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The Credit and Re-bill Process The Manufacturer Perspective

The Credit and Re-bill Process The Manufacturer Perspective. 14 th Annual 340B Coalition Conference On Improving Access to Pharmaceutical Care and Ensuring Compliance with Federal and State Laws. Omni Shoreham Hotel, Washington D.C. Monday, July 19 th – Wednesday, January 21 st.

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The Credit and Re-bill Process The Manufacturer Perspective

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  1. The Credit and Re-bill Process The Manufacturer Perspective 14th Annual 340B Coalition ConferenceOn Improving Access to Pharmaceutical Care and Ensuring Compliance with Federal and State Laws Omni Shoreham Hotel, Washington D.C.Monday, July 19th – Wednesday, January 21st www.340bcoalition.org

  2. Manufacturer Perspective • Manufacturers have a heavy operational burden • Sign blanket agreement, applies to all covered products • Calculate and publish the PHS Price • Maintain accurate PHS Contract Eligibility • Process and pay the chargeback • Program is very visible and high risk from compliance perspective • The manufacturer has limited view to the purchasing entity • It is not the manufacturer’s accountability to ensure the entity is compliant • Manufacturer’s have limited visibility to the wholesale and the entity, rely primarily on chargeback data, which is after the purchase • Lack of guidance on what action/recourse is available

  3. Various Drivers to the Process • Important to understand what is driving the process • Routine/administrative • Normally within a certain time period • Multi-year look-backs • Applying retroactive pricing • Retroactive eligibility • i.e., Children’s hospital eligibility

  4. Challenges/Issues • Compliance and Statutory Pricing • Driving restatements in Medicaid and PHS, as Commercial GPO purchases become exempt Government Purchases • Limited view as to whether the purchase is a legitimate out-patient PHS purchase • Manufacturers are expected to do appropriate due diligence to only honor chargebacks for what they deem to be eligible entities and purchases • Accounting Challenges • Reconciling historical chargebacks • Impact on GPO Administrative Fees

  5. Need to establish appropriate controls and processes • Where there is a legitimate PHS purchase that needs to be “reclassified” • Was the driver a result of the product being shifted from GPO inventory to PHS Clinic inventory to fill the need? • Can the purchase to refill inventory now be through a PHS contract? • Was it a case where an entity determined that they could have purchased under the PHS contract and did not?

  6. Putting process and controls in place Seek an efficient way to manage the routine, operational aspect of legitimate “rebills,” while also having polices and controls in place for multi-year lookbacks

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