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
Some or all of the services described herein may not be permissible for HealthBridge US clients and their affiliates or related entities.
The information provided is general in nature and is not intended to address the specific circumstances of any individual or entity. While we strive to offer accurate and timely information, we cannot guarantee that such information remains accurate after it is received or that it will continue to be accurate over time. Anyone seeking to act on such information should first seek professional advice tailored to their specific situation. HealthBridge US does not offer legal services.
HealthBridge US is not affiliated with any department of public health agencies in any state, nor with the Centers for Medicare & Medicaid Services (CMS). We offer healthcare consulting services exclusively and are an independent consulting firm not affiliated with any regulatory organizations, including but not limited to the Accrediting Organizations, the Centers for Medicare & Medicaid Services (CMS), and state departments. HealthBridge is an anti-fraud company in full compliance with all applicable federal and state regulations for CMS, as well as other relevant business and healthcare laws.
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