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FAQs on marketing and refill reminders

This is guidance on permitted disclosures of PHI that covered entities may make related to sending prescription refill reminders and omarketing communciations

Final

Issued by: Office for Civil Rights (OCR)

Marketing - Refill Reminders

Can a doctor or pharmacy be paid to make a prescription refill reminder without a prior authorization under the HIPAA Privacy Rule?
Are communications concerning information to beneficiaries about government programs or government-sponsored programs "marketing" under the HIPAA Privacy Rule?
What types of communications fall within the “refill reminder” exception to marketing?
Do communications about recently-lapsed prescriptions for a medicine fall within the “refill reminder” exception to marketing?
Do communications about drug delivery systems fall within the “refill reminder” exception to marketing?
Do communications about specific adjunctive drugs related to the currently prescribed drug fall within the “refill reminder” exception to marketing?
Do communications about new formulations of a currently prescribed medicine fall within the “refill reminder” exception to marketing?
Do communications encouraging individuals to switch from a prescribed medicine to an alternative therapy fall within the “refill reminder” exception to marketing?
What is permitted remuneration for purposes of the “refill reminder” exception to marketing?
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?
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?
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?
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?
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?
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)?
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?

Marketing - Refill Reminders

Can a doctor or pharmacy be paid to make a prescription refill reminder without a prior authorization under the HIPAA Privacy Rule?
Are communications concerning information to beneficiaries about government programs or government-sponsored programs "marketing" under the HIPAA Privacy Rule?
What types of communications fall within the “refill reminder” exception to marketing?
Do communications about recently-lapsed prescriptions for a medicine fall within the “refill reminder” exception to marketing?
Do communications about drug delivery systems fall within the “refill reminder” exception to marketing?
Do communications about specific adjunctive drugs related to the currently prescribed drug fall within the “refill reminder” exception to marketing?
Do communications about new formulations of a currently prescribed medicine fall within the “refill reminder” exception to marketing?
Do communications encouraging individuals to switch from a prescribed medicine to an alternative therapy fall within the “refill reminder” exception to marketing?
What is permitted remuneration for purposes of the “refill reminder” exception to marketing?
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?
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?
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?
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?
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?
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)?
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?

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