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This proposed rule would provide access to life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements.

Statement of Need:

On March 13, 2020, President Trump declared the ongoing Coronavirus Disease COVID-19 pandemic of sufficient severity and magnitude to warrant an emergency declaration for all States, territories, and the District of Columbia. With the COVID-19 emergency, many low-income individuals are experiencing significant economic hardship. As a result, many low-income individuals who are dependent upon the life-saving medications of insulin or injectable epinephrine are less able to access these drugs at an affordable price.

Summary of the Legal Basis:

On July 24, 2020, Executive Order 13937 (Executive Order), Executive Order on Access to Affordable Life-saving Medications, was issued to direct health centers that receive grants under section 330(e) of the PHS Act to support the improved access to certain life-saving medications by low-income individuals. More specifically, through the Executive Order, the President directed the Secretary of Health and Human Services (the Secretary) to take action, to the extent permitted by law, to ensure all future grants available under section 330(e) of the PHS Act, as amended, 42 U.S.C. 254b(e), are conditioned upon health centers having established practices to make insulin and injectable epinephrine available at the discounted price paid by the health center 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.

HRSA plans to implement the Executive Order through a Notice of Proposed Rulemaking (NPRM) to amend 42 CFR 51c.303 to add new subsection (w):

(w)(1) To the extent that an applicant has indicated that it plans to distribute, either directly, or through a written agreement, drugs purchased through the 340B Drug Discount Program (42 U.S.C. 256b), and to the extent that such applicant plans to make insulin and/or injectable epinephrine available to its patients, the applicant shall provide an assurance that it has established practices to do so at or below the discounted price paid by the health center 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 have a high cost sharing requirement for either insulin or injectable epinephrine; have a high unmet deductible; or have no health insurance.

The associated new requirement for all awards under section 330(e) would be proposed as follows:

Under Executive Order 13937, issued July 24, 2020, if your health center, or a subrecipient, receives section 330(e) funding, is enrolled in the 340B Drug Pricing Program and purchases, is reimbursed, or provides reimbursement to other entities for insulin and injectable epinephrine, whether obtained using Federal or non-federal funds, your health center must have established practices to make these two outpatient prescription drug categories available to low-income health center patients (defined herein as those individuals or families with annual incomes at or below 350% of the Federal Poverty Guidelines) who either have insurance with a high cost sharing requirement for either insulin or injectable epinephrine, as applicable, a high unmet deductible, or who have no health insurance at or below the price the health center paid through the 340B Drug Pricing Program, plus a minimal administration fee. You are not required to charge third party payors this discounted price. 

The proposed Program Term would be included on all Notices of Award issued to health centers receiving grants under section 330(e).

Alternatives:

HRSA considered alternatives and determined the NPRM and associated term to be the most appropriate means of implementing the Executive Order.

Anticipated Costs and Benefits:

HRSA does not believe that this new rule will have an economic impact of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities. 

The final rule will allow low-income patients with medical conditions requiring insulin or injectable epinephrine to access these necessary and life-saving medications as soon and with as few financial barriers as possible during the ongoing pandemic, without a delay that would result from a process requiring prior notice and comment.

Risks:

HRSA does not anticipate significant risks associated with this regulatory action.