News & Analysis as of

False Claims Act (FCA) Risk Management Anti-Kickback Statute

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Fenwick & West LLP

CLE Takeaways: Federal Sales: Partner Compliance Programs and Investigations

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Channel partners offer significant benefits when your original equipment manufacturer, software manufacturer, or cloud-service provider is contracting with the federal government....more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

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Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - December 9th - 12th, San Diego, CA

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...more

Health Care Compliance Association (HCCA)

Due diligence and physician financial arrangements

Conducting due diligence for physician and provider compensation arrangements during a healthcare transaction is critical for the acquirer. Appropriate due diligence is necessary, regardless of whether the transaction is a...more

Health Care Compliance Association (HCCA)

[Event] Basic Healthcare Compliance Academy - July 15th - 18th, Charlotte, NC

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Farrell Fritz, P.C.

Second Circuit Defines “Willfulness” Standard Under Anti-Kickback Statute

Farrell Fritz, P.C. on

Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS). False Claims Act relator Adam Hart alleged that...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - June 3rd - 6th, New Orleans, LA

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Burr & Forman

A New Year’s Resolution: Update Your Compliance Program Based on New Government Guidance

Burr & Forman on

For the year ending September 30, 2023, federal False Claims Act settlements and judgments exceeded $2.5 billion, much of which came from the health care industry. The largest, at over $487 million, stems from a finding by a...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - March 11th - 14th, Nashville, TN

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Health Care Compliance Association (HCCA)

[Event] 28th Annual Compliance Institute - April 14th - 17th, Nashville, TN

Get ready to be inspired with game-changing insights and industry connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas, learn...more

American Conference Institute (ACI)

[Event] 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - January 23rd - 24th, New York, NY

Hosted by American Conference Institute, the 11th Annual Advanced Forum on False Claims and Qui Tam Enforcement returns for another exciting year for lively discussions on FCA enforcement including the ramifications of two...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

Morrison & Foerster LLP on

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

Gardner Law

[Hybrid Event] MASTERING TOMORROW'S HEALTHCARE TECH: A CUTTING-EDGE APPROACH TO REGULATORY, COMPLIANCE, AND PRIVACY DEMANDS -...

Gardner Law on

FDA law firm Gardner Law and EU-based Fieldfisher discuss regulatory, compliance, and privacy matters relevant to high-tech healthcare products. - - Harnessing AI and Connected Devices in Medical Innovation in an...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

Butler Snow LLP on

Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - December 11th - 14th, Orlando, FL

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - November 13th - 16th, Denver, CO

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Harris Beach Murtha PLLC

HHS Office of Inspector General July 2023 Enforcement Activity

Harris Beach invites you to register for its 7 Element compliance program series addressing New York’s 2020 and 2022 updates to Medicaid Compliance Program requirements. Starting on August 16th, each live program will be no...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - October 16th - 19th, San Francisco, CA

HCCA’s Healthcare Basic Compliance Academy provides three-and-a-half-days of classroom-style learning that addresses methods for implementing and managing compliance programs based on the Seven Element Approach. Academies...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - September 11th - 14th, Boston, MA

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

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