Ethics and Patient Safety Meet Fraud and Abuse

Transcription

1 Ethics and Patient Safety Meet Fraud and Abuse Jay Wolfson, DrPH, JD Distinguished Service Professor Public Health and Medicine Associate Vice President Health Law, Policy and Safety University of South Florida The Quality Colloquium 19 August 2008

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4 Three Views The University Surgeon and His Wonderful Device: Blinded by What We Believe to be True The Terri Schiavo Matter: Proffering Misleading/Unsupportable Clinical Advice The Medicare Secondary Payor Act: Charging to Fix the Window You Broke

5 What do health care providers have to worry about? Screwing up clinically Getting caught screwing up clinically Getting sued for screwing up clinically Seeing others proffering incorrect clinical advice Getting arrested by the Feds for fraud Having to fix something you screwed up Getting paid to fix something you screwed up Being the victim of somebody else s clinical error Having your error publicized nationally

6 Blinded by the Light: The Trephene Well respected chair of university Ophthalmology Department has a vision of a more efficient corneal transplantation process Receives federal grants to develop and test device and procedure Receives IRB approval and initiates multi-year study Non-cylindrical trephene cuts corneas from cadavers with tabs around circumference Fewer stitches, ostensibly faster healing Conduct study on cats and assess Deviates dramatically from IRB protocol.

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9 Lessons Learned? University IRBs have aggressively re-designed their oversight requirements; Federal and state agencies have stepped up compliance reviews of university billing and clinical operations Patients have initiated malpractice suits against physicians and institutions conducting/sponsoring research Some are calling for additional levels of research/practice oversight and reporting

10 The Schiavo Matter: Bearing (false?) Witness? The Quality/Good Science Interface Board Certified neurologist tells family that Ms. Schiavo s condition is reversible Family practitioner presents affidavit to court during appeal stating that condition is reversible U.S. Senate Majority Leader, also a respected cardiovascular surgeon, testifies on the floor of Congress that Ms. Schiavo is not PVS Dozens of physicians sign petitions and proffer letters to the court and the press stating that Ms. Schiavo s condition is reversible and that she is not PVS

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13 CT Scan (Normal and Schiavo s)

14 Lessons Learned? Monitoring and Sanctioning the Clinical Activities of Colleagues? What do we expect of our colleagues with respect to intellectual and scientific integrity, as it may relate to quality, safety and measurability? When does what a clinician or expert says become not only malpractice, but a contributing factor in quality or safety? How can we respond as a community of professionals to poor dangerous expert behaviors?

15 Charging to Fix the Window You Broke How habit, complacency and lack of enforcement by public and private payors and regulators has led to a combination of ethics, safety and fraud issues

16 Assessment of Progress Made By the Florida Patient Safety Corporation Toward Achieving Select Statutory Requirements Studies Performed by the Florida Academic Patient Safety Centers: The University of South Florida, Colleges of Public Health and Medicine Nova Southeastern University College of Osteopathic Medicine The Florida State University College of Medicine The University of Florida College of Medicine, Gainesville/Jacksonville Prepared For: The Florida Patient Safety Corporation June 2006

17 Figure 1: Annual Trend in Average Number of Code 15 Reports Per Hospital Florida,

18 Figure 3: The Occurrence of Foreign Body Left During Procedure Among the Top Most Frequent Hospitals for This Event for a Given Year in Florida. Number of Foreign Body Left during Procedure (PSI #5) Number of Code 15 reports for Foreign body left during procedure Hospital A 7 2 Hospital B 6 0 Hospital C 5 0 Hospital D 4 0 Hospital E 4 1 Total 26 3 Total number (all hospitals) of Code 15s reports for a foreign body left during procedure: 15 Total number of foreign body left during procedure per PSI #5: 85 Note: none of the hospitals in this table had the highest rate of foreign body left during procedure.

19 Figure 4: The Occurrence of Postoperative Hip Fractures Among the Top Most Frequent Hospitals for This Event for a Given Year in Florida. Number of postoperative hip fractures (PSI #8) Number of Code 15 reports for postoperative hip fractures Hospital A 4 2 Hospital B 3 0 Hospital C 3 0 Hospital D 3 0 Hospital E 3 0 Total 16 2 Total number (all hospitals) of Code 15s reports for a foreign body left during procedure: N/A Total number of foreign body left during procedure per PSI #8: 107 Note: none of the hospitals in this table had the highest rate of postoperative hip fractures.

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21 The Medicare Secondary Payer Act 42 USC Section 1395 y C b) Elements General Implications Specific Potential Applications Corporate hospital chains Not-for-profit chains Large independents Multispecialty groups Commercial insurance

22 Present on Admission Physicians and hospitals must code conditions at admission that can be used to assess the extent to which post admission processes may have caused a adverse event.

23 Shots Across the Bow Brockovich, on behalf of the United States of America v. Tenet Healthcare Corporation, et al.,case No. CV DOC (MLGx) (U.S. District Court for the Central District of California, 2006) Her seven lawsuits, filed in Los Angeles County Superior Court, allege that healthcare companies are charging Medicare, the federally funded health plan for seniors, to treat illnesses they helped cause by medical error or neglect. The lawsuits do not involve specific allegations of wrongdoing but seek instead to find evidence of such treatments, arguing that Medicare should be reimbursed.

24 In November 2006, Tenet s motion to dismiss a civil suit filed by plaintiff Erin Brockovich, was granted. Plaintiff alleged that Tenet and several subsidiaries inappropriately received reimbursement from Medicare for treatment given to patients whose injuries were caused by Tenet as a result of medical error or neglect, and sought damages of twice the amount that Tenet was allegedly obligated to pay or reimburse Medicare in connection with the treatment in question, plus interest, together with plaintiff s costs and fees, including attorneys fees. After Tenet s motion to dismiss was granted, Brockovich filed an appeal of the dismissal to the U.S. Court of Appeals for the Ninth Circuit, but later voluntarily dismissed the appeal in March 2008.

25 Ethics, Safety and Fraud More valid, accessible data, will afford a greater ability to monitor and measure clinical and administrative performance and activities against benchmarks for outcome, quality and safety, as well as fraud and abuse. Increasingly scarce resources will pit measures of quality and safety against clinicians and institutions The nexus of fraud safety and quality is at the crossroads of ethics.