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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5364 Introduced in House (IH)]

<DOC>

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.

    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 Insulin Act''.

SEC. 2. REFERENCE PRICE FOR INSULIN PRODUCTS.

    (a) Reference Price.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), in accordance with 
subsection (b), shall establish an annual reference price for insulin 
products. Notwithstanding any other provision of law, including section 
1860D-11(i) of the Social Security Act (42 U.S.C. 1395w-111(i)), with 
respect to enrollees or beneficiaries in any of the Federal health 
programs described in subsection (c), the wholesale acquisition cost 
for insulin products, including the cost-sharing amount, shall not 
exceed the reference price for the applicable year.
    (b) Criteria.--
            (1) In general.--Not later than 6 months after the date of 
        enactment of this Act and every 6 months thereafter, the 
        Secretary shall establish the reference price for insulin 
        products--
                    (A) by determining the median wholesale acquisition 
                cost or the commensurate list price in the reference 
                countries for insulin products among the reference 
                countries in which such products are available, if 
                insulin product pricing information is available for at 
                least three of such countries; or
                    (B) in the case that insulin product pricing 
                information or dosage equivalents are not available for 
                at least three of the reference countries, by 
                determining an appropriate price based on--
                            (i) the clinical and therapeutic effect and 
                        value of the product;
                            (ii) patient access to the product;
                            (iii) the costs associated with 
                        manufacturing, marketing, researching, and 
                        developing the product;
                            (iv) total revenues, net profit, and 
                        executive compensation associated with the 
                        manufacturer of the product; 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 price established under 
subsection (a) shall apply with respect to covered insulin products 
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 Insulin Products.--
Notwithstanding any other provision of law, an insulin product 
manufacturer shall offer such product 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.
    (e) Civil Penalty.--The Secretary shall enforce this section by 
imposing a civil penalty upon any insulin product manufacturer who does 
not comply with the requirements of subsection (a), for each year in 
which the violation occurs, in an amount equal to 10 times the 
difference between--
            (1) the total amount received by the manufacturer for sales 
        of insulin products under the Federal health programs under 
        subsection (c) for the year; less
            (2) the total amount the manufacturer would have received 
        for sales of insulin products under such programs for the year 
        if the manufacturer had complied with subsection (a).
    (f) Use of Amounts Collected.--Each year, the Secretary of the 
Treasury shall allocate the amount collected under subsection (e) for 
the previous year as follows:
            (1) Half of such amount shall be deposited in the Federal 
        Hospital Insurance Trust Fund and the Federal Supplementary 
        Medical Insurance Trust Fund (including the Medicare 
        Prescription Drug Account within such Trust Fund) in such 
        proportion as the Secretary of Health and Human Services 
        determines appropriate.
            (2) Half of such amount shall be transferred to the 
        National Institutes of Health, for purposes of carrying out 
        drug research and development.
    (g) Applicability to Brand and Generic Insulin Products.--The 
reference price established under subsection (a) shall apply to insulin 
products 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).
                                 <all>
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