Navigation Uncertainty: What the latest 340B federal restructuring means for the program

The 340B federal landscape is shifting in ways that have never been seen in decades. With the confirmation of federal re-alignment, it’s time for the 340B industry (especially the recipients of the STD Clinic and the Ryan White program), taking a closer look at what these changes mean and how to prepare for it.

At Ravin Consultants, we have been publishing official updates until we have verified the information that works. The past few months have been with rapid policy reversals, leadership restructuring and directive shifts across federal agencies. Now, by identifying multiple developments, we believe that it is crucial to provide clarity and strategic direction.

Key 340B federal readjustment will affect

1. CDC plans to transition to US Healthy US Government (AHA)

As Secretary of HHS Robert F. Kennedy Jr. This transition includes the removal of major CDC departments, including the prevention of chronic diseases and the Global Health Program.

What this means for 340b:
Many grant-funded 340B federal eligibility programs may not renew or may be earlier than expected.

Strategic Considerations:
Explore other Section 318 funding flows and evaluate whether a new 340B name, such as FQHC-LA, Ryan White, or STD clinic, can enhance the stability of your program.

2.340B transfer from HRSA to CMS

The supervision of the 340B program is expected to be transferred from HRSA to the Medicare & Medicaid Service Center (CMS) now under Dr. Mehmet Oz. This change introduces new uncertainties around audit, patient definition and procedure enforcement.

Lavin's point of view:
CMS may tighten the patient’s definitional requirements and adopt a more aggressive enforcement posture.

What you can do:

• Reevaluate your patient definition to ensure you capture all qualified encounters and prescriptions.
• Strengthen documentation protocols to protect non-developed compliance interpretations.
• Interact with public health stakeholders and strengthen relationships with your state DOH and local decision makers.

3. Reduce public health workforce

The sharp cuts in staffing by the CDC and other agencies have affected the availability of technical assistance, grant management support, and compliance guidelines for covering entities.

The recipients, especially the STD clinic and Ryan White recipients, should be:

• Delay or gap in HRSA communication
• Uncertainty in audit agreements
• Transfer of interpretation of qualifications and compliance under CMS supervision

Ravin's advice for the 340B industry

As we collectively browse this uncertain terrain, here are the positive steps that all covered entities should consider:

• Conduct regular compliance audits:
  Internal review and third-party review are crucial to maintaining defense, as CMS masters Reins.
• Review the definition and documentation of the patient:
  Make sure your eligibility criteria and recommendation tracking is accurate, consistent and well documented.
• Prepare data report changes:
  Reporting requirements may develop. Stay adaptable and be prepared to adjust the internal system with the support of consulting partners.
• Stay in touch and let:
  Whether monitoring federal updates or reviewing developments with the 340B team, maintaining knowledge is key to maintaining program integrity.
• Strategic Plan:
  We recommend that you convene your leadership team, 340B employees and external consultants to model impact scenarios and outline long-term continuity plans.

The final thought

Transitions may be disturbing, but they are also opportunities to strengthen the foundations of the 340B Program. At Ravin, we are monitoring every policy shift, advocating for community-based healthcare organizations, and supporting our partners through future changes.

If your organization needs help in assessing risks or planning the next step, we will help here.