March, 2021 Issue

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March 2021

Issue Summary:

We begin our March issue with the second installment of the series on the Top Ten compliance issues in 2020, and the potential implications for 2021.  Rounding out the issues are promotional messaging, patient assistance and support programs, compliance program incentives, and of course opioids.

Next, we continue our examination of speaker programs considering the latest OIG Special Fraud Alert and discuss the various gray areas and unanswered questions that remain.  We also take a stab at what the future may hold for in-person programs.   We also look at the recent OIG updates to the Anti-Kickback Statute safe harbors and their focus on value-based arrangements.

Rounding out this issue, we dive into the recent McKinsey opioid settlements and their implications for life science consultants across the industry.

Top Ten Compliance Issues of 2020 (Part 2)

COVID-19 Dominated 2020, but Compliance Developments Unfolded at Furious Pace

By Katherine Norris and Dr. Seth B. Whitelaw

Summary:  In January 2020, we highlighted 2019 as a watershed year for the life sciences ethics & compliance profession based on the number and significance of the developments we observed that year.  In retrospect, when compared to 2020, 2019 was the tip of the iceberg.  This article is the second of a two-part series discussing the Top 10 compliance issues of 2020 and the potential implications for 2021.

Governance & Operations – Speaker Programs

The Gospel According to Whom?

 Despite the OIG’s Special Fraud Alert, Speaker Program Gray Areas Remain

By Kirt Kraeuter, Staff Writer

Summary:  The Special Fraud Alert (“SFA”) issued in November 2020 laid bare OIG’s skepticism of speaker programs paid by the medical device and pharmaceutical industries. Yet gray areas abound, from tactical questions on the appropriateness of “virtual lunch and learns” to concerns about constraining educational opportunities and even the very future of speaker programs. While time will tell, the costs of getting it wrong and the continuing lack of clarity mean compliance professionals are left with little to divine the future.

Litigation & Enforcement

What a Difference 24 Hours Makes

HHS-OIG Safe Harbors Update Take Effect the Day Before the Inauguration

By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer

Summary:  During the final days of the Trump Administration, the OIG’s updates to the safe harbors under the AKS and a modification to Beneficiary Inducements Civil Monetary Penalties were finalized.  The final rule became effective the day before President Biden took the oath of office and represented changes that were a long time coming.

Opioids Are Toxic for Consultants

McKinsey Settlement is a Warning to Industry Consultants

By Robert N. Wilkey, Esq., Senior Staff Writer

Summary:  In February, one of the world’s largest consulting firms, McKinsey & Company (“McKinsey”), agreed to multi-million-dollar settlements for its role in the opioid crisis.  The settlement highlights the consultancy industry’s immense potential liability when such consulting firms may be determined to have assisted in promoting marketing schemes and consulting services manufacturers.