End Price Gouging for Medications Act

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. 1. Short title This Act may be cited as the End Price Gouging for Medications Act 2. Reference prices for prescription drugs (a) Reference prices The Secretary of Health and Human Services (referred to in this section as the Secretary (b) Criteria (1) In general Each year, the Secretary shall establish the reference price for each prescription drug under subsection (a)— (A) by determining the median retail list price for the drug among the reference countries in which the drug is available, if drug pricing information is available for at least 3 of such countries; or (B) in the case of a drug for which drug pricing information or dosage equivalents are not available for at least 3 of the reference countries, by determining an appropriate price based on the Secretary's determination of— (i) the added therapeutic effect of the drug; (ii) the value of the drug; (iii) patient access to the drug; (iv) the costs associated with researching and developing the drug; and (v) other factors, as the Secretary determines appropriate. (2) Reference countries For purposes of paragraph (1), the reference countries are Japan, Germany, the United Kingdom, France, Italy, Canada, Australia, Spain, the Netherlands, Switzerland, and Sweden. (c) Federal health programs The reference prices established under subsection (a) shall apply with respect to covered inpatient and outpatient drugs under— (1) the Medicare program under title XVIII of the Social Security Act ( 42 U.S.C. 1395 (2) a State Medicaid plan under title XIX of the Social Security Act ( 42 U.S.C. 1396 (3) the State Children's Health Insurance Program under title XXI of the Social Security Act ( 42 U.S.C. 1397aa (4) the TRICARE program under chapter 55 (5) hospital care and medical services furnished by the Department of Veterans Affairs under chapters 17 and 18 of title 38, United States Code; (6) the Federal Employees Health Benefits Program established under chapter 89 (7) any health program, service, function, activity, or facility funded, in whole or part, under the Indian Health Care Improvement Act ( 25 U.S.C. 1601 25 U.S.C. 5304 (d) Applicability to other purchasers of drugs Notwithstanding any other provision of law, a drug manufacturer shall offer prescription drugs at the reference price to all individuals, including individuals who are not insured and individuals who are covered under a group health plan or group or individual health insurance coverage. In the case of individuals covered by a group health plan or group or individual health insurance coverage, such requirement is met if the amount covered under such plan or coverage plus the cost-sharing amount does not exceed the reference price. (e) Enforcement (1) Civil penalty A drug manufacturer who does not comply with the requirements of subsection (a) shall be subject to a civil penalty, for each year in which the violation occurs and with respect to each drug for which the violation occurs, in an amount equal to 5 times the difference between— (A) the total amount received by the manufacturer for sales of the drug under the Federal health programs under subsection (c) for the year; less (B) the total amount the manufacturer would have received for sales of the drug under such programs for the year if the manufacturer had complied with subsection (a). (2) Amounts collected Each year, the Secretary of the Treasury shall transfer to the Director of the National Institutes of Health an amount equal to the amount collected in civil penalties under subsection (e) for the previous year. The Director of the National Institutes of Health shall use amounts so transferred for purposes of conducting drug research and development. (f) Applicability to brand and generic drugs The reference price established under subsection (a) shall apply to drugs approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 42 U.S.C. 262

Summary: End Price Gouging for Medications Act This bill requires the Department of Health and Human Services (HHS) to set maximum prices for prescription drugs under specified federal health programs. Specifically, HHS must establish reference prices based on certain factors, including drug prices in listed countries. Retail prices of covered drugs under specified federal health programs (e.g., Medicare and Medicaid) may not exceed the established reference prices. Drugs must also be available at such prices to uninsured individuals and to individuals with private health insurance.