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HRSA Clarifies 340B Enrollment & Recertification Requirements

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What changed: HRSA published an information-collection update covering how covered entities enroll, recertify, and report changes to administrative/eligibility data. The Notice reiterates the ongoing duty to immediately notify HRSA of any eligibility change in OPAIS and invites public comment through October 6, 2025.

Why this matters: Tighter documentation and faster updates in OPAIS lower audit risk and reduce chances of a surprise program removal during recertification. Hospitals watching DSH% dips should pay close attention to how eligibility evidence is stored and refreshed.

What changed: HRSA published an information-collection update covering how covered entities enroll, recertify, and report changes to administrative/eligibility data. The Notice reiterates the ongoing duty to immediately notify HRSA of any eligibility change in OPAIS and invites public comment through October 6, 2025.

Why this matters: Tighter documentation and faster updates in OPAIS lower audit risk and reduce chances of a surprise program removal during recertification. Hospitals watching DSH% dips should pay close attention to how eligibility evidence is stored and refreshed.

RxX Perspective

“Treat this like an enforcement preview. HRSA is signaling less tolerance for stale records and fuzzy eligibility files. If your OPAIS profile, cost report references, or prescriber/location documentation live in different places (or different people’s inboxes), close those gaps now. Aim for a single ‘eligibility binder’ you can open in under five minutes during an audit.” — Madeline

Program Updates (Briefs)

  • Rebate Pilot Program (FYI): HRSA’s pilot invites manufacturers (not providers) to submit rebate plans by Sept 15, 2025 for potential Jan 1, 2026 go-lives. Covered entities should monitor for operational impacts (timing, chargeback/rebate reconciliation).

  • OPAIS hygiene: HRSA continues to emphasize prompt updates and annual recertification discipline. If you’ve had leadership or site changes this summer, verify they’re reflected in OPAIS this week.

Operations Corner — Five-Minute Checklist

  • Pull a current OPAIS snapshot and save to your “Eligibility” folder.

  • Cross-check entity type & child sites with finance/compliance records.

  • Confirm your change-notification owners (primary + backup) and SLAs.

  • Save exception logs (ESP/data anomalies) alongside eligibility evidence.

  • Calendar a quarterly OPAIS review (even outside recertification).

Key Dates

  • Sept 15, 2025 — Manufacturer rebate-pilot plan submissions due (watch for downstream impacts).

  • Oct 6, 2025 — HRSA comment deadline on enrollment/recertification information collection.

Quick Links (show to logged-in clients or route to your portal pages)

  • HRSA Information-Collection Notice — summary & client guidance

  • OPAIS self-audit worksheet (download)

  • “Ask Rx|X” — submit a question on eligibility/recertification

Need help?

Reply inside NextPhase with “HELP – eligibility” and we’ll review your OPAIS profile, evidence binder, and change-notification workflow.

Sources (internal — remove before publishing)

  • Federal Register: Enrollment and Re-Certification of Entities in the 340B Drug Pricing Program; comments due Oct 6, 2025. Federal Register+1

  • HRSA: Eligibility & Registration (ongoing duty to update OPAIS). HRSA

  • Federal Register/HRSA: 340B Rebate Model Pilot Program timeline (manufacturer plans by Sept 15; approvals by Oct 15; potential 1/1/2026 start). Federal Register+1HRSA