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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; and
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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