Skip to main content
U.S. flag

An official website of the United States government

Return to Search

FAQ 1516 Do communicatiosn about drug delivery systems fall within the refill reminder exception?

This is a FAQ about HIPAA and marketing communications.

Final

Issued by: Office for Civil Rights (OCR)

Do communications about drug delivery systems fall within the “refill reminder” exception to marketing?

Answer:

Yes.  Where an individual is prescribed a self-administered drug or biologic, such as insulin, communications regarding all aspects of a drug delivery system, such as an insulin pump, fall within the refill reminder exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501, provided any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication.

 

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.