Confidentiality: Statutes Affecting Peer Review Activities' AAMSS April 5, 2002

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Confidentiality Statutes Affecting Peer Review
Activities.AAMSSApril 5, 2002

• Robert J. Milligan
• Gallagher Kennedy
• 2575 E. Camelback
• Phoenix AZ 85016-9225
• 602-530-8525
• rjm_at_gknet.com

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CMS Healthcare Spending Will More than Double
in the Next Decade

• National Health Expenditures Projections
  2001-2011, released by CMS on March 11, 2002 CMS
  predicts that health expenditures will reach 2.8
  trillion in 2011, more than double (7.3
  annualized) the 1.3 trillion spent in 2000.
• CMS predicts that prescription drugs will be the
  fastest-growing portion of health care
  expenditures.

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Drug spending surged 17 last year

• 22.6 Billion increase over 2000
• Retail spending has doubled since 1997
• Cost drivers
• Increased prescription use
• Increased prices ( 10)
• Switch to newer, more expensive drugs
• USA Today, Friday, March 29, 2001

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What is a Medical Staff?
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What is a Medical Staff

• A creature of statute
• The governing body of each licensed
  hospitalshall require that the physicians
  admitted to practiceorganize into committees or
  other organizational structures to review the
  professional practices within the hospital.

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Medical Staff Functions

• To review the professional practices within
  the hospital...for the purposes of reducing
  morbidity and mortality and for the improvement
  of the care of patients provided in the
  institution.
• Including nature, quality and necessity of the
  care.
• And, the preventability of complications and
  deaths.

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Medical Staff Functions

• Peer Review
• Credentialling
• Investigations
• Utilization Review Health care utilization
  committees reviewthe utilization,
  appropriateness and necessity of health care
  services provided in a facility.

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Medical Staff Protections

• Statutory Protections
• State law
• Federal law
• Contract Protections
• Bylaws and indemnification policies?
• Professional liability insurance ?

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Statutory Protections in a Nutshell

• The protections apply only to true peer review
  activities
• Even then, the protections are not absolute
• Trying to characterize everything as privileged
  could jeopardize true peer review activities
• Maximize non-statutory protections

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Asking the Right Question

• Are Incident Reports Confidential?
• Is _________, which has been maintained in a
  secure fashion, protected from discovery by a
  _________ in the _________ setting?

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ConfidentialityWho gets What?

• The affected practitioner
• Medical malpractice plaintiffs
• HMOs
• P/L insurers
• Other facilities
• In the same system
• In different systems

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The Judicial View of Confidentiality A Necessary
Evil

• Evil, since it interferes with the full and fair
  discovery of all potentially relevant facts.
• Necessary, because meaningful peer review will
  cease if the participants are subjected to
  complete discovery. Yuma Regional

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Balancing Competing Policy Interests

• Identify competing interests
• The Process
• Plaintiffs
• Affected Physicians
• Balance the interests
• Fact-intensive
• Subjective
• Uncertain

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The Peer Review Commandments
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Uncertainty

• Interpreting the scope of peer review
  privilege is not unlike trying to draw a bright
  line in shifting sand....
• Yuma Regional

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Competing Interests The P/I Plaintiff

• A sympathetic victim of neglect and
  indifference
• A roadblock in the search for the truth
• The conspiracy of silence
• A negligent credentialling claim (Humana)

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Competing Interests The Affected Physician

• The ability to earn a living
• A conspiracy of competitors
• A right to confront your accusers
• Contract rights (the Medical Staff Bylaws)

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Competing Interests Confidentiality

• The necessity of peer review
• The importance of candor
• The burden on participants

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A Thankless Job

• Review by ones peers within a hospital is not
  only time consuming unpaid work, it is also
  likely to generate bad feelings and result in
  unpopularity. Humana Hospital

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A Thankless Job

• Doctors seem to be reluctant to engage in
  strict peer review due to a number of
  apprehensions loss of referrals, respect, and
  friends, possible retaliations, vulnerability to
  torts, and fear of malpractice actions in which
  the records of the peer review proceedings might
  be used. Humana

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Competing Interests Does the Staff Really Think
the Information is Confidential?

• What is characterized as confidential?
• How is it protected?
• Who has access?
• to what portions?
• for what purposes?

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What is Characterized as Confidential?

• Confidential Pursuant to A.R.S. 36-445

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How is Confidential Information Protected?
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How is Confidential Information Protected?

• Written policies regarding creation, storage
  and access.
• Strict compliance with the policies.
• Separation of peer review from medical staff
  administration, e.g., separate books and meetings
  at Med Exec.
• Boilerplate captions on true peer review
  documents documents.

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How is Confidential Information Protected?

• What about stampingConfidential under ARS
  36-445.01 on everything?
• Trying to stretch the protection to things that
  are not peer review-related may jeopardize the
  protection for things that are peer
  review-related.

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Who has Access to Peer Review Information

• Peers.
• The Affected Physician
• Others engaged in assisting the hospital to
  carry out peer review.
• Any person furnishing information to a committee
  performing peer review (e.g., outside reviewers).
• Others?

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to what portions?

• What is in the Peer Review File
• Public Information?
• Sensitive Information?
• Confidential Information?
• HIPAA Information?

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for what purposes?

• to review the professional practices within the
  hospital or center for the purposes of reducing
  morbidity and mortality and for the improvement
  of the care of patients provided in the
  institution. A.R.S. 36-445
• Any other use jeopardizes the confidentiality and
  immunity protections.

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State Law Protections-Confidentiality

• ARS 36-445.01
• The confidentiality protection applies to
  proceedings, records and materials
• The protection against disclosure does not apply
  to
• Proceedings before the Medical Boards
• Suits challenging a peer review action

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The Affected Practitioners Right to Access

• State Statutory Requirements
• Federal Statutory Requirements
• Bylaws Requirements
• Case Law
• It is safe to say that fair procedure requires
  disclosure of all the evidence forming the basis
  of the charges and other evidence which is made
  available to the hearing panel.
• Hackenthal v. California Medical Assn.

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The Affected Practitioners Right to Access

• Disclosure Algorithm
• Is the requested information relevant?
• Is the requested information privileged or
  confidential under any law or regulation (not
  A.R.S. 36-445)?
• Was the supplier of the information promised
  confidentiality?
• Understand expectations and limitations.

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The Affected Practitioners Right to Access

• At some point in the process, the affected
  practitioner
• Will have access to everything the decision
  making body reviewed.
• May have access to everything relating to the
  discussion his or her file.
• Therefore, be deliberate and precise in your
  minutes.

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Scope of Protection of A.R.S. 36-445 in the
Malpractice Setting

• Per the Arizona Supreme Court, the statute
  protects the peer review process itself-the
  discussions, exchanges and opinions found in the
  committee minutes. Yuma Regional

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Scope of A.R.S. 36-445 in the Malpractice Setting

• The Statute does not protect otherwise
  discoverable information that is analyzed or
  reviewed through the peer review process.

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Scope of Confidentiality in Malpractice Actions

• Minutes of the discussions?
• Deposition testimony of the participants?
• Identity of the participants?
• List of documents submitted to the committee?
• Copies of documents reviewed by the committee
  (e.g., incident reports)?
• The committees action?

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Confidential in a Malpractice Action? (Yuma
Regional)

• Minutes of the discussions? Yes
• Deposition testimony of the participants? No
• Identity of the participants? Yes
• List of documents submitted to the committee? Yes
• Copies of documents reviewed by the committee
  (e.g., incident reports)? Yes/No
• The committees action? No

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State Law Protections -Confidentiality

• 36-445.01 does not protect against disclosure of
• Parking lot of doctors lounge conversations
• Risk management activities?
• Sentinel event reports?

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State Law Protections -Immunity

• ARS 36-445.02
• Par. A provides immunity from civil damages or
  legal action to
• Any individual who makes a decision or
  recommendation or
• Furnishes records, information or assistance
• In connection with a hospital or ASC proceeding
  under 36-445

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State Law Protections-Immunity

• Par. B provides that
• No hospital, ASC or individual
• May be liable in damages
• To any person who is denied privileges or whose
  privileges are adversely affected
• Par. B does not preclude an affected physician
  from seeking injunctive relief.

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State Law Protections for Utilization Review
Activities

• Confidentiality ARS 36-441(B) (Tab B)
• Par. B provides that all proceedings, records
  and materials prepared in connection with the
  activities of a utilization review committee are
  confidential.
• Except
• Proceedings before a Medical Board
• Actions brought by the affected physician

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State Law Protections for Utilization Review
Activities

• Immunity ARS 36-441(A)
• Par. A provides that any individual who
  without malice makes a decision or
  recommendation ... or who furnishes any
  information to a HCUC
• is not subject to civil damages or any legal
  action.
• Absence of malice is presumed and may be overcome
  only by clear and convincing evidence.

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Federal Law Protections The Health Care Quality
Improvement Act (Tab E)

• Confidentiality (42 USC 11101)
• The confidentiality provision applies only to
  reports of professional review activity to the
  National Practitioner Data Bank.
• Disclosure is permitted to
• The physician
• State Licensing Boards
• Any hospital or health care entity

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The Health Care Quality Improvement Act

• Immunity
• HCQIA Section 11111(a) provides immunity from
  civil damages for
• Professional Review Actions
• conducted by
• Professional Review Bodies

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The Health Care Quality Improvement Act

• A Professional Review Activity is an activity
  regarding an individual physician
• To determine whether the physician may have
  membership or privileges
• To determine the scope or conditions of the
  physicians membership or privileges
• To change or modify the privileges

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The Health Care Quality Improvement Act

• A Professional Review Body is
• A Hospital
• The Board of Directors
• A Peer Review Committee
• Any committee of the medical staff when
  assisting the Board of Directors in a
  professional review activity.

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The Health Care Quality Improvement Act

• Section 11111(a) protects
• The Professional Review Body
• Any person acting as a PRB member or staff
• Any person under contract with the PRB
• Any person who participates or assists the PRB
• If the Professional Review Action complies with
  Section 11112(a)

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The Health Care Quality Improvement Act

• Section 11111(a) does not provide immunity from
  claims under state or federal civil rights laws

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The Health Care Quality Improvement Act

• Section 11111(a) applies where the Professional
  Review Activity is taken
• In the reasonable belieffurtherance of quality
  health care
• After a reasonable effort to get the facts
• After adequate notice and hearing procedures
  (safe harbor at 11112(b)) and
• In the reasonable belief that the action was
  warranted
• Reasonableness is presumed

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The Health Care Quality Improvement Act

• Immunity
• HCQIA Section 11111(b) provides immunity from
  civil damages for
• Any person who provides information to a PRB
  regarding the competence or professional conduct
  of a physician
• Unless the information was known to be false by
  the person providing it

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The Health Care Quality Improvement Act

• Neither Section 11111 (a) or (b) provide immunity
  from
• Claims by the U.S. or a state under the Clayton
  Act
• Suit
• Injunctive relief
• Claims by non-physician practitioners

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Involvement of CompetitorsMathews v. Lancaster

• HCQIA Hearing officer may not be in direct
  economic competition with the affected
  physician.
• Competitors participated in the process.
• The committees findings were supported by
  outside review.
• The competitors abstained from voting.
• Therefore, participation by competitors does not
  preclude HCQIA immunity

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Involvement of Competitors

• Competitors provide
• Clinical expertise
• Familiarity with the department process and
  recommendations
• Some degree of competition is inherent in peer
  review. Rogers v. Columbia HCA

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Medical Staff Protections-Contract

• Bylaws Provisions
• Separate Release Documents
• Hospital Indemnification

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Medical Staff Bylaws as a Contract

• Between the Staff and the Physicians
• Bylaws
• Between the Staff and the Hospital
• Case law
• Bylaws

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Medical Staff Bylaws as a Contract

• Significance
• May be enforced by any party
• May not be amended without the consent of the
  parties

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JCAHO

• JCAHO standards were incorporated into the
  Medicare program
• Essentially, JCAHO compliance is required for
  Medicare participation

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JCAHO Provisions Affecting the Medical Staff

• JCAHO Hospital Accreditation Standards, Medical
  Staff
• Required characteristics of the Medical Staff
• Required bylaws provisions
• Medical Staff functions and governance
• Credentialling, peer review and fair hearing
• Patient Care
• CME

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JCAHO Sentinel Event Policy

• A Sentinel Event is an unexpected occurrence
  involving death or serious physical or
  psychological injury, or the risk thereof.
• All Sentinel Events require a thorough and
  credible root cause analysis, implementation of
  improvements to reduce risk, and monitoring of
  the effectiveness of those improvements.

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Reportable Sentinel Events

• Any occurrence that results in an unanticipated
  death or major permanent loss of function not
  related to the patients underlying condition
• or
• Any of the following certain types of suicide
  infant abduction or discharge to the wrong
  family rape hemolytic transfusion reactions
  involving major blood group incompatibilities
  surgery on the wrong patient, side or organ
• Not near misses

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The Dilemma

• Refusal to disclose Sentinel Event information to
  JCAHO may jeopardize accreditation
• Reporting risks loss of confidentiality

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Short Term Suggestions

• Recognize that all Sentinel Event discussions
  and documents may be discoverable
• Keep review of physician conduct within the peer
  review process
• Control participation in the peer review process,
  e.g., risk management

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Is It Confidential?

• It Depends.
• Interpreting the scope of peer review
  privilege is not unlike trying to draw a bright
  line in shifting sand....
• Yuma Regional