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Anti-Kickback Statute › Department of Justice (DOJ) › 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 -
Husch Blackwell LLP

False Claims Act Insights - Assessing the Fallout from a Thermonuclear FCA Verdict

Husch Blackwell LLP on

Host Jonathan Porter welcomes Tynan Kugler, Principal with PYA, P.C., and Mara Smith Kouba, legal and compliance counsel with Bristol Myers Squibb, to discuss a recent False Claims Act trial verdict from a New Jersey federal...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part III

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In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part II

Jones Day on

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part I

Jones Day on

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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

Morrison & Foerster LLP

Artificial Intelligence in Healthcare: New Avenues for Liability

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Artificial Intelligence (AI), specifically generative AI technologies, hold significant promise for improving the healthcare industry by streamlining clinical operations, freeing service providers from mundane tasks, and...more

Epstein Becker & Green

Sponsored Genetic Testing Programs: Compliance Considerations Following DOJ False Claims Act Settlement

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Manufacturer-sponsored genetic testing programs provide several benefits to patients, including expanding access to genetic testing, providing opportunities for patients to participate in research, empowering patients to make...more

Morrison & Foerster LLP

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Troutman Pepper

8 Ways Life Sciences Cos. Can Adapt to the Social Media Era

Troutman Pepper on

Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Paul Hastings LLP

New OIG Developments Provide Additional Avenues for Feedback and Compliance Guidance

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In recent months, the Department of Health and Human Services, Office of Inspector General (“OIG” or “the agency”) announced two major developments in its effort to provide enhanced health care and life sciences industry...more

Morgan Lewis

Speaker Program Compliance: Biotech Company Settles False Claims Act Allegations for $900 Million

Morgan Lewis on

Biogen Inc., a global biotechnology company, denies that it violated the federal Anti-Kickback Statute and False Claims Act by paying healthcare professionals for fraudulent speaking engagements in order to incentivize them...more

Epstein Becker & Green

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

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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

Goodwin

DOJ False Claims Act Recoveries Exceed $5.6 Billion in 2021

Goodwin on

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

Skadden, Arps, Slate, Meagher & Flom LLP

Will FDA and DOJ Reassert Their Enforcement Muscle With Life Sciences in 2022?

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Takeaways - Despite predictions that the Biden administration would devote increased enforcement resources to the life sciences industry broadly, so far, the FDA and DOJ have focused their efforts on COVID-related conduct. ...more

Goodwin

Heating Up: Federal Sunshine Act Enforcement on the Rise

Goodwin on

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

The Volkov Law Group

Taro, Sandoz and Apotex Pay $447.2 Million to Settle False Claims Act Liability for Price-Fixing of Generic Drugs

The Volkov Law Group on

The healthcare industry faces cascading risks – one risk flows to another with compounding financial results.  Three generic drug companies just experienced this cascading liability. ...more

Skadden, Arps, Slate, Meagher & Flom LLP

Navigating Relationships With Practice Support and Other Tech Vendors

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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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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

Arnall Golden Gregory LLP

Life Sciences Investigations – 2020 Year in Review and 2021 Outlook

Arnall Golden Gregory LLP on

On February 11, 2020, AGG’s Government Investigations practice chairs, Aaron M. Danzig and Sara M. Lord, conducted a webinar, titled “Life Sciences Investigations and Enforcement Actions: 2020 Year in Review and 2021...more

Mintz - Health Care Viewpoints

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

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Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

McDermott Will & Emery

Special Report - 2019 Digital Health Year in Review - January 2020

McDermott Will & Emery on

Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

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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

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