News & Analysis as of August 11, 2025

Anti-Kickback Statute › Risk Management › Healthcare Fraud

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

EKRA's Application to Marketing Arrangements: Laboratories and Other Providers

Baker Donelson on 8/6/2025

The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

Epstein Becker & Green on 8/5/2025

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on 5/29/2025

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Ep. 63 – Speaking Fees and Safe Harbors: Lessons from a $202M AKS Settlement

Dentons on 5/28/2025

In April, a pharmaceutical manufacturer agreed to pay a $202 million settlement to resolve allegations of Anti-Kickback Statute (AKS) violations. At the heart of the case were speaker programs, where physicians and...more

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

Morrison & Foerster LLP on 4/28/2025

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

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

Paul Hastings LLP on 3/11/2025

In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

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

Baker Donelson on 2/21/2025

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

HHS-OIG Year in Review 2024

Bass, Berry & Sims PLC on 2/7/2025

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

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

Arnall Golden Gregory LLP on 1/9/2025

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

At Long Last, the OIG Issues Its Compliance Program Guidance for Nursing Facilities

ArentFox Schiff on 1/9/2025

On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG)....more

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

Gardner Law on 4/2/2024

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

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

Burr & Forman on 2/23/2024

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

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

Health Care Compliance Association (HCCA) on 12/5/2023

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

A Recap of Nelson Mullins 2023 Value-Based Care Conference; Implementing Value Based Strategies

Nelson Mullins Riley & Scarborough LLP on 11/29/2023

The Nelson Mullins 2023 Value Based Care Conference: Implementing Value Based Strategies, was held on November 2, 2023, at the Tower Club in Fort Lauderdale. By any definition, the event, which has become an annual “can’t...more

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

American Conference Institute (ACI) on 11/22/2023

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

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

Morrison & Foerster LLP on 10/11/2023

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

HHS Office of Inspector General July 2023 Enforcement Activity

Harris Beach Murtha PLLC on 8/10/2023

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

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

Health Care Compliance Association (HCCA) on 8/8/2023

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

[Event] Regional Healthcare Compliance Conference - January 27th, Lake Buena Vista, FL

Health Care Compliance Association (HCCA) on 1/18/2023

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more

[Virtual Conference] Nashville Healthcare Fraud Conference - December 15th - 16th, 8:00 am - 1:00 pm CST

Bass, Berry & Sims PLC on 11/15/2022

Please join us for the 8th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more

[Virtual Event] Healthcare Enforcement Compliance Conference - November 7th - 9th, 8:55 am - 3:30 pm CST

Health Care Compliance Association (HCCA) on 9/1/2022

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

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

Health Care Compliance Association (HCCA) on 8/3/2022

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

[Virtual Event] Portland Regional Healthcare Compliance Conference - February 4th, 8:25 am - 4:30 pm PST

Health Care Compliance Association (HCCA) on 1/7/2022

General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more

[Event] Regional Healthcare Compliance Conference - January 28th, Orlando, FL

Health Care Compliance Association (HCCA) on 1/4/2022

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

[Event] Nashville Regional Healthcare Compliance Conference - November 5th, Nashville, TN

Health Care Compliance Association (HCCA) on 10/12/2021

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

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