FAQs Archive

Q: 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?

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.

Q: May a covered entity pay a business associate to assist in making a refill reminder or other communication that falls within the “refill reminder” exception to marketing?

Yes. The Privacy Rule permits a covered entity to engage and pay a business associate to assist in making otherwise permitted communications to individuals and does not prescribe what the covered entity itself may pay the business associate for such services. However, where financial remuneration is received from the pharmaceutical manufacturer or other third party whose product is being described to make such communications, there are limits on what the business associate may be paid from that financial remuneration. In particular, a business associate only may receive, whether directly from the third party or through the covered entity from the financial remuneration the covered entity receives from the third party, payments not to exceed the fair market value of its services.

Q: Do communications about recently-lapsed prescriptions for a medicine fall within the “refill reminder” exception to marketing?

Yes, so long as the prescription lapsed within the last 90 calendar days and any financial remuneration received in exchange for making the communication is reasonably related to the covered entity’s cost of making the communication. Communications encouraging individuals to renew recently lapsed prescriptions are consistent with the purpose of refill reminder and medication adherence communications, which is to encourage individuals to continue to take their medication as directed. However, once a prescription has lapsed for more than 90 calendar days, it is no longer reasonable to treat such communications as refill reminders or medication adherence communications for a currently prescribed drug or biologic.