Health Center Program Compliance Frequently Asked Questions (FAQ)
Can’t find your answer here? Please submit your question through the BPHC Contact Form and select the appropriate issue type, or call Health Center Program Support at 1-877-464-4772.
The term “site visit” in these FAQ refers to:
- Operational Site Visits (OSVs) conducted for awardees
- OSVs conducted for look-alikes
- Initial Designation (ID) site visits conducted for look-alike applicants
The information in these FAQ only relates to requirements and processes of the HRSA Health Center Program.
340B Drug Pricing Program
On April 15, 2025, President Trump signed Executive Order (EO) 14273, Lowering Drug Prices by Once Again Putting America First. Section 7 of the EO directed HHS, within 90 days, to condition awards authorized by section 330(e) of the Public Health Service Act upon health centers establishing practices to make insulin and injectable epinephrine available at or below the discounted price paid by the health center grantee or sub-grantee (“subrecipient”) 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 healthcare insurance. References to the 340B Prescription Drug Program in the EO are understood to refer to the 340B Drug Pricing Program administered by HRSA. For this purpose, the Secretary has determined that a “low-income” individual means an individual living in a household with an income level at or below 200 percent of the Federal Poverty Guidelines. HRSA has implemented this EO through a new grant term applied to Health Center Program operating grants.
(Updated: 9/9/2025)
Consistent with Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First, HRSA has issued a new grant term that is applicable to all recipients of Health Center Program operating awards provided under section 330 of the Public Health Service Act that also participate in the 340B Drug Pricing Program. This includes health centers funded to serve migratory and seasonal agricultural workers, homeless population, and residents of public housing as awards for such grants are authorized for purposes described in subsection 330(e).
Recipients also will be required to monitor subrecipients to ensure entities that carry out all or part of the Health Center Program project on behalf of the recipient health center, irrespective of whether the health center considers such an entity to be a subrecipient or a contractor, and that also participate in the 340B program in connection with the Health Center Program project, comply with this requirement.
(Updated: 9/9/2025)
For the purposes of this grant term, “a low-income individual” means an individual living in a household with an income level at or below 200 percent of the Federal Poverty Guidelines. Your health center’s policies and supporting procedures should establish applicable definitions of the other terms listed above, which will make these individuals eligible for the discounted drug price. Specifically, your policies should define the following factors—(1) “high cost sharing requirement for insulin or epinephrine,” (2) “high unmet deductible,” and (3) “no health care insurance” for this purpose. Such definitions should also be applied to subrecipients. Beginning with your fiscal year 2026 Service Area Competition applications or Budget Period Progress Reports, you will document on Form 1C: Documents on File that your health center has established and maintains policies and procedures for its grant-supported project that are consistent with the grant term. Records demonstrating implementation of required policies and procedures must be available for review when requested.
(Updated: 9/9/2025)
As required by the applicable grant term, beginning in fiscal year 2026, health centers will document on Form 1C: Documents on File in the Fiscal Year 2026 Service Area Competition applications or Budget Period Progress Reports that they have policies/procedures in place to ensure compliance with this grant term. Records demonstrating the implementation of required policies and procedures must be made available for review when requested.
(Updated: 9/9/2025)
The applicable grant term only applies to health centers and sub-grantees (subrecipients) receiving Health Center Program operating awards and that also participate in the 340B Drug Pricing Program. If a health center does not participate in the 340B Drug Pricing Program, they should select N/A on Form 1C.
(Updated: 9/9/2025)
HRSA’s grant term requires a health center to have written policies and procedures demonstrating that it has established practices to offer insulin and injectable epinephrine at or below the discounted price paid by the health center under the 340B Drug Pricing Program plus a minimal administration fee. Such established policies may reflect that provision of insulin and injectable epinephrine at or below the 340B discounted price is subject to the availability of the 340B discount from drug manufacturers. 340B Program covered entities are encouraged to submit a Price Unavailable Form (PDF - 442 KB) to HRSA’s Office of Pharmacy Affairs if a manufacturer fails to make a covered outpatient drug available at or below the 340B ceiling price.
(Updated: 9/9/2025)
The new grant term requires that health centers or sub-grantees (“subrecipients”) make insulin and injectable epinephrine available at or below the discounted price paid by the health center or subrecipient under the 340B Drug Pricing Program (plus a minimal administration fee) to patients who meet the criteria set forth in the grant term (i.e., low-income patients with a high cost-sharing requirement, high unmet deductible, or no insurance).Other medications are not addressed by this requirement.
(Updated: 9/9/2025)