News & Analysis as of

Healthcare Anti-Kickback Statute Pharmaceutical Industry

Kohn, Kohn & Colapinto LLP

DOJ and Whistleblowers Crack Down on Illegal Kickbacks: Major Qui Tam Settlements from July 2024

In July, the U.S. Department of Justice (DOJ) and U.S. Attorneys Offices announced several large False Claims Act (FCA) settlements stemming from qui tam whistleblower suits....more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

The Volkov Law Group

DaVita Pays $34 Million to Settle Kickback Violations

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DaVita is a regular target of government enforcement actions involving fraud and illegal kickbacks.  It has an extensive history of violations and settlements....more

Bass, Berry & Sims PLC

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

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On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Akerman LLP - Health Law Rx

When a Gift Becomes a Kickback: Gifts from Florida Pharmacies to Long-Term Care Facilities

The Florida Board of Pharmacy permits pharmacies serving residents and patients at long-term care facilities (nursing homes, ALFs, homes for DD residents, etc.) as either Special Closed System Pharmacies or Community...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

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Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | March 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for March 2024. We summarize a US Court of Appeals for the Second Circuit decision interpreting the intent standard under the federal...more

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

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Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more

Bass, Berry & Sims PLC

12th Annual Healthcare Fraud & Abuse Review - A Critical Resource for Healthcare Providers

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We are pleased to bring you our 12th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

Troutman Pepper

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

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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

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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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

Nelson Mullins Riley & Scarborough LLP

OIG Issues Unfavorable Opinion About Bundling Free Items with Reimbursable Services

On Oct. 25, 2023, the Office of Inspector General (OIG) for the Department of Health and Human Services (DHHS) issued an unfavorable opinion in response to a manufacturer’s proposal to offer and provide a free compatible...more

The Volkov Law Group

BioTek, its CEO, Chaitanya Gadde, and Physician, Dr. David Tabby, Agreed to Pay $20 Million to Resolve Anti-Kickback Violations

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The reach of the Anti-Kickback Statute and the False Claims Act is broad.  As a result, AKS liability is a real and significant risk for healthcare companies and providers. Healthcare companies and providers have to resolve...more

Bradley Arant Boult Cummings LLP

Circuit Split on FCA Causation Deepens with Upcoming First Circuit Ruling

The First Circuit will decide the causation standard required in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS), deepening a circuit split on the issue and potentially teeing up Supreme Court...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

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

Akerman LLP - Health Law Rx

Teva FCA Decision Sheds Light on Varying Interpretations of the Elements of an FCA Claim

How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | June 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for June 2023. We discuss several civil enforcement actions involving false claims, the Anti-Kickback Statute (AKS) and...more

Manatt, Phelps & Phillips, LLP

False Claims Act 2023: What Every Health Care Entity Working with the Government Needs to Know

In our July 18, 2023, webinar titled “False Claims Act 2023: What Every Health Care Entity Working with the Government Needs to Know,” Manatt posed the following hypothetical and asked three questions about it in our live...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q2 2023

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There have been several noteworthy False Claims Act (FCA) settlements in the second quarter of 2023.  Four of these settlements have come in over $20 million. This post summarizes key settlements of interest....more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2023 Recap

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

Polsinelli

DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

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Signaling its continued scrutiny of the laboratory industry, the Department of Justice (DOJ) entered into a settlement agreement with Texas lab Genotox Laboratories Ltd. last month related to compensation Genotox paid to...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

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