News & Analysis as of

Anti-Kickback Statute Regulatory Requirements Life Sciences

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 -
White & Case LLP

Life Science Private Equity Risk

White & Case LLP on

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

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When...

In this episode, Michael Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more

Arnall Golden Gregory LLP

How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by David Blank, AGG Healthcare partner, to discuss how foreign life sciences companies can proactively address...more

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

Goodwin

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

Goodwin on

In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

McDermott Will & Schulte

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

McDermott Will & Schulte on

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

Stinson LLP

New Federal Anti-Kickback Prohibition Applicable to Clinical Laboratories

Stinson LLP on

Notwithstanding its name, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 or the SUPPORT Act appears to regulate behavior that has nothing to do with...more

Hogan Lovells

Massachusetts anti-opioid law bans manufacturer copay assistance

Hogan Lovells on

On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately. ...more

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