Presidential DocumentExecutive Order 139372020-16623
Access to Affordable Life-Saving Medications
Primary source
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Published
July 29, 2020
Signed
July 24, 2020
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 85 Issue 146 (Wednesday, July 29, 2020)</title>
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[Federal Register Volume 85, Number 146 (Wednesday, July 29, 2020)]
[Presidential Documents]
[Pages 45755-45756]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2020-16623]
[[Page 45753]]
Vol. 85
Wednesday,
No. 146
July 29, 2020
Part IV
The President
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Executive Order 13937--Access to Affordable Life-Saving Medications
Executive Order 13938--Increasing Drug Importation To Lower Prices for
American Patients
Executive Order 13939--Lowering Prices for Patients by Eliminating
Kickbacks to Middlemen
Presidential Documents
Federal Register / Vol. 85, No. 146 / Wednesday, July 29, 2020 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 45755]]
Executive Order 13937 of July 24, 2020
Access to Affordable Life-Saving Medications
By the authority vested in me as President by the
Constitution and the laws of the United States of
America, it is hereby ordered as follows:
Section 1. Purpose. Insulin is a critical and life-
saving medication that approximately 8 million
Americans rely on to manage diabetes. Likewise,
injectable epinephrine is a life-saving medication used
to stop severe allergic reactions.
The price of insulin in the United States has risen
dramatically over the past decade. The list price for a
single vial of insulin today is often more than $250
and most patients use at least two vials per month. As
for injectable epinephrine, recent increased
competition is helping to drive prices down.
Nevertheless, the price for some types of injectable
epinephrine remains more than $600 per kit. While
Americans with diabetes and severe allergic reactions
may have access to affordable insulin and injectable
epinephrine through commercial insurance or Federal
programs such as Medicare and Medicaid, many Americans
still struggle to purchase these products.
Federally Qualified Health Centers (FQHCs), as defined
in section 1905(l)(2)(B)(i) and (ii) of the Social
Security Act, as amended, 42 U.S.C. 1396d(l)(2)(B)(i)
and (ii), receive discounted prices through the 340B
Prescription Drug Program on prescription drugs. Due to
the sharp increases in list prices for many insulins
and some types of injectable epinephrine in recent
years, many of these products may be subject to the
``penny pricing'' policy when distributed to FQHCs,
meaning FQHCs may purchase the drug at a price of one
penny per unit of measure. These steep discounts,
however, are not always passed through to low-income
Americans at the point of sale. Those with low-incomes
can be exposed to high insulin and injectable
epinephrine prices, as they often do not benefit from
discounts negotiated by insurers or the Federal or
State governments.
Sec. 2. Policy. It is the policy of the United States
to enable Americans without access to affordable
insulin and injectable epinephrine through commercial
insurance or Federal programs, such as Medicare and
Medicaid, to purchase these pharmaceuticals from an
FQHC at a price that aligns with the cost at which the
FQHC acquired the medication.
Sec. 3. Improving the Availability of Insulin and
Injectable Epinephrine for the Uninsured. To the extent
permitted by law, the Secretary of Health and Human
Services shall take action to ensure future grants
available under section 330(e) of the Public Health
Service Act, as amended, 42 U.S.C. 254b(e), are
conditioned upon FQHCs' having established practices to
make insulin and injectable epinephrine available at
the discounted price paid by the FQHC grantee or sub-
grantee under the 340B Prescription Drug Program (plus
a minimal administration fee) to individuals with low
incomes, as determined by the Secretary, who:
(a) have a high cost sharing requirement for either
insulin or injectable epinephrine;
(b) have a high unmet deductible; or
(c) have no health care insurance.
Sec. 4. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
[[Page 45756]]
(i) the authority granted by law to an executive department or agency, or
the head thereof;
(ii) the functions of the Director of the Office of Management and Budget
relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the availability of
appropriations.
(c) This order is not intended to, and does not,
create any right or benefit, substantive or procedural,
enforceable at law or in equity by any party against
the United States, its departments, agencies, or
entities, its officers, employees, or agents, or any
other person.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
July 24, 2020.
[FR Doc. 2020-16623
Filed 7-28-20; 2:00 pm]
Billing code 3295-F0-P
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