340B Drug Pricing Program Compliance & Optimization

340B Drug Pricing Program Compliance & Optimization

The 340B drug pricing program allows covered entities — including all FQHCs — to purchase outpatient drugs at significantly reduced prices, typically 25 to 50 percent below average wholesale price. For most health centers, 340B savings represent one of the largest non-grant revenue streams available, often used to expand services, hire clinical staff, or reduce patient out-of-pocket costs.

However, HRSA's Office of Pharmacy Affairs enforces strict eligibility, diversion prevention, and duplicate discount requirements. Audit findings — even unintentional compliance gaps — can result in loss of 340B eligibility, repayment obligations, and serious reputational harm. Our consultants ensure your program is structured for both maximum benefit and complete compliance.

Service Areas

- Program Eligibility & Registration — OPAIS registration support, child site registration, and ongoing eligibility maintenance

- Policy & Procedure Development — Written 340B policies covering patient definition, covered outpatient drugs, diversion prevention, and duplicate discount avoidance

- Contract Pharmacy Oversight — Contract pharmacy selection guidance, agreement review, compliance monitoring, and TPA management

- Audit Readiness Assessments — Mock HRSA audit walkthroughs, documentation gap analysis, and corrective action planning

- Staff Training — Pharmacy, clinical, and administrative staff training tailored to your program structure and HRSA requirements

- Program Optimization — Formulary analysis, savings calculations, and strategy for maximizing program value within compliance boundaries

- Replenishment & Inventory Management Review — Virtual and in-house pharmacy model analysis and recommendations

What We Deliver

- 340B Compliance Assessment — Comprehensive review of your current program structure against HRSA requirements with a written findings report

- Policy Manual — Complete 340B policy and procedure manual tailored to your organization's specific program model

- Corrective Action Plan — A prioritized remediation roadmap addressing all identified compliance gaps

- Ongoing Compliance Support — Quarterly check-ins, regulatory update briefings, and on-call consulting for emerging compliance questions