Multiple HRSA findings challenge 340B Covered Entity to overhaul program operations

of all claims that were qualifying as 340B eligible were in error
of claims fall out as ineligible
A Covered Entity approached Visante for guidance after receiving numerous findings through a HRSA audit. Visante’s 340B team helped the CE to make significant changes to all aspects program operations, including intensive work with multiple split-billing systems.

The responsibility to manage compliance related to inventory, purchasing, and dispensation (replenishment) is complicated, and becomes increasingly complex with an increased number of split-billing vendors.  In this case, the CE worked through five disparate split-billing platforms (one for mixed-use, four for retail owned and contract pharmacy relationships). Adding further difficulty, the CE did not have sufficient resources to manage any of these platforms and conduct internal audits or routine system configurations and maintenance. In order to untangle the web of multiple split-billing vendors, many with crossover within the contract pharmacy space, it was necessary to migrate to a new split-billing vendor that could provide support across BOTH mixed-use and retail owned/contract pharmacy.  This process allowed a foundation of new operational processes to support compliance and revised Policies and Procedures to govern all aspects of compliance related to the 340B Program.  Billing, reimbursement, management of Medicaid (both in state and out of state, along with Fee-For-Service and Managed Medicaid) were a focus, and the Visante team was successful in overhauling the processes that had 340B implications.


After forming a 340B Compliance Committee of Covered Entity stakeholders, forward movement took place over the course of twelve months. This overhaul focused on the foundation of the 340B Program, and all aspects of supply chain/purchasing, billing, reimbursement, contract review and support (contract pharmacy), and split-billing maintenance and oversight.  Compliance oversight was structured around the Corrective Action Plan provided to HRSA, and allowed the Covered Entity to forecast resources and tools necessary to maintain full compliance.