The 340B Drug Pricing Program remains one of the most dynamic and closely scrutinized areas in healthcare compliance. Recent updates from the Health Resources and Services Administration (HRSA) have redefined expectations for covered entities, vendors, and manufacturers alike—introducing new reporting structures, enhanced audit transparency, and a transformative rebate-based pricing model.
These changes reinforce a single message: 340B compliance is no longer static. It requires continuous governance, data precision, and a proactive compliance posture.
This article highlights the key updates from HRSA’s latest guidance, how they impact covered entities, and what Cooper Strategy recommends to stay compliant and audit-ready.
1. HRSA’s 340B Rebate Model Pilot Program
HRSA’s newly launched Rebate Model Pilot Program, set to begin January 1, 2026, represents a significant shift in 340B operations. Rather than the traditional point-of-sale discount model, the pilot introduces post-purchase rebates for select drugs.
Key Details
- The program is voluntary for manufacturers, but mandatory for covered entities that choose to participate.
- Participants will continue purchasing through 340B accounts but will receive rebates after submitting detailed claims data.
- HRSA and manufacturers will jointly audit rebate submissions for accuracy and compliance.
Implications for Covered Entities
- Cash-flow management: Hospitals will pay at WAC (Wholesale Acquisition Cost) initially and await rebate reimbursement. This shift could affect pharmacy budgets and forecasting.
- Data burden: Each transaction must include precise claims-level data, adding complexity to data management and vendor oversight.
- Audit exposure: HRSA and manufacturers will both monitor accuracy, requiring airtight audit trails.
Action Steps
- Identify which drugs and manufacturers are included in the pilot.
- Assess your vendor’s ability to manage rebate logic and submit claims data.
- Re-evaluate cash-flow strategies and reconciliation workflows.
- Update policies and audit documentation to address the rebate model process.
2. Updated Enrollment and Recertification Requirements
HRSA’s August 2025 Federal Register notice proposed key changes to the enrollment and recertification process. These updates strengthen accuracy, clarify data definitions, and improve transparency in the Office of Pharmacy Affairs Information System (OPAIS).
Key Updates
- New site address classifications (e.g., pharmacy, clinical site, or delivery point).
- Additional documentation requirements for sub-recipients of federal grants.
- Clarified use of CMS Certification Numbers and Medicare Provider Numbers for hospital registrations.
- Tribal and Urban Indian entities must include Tribal Agreement identifiers.
Why It Matters
- Data accuracy: OPAIS entries must precisely match cost reports, site designations, and grant documentation.
- Audit readiness: Inaccurate or incomplete data can lead to findings or recertification delays.
- Administrative workload: Compliance and registration teams must gather more detailed documentation for each cycle.
Recommended Actions
- Conduct an internal audit of all OPAIS entries, ensuring addresses, provider numbers, and designations are correct.
- Store all grant and sub-recipient documentation in a centralized repository.
- Train staff on updated definitions and timelines before the next recertification cycle.
3. Contract Pharmacy and Site-Registration Oversight
HRSA continues to focus on contract pharmacy arrangements and child site registration accuracy—two areas frequently cited in audits.
Key Focus Areas
- Ensuring that all child sites provide services consistent with their HRSA registration.
- Maintaining contract pharmacy agreements that align with OPAIS records and actual dispensing data.
- Requiring vendor transparency for eligibility and replenishment logic.
Implications
- Any mismatch between OPAIS data, service delivery, and pharmacy activity can be deemed diversion.
- Covered entities remain fully responsible for compliance—even when a vendor manages transactions.
Next Steps
- Cross-reference all contract pharmacy and child-site relationships against OPAIS listings.
- Require your vendor or TPA to provide auditable documentation of eligibility logic.
- Establish quarterly reviews to ensure ongoing accuracy.
4. Duplicate Discount and Medicaid Coordination Emphasis
Duplicate discounts remain a top HRSA enforcement priority. With new rebate logic entering the market, the complexity of duplicate-discount prevention has grown.
Updated Guidance Highlights
- Covered entities must maintain precise carve-in/carve-out logic across both Medicaid fee-for-service and managed care claims.
- HRSA’s Medicaid Exclusion File (MEF) will now be compared more directly against state billing data.
- The rebate pilot introduces claims-level reconciliation, which further exposes potential overlaps.
Action Plan
- Validate your MEF setting and ensure it matches billing practices in every state where you operate.
- Conduct a duplicate-discount audit quarterly, reviewing both Medicaid and non-Medicaid claims.
- Require vendors to produce transparent logs of claim exclusions, rebates, and carve-status logic.
5. Data Transparency and Audit-Trail Requirements
With new HRSA expectations around data transparency, covered entities must demonstrate total visibility into how their vendors capture, process, and reconcile data.
What HRSA Expects
- Clear, auditable data trails from purchase to dispense.
- Vendor systems that store version-controlled logic and can generate audit files upon request.
- Covered entities capable of independently verifying eligibility logic and data accuracy.
Operational Implications
- Vendors using proprietary “black-box” systems represent compliance risk.
- HRSA’s direction favors open-architecture, auditable data systems where logic can be verified and validated.
What To Do Now
- Request written documentation of vendor logic, data schema, and audit-file examples.
- Establish data-ownership clauses in contracts to guarantee access for HRSA audits.
- Add audit-trail verification to your internal compliance audit checklist.
6. Strengthening Governance and Oversight
These regulatory updates underscore the importance of robust governance. Covered entities must move beyond siloed 340B management and establish cross-functional oversight that includes compliance, finance, IT, and pharmacy leadership.
Best Practice Governance Actions
- Establish a 340B Oversight Committee with quarterly reporting.
- Track new HRSA rules and manufacturer developments as standing agenda items.
- Align governance outputs with your risk register and internal audit schedule.
- Document all compliance reviews and approvals in meeting minutes.
Conclusion: Compliance Through Proactive Strategy
The latest HRSA updates reinforce that compliance is no longer reactive—it’s strategic.
Covered entities that proactively adjust policies, strengthen vendor controls, and maintain data integrity will not only avoid findings but also maximize program sustainability.
Regulatory change doesn’t have to create chaos—it can be an opportunity to modernize systems, improve transparency, and align your 340B program with your mission to serve patients and communities.
Schedule a 340B Regulatory Readiness Review: Contact Cooper Strategy
Frequently Asked Questions About 340B Regulatory Updates: Key Changes from the Latest HRSA Guidance
1. Why is HRSA introducing a rebate-based pricing pilot?
The rebate model addresses longstanding challenges between manufacturers and covered entities, including disputes over duplicate discounts and transparency. By shifting to post-purchase rebates, HRSA aims to collect more detailed claims-level data, which provides clarity around utilization and prevents over-discounting. For covered entities, this means more reporting obligations and tighter audit exposure but also an opportunity to participate in shaping a more data-driven 340B model. Understanding and preparing for these changes is essential to maintain compliance and protect your savings integrity under the new structure.
2. How do the enrollment and recertification changes affect covered entities?
The new HRSA proposals heighten documentation and data-accuracy requirements within OPAIS. Hospitals and grantees must now provide clearer site classifications, address details, and cost-report validation. For compliance teams, that means more internal coordination with finance and registration teams to ensure accuracy before submission. Failing to meet these updated standards can delay certification or invite audit findings. Covered entities should treat registration data as compliance data—subject to internal controls, reviews, and version-control documentation that aligns with HRSA’s expectations for audit transparency.
3. What’s the biggest operational impact of the Rebate Model Pilot?
The largest operational shift is the transition from upfront 340B discounts to delayed rebate reimbursement. Covered entities will pay WAC initially, submit detailed claims data, and then receive rebates later—introducing potential cash-flow challenges. Pharmacy and finance teams must coordinate to forecast reimbursement timing, reconcile data accuracy, and ensure systems can manage claim-level submissions. Without proper tracking and vendor readiness, organizations risk reconciliation errors or audit exposure. The pilot will test whether this model offers greater transparency while maintaining the financial benefits of traditional 340B pricing.
4. How should covered entities manage vendor transparency under these new rules?
Vendor transparency is no longer optional—it’s a compliance mandate. Covered entities must demand full visibility into eligibility logic, data processes, and audit-file generation. HRSA expects hospitals to understand—not just delegate—the methods vendors use to qualify prescriptions and prevent duplicate discounts. Cooper Strategy recommends including data-ownership clauses in all vendor contracts, requiring vendors to provide access to audit logs, logic documentation, and compliance certifications. Regular vendor performance reviews and mock audits help ensure sustained compliance and data integrity across all partnerships.
5. How can Cooper Strategy help navigate these regulatory changes?
Cooper Strategy provides comprehensive 340B regulatory readiness assessments and compliance modernization services. We evaluate your organization’s exposure to the rebate model pilot, enrollment changes, data-integrity requirements, and vendor transparency gaps. Our team builds customized mitigation plans, updates governance frameworks, and trains staff to meet HRSA’s evolving expectations. With deep 340B expertise and proven audit-response experience, we ensure your program remains both compliant and financially optimized—turning regulatory change into a strategic advantage.
Contact Cooper Strategy to schedule a readiness consultation.