HRSA announced new requirements related to the April 15th 2025 Executive Order. Health centers participating in 340B and receiving 330(e) funding must provide insulins and injectable epinephrine at 340B discounts to low-income patients who are uninsured, have a high unmet deductible, or have a high cost-sharing requirement.
HRSA’s official press release explains that the health center notice of award terms have been updated to reflect the recent changes.
New Notice of Award (NOA) terms, as of 6/24/2025 (emphasis added):
Consistent with Executive Order 14273, the recipient of a grant under section 330(e) of the Public Health Service Act (42 U.S.C. 254b(e)) must have established practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee (award recipient) or sub-grantee (subrecipient) under the 340B Drug Pricing 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.
For this purpose, a “low-income individual” is an individual living in a household with an income level at or below 200 percent of the Federal Poverty Guidelines (see 42 CFR 51c.303(f), Poverty Guidelines | ASPE). Your practices should be incorporated in written policies and supporting procedures that reflect this determination and that define a “high cost sharing requirement,” a “high unmet deductible,” and “no health care insurance” for this purpose.
You will document on Form 1C: Documents on File in your future Service Area Competition (SAC) applications or Budget Period Progress Reports (BPRs) that you have current practices, supported by written policies/procedures, that demonstrate your compliance with this term of your award, and you will make those documents available for review upon HRSA’s request.
As always, the 340B team at Draffin Tucker is here to help! Please reach out to us with any questions you may have.