Access to Affordable Life-Saving Medications, 45755-45756 [2020-16623]

Agencies

• Executive Office of the President

[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 [www.gpo.gov]
[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.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    July 24, 2020.

[FR Doc. 2020-16623
Filed 7-28-20; 2:00 pm]
Billing code 3295-F0-P