340B Compliance & Pharmacy Operations
Effectively Enhancing Pharmacy Operations
Advis has a proven track record of enhancing health system and grantee pharmacy operations, including within retail and inpatient pharmacy settings. Our overall objective is to deliver enhanced optimization to the pharmacy landscape in an area of increasing complexity and unparalleled regulatory oversight. Ultimately, our unique approach which brings in the expertise of attorneys, pharmacists, data scientist and 340B ACE certified consultants leads to improved compliance and optimized savings.
Pharmacy Operations and 340B Program Experience
Advis has extensive experience in assisting clients with many aspects of the 340B program, including the enrollment and auditing processes. Advis assists 340B-covered entities and 340B contract pharmacies with the development of: HRSA-compliant inventory/dispensing methodologies, Dispensing and invoicing of 340B drugs, Ongoing compliance initiatives, and 340B compliance management. Our experience translates into an in-depth, sophisticated understanding of the program—expertise that can assist you in setting-up and operating a highly successful 340B program. Our focus not only helps to ensure compliance but also to help make operational decisions based on best practices and industry standards.
Increased scrutiny of 340B Programs From HRSA OPA
The Advis approach is unique in that it includes:
- A review of pharmacy and 340B strategies
- Infusion center assessment
- Retail pharmacy development and operations
- Credentialing and Enrollment services
- Contract Pharmacy optimization through development and improvement of existing
- Routine Auditing Compliance
- Referral Assessment services
- External annual audits
- A national leader in 340B compliance requirements and program optimization.
- External auditing
- HRSA audit support
- Contract/specialty pharmacy development
- Financial impact analysis
- Manufacturer Restriction
- Impact Analysis
- Third-Party Administrator RFP development and Implementation Assistance
- Strategic development
Compliance review - Staff training
- Cost Report Assessment
Advis is in a unique position to help you
Advis’ 340B consultants are acutely familiar with the benefits as well as the resulting 340B compliance obligations of the 340B program. We have been assisting various types of covered entities, including hospitals, FQHCs, community clinics, and contract pharmacies, with program compliance components, including Initial program feasibility, Registration, and implementation, Situational audits, Day-to-day compliance assistance, operational assistance, 340B voluntary disclosures, and 340B-Medicaid overpayments/repayments. Once up and running, we will continually apprise you of regulatory developments that could impact your program. We help to lay out courses of action to ensure your continuing compliance with regulations while minimizing additional administrative costs. On our expert team of 340B consultants, we also employ the insight of knowledgeable pharmacists who partner to guide your organization through every step of the 340B and pharmacy process.
Best Practice for an Effective 340B Compliance Audit
Many of the HRSA audits have resulted in the Covered Entity being levied with sanctions or repayments to manufacturers. The best way to prepare yourself for a HRSA audit is to ensure that you are adhering to a system of best practices and continuous improvements. Advis has developed these best practices, which include internal and external road maps designed to meet HRSA and manufacturer specific inquiries, and stands ready to assist with their implementation and maintenance. How can we help? Our 340B compliance audit program, developed to align with the actual audit process employed by HRSA, involves an assessment as well as remediation. Our teams work closely with you to identify the procedures that need to be put in place for compliance, then we strategize with you to develop processes to remediate and control flaws or weaknesses in the program. We analyze the efficiency of your program and look for ways to maximize your benefits further. Our reports are meant to be actionable, not merely an exercise to check a box during an audit. These reports result in a meaningful way to improve the 340B program at your covered entity.
Manufacturer Restriction Mitigation
In light of the increasing complexity surrounding the 340B program and the restrictions being imposed by the manufacturers, Advis is prepared to assist your team identify strategies to mitigate the restrictive measures being put in place that ensures a compliant and financially improved operations. How can we help? Our team of experts will review all contract pharmacy data and any Rx data that your team is able to present and identify the best way to employ the exceptions permitted by each manufacturer and prepare a full plan to help improve 340B savings, through designation improvement, retail pharmacy development, alternative operational strategies, or entity owned pharmacy development.
340B Mock Auditing
Be HRSA‑ready. Protect savings. Strengthen compliance.
Healthcare changes constantly. Our 340B Mock Audit gives you clear, practical answers that offers insights and specific recommendations of how to implement recommended strategies. We replicate HRSA and manufacturer scrutiny across data, processes, and people—then deliver a remediation plan your team can execute without delay. Your mission is our mission; everything is approached with care.
What this service delivers
- Comprehensive simulation aligned to HRSA audit logic and manufacturer expectations.
- End‑to‑end testing across eligibility, diversion, duplicate discount prevention, GPO exclusion, inventory integrity, and contract pharmacy oversight.
- Independent review of policies, governance, staffing, and training—paired with operational guidance from attorneys, pharmacists, data scientists, and 340B‑certified consultants.
- Deep data validation using your EMR/ADT, split‑billing and contract pharmacy platforms, and purchasing/finance systems.
- A prioritized remediation roadmap with owners, timelines, and ready‑to‑use policy language.
- Executive‑ready reporting and optional hands‑on remediation and re‑testing.
- Our process allows for a 1-day onsite audit, ensuring minimal impact to staff.
Next Steps:
- Schedule a 30‑minute consultation
- Request a sample report
- Get a tailored proposal
How our 340B Mock Audit works
- Discovery and Scoping
We confirm covered entity type(s), child sites, contract pharmacies, TPAs, and data sources; set the audit window; and establish a secure data plan.
Deliverables: Engagement plan, data request list, interview schedule. - Data Intake and Validation
We ingest and reconcile encounters, prescribing, purchases (WAC/GPO), accumulations, Medicaid carve‑in/out indicators, and contract pharmacy claims. We also validate identifiers, mappings, and timing rules.
Deliverables: Data integrity scorecard, system map, risk‑based sampling plan. - Program Controls Review
We assess policies and procedures against HRSA expectations: patient definition, diversion controls, duplicate discount prevention, inventory management, GPO exclusion, contract pharmacy oversight, documentation, and governance cadence.
Deliverables: Policy gap analysis with recommended language. - Transaction Testing and Tracing
We test targeted and random samples across in‑house administrations / dispensations and registered contract pharmacies. We recreate eligibility determinations, verify prescriber relationship and encounter documentation, and validate duplicate discount controls (MEF alignment; FFS vs. managed Medicaid).
Deliverables: Exception log with root cause, severity, corrective actions. - Inventory and Purchasing Analysis
We evaluate mixed‑use and virtual inventory models, replenishment logic, and splitter configurations; cross‑walk purchases to accumulations/dispenses to confirm GPO/WAC compliance.
Deliverables: Inventory compliance assessment, purchasing reconciliation. - Readout, Remediation, and Readiness
We present findings to executives and operational leaders, quantify risk and potential financial impact, and deliver a remediation roadmap. We also conduct mock entrance/exit conferences to prepare your team for live Q&A.
Deliverables: Final report, remediation plan, optional retest.
Representative engagement (proof of rigor)
In a recent hospital engagement, our team partnered with the 340B coordinator, pharmacy, finance, and executives to:
- Confirm proper registrations and potential child sites using the Medicare cost report/trial balance, OPAIS, local government contracts, and pharmacy service agreements.
- Validate diversion controls by tracing product from wholesaler order through patient administration/dispense, and confirming provider credentialing and employment/contract status.
- Verify duplicate discount prevention by reviewing Medicaid billing (FFS and managed care), ensuring MEF listings for billing numbers and NPIs, and testing patient/inventory data for correct 340B use.
- Assess staffing, structure, and training to sustain compliance and maximize appropriate utilization.
- Complete a structured desk review (policies, purchasing accounts, recent purchases, software systems, credentialed practitioners, eligible locations) followed by on‑site interviews to confirm control execution.
- Execute transaction testing across 100 patient samples spanning in‑house administrations, pharmacy dispensations, and contract pharmacy activity.
Outcome: a prioritized remediation plan, strengthened documentation, and improved data assessment/reporting to support effective internal audits.
Why Advis
- Relationship‑driven, results‑focused
Accessible, responsive partners who move quickly from findings to fixes. - Regulatory depth, operational pragmatism
340B expertise paired with hands‑on pharmacy, TPA, revenue cycle, and compliance experience. - Data‑driven sampling
Risk‑based selection to surface material issues sooner. - Actionable deliverables
Not just observations—playbooks your team can execute with confidence.
Timeline and effort
- Typical duration: 4–8 weeks, depending on scope and data readiness.
- Client time: Concentrated during data pulls, interviews, and findings reviews.
- Early insights: Often within 2–3 weeks of complete data receipt.
What we review
- Eligibility and patient definition evidence
- Duplicate discount prevention (MEF alignment; FFS and managed Medicaid)
- Diversion controls and prescriber alignment
- GPO exclusion and WAC purchasing compliance
- Inventory models (mixed‑use, virtual), accumulator accuracy, splitter configurations
- Contract pharmacy oversight and reconciliation cadence
- TPA configuration and data mappings
- Policies, procedures, governance, and training effectiveness