The New Standard for 340B Compliance in Specialty Pharmacy

About this Brochure

A strategic guide for Chief Pharmacy Officers and specialty pharmacy leaders ready to shift 340B from retrospective reconciliation to prospective, workflow-embedded compliance. Specialty pharmacy programs are operating under unprecedented pressure. Higher-cost therapies, growing regulatory scrutiny from HRSA and manufacturers, fragmented data across EHRs, TPAs, wholesalers, and contract pharmacies, all layered on top of compliance workflows that were never designed for this level of complexity. Retrospective validation models are creating operational drag. Eligibility is assumed at dispense and confirmed later. Reconciliation is manual and correction-heavy. And pharmacy leaders are often left without a real-time answer to a fundamental question: was this claim truly compliant? Meanwhile, the gap between compliance confidence and compliance reality continues to widen, putting program integrity, audit readiness, and operational margins at risk. It is time to move beyond retrospective 340B. This guide shows how health systems can shift from post-dispense validation to prospective orchestration, embedding compliance directly into the specialty prescription journey from the point of order through therapy initiation. Inside the ebook, you'll find:

• Why traditional 340B workflows are starting to show strain under the growing complexity of specialty pharmacy
• What changes when eligibility and access decisions happen earlier in the process, not after the fact
• A new approach to connecting EHR, payer, pharmacy, and 340B data into a more unified operational layer
• How reducing manual touchpoints can improve consistency while allowing teams to focus on higher-impact work
• The shifting role of pharmacy leadership as specialty pharmacy becomes more central to system-wide performance

Resources

The New CMS Compliance: What Every Payer Needs to Know
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Unifying Specialty Pharmacy, 340B, and Patient Data: How LRx × Gravity Works

CMS-0057-F Readiness Gap
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