2026 340B Program Federal Grantee Recertification: What Covered Entities Need to Know
Federal grantees participating in the 340B Drug Pricing Program must complete annual recertification to maintain program eligibility. For 2026, the Health Resources and Services Administration (HRSA) will again require covered entities to attest that their information is accurate and that they remain fully compliant with all 340B statutory and program requirements.
Recertification is not a formality. Failure to complete the process accurately and on time can result in termination from the 340B Program, disrupting access to discounted drug pricing and creating downstream financial and operational risk.
Recertification Timeline and Scope
HRSA conducts recertification through the 340B Office of Pharmacy Affairs Information System (OPAIS). Authorizing Officials must review and attest to the accuracy of all registered information, including:
- Covered entity eligibility status
- Child site registrations
- Contract pharmacy arrangements
- Medicaid billing and carve-in/carve-out designations
Each attestation confirms that the organization complies with core 340B requirements, including prevention of diversion and duplicate discounts.
Why This Matters
For eligible providers, 340B savings are often reinvested into patient access initiatives, pharmacy services, and support for underserved populations. A lapse in recertification — or inaccuracies that trigger HRSA scrutiny — can jeopardize those savings and expose organizations to corrective action plans, audits, or removal from the program.
As HRSA oversight continues to intensify, recertification should be viewed as a risk management exercise, not a clerical task.
Key Risk Areas to Review Before Attestation
Before completing recertification, covered entities should confirm:
- All child sites remain eligible and accurately reflected in OPAIS
- Contract pharmacy relationships are current and compliant
- Medicaid billing designations align with state policy and internal practice
- Internal audit and compliance documentation is complete and up to date
Discrepancies between operational practice and OPAIS registration are a common source of findings during HRSA audits.
Strategic Considerations for Leadership
For finance, compliance, and pharmacy leaders, recertification is an opportunity to reassess governance and oversight of the 340B Program. Strong internal controls, cross-functional coordination, and clear ownership of compliance responsibilities help protect program participation and long-term financial benefit.
Alliant Support for Members
340B compliance continues to evolve, and recertification carries real financial consequences. Alliant supports member organizations by helping evaluate recertification readiness, identify compliance risk areas, and align 340B program oversight with broader operational and financial strategies — ensuring organizations are positioned to maintain eligibility and protect program value.
