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Legal Challenges, Risks Of Rx Drug Adherence Programs

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:

  1. comparative effectiveness research and the push to incentivize and compensate health care providers based on outcomes and clinical effectiveness; and
  2. coordinated care initiatives (such as accountable care organizations, or ACOs) aimed at increasing collaboration between payors, providers and related stakeholders involved in the delivery of health care services.

While adherence programs have laudable goals, there are also many legal and health regulatory factors that must be considered when structuring such programs. Entities offering adherence programs must carefully consider whether federal and state fraud and abuse laws and the patient privacy protections of the Health Insurance Portability and Accountability Act may affect such programs’ scope and structure.


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Karen S. Lovitch

Chair, Health Law and Health Care Enforcement Defense Practices

Karen advises industry clients on regulatory, transactional, operational, and enforcement matters. She has deep experience handling FCA investigations and qui tam litigation for laboratories and diagnostics companies.