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Mintz Member Karen Lovitch, Chair of the firm’s Health Law Practice and Co-Chair of the Health Care Enforcement Defense Practice, was interviewed for an article included in the May 2023 issue of Laboratory Economics, concerning the federal government's continued focus on Covid-19 fraud and recent criminal charges brought by the Department of Justice.
Health Law Diagnosed – EnforceMintz – Part 2: DOJ Regulatory and Policy Update
April 25, 2023 | Podcast | By Bridgette Keller, Eoin Beirne, Karen Lovitch , Brian Dunphy
In this episode, Health Care Enforcement Defense specialists Eoin Beirne, Karen Lovitch, and Brian Dunphy discuss key regulatory and policy updates issued by the DOJ and their potential impact on False Claims Act cases, from self-disclosure to privacy regulations.
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Health Law Diagnosed – EnforceMintz: Analyzing Health Care False Claims Act Cases
April 18, 2023 | Podcast | By Bridgette Keller, Karen Lovitch , Brian Dunphy, Eoin Beirne
Bridgette Keller speaks with Karen Lovitch, Brian Dunphy, and Eoin Beirne about the Mintz Health Care Enforcement Defense Practice’s recent edition of the EnforceMintz newsletter, Analyzing Health Care False Claims Act Cases, and key health care enforcement trends.
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EnforceMintz: False Claims Act Statistical Year in Review — A Study in Contrasts
February 27, 2023 | Article | By Kevin McGinty
Mintz's Health Care Enforcement group analyzes trends in False Claims Act (FCA) investigations and lawsuits using data compiled its Qui Tam Database, the Department of Justice's (DOJ) annual report of FCA statistics, and the DOJ’s discussion of FCA enforcement trends.
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EnforceMintz — The Pandemic May Be Ending, But Fraud Prosecutions Will Keep Coming
February 9, 2023 | Blog | By Cory S. Flashner
EnforceMintz — Medicare Advantage Remains a Top Enforcement Priority
February 9, 2023 | Blog | By Brian Dunphy
Analyzing Health Care False Claims Act Cases
February 9, 2023 | Article | By Karen Lovitch , Brian Dunphy, Grady Campion, Kathryn Edgerton, Cory S. Flashner, Samantha Kingsbury, Kevin McGinty
The vast majority of False Claims Act recoveries in fiscal year 2022 came from health care–related cases, and new case filings remained high, despite an ongoing decline in health care FCA case volume. Mintz’s Health Care Enforcement Defense team explores FCA litigation trends using annual DOJ statistics and activity tracked in our database of health care whistleblower cases.
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EnforceMintz Newsletter — Quick Hits
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — 2022 Saw the Expansion of EKRA Outside of the Addiction Treatment Setting
February 9, 2023 | Blog | By Kathryn Edgerton
EnforceMintz — With Telemedicine Here to Stay, Enforcement Agencies Continued their Scrutiny
February 9, 2023 | Blog | By Karen Lovitch
EnforceMintz — Significant 2022 Regulatory and Policy Developments
February 9, 2023 | Blog | By Samantha Kingsbury
Mintz Member and Chair of the firm’s Health Law and Health Care Enforcement Defense Practices Karen Lovitch was interviewed for an article included in the January 2023 issue of Laboratory Economics covering the top compliance challenges faced by clinical laboratories, Covid-19 testing fraud, and more.
Supreme Court Justices Agree to Hear Second FCA Issue This Term
January 19, 2023 | Blog | By Samantha Kingsbury, Kevin McGinty
As many of our readers are likely aware, last week the Supreme Court agreed to hear a second False Claims Act (FCA) issue this term. Having previously accepted and heard argument on a case concerning the government’s authority to dismiss an FCA whistleblower case after declining to intervene, the Court has now granted certiorari to hear two cases addressing what constitutes a “knowing” violation of the FCA. Hanging in the balance is the fate of two lower court decisions that endorsed a powerful defense to FCA liability.
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OCR Warns Providers Against Disclosing PHI on Social Media Platforms in Response to Negative Reviews in Settlement with Dental Practice
December 22, 2022 | Blog | By Lara Compton, Kathryn Edgerton, Pat Ouellette
As illustrated by a recent Office for Civil Rights (OCR) settlement with a dental practice, health care entities continue to struggle with how to respond to negative online reviews while maintaining compliance with the HIPAA Privacy Rule. Given the significant reputational harm that negative reviews on Yelp and other social media and public platforms (Platforms) can create, providers may be tempted to respond to such negative comments with patient specifics in an attempt to mitigate harm to their businesses.
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Supreme Court Declines to Weigh in on False Claims Act Pleading Requirements
October 25, 2022 | Blog | By Brian Dunphy, Laurence Freedman, Ashley Markson
The Supreme Court recently denied petitions for writs of certiorari in three closely watched cases where parties asked the Court to clarify the heightened pleading standard governing fraud allegations under the False Claims Act (FCA). The heightened pleading requirements of Federal Rule of Civil Procedure 9(b) require that, for allegations of fraud (which include FCA claims), “a party must state with particularity the circumstances constituting fraud or mistake.” Among other things, a cause of action for “false claims” must allege the defendants submitted false claims, or caused false claims to be submitted, to the government. The crux of the issue petitioners asked the Court to address is whether, to meet Rule 9(b)’s requirements for FCA causes of action, relators must allege in the complaint specific details of false claims allegedly submitted to the government for payment. This issue typically arises in qui tam cases under the FCA after the government declines to intervene.
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Pharmaceutical Manufacturer Pays $7.9 Million to Resolve Allegations that it Caused the Submission of Over-the-Counter Drugs to Medicare Part D
September 20, 2022 | Blog | By Joanne Hawana , Rachel Yount
On September 15, 2022, the Department of Justice (DOJ) announced a $7.9 million settlement with generic manufacturer Akorn Operating Company LLC (Akorn) to resolve allegations that Akorn caused the submission of over-the-counter (OTC) drugs to Medicare Part D in violation of the False Claims Act (FCA). Because Medicare Part D only covers prescription drugs, the pertinent drugs were not eligible for Medicare reimbursement. The conduct at issue under this settlement is a relatively novel basis for FCA liability, but we may see similar government enforcement actions in the future as the federal government actively encourages drug manufacturers to “switch” prescription drugs to OTC status in order to enhance their accessibility and reduce costs. This blog post provides an overview and analysis of the settlement.
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Eighth Circuit Adopts Stricter But-For Causation Standard for False Claims Act Claims based on Anti-Kickback Violations
August 18, 2022 | Blog | By Kevin McGinty, Rachel Yount
In a significant win for False Claims Act (FCA) defendants, the Eighth Circuit recently reversed a district court decision that defendants violated the FCA premised on violations of the Anti-Kickback Statute (AKS). The Eighth Circuit adopted a stricter but-for causation standard for FCA claims based on AKS violations, holding that, in order to prevail on these claims, the government must prove that FCA defendants would not have submitted claims for particular items or services to Medicare or Medicaid absent the illegal kickbacks.
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