Services
Independent 340B audits
HRSA strongly encourages Covered Entities to obtain an annual independent 340B audit conducted by a qualified external reviewer. An unbiased evaluation—performed by a professional outside of daily program operations—often reveals compliance risks, workflow gaps, and improvement opportunities that internal teams may overlook. Independent audits not only strengthen program integrity but also help ensure ongoing audit readiness and long-term operational stability.
Policy and procedure alignment
Clear, comprehensive, and up-to-date policies are essential for maintaining compliance. We evaluate your existing policies, identify gaps, and develop aligned, audit-ready documents that accurately reflect daily workflows, HRSA expectations, and operational realities. Our goal is to ensure your written policies support consistent practice and strong program stewardship.
Diversion and duplicate discount risk mitigation
We conduct thorough assessments to identify risks related to diversion, duplicate discounts, Medicaid carve-in/out status, and contract pharmacy claims. By analyzing data across EMRs, TPA platforms, and billing systems, we uncover hidden vulnerabilities and provide clear solutions that protect program integrity and reimbursement accuracy.
Inventory management strategy
Accurate inventory practices are fundamental to 340B integrity. We evaluate replenishment models, NDC drift, package-size variations, WAC-to-340B conversions, and EMR/TPA synchronization. Our recommendations improve accuracy, reduce write-offs, and help maintain compliant inventory movement throughout the continuum of care.
Findings review and remediation plans
Following any audit or operational assessment, we provide a clear, detailed review of all findings with actionable recommendations tailored to your program’s structure and resources. Our remediation plans outline practical steps to correct deficiencies, strengthen controls, and prevent future risk—whether related to diversion, eligibility, duplicate discounts, inventory discrepancies, or policy gaps. We work collaboratively with your team to implement sustainable improvements that enhance compliance, optimize workflows, and ensure long-term audit readiness.
Operations tune-ups
Our Operations Tune-Up provides a comprehensive evaluation of your entire 340B workflow—from eligibility and capture logic to billing, replenishment, contract pharmacy performance, and documentation. We examine how each component of your program functions day-to-day, identify inefficiencies or risk areas, and highlight missed opportunities for optimization. This deep-dive assessment delivers clear, prioritized recommendations that strengthen compliance, streamline processes, improve data integrity, and enhance overall 340B performance. The result is a more efficient, audit-ready program built for long-term success.
Contract pharmacy oversight
With manufacturer restrictions, payer variation, and increasing scrutiny, contract pharmacy relationships require consistent and proactive oversight. HRSA maintains that Covered Entities are fully responsible for ensuring compliance across all contract pharmacy arrangements, regardless of who manages daily operations. We analyze contract terms, dispense patterns, replenishment models, and financial performance to identify risks, strengthen safeguards, and optimize outcomes. Our oversight enhances transparency, protects revenue, and reinforces the operational control necessary to maintain a compliant and audit-ready program.
Payer and manufacturer alignment
The 340B landscape is evolving rapidly. We help Covered Entities adapt to manufacturer restrictions, rebate models, payer edits, and evolving contract terms. Our analysis ensures proper classification, claim submission accuracy, and strategic alignment with changing rules—reducing risk and safeguarding access.
Pharmacist-driven specialty program development
As specialty medications grow in complexity and cost, strong oversight becomes essential. We assist with specialty program design, documentation, clinical alignment, and capture accuracy to ensure your high-cost therapies remain compliant, well-documented, and properly integrated into your 340B framework.
Ongoing Support
We offer continuous, dependable guidance to help maintain the integrity and efficiency of your 340B program. Through regular check-ins, timely consultation, and proactive oversight, we ensure your team remains informed, compliant, and prepared for program changes. You gain a consistent partner dedicated to supporting your operations and sustaining long-term success.
Ready to Strengthen Your 340B Program?
Every program has opportunities for optimization. Whether you need an independent audit, a full operations tune-up, or guidance navigating today’s evolving 340B landscape, we’re here to help you build clarity, compliance, and confidence.
Let’s take your program to the next level.
