Policy & Medicine Compliance Update
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June 2023 Issue
We begin this month by exploring the Precision Lens kickbacks false claims case. Not only is this case unusual because it went to trial, but the verdict and final judgment provide meaningful insight into the actual non-compliance costs facing life science companies.
Next, we continue our coverage of the legal issues facing Novo Nordisk in the U.S. and U.K. surrounding the promotion of its obesity and hemophilia drugs. In this installment, we focus on the inducements that the company allegedly provided to HCPs and patients.
Also, under the banner of litigation and enforcement, we examine the recent GoodRx case and the FTC’s increasing role in healthcare privacy. Beyond the use of traditional remedies under the FTC Act, this case provides the first test of the Health Breach Notification Rule promulgated in 2009.
Rounding out this month’s issue, we continue examining the impact of generative AI, including ChatGPT, in life sciences. Last month, we looked at the positive case for using AI. This month, we present the counterpoint and the need for caution by drug and device companies surrounding the adoption and use of generative AI in our highly regulated industry.
Articles
FEATURE
Seeing is Believing
Precision Lens’s AKS/FCA Challenge Comes with a Huge Price Tag
By Robert N. Wilkey, Esq., Senior Staff Writer, and Dr. Seth B. Whitelaw, Editor
Summary: After more than a decade, a federal civil jury determined that Precision Lens, and its owner, Paul Ehlen, submitted tens of thousands of false claims to Medicare, resulting in a final judgment of approximately $487 million. For compliance professionals, this case provides an excellent case study demonstrating the need for appropriate compliance investments and actual non-compliance costs.
Tags: Kickbacks, False Claims, Precision Lens, Sightpath Medical, Minnesota, Travel, Entertainment, HCPs, Bankruptcy, Treble Damages, Medicare, DOJ, Whistleblower, Trial, Digital Information, Health Records, Unfairness
Litigation & Enforcement
Bigger than a Bread Box
Novo Nordisk’s Trans-Atlantic Woes Expand
By Kirt Kraeuter, Staff Writer
Summary: A recently unsealed FCA whistleblower case involving a Novo Nordisk hemophilia product, coupled with a previous U.K. PMCPA finding that the company provided “inducements” to U.K. HCPs, suggests that Novo could have more expansive and serious issues involving multiple markets and therapeutic areas.
Tags: Novo Nordisk, APBI, DOJ, Obesity, Saxenda, Wegovy, Ozempic, Hemophilia, NovoSeven, Children, Promotion, Education, Inducements, PCMPA, State of Washington, DOJ, State of Oklahoma, Whistleblower, RxCrossroads, MHRA, Serious Fraud Office, Takeda, Kickbacks, False Claims, Off-label, FDA,
Another Sheriff in Town
The GoodRx Case Highlights the FTC’s Role in Protecting Healthcare Privacy
By Gwendolyn A. Ball, Staff Writer
Summary: The GoodRx case highlights that in addition to HHS, the FTC has a substantial role in protecting healthcare privacy. It also provides the first test of the Health Breach Notification Rule promulgated in 2009.
Tags: FTC, Health Breach Notification Rule, GoodRx, Privacy, Deceptive Practices, Privacy, HIPAA, Social Media, Drug Discounts, Telehealth, Consent, Settlement, Health Information, Data Breach
Governance & Operations
Generative AI and Life Sciences
Making a Case for Hitting the “Pause” Button
By Dr. Seth B. Whitelaw, Editor
Summary: While generative AI promises to become a useful tool, the new technology also poses significant risks. Therefore, life science companies must pause and take a more deliberate, considered, and balanced approach to its adoption.
Tags: Artificial Intelligence, Generative AI, chatGPT, OpenAI, Google, Bard, Black Box, Hallucinations, Bias, Privacy, Patient Centricity, Human Genome Project, PBMs
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy. And as always, thank you for subscribing and for your continuing support in making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.
Wishing you all the best,
Dr. Seth B. Whitelaw
Editor