Constitutional Challenge to HIPAA: HHS Responds

The U.S. Department of Health and Human Services (“HHS”) has responded to a legal challenge filed last week alleging that the Final HIPAA Omnibus Rule (the “Omnibus Rule”) is unconstitutional because it infringes on the First Amendment. Adheris, Inc. (“Adheris”), a company that sends patients prescription refill reminders and educational information regarding diseases, filed a Motion for Preliminary Injunction to preclude enforcement of a provision of the Omnibus Rule that limits the ways in which Protected Health Information may be used or disclosed for marketing purposes. HHS promptly filed a Joint Motion on September 11, 2013, responding in multiple ways.

First, HHS states that it has decided to issue additional guidance regarding reasonable remuneration for providing refill reminders or other communications regarding prescription drugs. HHS plans to issue this guidance by September 23, 2013. Second, in order to preclude the need for a ruling on Adheris’s Motion for Preliminary Injunction, HHS has decided to postpone enforcement of the Omnibus Rule provision at issue. Specifically, HHS has agreed not to enforce new restrictions on refill reminder programs and related communications until November 7, 2013.

Any additional guidance issued by HHS will have significant implications for pharmacies and the pharmaceutical industry. We will keep readers up to date on further developments.