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OCR Guidance to Address HIPAA Marketing Turmoil

Written by:  Dianne J. Bourque and Theresa C. Carnegie

In response to a recent lawsuit and outcry from a variety of players in the health care market, the Department of Health and Human Services (“HHS”) has committed to issuing guidance by September 23rd (the compliance date for the Rule) on the drug refill provisions in the HIPAA Omnibus Rule (the “Rule”).  In a joint motion filed September 11th, the plaintiff, Adheris, Inc., and HHS state that “recent developments have obviated any need for the parties to provide further briefing, or for the Court to resolve, plaintiff’s motion prior to September 23, 2013.”  The joint motion also states that HHS will “not enforce the restrictions on remunerated refill reminders and other communications” until November 7th.  We are closely monitoring developments on this complex aspect of the Rule.  Meanwhile, regulated entities should consider waiting for the release of OCR’s guidance before entering into subsidized marketing arrangements.



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Theresa advises clients on all aspects of the pharmaceutical supply chain, including counseling industry stakeholders on a range of business, legal, transactional, and compliance matters. She provides clients with strategic counseling and creative business modeling that considers legal restrictions and regulatory risk in light of innovation and business goals.