May 27, 2010 – Refunds will be coming to 340B covered entities that bought the Upsher-Smith Laboratories (USL) women’s health drugs Fortical and Vandazole from the fourth quarter of 2006 through October 2009. And for the first time, the government contractor that runs the 340B Prime Vendor Program (PVP) will be involved in processing the payments.
The National Drug Code (NDC) for the formulation of Fortical, a nasal spray for the treatment of osteoporosis, is 00245-0008-35. The NDC for the formulation of Vandazole, a gel for the treatment of bacterial vaginosis, is 00245-0860-70. The Office of Pharmacy Affairs (OPA) announced the refunds, which USL is making voluntarily, on its Web site on May 24.
The company will also provide refunds for overpayments on its generic products with labeler code 00245 from the first quarter of 1993 through the fourth quarter of 2006, and for those with labeler code 00832 from the fourth quarter of 2003 through the fourth quarter of 2006.
Apexus Involved in Processing
In a first-of-its-kind collaboration, Minnesota-based USL said it will work with Apexus, which runs PVP under contract to Health Resources and Services Administration (HRSA), to validate pharmacy account information for each 340B covered entity that is owed a credit for overpayments. Once validated, USL and Apexus will work with the entity’s wholesaler to process their credit. If an active wholesaler account cannot be found, USL will issue the entity a check.
Christopher Hatwig, the Apexus vice president in charge of PVP, says Apexus began marketing the service to manufacturers during the past year after learning that many lacked efficient methods of processing overcharges owed to covered entities.
“Apexus’ relationship between the entities, wholesalers and manufacturers positions it to provide a unique solution to address all stakeholders’ needs and enables the companies to make restitution with entities that some have not addressed for many years,” he says.
Service Mirrors New Requirement
Hatwig emphasizes that the service is being offered by Apexus for now, not PVP, but went on to note that it could become a PVP function if HRSA elects to add the job to the PVP contractor’s portfolio. He says HRSA has been made aware of the service and points out that it addresses a provision in the new health care reform law requiring the Secretary of Health and Human Services to establish procedures for manufacturers to issue refunds to covered entities and to oversee those refunds when there is an overcharge.
“We are piloting our model with two different suppliers at this time,” Hatwig continues. “USL is the first. We are in discussion with others…. We are in no way involved with the manufacturers’ obligations for government price reporting or determining who is owed what. Once a manufacturer has determined what is owed, we are engaged in validating all account information between the manufacturer and wholesaler so that electronic credits can be efficiently applied to each eligible customer’s account.”
340B providers that believe they are due a refund from Upsher-Smith should contact Annamarie Lee at annamarie.lee@upsher-smith.com or (763) 315-2221.