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.

For our final issue of 2021 Policy and Medicine Compliance Update, we are focusing on timely operational issues impacting life sciences.  We begin with the results from the latest Helio Health Group’s Patient Support Services Compliance Survey.  It is the fifth year Helio has conducted the survey, but this year, they updated it to reflect the changing compliance landscape.

Next, we turn to the emerging developments involving data privacy and protection in the United States.  As Epsilon Life Science team highlight, California, Colorado, Virginia have enacted new requirements that compliance programs need to consider as the laws’ effective dates draw near.

We also examine the well-settled compliance maxim of separating the Commerical and Medical Affairs functions.  With the advent of overly restrictive controls and an evolving role for Medical Affairs and MSLs, there is a need to revisit the history and develop thoughtful risk mitigation approaches for the modern function.

Moving on to litigation and enforcement developments, even those cases are highly operations focused.  We start with a laboratory services case that focuses on when sales representative commissions become kickbacks.  The case went all the way to the U.S. Supreme Court, which declined to address the issue.

Finally, we conclude this issue with an examination of the recent Arthrex, Inc. settlement.  Another medical device case, Arthrex involves the payments of royalties to a surgeon-consultant-inventor that the Government contended were kickbacks that was brought by a former sales representative involved in the scheme.

Helio Health Group’s Fifth Annual Patient Support Services Compliance Survey

Patient Support Program Compliance Continues Evolving

By Marci Juneau, and Ava Mandele

Summary: 2021 caps another active year involving Patient Support and Patient Assistance Programs.  This year’s Helio Health Group’s survey, with its refined questions, continues to provide insights to help compliance professionals balance the legitimate need for these programs with the ongoing legal and compliance risks.

Governance & Operations

Bracing for Impact

Preparing to Operationalize the California, Virginia, and Colorado Data Privacy Laws

By Brian Segobiano, Sei Unno, and Katherine Norris

Summary: An emphasis on data privacy and data protection is emerging worldwide.  In the United States, the absence of federal privacy legislation leaves states stepping into the void to create a piecemeal of regulatory requirements with varying obligations for corporations. This article outlines key provisions of emerging state laws in California, Colorado, and Virginia and implications for compliance programs to consider as effective dates draw near.

Separating Church and State

Addressing Commercial Involvement with Medical Affairs

By Kirt Kraeuter, Staff Writer

Summary:  One of the earliest maxims of life science compliance programs is separating the Commercial and Medical Affairs functions.  However, a lack of understanding has allowed overly restrictive controls to emerge as so-called “leading practices” that unduly hamper operations.  At the same time, the role of Medical Affairs continues to evolve.  Therefore, there is a need to revisit the history and adopt thoughtful risk mitigation approaches for the modern Medical Affairs function.

Litigation & Enforcement

A Blue Tidal Wave

When Sale Representative Commissions Become Kickbacks

By Robert N. Wilkey, Esq., Senior Staff Writer and Dr. Seth B. Whitelaw, Editor

Summary: The story of BlueWave, HDL, and Singulex is a cautionary tale of the dangers for healthcare companies and their executives of volume-based incentive compensation.  With the recent Supreme Court’s refusal to take up the case, the tension between using incentives to motivate sale representatives without running afoul of the AKS and FCA continues.  Although it is a complex and potentially costly area, compliance professionals need to examine it regularly.

The Cost of Loyalty

Arthrex & DOJ Reach a $16 Million False Claims Act Settlement

By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer

Summary:  In November 2021, the United States Department of Justice reached a $16 million settlement with Arthrex, Inc., a medical device company, over allegations that the company paid kickbacks via royalty payments to an orthopedic surgeon to retain his continued commitment to use and recommend their products.

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.