There’s an update to a lawsuit I mentioned the other day. The parties have filed a joint motion to suspend the schedule for briefing and motion for an injunction as HHS has agreed not to enforce the guidelines starting September 23 and to issue guidance. The key paragraphs of the joint motion:
Following that telephonic status conference, undersigned counsel for defendants was informed that HHS intends to issue further guidance concerning the provision challenged by plaintiff in this litigation. The guidance will pertain 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. HHS expects to issue such guidance by September 23, 2013.
In order to avoid the need for the Court to rule on plaintiff’s Motion for Preliminary Injunction before the forthcoming guidance has been issued and fully considered by plaintiff, the Secretary has decided, as an exercise of her discretion, not to enforce the restrictions on remunerated 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 following the announced compliance date, or until November 7, 2013.