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Ask About Adherence is a blog series featuring Q&A’s with experts and new medication adherence resources. In this post, we feature a recent study on medication non-adherence and discuss how a safe harbor could help fix this problem.

Medication non-adherence costs hundreds of billions of dollars each year and makes up 7 to 13 percent of all health spending in the U.S. A recent report from Prescriptions for a Healthy America (P4HA) found that in Medicare alone:

  • 45 percent of beneficiaries with diabetes fail to fill new prescriptions
  • 60 percent of beneficiaries with chronic obstructive pulmonary disease (COPD) are non-adherent
  • Among beneficiaries who do fill prescriptions, just 25 percent still take their medicines after three years

Despite these alarming statistics, this is a treatable problem. Medication management interventions can improve adherence, resulting in better patient outcomes such as fewer hospitalizations, physician visits and trips to the emergency room. Additionally, improved self-management of chronic diseases would exceed the cost of adherence programs by 10:1.

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Unfortunately, efforts to implement these state-of-the-art adherence programs are often impeded by regulations. The broad reach of the federal Anti-Kickback Statute (AKS) thwarts beneficial adherence programs by prohibiting the offering of anything of value with the intent to induce the purchase of items or services paid for by federal health care programs. 

Due to the broad nature of the statute, Congress empowered the Office of the Inspector General of the Department of Health and Human Services to create “safe harbors” for certain arrangements that pose little risk of fraud and abuse. Twenty-eight safe harbors exist today, and the P4HA study recommends creating a medication adherence regulatory safe harbor to help patients follow their treatment regimens and reduce costs to the health care system.

Read P4HA's report to learn more about how a safe harbor for adherence programs could solve one of America’s most overlooked behavioral health crises.

Carolyn Ha

Carolyn Ha, Pharm.D., is a Deputy Vice President in the Policy and Research Department at PhRMA, where she provides clinical expertise to shape policy development and advocacy related to population health and chronic disease management, improvement of medication use and clinical and quality management strategies. As a clinician, she is passionate about patient care and translating research into actionable policies that will ensure patients get the most out of their medications and creating a sustainable health care delivery system that incentivizes innovation. Carolyn received her Doctor of Pharmacy from Rutgers University and is a registered pharmacist in Virginia. Prior to joining PhRMA, she spent time as a practitioner in a community pharmacy and advocated on behalf of independent pharmacy owners. When she’s not working to improve the lives of patients through better use of medicines, Carolyn can be found spoiling her nephew & niece, exploring new restaurants, traveling and cheering on the New York Giants.

Carolyn Ha

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