14 (1) improving the timeliness and quality of data 

15 on the opioid use disorder epidemic, including im16 provement of— 

17 (A) data on fatal and nonfatal overdoses; 

18 (B) syndromic surveillance; 

19 (C) data on long-term sequelae (including 

20 neonatal abstinence syndrome); and 

21 (D) cause of death reporting related to 

22 substance abuse or opioid overdose; 

23 (2) expanding and strengthening evidence-based 

24 prevention and education strategies; 
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1 (3) supporting responsible prescribing practices, 

2 including through development and dissemination of 

3 prescriber guidelines; 

4 (4) improving access to and use of effective pre5 vention, treatment, and recovery support, including 

6 through grants and the provision of technical assist7 ance to States and localities; 

8 (5) strengthening partnerships with first re9 sponders, including to protect their safety; 

10 (6) considering the needs of vulnerable popu11 lations; 

12 (7) addressing infectious diseases linked to the 

13 opioid crisis; 

14 (8) strengthening prescription drug monitoring 

15 programs; and 

16 (9) providing financial and technical assistance 

17 to State and local health department efforts to treat 

18 and prevent substance use disorder. 

19 (b) LIMITATION.—Of the funds made available pur20 suant to section 721(c)(2) for carrying out this section, 

21 not more than 20 percent may be used for intramural pur22 poses. 

23 SEC. 724. FOOD AND DRUG ADMINISTRATION. 

24 The entirety of the funds made available pursuant to 

25 section 721(c)(3) shall be for the Commissioner of Food 
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1 and Drugs, pursuant to applicable authorities in the Pub2 lic Health Service Act (42 U.S.C. 201 et seq.) or the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

4 seq.) and other applicable law, to support widespread inno5 vation in non-opioid and non-addictive medical products 

6 for pain treatment, access to opioid addiction treatments, 

7 appropriate use of approved opioids, and efforts to reduce 

8 illicit importation of opioids. Such support may include the 

9 following: 

10 (1) Facilitating the development of non-opioid 

11 and non-addictive pain treatments. 

12 (2) Advancing guidance documents for sponsors 

13 of non-opioid pain products. 

14 (3) Developing evidence to inform the potential 

15 for nonprescription overdose therapies. 

16 (4) Examining expanded labeling indications for 

17 medication-assisted treatment. 

18 (5) Conducting public education and outreach, 

19 including public workshops or public meetings, re20 garding the benefits of medication-assisted treat21 ment, including all drugs approved by the Food and 

22 Drug Administration, and device treatment options 

23 approved or cleared by the Food and Drug Adminis24 tration. 
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1 (6) Exploring the expansion and possible man2 datory nature of prescriber education regarding pain 

3 management and appropriate opioid prescribing 

4 through authorities under section 505–1 of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 355– 

6 1). 

7 (7) Examining options to limit the duration of 

8 opioid prescriptions for acute pain, including 

9 through packaging options. 

10 (8) Increasing staff and infrastructure capacity 

11 to inspect and analyze packages at international 

12 mail facilities and pursue criminal investigations. 

13 SEC. 725. NATIONAL INSTITUTES OF HEALTH. 

14 The entirety of the funds made available pursuant to 

15 section 721(c)(4) shall be for the Director of the National 

16 Institutes of Health, pursuant to applicable authorities in 

17 the Public Health Service Act (42 U.S.C. 201 et seq.), 

18 to carry out activities related to— 

19 (1) accelerating research for addressing the 

20 opioid use disorder epidemic, including developing 

21 non-opioid medications and interventions, including 

22 non-addictive medications, to manage pain, as well 

23 as developing medications and interventions to treat 

24 and to prevent substance use disorders; 
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1 (2) conducting and supporting research on 

2 which treatments (in terms of pain management as 

3 well as treating and preventing substance use dis4 orders) are optimal for which patients; and 

5 (3) conducting and supporting research on cre6 ating longer-lasting or faster-acting antidotes for 

7 opioid overdose, particularly in response to the prev8 alence of fentanyl and carfentanyl overdoses. 

9 SEC. 726. HEALTH RESOURCES AND SERVICES ADMINIS10 TRATION. 

11 The entirety of the funds made available pursuant to 

12 section 721(c)(5) shall be for the Administrator of the 

13 Health Resources and Services Administration, pursuant 

14 to applicable authorities in titles III, VII, and VIII of the 

15 Public Health Service Act (42 U.S.C. 241 et seq.), to 

16 carry out activities that increase the availability and ca17 pacity of the behavioral health workforce. Such activities 

18 shall include providing loan repayment assistance for sub19 stance use disorder treatment providers. 

20 SEC. 727. ADMINISTRATION FOR CHILDREN AND FAMILIES. 

21 Of the funds made available pursuant to section 

22 721(c)(6) for each of fiscal years 2021 through 2025, 

23 $20,000,000 for each such fiscal year shall be for the Sec24 retary of Health and Human Services to carry out title 
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1 I of the Child Abuse Prevention and Treatment Act (42 

2 U.S.C. 5101 et seq.). 

3 Subtitle D—Reducing Administra4 tive Costs and Burdens in 

5 Health Care 

6 SEC. 731. REDUCING ADMINISTRATIVE COSTS AND BUR7 DENS IN HEALTH CARE. 

8 Title II of the Public Health Service Act (42 U.S.C. 

9 202 et seq.) is amended by adding at the end the fol10 lowing: 

11 ‘‘PART E—REDUCING ADMINISTRATIVE COSTS 

12 AND BURDENS IN HEALTH CARE 

13 ‘‘SEC. 281. ELIMINATING UNNECESSARY ADMINISTRATIVE 

14 BURDENS AND COSTS. 

15 ‘‘(a) REDUCING ADMINISTRATIVE BURDENS AND

16 COSTS.—The Secretary, in consultation with providers of 

17 health services, health care suppliers of services, health 

18 care payers, health professional societies, health vendors 

19 and developers, health care standard development organi20 zations and operating rule entities, health care quality or21 ganizations, health care accreditation organizations, public 

22 health entities, States, patients, and other appropriate en23 tities, shall, in accordance with subsection (b)— 

24 ‘‘(1) establish a goal of reducing unnecessary 

25 costs and administrative burdens across the health 
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1 care system, including the Medicare program under 

2 title XVIII of the Social Security Act, the Medicaid 

3 program under title XIX of such Act, and the pri4 vate health insurance market, by at least half over 

5 a period of 10 years from the date of enactment of 

6 this section; 

7 ‘‘(2) develop strategies and benchmarks for 

8 meeting the goal established under paragraph (1); 

9 ‘‘(3) develop recommendations for meeting the 

10 goal established under paragraph (1); and 

11 ‘‘(4) take action to reduce unnecessary costs 

12 and administrative burdens based on recommenda13 tions identified in this subsection. 

14 ‘‘(b) STRATEGIES, RECOMMENDATIONS, AND AC15 TIONS.— 

16 ‘‘(1) IN GENERAL.—To achieve the goal estab17 lished under subsection (a)(1), the Secretary, in con18 sultation with the entities described in such sub19 section, shall not later than 1 year after the date of 

20 enactment of this section, develop strategies and rec21 ommendations and take actions to meet such goal in 

22 accordance with this subsection. No strategies, rec23 ommendation, or action shall undermine the quality 

24 of patient care or patient health outcomes. 
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1 ‘‘(2) STRATEGIES.—The strategies developed 

2 under paragraph (1) shall address unnecessary costs 

3 and administrative burdens. Such strategies shall in4 clude broad public comment and shall prioritize— 

5 ‘‘(A) recommendations identified as a re6 sult of efforts undertaken to implement section 

7 3001; 

8 ‘‘(B) recommendations and best practices 

9 identified as a result of efforts undertaken 

10 under this part; 

11 ‘‘(C) a review of regulations, rules, and re12 quirements of the Department of Health and 

13 Human Services that could be modified or 

14 eliminated to reduce unnecessary costs and ad15 ministrative burden imposed on patients, pro16 viders, payers, and other stakeholders across 

17 the health care system; and 

18 ‘‘(D) feedback from stakeholders in rural 

19 or frontier areas on how to reduce unnecessary 

20 costs and administrative burdens on the health 

21 care system in those areas. 

22 ‘‘(3) RECOMMENDATIONS.—The recommenda23 tions developed under paragraph (1) shall include— 
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1 ‘‘(A) actions that improve the standardiza2 tion and automation of administrative trans3 actions; 

4 ‘‘(B) actions that integrate clinical and ad5 ministrative functions; 

6 ‘‘(C) actions that improve patient care and 

7 reduce unnecessary costs and administrative 

8 burdens borne by patients, their families, and 

9 other caretakers; 

10 ‘‘(D) actions that advance the development 

11 and adoption of open application programming 

12 interfaces and other emerging technologies to 

13 increase transparency and interoperability, em14 power patients, and facilitate better integration 

15 of clinical and administrative functions; 

16 ‘‘(E) actions to be taken by the Secretary 

17 and actions that need to be taken by other enti18 ties; and 

19 ‘‘(F) other areas, as the Secretary deter20 mines appropriate, to reduce unnecessary costs 

21 and administrative burdens required of health 

22 care providers. 

23 ‘‘(4) CONSISTENCY.—Any improvements in 

24 electronic processes proposed by the Secretary under 

25 this section should leverage existing information 
225 

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1 technology definitions under Federal Law. Specifi2 cally, any electronic processes should not be con3 strued to include a facsimile, a proprietary payer 

4 portal that does not meet standards specified by the 

5 Secretary, or an electronic form image. 

6 ‘‘(5) ACTIONS.—The Secretary shall take action 

7 to achieve the goal established under subsection 

8 (a)(1), and, not later than 1 year after the date of 

9 enactment of this section, and biennially thereafter, 

10 submit to Congress and make publically available, a 

11 report describing the actions taken by the Secretary 

12 pursuant to goals, strategies, and recommendations 

13 described in this subsection. 

14 ‘‘(6) FACA.—The Federal Advisory Committee 

15 Act (5 U.S.C. App.) shall not apply to the develop16 ment of the goal, strategies, recommendations, or 

17 actions described in this section. 

18 ‘‘(7) RULE OF CONSTRUCTION.—Nothing in 

19 this subsection shall be construed to authorize, or be 

20 used by, the Federal Government to inhibit or other21 wise restrain efforts made to reduce waste, fraud, 

22 and abuse across the health care system. 
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1 ‘‘SEC. 282. GRANTS TO STATES TO DEVELOP AND IMPLE2 MENT RECOMMENDATIONS TO ACCELERATE 

3 STATE INNOVATION TO REDUCE HEALTH 

4 CARE ADMINISTRATIVE COSTS. 

5 ‘‘(a) GRANTS.— 

6 ‘‘(1) IN GENERAL.—Not later than 6 months 

7 after the date of enactment of this section, the Sec8 retary shall award grants to at least 15 States, and 

9 one coordinating entity designated as provided for 

10 under subsection (e), to enable such States to estab11 lish and administer private-public multi-stakeholder 

12 commissions for the purpose of reducing health care 

13 administrative costs and burden within and across 

14 States. Not less than 3 of such grants shall be 

15 awarded to States that are primarily rural, frontier, 

16 or a combination thereof, in nature. 

17 ‘‘(2) ENTITIES.—For purposes of this section, 

18 the term ‘State’ means a State, a State designated 

19 entity, or a multi-State collaborative (as defined by 

20 the Secretary). 

21 ‘‘(3) PRIORITY.—In awarding grants under this 

22 section, the Secretary shall give priority to applica23 tions submitted by States that propose to carry out 

24 a pilot program or support the adoption of electronic 

25 health care transactions and operating rules. 

26 ‘‘(b) APPLICATION.— 
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1 ‘‘(1) IN GENERAL.—To be eligible to receive a 

2 grant under subsection (a) a State shall submit to 

3 the Secretary an application in such a manner and 

4 containing such information as the Secretary may 

5 reasonably require, including the information de6 scribed in paragraph (2). 

7 ‘‘(2) REQUIRED INFORMATION.—In addition to 

8 any additional information required by the Secretary 

9 under this subsection, an application shall include a 

10 description of— 

11 ‘‘(A) the size and composition of the com12 mission to be established under the grant, in13 cluding the stakeholders represented and the 

14 degree to which the commission reflects impor15 tant geographic and population characteristics 

16 of the State; 

17 ‘‘(B) the relationship of the commission to 

18 the State official responsible for coordinating 

19 and implementing the recommendations result20 ing from the commission, and the role and re21 sponsibilities of the State with respect to the 

22 commission, including any participation, review, 

23 oversight, implementation or other related func24 tions; 
228 

•HR 3 EH

1 ‘‘(C) the history and experience of the 

2 State in addressing health care administrative 

3 costs, and any experience similar to the purpose 

4 of the commission to improve health care ad5 ministrative processes and the exchange of 

6 health care administrative data; 

7 ‘‘(D) the resources and expertise that will 

8 be made available to the commission by com9 mission members or other possible sources, and 

10 how Federal funds will be used to leverage and 

11 complement these resources; 

12 ‘‘(E) the governance structure and proce13 dures that the commission will follow to make, 

14 implement, and pilot recommendations; 

15 ‘‘(F) the proposed objectives relating to the 

16 simplification of administrative transactions 

17 and operating rules, increased standardization, 

18 and the efficiency and effectiveness of the 

19 transmission of health information; 

20 ‘‘(G) potential cost savings and other im21 provements in meeting the objectives described 

22 in subparagraph (F); and 

23 ‘‘(H) the method or methods by which the 

24 recommendations described in subsection (c) 
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1 will be reviewed, tested, adopted, implemented, 

2 and updated as needed. 

3 ‘‘(c) MULTI-STAKEHOLDER COMMISSION.— 

4 ‘‘(1) IN GENERAL.—Not later than 90 days 

5 after the date on which a grant is awarded to a 

6 State under this section, the State official described 

7 in subsection (b)(2)(B), the State insurance commis8 sioner, or other appropriate State official shall con9 vene a multi-stakeholder commission, in accordance 

10 with this subsection. 

11 ‘‘(2) MEMBERSHIP.—The commission convened 

12 under paragraph (1) shall include representatives 

13 from health plans, health care providers, health ven14 dors, relevant State agencies, health care standard 

15 development organizations, and operating rule enti16 ties, relevant professional and trade associations, pa17 tients, and other entities determined appropriate by 

18 the State. 

19 ‘‘(3) RECOMMENDATIONS.—Not later than one 

20 year after the date on which a grant is awarded to 

21 a State under this section, the commission shall 

22 make recommendations and plans, consistent with 

23 the application submitted by the State under sub24 section (b), and intended to meet the objectives de25 fined in the application. Such recommendations shall 
230 

•HR 3 EH

1 comply with, and build upon, all relevant Federal re2 quirements and regulations, and may include— 

3 ‘‘(A) common, uniform specifications, best 

4 practices, and conventions, for the efficient, ef5 fective exchange of administrative transactions 

6 adopted pursuant to the Health Insurance Port7 ability and Accountability Act of 1996 (Public 

8 Law 104–191); 

9 ‘‘(B) the development of streamlined busi10 ness processes for the exchange and use of 

11 health care administrative data; and 

12 ‘‘(C) specifications, incentives, require13 ments, tools, mechanisms, and resources to im14 prove— 

15 ‘‘(i) the access, exchange, and use of 

16 health care administrative information 

17 through electronic means; 

18 ‘‘(ii) the implementation of utilization 

19 management protocols; and 

20 ‘‘(iii) compliance with Federal and 

21 State laws. 

22 ‘‘(d) USE OF FUNDS FOR IMPLEMENTATION.—A 

23 State may use amounts received under a grant under this 

24 section for one or more of the following: 
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1 ‘‘(1) The development, implementation, and 

2 best use of shared data infrastructure that supports 

3 the electronic transmission of administrative data. 

4 ‘‘(2) The development and provision of training 

5 and educational materials, forums, and activities as 

6 well as technical assistance to effectively implement, 

7 use, and benefit from electronic health care trans8 actions and operating rules. 

9 ‘‘(3) To accelerate the early adoption and im10 plementation of administrative transactions and op11 erating rules designated by the Secretary and that 

12 have been adopted pursuant to the Health Insurance 

13 Portability and Accountability Act of 1996 (Public 

14 Law 104–191), including transactions and operating 

15 rules described in section 1173(a)(2) of the Social 

16 Security Act. 

17 ‘‘(4) To accelerate the early adoption and im18 plementation of additional or updated administrative 

19 transactions, operating rules, and related data ex20 change standards that are being considered for 

21 adoption under the Health Insurance Portability and 

22 Accountability Act of 1996 or are adopted pursuant 

23 to such Act, or as designated by the Secretary, in24 cluding the electronic claim attachment. 
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1 ‘‘(5) To conduct pilot projects to test ap2 proaches to implement and use the electronic health 

3 care transactions and operating rules in practice 

4 under a variety of different settings. With respect to 

5 the electronic attachment transaction, priority shall 

6 be given to pilot projects that test and evaluate 

7 methods and mechanisms to most effectively incor8 porate patient health data from electronic health 

9 records and other electronic sources with the elec10 tronic attachment transaction. 

11 ‘‘(6) To assess barriers to the adoption, imple12 mentation, and effective use of electronic health care 

13 transactions and operating rules, as well as to ex14 plore, identify, and plan options, approaches, and re15 sources to address barriers and make improvements. 

16 ‘‘(7) The facilitation of public and private ini17 tiatives to reduce administrative costs and accelerate 

18 the adoption, implementation, and effective use of 

19 electronic health care transactions and operating 

20 rules for State programs. 

21 ‘‘(8) Developing, testing, implementing, and as22 sessing additional data exchange specifications, oper23 ating rules, incentives, requirements, tools, mecha24 nisms, and resources to accelerate the adoption and 

25 effective use of the transactions and operating rules. 
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1 ‘‘(9) Ongoing needs assessments and planning 

2 related to the development and implementation of 

3 administrative simplification initiatives. 

4 ‘‘(e) COORDINATING ENTITY.— 

5 ‘‘(1) FUNCTIONS.—Not later than 6 months 

6 after the date of enactment of this section, the Sec7 retary shall designate a coordinating entity under 

8 this subsection for the purpose of— 

9 ‘‘(A) providing technical assistance to 

10 States relating to the simplification of adminis11 trative transactions and operating rules, in12 creased standardization, and the efficiency and 

13 effectiveness of the transmission of health care 

14 information; 

15 ‘‘(B) evaluating pilot projects and other ef16 forts conducted under this section for impact 

17 and best practices to inform broader national 

18 use; 

19 ‘‘(C) using consistent evaluation meth20 odologies to compare return on investment 

21 across efforts conducted under this section; 

22 ‘‘(D) compiling, synthesizing, dissemi23 nating, and adopting lessons learned to promote 

24 the adoption of electronic health care trans-
234 

•HR 3 EH

1 actions and operating rules across the health 

2 care system; and 

3 ‘‘(E) making recommendations to the Sec4 retary and the National Committee on Vital 

5 and Health Statistics regarding the national 

6 adoption of efforts conducted under this sec7 tion. 

8 ‘‘(2) ELIGIBILITY.—The entity designated 

9 under paragraph (1) shall be a qualified nonprofit 

10 entity that— 

11 ‘‘(A) focuses its mission on administrative 

12 simplification; 

13 ‘‘(B) has demonstrated experience using a 

14 multi-stakeholder and consensus-based process 

15 for the development of common, uniform speci16 fications, operating rules, best practices, and 

17 conventions, for the efficient, effective exchange 

18 of administrative transactions that includes rep19 resentation by or participation from health 

20 plans, health care providers, vendors, States, 

21 relevant Federal agencies, and other health care 

22 standard development organizations; 

23 ‘‘(C) has demonstrated experience pro24 viding technical assistance to health plans, 

25 health care providers, vendors, and States relat-
235 

•HR 3 EH

1 ing to the simplification of administrative trans2 actions and operating rules, increased standard3 ization, and the efficiency and effectiveness of 

4 the transmission of health care information; 

5 ‘‘(D) has demonstrated experience evalu6 ating and measuring the adoption and return 

7 on investment of administrative transactions 

8 and operating rules; 

9 ‘‘(E) has demonstrated experience gath10 ering, synthesizing, and adopting common, uni11 form specifications, operating rules, best prac12 tices, and conventions for national use based on 

13 lessons learned to promote the adoption of elec14 tronic health care transactions and operating 

15 rules across the health care system; 

16 ‘‘(F) has a public set of guiding principles 

17 that ensure processes are open and transparent, 

18 and supports nondiscrimination and conflict of 

19 interest policies that demonstrate a commit20 ment to open, fair, and nondiscriminatory prac21 tices; 

22 ‘‘(G) builds on the transaction standards 

23 issued under Health Insurance Portability and 

24 Accountability Act of 1996; and 
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1 ‘‘(H) allows for public review and updates 

2 of common, uniform specifications, operating 

3 rules, best practices, and conventions to support 

4 administrative simplification. 

5 ‘‘(f) PERIOD AND AMOUNT.—A grant awarded to a 

6 State under this section shall be for a period of 5 years 

7 and shall not exceed $50,000,000 for such 5-year period. 

8 A grant awarded to the coordinating entity designated by 

9 the Secretary under subsection (e) shall be for a period 

10 of 5 years and shall not exceed $15,000,000 for such 5- 

11 year period. 

12 ‘‘(g) REPORTS.— 

13 ‘‘(1) STATES.—Not later than 1 year after re14 ceiving a grant under this section, and biennially 

15 thereafter, a State shall submit to the Secretary a 

16 report on the outcomes experienced by the State 

17 under the grant. 

18 ‘‘(2) COORDINATING ENTITY.—Not later than 1 

19 year after receiving a grant under this section, and 

20 at least biennially thereafter, the coordinating entity 

21 shall submit to the Secretary and the National Com22 mittee on Vital and Health Statistics a report of 

23 evaluations conducted under the grant under this 

24 section and recommendations regarding the national 

25 adoption of efforts conducted under this section. 
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1 ‘‘(3) SECRETARY.—Not later than 6 months 

2 after the date on which the States and coordinating 

3 entity submit the report required under paragraphs 

4 (1) and (2), the Secretary, in consultation with Na5 tional Committee on Vital and Health Statistics, 

6 shall submit to the Committee on Health, Edu7 cation, Labor, and Pensions of the Senate and the 

8 Committee on Energy and Commerce of the House 

9 of Representatives, a report on the outcomes 

10 achieved under the grants under this section. 

11 ‘‘(4) GAO.—Not later than 6 months after the 

12 date on which the Secretary submits the final report 

13 under paragraph (3), the Comptroller General of the 

14 United States shall conduct a study, and submit to 

15 the Committee on Health, Education, Labor, and 

16 Pensions of the Senate and the Committee on En17 ergy and Commerce of the House of Representa18 tives, a report on the outcomes of the activities car19 ried out under this section which shall contain a list 

20 of best practices and recommendations to States 

21 concerning administrative simplification. 

22 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—There 

23 is authorized to be appropriated to carry out this section, 

24 $250,000,000 for the 5-fiscal-year period beginning with 

25 fiscal year 2020.’’. 
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1 TITLE VIII—MISCELLANEOUS 

2 SEC. 801. GUARANTEED ISSUE OF CERTAIN MEDIGAP POLI3 CIES. 

4 (a) GUARANTEED ISSUE OF MEDIGAP POLICIES TO

5 ALL MEDIGAP-ELIGIBLE MEDICARE BENEFICIARIES.— 

6 (1) IN GENERAL.—Section 1882(s) of the So7 cial Security Act (42 U.S.C. 1395ss(s)) is amend8 ed— 

9 (A) in paragraph (2)(A), by striking ‘‘65 

10 years of age or older and is enrolled for benefits 

11 under part B’’ and inserting ‘‘entitled to, or en12 rolled for, benefits under part A and enrolled 

13 for benefits under part B’’; 

14 (B) in paragraph (2)(D), by striking ‘‘who 

15 is 65 years of age or older as of the date of 

16 issuance and’’; 

17 (C) in paragraph (3)(B)(ii), by striking ‘‘is 

18 65 years of age or older and’’; and 

19 (D) in paragraph (3)(B)(vi), by striking 

20 ‘‘at age 65’’. 

21 (2) ADDITIONAL ENROLLMENT PERIOD FOR

22 CERTAIN INDIVIDUALS.— 

23 (A) ONE-TIME ENROLLMENT PERIOD.— 

24 (i) IN GENERAL.—In the case of a 

25 specified individual, the Secretary shall es-
239 

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1 tablish a one-time enrollment period de2 scribed in clause (iii) during which such an 

3 individual may enroll in any medicare sup4 plemental policy of the individual’s choos5 ing. 

6 (ii) APPLICATION.—The provisions 

7 of— 

8 (I) paragraph (2) of section 

9 1882(s) of the Social Security Act (42 

10 U.S.C. 1395ss(s)) shall apply with re11 spect to a specified individual who is 

12 described in subclause (I) of subpara13 graph (B)(iii) as if references in such 

14 paragraph (2) to the 6 month period 

15 described in subparagraph (A) of such 

16 paragraph were references to the one17 time enrollment period established 

18 under clause (i); and 

19 (II) paragraph (3) of such sec20 tion shall apply with respect to a spec21 ified individual who is described in 

22 subclause (II) of subparagraph 

23 (B)(iii) as if references in such para24 graph (3) to the period specified in 

25 subparagraph (E) of such paragraph 
240 

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1 were references to the one-time enroll2 ment period established under clause 

3 (i). 

4 (iii) PERIOD.—The enrollment period 

5 established under clause (i) shall be the 6- 

6 month period beginning on January 1, 

7 2024. 

8 (B) SPECIFIED INDIVIDUAL.—For pur9 poses of this paragraph, the term ‘‘specified in10 dividual’’ means an individual who— 

11 (i) is entitled to hospital insurance 

12 benefits under part A of title XVIII of the 

13 Social Security Act (42 U.S.C. 1395c et 

14 seq.) pursuant to section 226(b) or section 

15 226A of such Act (42 U.S.C. 426(b); 426– 

16 1); 

17 (ii) is enrolled for benefits under part 

18 B of such Act (42 U.S.C. 1395j et seq.); 

19 and 

20 (iii)(I) would not, but for the amend21 ments made by subparagraphs (A) and (B) 

22 of paragraph (1) and the provisions of this 

23 paragraph (if such provisions applied to 

24 such individual), be eligible for the guaran25 teed issue of a medicare supplemental pol-
241 

•HR 3 EH

1 icy under paragraph (2) of section 1882(s) 

2 of such Act (42 U.S.C. 1395ss(s)); or 

3 (II) would not, but for the amend4 ments made by subparagraphs (C) and (D) 

5 of paragraph (1) and the provisions of this 

6 paragraph (if such provisions applied to 

7 such individual), be eligible for the guaran8 teed issue of a medicare supplemental pol9 icy under paragraph (3) of such section. 

10 (C) OUTREACH PLAN.— 

11 (i) IN GENERAL.—The Secretary shall 

12 develop an outreach plan to notify specified 

13 individuals of the one-time enrollment pe14 riod established under subparagraph (A). 

15 (ii) CONSULTATION.—In imple16 menting the outreach plan developed under 

17 clause (i), the Secretary shall consult with 

18 consumer advocates, brokers, insurers, the 

19 National Association of Insurance Commis20 sioners, and State Health Insurance As21 sistance Programs. 

22 (3) EFFECTIVE DATE.—The amendments made 

23 by paragraph (1) shall apply to medicare supple24 mental policies effective on or after January 1, 

25 2024. 
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1 (b) GUARANTEED ISSUE OF MEDIGAP POLICIES FOR

2 MEDICARE ADVANTAGE ENROLLEES.— 

3 (1) IN GENERAL.—Section 1882(s)(3) of the 

4 Social Security Act (42 U.S.C. 1395ss(s)(3)), as 

5 amended by subsection (a), is further amended— 

6 (A) in subparagraph (B), by adding at the 

7 end the following new clause: 

8 ‘‘(vii) The individual— 

9 ‘‘(I) was enrolled in a Medicare Advantage 

10 plan under part C for not less than 12 months; 

11 ‘‘(II) subsequently disenrolled from such 

12 plan; 

13 ‘‘(III) elects to receive benefits under this 

14 title through the original Medicare fee-for-serv15 ice program under parts A and B; and 

16 ‘‘(IV) has not previously elected to receive 

17 benefits under this title through the original 

18 Medicare fee-for-service program pursuant to 

19 disenrollment from a Medicare Advantage plan 

20 under part C.’’; 

21 (B) by striking subparagraph (C)(iii) and 

22 inserting the following: 

23 ‘‘(iii) Subject to subsection (v)(1), for purposes of an 

24 individual described in clause (vi) or (vii) of subparagraph 

25 (B), a medicare supplemental policy described in this sub-
243 

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1 paragraph shall include any medicare supplemental pol2 icy.’’; and 

3 (C) in subparagraph (E)— 

4 (i) in clause (iv), by striking ‘‘and’’ at 

5 the end; 

6 (ii) in clause (v), by striking the pe7 riod at the end and inserting ‘‘; and’’; and 

8 (iii) by adding at the end the fol9 lowing new clause— 

10 ‘‘(vi) in the case of an individual described in 

11 subparagraph (B)(vii), the annual, coordinated elec12 tion period (as defined in section 1851(e)(3)(B)) or 

13 a continuous open enrollment period (as defined in 

14 section 1851(e)(2)) during which the individual 

15 disenrolls from a Medicare Advantage plan under 

16 part C.’’. 

17 (2) EFFECTIVE DATE.—The amendments made 

18 by paragraph (1) shall apply to medicare supple19 mental policies effective on or after January 1, 

20 2024. 
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1 SEC. 802. REPORTING REQUIREMENTS FOR PDP SPONSORS 

2 REGARDING POINT-OF-SALE REJECTIONS 

3 UNDER MEDICARE PART D. 

4 Section 1860D–4(g) of the Social Security Act (42 

5 U.S.C. 1395w–104(g)) is amended by adding at the end 

6 the following new paragraph: 

7 ‘‘(3) REPORTING REQUIREMENTS REGARDING

8 POINT-OF-SALE REJECTIONS.— 

9 ‘‘(A) IN GENERAL.—With respect to a plan 

10 year beginning on or after January 1, 2020, a 

11 PDP sponsor offering a prescription drug plan 

12 shall submit to the Secretary, in a form and 

13 manner specified by the Secretary, information 

14 on point-of-sale rejections made during a period 

15 of time occurring in such plan year (as specified 

16 by the Secretary), including each of the fol17 lowing: 

18 ‘‘(i) The reason for each point-of-sale 

19 rejection. 

20 ‘‘(ii) Identifying information for each 

21 drug with respect to which a point-of-sale 

22 rejection was made. 

23 ‘‘(iii) With respect to applicable types 

24 of point-of-sale rejections (as specified by 

25 the Secretary), each of the following: 
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1 ‘‘(I) Whether such a rejection 

2 was consistent with the formulary of 

3 the plan (as approved by the Sec4 retary). 

5 ‘‘(II) Whether a coverage deter6 mination or appeal of a coverage de7 termination was requested for the 

8 drug with respect to which such a re9 jection was made. 

10 ‘‘(III) The outcome of any such 

11 coverage determination or appeal of a 

12 coverage determination. 

13 ‘‘(IV) The length of time between 

14 when such a rejection was made and 

15 when the drug with respect to which 

16 such rejection was made is dispensed, 

17 as applicable. 

18 ‘‘(B) PUBLIC AVAILABILITY OF INFORMA19 TION.—The Secretary shall make publicly avail20 able on the public website of the Centers for 

21 Medicare & Medicaid Services information sub22 mitted under subparagraph (A). 

23 ‘‘(C) USE OF INFORMATION.—The Sec24 retary may use information submitted under 

25 subparagraph (A), as determined appropriate, 
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1 in developing measures for the 5-star rating 

2 system under section 1853(o)(4). 

3 ‘‘(D) IMPLEMENTATION.—Notwithstanding 

4 any other provision of law, the Secretary may 

5 implement this paragraph through program in6 struction or otherwise. 

7 ‘‘(E) FUNDING.—The are authorized to be 

8 appropriated to the Secretary from the Federal 

9 Supplementary Medical Insurance Trust Fund 

10 under section 1841 such sums as may be nec11 essary to implement this paragraph.’’. 

12 SEC. 803. PROVIDING ACCESS TO ANNUAL MEDICARE NOTI13 FICATIONS IN MULTIPLE LANGUAGES. 

14 (a) IN GENERAL.—Section 1804 of the Social Secu15 rity Act (42 U.S.C. 1395b–2) is amended by adding at 

16 the end the following new subsection: 

17 ‘‘(e) The notice provided under subsection (a) shall 

18 be translated into languages in addition to English and 

19 Spanish. In carrying out the previous sentence, the Sec20 retary shall prioritize translation of the notice into lan21 guages in which documents provided by the Commissioner 

22 of Social Security are translated and language that are 

23 the most frequently requested for translation for purposes 

24 of applying for old-age insurance benefits under title II.’’. 
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1 (b) EFFECTIVE DATE.—The amendment made by 

2 subsection (a) shall apply to notices distributed prior to 

3 each Medicare open enrollment period beginning after 

4 January 1, 2020. 

5 SEC. 804. TEMPORARY INCREASE IN MEDICARE PART B 

6 PAYMENT FOR CERTAIN BIOSIMILAR BIO7 LOGICAL PRODUCTS. 

8 Section 1847A(b)(8) of the Social Security Act (42 

9 U.S.C. 1395w–3a(b)(8)) is amended— 

10 (1) by redesignating subparagraphs (A) and 

11 (B) as clauses (i) and (ii), respectively, and moving 

12 the margin of each such redesignated clause 2 ems 

13 to the right; 

14 (2) by striking ‘‘PRODUCT.—The amount’’ and 

15 inserting the following: ‘‘PRODUCT.— 

16 ‘‘(A) IN GENERAL.—Subject to subpara17 graph (B), the amount’’; and 

18 (3) by adding at the end the following new sub19 paragraph: 

20 ‘‘(B) TEMPORARY PAYMENT INCREASE.— 

21 ‘‘(i) IN GENERAL.—In the case of a 

22 qualifying biosimilar biological product 

23 that is furnished during the applicable 5- 

24 year period for such product, the amount 

25 specified in this paragraph for such prod-
248 

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1 uct with respect to such period is the sum 

2 determined under subparagraph (A), ex3 cept that clause (ii) of such subparagraph 

4 shall be applied by substituting ‘8 percent’ 

5 for ‘6 percent’. 

6 ‘‘(ii) APPLICABLE 5-YEAR PERIOD.— 

7 For purposes of clause (i), the applicable 

8 5-year period for a biosimilar biological 

9 product is— 

10 ‘‘(I) in the case of such a product 

11 for which payment was made under 

12 this paragraph as of December 31, 

13 2019, the 5-year period beginning on 

14 January 1, 2020; and 

15 ‘‘(II) in the case of such a prod16 uct for which payment is first made 

17 under this paragraph during a cal18 endar quarter during the period be19 ginning January 1, 2020, and ending 

20 December 31, 2024, the 5-year period 

21 beginning on the first day of such cal22 endar quarter during which such pay23 ment is first made. 

24 ‘‘(iii) QUALIFYING BIOSIMILAR BIO25 LOGICAL PRODUCT DEFINED.—For pur-
249 

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1 poses of this subparagraph, the term 

2 ‘qualifying biosimilar biological product’ 

3 means a biosimilar biological product de4 scribed in paragraph (1)(C) with respect to 

5 which— 

6 ‘‘(I) in the case of a product de7 scribed in clause (ii)(I), the average 

8 sales price is not more than the aver9 age sales price for the reference bio10 logical product; and 

11 ‘‘(II) in the case of a product de12 scribed in clause (ii)(II), the wholesale 

13 acquisition cost is not more than the 

14 wholesale acquisition cost for the ref15 erence biological product.’’. 

16 SEC. 805. WAIVING MEDICARE COINSURANCE FOR 

17 COLORECTAL CANCER SCREENING TESTS. 

18 Section 1833(a) of the Social Security Act (42 U.S.C. 

19 1395l(a)) is amended— 

20 (1) in the second sentence, by striking ‘‘section 

21 1834(0)’’ and inserting ‘‘section 1834(o)’’; 

22 (2) by moving such second sentence 2 ems to 

23 the left; and 

24 (3) by inserting the following third sentence fol25 lowing such second sentence: ‘‘For services furnished 
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1 on or after January 1, 2021, paragraph (1)(Y) shall 

2 apply with respect to a colorectal cancer screening 

3 test regardless of the code that is billed for the es4 tablishment of a diagnosis as a result of the test, or 

5 for the removal of tissue or other matter or other 

6 procedure that is furnished in connection with, as a 

7 result of, and in the same clinical encounter as the 

8 screening test.’’. 

9 SEC. 806. MEDICARE COVERAGE OF CERTAIN 

10 LYMPHEDEMA COMPRESSION TREATMENT 

11 ITEMS. 

12 (a) COVERAGE.— 

13 (1) IN GENERAL.—Section 1861 of the Social 

14 Security Act (42 U.S.C. 1395x), as amended by sec15 tion 601 and section 603, is further amended— 

16 (A) in subsection (s)(2)— 

17 (i) in subparagraph (II), by striking 

18 ‘‘and’’ after the semicolon at the end; 

19 (ii) in subparagraph (JJ), by striking 

20 the period at the end and inserting ‘‘; 

21 and’’; and 

22 (iii) by adding at the end the fol23 lowing new subparagraph: 

24 ‘‘(KK) lymphedema compression treatment 

25 items (as defined in subsection (mmm));’’; and 
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1 (B) by adding at the end the following new 

2 subsection: 

3 ‘‘(mmm) LYMPHEDEMA COMPRESSION TREATMENT

4 ITEMS.—The term ‘lymphedema compression treatment 

5 items’ means compression garments, devices, bandaging 

6 systems, components, and supplies, including multilayer 

7 compression bandaging systems, standard fit gradient 

8 compression garments, and other compression garments, 

9 devices, bandaging systems, components, or supplies (as 

10 determined by the Secretary), that are— 

11 ‘‘(1) furnished on or after January 1, 2022, to 

12 an individual with a diagnosis of lymphedema for the 

13 treatment of such condition; 

14 ‘‘(2) primarily and customarily used in the 

15 medical treatment of lymphedema, as determined by 

16 the Secretary; and 

17 ‘‘(3) prescribed by a physician (or a physician 

18 assistant, nurse practitioner, or a clinical nurse spe19 cialist (as those terms are defined in section 

20 1861(aa)(5)) to the extent authorized under State 

21 law).’’. 

22 (2) PAYMENT.— 

23 (A) IN GENERAL.—Section 1833(a)(1) of 

24 the Social Security Act (42 U.S.C. 
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1 1395l(a)(1)), as amended by section 601(c)(1), 

2 is further amended— 

3 (i) by striking ‘‘and’’ before ‘‘(DD)’’; 

4 and 

5 (ii) by inserting before the semicolon 

6 at the end the following: ‘‘, and (EE) with 

7 respect to lymphedema compression treat8 ment items (as defined in section 

9 1861(mmm)), the amount paid shall be 

10 equal to 80 percent of the lesser of the ac11 tual charge or the amount determined 

12 under the payment basis determined under 

13 section 1834(z)’’. 

14 (B) PAYMENT BASIS AND LIMITATIONS.— 

15 Section 1834 of the Social Security Act (42 

16 U.S.C. 1395m), as amended by sections 

17 601(c)(2) and 603(c), is further amended by 

18 adding at the end the following new subsection: 

19 ‘‘(z) PAYMENT FOR LYMPHEDEMA COMPRESSION

20 TREATMENT ITEMS.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall deter22 mine an appropriate payment basis for lymphedema 

23 compression treatment items (as defined in section 

24 1861(mmm)). In making such a determination, the 

25 Secretary may take into account payment rates for 
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1 such items under State plans (or waivers of such 

2 plans) under title XIX, the Veterans Health Admin3 istration, and group health plans and health insur4 ance coverage (as such terms are defined in section 

5 2791 of the Public Health Service Act), and such 

6 other information as the Secretary determines ap7 propriate. 

8 ‘‘(2) FREQUENCY LIMITATION.—No payment 

9 may be made under this part for lymphedema com10 pression treatment items furnished other than at 

11 such frequency as the Secretary may establish. 

12 ‘‘(3) APPLICATION OF COMPETITIVE ACQUISI13 TION.—In the case of lymphedema compression 

14 treatment items that are included in a competitive 

15 acquisition program in a competitive acquisition area 

16 under section 1847(a)— 

17 ‘‘(A) the payment basis under this sub18 section for such items furnished in such area 

19 shall be the payment basis determined under 

20 such competitive acquisition program; and 

21 ‘‘(B) the Secretary may use information on 

22 the payment determined under such competitive 

23 acquisition programs to adjust the payment 

24 amount otherwise determined under this sub25 section for an area that is not a competitive ac-
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1 quisition area under section 1847, and in the 

2 case of such adjustment, paragraphs (8) and 

3 (9) of section 1842(b) shall not be applied.’’. 

4 (3) CONFORMING AMENDMENTS.— 

5 (A) EXCLUSIONS.—Section 1862(a)(1) of 

6 the Social Security Act (42 U.S.C. 

7 1395y(a)(1)), as amended by section 601(f) and 

8 section 603(g), is further amended— 

9 (i) in subparagraph (Q), by striking 

10 ‘‘and’’ at the end; 

11 (ii) in subparagraph (R), by striking 

12 the semicolon and inserting ‘‘, and’’; and 

13 (iii) by adding at the end the fol14 lowing new subparagraph: 

15 ‘‘(S) in the case of lymphedema compression 

16 treatment items (as defined in section 1861(mmm)), 

17 which are furnished more frequently than is estab18 lished pursuant to section 1834(z)(2);’’. 

19 (B) APPLICATION OF COMPETITIVE ACQUI20 SITION.— 

21 (i) IN GENERAL.—Section 1847(a)(2) 

22 of the Social Security Act (42 U.S.C. 

23 1395w–3(a)(2)), as amended by sections 

24 601(e)(2)(B)(ii), 602(b)(3)(B)(i), and 

25 603(f)(2)(B), is further amended by add-
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1 ing at the end the following new subpara2 graph: 

3 ‘‘(G) LYMPHEDEMA COMPRESSION TREAT4 MENT ITEMS.—Lymphedema compression treat5 ment items (as defined in section 1861(mmm)) 

6 for which payment would otherwise be made 

7 under section 1834(z).’’. 

8 (b) INCLUSION IN REQUIREMENTS FOR SUPPLIERS

9 OF MEDICAL EQUIPMENT AND SUPPLIES.—Section 

10 1834(j)(5) of the Social Security Act (42 U.S.C. 

11 1395m(j)(5)) is amended— 

12 (1) by redesignating subparagraphs (E) and 

13 (F) as subparagraphs (F) and (G), respectively; and 

14 (2) by inserting after subparagraph (D) the fol15 lowing new subparagraph: 

16 ‘‘(E) lymphedema compression treatment 

17 items (as defined in section 1861(mmm));’’. 

18 (c) STUDY AND REPORT ON IMPLEMENTATION.— 

19 (1) STUDY.—The Secretary of Health and 

20 Human Services (in this section referred to as the 

21 ‘‘Secretary’’) shall conduct a study on the implemen22 tation of Medicare coverage of certain lymphedema 

23 compression treatment items under the amendments 

24 made by this Act. Such study shall include an eval25 uation of the following: 
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1 (A) Medicare beneficiary utilization of 

2 items and services under parts A and B of title 

3 XVIII of the Social Security Act as a result of 

4 the implementation of such amendments. 

5 (B) Whether the Secretary has determined, 

6 pursuant to section 1861(mmm) of the Social 

7 Security Act, as added by subsection (a)(1), 

8 that lymphedema compression treatment items 

9 other than compression bandaging systems and 

10 standard fit gradient compression garments are 

11 covered under such section. 

12 (2) REPORT.—Not later than January 1, 2024, 

13 the Secretary shall submit to Congress and make 

14 available to the public a report on the study con15 ducted under paragraph (1). 

16 SEC. 807. PHYSICIAN FEE UPDATE. 

17 Section 1848(d)(19) of the Social Security Act (42 

18 U.S.C. 1395w–4(d)(19)) is amended to read as follows: 

19 ‘‘(19) UPDATE FOR 2020 THROUGH 2025.—The 

20 update to the single conversion factor established in 

21 paragraph (1)(C)— 

22 ‘‘(A) for each of 2020 through 2022 shall 

23 be 0.5 percent; and 

24 ‘‘(B) for each of 2023 through 2025 shall 

25 be 0.0 percent.’’. 
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1 SEC. 808. ADDITIONAL COMMUNITY HEALTH CENTER 

2 FUNDING. 

3 Section 10503 of the Patient Protection and Afford4 able Care Act (42 U.S.C. 254b–2) is amended by striking 

5 subsection (c) and inserting the following: 

6 ‘‘(c) ADDITIONAL ENHANCED FUNDING; CAPITAL

7 PROJECTS.—There is authorized to be appropriated, and 

8 there is appropriated, out of any monies in the Treasury 

9 not otherwise appropriated, to the CHC Fund— 

10 ‘‘(1) to be transferred to the Secretary of 

11 Health and Human Services to provide additional 

12 enhanced funding for the community health center 

13 program under section 330 of the Public Health 

14 Service Act, $1,000,000,000 for each of fiscal years 

15 2021 through 2025; and 

16 ‘‘(2) to be transferred to the Secretary of 

17 Health and Human Services for capital projects of 

18 the community health center program under section 

19 330 of the Public Health Service Act, 

20 $5,000,000,000 for the period of fiscal years 2021 

21 through 2025.’’. 
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1 SEC. 809. GRANTS TO IMPROVE TRAUMA SUPPORT SERV2 ICES AND MENTAL HEALTH CARE FOR CHIL3 DREN AND YOUTH IN EDUCATIONAL SET4 TINGS. 

5 (a) GRANTS, CONTRACTS, AND COOPERATIVE

6 AGREEMENTS AUTHORIZED.—The Secretary, in coordina7 tion with the Assistant Secretary for Mental Health and 

8 Substance Use, is authorized to award grants to, or enter 

9 into contracts or cooperative agreements with, State edu10 cational agencies, local educational agencies, Indian Tribes 

11 (as defined in section 4 of the Indian Self-Determination 

12 and Education Assistance Act) or their tribal educational 

13 agencies, a school operated by the Bureau of Indian Edu14 cation, a Regional Corporation, or a Native Hawaiian edu15 cational organization, for the purpose of increasing stu16 dent access to evidence-based trauma support services and 

17 mental health care by developing innovative initiatives, ac18 tivities, or programs to link local school systems with local 

19 trauma-informed support and mental health systems, in20 cluding those under the Indian Health Service. 

21 (b) DURATION.—With respect to a grant, contract, 

22 or cooperative agreement awarded or entered into under 

23 this section, the period during which payments under such 

24 grant, contract, or agreement are made to the recipient 

25 may not exceed 4 years. 
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1 (c) USE OF FUNDS.—An entity that receives a grant, 

2 contract, or cooperative agreement under this section shall 

3 use amounts made available through such grant, contract, 

4 or cooperative agreement for evidence-based activities, 

5 which shall include any of the following: 

6 (1) Collaborative efforts between school-based 

7 service systems and trauma-informed support and 

8 mental health service systems to provide, develop, or 

9 improve prevention, screening, referral, and treat10 ment and support services to students, such as pro11 viding trauma screenings to identify students in 

12 need of specialized support. 

13 (2) To implement schoolwide positive behavioral 

14 interventions and supports, or other trauma-in15 formed models of support. 

16 (3) To provide professional development to 

17 teachers, teacher assistants, school leaders, special18 ized instructional support personnel, and mental 

19 health professionals that— 

20 (A) fosters safe and stable learning envi21 ronments that prevent and mitigate the effects 

22 of trauma, including through social and emo23 tional learning; 

24 (B) improves school capacity to identify, 

25 refer, and provide services to students in need 
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1 of trauma support or behavioral health services; 

2 or 

3 (C) reflects the best practices for trauma4 informed identification, referral, and support 

5 developed by the Interagency Task Force on 

6 Trauma-Informed Care. 

7 (4) Services at a full-service community school 

8 that focuses on trauma-informed supports, which 

9 may include a full-time site coordinator, or other ac10 tivities consistent with section 4625 of the Elemen11 tary and Secondary Education Act of 1965 (20 

12 U.S.C. 7275). 

13 (5) Engaging families and communities in ef14 forts to increase awareness of child and youth trau15 ma, which may include sharing best practices with 

16 law enforcement regarding trauma-informed care 

17 and working with mental health professionals to pro18 vide interventions, as well as longer term coordi19 nated care within the community for children and 

20 youth who have experienced trauma and their fami21 lies. 

22 (6) To provide technical assistance to school 

23 systems and mental health agencies. 

24 (7) To evaluate the effectiveness of the program 

25 carried out under this section in increasing student 
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1 access to evidence-based trauma support services 

2 and mental health care. 

3 (8) To establish partnerships with or provide 

4 subgrants to Head Start agencies (including Early 

5 Head Start agencies), public and private preschool 

6 programs, child care programs (including home7 based providers), or other entities described in sub8 section (a), to include such entities described in this 

9 paragraph in the evidence-based trauma initiatives, 

10 activities, support services, and mental health sys11 tems established under this section in order to pro12 vide, develop, or improve prevention, screening, re13 ferral, and treatment and support services to young 

14 children and their families. 

15 (d) APPLICATIONS.—To be eligible to receive a grant, 

16 contract, or cooperative agreement under this section, an 

17 entity described in subsection (a) shall submit an applica18 tion to the Secretary at such time, in such manner, and 

19 containing such information as the Secretary may reason20 ably require, which shall include the following: 

21 (1) A description of the innovative initiatives, 

22 activities, or programs to be funded under the grant, 

23 contract, or cooperative agreement, including how 

24 such program will increase access to evidence-based 

25 trauma support services and mental health care for 
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1 students, and, as applicable, the families of such stu2 dents. 

3 (2) A description of how the program will pro4 vide linguistically appropriate and culturally com5 petent services. 

6 (3) A description of how the program will sup7 port students and the school in improving the school 

8 climate in order to support an environment condu9 cive to learning. 

10 (4) An assurance that— 

11 (A) persons providing services under the 

12 grant, contract, or cooperative agreement are 

13 adequately trained to provide such services; and 

14 (B) teachers, school leaders, administra15 tors, specialized instructional support personnel, 

16 representatives of local Indian Tribes or tribal 

17 organizations as appropriate, other school per18 sonnel, and parents or guardians of students 

19 participating in services under this section will 

20 be engaged and involved in the design and im21 plementation of the services. 

22 (5) A description of how the applicant will sup23 port and integrate existing school-based services 

24 with the program in order to provide mental health 

25 services for students, as appropriate. 
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1 (6) A description of the entities in the commu2 nity with which the applicant will partner or to 

3 which the applicant will provide subgrants in accord4 ance with subsection (c)(8). 

5 (e) INTERAGENCY AGREEMENTS.— 

6 (1) LOCAL INTERAGENCY AGREEMENTS.—To 

7 ensure the provision of the services described in sub8 section (c), a recipient of a grant, contract, or coop9 erative agreement under this section, or their des10 ignee, shall establish a local interagency agreement 

11 among local educational agencies, agencies respon12 sible for early childhood education programs, Head 

13 Start agencies (including Early Head Start agen14 cies), juvenile justice authorities, mental health 

15 agencies, child welfare agencies, and other relevant 

16 agencies, authorities, or entities in the community 

17 that will be involved in the provision of such serv18 ices. 

19 (2) CONTENTS.—In ensuring the provision of 

20 the services described in subsection (c), the local 

21 interagency agreement shall specify with respect to 

22 each agency, authority, or entity that is a party to 

23 such agreement— 

24 (A) the financial responsibility for the serv25 ices; 
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1 (B) the conditions and terms of responsi2 bility for the services, including quality, ac3 countability, and coordination of the services; 

4 and 

5 (C) the conditions and terms of reimburse6 ment among such agencies, authorities, or enti7 ties, including procedures for dispute resolution. 

8 (f) EVALUATION.—The Secretary shall reserve not 

9 more than 3 percent of the funds made available under 

10 subsection (l) for each fiscal year to— 

11 (1) conduct a rigorous, independent evaluation 

12 of the activities funded under this section; and 

13 (2) disseminate and promote the utilization of 

14 evidence-based practices regarding trauma support 

15 services and mental health care. 

16 (g) DISTRIBUTION OF AWARDS.—The Secretary shall 

17 ensure that grants, contracts, and cooperative agreements 

18 awarded or entered into under this section are equitably 

19 distributed among the geographical regions of the United 

20 States and among tribal, urban, suburban, and rural pop21 ulations. 

22 (h) RULE OF CONSTRUCTION.—Nothing in this sec23 tion shall be construed— 

24 (1) to prohibit an entity involved with a pro25 gram carried out under this section from reporting 
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1 a crime that is committed by a student to appro2 priate authorities; or 

3 (2) to prevent Federal, State, and tribal law en4 forcement and judicial authorities from exercising 

5 their responsibilities with regard to the application 

6 of Federal, tribal, and State law to crimes com7 mitted by a student. 

8 (i) SUPPLEMENT, NOT SUPPLANT.—Any services 

9 provided through programs carried out under this section 

10 shall supplement, and not supplant, existing mental health 

11 services, including any special education and related serv12 ices provided under the Individuals with Disabilities Edu13 cation Act (20 U.S.C. 1400 et seq.). 

14 (j) CONSULTATION WITH INDIAN TRIBES.—In car15 rying out subsection (a), the Secretary shall, in a timely 

16 manner, meaningfully consult with Indian Tribes and their 

17 representatives to ensure notice of eligibility. 

18 (k) DEFINITIONS.—In this section: 

19 (1) ELEMENTARY SCHOOL.—The term ‘‘elemen20 tary school’’ has the meaning given such term in 

21 section 8101 of the Elementary and Secondary Edu22 cation Act of 1965 (20 U.S.C. 7801). 

23 (2) EVIDENCE-BASED.—The term ‘‘evidence24 based’’ has the meaning given such term in section 
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1 8101(21)(A)(i) of the Elementary and Secondary 

2 Education Act of 1965 (20 U.S.C. 7801(21)(A)(i)). 

3 (3) NATIVE HAWAIIAN EDUCATIONAL ORGANI4 ZATION.—The term ‘‘Native Hawaiian educational 

5 organization’’ has the meaning given such term in 

6 section 6207 of the Elementary and Secondary Edu7 cation Act of 1965 (20 U.S.C. 7517). 

8 (4) LOCAL EDUCATIONAL AGENCY.—The term 

9 ‘‘local educational agency’’ has the meaning given 

10 such term in section 8101 of the Elementary and 

11 Secondary Education Act of 1965 (20 U.S.C. 7801). 

12 (5) REGIONAL CORPORATION.—The term ‘‘Re13 gional Corporation’’ has the meaning given the term 

14 in section 3 of the Alaska Native Claims Settlement 

15 Act (43 U.S.C. 1602). 

16 (6) SCHOOL.—The term ‘‘school’’ means a pub17 lic elementary school or public secondary school. 

18 (7) SCHOOL LEADER.—The term ‘‘school lead19 er’’ has the meaning given such term in section 

20 8101 of the Elementary and Secondary Education 

21 Act of 1965 (20 U.S.C. 7801). 

22 (8) SECONDARY SCHOOL.—The term ‘‘sec23 ondary school’’ has the meaning given such term in 

24 section 8101 of the Elementary and Secondary Edu25 cation Act of 1965 (20 U.S.C. 7801). 
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1 (9) SECRETARY.—The term ‘‘Secretary’’ means 

2 the Secretary of Education. 

3 (10) SPECIALIZED INSTRUCTIONAL SUPPORT

4 PERSONNEL.—The term ‘‘specialized instructional 

5 support personnel’’ has the meaning given such term 

6 in section 8101 of the Elementary and Secondary 

7 Education Act of 1965 (20 U.S.C. 7801). 

8 (11) STATE EDUCATIONAL AGENCY.—The term 

9 ‘‘State educational agency’’ has the meaning given 

10 such term in section 8101 of the Elementary and 

11 Secondary Education Act of 1965 (20 U.S.C. 7801). 

12 (l) AUTHORIZATION OF APPROPRIATIONS.—There is 

13 authorized to be appropriated, and there is appropriated, 

14 out of any money in the Treasury not otherwise appro15 priated, to carry out this section, $20,000,000 for each 

16 of fiscal years 2021 through 2025. 

17 SEC. 810. PATHWAY TO HEALTH CAREERS ACT. 

18 (a) SHORT TITLE.—This section may be cited as the 

19 ‘‘Pathways to Health Careers Act’’. 

20 (b) EXTENSION THROUGH FISCAL YEAR 2020 OF

21 FUNDING FOR DEMONSTRATION PROJECTS TO ADDRESS

22 HEALTH PROFESSIONS WORKFORCE NEEDS.— 

23 (1) IN GENERAL.—Section 2008(c)(1) of the 

24 Social Security Act (42 U.S.C. 1397g(c)(1)) is 

25 amended by striking ‘‘2019.’’ and inserting ‘‘2020, 
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1 and to provide technical assistance and cover admin2 istrative costs associated with implementing the suc3 cessor to this section $15,000,000 for fiscal year 

4 2020.’’. 

5 (2) AVAILABILITY OF OTHER FUNDS.—Upon 

6 the date of the enactment of this section— 

7 (A) amounts expended pursuant to section 

8 1501 of division B of Public Law 116–59, or 

9 any other prior law making amounts available 

10 for fiscal year 2020 for activities authorized by 

11 section 2008 of the Social Security Act, shall be 

12 charged to the appropriation made by sub13 section (c)(1) of such section 2008 for fiscal 

14 year 2020 (not including the amount for tech15 nical assistance and administrative costs); and 

16 (B) if such enactment occurs on or before 

17 November 21, 2019, the availability of funds 

18 appropriated in, and the authority provided 

19 under, such section 1501 shall terminate. 

20 (c) CAREER PATHWAYS THROUGH HEALTH PROFES21 SION OPPORTUNITY GRANTS.—Effective October 1, 2020, 

22 section 2008 of the Social Security Act (42 U.S.C. 1397g) 

23 is amended to read as follows: 
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1 ‘‘SEC. 2008. CAREER PATHWAYS THROUGH HEALTH PRO2 FESSION OPPORTUNITY GRANTS. 

3 ‘‘(a) APPLICATION REQUIREMENTS.—An eligible en4 tity desiring a grant under this section for a project shall 

5 submit to the Secretary an application for the grant, that 

6 includes the following: 

7 ‘‘(1) A description of how the applicant will use 

8 a career pathways approach to train eligible individ9 uals for health professions that pay well or will put 

10 eligible individuals on a career path to an occupation 

11 that pays well, under the project. 

12 ‘‘(2) A description of the adult basic education 

13 and literacy activities, work readiness activities, 

14 training activities, and case management and career 

15 coaching services that the applicant will use to assist 

16 eligible individuals to gain work experience, connec17 tion to employers, and job placement, and a descrip18 tion of the plan for recruiting, hiring, and training 

19 staff to provide the case management, mentoring, 

20 and career coaching services, under the project di21 rectly or through local governmental, apprenticeship, 

22 educational, or charitable institutions. 

23 ‘‘(3) In the case of an application for a grant 

24 under this section for a demonstration project de25 scribed in subsection (c)(2)(B)(i)(I)— 
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1 ‘‘(A) a demonstration that the State in 

2 which the demonstration project is to be con3 ducted has in effect policies or laws that permit 

4 certain allied health and behavioral health care 

5 credentials to be awarded to people with certain 

6 arrest or conviction records (which policies or 

7 laws shall include appeals processes, waivers, 

8 certificates, and other opportunities to dem9 onstrate rehabilitation to obtain credentials, li10 censure, and approval to work in the proposed 

11 health careers), and a plan described in the ap12 plication that will use a career pathway to as13 sist participants with such a record in acquiring 

14 credentials, licensing, and employment in the 

15 specified careers; 

16 ‘‘(B) a discussion of how the project or fu17 ture strategic hiring decisions will demonstrate 

18 the experience and expertise of the project in 

19 working with job seekers who have arrest or 

20 conviction records or employers with experience 

21 working with people with arrest or conviction 

22 records; 

23 ‘‘(C) an identification of promising innova24 tions or best practices that can be used to pro25 vide the training; 
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1 ‘‘(D) a proof of concept or demonstration 

2 that the applicant has done sufficient research 

3 on workforce shortage or in-demand jobs for 

4 which people with certain types of arrest or 

5 conviction records can be hired; 

6 ‘‘(E) a plan for recruiting students who 

7 are eligible individuals into the project; and 

8 ‘‘(F) a plan for providing post-employment 

9 support and ongoing training as part of a ca10 reer pathway under the project. 

11 ‘‘(4) In the case of an application for a grant 

12 under this section for a demonstration project de13 scribed in subsection (c)(2)(B)(i)(II)— 

14 ‘‘(A) a description of the partnerships, 

15 strategic staff hiring decisions, tailored program 

16 activities, or other programmatic elements of 

17 the project, such as training plans for doulas 

18 and other community health workers and train19 ing plans for midwives and other allied health 

20 professions, that are designed to support a ca21 reer pathway in pregnancy, birth, or post22 partum services; and 

23 ‘‘(B) a demonstration that the State in 

24 which the demonstration project is to be con-
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1 ducted recognizes doulas or midwives, as the 

2 case may be. 

3 ‘‘(5) A demonstration that the applicant has ex4 perience working with low-income populations, or a 

5 description of the plan of the applicant to work with 

6 a partner organization that has the experience. 

7 ‘‘(6) A plan for providing post-employment sup8 port and ongoing training as part of a career path9 way under the project. 

10 ‘‘(7) A description of the support services that 

11 the applicant will provide under the project, includ12 ing a plan for how child care and transportation 

13 support services will be guaranteed and, if the appli14 cant will provide a cash stipend or wage supplement, 

15 how the stipend or supplement would be calculated 

16 and distributed. 

17 ‘‘(8) A certification by the applicant that the 

18 project development included— 

19 ‘‘(A) consultation with a local workforce 

20 development board established under section 

21 107 of the Workforce Innovation and Oppor22 tunity Act; 

23 ‘‘(B) consideration of apprenticeship and 

24 pre-apprenticeship models registered under the 
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1 Act of August 16, 1937 (also known as the 

2 ‘National Apprenticeship Act’); 

3 ‘‘(C) consideration of career pathway pro4 grams in the State in which the project is to be 

5 conducted; and 

6 ‘‘(D) a review of the State plan under sec7 tion 102 or 103 of the Workforce Innovation 

8 and Opportunity Act. 

9 ‘‘(9) A description of the availability and rel10 evance of recent labor market information and other 

11 pertinent evidence of in-demand jobs or worker 

12 shortages. 

13 ‘‘(10) A certification that the applicant will di14 rectly provide or contract for the training services 

15 described in the application. 

16 ‘‘(11) A commitment by the applicant that, if 

17 the grant is made to the applicant, the applicant 

18 will— 

19 ‘‘(A) during the planning period for the 

20 project, provide the Secretary with any informa21 tion needed by the Secretary to establish ade22 quate data reporting and administrative struc23 ture for the project; 
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1 ‘‘(B) hire a person to direct the project not 

2 later than the end of the planning period appli3 cable to the project; 

4 ‘‘(C) accept all technical assistance offered 

5 by the Secretary with respect to the grant; 

6 ‘‘(D) participate in such in-person grantee 

7 conferences as are regularly scheduled by the 

8 Secretary; 

9 ‘‘(E) provide all data required by the Sec10 retary under subsection (g); and 

11 ‘‘(F) notify the local disabled veterans’ 

12 outreach program specialists under section 

13 4103A of title 38, United States Code, and the 

14 local veterans’ employment representatives 

15 under section 4104 of such title, of the grant16 ee’s outreach plan for advertising training op17 portunities to potential participants in the 

18 project. 

19 ‘‘(b) PREFERENCES IN CONSIDERING APPLICA20 TIONS.—In considering applications for a grant under this 

21 section, the Secretary shall give preference to— 

22 ‘‘(1) applications submitted by applicants to 

23 whom a grant was made under this section or any 

24 predecessor to this section; 
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1 ‘‘(2) applications submitted by applicants who 

2 have business and community partners in each of 

3 the following categories: 

4 ‘‘(A) State and local government agencies 

5 and social service providers, including a State 

6 or local entity that administers a State program 

7 funded under part A of this title; 

8 ‘‘(B) institutions of higher education, ap9 prenticeship programs, and local workforce de10 velopment boards established under section 107 

11 of the Workforce Innovation and Opportunity 

12 Act; and 

13 ‘‘(C) health care employers, health care in14 dustry or sector partnerships, labor unions, and 

15 labor-management partnerships; 

16 ‘‘(3) applications that include opportunities for 

17 mentoring or peer support, and make career coach18 ing available, as part of the case management plan; 

19 ‘‘(4) applications which describe a project that 

20 will serve a rural area in which— 

21 ‘‘(A) the community in which the individ22 uals to be enrolled in the project reside is lo23 cated; 

24 ‘‘(B) the project will be conducted; or 
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1 ‘‘(C) an employer partnership that has 

2 committed to hiring individuals who successfully 

3 complete all activities under the project is lo4 cated; 

5 ‘‘(5) applications that include a commitment to 

6 providing project participants with a cash stipend or 

7 wage supplement; and 

8 ‘‘(6) applications which have an emergency cash 

9 fund to assist project participants financially in 

10 emergency situations. 

11 ‘‘(c) GRANTS.— 

12 ‘‘(1) COMPETITIVE GRANTS.— 

13 ‘‘(A) GRANT AUTHORITY.— 

14 ‘‘(i) IN GENERAL.—The Secretary, in 

15 consultation with the Secretary of Labor 

16 and the Secretary of Education, may make 

17 a grant in accordance with this paragraph 

18 to an eligible entity whose application for 

19 the grant is approved by the Secretary, to 

20 conduct a project designed to train low-in21 come individuals for allied health profes22 sions, health information technology, physi23 cians assistants, nursing assistants, reg24 istered nurse, advanced practice nurse, and 
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1 other professions considered part of a 

2 health care career pathway model. 

3 ‘‘(ii) GUARANTEE OF GRANTEES IN

4 EACH STATE AND THE DISTRICT OF CO5 LUMBIA.—For each grant cycle, the Sec6 retary shall award a grant under this para7 graph to at least 2 eligible entities in each 

8 State that is not a territory, to the extent 

9 there are a sufficient number of applica10 tions submitted by the entities that meet 

11 the requirements applicable with respect to 

12 such a grant. If, for a grant cycle, there 

13 are fewer than 2 such eligible entities in a 

14 State, the Secretary shall include that in15 formation in the report required by sub16 section (g)(2) that covers the fiscal year. 

17 ‘‘(B) GUARANTEE OF GRANTS FOR INDIAN

18 POPULATIONS.—From the amount reserved 

19 under subsection (i)(2)(B) for each fiscal year, 

20 the Secretary shall award a grant under this 

21 paragraph to at least 10 eligible entities that 

22 are an Indian tribe, a tribal organization, or a 

23 tribal college or university, to the extent there 

24 are a sufficient number of applications sub-
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1 mitted by the entities that meet the require2 ments applicable with respect to such a grant. 

3 ‘‘(C) GUARANTEE OF GRANTEES IN THE

4 TERRITORIES.—From the amount reserved 

5 under subsection (i)(2)(C) for each fiscal year, 

6 the Secretary shall award a grant under this 

7 paragraph to at least 2 eligible entities that are 

8 located in a territory, to the extent there are a 

9 sufficient number of applications submitted by 

10 the entities that meet the requirements applica11 ble with respect to such a grant. 

12 ‘‘(2) GRANTS FOR DEMONSTRATION

13 PROJECTS.— 

14 ‘‘(A) GRANT AUTHORITY.—The Secretary, 

15 in consultation with the Secretary of Labor and 

16 the Secretary of Education (and, with respect 

17 to demonstration projects of the type described 

18 in subparagraph (B)(i)(I), the Attorney Gen19 eral) shall make a grant in accordance with this 

20 subsection to an eligible entity whose applica21 tion for the grant is approved by the Secretary, 

22 to conduct a demonstration project that meets 

23 the requirements of subparagraph (B). 

24 ‘‘(B) REQUIREMENTS.—The requirements 

25 of this subparagraph are the following: 
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1 ‘‘(i) TYPE OF PROJECT.—The dem2 onstration project shall be of 1 of the fol3 lowing types: 

4 ‘‘(I) INDIVIDUALS WITH ARREST

5 OR CONVICTION RECORDS DEM6 ONSTRATION.—The demonstration 

7 project shall be of a type designed to 

8 provide education and training for eli9 gible individuals with arrest or convic10 tion records to enter and follow a ca11 reer pathway in the health professions 

12 through occupations that pay well and 

13 are expected to experience a labor 

14 shortage or be in high demand. 

15 ‘‘(II) PREGNANCY AND CHILD16 BIRTH CAREER PATHWAY DEM17 ONSTRATION.—The demonstration 

18 project shall be of a type designed to 

19 provide education and training for eli20 gible individuals to enter and follow a 

21 career pathway in the field of preg22 nancy, childbirth, or post-partum, in a 

23 State that recognizes doulas or mid24 wives and that provides payment for 

25 services provided by doulas or mid-
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1 wives, as the case may be, under pri2 vate or public health insurance plans. 

3 ‘‘(ii) DURATION.—The demonstration 

4 project shall be conducted for not less than 

5 5 years. 

6 ‘‘(C) MINIMUM ALLOCATION OF FUNDS

7 FOR EACH TYPE OF DEMONSTRATION

8 PROJECT.— 

9 ‘‘(i) INDIVIDUALS WITH ARREST OR

10 CONVICTION RECORDS DEMONSTRA11 TIONS.—Not less than 25 percent of the 

12 amounts made available for grants under 

13 this paragraph shall be used to make 

14 grants for demonstration projects of the 

15 type described in subparagraph (B)(i)(I). 

16 ‘‘(ii) PREGNANCY AND CHILDBIRTH

17 CAREER PATHWAY DEMONSTRATIONS.— 

18 Not less than 25 percent of the amounts 

19 made available for grants under this para20 graph shall be used to make grants for 

21 demonstration projects of the type de22 scribed in subparagraph (B)(i)(II). 

23 ‘‘(3) GRANT CYCLE.—The grant cycle under 

24 this section shall be not less than 5 years, with a 

25 planning period of not more than the 1st 12 months 
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1 of the grant cycle. During the planning period, the 

2 amount of the grant shall be in such lesser amount 

3 as the Secretary determines appropriate. 

4 ‘‘(d) USE OF GRANT.— 

5 ‘‘(1) IN GENERAL.—An entity to which a grant 

6 is made under this section shall use the grant in ac7 cordance with the approved application for the 

8 grant. 

9 ‘‘(2) SUPPORT TO BE PROVIDED.— 

10 ‘‘(A) REQUIRED SUPPORT.—A project for 

11 which a grant is made under this section shall 

12 include the following: 

13 ‘‘(i) An assessment for adult basic 

14 skill competency, and provision of adult 

15 basic skills education if necessary for 

16 lower-skilled eligible individuals to enroll in 

17 the project and go on to enter and com18 plete post-secondary training, through 

19 means including the following: 

20 ‘‘(I) Establishing a network of 

21 partners that offer pre-training activi22 ties for project participants who need 

23 to improve basic academic skills or 

24 English language proficiency before 
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1 entering a health occupational train2 ing career pathway program. 

3 ‘‘(II) Offering resources to enable 

4 project participants to continue ad5 vancing adult basic skill proficiency 

6 while enrolled in a career pathway 

7 program. 

8 ‘‘(III) Embedding adult basic 

9 skill maintenance as part of ongoing 

10 post-graduation career coaching and 

11 mentoring. 

12 ‘‘(ii) A guarantee that child care is an 

13 available and affordable support service for 

14 project participants through means such as 

15 the following: 

16 ‘‘(I) Referral to, and assistance 

17 with, enrollment in a subsidized child 

18 care program. 

19 ‘‘(II) Direct payment to a child 

20 care provider if a slot in a subsidized 

21 child care program is not available or 

22 reasonably accessible. 

23 ‘‘(III) Payment of co-payments 

24 or associated fees for child care. 
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1 ‘‘(iii) Case management plans that in2 clude career coaching (with the option to 

3 offer appropriate peer support and men4 toring opportunities to help develop soft 

5 skills and social capital), which may be of6 fered on an ongoing basis before, during, 

7 and after initial training as part of a ca8 reer pathway model. 

9 ‘‘(iv) A plan to provide project partici10 pants with transportation through means 

11 such as the following: 

12 ‘‘(I) Referral to, and assistance 

13 with enrollment in, a subsidized trans14 portation program. 

15 ‘‘(II) If a subsidized transpor16 tation program is not reasonably 

17 available, direct payments to subsidize 

18 transportation costs. 

19 For purposes of this clause, the term 

20 ‘transportation’ includes public transit, or 

21 gasoline for a personal vehicle if public 

22 transit is not reasonably accessible or 

23 available. 

24 ‘‘(v) In the case of a demonstration 

25 project of the type described in subsection 
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1 (c)(2)(B)(i)(I), access to legal assistance 

2 for project participants for the purpose of 

3 addressing arrest or conviction records and 

4 associated workforce barriers. 

5 ‘‘(B) ALLOWED SUPPORT.—The goods and 

6 services provided under a project for which a 

7 grant is made under this section may include 

8 the following: 

9 ‘‘(i) A cash stipend that is at least 

10 monthly. 

11 ‘‘(ii) A reserve fund for financial as12 sistance to project participants in emer13 gency situations. 

14 ‘‘(iii) Tuition, and training materials 

15 such as books, software, uniforms, shoes, 

16 and hair nets. 

17 ‘‘(iv) In-kind resource donations such 

18 as interview clothing and conference at19 tendance fees. 

20 ‘‘(v) Assistance with accessing and 

21 completing high school equivalency or adult 

22 basic education courses as necessary to 

23 achieve success in the project and make 

24 progress toward career goals. 
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1 ‘‘(vi) Assistance with programs and 

2 activities, including legal assistance, 

3 deemed necessary to address arrest or con4 viction records as an employment barrier. 

5 ‘‘(vii) Other support services as 

6 deemed necessary for family well-being, 

7 success in the project, and progress toward 

8 career goals. 

9 ‘‘(C) TREATMENT OF SUPPORT FOR PUR10 POSES OF MEANS-TESTED PROGRAMS.—Any 

11 goods or services provided to an eligible indi12 vidual participating in a project for which a 

13 grant is made under this section shall not be 

14 considered income, and shall not be taken into 

15 account for purposes of determining the eligi16 bility of the individual for, or amount of bene17 fits to be provided to the individual, under any 

18 means-tested program. 

19 ‘‘(3) TRAINING.—The number of hours of train20 ing provided to an eligible individual under a project 

21 for which a grant is made under this section, for a 

22 recognized postsecondary credential, including an in23 dustry-recognized credential, which is awarded in 

24 recognition of attainment of measurable technical or 

25 occupational skills necessary to gain employment or 
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1 advance within an occupation (including a certificate 

2 awarded by a local workforce development board es3 tablished under section 107 of the Workforce Inno4 vation and Opportunity Act), shall be— 

5 ‘‘(A) not less than the number of hours of 

6 training required for certification in that level 

7 of skill by the State in which the project is con8 ducted; or 

9 ‘‘(B) if there is no such requirement, such 

10 number of hours of training as the Secretary 

11 finds is necessary to achieve that skill level. 

12 ‘‘(4) INCOME LIMITATION.—An entity to which 

13 a grant is made under this section shall not use the 

14 grant to provide support to a person who is not an 

15 eligible individual. 

16 ‘‘(5) INCLUSION OF TANF RECIPIENTS.—In the 

17 case of a project for which a grant is made under 

18 this section that is conducted in a State that has a 

19 program funded under part A of title IV, at least 10 

20 percent of the eligible individuals to whom support 

21 is provided under the project shall meet the income 

22 eligibility requirements under that State program, 

23 without regard to whether the individuals receive 

24 benefits or services directly under that State pro25 gram. 
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1 ‘‘(6) PROHIBITION.—An entity to which a grant 

2 is made under this section shall not use the grant 

3 for purposes of entertainment, except that case man4 agement and career coaching services may include 

5 celebrations of specific career-based milestones such 

6 as completing a semester, graduation, or job place7 ment. 

8 ‘‘(e) TECHNICAL ASSISTANCE.— 

9 ‘‘(1) IN GENERAL.—The Secretary shall provide 

10 technical assistance— 

11 ‘‘(A) to assist eligible entities in applying 

12 for grants under this section; 

13 ‘‘(B) that is tailored to meet the needs of 

14 grantees at each stage of the administration of 

15 projects for which grants are made under this 

16 section; 

17 ‘‘(C) that is tailored to meet the specific 

18 needs of Indian tribes, tribal organizations, and 

19 tribal colleges and universities; 

20 ‘‘(D) that is tailored to meet the specific 

21 needs of the territories; 

22 ‘‘(E) that is tailored to meet the specific 

23 needs of eligible entities in carrying out dem24 onstration projects for which a grant is made 

25 under this section; and 
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1 ‘‘(F) to facilitate the exchange of informa2 tion among eligible entities regarding best prac3 tices and promising practices used in the 

4 projects. 

5 ‘‘(2) CONTINUATION OF PEER TECHNICAL AS6 SISTANCE CONFERENCES.—The Secretary shall con7 tinue to hold peer technical assistance conferences 

8 for entities to which a grant is made under this sec9 tion or was made under the immediate predecessor 

10 of this section. 

11 ‘‘(f) EVALUATION OF DEMONSTRATION PROJECTS.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall, by 

13 grant, contract, or interagency agreement, conduct 

14 rigorous and well-designed evaluations of the dem15 onstration projects for which a grant is made under 

16 this section. 

17 ‘‘(2) REQUIREMENT APPLICABLE TO INDIVID18 UALS WITH ARREST OR CONVICTION RECORDS DEM19 ONSTRATION.—In the case of a project of the type 

20 described in subsection (c)(2)(B)(i)(I), the evalua21 tion shall include identification of successful activi22 ties for creating opportunities for developing and 

23 sustaining, particularly with respect to low-income 

24 individuals with arrest or conviction records, a 

25 health professions workforce that has accessible 
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1 entry points, that meets high standards for edu2 cation, training, certification, and professional devel3 opment, and that provides increased wages and af4 fordable benefits, including health care coverage, 

5 that are responsive to the needs of the workforce. 

6 ‘‘(3) REQUIREMENT APPLICABLE TO PREG7 NANCY AND CHILDBIRTH CAREER PATHWAY DEM8 ONSTRATION.—In the case of a project of the type 

9 described in subsection (c)(2)(B)(i)(II), the evalua10 tion shall include identification of successful activi11 ties for creating opportunities for developing and 

12 sustaining, particularly with respect to low-income 

13 individuals and other entry-level workers, a career 

14 pathway that has accessible entry points, that meets 

15 high standards for education, training, certification, 

16 and professional development, and that provides in17 creased wages and affordable benefits, including 

18 health care coverage, that are responsive to the 

19 needs of the birth, pregnancy, and post-partum 

20 workforce. 

21 ‘‘(4) RULE OF INTERPRETATION.—Evaluations 

22 conducted pursuant to this subsection may include a 

23 randomized controlled trial, but this subsection shall 

24 not be interpreted to require an evaluation to include 

25 such a trial. 
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1 ‘‘(g) REPORTS.— 

2 ‘‘(1) TO THE SECRETARY.—An eligible entity 

3 awarded a grant to conduct a project under this sec4 tion shall submit interim reports to the Secretary on 

5 the activities carried out under the project, and, on 

6 the conclusion of the project, a final report on the 

7 activities. Each such report shall include data on 

8 participant outcomes related to earnings, employ9 ment in health professions, graduation rate, gradua10 tion timeliness, credential attainment, participant 

11 demographics, and other data specified by the Sec12 retary. 

13 ‘‘(2) TO THE CONGRESS.—During each Con14 gress, the Secretary shall submit to the Committee 

15 on Ways and Means of the House of Representatives 

16 and the Committee on Finance of the Senate a re17 port— 

18 ‘‘(A) on the demographics of the partici19 pants in the projects for which a grant is made 

20 under this section; 

21 ‘‘(B) on the rate of which project partici22 pants completed all activities under the 

23 projects; 

24 ‘‘(C) on the employment credentials ac25 quired by project participants; 
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1 ‘‘(D) on the employment of project partici2 pants on completion of activities under the 

3 projects, and the earnings of project partici4 pants at entry into employment; 

5 ‘‘(E) on best practices and promising prac6 tices used in the projects; 

7 ‘‘(F) on the nature of any technical assist8 ance provided to grantees under this section; 

9 ‘‘(G) on, with respect to the period since 

10 the period covered in the most recent prior re11 port submitted under this paragraph— 

12 ‘‘(i) the number of applications sub13 mitted under this section, with a separate 

14 statement of the number of applications re15 ferred to in subsection (b)(5); 

16 ‘‘(ii) the number of applications that 

17 were approved, with a separate statement 

18 of the number of such applications referred 

19 to in subsection (b)(5); and 

20 ‘‘(iii) a description of how grants were 

21 made in any case described in the last sen22 tence of subsection (c)(1)(A)(ii); and 

23 ‘‘(H) that includes an assessment of the ef24 fectiveness of the projects with respect to ad-
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1 dressing health professions workforce shortages 

2 or in-demand jobs. 

3 ‘‘(h) DEFINITIONS.—In this section: 

4 ‘‘(1) ALLIED HEALTH PROFESSION.—The term 

5 ‘allied health profession’ has the meaning given in 

6 section 799B(5) of the Public Health Service Act. 

7 ‘‘(2) CAREER PATHWAY.—The term ‘career 

8 pathway’ has the meaning given that term in section 

9 3(7) of the Workforce Innovation and Opportunity 

10 Act. 

11 ‘‘(3) DOULA.—The term ‘doula’ means an indi12 vidual who— 

13 ‘‘(A) is certified by an organization that 

14 has been established for not less than 5 years 

15 and that requires the completion of continuing 

16 education to maintain the certification, to pro17 vide non-medical advice, information, emotional 

18 support, and physical comfort to an individual 

19 during the individual’s pregnancy, childbirth, 

20 and post-partum period; and 

21 ‘‘(B) maintains the certification by com22 pleting the required continuing education. 

23 ‘‘(4) ELIGIBLE ENTITY.—The term ‘eligible en24 tity’ means any of the following entities that dem25 onstrates in an application submitted under this sec-
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1 tion that the entity has the capacity to fully develop 

2 and administer the project described in the applica3 tion: 

4 ‘‘(A) A local workforce development board 

5 established under section 107 of the Workforce 

6 Innovation and Opportunity Act. 

7 ‘‘(B) A State or territory, a political sub8 division of a State or territory, or an agency of 

9 a State, territory, or such a political subdivi10 sion, including a State or local entity that ad11 ministers a State program funded under part A 

12 of this title. 

13 ‘‘(C) An Indian tribe, a tribal organization, 

14 or a tribal college or university. 

15 ‘‘(D) An institution of higher education (as 

16 defined in the Higher Education Act of 1965). 

17 ‘‘(E) A hospital (as defined in section 

18 1861(e)). 

19 ‘‘(F) A high-quality skilled nursing facility. 

20 ‘‘(G) A Federally qualified health center 

21 (as defined in section 1861(aa)(4)). 

22 ‘‘(H) A nonprofit organization described in 

23 section 501(c)(3) of the Internal Revenue Code 

24 of 1986, a labor organization, or an entity with 

25 shared labor-management oversight, that has a 
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1 demonstrated history of providing health profes2 sion training to eligible individuals. 

3 ‘‘(I) In the case of a demonstration project 

4 of the type provided for in subsection 

5 (c)(2)(B)(i)(II) of this section, an entity recog6 nized by a State, Indian tribe, or tribal organi7 zation as qualified to train doulas or midwives, 

8 if midwives or doulas, as the case may be, are 

9 permitted to practice in the State involved. 

10 ‘‘(J) An opioid treatment program (as de11 fined in section 1861(jjj)(2)), and other high 

12 quality comprehensive addiction care providers. 

13 ‘‘(5) ELIGIBLE INDIVIDUAL.—The term ‘eligible 

14 individual’ means an individual whose family income 

15 does not exceed 200 percent of the Federal poverty 

16 level. 

17 ‘‘(6) FEDERAL POVERTY LEVEL.—The term 

18 ‘Federal poverty level’ means the poverty line (as de19 fined in section 673(2) of the Omnibus Budget Rec20 onciliation Act of 1981, including any revision re21 quired by such section applicable to a family of the 

22 size involved). 

23 ‘‘(7) INDIAN TRIBE; TRIBAL ORGANIZATION.— 

24 The terms ‘Indian tribe’ and ‘tribal organization’ 

25 have the meaning given the terms in section 4 of the 
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1 Indian Self-Determination and Education Assistance 

2 Act (25 U.S.C. 450b). 

3 ‘‘(8) INSTITUTION OF HIGHER EDUCATION.— 

4 The term ‘institution of higher education’ has the 

5 meaning given the term in section 101 or 

6 102(a)(1)(B) of the Higher Education Act of 1965. 

7 ‘‘(9) TERRITORY.—The term ‘territory’ means 

8 the Commonwealth of Puerto Rico, the United 

9 States Virgin Islands, Guam, the Northern Mariana 

10 Islands, and American Samoa. 

11 ‘‘(10) TRIBAL COLLEGE OR UNIVERSITY.—The 

12 term ‘tribal college or university’ has the meaning 

13 given the term in section 316(b) of the Higher Edu14 cation Act of 1965. 

15 ‘‘(i) FUNDING.— 

16 ‘‘(1) IN GENERAL.—Out of any funds in the 

17 Treasury of the United States not otherwise appro18 priated, there are appropriated to the Secretary to 

19 carry out this section $425,000,000 for each of fis20 cal years 2021 through 2025. 

21 ‘‘(2) ALLOCATION OF FUNDS.—Of the amount 

22 appropriated for a fiscal year under paragraph (1) 

23 of this subsection— 

24 ‘‘(A) 75 percent shall be available for 

25 grants under subsection (c)(1)(A); 
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1 ‘‘(B) 4 percent shall be reserved for grants 

2 under subsection (c)(1)(B); 

3 ‘‘(C) 5 percent shall be reserved for grants 

4 under subsection (c)(1)(C); 

5 ‘‘(D) 6 percent shall be available for dem6 onstration project grants under subsection 

7 (c)(2); 

8 ‘‘(E) 6 percent, plus all amounts referred 

9 to in subparagraphs (A) through (D) of this 

10 paragraph that remain unused after all grant 

11 awards are made for the fiscal year, shall be 

12 available for the provision of technical assist13 ance and associated staffing; and 

14 ‘‘(F) 4 percent shall be available for study15 ing the effects of the demonstration and non16 demonstration projects for which a grant is 

17 made under this section, and for associated 

18 staffing, for the purpose of supporting the rig19 orous evaluation of the demonstration projects, 

20 and supporting the continued study of the 

21 short-, medium-, and long-term effects of all 

22 such projects, including the effectiveness of new 

23 or added elements of the non-demonstration 

24 projects. 
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1 ‘‘(j) NONAPPLICABILITY OF PRECEDING SECTIONS

2 OF THIS SUBTITLE.— 

3 ‘‘(1) IN GENERAL.—Except as provided in para4 graph (2), the preceding sections of this subtitle 

5 shall not apply to a grant awarded under this sec6 tion. 

7 ‘‘(2) EXCEPTION FOR CERTAIN LIMITATIONS ON

8 USE OF GRANTS.—Section 2005(a) (other than para9 graphs (2), (3), (5), (6), and (8)) shall apply to a 

10 grant awarded under this section to the same extent 

11 and in the same manner as such section applies to 

12 payments to States under this subtitle.’’. 

13 SEC. 811. HOME VISITING TO REDUCE MATERNAL MOR14 TALITY AND MORBIDITY ACT. 

15 (a) SHORT TITLE.—This section may be cited as the 

16 ‘‘Home Visiting to Reduce Maternal Mortality and Mor17 bidity Act’’. 

18 (b) INCREASE IN TRIBAL SET-ASIDE PERCENT19 AGE.— 

20 (1) IN GENERAL.—Section 511(j)(2)(A) of the 

21 Social Security Act (42 U.S.C. 711(j)(2)(A)) is 

22 amended by striking ‘‘3’’ and inserting ‘‘6’’. 

23 (2) EFFECTIVE DATE.—The amendment made 

24 by paragraph (1) shall take effect on October 1, 

25 2020. 
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1 (c) INCREASE IN FUNDING.—Section 511(j)(1) of 

2 such Act (42 U.S.C. 711(j)(1)) is amended— 

3 (1) by striking ‘‘and’’ at the end of subpara4 graph (G); and 

5 (2) by striking subparagraph (H) and inserting 

6 the following: 

7 ‘‘(H) $400,000,000 for each of fiscal years 

8 2017 through 2020; 

9 ‘‘(I) $600,000,000 for fiscal year 2021; 

10 and 

11 ‘‘(J) $800,000,000 for fiscal year 2022.’’. 

12 (d) USE OF ADDITIONAL FUNDS.—Section 511(c) of 

13 such Act (42 U.S.C. 711(c)) is amended by adding at the 

14 end the following: 

15 ‘‘(6) USE OF CERTAIN FUNDS TO PROVIDE AD16 DITIONAL RESOURCES TO ADDRESS HIGH RATES OF

17 MATERNAL MORTALITY AND MORBIDITY, SUPPORT

18 UNMET NEEDS IDENTIFIED BY THE NEEDS ASSESS19 MENT, OR INCREASE ALLOCATIONS TO STATES AND

20 TERRITORIES BASED ON RELATIVE POPULATION OR

21 POVERTY.—The Secretary shall ensure that any 

22 amounts exceeding $400,000,000 that are used for 

23 grants under this subsection for a fiscal year are 

24 used to— 
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1 ‘‘(A) provide additional funding priority to 

2 States, tribes, and territories to address high 

3 rates of maternal mortality and morbidity; 

4 ‘‘(B) address unmet needs identified by a 

5 needs assessment conducted under subsection 

6 (b); or 

7 ‘‘(C) increase the amounts allocated under 

8 this section to States and to Puerto Rico, 

9 Guam, the Virgin Islands, the Northern Mar10 iana Islands, and American Samoa, based on 

11 the proportion of children who have not at12 tained 5 years of age and are living in pov13 erty.’’. 

14 SEC. 812. ADDITION OF NEW MEASURES BASED ON ACCESS 

15 TO BIOSIMILAR BIOLOGICAL PRODUCTS TO 

16 THE 5-STAR RATING SYSTEM UNDER MEDI17 CARE ADVANTAGE. 

18 (a) IN GENERAL.—Section 1853(o)(4) of the Social 

19 Security Act (42 U.S.C. 1395w–23(o)(4)) is amended by 

20 adding at the end the following new subparagraph: 

21 ‘‘(E) ADDITION OF NEW MEASURES BASED

22 ON ACCESS TO BIOSIMILAR BIOLOGICAL PROD23 UCTS.— 

24 ‘‘(i) IN GENERAL.—For 2021 and 

25 subsequent years, the Secretary shall add a 
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1 new set of measures to the 5-star rating 

2 system based on access to biosimilar bio3 logical products covered under part B and, 

4 in the case of MA–PD plans, such prod5 ucts that are covered part D drugs. Such 

6 measures shall assess the impact a plan’s 

7 benefit structure may have on enrollees’ 

8 utilization of or ability to access biosimilar 

9 biological products, including in compari10 son to the reference biological product, and 

11 shall include measures, as applicable, with 

12 respect to the following: 

13 ‘‘(I) COVERAGE.—Assessing 

14 whether a biosimilar biological prod15 uct is on the plan formulary in lieu of 

16 or in addition to the reference biologi17 cal product. 

18 ‘‘(II) PREFERENCING.—Assess19 ing tier placement or cost-sharing for 

20 a biosimilar biological product relative 

21 to the reference biological product. 

22 ‘‘(III) UTILIZATION MANAGE23 MENT TOOLS.—Assessing whether and 

24 how utilization management tools are 

25 used with respect to a biosimilar bio-
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1 logical product relative to the ref2 erence biological product. 

3 ‘‘(IV) UTILIZATION.—Assessing 

4 the percentage of enrollees prescribed 

5 the biosimilar biological product when 

6 the reference biological product is also 

7 available. 

8 ‘‘(ii) DEFINITIONS.—In this subpara9 graph, the terms ‘biosimilar biological 

10 product’ and ‘reference biological product’ 

11 have the meaning given those terms in sec12 tion 1847A(c)(6). 

13 ‘‘(iii) PROTECTING PATIENT INTER14 ESTS.—In developing such measures, the 

15 Secretary shall ensure that each measure 

16 developed to address coverage, 

17 preferencing, or utilization management is 

18 constructed such that patients retain equal 

19 access to appropriate therapeutic options 

20 without undue administrative burden.’’. 

21 (b) CLARIFICATION REGARDING APPLICATION TO

22 PRESCRIPTION DRUG PLANS.—To the extent the Sec23 retary of Health and Human Services applies the 5-star 

24 rating system under section 1853(o)(4) of the Social Secu25 rity Act (42 U.S.C. 1395w–23(o)(4)), or a similar system, 
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1 to prescription drug plans under part D of title XVIII of 

2 such Act, the provisions of subparagraph (E) of such sec3 tion, as added by subsection (a) of this section, shall apply 

4 under the system with respect to such plans in the same 

5 manner as such provisions apply to the 5-star rating sys6 tem under such section 1853(o)(4). 

7 SEC. 813. SENSE OF CONGRESS REGARDING THE IMPACT 

8 OF THE HIGH COST OF PRESCRIPTION 

9 DRUGS ON COMMUNITIES OF COLOR AND 

10 PERSONS LIVING IN RURAL OR SPARSELY 

11 POPULATED AREAS OF THE UNITED STATES. 

12 It is the sense of the Congress that— 

13 (1) the United States has the highest drug 

14 prices in the world and for millions of Americans the 

15 cost of prescription drugs is increasing as a barrier 

16 to proper disease treatment, especially for commu17 nities of color and for persons living in rural or 

18 sparsely populated areas of the nation; 

19 (2) the Patient Protection and Affordable Care 

20 Act (Public Law 111–148) substantially reduced the 

21 number of uninsured Americans, but over 28 million 

22 Americans remain without insurance and approxi23 mately 55 percent of uninsured Americans under the 

24 age of 65 are persons of color; 
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1 (3) without health insurance, paying retail 

2 prices for medications is invariably burdensome or 

3 financially impossible; 

4 (4) the median net worth of Caucasian house5 holds in 2016 was 9.7 times higher than African6 American households and 8.3 times higher than His7 panic households, which contributes to disparities in 

8 negative health consequences, including for example 

9 the underuse of insulin among insured adults with 

10 diabetes; and 

11 (5) due to the high cost of prescription drugs 

12 to communities of color and for persons living in 

13 rural or sparsely populated areas of the nation, this 

14 Act should positively impact such communities and 

15 persons (and the Secretaries of Health and Human 

16 Services, Labor, and Treasury should monitor such 

17 impact). 

18 SEC. 814. REGULATIONS REQUIRING DIRECT-TO-CON19 SUMER ADVERTISEMENTS FOR PRESCRIP20 TION DRUGS AND BIOLOGICAL PRODUCTS TO 

21 INCLUDE TRUTHFUL AND NOT MISLEADING 

22 PRICING INFORMATION. 

23 (a) IN GENERAL.—Not later than the date that is 

24 one year after the date of the enactment of the Elijah E. 

25 Cummings Lower Drug Costs Now Act, the Secretary of 
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1 Health and Human Services, acting through the Adminis2 trator of the Centers for Medicare & Medicaid Services 

3 (referred to in this section as the ‘‘Administrator’’), shall 

4 promulgate final regulations requiring each direct-to-con5 sumer advertisement on television (including broadcast, 

6 cable, streaming, and satellite television) for a prescription 

7 drug or biological product for which payment is available 

8 under title XVIII or XIX of the Social Security Act to 

9 include a textual statement, which shall be truthful and 

10 not misleading, indicating the list price, as determined on 

11 the first day of the quarter during which the advertise12 ment is being aired or otherwise broadcast, for a typical 

13 30-day regimen or typical course of treatment (whichever 

14 is most appropriate). 

15 (b) DETERMINATIONS.—In promulgating final regu16 lations under subsection (a), the Administrator shall de17 termine— 

18 (1) whether such regulations should apply with 

19 respect to additional forms of advertising; 

20 (2) the manner and format of textual state21 ments described in such subsection; 

22 (3) appropriate enforcement mechanisms; and 

23 (4) whether such textual statements should in24 clude any other price information, as appropriate. 
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1 SEC. 815. IMPROVING TRANSPARENCY AND PREVENTING 

2 THE USE OF ABUSIVE SPREAD PRICING AND 

3 RELATED PRACTICES IN MEDICAID. 

4 (a) PASS-THROUGH PRICING REQUIRED.— 

5 (1) IN GENERAL.—Section 1927(e) of the So6 cial Security Act (42 U.S.C. 1396r–8(e)) is amended 

7 by adding at the end the following: 

8 ‘‘(6) PASS-THROUGH PRICING REQUIRED.—A 

9 contract between the State and a pharmacy benefit 

10 manager (referred to in this paragraph as a ‘PBM’), 

11 or a contract between the State and a managed care 

12 entity or other specified entity (as such terms are 

13 defined in section 1903(m)(9)(D)) that includes pro14 visions making the entity responsible for coverage of 

15 covered outpatient drugs dispensed to individuals en16 rolled with the entity, shall require that payment for 

17 such drugs and related administrative services (as 

18 applicable), including payments made by a PBM on 

19 behalf of the State or entity, is based on a pass20 through pricing model under which— 

21 ‘‘(A) any payment made by the entity or 

22 the PBM (as applicable) for such a drug— 

23 ‘‘(i) is limited to— 

24 ‘‘(I) ingredient cost; and 

25 ‘‘(II) a professional dispensing 

26 fee that is not less than the profes-
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1 sional dispensing fee that the State 

2 plan or waiver would pay if the plan 

3 or waiver was making the payment di4 rectly; 

5 ‘‘(ii) is passed through in its entirety 

6 by the entity or PBM to the pharmacy 

7 that dispenses the drug; and 

8 ‘‘(iii) is made in a manner that is con9 sistent with section 1902(a)(30)(A) and 

10 sections 447.512, 447.514, and 447.518 of 

11 title 42, Code of Federal Regulations (or 

12 any successor regulation) as if such re13 quirements applied directly to the entity or 

14 the PBM; 

15 ‘‘(B) payment to the entity or the PBM 

16 (as applicable) for administrative services per17 formed by the entity or PBM is limited to a 

18 reasonable administrative fee that covers the 

19 reasonable cost of providing such services; 

20 ‘‘(C) the entity or the PBM (as applicable) 

21 shall make available to the State, and the Sec22 retary upon request, all costs and payments re23 lated to covered outpatient drugs and accom24 panying administrative services incurred, re25 ceived, or made by the entity or the PBM, in-
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1 cluding ingredient costs, professional dispensing 

2 fees, administrative fees, post-sale and post-in3 voice fees. Discounts, or related adjustments 

4 such as direct and indirect remuneration fees, 

5 and any and all remuneration; and 

6 ‘‘(D) any form of spread pricing whereby 

7 any amount charged or claimed by the entity or 

8 the PBM (as applicable) that is in excess of the 

9 amount paid to the pharmacies on behalf of the 

10 entity, including any post-sale or post-invoice 

11 fees, discounts, or related adjustments such as 

12 direct and indirect remuneration fees or assess13 ments (after allowing for a reasonable adminis14 trative fee as described in subparagraph (B)), is 

15 not allowable for purposes of claiming Federal 

16 matching payments under this title.’’. 

17 (2) CONFORMING AMENDMENT.—Clause (xiii) 

18 of section 1903(m)(2)(A) of such Act (42 U.S.C. 

19 1396b(m)(2)(A)) is amended— 

20 (A) by striking ‘‘and (III)’’ and inserting 

21 ‘‘(III)’’; and 

22 (B) by inserting before the period at the 

23 end the following: ‘‘, and (IV) pharmacy benefit 

24 management services provided by the entity, or 

25 provided by a pharmacy benefit manager on be-
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1 half of the entity under a contract or other ar2 rangement between the entity and the phar3 macy benefit manager, shall comply with the re4 quirements of section 1927(e)(6)’’. 

5 (3) EFFECTIVE DATE.—The amendments made 

6 by this subsection apply to contracts between States 

7 and managed care entities, other specified entities, 

8 or pharmacy benefits managers that are entered into 

9 or renewed on or after the date that is 18 months 

10 after the date of enactment of this Act. 

11 (b) SURVEY OF RETAIL PRICES.— 

12 (1) IN GENERAL.—Section 1927(f) of the Social 

13 Security Act (42 U.S.C. 1396r–8(f)) is amended— 

14 (A) by striking ‘‘and’’ after the semicolon 

15 at the end of paragraph (1)(A)(i) and all that 

16 precedes it through ‘‘(1)’’ and inserting the fol17 lowing: 

18 ‘‘(1) SURVEY OF RETAIL PRICES.—The Sec19 retary shall conduct a survey of retail community 

20 drug prices, to include at least the national average 

21 drug acquisition cost, as follows: 

22 ‘‘(A) USE OF VENDOR.—The Secretary 

23 may contract services for— 

24 ‘‘(i) with respect to retail community 

25 pharmacies, the determination on a month-
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1 ly basis of retail survey prices of the na2 tional average drug acquisition cost for 

3 covered outpatient drugs for such phar4 macies, net of all discounts and rebates (to 

5 the extent any information with respect to 

6 such discounts and rebates is available), 

7 the average reimbursement received for 

8 such drugs by such pharmacies from all 

9 sources of payment, including third par10 ties, and, to the extent available, the usual 

11 and customary charges to consumers for 

12 such drugs; and’’; 

13 (B) by adding at the end of paragraph (1) 

14 the following: 

15 ‘‘(F) SURVEY REPORTING.—In order to 

16 meet the requirement of section 1902(a)(54), a 

17 State shall require that any retail community 

18 pharmacy in the State that receives any pay19 ment, administrative fee, discount, or rebate re20 lated to the dispensing of covered outpatient 

21 drugs to individuals receiving benefits under 

22 this title, regardless of whether such payment, 

23 fee, discount, or rebate is received from the 

24 State or a managed care entity directly or from 

25 a pharmacy benefit manager or another entity 
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1 that has a contract with the State or a man2 aged care entity, shall respond to surveys of re3 tail prices conducted under this subsection. 

4 ‘‘(G) SURVEY INFORMATION.—Information 

5 on retail community prices obtained under this 

6 paragraph shall be made publicly available and 

7 shall include at least the following: 

8 ‘‘(i) The monthly response rate of the 

9 survey including a list of pharmacies not in 

10 compliance with subparagraph (F). 

11 ‘‘(ii) The sampling frame and number 

12 of pharmacies sampled monthly. 

13 ‘‘(iii) Characteristics of reporting 

14 pharmacies, including type (such as inde15 pendent or chain), geographic or regional 

16 location, and dispensing volume. 

17 ‘‘(iv) Reporting of a separate national 

18 average drug acquisition cost for each drug 

19 for independent retail pharmacies and 

20 chain operated pharmacies. 

21 ‘‘(v) Information on price concessions 

22 including on and off invoice discounts, re23 bates, and other price concessions. 

24 ‘‘(vi) Information on average profes25 sional dispensing fees paid. 
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1 ‘‘(H) PENALTIES.— 

2 ‘‘(i) FAILURE TO PROVIDE TIMELY IN3 FORMATION.—A retail community phar4 macy that fails to respond to a survey con5 ducted under this subsection on a timely 

6 basis may be subject to a civil monetary 

7 penalty in the amount of $10,000 for each 

8 day in which such information has not 

9 been provided. 

10 ‘‘(ii) FALSE INFORMATION.—A retail 

11 community pharmacy that knowingly pro12 vides false information in response to a 

13 survey conducted under this subsection 

14 may be subject to a civil money penalty in 

15 an amount not to exceed $100,000 for 

16 each item of false information. 

17 ‘‘(iii) OTHER PENALTIES.—Any civil 

18 money penalties imposed under this sub19 paragraph shall be in addition to other 

20 penalties as may be prescribed by law. The 

21 provisions of section 1128A (other than 

22 subsections (a) and (b)) shall apply to a 

23 civil money penalty under this subpara24 graph in the same manner as such provi-
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1 sions apply to a penalty or proceedings 

2 under section 1128A(a). 

3 ‘‘(I) REPORT ON SPECIALTY PHAR4 MACIES.— 

5 ‘‘(i) IN GENERAL.—Not later than 1 

6 year after the effective date of this sub7 paragraph, the Secretary shall submit a re8 port to Congress examining specialty drug 

9 coverage and reimbursement under this 

10 title. 

11 ‘‘(ii) CONTENT OF REPORT.—Such re12 port shall include a description of how 

13 State Medicaid programs define specialty 

14 drugs, how much State Medicaid programs 

15 pay for specialty drugs, how States and 

16 managed care plans determine payment for 

17 specialty drugs, the settings in which spe18 cialty drugs are dispensed (such as retail 

19 community pharmacies or specialty phar20 macies), whether acquisition costs for spe21 cialty drugs are captured in the national 

22 average drug acquisition cost survey, and 

23 recommendations as to whether specialty 

24 pharmacies should be included in the sur25 vey of retail prices to ensure national aver-
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1 age drug acquisition costs capture drugs 

2 sold at specialty pharmacies and how such 

3 specialty pharmacies should be defined.’’; 

4 (C) in paragraph (2)— 

5 (i) in subparagraph (A), by inserting 

6 ‘‘, including payments rates under Med7 icaid managed care plans,’’ after ‘‘under 

8 this title’’; and 

9 (ii) in subparagraph (B), by inserting 

10 ‘‘and the basis for such dispensing fees’’ 

11 before the semicolon; and 

12 (D) in paragraph (4), by inserting ‘‘, and 

13 $5,000,000 for fiscal year 2020 and each fiscal 

14 year thereafter,’’ after ‘‘2010’’. 

15 (2) EFFECTIVE DATE.—The amendments made 

16 by this subsection take effect on the 1st day of the 

17 1st quarter that begins on or after the date that is 

18 18 months after the date of enactment of this Act. 

19 (c) MANUFACTURER REPORTING OF WHOLESALE

20 ACQUISITION COST.—Section 1927(b)(3) of such Act (42 

21 U.S.C. 1396r–8(b)(3)) is amended— 

22 (1) in subparagraph (A)(i)— 

23 (A) in subclause (I), by striking ‘‘and’’ 

24 after the semicolon; 
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1 (B) in subclause (II), by adding ‘‘and’’ 

2 after the semicolon; 

3 (C) by moving the left margins of sub4 clause (I) and (II) 2 ems to the right; and 

5 (D) by adding at the end the following: 

6 ‘‘(III) in the case of rebate peri7 ods that begin on or after the date of 

8 enactment of this subclause, on the 

9 wholesale acquisition cost (as defined 

10 in section 1847A(c)(6)(B)) for cov11 ered outpatient drugs for the rebate 

12 period under the agreement (including 

13 for all such drugs that are sold under 

14 a new drug application approved 

15 under section 505(c) of the Federal 

16 Food, Drug, and Cosmetic Act);’’; and 

17 (2) in subparagraph (D)— 

18 (A) in the matter preceding clause (i), by 

19 inserting ‘‘and clause (vii) of this subpara20 graph’’ after ‘‘1847A’’; 

21 (B) in clause (v), by striking ‘‘and’’ after 

22 the comma; 

23 (C) in clause (vi), by striking the period 

24 and inserting ‘‘, and’’; and 
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1 (D) by inserting after clause (vi) the fol2 lowing: 

3 ‘‘(vii) to the Secretary to disclose 

4 (through a website accessible to the public) 

5 the most recently reported wholesale acqui6 sition cost (as defined in section 

7 1847A(c)(6)(B)) for each covered out8 patient drug (including for all such drugs 

9 that are sold under a new drug application 

10 approved under section 505(c) of the Fed11 eral Food, Drug, and Cosmetic Act), as re12 ported under subparagraph (A)(i)(III).’’. 

13 SEC. 816. GRADUATE MEDICAL EDUCATION IMPROVE14 MENTS IN RURAL AND UNDERSERVED COM15 MUNITIES. 

16 Part P of title III of the Public Health Service Act 

17 (42 U.S.C. 280g et seq.) is amended by adding at the end 

18 the following new section: 

19 ‘‘SEC. 399V–7. GRADUATE MEDICAL EDUCATION IMPROVE20 MENTS IN RURAL AND UNDERSERVED COM21 MUNITIES. 

22 ‘‘(a) RURAL AND UNDERSERVED COMMUNITY GME 

23 GRANT PROGRAM.—Not later than 1 year after the date 

24 of the enactment of this Act, the Secretary of Health and 

25 Human Services (in this section referred to as the ‘Sec-
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1 retary’), acting through the Administrator of the Health 

2 Resources and Services Administration, shall establish a 

3 rural and underserved community graduate medical edu4 cation grant program under which the Secretary shall 

5 award grants to specified hospitals (as defined in sub6 section (b)) that have not established an approved medical 

7 residency training program (as defined for purposes of 

8 section 1886(h) of the Social Security Act (42 U.S.C. 

9 1395ww(h))) in order to encourage such hospitals to es10 tablish such a program, or to establish an affiliation with 

11 a hospital that has established such a program in order 

12 to host residents under such program. 

13 ‘‘(b) USE OF FUNDS.—Grants awarded under sub14 section (a) may be used by a specified hospital for any 

15 initial costs associated with establishing such a program 

16 or such an affiliation, including costs associated with fac17 ulty development, administration, infrastructure, supplies, 

18 and legal and consultant services. 

19 ‘‘(c) SPECIFIED HOSPITAL DEFINED.—For purposes 

20 of subsection (a), the term ‘specified hospital’ means a 

21 hospital or critical access hospital (as such terms are de22 fined in section 1861 of the Social Security Act (42 U.S.C. 

23 1395x)) that— 

24 ‘‘(1) is— 
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1 ‘‘(A) located in a rural area (as defined in 

2 section 1886(d)(2)(D) of such Act (42 U.S.C. 

3 1395ww(d)(2)(D))); or 

4 ‘‘(B) treated as being located in a rural 

5 area pursuant to section 1886(d)(8)(E) of such 

6 Act (42 U.S.C. 1395ww(d)(8)(E)); and 

7 ‘‘(2) is located in a medically underserved area 

8 (as defined in section 330I(a) of the Public Health 

9 Service Act (42 U.S.C. 254c–14(a))). 

10 ‘‘(d) CRITICAL ACCESS HOSPITAL GRANT PRO11 GRAM.—Not later than 1 year after the date of the enact12 ment of this Act, the Secretary, acting through the Admin13 istrator of the Health Resources and Services Administra14 tion, shall establish a grant program under which the Sec15 retary awards grants to critical access hospitals (as de16 fined in section 1861 of the Social Security Act (42 U.S.C. 

17 1395x)) that do not have in effect an affiliation with a 

18 hospital with an approved medical residency training pro19 gram to host residents of such program in order to assist 

20 such critical access hospitals in setting up such affiliations 

21 in order to host such residents. 

22 ‘‘(e) LIMITATION ON GRANT AMOUNTS.—No hospital 

23 may receive an aggregate amount of grants under this sec24 tion in excess of $250,000. 

25 ‘‘(f) REPORTS.— 
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1 ‘‘(1) HHS.—Not later than 5 years after the 

2 date of the enactment of this Act, the Secretary of 

3 Health and Human Services shall submit to the 

4 Committee on Energy and Commerce of the House 

5 of Representatives and the Committee on Health, 

6 Education, Labor, and Pensions of the Senate a re7 port on graduate medical residency training pro8 grams of hospitals that received a grant under sub9 section (a) or (d). Such report shall include the fol10 lowing: 

11 ‘‘(A) The number of hospitals that applied 

12 for a grant under this section. 

13 ‘‘(B) The number of hospitals that were 

14 awarded such a grant. 

15 ‘‘(C) The number of residency positions 

16 created by hospitals receiving such a grant. 

17 ‘‘(D) An estimate of the number of such 

18 positions such hospitals will create after the 

19 date of the submission of such report. 

20 ‘‘(E) A description of any challenges faced 

21 by hospitals in applying for such a grant or 

22 using funds awarded under such a grant. 

23 ‘‘(2) GAO.—Not later than 10 years after the 

24 date of the enactment of this Act, the Comptroller 
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1 General of the United States shall submit to Con2 gress a report containing an analysis of— 

3 ‘‘(A) the number of residents who trained 

4 at a hospital or critical access hospital that re5 ceived a grant under subsection (a) or (d); and 

6 ‘‘(B) whether such residents continued to 

7 practice medicine in a rural area (as defined in 

8 section 1886(d)(2)(D) of the Social Security 

9 Act (42 U.S.C. 1395ww(d)(2)(D))) or in a 

10 medically underserved area (as defined in sec11 tion 330I(a) of the Public Health Service Act 

12 (42 U.S.C. 254c–14(a))) after completing such 

13 training. 

14 ‘‘(g) FUNDING.—There are authorized to be appro15 priated such sums as are necessary for purposes of making 

16 grants under this section for each of fiscal years 2020 

17 through 2029.’’. 

Passed the House of Representatives December 12, 

2019. 

Attest: 

Clerk. 
116TH CONGRESS 

1ST SESSION H. R. 3 

AN ACT 

To establish a fair price negotiation program, proother purposes. imum for Medicare part D enrollees, and for increases, and establish an out-of-pocket max- tect the Medicare program from excessive price