FAQ 1523 May a covered entity contract with a business associate to assist in administering a refill reminder or medication adherence program paid for by a pharmaceutical manufacturer?
This is a FAQ about the Privacy Rule and the marketing communications exception.
Final
Issued by: Office for Civil Rights (OCR)
May a covered entity contract with a business associate to assist in administering a refill reminder or medication adherence program paid for by a pharmaceutical manufacturer?
Answer:
Yes. However, in order for the refill reminders or other program communications to fall within the “refill reminder” exception to marketing, any financial remuneration received by the business associate from the pharmaceutical manufacturer (either directly or through the covered entity) must not exceed the fair market value of the business associate’s services. See paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501. Such limitations do not apply to what the covered entity itself may pay the business associate for such services when no financial remuneration is received from the pharmaceutical manufacturer or other third party whose product or service is being described.
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