340B Consulting and Compliance Services

From audits to optimization, we help covered entities protect program integrity, stretch savings, and stay HRSA audit-ready — every step of the way.

  • Internal Audits

    Regular monthly or quarterly internal audits to catch issues before HRSA or manufacturers do. We assess claims for diversion, duplicate discounts, eligibility, and ESP risks — all backed by detailed findings and remediation recommendations.

  • Annual External Audits

    This required annual review mimics an actual HRSA audit. We assess accumulations, policies, contract pharmacy activity, Medicaid billing practices, and more. You'll also receive clear recommendations to improve compliance and program performance.

  • Policies & Procedures

    We draft new HRSA-aligned 340B policies or review and strengthen your existing documentation. Whether you’re launching a new program, recovering from a compliance event, or simply modernizing outdated SOPs, we ensure your policies are clear, defensible, and audit-ready.

  • Program Optimization & Strategic Consulting

    Maximize your program’s potential without compromising compliance. Our strategic consulting services are designed to uncover missed savings, correct inefficiencies, and help your team build long-term operational resilience. We provide expert assistance with OPAIS registration and updates, help restore pricing access through 340B ESP, and guide you through eligibility logic, carve-in/out strategy, and reporting enhancements. Whether you're scaling your program or cleaning up after internal turnover, we bring structure, clarity, and performance back to your 340B operations.

  • Entity-Owned Pharmacy Planning

    If you’re considering opening or expanding your own in-house pharmacy, we help you do it right — from day one. Our consultants walk you through feasibility assessment, compliance-focused workflow design, and vendor setup to ensure your pharmacy is fully aligned with 340B program expectations. We offer expert guidance on inventory management, replenishment models, and integration with your third-party administrator and wholesaler. Whether you’re starting from scratch or upgrading a pharmacy already in operation, we’ll make sure it supports your clinical and financial goals without creating audit risk.

  • Contract Pharmacy & Manufacturer Consulting

    Managing multiple contract pharmacies requires more than good intentions — it takes active oversight and a strong compliance infrastructure. We help covered entities review and strengthen their Pharmacy Services Agreements, align third-party administrator logic with HRSA guidance, and ensure consistent policy application across all contract partners. Our team provides technical support for 340B ESP, including manufacturer designations and assistance with file submissions. If you're facing manufacturer restrictions or struggling with inconsistent claims, we’re here to bring order and accountability to your contract pharmacy program.