119-hr3391

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3391 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 3391

 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

 May 14, 2025

 Mrs. Dingell 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 
 Government 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 purposes.

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

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``End Price Gouging for Medications 
Act''.

SEC. 2. REFERENCE PRICES FOR PRESCRIPTION DRUGS.

    (a) Reference Prices.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in accordance with 
subsection

    (b) , shall establish annual reference prices for each 
prescription drug. Notwithstanding any other provision of law, with 
respect to enrollees or beneficiaries in any of the Federal health 
programs described in subsection
            (c) , the retail list price for a drug 
shall not exceed the reference price for such drug.

    (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 lowest 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 Australia, Austria, Belgium, 
 Canada, France, Germany, Italy, Japan, the Netherlands, Sweden, 
 Switzerland, and the United Kingdom.
            (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 et seq.);

    (2) a State Medicaid plan under title XIX of the Social 
 Security Act (42 U.S.C. 1396 et seq.);

    (3) the State Children's Health Insurance Program under 
 title XXI of the Social Security Act (42 U.S.C. 1397aa et 
 seq.);

    (4) the TRICARE program under chapter 55 of title 10, 
 United States Code;

    (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 of title 5, United States Code; 
 and

    (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 et seq.), including through 
 direct or contract care provided under such Act or through a 
 contract or compact under the Indian Self-Determination and 
 Education Assistance Act (25 U.S.C. 5304 et seq.).
            (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) or under subsection

    (a) or

    (k) of 

section 351 of the Public Health Service Act (42 U.S.C. 262).
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