End Price Gouging for Medications Act

I 117TH CONGRESS 1ST SESSION H. R. 2829 To require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs, and for other purposes. IN THE HOUSE OF REPRESENTATIVES APRIL 22, 2021 Mr. WELCH 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 reference prices for prescription drugs for purposes of Federal health programs, and for other pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘End Price Gouging 4 for Medications Act’’. 5 VerDate Sep 11 2014 01:29 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2829.IH H2829 kjohnson on DSK79L0C42PROD with BILLS 2 •HR 2829 IH SEC. 2. REFERENCE PRICES FOR PRESCRIPTION DRUGS. 1 (a) REFERENCE PRICES.—The Secretary of Health 2 and Human Services (referred to in this section as the 3 ‘‘Secretary’’), in accordance with subsection (b), shall es- 4 tablish annual reference prices for each prescription drug. 5 Notwithstanding any other provision of law, with respect 6 to enrollees or beneficiaries in any of the Federal health 7 programs described in subsection (c), the retail list price 8 for a drug shall not exceed the reference price for such 9 drug. 10 (b) CRITERIA.— 11 (1) IN GENERAL.—Each year, the Secretary 12 shall establish the reference price for each prescrip- 13 tion drug under subsection (a)— 14 (A) by determining the median retail list 15 price for the drug among the reference coun- 16 tries in which the drug is available, if drug pric- 17 ing information is available for at least 3 of 18 such countries; or 19 (B) in the case of a drug for which drug 20 pricing information or dosage equivalents are 21 not available for at least 3 of the reference 22 countries, by determining an appropriate price 23 based on the Secretary’s determination of— 24 (i) the added therapeutic effect of the 25 drug; 26 VerDate Sep 11 2014 01:29 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2829.IH H2829 kjohnson on DSK79L0C42PROD with BILLS 3 •HR 2829 IH (ii) the value of the drug; 1 (iii) patient access to the drug; 2 (iv) the costs associated with re- 3 searching and developing the drug; and 4 (v) other factors, as the Secretary de- 5 termines appropriate. 6 (2) REFERENCE COUNTRIES.—For purposes of 7 paragraph (1), the reference countries are Japan, 8 Germany, the United Kingdom, France, Italy, Can- 9 ada, Australia, Spain, the Netherlands, Switzerland, 10 and Sweden. 11 (c) FEDERAL HEALTH PROGRAMS.—The reference 12 prices established under subsection (a) shall apply with re- 13 spect to covered inpatient and outpatient drugs under— 14 (1) the Medicare program under title XVIII of 15 the Social Security Act (42 U.S.C. 1395 et seq.); 16 (2) a State Medicaid plan under title XIX of 17 the Social Security Act (42 U.S.C. 1396 et seq.); 18 (3) the State Children’s Health Insurance Pro- 19 gram under title XXI of the Social Security Act (42 20 U.S.C. 1397aa et seq.); 21 (4) the TRICARE program under chapter 55 of 22 title 10, United States Code; 23 VerDate Sep 11 2014 01:29 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2829.IH H2829 kjohnson on DSK79L0C42PROD with BILLS 4 •HR 2829 IH (5) hospital care and medical services furnished 1 by the Department of Veterans Affairs under chap- 2 ters 17 and 18 of title 38, United States Code; 3 (6) the Federal Employees Health Benefits 4 Program established under chapter 89 of title 5, 5 United States Code; and 6 (7) any health program, service, function, activ- 7 ity, or facility funded, in whole or part, under the 8 Indian Health Care Improvement Act (25 U.S.C. 9 1601 et seq.), including through direct or contract 10 care provided under such Act or through a contract 11 or compact under the Indian Self-Determination and 12 Education Assistance Act (25 U.S.C. 5304 et seq.). 13 (d) APPLICABILITY TO OTHER PURCHASERS OF 14 DRUGS.—Notwithstanding any other provision of law, a 15 drug manufacturer shall offer prescription drugs at the 16 reference price to all individuals, including individuals who 17 are not insured and individuals who are covered under a 18 group health plan or group or individual health insurance 19 coverage. In the case of individuals covered by a group 20 health plan or group or individual health insurance cov- 21 erage, such requirement is met if the amount covered 22 under such plan or coverage plus the cost-sharing amount 23 does not exceed the reference price. 24 (e) ENFORCEMENT.— 25 VerDate Sep 11 2014 01:29 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2829.IH H2829 kjohnson on DSK79L0C42PROD with BILLS 5 •HR 2829 IH (1) CIVIL PENALTY.—A drug manufacturer who 1 does not comply with the requirements of subsection 2 (a) shall be subject to a civil penalty, for each year 3 in which the violation occurs and with respect to 4 each drug for which the violation occurs, in an 5 amount equal to 5 times the difference between— 6 (A) the total amount received by the man- 7 ufacturer for sales of the drug under the Fed- 8 eral health programs under subsection (c) for 9 the year; less 10 (B) the total amount the manufacturer 11 would have received for sales of the drug under 12 such programs for the year if the manufacturer 13 had complied with subsection (a). 14 (2) AMOUNTS COLLECTED.—Each year, the 15 Secretary of the Treasury shall transfer to the Di- 16 rector of the National Institutes of Health an 17 amount equal to the amount collected in civil pen- 18 alties under subsection (e) for the previous year. The 19 Director of the National Institutes of Health shall 20 use amounts so transferred for purposes of con- 21 ducting drug research and development. 22 (f) APPLICABILITY TO BRAND AND GENERIC 23 DRUGS.—The reference price established under subsection 24 (a) shall apply to drugs approved under subsection (c) or 25 VerDate Sep 11 2014 01:29 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2829.IH H2829 kjohnson on DSK79L0C42PROD with BILLS 6 •HR 2829 IH (j) of section 505 of the Federal Food, Drug, and Cos- 1 metic Act (21 U.S.C. 355) or under subsection (a) or (k) 2 of section 351 of the Public Health Service Act (42 U.S.C. 3 262). 4 Æ VerDate Sep 11 2014 01:29 Jun 08, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H2829.IH H2829 kjohnson on DSK79L0C42PROD with BILLS