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False Claims Act (FCA) Medicaid Food and Drug Administration (FDA)

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

ArentFox Schiff

Investigations Newsletter: DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence

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DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more

Cozen O'Connor

Advanced Bionics Must Pay $12.6 Million to Settle Medicaid Fraud Allegations

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Advanced Bionics Corporation—a manufacturer and distributor of cochlear implants—entered settlements with six AGs to resolve allegations that the company violated federal and state False Claims Acts by submitting fraudulent...more

Harris Beach PLLC

OIG Enforcement Summary: August 16, 2022 – August 31, 2022

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The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more

Holland & Knight LLP

Healthcare Law Update: October 2021

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Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more

Cozen O'Connor

The State AG Report – Volume 7, Issue 34 | August 2021

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Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: Cannoli Factory Feels the Heat over Alleged Wage...more

Kohn, Kohn & Colapinto LLP

Manufacturer of Defective Heart Devices Settles False Claims Act Case for $27 Million

St. Jude Medical Inc. (“St. Jude”), which was acquired by Abbott Laboratories in 2017, entered into a settlement last week with the United States Department of Justice (“DOJ”) for $27 million to resolve allegations it had...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Cozen O'Connor

FTC Under New Management | First Assertion Of The BOTS Act | Ash Cleanup Costs Redistributed

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Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...more

ArentFox Schiff

Investigations Newsletter: DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008

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DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more

Dorsey & Whitney LLP

In the First FCA Appellate Case of 2021, the Fourth Circuit Affirms the Dismissal of Relators’ Claims for Lack of Scienter and...

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On January 8, 2021, in the first appellate decision of the year addressing a False Claims Act case, the Fourth Circuit affirmed the summary judgment dismissal of relators’ claims that a manufacturer of allergenic extracts...more

Cozen O'Connor

The State AG Report Weekly Update July 2019 # 3

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Cannabis/Marijuana- Bipartisan Coalition of 37 Attorneys General Submits Comment to FDA Regarding Cannabis Products- The National Association of Attorneys General (“NAAG”) submitted a comment to the U.S. Food and Drug...more

Holland & Knight LLP

Healthcare Law Update: December 2018

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Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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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

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Troutman Pepper

Value-Based Contracting for Prescription Drugs and Medical Devices: An Innovative Solution Impaired by Outdated Regulations

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Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more

Holland & Knight LLP

Healthcare Law Update: June 2017

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Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Congress remains in recess, but members write letters on Mylan’s EpiPen…CBO says repealing Part B Demo would cost $395 million…CMS releases data on hospice utilization and finds spending and utilization vary in...more

Manatt, Phelps & Phillips, LLP

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Manatt, Phelps & Phillips, LLP

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Arnall Golden Gregory LLP

Lack of Materiality as a Defense in False Claims Act Cases

The False Claims Act (the “Act”) imposes liability on those who “’knowingly’ present, or cause to be presented, ‘a false or fraudulent claim for payment or approval’” to the government. Persons who act in “deliberate...more

Cooley LLP

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

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Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

Saul Ewing LLP

White Collar Watch - July 2014

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In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract ambiguity ...more

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