March Madness and Other Things Risk

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March Madness and Other Things Risk

• South Carolina Society for Healthcare
• Risk Management
• March, 2008
• Fay A. Rozovsky, JD, MPH

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Objectives
Identify Major Influence Drivers
Shaping Contemporary RM Pt. Safety
Describe key RM Pt. Safety Issues Impacting
Quality, Patient-Centered Care
Articulate Strategies for Addressing Pt. Safety
Risk Management Concerns
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The Influence Drivers Behind March Madness
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The Drivers
CONSUMERS
CMS
NQF
THE JOINT COMMISSION
LEAPFROG
CMS
CONGRESS
THE STATES
THE COURTS
PAYERS
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The Common Themesin the March Madness Drivers

• Transparency
• Accountability
• Efficiency
• Effectiveness
• Patient-Centered Care

But how do we meet all these benchmarks through
risk management and patient safety?
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Disclosure
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The Flavors of Disclosure
Mandatory State Reports a form of disclosure
Never Events
Adverse Event Unanticipated Outcome
Patient Grievance Response- a form of disclosure
Apology Laws
Hospital Quality Initiative a form of disclosure
South Carolina Code Ch.1, Title19 1976, 19-1-190
(2006)
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Disclosure in Perspective

• The apology type of disclosure may help reduce
  risk of litigation.
• The apology type of disclosure may help the
  care provider as well.
• If not done well, however, it can be a source of
  risk.
• If no one looks after the care provider, we end
  up with two victims.
• Billing office told to hold submission of
  claims.

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Disclosure in a Larger Context

• A 56 year-old man undergoes surgery for removal
  of scar tissue from an earlier abdominal
  procedure. He wakes up to learn that the surgery
  involved removal of his left kidney. The surgery
  was not medically necessary.
• Angry and upset, the man files a formal patient
  grievance with the hospital. He also calls the
  state agency and the regional office of CMS.

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The Case Continues

• Patient relations issues a standard, boilerplate
  explanation in response to the patient grievance.
• State cites the hospital for non-compliance with
  the CoPs. Notifies CMS of serious
  discrepancies.
• Joint Commission wants the reviewable sentinel
  event.
• Apology does not mesh with the written patient
  grievance.

What will plaintiffs counsel do in such a
situation? What are the risk issues?
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Consent to Treatment and March Madness
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The Madness of Consent

• Consent to Treatment No longer Me Doctor, You
  Patient.
• Consent is now a group exercise.
• The influence drivers are helping to re-define
  the theories of consent litigation.
• The influence drivers are re-shaping what needs
  to be disclosed in the consent process.

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The Flavors of Consent Litigation
Negligence
Corporate Liability the CMS Issue
Battery
Misrepresentation, Deceit and Fraud
Breach of Contract
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Consent Risks

• The same old issues remain constants negligence
  and battery.
• On the increase misrepresentation, deceit and
  fraud.

The hospital general admission form as the basis
for breach of contract in consent.
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The CMS Syndrome in Consent
The H P
The CoP Standard on Consent
The Revised Interpretive Guideline on Consent
Up-to-date History and Physical documented in the
record. Written Informed Consent to
Surgery. Hospitals must assure that the
practitioner(s) responsible for the surgery
obtain informed consent from patients in a manner
consistent with the hospitals policies governing
the informed consent process. Interpretive
Guideline, 2007
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Case Example

• E.Y. saw her family doctor 15 days ago. He
  cleared her for surgery to remove a bone chip in
  left elbow region. Ten days ago, a specialist
  placed E.Y. on a prescription medication to
  address an issue with her blood pressure. The PA
  doing the HP confirmation did not drill down
  into the any changes category.
• The consent for the surgery was obtained in the
  orthopedists office. Hospital policy recognized
  physician practice-based consents as long as
  there was a confirmation upon admission. This
  was not completed.

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Case Continued

• Inter-operatively, E.Y. experienced a serious
  adverse event. The anesthesiologist had no idea
  that E.Y. was receiving the new medication.

What are the risk exposures here? What will the
plaintiff use as a standard of care? What are the
likely derivative consequences?
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Material Significant InformationMarch Madness

• It has long been recognized that patients should
  be provided with material and significant
  information.
• Today, we live in the world of transparency.
• What has to be disclosed about

• Provider performance?
• Facility outcomes?
• Infection control?
• Remote risks?

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The Consent Material Girl

• G.N. agreed to a total right hip replacement.
  Her physician, Dr. Infectious, informed G.N. that
  he was on staff of two hospitals. If it were
  me, I would have it done at AGC. It is a great
  hospital with a good team, and state-of-the-art
  equipment, said Dr. Infectious.
• G.N. did her homework. She scoped out AGC using
  the Internet. She was concerned that the other
  faciilty, Grainter Regional, had better
  statistics.
• G.N. called AGC and asked the receptionist for
  help.

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Material Case Continued

• The receptionist referred the call to Madonna
  Songster in the PR Department. Ms. Songster told
  G.N., Oh wow. What a cool question. Dr.
  Infectious is so cute. We all love him. If he
  thinks this the place for you, I would not give
  it a second thought.
• But what about your high infection rate in
  orthopedics? Ms. Songster said, Dont worry.
• G.N. had the procedure at AGC. She developed an
  infection and suffered terrible injuries.

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The Material Girl Sues

• You are the risk manager.

• Would you consider the infection rate material
  and
• significant information?
• Would Ms. G.N. have a claim for negligent
  consent?
• Would the actions of Madonna Songster create
• a corporate liability exposure for lack of
  informed consent?

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Pay-for-Performance and NEVER EVENTS
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The Driversin Pay-for-Performance Never Events
CMS
National Quality Forum
Health Plans Insurers
State Laws
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Why Healthcare Pay-for-Performance

• The Goal Only pay for the right care for each
  patient.
• Right Care Treatment that is criteria-based

• Safe
• Effective
• Patient-Centered
• Timely
• Efficient
• Equitable.

Shift from payment for the PROCESS of care to
payment linked to treatment OUTCOMES.
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Expectations in Healthcare P-4-P
Private Payers
MONEY
QUALITY
HEALTHCARE AS A BUSINESS
Patients
CMS
Business Groups
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Risk Concerns About P-4-P

• Pay-for-performance is very data-intensive.
• Systems are not ready to capture required data.
• Healthcare is dealing with sicker patient who
  utilize high cost resources.
• Medicare reimbursement is down.
• Scrutiny has intensified from both the regulatory
  and private payer scrutiny.
• The public is insisting upon better clinical,
  patient-centered outcomes.

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Why Business Likes P-4-P

• Metrics Rely upon measurable expectations and
  measurable clinical results.
• Promote effective change Use the data to improve
  care, cut costs, and increase efficiency.
• Eliminate Waste reduce process variation by
  focusing on evidence-based, quality care.
• Reward good performance Use financial
  incentives to recognize those who meet or exceed
  performance measures.

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Reward or Punish
NQF NEVER EVENTS
Accreditation
Federal Reporting
LEAPFROG
Affordable Effective Safe Patient-Centered Efficie
nt Quality Care
CMS QAPI
State Reporting
State Sanctions
Federal Initiatives
The Signals are Unclear
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Some Key Risk Management Concerns
Adverse Publicity
Cherry-Picking Patients
Consent Transparency
Contracting Issues
Economic Credentialing
Standard Of Care
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Cherry-Picking in P-4-P

• Doctor Please do not book those patients.
  They will turn us into outliers, not high
  performers.
• Practice Administrator Doctor, just beware of
  that patient. He is chronic complainer, in here
  all the time. He will ruin our group outcome
  measures.

Everyone wants good numbers Pay-for-Performance
- a new type of patient dumping?
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Transparent Consent and P-4-P

• Pay-for-Performance data Material and
  Significant Information?

My client read that the hospital received a huge
financial reward for providing quality care.
This is Interesting, members of the jury. This
is the same hospital that delayed purposely his
critical, costly MRI, a test that could have
prevented his catastrophic injury. So I ask you,
why wasnt he told that the hospitals quality
payment involved how well it managed expensive
tests?
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P-4-P Contracting Issues
Variable Measures
Definitions Anyone?
Do not worry. It is a standard
pay-for-performance contract.
Inaccurate Marketing Data
No Cure Clause
Time Frames for Payment
No carve-outs for outliers
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The Risk of Economic Credentialing
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PFP UCL
2
4
3
PFP LCL
MD 1 looks like an outlier, but Is the data
accurate? What if a withhold is issued by the
payer against the hospital and the facility then
denies reappointment based on quality outcome
data. During litigation it is disclosed that the
data was not risk adjusted. The Board had
decided to terminate the agreement with the only
nephrology group in the area.
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Standards of Care in P4P
When P-4-P standards do not meet recognized
standards of care.

• Patient asserts that the failure to follow
  prevailing standards was based on economic, not
  quality factors.

Recognized Standard Of Care
P4P standard
Below the standard of care.
Do you see the prospect of litigation here?
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P-4-P Standard of Care and EnterpriseLiability

• Claim Facility had a Non-Delegable Standard or
  Duty of Care.
• Cannot say we were just basing our work on the
  P-4-P data provided by that third party who told
  us the performance level was Okay.

South Carolina has case law on enterprise
liability.
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The Link Between Pay-for-Performanceand Never
Events
Financial Reward for Meeting or Exceeding
Performance and Outcomes
Pay-for-Performance

• Not meeting the mark
• Never Events
• POAs
• Serious Preventable
• Hospital Acquired Conditions

Decreased or no Payment
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Speaking of Never Events
Present On Admission
Hospital Acquired Condition
Serious Preventable Events
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Withholds, MS-DRGs, and MoreMarch Madness
IPPS Regulation
LeapFrog
Deficit Reduction Act
Adverse Event or Hospital Acquired Infection
Substandard Quality Breach of Standard of Care
Breach of Contract NO PAYMENT Regulatory
Non-Compliance?
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The Types of Never Events
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Teleradiology
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March Madness of Teleradiology

• Lack of Licensure to Provide Service.
• Failure to Obtain Patient Consent.
• Potential violations of Patient Privacy,
  Confidentiality.
• Potential Violations of HIPAA Privacy and
  Security.
• Lack of Credentialing.

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More of the Teleradiology Risks

• Failure to Meet the Expected Standard of Care.
• Who to Follow CMS or Joint Commission?
• Inappropriate Billing and Regulatory Risks.
• Failure to Obtain and Maintain Appropriate
  Insurance Coverages.

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And There is More

• Equipment Incompatibility.
• Problems with Internet Line Speed and Security.
• Lack of Specificity as to Terminology, Report
  -writing, and Time Frame for Reporting.
• Failure to Address Quality of Care and Oversight.

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What Makes ACR Mad
It is unethical and likely fraudulent for a
physician who has not personally interpreted
images obtained in a radiologic examination to
sign a report to take attribution of an
interpretation of that examination rendered by
another physician in a manner that causes the
reader of a report to believe that the signing
radiologist was the interpreter.
Revised statement of the American College of
Radiology Council on the interpretation of
radiology images outside the United States, May
23, 2006.
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What Makes CMS Mad
Payment may not be made for a medical service
(or a portion of it) that was subcontracted to
another provider or supplier located outside the
United States. For example, if a radiologist who
practices in India analyzes imaging tests that
were performed on a beneficiary in the United
States, Medicare would not pay the radiologist or
the U.S. facility that performed the imaging test
for any of the services that were performed by
the radiologist in India.
Source Pub 100-02 Medicare Benefit Policy,
Transmittal 66.
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A Case Illustration

• P.J. fell and injured her right wrist while
  ice-skating in the park. It was 2245 hours by
  the time she was seen by the emergency physician.
  The hospital contracted with Radiology Associates
  to provide coverage 24/7/365.
• The hospital did not know that Radiology
  Associates had a backroom agreement with Over
  Nite Diagnostic based in New Zealand. The
  hospital radiology tech transmitted the digital
  images taken of P.J.s wrist to Radiology
  Associates. The message was re-routed to
  Auckland, NZ.

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P.J.s Wrist Case

• The image was degraded and the diagnostic image
  was not clear. The radiologist, a doctor who had
  sought asylum from a third world nation, wrong a
  report that said in part

You would do well to have another radiographer
review the image as it is difficult for us here
to see the image clearly. Appears, I think,
there may be a problem. 3 April 2008 0755 hours.
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The Wrist

• The report was received by the ED Physician at
  2345 hours on April 2, 2008.
• This is worthless. Get me Dr. Roupel on the
  phone, he said. After discussing the situation
  with Dr. Roupel, a member of Radiology
  Associates, it was decided that the image would
  be re-interpreted at 0700 hours. The patient was
  discharged.
• A horrific late storm clogged the roads with ice.
  Dr. Roupel did not get in until 1130 hours.

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The Wrist Case

• At 1245 hours, the patient returned, complaining
  that she had numbness in her fingers. The digits
  were cold and discolored.
• The re-read of the digital image revealed a major
  comprehension injury and multiple, minute
  fractures. The delay in care led to complete
  loss of function of the hand.

Who will be held accountable? What are the
liability risk exposures?
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The Patient as Self-Credentialer
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The Interloper Called the Internet
Federal of State Medical Boards
Hospital Compare
Private Sector Proprietary Sources
Quality Check
State Data Bases
Your Very Own Websites
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The Problems

• Do Patients understand what is portrayed as data?
• Who handles the contradiction among competing
  websites?
• Does the website hold your organization out to
  a higher standard of care?
• Is there a risk of misrepresentation, deceit and
  fraud?
• Do your contracts with third parties allow them
  to use your data as they wish?

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The Risks
Common Law Misrepresentation, Deceit and Fraud
Negligence and Detrimental Reliance
FTC Issues
Adverse Publicity
Deceptive Trade Practice Act Violations
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Removing the Madness from March Ten Practical
Risk Management Strategies
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Strategy One Disclosure
Complete an inventory

• Follow the requirements in SC Law!
• Do an assessment of the requisite disclosures.
• Consider a disclosure matrix.
• Develop a disclosure team.
• Remember the initial disclosure is one of many
  possible sessions!
• Take care of the second victim!

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Strategy Two Reporting Matrix

• Team education
• All Legal Counsel
• Compliance
• Billing
• Media

Need to Know
Timeframe Format
Coordinated with other Reporting Disclosures
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Strategy Three Consent Coordination

• Physician Office Consent

H and P Revisited
Consent Check
Okay
STOP
Confirmation Documentation
Back to the Drawing Board
Re do Consent
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Strategy Four Define Material Significant

• Work with medical staff to define material and
  significant for purposes of consent.
• Have a process in place to address those calls
  testing the waters about external data that calls
  into question the performance of the hospital or
  care provider.
• Have a documentation process to capture the
  information and resolution.

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Strategy Four - Continued

• Think about Model Language.

Our hospital participates in a number of
programs that offer the community information
about how well we do in clinical treatment. This
information is designed to provide a broad basis
for comparison only. It is not a substitute for
a discussion of individual treatment
needs. Patients and those considering treatment
at our facility should ask their physician or
care providers how this comparative information
relates to their individual care-giving needs.
Websites
Signage
Brochures
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Strategy Five P-4-P Contracting

• Use the contract as a tool to control MANY of the
  risks exposures with Pay-for-Performance.

• Data Aggregation and Risk Adjusting
• Data Timing and Dissemination
• Data Explanations provided to inform patients
• Definitions
• Curing Defects
• Payment One Defined Formula ONLY!

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Strategy Five Contracting Contd
Right to Prior Review
Disclaimer Provision on Use
Right to Insist on Corrections

• Control the Uses and Portrayal of Never
  Events and Quality Data

Requirement for Updated Information
Liability Issues Coverage
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Strategy Six Test the System
Monitor! Monitor! Monitor!

• Validate the accuracy, timeliness, and clarity of
  data.
• Confirm Contract Terms are Being Met Payments,
  prior review of data, etc. Contracts terms and
  conditions are being met.

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Strategy Seven Teleradiology

• Insist on complete and thorough review of
  contracts.
• Prohibit subcontracting without prior approval.
• Credentialing.
• Consent
• Security and Privacy.
• Line integrity.
• Insurance confirmation from the insurer.

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Strategy Seven - continued

• Standardize reporting from teleradiologist.
• Standardize timeframe for reporting.
• Over-reads that do not incur a delay in care.
• On call means on call.
• Process to jump on integrity and security issues.
• Right to switch to another vendor when system is
  down- business and patient care continuity.

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Strategy Eight The Internet
The Go To Answer Person

• DO expect calls from patients and prospective
  patients about publicly accessible outcomes and
  Never Events data.
• Expect calls about what does this mean for me
  after media reports on Never Events and
  outcomes data.
• Identify one person or one office to direct
  inquiries.

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Strategy Eight - Continued
Make Certain Folks Know What to Do and How to
Say it on the Internet Calls.

• Physicians, volunteers, receptionists, patient
  relations, nursing personnel.
• Process for handling questions to whom to refer
  calls or emails.
• Anticipate specific issues such as literacy
  problems.
• PROHIBIT false assurances.

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Strategy Nine Educate
Care Givers
The Board
Administration
Volunteers
Take the time to educate the community and the
media, too!
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Strategy Ten Be Ready for Action

• Adjust Your PCE Antenna Anticipate complaints,
  patient grievances, and poor scores on
  satisfaction data.
• Use it as your early warning system.
• Take a Team Approach Compliance, Quality,
  Patient Safety, Patient Satisfaction and More.
• Develop some anticipated plans of action, too.

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Conclusion

• March Madness need not drive you crazy.
• Risk Management offers unique, flexible and
  practical approaches to some of the evolving
  issues in healthcare.
• Take the time now to identify the issues and
  develop solutions consistent with quality, safe
  patient care.