HHS issues guidance on refill reminders and other Rx adherence communications under HITECH Act Omnibus Rule

September 19, 2013

Today, the HHS Office for Civil Rights (OCR) issued guidance on how the changes to the HIPAA Privacy Rule’s marketing provisions under the Health Information Technology for Economic and Clinical Health (HITECH) Act and Omnibus Rule apply to refill reminders and other communications about drugs or biologics currently being prescribed for individuals.  The new Fact Sheet and corresponding Frequently Asked Questions (FAQs) explain how the refill reminder exception to the marketing rule works, and address both the scope of communications that fall within the exception, as well as the types of third party payments that are considered “reasonable” under the statute and regulations for making such communications.  In addition, the Secretary has decided, as an exercise of her discretion, not to enforce the restrictions on remunerated refill reminders and other communications about drugs and biologics for a period of 45 days following the September 23, 2013, compliance date, or until November 7, 2013.

Also released today are new fact sheets and FAQs that provide guidance on the Omnibus Rule changes to how the HIPAA Privacy Rule applies to decedent information and disclosures of proof of student immunizations to schools.

You can access the new guidance materials at http://www.hhs.gov/ocr/hipaa/.


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