HHS to Delay Enforcement and Provide Guidance on HIPAA/HITECH Act Final Rule on the Heels of Adheris Lawsuit

By Jeffrey N. Wasserstein and Alexander J. Varond –

On September 11, 2013, Adheris, Inc. (“Adheris”) and the Department of Health and Human Services (“HHS”) filed a joint motion requesting the suspension of Adheris’s motion for a preliminary injunction seeking to prohibit HHS from enforcing its final rule restricting certain paid marketing communications.  We posted on that case earlier this week (see here). 

HHS informed the court that that it intends to issue guidance pertaining “to the final remuneration that would be considered ‘reasonable’ for providing refill reminders or other communications about a drug or biologic currently being prescribed to an individual.”  HHS stated that it expects to issue such guidance by September 23, 2013.  In addition, HHS announced that it decided “not to enforce the restrictions on remuneration refill reminders and other communications about drugs and biologics (as set forth in 45 C.F.R. § 164.501) for a period of 45 days . . . or until November 7, 2013.” 

We will keep you posted on this developing issue.