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Immigration Enforcement Directives Create New Hurdles for Hospitals Advancing Standard Patient Care

While hospitals will no longer be formally considered sensitive locations under new immigration directives, health care facilities and providers maintain responsibility to protect access to patient care and confidentiality....more

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

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

Consumer Health Information and Increased Scrutiny: FTC Brings First Action Under Health Breach Notification Rule

The Federal Trade Commission ("FTC") has brought its first enforcement action for violations of the Health Breach Notification Rule ("HBNR"), signaling heightened federal agency scrutiny of digital health platforms,...more

DOJ Announces Second-Largest Annual Total Recoveries in False Claims Act History

DOJ recovers a record $5.6 billion from FCA cases in 2021, the largest annual total since 2014. - The United States Department of Justice Civil Division ("DOJ") recently announced a recovery of more than $5.6 billion in...more

Federal Enforcement Keeps Pace with the Expansion of Telemedicine Services

Federal government enforcement in the telemedicine space continues to escalate, with three separate announcements in just the last three weeks regarding criminal and civil telemedicine-related actions. These enforcement...more

Federal Court of Appeals Emphasizes Only Defendants Who Act "Knowingly" Can Be Liable Under the False Claims Act

A recent split decision from the United States Court of Appeals for the Seventh Circuit strengthens an argument many defendants of False Claims Act ("FCA") cases have been advancing for years: the violation of an ambiguous...more

DOJ Ramps Up Coordinated Law Enforcement Action to Combat Health Care Fraud Related to COVID-19

On May 26, 2021, DOJ announced a series of coordinated law enforcement actions against 14 defendants across seven federal districts for alleged participation in fraudulent health care schemes that, according to the...more

DOJ Announces $2.2 Billion in 2020 FCA Recoveries and Identifies 2021 Priorities

The Situation: The U.S. Department of Justice ("DOJ") published its annual report regarding False Claims Act ("FCA") recoveries for fiscal year 2020 (ending September 2020) and announced its priorities for 2021. The...more

DOJ Civil Division Gives Clarity on “Inability-to-Pay” Determinations in the Midst of Ongoing Pandemic

The Situation: Companies facing the twin prospects of a significant Department of Justice ("DOJ") settlement and financial distress have historically had little insight into how the DOJ evaluates an assertion by a company...more

HHS Releases Guidance on Direct Liability for Business Associates Under HIPAA

The Situation: On May 24, 2019, the Department of Health and Human Services ("HHS") issued a new fact sheet clarifying business associates' direct liability for violations of the Health Insurance Portability and...more

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