Policy & Medicine Compliance Update
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November 2023 Issue
November 2023
We begin our coverage this month by exploring the complex world of patient/industry interactions. Using patients as spokespeople and influencers is a relatively new phenomenon but brings heightened risks for life science companies.
Shifting to litigation and enforcement, we start by examining efforts to control the ever-rising price of insulin. In the wake of a limited federal response, private plaintiffs, states, and local governments have turned to the federal courts to address alleged conspiratorial conduct by drug makers and PBMs to inflate insulin prices.
Next, we review the recent decision by the U.S. Supreme Court not to review a Sixth Circuit case on the issues of remuneration and causation under a provision of the AKS. The Supreme Court’s decision failed to resolve the ongoing circuit split, creating uncertainty about what constitutes illegal remuneration.
Finally, we review the recent DOJ announcement establishing a safe harbor for voluntary self-disclosures involving mergers and acquisitions. The new Safe Harbor Policy is another step in the DOJ’s ongoing efforts to improve corporate and individual accountability. However, it also creates new challenges for acquiring companies and compliance.
Articles
FEATURE
The Conundrum of Paying Patients
Embracing Patient Centricity or Buying Brand Loyalty?
By Kirt Kraeuter, Staff Writer
Summary: The direct engagement of patients by life science companies as spokespeople and influencers is a relatively new phenomenon. However, like HCP interactions, these interactions present a substantial risk of government enforcement if essential controls (e.g., FMV calculations) are lacking. This article explores the rise in patient involvement with drug and device companies and the potential implications.
Tags: Patient Centricity, Patient Empowerment, Payments, AKS, Beneficiary Inducement CMP, FMV, PhRMA, AdvaMed, IFPMA, Clinical Trials, FDA, HHS-OIG, FTC, DOJ, Advisory Boards, Speakers, Influencers, Endorsements, Surveys, Real-World Evidence, Real-World Data, AI, Kardashian, Celebrities, Caring Voice Coalition
Litigation & Enforcement
Fighting a War on Multiple Fronts
The Battle Over High Insulin Prices Moves to the Courts
By Gwendolyn A. Ball, Staff Writer
Summary: Insulin prices are emblematic of the ongoing battle over high prescription drug prices. In the wake of a federal response limited to capping insulin expenditures for Medicare patients, private plaintiffs, states, and local governments have turned to the federal courts to address alleged conspiratorial conduct by drug makers and PBMs to inflate insulin prices. As a result, the courts have consolidated numerous cases into a new Insulin Pricing Litigation MDL. If the Opioid MDL is any guide, the new, complex MDL represents a significant liability exposure for the pharmaceutical industry.
Tags: DOJ, Insulin, Drug Pricing, Eli Lilly, Novo Nordisk, Sanofi, Express Scripts, CVS, OptumRx, Caremark, MDL, Conspiracy, List Price, Antitrust, RICO
Punting the Issue
The U.S. Supreme Court Declines to Address Remuneration & Kickbacks
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The U.S. Supreme Court recently denied a whistleblower’s petition and declined to address the issue of causation under a portion of the AKS. In doing so, the Supreme Court left a split among the Third, Eighth and now Sixth Circuit unresolved, creating uncertainty on what constitutes illegal remuneration in the context of AKS and FCA cases.
Tags: Supreme Court, Remuneration, Sixth Circuit, Third Circuit, Eighth Circuit, First Circuit, AKS, FCA, But-For Causation, Circuit Split, Regeneron, Chronic Disease Fund, Patient Assistance Programs, Copay Charities
Regulatory Update
An Ever-Changing Enforcement Landscape
DOJ’s New Mergers & Acquisitions Safe Harbor Policy
By Dr. Seth B. Whitelaw
Summary: In the latest update to its enforcement policies, the Justice Department recently announced a new Safe Harbor Policy for mergers and acquisitions. Although an improvement over prior guidance, the new policy presents significant uncertainties and challenges for buyers.
Tags: DOJ, Mergers, Acquisitions, Safe Harbor, Fresenius, Akorn, Successor Liability, Voluntary Self-Disclosure, Cooperation, FCPA, CCO Certifications, Due Diligence, Investigations
About THE Authors & Contributors[i]
Gwendolyn Ball: Ms. Ball is a Policy & Medicine Compliance Update staff writer. In addition, she holds advanced degrees in economics and law. Ms. Ball consults on health policy, especially the economics of healthcare and drug markets for firms and nonprofits and teaches undergraduate and graduate economics and law courses.
Kirt Kraeuter: Besides being a staff writer for the Policy & Medicine Compliance Update and providing compliance advisory services, Mr. Kraeuter is the former Senior Director of Corporate Compliance at Moderna.
Maureen Lloyd: Ms. Lloyd is the Executive Director of LLOYDMJMC LLC. and a Policy & Medicine Compliance Update Editorial Board member.
Jenny McVey: Ms. McVey is the North American Compliance Officer for bioMérieux and a Policy & Medicine Compliance Update Editorial Board member.
Dr. Seth B. Whitelaw: Dr. Whitelaw is a Senior Fellow and Adjunct Professor of Life Science Compliance at Mitchell Hamline School of Law, President & CEO of Whitelaw Compliance Group, LLC, and the Editor of the Policy & Medicine Compliance Update.
Robert Wilkey: Mr. Wilkey is the Principal Attorney at Wilkey Legal Consultants, LLC, and focuses on complex civil litigation and legal consultation involving class action matters within the pharmaceutical, medical device, environmental, and consumer protection fields. He is also a senior staff writer with the Policy and Medicine Compliance Update.
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy. As always, thank you for subscribing and 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
sbwhitelaw@whitelawcompliance.com
[1] The views expressed in the articles are solely those of the authors and do not reflect those of the authors’ current or former employers and clients.