Clarification on “refill reminder” programs, a win for patients and consumers – National Consumers League

By Rebecca Burkholder, NCL Vice President for Health Policy In a significant win for patients and consumers, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued important Guidance on pharmacy-run sponsored medication adherence (i.e., “refill reminder”) programs last week, reinforcing that patient health cannot take a back seat to privacy concerns.

In the wake of widespread confusion following OCR’s January 2013 final rule on medical privacy, the Guidance clarifies that “refill reminder” programs may include a wide array of patient communications, including messages about prescriptions that lapsed within the last 90 days.  OCR clarified that the payments that sponsors (e.g., pharmaceutical companies) provide to pharmacies for running these often costly programs may include all of the pharmacy’s “reasonable direct and indirect costs … including labor, materials, and supplies, as well as capital, and overhead costs.”

As a founding member of the Best Privacy Practices Coalition, the National Consumers League (NCL), strongly supported the final rule’s enhancement of patient privacy and data security protections.  But patient health is an equally important goal. Poor medication adherence is $290 billion problem in this country, resulting in an estimated 125,000 deaths annually.  In an effort to combat this ongoing public health challenge, NCL leads Script Your Future, a medication adherence public awareness campaign with partners across the health care spectrum.  The sponsored “refill reminder” programs addressed in OCR’s Guidance are critical support for our efforts. To help clear up misunderstandings about HHS’s January rule, NCL met with OCR leadership this summer, emphasizing the importance of compliance programs and asking for clarification on the two key issues discussed above.

We are pleased that OCR heard the concerns NCL and many others expressed and responded with this important Guidance. This much-needed clarification is a big win for patients and, given the September 23, 2013, compliance date of the final rule, arrived in the nick of time.  Recognizing the essential nature of sponsored medication adherence programs, OCR announced that it will not enforce the “refill reminder” provisions of the final rule until November 7, 2013.  This will pave the way for these vital programs to continue, and should encourage those pharmacies -such as CVS -and their sponsors that discontinued their programs in the wake of recent uncertainty to jumpstart them again. The new Guidance is also a win for American consumers.

The non-partisan Congressional Budget Office estimates that even a very small 1% increase in the number of prescriptions that are refilled translates into more than $1 billion in annual Medicare savings.  By helping address the ever-growing deficit in the Medicare program, OCR’s Guidance helps save tax dollars and benefits all American consumers. NCL applauds OCR for responding to these concerns and balancing the important public interests of patient privacy with patient health.