News & Analysis as of August 10, 2025

Drug Pricing

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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 -

Healthcare Regulatory Check-Up Newsletter | May 2025

McDermott Will & Schulte on 7/1/2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more

Life Science Private Equity Risk

White & Case LLP on 5/6/2025

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

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Schulte on 4/28/2025

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

As Health Care Enforcement Surges, Buckle Up for a Bumpy Ride

Wiley Rein LLP on 4/18/2025

As the saying goes, the more things change, the more they stay the same – and the world of health care fraud enforcement is no exception. Recent years have seen a wave of novel technologies, emerging threats to our nation’s...more

Teva Pharmaceuticals Pays $450 Million to Resolve Anti-Kickback and False Claims Act Violations

The Volkov Law Group on 10/23/2024

Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is...more

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

Goodwin on 4/22/2024

As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more

Supreme Court Removes Some Defenses to False Claims Act Liability for Government Contractors and Health Care Providers

Warner Norcross + Judd on 6/9/2023

Government contractors, health care providers and many other parties who submit claims for payment to the federal government are subject to liability under the False Claims Act (FCA). This month, the U.S. Supreme Court issued...more

Investigations Newsletter: Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback...

ArentFox Schiff on 5/8/2023

Recent Interview With FCA Plaintiff Bar Attorneys Offers Key Insight into Trends in Anti-Kickback Litigation - During a recent interview commemorating the 50th anniversary of the enactment of the Anti-Kickback Statute, two...more

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

McDermott Will & Schulte on 9/1/2022

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

Healthcare Regulatory Check-Up Newsletter | January - April 2022 Recap

McDermott Will & Schulte on 5/27/2022

This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

Recent Litigation Shines Spotlight on Hospital and Physician Group Transactions

McDermott Will & Schulte on 4/19/2022

The US Department of Justice recently intervened in an qui tam alleging false and fraudulent claims involving the acquisition of physician practice locations by a health system and subsequent management of the health system’s...more

Trump Administration’s Eleventh-Hour Drug Pricing Regulations Face an Uncertain Path Forward

White & Case LLP on 12/4/2020

The Trump Administration recently announced two final rules that implement policy objectives to lower drug prices by tying certain Medicare Part B payments to prices paid by other countries and by replacing an anti-kickback...more

Gilead Reaches $97 Million FCA/AKS Settlement

Rivkin Radler LLP on 9/30/2020

On September 23, the U.S. Department of Justice announced that pharmaceutical company Gilead Sciences, Inc. agreed to pay $97 million to resolve claims that it illegally used a foundation as a conduit to pay the copays of...more

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

Skadden, Arps, Slate, Meagher & Flom LLP on 1/24/2020

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

A Dialogue With Corporate Counsel: Skadden’s Ninth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/2/2019

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Healthcare Law Update: July 2019

Holland & Knight LLP on 7/10/2019

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

HHS Proposes 'Sweeping' Changes to Pharmacy Drug Pricing

Troutman Pepper Locke on 2/8/2019

The pharmacy benefit manager (PBM) industry recently has come under significant scrutiny by the Trump administration....more

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 12/13/2018

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Healthcare Law Update: May 2018

Holland & Knight LLP on 5/30/2018

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2018

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

AGG Food & Drug Newsletter - January 2018

Arnall Golden Gregory LLP on 1/26/2018

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

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Anti-Kickback Statute › False Claims Act (FCA) › Drug Pricing

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