Practitioners who want to prescribe controlled substances via telehealth to patients in Florida must meet the requirements of both federal and state law. The federal Drug Enforcement Administration (DEA) and the Florida legislature have recently amended the applicable federal regulations and state laws, respectively, to allow the prescribing of controlled substances via telehealth[*] without
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No (Public) Comment: HHS Rescinds Policy on Public Participation in Rulemaking
By Jeremy Burnette & John Hood
The Department of Health and Human Services (HHS) recently rescinded its policy dating back to 1971 to now allow its agencies and offices to quickly alter certain rules and regulations without public notice and comment. The Nixon-era policy had waived the statutory exemption from procedural rulemaking requirements for rules and regulations relating to public property,…
Blizzard of Executive Orders Signals Trump Administration’s Healthcare Priorities
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…
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. …