As discussed in a previous article, the Health Resources & Services Administration (HRSA) 340B Rebate Pilot Program is set to begin on January 1, 2026. The rebate pilot does not simply replace one pricing mechanism with another. It shifts operational risk, working capital exposure, and compliance responsibility onto covered entities in a compressed implementation timeline with limited transparency. The window for preparation is short, and the consequences of being unprepared are immediate and financial.
Although HRSA missed its October 15, 2025 approval target for the 340B Rebate Model Pilot, the agency ultimately approved eight manufacturers covering nine IRA negotiation drugs on October 30, 2025. To date, HRSA has posted FAQs but has not responded to stakeholder comments or published manufacturer plans, leaving transparency and readiness gaps. Covered entities now face a shorter window leading up to January 1, 2026, to be prepared for HRSA’s manufacturer rebates, in lieu of point‑of‑sale 340B discounts for a limited set of drugs and claims.
HRSA originally planned to approve manufacturer applications by October 15, 2025, to allow onboarding during November and December. That approval did not occur. Instead, HRSA issued approvals on October 30, 2025, for eight manufacturers and nine drugs. This two‑week delay shortens the runway for covered entities to finalize internal processes and test end‑to‑end submissions and payments.
The agency has also not adjusted the January 1, 2026 effective date or issued supplemental guidance addressing readiness concerns. HRSA expects covered entities and manufacturers to work through early operational issues within the pilot structure, escalating to HRSA only after resolution attempts with manufacturers fail. Under the pilot, covered entities purchase drugs at wholesale acquisition cost and submit unit‑level pharmacy‑claim data to substantiate rebates to the applicable 340B ceiling price. Because rebates are post‑dispense, accurate claim fields, consistent identifiers, and timely submissions are critical – especially for high‑volume networks with multiple contract pharmacies.
Manufacturers are expected to determine rebates within approximately ten calendar days. If payments lag, providers are expected to first engage manufacturers with detailed supporting details before elevating issues to HRSA. Practical readiness includes on accurate and correct documentation, secure data handling within the organization, and strong policies intact to resolve potential denials or short‑pays rapidly.
What Now until January 1, 2026?
With limited time before January 1, preparation must be practical rather than theoretical. Covered entities should be actively aligning data extracts, validating claim fields, and conducting test submissions where possible. All manufacturer communications should be documented and retained, particularly where timelines, data specifications, or access credentials are delayed or incomplete.
Finance teams should establish clear accounting treatment for rebate receivables, define acceptable variance thresholds, and implement reporting that tracks aging, denials, and dispute rationales. Preparing for those scenarios now is materially easier than after the fact.
Again, early operational risks include delayed payments and inconsistent rebate determinations. Providers should coordinate and push for transparent reporting on timeliness and denials while preserving access to 340B value.
Immediate Implications for Covered Entities and Contract Pharmacies
There is an increased financial risk moving forward for entities buying high‑cost negotiation‑list drugs at wholesale acquisition cost without up‑front 340B discounts. They now require additional working capital and a new operational risk is tied to their rebate timing and accuracy. As a result, providers should forecast cash needs monthly, model delays, and set reserves to cushion ten‑day cycles that may stretch during early rollout. Additionally, there will be increased administrative burden, as new workflows for submission, reconciliation, and dispute management will demand staffing and additional training.
How Frier Levitt Can Help
Frier Levitt helps covered entities and contract pharmacy stakeholders with implementing new The Office of Pharmacy Affairs (OPA) guidance, structuring compliant rebate workflows, and mitigating risk associated with manufacturer participation in the 340B Rebate Model Pilot Program. Our team supports readiness assessments, policy development, dispute escalation strategies, and broader 340B compliance considerations as this model rolls out.
Contact us to speak with an attorney about how the new voluntary 340B Rebate Model Pilot Program can affect your practice.
