In a classic case of competing public interests, the U.S. Department of Health and Human Services (HHS) Office For Civil Rights (OCR) has, we believe, compromised outreach to improve medication adherence programs in the name of patient privacy, when these programs never really compromise patient privacy in the first place. Unless OCR takes critically needed action between now and Sept. 23, a majority of sponsored medication adherence programs will stop.
The National Consumers League (NCL), a founding member of the Best Privacy Practices Coalition, applauds OCR for strengthening consumer privacy and data security protections in its January 2013 final rule on medical privacy. Unfortunately, an unclear preamble to the final rule is threatening to leave patients by the wayside. Critical medication adherence programs are disappearing in the wake of significant confusion surrounding "refill reminder" programs. Moreover, the uncertainty is widespread and real. Just ask CVS/pharmacy. The nation's second largest retail pharmacy chain shut down its sponsored programs given uncertainty in OCR's requirements.
Poor medication adherence is a $290 billion problem plaguing the country's health care system and leading to negative health outcomes for patients. It results in more than one-third of medicine-related hospitalizations and almost 125,000 deaths in the United States each year. To help combat this growing challenge, NCL leads a medication adherence public awareness campaign, Script Your Future, with partners from every sector of the health care system, including the federal government. Our campaign encourages patients to take their prescribed medication as directed and better manage their chronic health problems. Sponsored "refill reminder" programs help support our efforts.
Reminders to patients to take their prescriptions and refill them as needed are thus critical to improved medication adherence. But someone has to pay for these reminders.
As such, NCL hopes that OCR will promptly clarify two key points. First, sponsored "refill reminders" should encompass a broad range of adherence messages to patients.
Second, that the limitation that any third party payment to pharmacies for refill reminders be "reasonably related" to the cost of the communication be interpreted in the most reasonable way to ensure that patients are able to continue to receive the adherence messaging.
Such clarification would be in step with the ongoing efforts of OCR's sister agencies within HHS, including HHS's Agency for Healthcare Research and Quality and its Centers for Medicare and Medicaid Services. These other components of HHS clearly recognize the benefits of adherence programs by supporting both adherence research and interventions, and meaningful use of health IT recommendations. OCR should get on the HHS bandwagon and echo that support by issuing prompt clarification.
OCR has repeatedly stated that it plans to clarify ambiguous issues. To date, however, the office has offered no timeframe for issuing clarification. OCR needs to do so by Sept. 23, the final date by which companies must comply with OCR requirements.
Protecting patient privacy is a principle we strongly support. But imposing restrictive content and financial compensation restrictions on adherence programs does nothing to improve privacy and punishes patients, particularly seniors and those with chronic illness and many others who benefit from timely medication reminders. OCR should clear the path for the continuation of sponsored "refill reminder" programs by issuing clarification by Sept. 23.
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