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					                        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
Jay Wolfson USF Health
Jay Wolfson USF Health
             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


                 Jay Wolfson USF Health
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


                       Jay Wolfson USF Health
           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 …….


                     Jay Wolfson USF Health
Jay Wolfson USF Health
         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


                 Jay Wolfson USF Health
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

                    Jay Wolfson USF Health
Jay Wolfson USF Health
Jay Wolfson USF Health
CT Scan (Normal and Schiavo’s)




          Jay Wolfson USF Health
            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?

                  Jay Wolfson USF Health
   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




                 Jay Wolfson USF Health
Assessment of Progress Made By the Florida
        Patient Safety Corporation
             Toward Achieving
      Select Statutory Requirements




                                           c m
                                        Qu i k Ti e™a nd a
                                             co res o
                                           de mp s r
                                        de         h        u
                                 aren ee dto see t i s p i ct re.




  Studies Pe rforme dby the Florida Acade mic Patie nt Safety Ce nte rs:

The Unive rsityof South Florida, College s of Public He alth and M e dicine
                      n                                          c
    Nova Southeaste r Unive rsity Colle ge ofOsteopathic M e di ine
           The Florida State Unive rsity Colle ge ofMedicine
                      ida
The Unive rsityof Flor Colle ge ofMe dicine , Gaine sville /Jacksonville

          Prepared For: The Flori da Patient Safety Corporation
                               June 2006




                        Jay Wolfson USF Health
                                            Figure 1: Annual Trend in Average Number of Code 15 Reports Per Hospital
                                                                       Florida, 2000- 2005
                                       4

                                      3.5

                                       3
Mean number of reports per hospital




                                      2.5

                                       2

                                      1.5

                                       1

                                      0.5

                                       0
                                                2000      2001       2002      2003       2004     2005




                                                                 Jay Wolfson USF Health
  Figure 3: The Occurre nce 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         Number of Code 15
                Left during Procedure      reports for Foreign body
                       (PSI #5)              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.




             Jay Wolfson USF Health
        Figure 4: The Occurre nce of Postoperative Hip Fractures
        Among the Top Most Frequent Hospitals for This Event
                      for a Given Year in Florida.


                       Number of            Number of Code 15
                   postoperative hip      reports for postoperative
                   fractures (PSI #8)           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.


           Jay Wolfson USF Health
Jay Wolfson USF Health
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

                Jay Wolfson USF Health
        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.




                 Jay Wolfson USF Health
           Shots Across the Bow
 Brockovich, on behalf of the United States of America v.
  Tenet Healthcare Corporation, et al.,Case No. CV 06-4542
  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.


                        Jay Wolfson USF Health
   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.




                        Jay Wolfson USF Health
       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.
                    Jay Wolfson USF Health

				
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