I 

116TH CONGRESS 

1ST SESSION H. R. 5364 

To require the Secretary of Health and Human Services to establish an 

annual reference price for insulin products for purposes of Federal health 

programs, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 9, 2019 

Mrs. BEATTY (for herself, Mr. PAYNE, Mr. BISHOP of Georgia, Ms. NORTON, 

Mr. MCEACHIN, Mr. CLAY, Mr. LIPINSKI, Mr. THOMPSON of Mississippi, 

and Mr. BROWN of Maryland) introduced the following bill; which was 

referred to the Committee on Energy and Commerce, and in addition to 

the Committees on Ways and Means, Armed Services, Veterans’ Affairs, 

Oversight and Reform, and Natural Resources, for a period to be subsequently determined by the Speaker, in each case for consideration of such 

provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To require the Secretary of Health and Human Services 

to establish an annual reference price for insulin products for purposes of Federal health programs, and for 

other purposes. 

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘End Price Gouging 

5 for Insulin Act’’. 


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1 SEC. 2. REFERENCE PRICE FOR INSULIN PRODUCTS. 

2 (a) REFERENCE PRICE.—The Secretary of Health 

3 and Human Services (referred to in this section as the 

4 ‘‘Secretary’’), in accordance with subsection (b), shall es5 tablish an annual reference price for insulin products. 

6 Notwithstanding any other provision of law, including sec7 tion 1860D–11(i) of the Social Security Act (42 U.S.C. 

8 1395w–111(i)), with respect to enrollees or beneficiaries 

9 in any of the Federal health programs described in sub10 section (c), the wholesale acquisition cost for insulin prod11 ucts, including the cost-sharing amount, shall not exceed 

12 the reference price for the applicable year. 

13 (b) CRITERIA.— 

14 (1) IN GENERAL.—Not later than 6 months 

15 after the date of enactment of this Act and every 6 

16 months thereafter, the Secretary shall establish the 

17 reference price for insulin products— 

18 (A) by determining the median wholesale 

19 acquisition cost or the commensurate list price 

20 in the reference countries for insulin products 

21 among the reference countries in which such 

22 products are available, if insulin product pricing 

23 information is available for at least three of 

24 such countries; or 

25 (B) in the case that insulin product pricing 

26 information or dosage equivalents are not availVerDate Sep 11 2014 18:35 Dec 12, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5364.IH H5364

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1 able for at least three of the reference coun2 tries, by determining an appropriate price based 

3 on— 

4 (i) the clinical and therapeutic effect 

5 and value of the product; 

6 (ii) patient access to the product; 

7 (iii) the costs associated with manu8 facturing, marketing, researching, and de9 veloping the product; 

10 (iv) total revenues, net profit, and ex11 ecutive compensation associated with the 

12 manufacturer of the product; and 

13 (v) other factors, as the Secretary de14 termines appropriate. 

15 (2) REFERENCE COUNTRIES.—For purposes of 

16 paragraph (1), the reference countries are Japan, 

17 Germany, the United Kingdom, France, Italy, Can18 ada, Australia, Spain, the Netherlands, Switzerland, 

19 and Sweden. 

20 (c) FEDERAL HEALTH PROGRAMS.—The reference 

21 price established under subsection (a) shall apply with re22 spect to covered insulin products under— 

23 (1) the Medicare program under title XVIII of 

24 the Social Security Act (42 U.S.C. 1395 et seq.); 


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1 (2) a State Medicaid plan under title XIX of 

2 the Social Security Act (42 U.S.C. 1396 et seq.); 

3 (3) the State Children’s Health Insurance Pro4 gram under title XXI of the Social Security Act (42 

5 U.S.C. 1397aa et seq.); 

6 (4) the TRICARE program under chapter 55 of 

7 title 10, United States Code; 

8 (5) hospital care and medical services furnished 

9 by the Department of Veterans Affairs under chap10 ters 17 and 18 of title 38, United States Code; 

11 (6) the Federal Employees Health Benefits 

12 Program established under chapter 89 of title 5, 

13 United States Code; and 

14 (7) any health program, service, function, activ15 ity, or facility funded, in whole or part, under the 

16 Indian Health Care Improvement Act (25 U.S.C. 

17 1601 et seq.), including through direct or contract 

18 care provided under such Act or through a contract 

19 or compact under the Indian Self-Determination and 

20 Education Assistance Act (25 U.S.C. 5304 et seq.). 

21 (d) APPLICABILITY TO OTHER PURCHASERS OF IN22 SULIN PRODUCTS.—Notwithstanding any other provision 

23 of law, an insulin product manufacturer shall offer such 

24 product at the reference price to all individuals, including 

25 individuals who are not insured and individuals who are 


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1 covered under a group health plan or group or individual 

2 health insurance coverage. 

3 (e) CIVIL PENALTY.—The Secretary shall enforce 

4 this section by imposing a civil penalty upon any insulin 

5 product manufacturer who does not comply with the re6 quirements of subsection (a), for each year in which the 

7 violation occurs, in an amount equal to 10 times the dif8 ference between— 

9 (1) the total amount received by the manufac10 turer for sales of insulin products under the Federal 

11 health programs under subsection (c) for the year; 

12 less 

13 (2) the total amount the manufacturer would 

14 have received for sales of insulin products under 

15 such programs for the year if the manufacturer had 

16 complied with subsection (a). 

17 (f) USE OF AMOUNTS COLLECTED.—Each year, the 

18 Secretary of the Treasury shall allocate the amount col19 lected under subsection (e) for the previous year as fol20 lows: 

21 (1) Half of such amount shall be deposited in 

22 the Federal Hospital Insurance Trust Fund and the 

23 Federal Supplementary Medical Insurance Trust 

24 Fund (including the Medicare Prescription Drug Ac25 count within such Trust Fund) in such proportion 


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1 as the Secretary of Health and Human Services de2 termines appropriate. 

3 (2) Half of such amount shall be transferred to 

4 the National Institutes of Health, for purposes of 

5 carrying out drug research and development. 

6 (g) APPLICABILITY TO BRAND AND GENERIC INSU7 LIN PRODUCTS.—The reference price established under 

8 subsection (a) shall apply to insulin products approved 

9 under subsection (c) or (j) of section 505 of the Federal 

10 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or under 

11 subsection (a) or (k) of section 351 of the Public Health 

12 Service Act (42 U.S.C. 262). 

Æ 


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