Legal Challenges, Risks Of Rx Drug Adherence Programs

A Law360 article written by my colleague, Theresa Carnegie, provides an overview of the key health regulatory issues that manufacturers, plans, pharmacy benefit managers (PBMs), pharmacies and related providers may face when structuring drug adherence programs and suggests approaches for minimizing legal risks.

Although the benefits of increasing patient compliance with drug regimens has been acknowledged for many years, there has been a renewed interest in and commitment to increasing prescription drug adherence levels following enactment of the Patient Protection and Affordable Care Act.

This renewed commitment is driven mainly by the costs of nonadherence to the health care system and the potential savings that may result from successful adherence programs. Adherence programs are also a natural extension of several of the main tenets of the health care reform legislation:

comparative effectiveness research and the push to incentivize and compensate health care providers based on outcomes and clinical effectiveness...