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December 2023 Issue
December 2023
For our final issue of 2023, we begin our coverage this month by exploring the complex world of government pricing programs (GPP). GPP compliance is an increasingly important topic, and this article outlines the complexities and role of compliance.
Next, we examine the new General Compliance Program Guidance (GCPG) issued by the HHS-OIG. As the first update in twenty years, the GCPG is a blend of familiar concepts and new materials presented via a radical new format.
We also review the latest draft guidance from the FDA on communicating scientific information about unapproved uses for approved products. It contains significant new concepts and provisions that manufacturers should carefully review and make appropriate comments.
Shifting to litigation and enforcement, we highlight FTC’s latest anticompetitive initiative to address patent listings in the FDA’s Orange Book. Finally, we close the issue with a review of CMS’ data on SRDP settlements.
Articles
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
Summary: GPP compliance is an increasingly significant focus area for life science companies. However, although compliance functions are essential in guiding their organizations, many professionals struggle to appreciate GPP complexities and how best to effectuate that role. This article discusses those complexities and the role of compliance.
Tags: Government Pricing Programs, Drug Pricing, Kickbacks, False Claims, Medicare, Medicaid, 340B, Veterans Affairs, Federal Supply Schedule, Bona Fide Services, FMV, Independent Assessments
Regulatory Update
Hitting the Mark
The HHS-OIG Issues Effective Compliance Program Guidance
By Kirt Kraeuter, Staff Writer
Summary: It is rare that final regulatory guidance documents arrive on time and contain easily comprehensible, pragmatic advice. However, HHS-OIG’s new General Compliance Program Guidance is an exception. The new GCPG hit the mark by delivering revitalized, expanded general guidance reflecting the current healthcare environment before HHS-OIG’s target date.
Tags: HHS-OIG, Compliance Program Guidance, Fraud and Abuse, Effectiveness, Seven Elements, Kickbacks, False Claims, 340B, Bribery, Stark Law, HIPAA, Quality, Product Safety, Technology, Monitoring
Adding Complexity in a Complex World
FDA Proposes New Guidance on Disseminating Scientific Information
By Dr. Seth B. Whitelaw and Darshan Kulkarni, Pharm.D., M.S., Esq.
Summary: In October 2023, the FDA issued draft guidance on communications of certain scientific information about unapproved uses of approved products. The draft contains significant new concepts and provisions that manufacturers should carefully review and make appropriate comments.
Tags: FDA, Communications, Scientific Information, Unapproved Uses, Misbranding, False or Misleading, Free Speech, SIUU, Reprints, Social Media, Clinical Practice Guides
Litigation & Enforcement
On a New Warpath
The FTC Targets Patent Listings in the “Orange Book”
By Gwendolyn A. Ball, Staff Writer
Summary: In September and November 2023, the FTC launched a new initiative to address “improper” patents listed in the FDA’s Orange Book. While questions abound about these efforts, the initiative is yet another significant data point on the FTC’s ever-increasing enforcement curve.
Tags: FDA, FTC, Orange Book, Patents, Competition, Unfair Trade Practices, Monopolies, Generics, ANDA, Listing, Patent Listing Dispute, AbbVie, AstraZeneca, Mylan, Boehringer Ingelheim, GSK, Teva
An Upward Trend
Examining the Latest Self-Referral Disclosure Protocol Data from CMS
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In July 2023, the Centers for Medicare & Medicaid Services published updated data regarding settlements made under the voluntary Self-Referral Disclosure Protocol. Although the data remains limited and focused on provider arrangements, it offers insights for life science companies contending with other voluntary self-disclosure policies.
Tags: CMS, Self-Referral Disclosure Protocol, Voluntary Self-Disclosure, DOJ, Stark Law, Settlements, Providers, Self-Referral’[;
About THE Authors & Contributors[1]
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.
Chris Coburn: Mr. Colburn is an experienced Government Pricing Program consultant who provides GPP advisory services with Helio Health Group.
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.
Darshan Kulkarni: Dr. Kulkarni is the Principal Attorney at the Kulkarni Law Firm where he provides regulatory advice and general counsel services to FDA regulated companies. He is Adjunct Professor at the Drexel University School of Law, was previously chair of the ABA Life Sciences Interest Group and currently serves as a board member for the Emily Whitehead Foundation. He previously served as Director of Compliance for PhaCTMI, an industry consortium of Medical Information professionals and was Chair of the Life Sciences Interest Group in the Health Law Section of the American Bar Association. He currently serves as Chair of the Life Sciences Subcommittee for the M&A group of the Business Law Section.
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 a wonderful and peaceful Holiday Season!
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.