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?

Answer:

No.  With respect to obtaining authorizations from patients already enrolled in these programs, OCR will not determine that a covered entity is in violation of the marketing provisions if it has not obtained authorizations from all existing patients to whom it is making such communications by the September 23, 2013, compliance date, provided the patients from whom authorizations have not been obtained have not opted out or declined to receive such communications and the patients’ authorizations are obtained at the next time their prescriptions are renewed, but no later than September 23, 2014.

Created 9/19/13

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