On September 6, 2013, Adheris, Inc. (“Adheris”), an inVentiv company that works with pharmacies and pharmaceutical manufacturers to send medication refill reminders and educational information regarding diseases to patients, filed suit against the U.S. Department of Health and Human Services (“HHS”).  Adheris alleges that certain provisions of the Final HIPAA Omnibus Rule (the “Omnibus Rule”) scheduled to go into effect on September 23, 2013 violate the First Amendment by hindering refill reminder services.  In support of its position, Adheris filed a Motion for a Preliminary Injunction that cites Sorrell vs. IMS Health, Inc., in which the Supreme Court affirmed that “speech in aid of pharmaceutical marketing…is a form of expression protected by the Free Speech Clause of the First Amendment.”

Adheris maintains a partnership with over three dozen large pharmacy chains, through which it sends communications sponsored by pharmaceutical companies to millions of patients.  Patients are given information regarding both who sponsors such communications and how to opt out.  The Adheris business model is threatened by the new limits set forth in the Omnibus Rule regarding how Protected Health Information may be used or disclosed for marketing purposes.

Since the Omnibus Rule was released in March, it has prompted significant action regarding refill reminder services.  In May, CVS announced that it would terminate its refill reminder program sponsored by the pharmaceutical industry.  In July, the Specialty Pharmacy Association of America (“SPAARx”) wrote a letter to HHS requesting clarification regarding the provision in the Omnibus Rule regarding refill reminders and suggesting use of a fair market value standard to determine reasonable compensation for refill reminder programs.  In August, the World Privacy Forum opposed SPAARx’s proposal in a separate letter to HHS.

Given the number of parties and the amount of revenue involved in providing refill reminder services, how HHS responds will have a significant impact on the industry.

Posted by Leah Roffman

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