The 340B Drug Pricing Program faces mounting pressure from multiple directions as we head into fall 2025. Recent developments signal that covered entities must take proactive steps to protect their programs and prepare for potential changes. Here’s what your organization needs to know and do right now.
The Current Landscape
Congressional scrutiny of 340B is intensifying, led by Chairman Cassidy who consistently raises program concerns at Senate hearings. Meanwhile, HRSA’s new rebate pilot program represents a fundamental shift that could create cash flow challenges for healthcare providers. Most concerning, upheaval at the CDC threatens the grant processes that underpin 340B eligibility.
These pressures aren’t theoretical. They require immediate action from covered entities to ensure
program sustainability.
Five Critical Actions for Your Organization
1. Strengthen Your Compliance Infrastructure Now
Enhanced documentation requirements for STD and TB grantees may preview broader changes
across all covered entities. Don’t wait for expanded requirements to hit your organization.
Take these steps immediately:
- Conduct a comprehensive compliance audit of your current 340B program
- Ensure you have copies of all federal grant awards with complete grantor details, grant
- numbers, and funding periods
- Implement real-time compliance tracking systems
- Train staff on proper documentation and record-keeping procedures
- Establish clear protocols for patient eligibility verification
2. Prepare for Potential Cash Flow Disruptions
HRSA’s rebate pilot shifts from upfront discounts to backend rebates for negotiated drugs. While currently limited to 10 drugs, this model could expand.
Financial preparation steps:
- Model the cash flow impact if rebate programs expand to more drugs
- Establish credit facilities or cash reserves to handle upfront costs
- Review your current pharmacy partnerships and contract terms
- Develop contingency plans for managing working capital needs
- Consider how rebate timing (10-day payment requirement) affects your operations
3. Secure Your Grant Eligibility Foundation
CDC upheaval poses a new threat to grant renewal processes that determine 340B eligibility. This represents an unprecedented risk to the program’s foundation.
Protective measures include:
- Document all current grant statuses and renewal timelines
- Establish direct communication with relevant program officers
- Prepare backup documentation for all eligibility criteria
- Consider diversifying funding sources where possible
- Monitor grant renewal processes more closely than ever
4. Build Political and Community Support
As 340B moves higher on pharmaceutical lobbying priority lists, covered entities need stronger advocacy positioning.
Advocacy strategies:
- Document concrete patient impact stories from your 340B program
- Quantify how 340B savings support your mission-critical services
- Engage with local elected officials about your program’s community benefits
- Coordinate with other covered entities in your region for unified messaging
- Prepare talking points that emphasize patient access and care quality
5. Optimize Program Performance Before Changes Hit
With potential reforms on the horizon, maximize your program’s value and defensibility now. Optimization actions:
- Conduct a full revenue capture analysis to identify missed opportunities
- Streamline operations to reduce administrative burden
- Expand compliant partnerships with retail and specialty pharmacies
- Implement data analytics to track program performance metrics
- Ensure your program clearly demonstrates mission alignment
What to Expect Moving Forward
Congressional appetite for healthcare changes remains limited following recent reconciliation legislation, but 340B transparency measures could gain traction due to sustained industry advocacy. The convergence of administrative action, Congressional oversight, and active litigation indicates pressure will continue from multiple directions.
Medicaid cuts in the reconciliation bill will likely increase reliance on 340B by hospitals and health centers, potentially building political support for the program as a necessary funding source. However, as 340B expenditures increase and pharmaceutical lobbying intensifies, pressure for policy changes will accelerate.
The Bottom Line
Record-keeping and compliance requirements aimed at enhanced transparency and accountability will remain priorities for the foreseeable future. Organizations that strengthen their compliance infrastructure, prepare for operational changes, and build community support will be best positioned to weather current pressures and thrive under whatever regulatory
framework emerges.
The time for preparation is now. Covered entities that take proactive steps today will be ready for whatever changes tomorrow brings to the 340B program.
For organizations seeking comprehensive 340B program optimization and compliance support, professional guidance can help navigate these complex challenges while maximizing program benefits and ensuring regulatory adherence.