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On August 7, 2025, the Health Resources and Services Administration (HRSA) published a proposed Information Collection Request (ICR) outlining changes to how covered entities enroll in and recertify for the 340B Drug Pricing Program. These changes are not yet final. They are open for public comment until October 6, 2025 and if approved by the Office of Management and Budget (OMB) they could go into effect as early as late 2025 or early 2026.
While the proposal includes some technical updates for hospitals and other entity types, the most significant changes apply to STD grantees, including both primary grantees and subrecipients. HRSA is proposing new documentation requirements that would affect the annual recertification process.
What’s Changing in the Proposal:
- New documentation for STD grantees: Primary grantees and subrecipients would be required to submit program eligibility documentation both at initial registration and again at recertification. This is the most substantial proposed change, and it means that STD programs should begin gathering their Notices of Award and subrecipient agreements now to be ready.
- Shipping address classification: Covered entities would be required to clearly classify each shipping address in OPAIS as a pharmacy, healthcare delivery site, or other receiving location. If a site’s street address changes, HRSA would ask whether the site still receives qualifying federal funds and whether services remain open.
- Family planning grantees: Would need to include the time period during which assistance has been received when registering or recertifying.
- Urban Indian and Tribal FQHCs (Type 638): Would need to provide their tribal agreement number at registration and recertification.
- Hospitals: HRSA proposes aligning terminology with CMS (for example, moving from “Medicare provider number” to “CMS certification number”) and clarifying requirements for Worksheet S and trial balance uploads. These changes are less impactful but reflect HRSA’s effort to standardize across federal programs.
Steps Covered Entities Can Take Now:
Although these requirements are still only proposed, we recommend that STD programs begin readiness checks now.
- Review the official notice: HRSA’s proposal is available in the Federal Register here.
- Gather key documentation: For STD grantees, this includes your Federal Notice of Award (NOA) and, if you are a subgrantee, an executed subrecipient agreement that lists recipient and subrecipient names and addresses, grant and NOFO numbers, and terms.
- Check your OPAIS records: Verify that shipping addresses are current and correctly classified. If a site’s address has changed, confirm whether it still receives qualifying funds and whether services remain open.
- Stay aware of timing: If approved, these changes could take effect in late 2025 or early 2026. Starting to prepare now will prevent delays once new requirements are enforced.
Comments on this proposal are due by October 6, 2025. Alchemy will continue to monitor developments closely and keep our partners updated as HRSA moves from proposal to implementation.
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