Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you to subscribe to our monthly publication Policy and Medicine Compliance Update.
This month we focus on two significant regulatory updates. First, we begin with the DOJ’s updated Evaluation of Compliance Program guidance. Although similar to the 2020 version, the updated guidance adds three new significant areas. Next, we tackle the upcoming end of the COVID-19 Public Health Emergency and explore the significant implications for healthcare organizations.
Shifting to litigation and enforcement, we examine the recent PCPA lawsuit challenging the HHS-OIG’s latest Advisory Opinion concerning charitable PAPs and its similarities to Pfizer’s challenge that the U.S. Supreme Court refused to address. Finally, we explore the outcomes in two criminal opioid distributor cases: Rochester Drug Cooperative and Miami-Luken.
Articles
Through the Looking Glass – The Sequel
DOJ Issues Updated Guidance on Evaluating Compliance Programs
By Kirt Kraeuter, Staff Writer[i]
DOJ has continued emphasizing effective compliance programs by updating the Evaluation of Corporate Compliance Programs guidance, last revised in 2020. While the update continues the organic evolution of the DOJ’s perspective on continuous improvement and monitoring, a fundamental change will require compliance officers to engage with digital and human resources leadership. Moreover, the revision now directly links an organization’s inclusion of compliance objectives in incentive compensation frameworks, including penalties and clawback provisions.
Regulatory Update
Transitioning from War to Peace
Potential Impacts of the “Official” End of the COVID-19 Pandemic
By Gwendolyn A. Ball, Esq., Staff Writer
More than three years have passed since the formal declaration of the COVID-19 Public Health Emergency. During the emergency, government agencies, especially CMS and the FDA, significantly changed the regulatory framework to meet the crisis. However, with the recent Biden Administration announcement of the official end of the emergency in May 2023, the impacts of returning to a pre-pandemic regulatory environment are just being felt.
Litigation & Enforcement
Following in Pfizer’s Footsteps
PCPA Challenges HHS’s Characterization of Its Patient Assistance Program
By Robert N. Wilkey, Esq., Senior Staff Writer
The Pharmaceutical Coalition for Patient Access has filed a lawsuit challenging an unfavorable HHS-OIG Advisory Opinion that its proposed program to provide cost-sharing subsidies to federal healthcare beneficiaries is a quid pro quo that violates the AKS. It is another wrinkle in the high-stakes world of compliance and enforcement involving charitable patient access programs.
The Cases of RDC and Miami-Luken Result in Different Outcomes
By Dr. Seth B. Whitelaw, Editor
In March 2023, two Rochester Drug Cooperative corporate executives were sentenced, marking an end to the criminal cases involving RDC and Miami-Luken. Despite the similarities between the two sets of cases, they produced different outcomes, pointing to the difficulty of holding opioid companies and their executives accountable.
[i] Besides being a staff writer for the Policy & Medicine Compliance Update, Mr. Kraeuter is the former Senior Director, Corporate Compliance at Moderna. The views expressed in the article are solely those of the author and do not reflect those of the author’s former employers and clients.
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