HHS States That It Will Issue Guidance On HIPAA Regulation For Prescription Refill Reminders


On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill reminders.  See Joint Motion.  According to the joint motion, HHS will not “enforce the restrictions on remunerated refill reminders and other communications” for a period of 45 days or until November 7, 2013, and will issue guidance on September 23, 2013 “pertain[ing] to the financial remuneration that would be considered ‘reasonable’ for providing refill reminders or other communications about a drug or biologic currently being prescribed to an individual.”  Id. ¶¶ 4-5. 

In its complaint, filed September 5, 2013, Massachusetts-based Adheris, Inc. seeks injunctive and declaratory relief prohibiting HHS from enforcing a rule restricting its prescription refill reminder program, from which it derives 90% of its revenue.  See Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules; Final Rule, 78 Fed. Reg. 5566, 5592-97, 5696 (Jan. 25, 2013) (the “Final Rule,” codified at 45 C.F.R. § 164.501).  Adheris claims that its business operations are being adversely affected by HHS’s position that its rule requires “authorization for all treatment and health care operations communications where the covered entity receives financial remuneration for making the communications from a third party whose product or service is being marketed.”  See Complaint ¶ 37.  Adheris asserts that its business has been adversely affected because its “customers read the Omnibus Final Rule to mean that Adheris’s refill reminder service, which uses [protected health information], cannot be conducted without patient authorization, which is not economically feasible to obtain,” and, as a result, have terminated or are planning to terminate their existing contracts with Adheris.  See id. ¶ 43.  Adheris further argues that the HIPAA provision violates its First Amendment free speech rights because “[i]t treats identical speech differently depending upon who compensates the speaker for the speech and whether the speaker derives a profit for that speech.”  Id. ¶ 56.

In the joint motion, the parties ask to defer briefing on Adheris’s motion for a preliminary injunction until after HHS issues its guidance, if any legal issues remain to be litigated at that point.  Joint Motion. ¶ 6.  The joint motion proposes the filing of a status report by September 27, 2013.

Reporter, Katy Lucas, Atlanta, +1 404 572 2822, klucas@kslaw.com.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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