Policy and Medicine Compliance Update December 2023 Issue:
Features Compliance with Government Pricing Programs, HHS OIG General Compliance Program Guidance, FDA Guidance on Communicating Scientific Information for Unapproved Uses and FTC Orange Book Listings
Welcome to the December 2023 issue of Policy and Medicine Compliance Update, a monthly subscription-based publication tailored for compliance professionals in the healthcare sector. As we wrap up the year, this issue dives into the evolving and complex landscape of life science compliance, offering insights and updates crucial for professionals navigating this dynamic field.
Our coverage kicks off with an in-depth look at the intricacies of Government Pricing Programs (GPP). Given its growing importance, understanding GPP compliance is vital, and our feature article provides a thorough exploration of its complexities and the crucial role of compliance functions in this area.
We then shift our focus to a significant milestone in regulatory guidance – the new General Compliance Program Guidance (GCPG) issued by HHS-OIG. Marking its first update in two decades, the GCPG presents a fusion of established concepts and innovative approaches, offering a fresh perspective on compliance practices.
Further enhancing our understanding of current regulatory trends, we delve into the FDA’s latest draft guidance on the communication of scientific information about unapproved uses for approved products. This draft introduces substantial new concepts and recommendations, demanding careful consideration and response from manufacturers.
In the realm of litigation and enforcement, we spotlight the FTC’s latest initiative targeting patent listings in the FDA’s Orange Book, a move indicative of the agency’s intensified enforcement efforts and the growing complexities of antitrust issues in healthcare.
Concluding this issue, we present a detailed review of the Centers for Medicare & Medicaid Services’ (CMS) recent data on settlements under the Self-Referral Disclosure Protocol (SRDP). This analysis offers invaluable insights for life science companies dealing with various voluntary self-disclosure policies.
As we close out 2023, this issue of Policy and Medicine Compliance Update serves as a comprehensive resource, guiding compliance professionals through the latest developments, challenges, and opportunities in the life science compliance landscape.
Feature
Back to Basics: Compliance Oversight of Government Pricing Programs
Where We Are Now and Where We Are Headed
By Chris Coburn and Helio Health Group
Understanding and navigating the complexities of Government Pricing Programs (GPP) is becoming increasingly crucial for life science companies. Compliance roles are essential in guiding organizations through these complexities. This article delves into the intricate aspects of GPP and the significance of effective compliance.
Regulatory Update
Hitting the Mark: The HHS-OIG Issues Effective Compliance Program Guidance
By Kirt Kraeuter, Staff Writer
After twenty years, HHS-OIG has released a new General Compliance Program Guidance (GCPG), blending familiar concepts with new materials in an innovative format. This update is timely and offers pragmatic advice, reflecting the current healthcare environment.
By Dr. Seth B. Whitelaw and Darshan Kulkarni, Pharm.D., M.S., Esq.
In a significant move, the FDA issued draft guidance in October 2023 on communicating scientific information regarding unapproved uses of approved products. This draft introduces new concepts and provisions that manufacturers should review meticulously and provide appropriate feedback.
Litigation & Enforcement
On a New Warpath: The FTC Targets Patent Listings in the “Orange Book”
By Gwendolyn A. Ball, Staff Writer
The FTC has initiated a new campaign to tackle “improper” patents listed in the FDA’s Orange Book. Launched in September and November 2023, this initiative marks a critical point in the FTC’s increasing enforcement actions, raising numerous questions.
An Upward Trend: Examining the Latest Self-Referral Disclosure Protocol Data from CMS
By Robert N. Wilkey, Esq., Senior Staff Writer
July 2023 saw the Centers for Medicare & Medicaid Services release updated data on settlements under the voluntary Self-Referral Disclosure Protocol. Although the data primarily focuses on provider arrangements, it provides valuable insights for life science companies dealing with voluntary self-disclosure policies.
Join us in this insightful journey through the evolving landscape of life science compliance and legal challenges. Stay informed with Policy and Medicine Compliance Update.
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