Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you to subscribe to our monthly publication Policy and Medicine Compliance Update.
We begin this month’s issue with two articles on voluntary self-disclosures. First, we examine the recent amendments to HHS’s Self-Disclosure Protocol. Next, we explore the latest updates to the DOJ’s Criminal Enforcement Policies. These updates build upon the DOJ’s earlier changes announced in March 2021.
Shifting focus, we explore the latest developments in the Omnicare FCA case. After a decade, the case continues and has yet to resolve the issue of when electronic data submissions constitute “false claims.” We also examine the FTC’s continued efforts to curtail anti-competitive activities in the healthcare sector. While the focus is on hospital mergers, the FTC’s effort may ultimately impact life sciences.
Finally, we cover two recent federal cases involving the FDA’ authority to regulate stem cells. Although based on similar facts, the courts reached opposite results about whether certain stem cell treatments constitute drugs under the Federal Food, Drug, and Cosmetic Act.
Articles
FEATURE
Speak Now or Forever Hold Your Peace
Latest Amendments to the Health Care Fraud Self-Disclosure Protocol
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The November 2021 update to the OIG’s Health Care Fraud Self-Disclosure Protocol made important changes to the 2013 version. However, considering the recent pronouncements from the DOJ regarding its criminal enforcement policies, life science compliance officers and legal counsel must understand the differences to navigate to successful healthcare fraud resolutions.
LITIGATION & Enforcement – DOJ CRIMINAL ENFORCEMENT Policies
Doubling Down on Accountability & Compliance
DOJ Announces New Criminal Enforcement Policies
By Dr. Seth B. Whitelaw, Editor
Summary: In September 2022, the Justice Department announced additional revisions to its criminal enforcement policies. These new developments make obtaining credit for voluntary self-disclosures and cooperation more difficult. Additionally, the DOJ signaled that it is not done, and further changes are in the offing.
Litigation & Enforcement – False Claims
After a Decade, the Omnicare FCA Suit Soldiers On
By Kirt Kraeuter, Staff Writer
Summary: In March 2011, a qui tam relator filed a complaint against four institutional pharmacies, alleging their provision of pharmacy services to skilled nursing facilities violated the Anti-Kickback Statute and, therefore, the False Claims Act. The conduct at the heart of the complaint is a form of a “swapping” program – charging below-market drug prices for Medicare Part A services to secure access to the skilled nursing facilities’ more lucrative Medicare Part D and Medicaid business. Two critical questions at play are essential for compliance professionals: do drug discounts that improve healthcare service providers’ bottom lines constitute an inducement when joined to other lines of business, and does an electronic data submission that does not contain billing information constitute a “claim” under the False Claims Act?
LITIGATION & ENFORCEMENT – Hospital Mergers
The Ever-Changing Face of Health Care
FTC Review of Hospital Mergers Has Broad Implications
By Gwendolyn A. Ball
Summary: Hospital consolidation continues to be a critical health care challenge. However, the Biden Administration and the FTC have made addressing it a cornerstone of their pro-competition agenda. Furthermore, the FTC’s new approaches are readily applicable to life sciences and thus are important to understand and monitor.
LITIGATION & ENFORCEMENT – FDA REGULATION OF STEM CELLS
California Federal Judge Rules FDA Cannot Regulate Stem Cell Treatments as Drugs
By Dr. Seth B. Whitelaw, Editor
Summary: Two U.S. District Courts recently reached opposite conclusions about whether specific stem cell treatments are drugs. Thus, the cases leave unsettled whether clinics using SVF procedures are producing drugs within the meaning of the FFDCA and therefore are subject to the full force of the FDA’s enforcement powers.
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