In time for the September 23 compliance date of the revamped HIPAA privacy and security rules, new guidance from the Department of Health and Human Services walks through the drug and biologics “refill reminder” exemption to provisions that restrict the use of protected health information for marketing purposes.

“The Privacy Rule expressly excludes from the definition of ‘marketing’ refill reminders or other communications about a drug or biologic that is currently being prescribed for the individual, provided that financial remuneration received by the covered entity, if any, is reasonably related to the covered entity’s cost of marking the communication,” according to the guidance from the HHS Office for Civil Rights.

Consequently, the guidance covers the separate components of whether the communication is about a current prescription and whether the communication involves remuneration. Exceptions for current prescriptions include: refill reminders; communications about generic equivalents, recently lapsed prescriptions or encouraging taking medication as prescribed; and communications regarding all aspects of a drug delivery system for individuals prescribed a self-administered drug.

Communications not within the exception include specific new formulations of a currently prescribed medication, specific adjunctive drugs related to the current prescription and encouraging the switching to an alternative medicine.

The eight-page guidance offers multiple examples of each scenario that would and would not be permissible, as well as 16 frequently asked questions.

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