Skip to main content
U.S. flag

An official website of the United States government

Return to Search

FAQ 1522 May a BA be paid by a pharma manufacturer to make a refill reminder?

This is a FAQ about the Privacy Rule and marketing communications exception.

Final

Issued by: Office for Civil Rights (OCR)

May a business associate be paid by a pharmaceutical manufacturer to assist a covered entity in making a refill reminder or other communication describing the manufacturer’s product that falls within the “refill reminder” exception to marketing?

Answer

Yes, provided any payments to the business associate do not exceed the fair market value of its services.  See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501.  The payments may be made by a pharmaceutical manufacturer through a covered entity to the business associate, or directly to the business associate, that is acting on behalf of the covered entity to assist in making the refill reminder or other communication describing the manufacturer’s product.

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.