Regulatory Updates

New HIPAA Guidance on Drug Refills

The Department of Health and Human Services’ Office for Civil Rights issued guidance on Friday on how changes to privacy rule marketing provisions, effective September 23 under the HITECH Act, apply to refill reminders and other communications about drugs or biologics. The guidance explains the refill reminder exception to the marketing rule, the scope of communications that fall within the exception, and the types of third-party payments for such communications that are considered “reasonable” under the statute and regulations. According to OCR, HHS will not enforce the restrictions on remunerated refill reminders and other communications about drugs and biologics until November 7.