Posted and filed under Compliance, Healthcare, Payers.

In an unexpected, albeit responsible move, Health and Human Services has retracted their support for a Patient Assistance Program.

The Caring Voice Coalition (CVC) is a patient assistance charity that provides financial support to Medicare beneficiaries and other patients. Found in 2003 with seemingly noble intentions, the CVC was founded in 2003 to support patients with rare and chronic diseases. HHS rescinded their support and advisory opinions for the charity after learning that CVC may in the throes of an inappropriate relationship with pharmaceutical companies. The OIG released a notice on November 28th detailing their determinations and stating that their actions would be effective immediately, though they had redacted an identifying information.

“In light of the information we have reviewed, including Requestor’s submission, we have determined that the public interest requires rescission, and hereby rescind 06-04 effective immediately.”

OIG reports that CVC had provided patient-specific data to their donors. This kind of reporting from the CVC would allow donors to “…correlate the amount and frequency of their donations with the number of subsidized prescriptions or order for their products, and (ii) allowed donors to directly or indirectly influence the identification or delineation of Requestor’s disease categories.”

In August 2017 the OIG issued a preliminary notice of termination to CVC, and granted the charity a grace period in which they could respond to the notice. While CVC did respond to the preliminary letter, they did not refute the OIG’s determination. Instead, they offered to modify  06-04 in order to add provisions related to the new compliance program. This proposal came along with the possibility of CVC ceasing operations if the OIG chose to officially terminate the 06-04 Advisory Opinion.

This discovery and determination is aligned with the Department of Justice’s current initiative to investigate pharmaceutical companies with suspect relationships with other Patient Assistance Programs.