Malpractice or Fraud? The False Claims Act and Quality of Care - PDF document

Malpractice or Fraud? The False Claims Act and Quality of Care Issues Malpractice or Fraud? False Claims Act Theories Based on Quality The False Claims Act and Quality of Care Issues  Lack of medical necessity  “Worthless” services  Negligent or “substandard” care  Violation of regulations Dan Mulholland Horty, Springer & Mattern Medical Necessity Worthless Services Medicare only pays for services “In a worthless services claim, the that are “reasonable and performance of the service is so necessary for the diagnosis or deficient that for all practical treatment of illness or injury or purposes it is the equivalent of no to improve the functioning of a performance at all.” malformed body member.” 42 U.S.C. § 1395y(a)(1)(A) Mikes v. Straus, 274 F.3d 687, 703 (2d Cir. 2001) Negligent or Substandard Care “permitting qui tam plaintiffs to assert Violation of Regulations that defendants’ quality of care failed to meet medical standards would promote  Conditions of Payment? federalization of medical malpractice, or as the federal government or the  Conditions of Participation? qui tam relator would replace the aggrieved patient as plaintiff.” Mikes v. Straus, 274 F.3d 687, 701 (2d Cir. 2001) 1

Malpractice or Fraud? The False Claims Act and Quality of Care Issues Anatomy of a Qui Tam Lawsuit  Complaint filed under seal by High-Risk Areas “whistleblower”  Interventional cardiology  Government investigates  Spine implants  Settlement discussions  Home Health/DME/SNFs  Intervention or declination  Suit continues with or without Government  Final settlement or judgment Corporate Integrity Agreement FCA Damages  Intensive training  Reports to OIG  3X amount paid for false claims +  Independent review organization  $5,500 to $11,000 per claim  Compliance consultant  Peer review consultant  $$$$$$$! Other Regulatory Headaches  Licensure Criminal Prosecutions  Hospital  Physicians  Physicians  Patient Safety Authority  Management  CMS  Accreditation 2

Malpractice or Fraud? The False Claims Act and Quality of Care Issues Patient Lawsuits Physician Lawsuits  Malpractice  Defamation  Class Actions  Interference with contracts How to Minimize Risk Should You Self-Disclose?  Upgrade your peer review process  Department of Justice  Review for medical necessity  Local U.S. Attorney  Open lines of communication  Main Justice in DC  Hospital peer review  Employed physician group  OIG  Compliance  PR challenge – how transparent  Risk management should you be?  Take corrective action before problem gets out of hand 3