The Department of Health & Human Services (HHS)
released on September 19, 2013 guidance on financially remunerated prescription
refill reminders.
Under the currently enforced Privacy Rule, covered entities must
obtain an individual's valid authorization prior to using and
disclosing the individual's protected health information for
"marketing" purposes – which includes
communications about a product or service that encourages the
recipients of the communication to purchase or use the product or
service. This requirement, however, includes a significant
exception for communications that also meet the definition of
"treatment" or "health care operations"
communications, including prescription refill reminders, even where
a third party subsidizes the covered entity's
communication.
Under the Privacy Rule, determining whether a communication falls
within the refill reminder exception depends on (1) whether the
communication is about a currently prescribed drug or biologic, and
(2) whether the communication involves financial remuneration and,
if it does, whether the financial remuneration is reasonably
related to the covered entity's cost of making the
communication. HHS now provides guidance on each of these aspects
of the refill reminder exception.
Among other points, HHS makes the following notable
determinations:
- Communications about specific formulations of a currently
prescribed medicine do not fall within the refill reminder
exception
- When remuneration involves payments to a business associate assisting a covered entity in carrying out a refill reminder or medication adherence program, or to make other excepted communications - which exceed the fair market value of the business associate's services - the communication does not fall within the refill reminder exception
The release of the guidance follows an announcement September 11, 2013, that HHS has decided not to enforce the restrictions on financially remunerated prescription refill reminders until November 7, 2013, 45 days after the general HITECH compliance date of September 23, 2013. HHS' decision to delay enforcement came on the heels of a lawsuit filed by Adheris, Inc., a Massachusetts company that provides prescription refill reminders. The lawsuit challenges the constitutionality of the HITECH Final Rule's restrictions on remunerated prescription refill reminders.
Reed Smith's HIPAA practice is in the process of
conducting a full review of the guidance and will release
additional analysis shortly.
This article is presented for informational purposes only and is not intended to constitute legal advice.
