Summary
At Ravin Consultants, our compliance services are designed to help covered entities stay prepared, organized, and confident. We support policy review, claims auditing, pharmacy oversight, HRSA audit preparation, manufacturer restriction support, wholesaler review, and ongoing education.
340B compliance is not a one-time project. It is an ongoing responsibility that requires consistent documentation, clear workflows, staff education, and regular review. For covered entities, compliance services can help reduce risk and create a stronger foundation for program performance.
The most effective 340B compliance services are practical. They help teams understand what is required, identify where gaps may exist, and take steps to correct issues before they become larger problems. They also support the mission of the program by protecting access to savings that can be used to serve patients.
Policy and procedure review
Policies and procedures are the backbone of a compliant 340B program. They should explain how the covered entity manages eligibility, patient definition, diversion prevention, duplicate discount prevention, Medicaid billing, contract pharmacy oversight, inventory controls, self-auditing, and record retention.
A compliance review should compare written policies with actual operations. If staff are doing something different from what the policy says, the organization needs to decide whether the process or the policy should change. Alignment is essential.
Claims testing and documentation
Claims testing is one of the most important parts of 340B compliance services. A review may evaluate whether selected claims meet patient eligibility requirements, whether the provider relationship is supported, whether the site is eligible, and whether the medication was dispensed through an appropriate pathway.
Documentation matters. A covered entity should be able to show why a claim was eligible for 340B. When documentation is incomplete or inconsistent, the program may face unnecessary risk.
Provider and location review
Covered entities should maintain accurate provider and location records. A provider review can help confirm that prescribers are appropriately connected to the covered entity and that claims are tied to eligible sites or services. A location review can help verify that OPAIS records, internal systems, and operational activity are aligned.
This is especially important for organizations that have expanded services, added locations, changed ownership structures, or modified care delivery models.
Contract pharmacy oversight
Contract pharmacy relationships can add value, but they also add complexity. Compliance services should include review of pharmacy contracts, claims files, split-billing processes, replenishment activity, and monitoring procedures. The covered entity remains responsible for compliance, even when outside vendors or pharmacies are involved.
A strong review should also consider manufacturer restrictions and how those restrictions may affect access, savings, reporting, and operational decisions.
Audit readiness
Audit readiness should be built into daily operations. Compliance services may include mock audits, data request list preparation, staff interviews, policy review, sample testing, and corrective action planning. The purpose of a mock audit is not to create pressure. It is to help the organization understand what would happen during an external review and address weaknesses before they are discovered by someone else.
Education and accountability
Compliance depends on people. Staff need to know what they are responsible for and how their work affects the 340B program. Training should be role-specific and updated when processes change.
An effective compliance structure may also include a 340B committee or recurring leadership review. This helps ensure that findings are discussed, decisions are documented, and improvements are tracked over time.
A compliance partner should bring clarity
At Ravin Consultants, our compliance services are designed to help covered entities stay prepared, organized, and confident. We support policy review, claims auditing, pharmacy oversight, HRSA audit preparation, manufacturer restriction support, wholesaler review, and ongoing education.
If your organization needs a clearer view of its compliance posture, Ravin Consultants can help. Schedule a consultation now to learn more about strengthening your 340B compliance program.