HRSA Proposes Updates to 340B Enrollment and Recertification: What Covered Entities Need to Know

On August 7, 2025, the Health Resources and Services Administration (HRSA) published a notice in the Federal Register outlining proposed revisions to the information collection process for covered entities participating in the 340B Drug Pricing Program.

This proposed Information Collection Request (ICR) is part of HRSA’s effort to maintain program efficiency, transparency, and integrity, while reducing back-and-forth exchanges with covered entities during enrollment, registration, and recertification.

👉 Full notice here: Federal Register – Agency Information Collection Activities: Proposed Collection, Public Comment Request

Essential Takeaways from Proposed Revisions

HRSA is not introducing new statutory requirements, but is clarifying and revising aspects of existing forms and processes. Some of the notable changes include:

1. Enhanced Shipping Address Clarifications

   • Covered entities will need to provide more precise information about shipping addresses in OPAIS, ensuring HRSA can determine whether a location is a pharmacy, healthcare delivery site, or other receiving point.

2. Additional Documentation for STD and TB Grantees

   • HRSA proposes requiring grant award documentation (and subrecipient agreements, where applicable) to verify eligibility at registration and recertification.

3. Family Planning Entities

   • Required to provide time period data for assistance received, aligning with requirements for other grant-funded covered entity types.

4. Hospital Registration Updates

   • Clarifying language around “CMS Certification Number” (replacing “Medicare Provider Number”) and documentation requirements for Worksheet S of Medicare Cost Reports.

5. Urban Indian and Tribal Entities

   • Must provide Tribal Agreement numbers in OPAIS for greater transparency and eligibility verification.

What This Means for Covered Entities

These revisions are largely clarifications, but they represent HRSA’s ongoing commitment to:

• Streamline reviews and reduce errors in OPAIS submissions.

• Increase transparency and accountability for both covered entities and HRSA.

• Ensure accuracy of data used for program eligibility and compliance monitoring.

For covered entities, the changes may add minor administrative steps, but they are aimed at reducing delays and fewer requests for resubmission during registration or recertification.

Public Comment Timeline

• The notice was published on August 7, 2025.

• HRSA is accepting public comments on the proposed information collection until October 6, 2025.

• Comments can be submitted by email to paperwork@hrsa.gov or mailed to the HRSA Information Collection Clearance Officer at 5600 Fishers Lane, Rockville, MD.

Concordia’s Perspective

At Concordia Pharma Solutions, we believe these updates underscore the importance of having strong internal compliance systems in place. Covered entities should:

• Review their OPAIS submissions carefully for accuracy.

• Keep grant documentation organized and readily available.

• Anticipate HRSA’s emphasis on transparency and efficiency in all compliance-related submissions.

📩 If your organization needs guidance on preparing for these proposed updates — or on strengthening your 340B compliance framework — our team is here to help.

✍️ Stay ahead of compliance changes. Partner with Concordia Pharma Solutions to keep your 340B program protected, efficient, and audit-ready.