Policy and Medicine Compliance Update – November 2023 Issue Features Patient Spokesman, Insulin Costs, SCOTUS Decision, and DOJ Safe Harbor for Mergers and Acquisitions.
Welcome to the latest edition of Policy and Medicine Compliance Update. In this month’s coverage, we delve into the intricate dynamics of patient and industry interactions, highlighting the emerging role of patients as spokespeople and influencers and its implications for life science companies.
We also examine the legal battles surrounding the escalating costs of insulin, spotlighting actions by various entities in response to limited federal intervention.
Further, we dissect the U.S. Supreme Court’s decision to sidestep a significant Anti-Kickback Statute case, leaving a legal quandary unresolved.
Concluding our update, we analyze the DOJ’s new Safe Harbor Policy related to mergers and acquisitions, a move that marks progress in corporate accountability but introduces fresh challenges for compliance in the evolving healthcare landscape.
Feature Article: The Conundrum of Paying Patients – Embracing Patient Centricity or Buying Brand Loyalty? By Kirt Kraeuter We explore the burgeoning trend of engaging patients as spokespeople in the life sciences sector, assessing the risks and potential government enforcement implications.
Litigation & Enforcement Focus: Fighting a War on Multiple Fronts – The Battle Over High Insulin Prices Moves to the Courts By Gwendolyn A. Ball Our coverage shifts to the intense legal battle over insulin pricing, examining the role of federal courts in addressing the alleged price inflation by drug manufacturers and PBMs.
Legal Analysis: Punting the Issue – The U.S. Supreme Court Declines to Address Remuneration & Kickbacks By Robert N. Wilkey, Esq. An in-depth analysis of the Supreme Court’s recent decision to bypass a pivotal AKS case, leaving a significant legal question unresolved regarding illegal remuneration.
Regulatory Update: An Ever-Changing Enforcement Landscape – DOJ’s New Mergers & Acquisitions Safe Harbor Policy By Dr. Seth B. Whitelaw We conclude with a look at the DOJ’s latest policy on mergers and acquisitions, discussing its potential impact and the challenges it poses for compliance in the corporate sphere.
Join us in this insightful journey through the evolving landscape of healthcare compliance and legal challenges. Stay informed with Policy and Medicine Compliance Update to subscribe to this monthly publication click here.