As harsh winter weather swept the nation’s capital, President Donald Trump commenced his second term by signing a blizzard of Executive Orders (EOs) that span many hot-button issues. Several of the EOs signal President Trump’s agenda for the U.S. healthcare system. These EOs rescind former President Joe Biden’s directives aimed at expanding healthcare coverage under
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False Claims Act Enforcement Trends in Healthcare: FY 2024
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 15, 2025, announcing that it had recovered in excess of $2.9 billion from FCA resolutions during Fiscal Year (FY) 2024 (ending September 30, 2024).…
Update: Appellate Showdown Over FCA Qui Tam Provision’s Constitutionality Reaches Eleventh Circuit
As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to hold that the qui tam provision of the federal False Claims Act violates the Appointments Clause…
New Year, New HIPAA Security Rule Requirements? OCR Proposes Sweeping Changes for HIPAA Security Rule To Bolster Cybersecurity
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently proposed a sweeping rewrite of the HIPAA Security Rule that, if finalized, will require that many Covered Entities and their Business Associates (Regulated Entities) invest significant resources to comply with new, less flexible requirements designed to strengthen the cybersecurity posture…
Year-End Watch List: Possible Simplification to Employer Group Health Plan Reporting
2024 might almost be over, but the Senate recently passed two bills that are intended to ease at least some employer burdens under the Patient Protection and Affordable Care Act (ACA). The bills, both of which are pending signature by President Biden, are:…
Don’t Be Suspicious, Don’t Be Suspicious: New OIG Special Fraud Alert Warns About Suspect Payments in Medicare Advantage Marketing Arrangements
The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage plans, health care professionals, and third-party marketers, such as agents and brokers. Issued on December 11, 2024, this new Special Fraud Alert focuses on…
NYDFS Highlights Strategies to Combat AI Cybersecurity Risks
The increased use of artificial intelligence (AI) in the banking, insurance, and financial services industries has led the New York State Department of Financial Services (NYDFS or Department) to publish an Industry Letter on October 16, 2024, that highlights cybersecurity risks resulting from the use of AI, the dangers posed by threat actors utilizing AI,…
New York Focuses on Healthcare Cybersecurity: Recent Regulatory and Enforcement Activities
The healthcare sector has seen an alarming uptick in cybersecurity incidents, including ransomware attacks, in recent years. In response to these cybersecurity threats, New York State is ramping-up efforts to protect patient data by issuing new cybersecurity regulations governing “general hospitals” and by requiring that a healthcare provider spend $2.25 million to improve its internal…
Zafirov Decision Sets Stage for Appellate Showdown Over Constitutionality of FCA’s Qui Tam Provision
For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional. …
MHPAEA Final Rule: Clarity on Mental Health Parity?
The three federal agencies tasked with enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) — the Departments of Labor, Health & Human Services (through CMS), and Treasury (the Departments) — issued their Final Rule to implement the MHPAEA on September 9, 2024, to mixed reviews.
Groups composed of providers, such as the…