News & Analysis as of November 15, 2024

Criminal Prosecution

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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 -

Petition for Certiorari Filed in Supreme Court in False Claims Act Case Seeking Review of Whether “Willful” Under the...

Mintz - Health Care Viewpoints on 7/9/2024

The Supreme Court now has the opportunity to define “willfulness” under the federal criminal Anti-Kickback Statute (AKS). In a declined qui tam case filed against McKesson Corporation, a pharmaceutical wholesaler, the...more

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

Lathrop GPM on 7/9/2024

The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...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

Healthcare Regulatory Check-up Newsletter | January 2023 Recap

McDermott Will & Emery on 3/9/2023

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more

Lead Generation Prosecution Reminds Pharmacies of Higher Risk Arrangements

Bass, Berry & Sims PLC on 2/16/2023

In January, a federal jury in the Northern District of Illinois convicted Mark Sorenson, owner of durable medical equipment (DME) pharmacy Symed Inc., for participating in a conspiracy to obtain $24.8 million in illegal...more

Eleventh Circuit Affirms Convictions Against Florida Physician, Pharmacist for Violating Anti-Kickback Statute

Burr & Forman on 6/20/2022

Prosecutions related to the submission of claims to Tricare for compounded pain creams continue. The Eleventh Circuit Court of Appeals affirmed convictions against a Florida pharmacist, physician, and Navy veteran for their...more

Marketer in Kickback Scheme Involving Compound Pharmacies Sentenced to Probation and Order to Pay $3.3 Million

Robinson+Cole Health Law Diagnosis on 4/1/2022

On March 30, 2022, the United States Department of Justice (DOJ) announced that Manual J. Bojorquez, the owner of a marketing company, was sentenced to 36 months’ probation and ordered to pay restitution of $3.3 million for...more

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 10/7/2021

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

NYC Pharmacy Owner Charged With Healthcare Fraud

Rivkin Radler LLP on 3/24/2021

The owner of Brooklyn Chemists in Gravesend, Brooklyn and Lucky Care Pharmacy in Flushing, Queens was recently indicted on charges of conspiracy to commit health care fraud, conspiracy to defraud the United States by paying...more

Opioid manufacturer pleads guilty to fraud

Health Care Compliance Association (HCCA) on 2/5/2021

Compliance Today (February 2021) - Purdue Pharma LP pleaded guilty to three felony offenses: “one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two...more

Healthcare Fraud & Abuse Review 2020

Bass, Berry & Sims PLC on 2/4/2021

Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more

Healthcare Fraud & Abuse Annual Review 2019

Bass, Berry & Sims PLC on 2/13/2020

Bass, Berry & Sims is pleased to announce the release of the 2019 edition of its Healthcare Fraud & Abuse Annual Review. Compiled by the firm’s Healthcare Fraud Task Force, the Review is an in-depth and comprehensive analysis...more

EHR vendor Practice Fusion agrees to $145 million settlement to resolve criminal and civil kickback violations

Bricker Graydon LLP on 2/11/2020

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with electronic health record (EHR) vendor Practice Fusion to resolve civil and criminal allegations that it violated the Anti-Kickback...more

DOJ Announces 2019 FCA Recovery, Majority Came from Healthcare Industry

Bass, Berry & Sims PLC on 2/4/2020

The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more

DOJ Announces Settlement with EHR Company to Resolve Criminal and Civil Kickback Investigations Tied to Opioid Prescribing

Robinson+Cole Health Law Diagnosis on 1/31/2020

On January 27, 2020, the Department of Justice (DOJ) announced a $145 million settlement with Practice Fusion Inc., an electronic health records (EHR) software company, that resolves parallel criminal and civil investigations...more

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

The Volkov Law Group on 10/23/2019

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more

Walking the Line Between Marketing and Malfeasance

Butler Snow LLP on 10/7/2019

Opioid manufacturers, distributors, pharmacies and prescribers are facing a deluge of lawsuits that involve criminal and civil claims in both federal and state courts. On May 2, 2019, a federal jury in Boston, Massachusetts,...more

Congress Creates a Mess by Enacting the Eliminating Kickbacks in Recovery Act of 2018

Ruder Ware on 6/14/2019

Congress has activated a new Anti-Kickback law known as Eliminating Kickbacks in Recovery Act of 2018 (commonly referred to as EKRA). The new Anti-Kickback law applies to arrangements involving recovery homes, clinical...more

Opioids, Healthcare Enforcement, and Increased Scrutiny of Corporate Conduct for Criminal Prosecution

Jackson Walker on 5/8/2019

The national opioid epidemic is almost unprecedented in every conceivable way—its catastrophic death toll, its broad effect on a wide swath of this country’s population, its rapid escalation (which is alleged to have been...more

Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act

Jones Day on 3/25/2019

With the passage of the Eliminating Kickbacks and Recovery Act in October 2018, Congress took aim at the ongoing opioid crisis threatening communities across the U.S. This new criminal statute targets healthcare providers...more

HHS Proposes to Revise Discount Safe Harbor Protection for Drug Rebates

McDermott Will & Emery on 2/4/2019

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify...more

K&L Gates Triage: 2018 Health Care Fraud Takedown

K&L Gates LLP on 7/19/2018

Recently, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced its largest ever national health care fraud takedown, resulting in charges against 601 diverse defendants including...more

DOJ Continues Aggressive Enforcement Action Against Opioid Manufacturers

Mintz - Health Care Viewpoints on 5/23/2018

Recently the U.S. Department of Justice (DOJ) issued a statement that it had intervened in a False Claims Act (FCA) case against Insys Therapeutics, Inc. and consolidated five separate qui tam cases into one case, U.S. ex rel...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

The Growing Number of Civil, Criminal, and Legislative Investigations of Insys Therapeutics, Inc. by Federal, State, and...

Arnall Golden Gregory LLP on 9/13/2017

On September 6, 2017, the U.S. Senate Homeland Security and Government Affairs Committee (HSGAC) released a Minority Staff Report: Fueling An Epidemic: Insys Therapeutics and the Systemic Manipulation of Prior Authorization....more

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