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 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.
At the outset, it should be noted that clinical education programs are not illegal per se. However, these programs must be carefully vetted and continuously reviewed to protect a company from the numerous compliance and legal challenges that await pharmaceutical manufacturers and companies that offer these programs. Companies must not only be compliant with federal laws (e.g., Anti-Kickback Statute, Food, Drug, and Cosmetic Act, etc.), but state laws as well (e.g., professional occupational licensing and if entering the patient’s home, home health agency regulations).