HHS To Issue Additional Guidance Regarding the New HIPAA Marketing Definition and “Refill Reminder” Exception

The Health and Human Services’ Office of Civil Rights (“HHS”) has modified the HIPAA Marketing definition and related exceptions as part of the HITECH “Omnibus” Final Rule which was published on January 25, 2013 and which has a compliance deadline of September 23, 2013. 

In short, the Final Rule defines Marketing to mean any communication about a product or service that encourages the individual receiving the communication to purchase the product or service.  Absent an exception, any such Marketing communication that relies on the use or disclosure of the individual’s Protected Health Information (“PHI”) requires a HIPAA authorization. 

There are several exceptions to the Marketing definition under the Final Rule, one of which is to provide refill reminders or otherwise communicate about a drug or biologic that is currently being prescribed for the individual, but only if any financial remuneration received by the HIPAA-covered entity in exchange for making the communication is reasonably related to the cost of making the communication.  Absent compliance with these criteria, a HIPAA authorization would be required before any such communications were permitted. 

As the September 23, 2013 compliance deadline nears, Adheris, Inc., a company that receives “financial remuneration” from pharmaceutical companies for sending refill reminders to patients, has filed a lawsuit and a motion for preliminary injunction suit against enforcement by HHS of this refill reminder exception under the Marketing definition.  As part of this legal process, Adheris is also seeking further delineation of what “reasonably related” means under this exception. 

According to a joint motion to suspend a briefing schedule on Adheris, Inc.’s motion for preliminary injunction filed on September 11, 2013, in Adheris, Inc. v. Sebelius et al., counsel for the defendants was informed that HHS:  

[I]ntends 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 communications or other communications about a drug or biologic currently being prescribed to an individual.  HHS expects to issue such guidance by September 23, 2013. 

The joint motion also states that the Secretary of HHS will not enforce the provision regarding financial remuneration for refill reminders for a period of 45 days after the September 23, 2013 date, or until November 7, 2013, but expects to provide guidance on this issue by the September 23, 2013 date.   (Joint Motion, at ¶¶ 4, 5).   

HIPAA’s updated Marketing definition and the many different exceptions are of particular interest to pharmacies, pharmaceutical companies and entities such as Adheris, which qualify as HIPAA business associates to the pharmacies.  Determining what is “reasonable” financial remuneration for a refill reminder is just one of the many issues with respect to the Marketing definition under HIPAA.  It remains to be seen what kind of guidance is issued by HHS in the next few weeks, and whether it will address any of the other exceptions to the Marketing definition. 

If you have any questions regarding the Final Rule, the updated Marketing definition under HIPAA, or the Adheris, Inc. v. Sebelius, et al. matter, please contact  Susan Ziel at sziel@kdlegal.com, Ed Rickert, at erickert@kdlegal.com, or Jaya White at jwhite@kdlegal.com.