News & Analysis as of

New Regulations Anti-Kickback Statute

ArentFox Schiff

What Life Sciences Companies Need to Know in 2025

ArentFox Schiff on

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

ArentFox Schiff

Investigations Newsletter: Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims

ArentFox Schiff on

Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims - Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Washington DC - March 5th, 8:25 am - 4:30 pm EST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

ArentFox Schiff

Searching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute Protection

ArentFox Schiff on

Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more

Health Care Compliance Association (HCCA)

[Webinar] What Compliance Professionals Need to Know About the New Stark and Anti-Kickback Regulations - January 29th, 12:00 pm -...

Learning Objectives: - Explain changes to existing concepts including fair market value, commercial reasonableness, and volume or value - Examine the new definitions, exceptions, and safe harbors and their impact on...more

Hinshaw & Culbertson - Health Care

New Stark Regulations Further Clarify Definitions of Fair Market Value and General Market Value

The Department of Health and Human Services (HHS), on November 20, 2020, released final rules for the federal physician self-referral law (Stark) and the anti-kickback statute (AKS). The Centers for Medicare & Medicaid...more

Tucker Arensberg, P.C.

New Federal Kick-Back Laws Regarding Opioid Treatment

Tucker Arensberg, P.C. on

“Eliminating Kick-Backs and Recovery Act of 2018” (EKRA) is a part of a group of laws recently passed by Congress to expand the law enforcement spectrum available to fight the opioid epidemic. EKRA is part of approximately 70...more

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