Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
Achieving patient adherence to prescribed medication through clinical educator programs is not a new concept. Neither is the U.S. Office of Inspector General of the Health and Human Services longstanding concern of the inherent issues these programs pose to when offered and provided by the pharmaceutical industry. A recently unsealed False Claims Act whistleblowers’ complaint provides an example of the delicate balance companies face in ensuring compliance with federal and state laws, regulations, sub-regulatory guidance, and industry codes. Expect additional cases in the future, especially if you think your “compliant” educator program is a pandora’s box.