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.
Our June 2022 issue focuses on compliance governance operations. We begin with a discussion of the ethics and compliance risks facing early-stage and small companies. David Davidovic’s article also explores how a right-sized, gated program tailored for each company can help address those risks.
Next, we examine the seemingly never-ending issue of industry speaker programs. Awet Gebrehiiwet-Wilder and Katherine Norris highlight issues they have observed during recent ongoing monitoring efforts outlining why speaker programs are still a risky endeavor for life science companies.
We round out our governance and operations coverage by highlighting the Justice Department’s new policy on requiring CCO Certificatons in future settlement agreements. In addition to announcing this new policy, the DOJ already has begun putting it into practice.
In the area of litigation and enforcement, we start by examining Senator Grassley’s amicus brief challenging the use of objective reasonableness in false claims act cases. Finally, we examine DOJ’s continuing enforcement efforts addressing medically unnecessary genetic testing. We discuss three recent cases suggesting that more will follow.
Articles
FEATURE
Right-Sized, Gated Ethics & Compliance Programs
Early-stage and small companies are not immune to ethics & compliance risks
By David Davidovic
Summary: Early-stage and small companies in all life-science sectors tend to unnecessarily delay foundational ethics and compliance initiatives, thinking they will be too costly and disruptive relative to where they are in terms of risk profile and resources. The reality is that they face many risks right from the start, and the most important risks can well be handled with a right-sized and gated program that takes into consideration the realities of a small company
governance & Operations
As In-Person Speaker Programs Resume, Monitoring Observations Come Full Circle
By Awet Gebrehiiwet-Wilder, CCEP, and Katherine Norris, MPA
Summary: Speaker programs remain an important but risky endeavor for pharmaceutical companies. This article highlights some of the issues uncovered during recent ongoing monitoring efforts.
Increasing the Pressure on Chief Compliance Officers
DOJ Moves to Implement CCO Settlement Certifications
By Dr. Seth B. Whitelaw, Editor
Summary: Recently, the DOJ announced and began implementing a new standard government settlement provision. This provision requires Chief Compliance Officers to certify that their company’s compliance program is reasonably designed to detect and prevent legal violations. Although claiming these certifications are not punitive and will empower CCOs, the DOJ’s efforts appear slated to have the opposite effect.
Litigation & Enforcement
Challenging Objective Reasonableness for FCA Cases
Senator Grassley Files an Amicus Brief with the U.S. Supreme Court
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The ongoing SuperValu case involves crucial questions about the breadth of false claims liability for defendants making objectively reasonable interpretations of the statute without definitive guidance. The case is now before the U.S. Supreme Court, which recently received the perspective of Senator Charles Grassley, a principal sponsor of the 1986 False Claims Act amendments. Thus, Grassley is uniquely positioned to guide the Court on what Congress intended when it enacted its three-part knowledge criteria.
A Recent Trio of Cases Highlight DOJ’s Enforcement Efforts
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: For the past year, the DOJ has engaged in a concerted effort to assert FCA-related lawsuits against those health care providers engaged in business activities involving medically unnecessary genetic testing. We examine a recent trio of cases and their compliance implications involving medically unnecessary genetic testing.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times. We encourage you to subscribe and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.