HHS backs away from rule restricting Rx refill reminders

September 12, 2013

After Adheris, Inc. sought a preliminary injunction to block a rule that would prevent companies from sending Rx refill reminders to patients, the U.S. Department of Health and Human Services has delayed its implementation.

After Adheris, Inc. sought a preliminary injunction to block a rule that would prevent companies from sending Rx refill reminders to patients, the U.S. Department of Health and Human Services (HHS) has delayed its implementation.

Adheris Inc. v Kathleen Sebelius was filed with the U.S. District Court in Washington, D.C. on September 5th. In the injunction request, Adheris asserted the new regulation violates the First Amendment by imposing unconstitutional restrictions on the company’s communications to patients reminding them to take their medicine.  Adheris is one of many companies that oppose the HHS regulation. The Center for Democracy and Technology asked HHS to further clarify the rule.

“This rule undermines a valuable extension of a physician’s treatment that promotes patient health, helps save lives, and reduces healthcare costs – all of which are in the public interest and consistent with the objectives of the Affordable Care Act,” said Eric Sherbet, general counsel for inVentiv Health, the parent company of Adheris. “It is a misguided regulation and one that impinges on our right to speech that serves a significant public health interest.”

Five days after the injunction request was filled, HHS announced plans to issue guidance by Sept. 23 on drug refill provisions and to delay implementation of the rule.

The agency stated that it has decided, “not to enforce the restrictions on remunerated refill reminders and other communications” until Nov. 7, and plans to issue guidance on the rule by Sept. 23.