Policy and Medicine Compliance Update — September 2021 Issue Reviews State Pricing Policies, Sakler Settlement, Compliance via Faith, DOJ’s Focus on Telemedicine

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 feature article in the August 2021 issue of Policy and Medicine Compliance Update a discussion of a persistent attitude towards compliance that we are calling the “faith-based” approach.  We explore the origins of this attitude, including significant misconceptions about compliance, why it is untenable, and how compliance can use data and data analytics to combat the attitude and misconceptions.

Next, we turn to the Purdue Pharma bankruptcy and the approval of the settlement.  The Sackler family liability remains a major source of friction and with appeals likely, the sage of Purdue and the Sacklers is likely to continue.

Shifting from the opioid litigation, we move to examine the latest updates by the states to control prescription drug prices in the wake of federal inaction.  This article provides a significant update to drug price initiatives since our last examination in 2020 and highlights the significant compliance challenges stemming from these efforts.

Finally, we take an in depth look at on telemedicine and telehealth as a source of health care fraud in this pandemic era.  The DOJ’s recent activities highlight that telemedicine and its use to market medical devices remain a high priority focus.

Ignorance is not Bliss

Why Hope and a “Faith-Based” Approach to Compliance are Untenable

By Dr. Seth B. Whitelaw and Manny Tzavlakis

Summary:  Despite evidence to the contrary, some life science companies continue to hope for the best when it comes to compliance.  However, this “faith-based” approach is untenable.  This article explores the persistence of these beliefs and suggests ways to address them.

OPIOIDS

It Ain’t Over Till It’s Over

Bankruptcy May Not Be the Final Chapter for Purdue Pharma & the Sackler Family

By Kirt Kraeuter, Staff Writer

Summary:  With a ruling from the U.S. Bankruptcy Court in New York’s Southern District planned for the beginning of September, it appears that final approval of a $4.5 billion settlement predicated on Purdue’s bankruptcy reorganization is imminent. Still, objections from eight states, the District of Columbia, and others threaten to derail the settlement.  However, even if approved, an appeal appears likely, thus guaranteeing more years of uncertainty and hardship to those allegedly harmed by Purdue and the Sackler family.

Drug Pricing

Prevarication Versus Action

Efforts to Control Prescription Drug Prices Shift to the States

By Gwendolyn A. Ball, Staff Author

Summary:  For many years, the federal government has talked about various policies to control high prescription drug prices.  Despite federal inaction, the states have actively passed legislation that not only reduces their obligations under Medicaid but intervenes in the drug supply chain by regulating PBMs and even directly producing some generic drugs.  It is uncertain what the impact will be of these legislative efforts, but it is clear that when it comes to drug policy, the states are living up to their assigned role as the “laboratories of democracy.”

Litigation & Enforcement

Expanding the War

The DOJ’s Focus on Telemedicine and Heath Care Fraud Increases

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

Summary:  The COVID-19 pandemic has significantly increased the use of telemedicine services by health care providers and companies over the year and, with it, a heightened risk of fraudulent billing practices.  A recap of the Justice Department’s activities highlights the expanded focus on telemedicine and the war against healthcare fraud.

Salute

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.  And as always, thank you for subscribing and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.