Policy & Medicine Compliance Update
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December 2020
Issue Summary:
As the year draws to a close, we begin this issue with the results from Helio’s latest Patient Services Compliance survey outlining the latest trends in the development of patient assistance programs. Next, we examine the latest patient assistance program and copay charity settlement with Gilead.
Sticking with the topic of litigation, we do an in-depth dive into the recent opioid settlements involving Purdue Pharma, the Sackler family, as well as the recent Opioid MDL settlement involving McKesson, Cardinal Health, Amerisource Bergen, and J&J. We also examine the now final settlement with Merit Medical, and we round out this issue with a look at recent enforcement surrounding genetic testing and telemedicine fraud.
Helio’s 4th Annual Patient Services Compliance Survey
Patient Services Program Compliance Continues Evolving in 2020
By Manny Tzavlakis, Managing Partner, Marci Juneau, Partner, and Ben Schein, Associate, Helio Health Group LLC
Summary: Patient Services Programs are likely to be an important cost containment tool in the fight against rising healthcare costs. However, as recent enforcement actions against life science companies demonstrate, these programs are fraught with compliance risks for the unwary. Therefore, companies must rely on their compliance professionals to ensure their organizations are taking appropriate action to plan, assess, and respond to a heightened enforcement focus on PSPs in 2021 and beyond.
Copay Charity Doesn’t Always Pay
Gilead’s False Claims Act Settlement
By Robert N. Wilkey, Esq., Senior Staff Writer for Life Science Compliance Update
Summary: With the announced settlement involving patient assistance programs administered through independent charities, Gilead Sciences became the eleventh company to settle with the Government. With recoveries topping $1 billion, companies and their compliance professionals need to take a hard look at their patient assistance programs to ensure they are truly “charitable.”
The Art of the Deal
Pharma Manufacturers and Distributors Race to Make Deals to Reduce Opioid Liability
By Dr. Seth B. Whitelaw, Editor
Summary: The final quarter of 2020 has seen some significant movement towards resolving the litigious nightmare surrounding the current opioid crisis. However, it is far from over and likely will persist into 2021 and perhaps beyond.
The Case of the Whistleblowing Compliance Officer
Merit Medical Seals the Deal and Gets a CIA
By Kaitlin Fallon Wildoner, Esq., Staff Writer
Summary: In mid-October 2020, Merit Medical Systems, Inc. finalized an $18 million settlement with the Justice Department over allegations that the company violated both the False Claims Act and the Anti-Kickback Statute. A comparison of the Merit CIA, with those recently agreed to by Novartis and Sun Pharma, illustrates that the Government tends to view pharmaceutical and medical device companies through the same lens. Thus, medical device compliance professionals should use pharmaceutical CIAs as a benchmark when evaluating their programs.
Genetic Testing & Telemedicine
The New Fraud Frontier of Patient Engagement
By Gwendolyn A. Ball, Ph.D., Staff Writer and Dr. Seth B. Whitelaw, Editor
Summary: Genetic testing has become a powerful new tool for improving health care and controlling health care costs. However, like many tools paid for by the Government, it is vulnerable to Medicare fraud. Therefore, for any company or compliance professional involved in the genetic testing area, increased vigilance and robust internal controls are essential to avoid being swept up in fraudulent activity.