340B PVP Manufacturer Refund Service

The Manufacturer Refund Service (MRS) helps support the integrity and transparency of the 340B Drug Pricing Program.

The Manufacturer Refund Service (MRS) helps support the integrity and transparency of the 340B Drug Pricing Program by providing a standardized and comprehensive approach for manufacturers and covered entities to efficiently resolve overcharges.

What is the Manufacturer Refund Service?

Manufacturer restatements of Medicaid best price (BP) or true-ups of provisional 340B ceiling prices for new products can result in 340B ceiling price recalculations, leading to refunds owed to covered entities (CEs) for past 340B purchases.

The 340B Prime Vendor Program (PVP), managed by Apexus, offers the Manufacturer Refund Service (MRS) to manage the resource-intensive, complex task of processing these refunds. MRS was introduced in 2011 at the request of several manufacturers that were looking for a more efficient way to manage the process of refunding CEs for product overcharges.

The 340B PVP MRS facilitates refunds to CEs by sending refunds directly to affected facilities, primarily through its PVP Distribution Network. This model can be used by manufacturers with varying product portfolios as a solution for both large and small refunds.

The 340B Prime Vendor facilitates the refund process

The 340B PVP Facilitates the Refund Process with Experience, Relationships, and Resources

Comprehensive reporting

Fully auditable final report with executive summary at project completion as well as detailed weekly progress updates.

Save time

The 340B Prime Vendor facilitates CE communication, refund processing, and collecting W-9 tax forms. The majority of refund projects are efficiently completed within 90 days with initial communications to CEs within 30 days.

Increase efficiency

To facilitate budget planning, the process is outlined prior to the start of the refund project. The 340B Prime Vendor then works with the distributor network and CE relationships, as well as its call center specialists, to process refunds efficiently.

Manufacturer Refund Service overview

Refund Preparation

  • Complete data analysis
  • Communications template(s)
  • Communications with CEs and distributors within 30 days

Refund Process

  • CE refunds through distributor credits and checks
  • Due diligence calls to send refunds by check or ACH when required
  • Collection of CE W-9s
  • Weekly status reports

Refund Project Completion

  • Executive summary
  • Fully auditable line item detailed reconciliation report
  • Preparation and sending of 1099 tax forms as required

Why are refunds important? The 340B CMP Final Rule.

The 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties (CMP) Regulation (340B CMP Final Rule) became effective January 1, 2019.

Manufacturers are required to charge CEs no more than the 340B ceiling price for covered outpatient drugs under the 340B statute and their pharmaceutical pricing agreement (PPA). Manufacturers are expected to restate and issue refunds for overcharges to CEs.

Read about 340B regulatory changes and their impact and best practices for manufacturers.

Learn more >

Learn more about 340B PVP MRS

Contact us for more information or to schedule a presentation.