News & Analysis as of August 20, 2025

Life Sciences

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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 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 -

State AGs Join $202M Settlement Over HIV Drug Kickback

Troutman Pepper Locke on 8/4/2025

On July 16, 49 attorneys general (AGs) announced that they joined a $202 million settlement with Gilead Sciences, Inc. (Gilead). Previously announced by the Department of Justice in April, the settlement resolved allegations...more

New HHS-OIG Guidance on Sponsored Genetic-Testing Programs

Morrison & Foerster LLP on 1/22/2025

On December 17, 2024, the Department of Health & Human Services, Office of Inspector General (HHS-OIG) issued its second favorable advisory opinion involving an arrangement in which a drug manufacturer sponsors genetic...more

Healthcare Providers, Agents, and Brokers: Please Stop, Look, and Listen Before Entering Into Suspect Medicare Advantage Plan...

Hinshaw & Culbertson - Health Care on 1/7/2025

The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) issues Special Fraud Alerts regarding healthcare fraud and abuse patterns or practices it has recently identified and intends to...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on 3/25/2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Life Sciences Companies Face Continuing Compliance Challenges in Developing Value-Based and Value-Added Models

McGuireWoods LLP on 12/29/2023

On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added...more

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

Jones Day on 12/1/2023

In Short - The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Schulte on 11/30/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

A Practical Look at OIG’s New Compliance Guidance

Goodwin on 11/27/2023

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...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

OIG Determines That Providing Free Hearing Aids to Bimodal-Hearing Candidates Implicates the Anti-Kickback Statute and Beneficiary...

Arnall Golden Gregory LLP on 11/3/2023

On October 20, 2023, the Office of Inspector General of the Department of Health and Human Services (“OIG”) issued an unfavorable Advisory Opinion No. 23-08 to a supplier of cochlear implants coupled with external sound...more

OIG Advisory Opinion Determines “Carve Out” Arrangement Limited to Commercially Insured Patients May Violate the Anti-Kickback...

Arnall Golden Gregory LLP on 10/26/2023

On September 25, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued an unfavorable Advisory Opinion No. 23-06 related to a proposed arrangement involving purchasing the technical...more

[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum 2023 - November 1st, Chicago, IL

McDermott Will & Schulte on 10/10/2023

McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more

Advisory Opinion 23-05: OIG Warns Sanctions Would Likely be Issued in Response to Certain Proposed Contractual Joint Venture

Robinson+Cole Health Law Diagnosis on 9/25/2023

On August 18, 2023, the Office of Inspector General (OIG) published Advisory Opinion 23-05 (Advisory Opinion), in which the OIG warned that it would likely issue sanctions under the Federal anti-kickback statute (AKS) if a...more

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 142: Erica Barnes, Maynard Nexsen Attorney

Maynard Nexsen on 5/9/2023

Our colleague Erica Barnes joins hosts Heather and Lauren for a conversation on the Anti-Kickback Statute. We dive into critical information for health care providers across the spectrum when navigating the Anti-Kickback...more

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

Mintz - Health Care Viewpoints on 4/6/2023

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

A Change Is Gonna Come: AdvaMed Revises Its Code of Ethics on Interactions With Health Care Professionals

Arnall Golden Gregory LLP on 4/5/2022

In 1964, Sam Cooke sang “A Change is Gonna Come.” In March 2022, the Advanced Medical Technology (AdvaMed) said the same when it announced revisions to its Code of Ethics on Interactions with Health Care Professionals (the...more

Video: Record-Shattering Year for FCA Recoveries in Health Care - Thought Leaders in Health Law

Epstein Becker & Green on 3/10/2022

The U.S. Department of Justice (DOJ) collected $5.6 billion in False Claims Act recoveries in fiscal year (FY) 2021. That is over twice as much as 2020, and a record 90 percent of the total was collected from the health care...more

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on 3/8/2022

The U.S. Department of Justice (“DOJ”) recently announced that over $5.6 billion in False Claims Act (“FCA”) settlements and judgments had been reached during the 2021 fiscal year, with over $5 billion of those settlements...more

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on 11/5/2021

After several years without any enforcement, the U.S. Department of Justice (“DOJ”) recently penalized medical device and life sciences companies for violating the U.S. Provider Payments Sunshine Act (“Sunshine Act”) (42...more

DOJ Introduces Novel Theories of Liability and Requires Unprecedented Controls in Speaker Program Settlement

Skadden, Arps, Slate, Meagher & Flom LLP on 4/22/2021

Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers - About the Enforcement in Life Sciences Series - Recent settlements between the U.S....more

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

McDermott Will & Schulte on 3/18/2021

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Special Fraud Alert from DHHS OIG Cautions Against Use of Health Care Speaker Programs

Polsinelli on 1/12/2021

The Department of Health and Human Services Office of Inspector General (“DHHS OIG”) recently issued a Special Fraud Alert regarding fraud and abuse concerns related to speaker programs offered by pharmaceutical and medical...more

Summary of Trump Administration Drug Pricing and AKS Rulemakings and Implications for Life Sciences Companies and Health Care...

Foley Hoag LLP on 11/30/2020

On Friday, November 20, 2020, 60 calendar days prior to the inauguration of President-Elect Biden, the Trump administration released three rulemakings with significant implications for life sciences companies and healthcare...more

Are Speaker Programs a Thing of the Past? OIG’s Fraud Alert Indicates It Thinks They Should Be

Mintz - Health Care Viewpoints on 11/30/2020

In the midst of the pandemic emergency, the Department of Health and Human Services Office of Inspector General (OIG) issued a stern warning about in-person educational programs for health care professionals (HCPs), known as...more

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Skadden, Arps, Slate, Meagher & Flom LLP on 8/24/2020

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

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