8/25/2025 – HRSA Proposes Stricter Requirements for STD Clinic Registration and Recertification and Shipping Location Registration
On August 7, 2025, HRSA published a notice proposing significant revisions to the data collection requirements for enrolling and recertifying STD clinics and for registering shipping locations. Comments are due no later than October 6, 2025.
The proposal includes two major changes:
New STD entity documentation requirements – HRSA is proposing that entities registering as an STD covered entity will have to submit supporting documentation. All STD registrants would be required to include a copy of the Centers for Disease Control and Prevention (CDC) notice of award, identifying the grantor, grant number, and period of funding. STD subgrantees – those that receive their award not from the CDC but from a unit of state or local government – would be required to provide a fully executed subrecipient agreement that includes the name and address of the grantee and subgrantee, the grant number and notice of opportunity number, and the “terms and conditions of support” in addition to the CDC award. The notice states that this information could also be requested at recertification and that STD clinics should have the documentation available prior to registration or recertification.
The new requirements might prove to be much more burdensome than HRSA realizes. STD covered entities typically are not privy to the CDC notice of award issued to the state (or, in some cases, city or county). Subawards from states, counties, and localities vary in format significantly from state to state, and requesting changes to those documents to reflect new HRSA requirements might be time-consuming if the government is even willing to entertain amendments. While HRSA states that these requirements are intended to verify STD clinic eligibility for participation in the 340B program, we believe many or even most current subgrantees do not have written agreements that include the information required under the proposal.
Expanded shipping address information– HRSA is proposing that at registration, recertification, or submission of a change request, all covered entities would be required to specify the relationship of each shipping address to the covered entity (g., pharmacy, health care delivery site, or other receiving location). If the covered entity states that the shipping address is a pharmacy, the covered entity must tell HRSA whether the pharmacy is owned by the covered entity. Powers obtained documents from HRSA to implement these changes and those documents state that, if the covered entity states that it owns the pharmacy, the covered entity must, “documentation to demonstrate entity ownership [which] may include a pharmacy license and listing of the pharmacy on the covered entity’s grant or Medicare Cost Report.” It is not clear whether this additional information will be required routinely or only if requested. The document also instructs covered entities that, if they answer “no” to this question, the covered entity should register the pharmacy as a contract pharmacy.
HRSA proposed similar changes for shipping address information in 2022. Five covered entity stakeholders, including RWC-340B, submitted comments to oppose the changes, principally because requiring a shipping address would prohibit covered entities in health care systems to use the same in-house pharmacy. HRSA did not implement the changes in response to these comments but stated that it would release guidance on shipping addresses in the future.
The notice also describes other changes to registration and recertification requirements. Powers has copies of the implementation documents and can provide them if requested.
Under the Paperwork Reduction Act, an agency is required to publish a 60-day notice of a proposed “information collection request” (ICR) in the Federal Register. The August 7, 2025 notice completes that step. HRSA next will consider comments received and publish another 30-day notice for public comment and concurrently submits the ICR to the Office of Management and Budget (OMB) for final review. Once OMB issues a decision, the ICR is either withdrawn or implemented.
The Powers team will continue to monitor developments as HRSA moves forward with this guidance.