Do communications encouraging individuals to switch from a prescribed medicine to an alternative therapy fall within the “refill reminder” exception to marketing?

Answer:

No, only communications about drugs or biologics currently prescribed to the individual fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501. Making a communication to an individual encouraging the individual to switch from a prescribed medicine to an alternative therapy would only be appropriate where such communication falls within the treatment exception to marketing at paragraph (2)(ii)(A) of the definition and the covered entity does not receive financial remuneration in exchange for making the communication; where the communication is made in a face-to-face encounter with the individual; or where the individual has authorized the use or disclosure of her protected health information to make such communications.

Created 9/19/13