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