340B compliance review areas
Organize the evidence behind your program and the controls your team uses.
Registration and eligibility
Review the covered-entity category, registered sites, pharmacy arrangements, and the records supporting program participation.
Transactions and controls
Examine purchasing and inventory, patient and prescriber controls, diversion risks, and duplicate-discount processes across the dispensing settings in scope.
Documentation and follow-up
Connect policies to actual workflows. Document the evidence reviewed, unresolved questions, findings, and corrective-action responsibilities.
Use the applicable source
Requirements depend on the entity, transaction, and arrangement. Consult HRSA program-integrity information, relevant state and payer sources, and the applicable manufacturer notices.
The Medicaid reference and manufacturer tool help locate information. Follow the source links and review status for the question at hand.
Set the review scope
An engagement may focus on particular records, activities, or risks. We agree on scope, sampling, timing, and reporting with your organization.
Discuss the support your program needs
Tell us about your entity, priorities, and timing. We will discuss an appropriate scope.