Marketing - Refill Reminders Archives - HIPAA Templates

Must a pharmacy obtain an individual’s written authorization prior to discussing with the individual an alternative medication to the one prescribed to the individual in a face-to-face encounter?

No. Face-to-face communications with an individual about specific products or [...]

Jason Russell2020-09-09T00:05:21-04:00Marketing - Refill Reminders|

Are pharmaceutical manufacturer-funded communications to patients concerning a prescribed drug considered marketing under the Privacy Rule if they are required by a Risk Evaluation and Mitigation Strategy (REMS)?

No. If the Food and Drug Administration (FDA) determines that [...]

Jason Russell2020-09-07T14:31:26-04:00Marketing - Refill Reminders|

If a covered entity is going to obtain authorizations from patients to make pharmaceutical manufacturer-funded communications to the patients about currently prescribed drugs or biologics, is the covered entity required to obtain a new authorization each time a prescription is renewed?

No. A HIPAA authorization remains valid until it expires or [...]

Jason Russell2020-09-07T14:31:00-04:00Marketing - Refill Reminders|

We operate specialty pharmacy programs that make pharmaceutical manufacturer-funded communications to patients concerning their prescribed drugs for chronic and complex diseases that require complicated therapies. Rather than ensure such communications meet the conditions of the “refill reminder” exception at paragraph (2)(i) of the definition of “marketing” at 45 CFR 164.501 of the Privacy Rule, we have decided to obtain authorizations going forward for such communications from new patients as they enroll in the programs. For existing patients, must we either obtain authorizations by the September 23, 2013, compliance date of the new provisions or terminate these sponsored communications with these patients?

No. With respect to obtaining authorizations from patients already enrolled [...]

Jason Russell2020-09-07T14:30:14-04:00Marketing - Refill Reminders|

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 [...]

Jason Russell2020-09-07T14:29:45-04:00Marketing - Refill Reminders|

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?

Yes, provided any payments to the business associate do not [...]

Jason Russell2020-09-07T14:29:01-04:00Marketing - Refill Reminders|

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 [...]

Jason Russell2020-09-07T14:28:25-04:00Marketing - Refill Reminders|

What is permitted remuneration for purposes of the “refill reminder” exception to marketing?

The Privacy Rule excepts from the definition of “marketing” refill [...]

Jason Russell2020-09-07T14:27:58-04:00Marketing - Refill Reminders|

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

No, only communications about drugs or biologics currently prescribed to [...]

Jason Russell2020-09-07T14:26:57-04:00Marketing - Refill Reminders|

Do communications about new formulations of a currently prescribed medicine fall within the “refill reminder” exception to marketing?

No, only communications about drugs or biologics currently prescribed to [...]

Jason Russell2020-09-07T14:26:15-04:00Marketing - Refill Reminders|