Summary
Times of transition can be unsettling, but they’re also an opportunity to strengthen the foundations of your 340B Program. At Ravin, we’re monitoring every policy shift, advocating for community-based healthcare organizations, and supporting our partners through the changes ahead.
The 340B federal landscape is shifting in ways we haven’t seen in decades. With sweeping federal realignments now confirmed, it’s time for the 340B industry—especially STD clinics and Ryan White Program grantees—to take a closer look at what these changes mean and how to prepare.
At Ravin Consultants, we’ve held off on publishing a formal update until we had verified, actionable information. The past few months have been marked by rapid policy reversals, leadership reshuffling, and shifting directives across federal agencies. Now, with multiple developments confirmed, we believe it’s critical to provide clarity and strategic direction.
Key 340B Federal Realignments Impacts
1. CDC Programs Transitioning to the Administration for a Healthy America (AHA)
As part of HHS Secretary Robert F. Kennedy Jr.’s restructuring efforts, the CDC is being absorbed into a newly formed agency—the Administration for a Healthy America (AHA). This transition includes the dismantling of major CDC divisions, including chronic disease prevention and global health programs.
What this means for 340B:
Many grant-funded 340b federal eligibility programs may not be renewed or could sunset earlier than expected.
Strategic Consideration:
Explore additional Section 318 funding streams and assess whether a new 340B designation (such as FQHC-LA, Ryan White, or STD clinic) could strengthen your program’s stability.
2. 340B Oversight Moving from HRSA to CMS
Oversight of the 340B Program is expected to shift from HRSA to the Centers for Medicare & Medicaid Services (CMS), now under the leadership of Dr. Mehmet Oz. This change introduces a new layer of uncertainty surrounding audits, patient definitions, and program enforcement.
Ravin’s Perspective:
CMS is likely to tighten patient definition requirements and adopt a more aggressive enforcement posture.
What You Can Do:
- Re-evaluate your patient definition to ensure you’re capturing all eligible encounters and prescriptions.
- Strengthen documentation protocols to safeguard against evolving compliance interpretations.
- Engage with public health stakeholders and strengthen relationships with your state DOH and local policymakers.
3. Public Health Workforce Reductions
Significant staffing cuts at the CDC and other agencies are already affecting the availability of technical assistance, grant management support, and compliance guidance for covered entities.
Grantees, especially STD clinics and Ryan White recipients, should be prepared for:
- Delays or gaps in HRSA communications
- Uncertainty around audit protocols
- Shifting interpretations of eligibility and compliance under CMS oversight
Ravin’s Recommendations for the 340B Industry
As we collectively navigate this uncertain terrain, here are proactive steps all covered entities should consider:
- Conduct Regular Compliance Audits:
Both internal reviews and third-party audits are crucial to maintaining defensibility as CMS takes the reins. - Review Patient Definition & Documentation:
Ensure your eligibility criteria and referral tracking are accurate, consistent, and well-documented. - Prepare for Data Reporting Changes:
Reporting requirements may evolve. Stay adaptable and be ready to adjust internal systems with support from your consulting partners. - Stay Connected & Informed:
Whether it’s monitoring federal updates or reviewing developments with your 340B teams, staying informed is key to maintaining program integrity. - Plan Ahead Strategically:
We recommend convening your leadership team, 340B staff, and external advisors to model impact scenarios and outline a long-term continuity plan.
Final Thoughts
Times of transition can be unsettling, but they’re also an opportunity to strengthen the foundations of your 340B Program. At Ravin, we’re monitoring every policy shift, advocating for community-based healthcare organizations, and supporting our partners through the changes ahead.
If your organization needs assistance assessing risk or planning next steps, we’re here to help.