Ethics and Patient Safety Meet Fraud and Abuse

1
Ethics andPatient Safety MeetFraud 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

2
(No Transcript)
3
(No Transcript)
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 elses clinical
  error
• Having your error publicized nationally

6
Blinded by the LightThe 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 .

7
(No Transcript)
8
(No Transcript)
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.
  Schiavos 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. Schiavos condition is reversible and that
  she is not PVS

11
(No Transcript)
12
(No Transcript)
13
CT Scan (Normal and Schiavos)
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
(No Transcript)
17
(No Transcript)
18
(No Transcript)
19
(No Transcript)
20
(No Transcript)
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 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.

24

• In November 2006, Tenets 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 plaintiffs costs
  and fees, including attorneys fees.
• After Tenets 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.