Dealing with Difficult Physicians Preparing For and Minimizing

Dealing with Difficult Physicians: Preparing For and Minimizing Trouble Colin Luke Leigh Anne Hodge Jo Moore November 3, 2009 1

Agenda A. Lessons Learned – Recent Horror Stories Leigh Anne Hodge 10: 00 – 10: 40 a. m. B. Are your Medical Staff Bylaws Up to Date? Colin Luke C. 10: 40 – 11: 10 a. m. Reporting to the National Practitioner Data Bank; When, Where and How Jo Moore 11: 15 – 12: 00 a. m. D. Responding to Recommendation Requests Regarding Difficult Physicians Colin Luke E. Strategies to Avoid Litigation/Settlement Options Leigh Anne Hodge F. 2 12: 45 – 1: 15 p. m. Questions and Answers 1: 20 – 2: 00 p. m.

Lessons Learned – Recent Horror Stories Leigh Anne Hodge 3

RECENT HEADLINES 4

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Butler County physician arrested for more sex crimes A Butler County physician was arrested Friday by state police and charged with sex crimes involving two male juveniles. The doctor, who spent more than two decades serving as a Boy Scout leader in Butler County, was also arrested in March by state police for earlier sex crimes in which former Scouts were the victims, police said. The Scouts came forward nearly two decades after the alleged crimes occurred, police said. Dr. David Allen Evanko, 56, of Butler, surrendered to state police Friday at the Butler barracks on the most recent charges. He was charged by state police with two counts each of institutional sexual assault, unlawful contact with a minor, corruption of minors, endangering the welfare of children and indecent assault. Police said the crimes occurred between April 2008 and March 2009 at Butler Medical Associates on Medical Center Road in Chicora, Butler County, and at Summit Academy on Herman Road in Summit Township, Butler County. Butler Medical Associates is a family practice that was operated by Evanko was arraigned before district judge Lewis Stoughton, and he was released on an unsecured $30, 000 bond. Evanko took a voluntary leave of absence from Butler Medical Associates and from the medical staff of Butler Memorial Hospital after the March arrest. 9

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Statutory Immunity 11

Two Sources of Statutory Immunity • Federal Immunity: Health Care Quality Improvement Act (HCQIA) • State Immunity: Alabama Peer Review Statutes 12

HCQIA Grants Qualified Immunity: • Peer Review Participants • Entities • “Engaging in Good Faith Peer Review” Confers Confidentiality: • Information reported to the National Practitioner Data Bank (“NPDB”) 13

Health Care Quality Improvement Act (HCQIA) 42 U. S. C. § § 11111 -11152 Standards for Professional Review Actions. In order to have immunity from liability, a professional review action must be taken – (1) in the reasonable belief that the action was in the furtherance of quality health care, (2) after a reasonable effort to obtain the facts of the matter, (3) after adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances, and (4) in the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain facts and after meeting the requirement of paragraph (3). 42 U. S. C. § 11112(a). 14

HCQIA Notice and Hearing Requirements Notice of Proposed Action – Information that a professional review action has been proposed against the physician. – Reasons for the review action. – Physician has right to request hearing. – Any time limit (not less than 30 days) within which to request hearing. – Summary of rights in the hearing. 42 U. S. C. § 11112(b). 15

HCQIA Notice and Hearing Requirements Notice of Hearing – If physician timely requests a hearing: – Notice must be given at least 30 days in advance of hearing. – Notice must include: • Place, time, and date of hearing; • A list of witnesses expected to testify for professional review body. 42 U. S. C. § 11112(b)(1)–(2). 16

HCQIA Notice and Hearing Requirements Hearing to be conducted by: – Mutually acceptable arbitrator; – Hearing officer appointed by the entity who is not in direct economic competition with the physician; or – Panel of individuals appointed by the entity and who are not in direct economic competition with physician. • Physician may waive hearing if he/she fails to appear, absent good cause. 17

HCQIA Notice and Hearing Requirements • At hearing, physician has the right – – To be represented by an attorney or other person of the physician’s choice; – To have a record of the proceedings upon payment of reasonable charges; – To call, examine, and cross-examine witnesses; – To present evidence; and – To submit a written statement at the close of the hearing. 18

HCQIA Notice and Hearing Requirements • Upon completion of the hearing, the physician has the right – To receive a written recommendation that includes the basis for the recommendation; and – To receive a written decision of the health care entity, including the reasons. 42 U. S. C. § 11112(b)(3). 19

Adequate Procedures for Investigations • Hearing and notice procedures not required if there is no adverse professional action. • Hearing and notice procedures not required in the case of a suspension or restriction of clinical privileges for 14 days or less, during which an investigation is being conducted. • Hospital may at any time take immediate action to suspend or restrict clinical privileges subject to subsequent notice and other adequate procedures, where failure to take action may result in imminent danger to the health of any individual. 42 U. S. C. § 11112(c). 20

For HCQIA Immunity to Apply: 1. Compliance with fairness standards. 2. Adequate notice and a hearing. 3. Members of hearing panel must not be in direct economic competition with affected physician. 4. Report the results of the review action to the appropriate authorities in compliance with 42 U. S. C. § § 11131 -34. 21

Alabama Peer Review Statutes Alabama Code § § 22 -21 -8; 34 -24 -58; 6 -5 -333 Alabama Peer Review Statutes: § Protect all records, documents and materials furnished to peer review committees concerning accreditation or quality assurance or similar functions. § Protect all records, documents and materials created by peer review committees; § Protect all decisions and actions taken by peer review committees acted upon in good faith and without malice on the basis of facts reasonably believed to exist. § Provide qualified immunity to action of peer review committee members. 22

Exceptions to Privilege / Confidentiality Under Alabama Peer Review Statutes: 23 1. Materials can be obtained from their primary source. Ex: medical records. 2. Information and facts within personal knowledge of physicians or other individuals participating on peer review committee.

Litigation Update 24

Potential Claims Against Hospital Arising out of Credentialing & Peer Review Activities 25

Claims by Patients • Negligent Credentialing – Public looks to hospital and not individual physicians for treatment • ER • Anesthesiologists • Pathologists – Hospital Potentially Liable – Not directly for malpractice, but for breach of duty to care for patient • Selecting physicians • Renewing staff privileges 26

Claims by Aggrieved Physicians 27

CLAIMS BY HOSPITAL STAFF HARASSED BY DISRUPTIVE PHYSICIANS 28

• • • 29 Rebecca, a surgical nurse, filed a suit against Dr. Michael and St. Vincent’s Hospital. Ms. Farr alleged Dr. Michael gripped her in a bear hug, held on to her while she thrashed to get away, rubbed his body against her chest, and actually reached down into her scrub top and pulled it away from her body so that he could stare down at her chest. Previously, at a different hospital, Dr. Michael had taken a staple gun and stapled a nurse’s forehead and forearm when she angered him. Ms. Farr is suing St. Vincent’s for its negligent hiring, training, and retention of Dr. Michael.

HCQIA Immunity Cases 30

Moore v. Williamsburg Regional Hospital (4 th Cir. 2009) (cert. denied by U. S. Supreme Court October 2009) HCQIA Immunity for hospital and members of peer review committee that suspended general surgeon over allegations that surgeon and his wife had sexually abused adopted teenage daughter. 31

Moore v. Williamsburg Regional Hospital (4 th Cir. 2009) (cert. denied by U. S. Supreme Court October 2009) • Review of Facts – Hospital Chief of Staff and Chairman of Medical Executive Committee learned that Department of Social Services (“DSS”) had taken surgeon’s three adopted children into emergency custody based upon allegations of sexual abuse. – General surgeon’s practice included adults and children. – Hospital summarily suspended privileges. – Hospital reported suspension to NPDB, because of “serious allegations of sexual misconduct of minor child. ” 32

Moore v. Williamsburg Regional Hospital (4 th Cir. 2009) (cert. denied by U. S. Supreme Court October 2009) • Hospital provided hearings, notice, and upheld summary suspension. • Months later, DSS dropped charges and surgeon petitioned for reinstatement of privileges. • Hospital did not reinstate. Surgeon would not authorize the hospital where he had been practicing to release credentialing information. 33

Moore v. Williamsburg Regional Hospital (4 th Cir. 2009) (cert. denied by U. S. Supreme Court October 2009) • Lawsuit – Defendants: Hospital and Peer Review Participants – Damages Claims: • • • 34 Intentional infliction of emotional distress Tortious interference with business relations Breach contract (hospital bylaws) Defamation Unfair trade practices Violation Federal Due Process

Moore v. Williamsburg Regional Hospital (4 th Cir. 2009) (cert. denied by U. S. Supreme Court October 2009) • Holding: – Hospital prevailed because it complied with fairness and procedural requirements for HCQIA immunity. – Pivotal Issue: Was peer review process a “professional review action. ” – Court rejected surgeon’s argument that his conduct was private and not properly the subject of peer review. – Nexus between allegations and potential harm to patients. – Limits: driving infractions, messy divorces, tax or financial difficulties - - tenuous or speculative relation to medical competence. 35

Chudacoff v. University Med. Ctr. of S. Nevada (D. Nev. April 14, 2009) No HCQIA Immunity For Hospital and Peer Review Committee Members For Failure to Comply with Notice and Hearing Requirements. 36

Chudacoff v. University Med. Ctr. of S. Nevada (D. Nev. April 14, 2009) Facts: 5/28/08: By letter, Hospital MCC notified Dr. Chudacoff, OB-Gyn, of suspension and ordered drug testing and physical and mental examinations. Dr. had no notice of proposed action or the reasons for the action. 6/2/08: Counsel for Dr. requested hearing. 6/16/08: Hospital filed NPDB report: privileges suspended for substandard or inadequate care. 6/18 -20/08: Dr. lost privileges at other facilities due to NPDB Report. 6/23/08: Dr. obtained medical record numbers for patients in NPDB Report. 37

Chudacoff v. University Med. Ctr. of S. Nevada (D. Nev. April 14, 2009) 7/2/08: 7/18/08: 9/5/08: 9/11/08: 38 Dr. filed lawsuit for damages and injunctive relief, alleging violation of Due Process rights. Still no response to request for Fair Hearing. Hospital MEC informed Dr. that Fair Hearing set for 9/11/08. MEC disclosed list of witnesses, but no information about nature of testimony. At hearing, Dr. ’s attorney not allowed to present evidence, question witnesses, or participate in hearing. In addition to substandard care allegations, Fair Hearing Committee addressed discrepancy on Dr. application to join staff.

Chudacoff v. University Med. Ctr. of S. Nevada (D. Nev. April 14, 2009) 10/1/08: 10/28/08: 11/7/08: Unknown: 39 Fair Hearing Committee decision. Disagreed with suspension, but recommended peer review. Indicated that concern about application would be addressed to MEC with appropriate action. MEC hearing to consider Fair Hearing Committee recommendations. MEC decision by two letters: (1) Adopted Fair Hearing Committee recommendation of peer review; (2) Suspended privileges pending revocation for material misrepresentations on application. Dr. requested Fair Hearing on suspension for application.

Chudacoff v. University Med. Ctr. of S. Nevada (D. Nev. April 14, 2009) 11/25/08: Dr. ’s attorney given 3 -hour notice of MEC meeting to discuss discrepancy in application. One hour after meeting, MEC informed Dr. that it was suspending privileges. 11/25/08: Dr. appeal substandard care issues. Early 2009: Board sided with Dr. and awarded Dr. $10, 000 for costs and fees. Board also opined there was a need to re-write reporting policies to allow procedural due process before suspension. 40

Chudacoff v. University Med. Ctr. of S. Nevada (D. Nev. April 14, 2009) Holding: Lessons Learned 41 1. Privileges revoked without any notice to Dr. that privileges were in jeopardy. 2. Hospital reported suspension to NPDB before Dr. had opportunity to be heard. 3. Failure to comply with procedural requirements results in loss of HCQIA immunity and potential liability for damages.

Poliner v. Texas Health Systems (5 th Cir. 2008) $366 Million Damages Award to physician reversed by appeals court. Hospital and Peer Review Committee Member entitled to HCQIA immunity where Hospital complied with HCQIA, notwithstanding failure to comply with Hospital Bylaws. 42

Poliner v. Texas Health Systems (5 th Cir. 2008) Facts: • Dr. Poliner, cardiologist, was granted temporary privileges at Hospital in 1996 and obtained full privileges in October 1997. However, questions about quality of care began to arise in September 1997 following a patient death after procedure in cath lab. • Dr. Poliner’s cases were under review by Clinical Risk Review Committee (“CRRC”) when, on May 12, 1998, he misdiagnosed a patient and performed angioplasty to wrong artery, leaving the blocked artery untouched. 43

Poliner v. Texas Health Systems (5 th Cir. 2008) • The next day, on May 13, 1998, Dr. Knochel, head of Department of Internal Medicine, requested Dr. Poliner to agree to “abeyance” for fourteen days to allow investigation. Hospital Bylaws required consent. • Dr. Knochel told Dr. Poliner that if he refused to agree to abeyance, he would suspend privileges. • Dr. Knochel testified at trial that at time of compulsory abeyance, he did not have enough evidence to determine if Dr. Poliner was a present danger to patients. • On June 12, Hospital suspended Dr. Poliner’s privileges. 44

Poliner v. Texas Health Systems (5 th Cir. 2008) Issue: • Damages at trial based solely on forced abeyance of May 13, 2009. • Jury found no agreement as required by Hospital Bylaws. • Jury found abeyance did not meet HCQIA standards for 14 day suspension in case of health emergency because Dr. Knochel testified that he did not have enough information to determine if Dr. Poliner was a present danger. 45

Poliner v. Texas Health Systems (5 th Cir. 2008) Holding: (1) HCQIA immunity applied. (2) 14 day HCQIA requirement satisfied - decision made before May 14 even though Hospital did not request Poliner’s consent to extension of abeyance until day 15. (3) Hospital met “imminent danger” standard based upon CRRC’s determination that Poliner had provided substandard care in half of cases reviewed plus seriousness of mistake in clinical judgment resulting in misdiagnosis and error in treatment of patient the day before the abeyance. 46

Poliner v. Texas Health Systems (5 th Cir. 2008) (4) HCQIA “reasonableness requirements” were intended to create objective standard of performance, rather than subjective good faith standard. (5) Focus of reasonableness standard is not whether peer review committee’s decisions were correct or even whether peer review committee had bad motives. Instead, focus should be on whether decision was reasonable based upon facts known at that time. 47

Poliner v. Texas Health Systems (5 th Cir. 2008) Lessons Learned: 1. Be diligent about time limitations for emergency suspensions. 2. Emergency suspensions based upon “imminent danger” must be based on reasonable belief and based upon facts. 48

Adkins v. Christie (11 th Cir. 2007) • No HCQIA privilege for documents relating to medical peer review proceedings in federal employment discrimination cases. • The court emphasized that the privilege must be considered against a corresponding and overriding goal – the discovery of evidence essential to determining whethere has been discrimination in employment. The documents that the Hospital seeks to protect are the very documents that Adkins needs to prove his discrimination claims. 49

ALABAMA PEER REVIEW STATUTE CASES 50

Ex parte Fairfield Nursing and Rehabilitation Center, L. L. C. (Ala. 2009) Holding: Incident reports and witness statements were privileged, notwithstanding the fact that they were not created by a peer review or quality assurance committee, where medical center established that reports and statements: 1. Are not kept in ordinary course of business; 2. Such documents do not become a part of a patient’s medical chart; and 3. Reports and witness statements are created for quality assurance purposes. 51

Ex parte St. Vincent’s Hospital v. Anesthesia Services of Birmingham (1994) Holding: Letter in possession of Hospital Infection Control Committee not privileged. • • • 52 Zeneca, Inc. and St. Vincent’s were codefendants in a medical malpractice/products liability action. St. Vincent’s filed a cross-claim against Zeneca alleging that Zeneca failed to warn St. Vincent’s of the dangers associated with using the scrub, Hibiclens. The plaintiff, a patient of St. Vincent’s, was injured when Hibiclens got into his eye during surgery because the medical staff used the scrub on his face.

Ex parte St. Vincent’s Hospital v. Anesthesia Services of Birmingham (1994) • Zeneca sought discovery of a letter in possession of the Infection Control Committee. Zeneca sent the letter to St. Vincent’s several months before the accident, warning St. Vincent’s that the scrub should not be used around the face or eyes. • St. Vincent’s refused on the grounds that the letter was privileged under Alabama Peer Review Statutes. • The Supreme Court of Alabama held that the letter was not privileged. • The court concluded that St. Vincent’s failed to show that the Infection Control Committee served as either a utilization review committee or that the Committee served as accreditation or peer review function. 53

Ex parte Burch (Ala. 1999) Holding: Physician participant of peer review committee prohibited from testifying about statements made by affected physician to Peer Review Committee for purpose of impeaching testimony. Facts • Surgeon and hospital were named as defendants in medical malpractice / wrongful death suit. • As a result of patient’s death, hospital’s Surgery Committee held a special meeting to review surgeon’s performance in case leading to patient’s death. • During discovery in lawsuit, surgeon’s deposition testimony conflicted with what he told Surgery Committee. 54

Ex parte Burch (Ala. 1999) • Dispute centered on what hospital staff communicated to surgeon about patient’s condition. • Hospital wanted to offer testimony of Head of Surgery Committee for purpose of impeaching surgeon’s trial statement. • Head of Surgery Committee had no knowledge of incident, other than what he learned in Committee meeting. • The Court refused to allow the Head of the Surgery Committee to offer testimony to impeach surgeon on the grounds that such information was privileged under Alabama Peer Review Statutes. 55

Ex parte Cryer (Ala. 2001) Holding: Handwritten notes of physician made in preparation for meeting with physician shareholders of a private medical practice not privileged by Alabama Peer Review Statute. 56

Ex parte Cryer (Ala. 2001) • Mr. and Mrs. Cryer filed suit against Dr. Corbett and her employer, Mobile Ob-Gyn (“MOG”) claiming the defendants negligently cared for the Cryer’s infant during labor and delivery, and that as a result, the infant died. • The Cryers sought damages against MOG alleging negligence in hiring and retaining Dr. Corbett. • Dr. Corbett refused to disclose handwritten notes she made in preparation for a meeting with the physician shareholders of MOG. 57

Ex parte Cryer (Ala. 2001) • The Supreme Court of Alabama held that the handwritten notes did not constitute part of the peer-review process, and thus fell outside the scope of § 22 -21 -8. The Court concluded that the written statement was made in preparation for a meeting to discuss job performance. • Shareholder physicians of a private corporation do not qualify as “medical staff” under Alabama Peer Review Statutes. 58

Lessons Learned from Recent Cases: 1. Provide adequate notice and hearing procedures. 2. Physicians win in the courtroom – and win big – if the hospital fails to provide adequate notice and hearing procedures. 3. Avoid allowing a physician in direct economic competition with affected physician to serve on committee. 59

Lessons Learned 4. Incident reports and witness statements should never become a part of the patient’s medical record. 5. Peer review and quality assurance discussions, and activities must remain confidential to guard privilege and qualified immunity. 60

Questions? 61

Are your Medical Staff Bylaws Up to Date For Dealing With Difficult Physicians? Colin Luke Presentation to Alabama Hospital Association November 3, 2009 62

Medical Staff Bylaws… • Can be the “First Line of Defense” if they are well written; • Will be Used Against the Hospital by Troublesome Physicians; • Create a Contract between the Hospital and each member of the medical staff; • Must be Followed Uniformly and Precisely. 63

The Health Care Quality Improvement Act of 1986 Requires the following for Professional Review Actions: 1. Notice of Action: • that a professional review action has been proposed to be taken against the practitioner and the reasons for the proposed action; • that the practitioner has the right to request a hearing on the proposed action and a time period, of not less than 30 days, within which to request such a hearing, and • a summary of rights in the hearing. 2. If a hearing is requested on a timely basis, the practitioner involved must be given notice stating: • the place, time, and date of the hearing, which shall not be less than 30 days after the date of the notice: • a list of the witnesses, if any, expected to testify at the hearing on behalf of the professional review body. 64

The Health Care Quality Improvement Act of 1986 Requires the following for Professional Review Actions: 3. If a hearing is requested on a timely basis: • the hearing shall be held, before a panel of individuals who are appointed by the entity and are not in direct economic competition with the practitioner involved; • the practitioner has a right to representation; • the practitioner has a right to have a record made of the hearing; • the practitioner has a right to call, examine and cross -examine witnesses; • the practitioner has a right to present evidence; and • the practitioner has a right to make a written statement at the close of the hearing 65

The Health Care Quality Improvement Act of 1986 Requires the following for Professional Review Actions: 4. Upon completion of the hearing: • • 66 The practitioner has a right to receive a written copy of the decision of the panel with a statement of why it was made; The practitioner has a right to receive a written copy of the final decision of the health care entity with a statement of why it was made.

JOINT COMMISSION HOSPITAL ACCREDITATION STANDARD: MS. 01. 01 requires the Medical Staff Bylaws to address: (a) (b) (c) (d) 67 Appointment and reappointment of medical staff membership and clinical privileges; Suspension of clinical privileges and memberships; The process of investigations and fair hearings; and The composition of the hearing committee.

ADDITIONAL JOINT COMMISSION REQUIREMENTS: Ongoing Professional Practice Evaluation (OPPE) • OPPE is achieved through routine monitoring of current competency for current Medical Staff members through systematic data collection and evaluation. • The OPPE information is factored into the decision to maintain an existing privilege, to revise an existing privilege, or to revoke an existing privilege to or at the time of re-appointment. 68

ADDITIONAL JOINT COMMISSION REQUIREMENTS: Focused Professional Practice Evaluation • A process whereby the organization evaluates the privilege-specific competence of the practitioner who does not have documented evidence of competency performing the requested privilege. • This process may also be used when a question arises regarding a currently privileged practitioner’s ability to provide safe, high quality care. 69

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The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 1. Credentialing Process: - - 71 Release of Liability Burden on Applicant - References - Gaps in History Retain Element of Subjectivity Probationary or “Associate” Status

The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 2. Call Responsibilities: - Emergency Room Consulting Responsibilities Timeframe for Response Ability to Refuse Call 3. Summary Staff Suspension - 72 How Initiated Clear Grounds for Invoking How Long it Can Last Appeal Rights

The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 4. Exclusive Contract Provisions - 5. Participation by Competing Physicians - 73 Which Departments Automatic Termination of Privileges if Contract is Terminated No Appeal Rights Definition of Competition Provisions for Outside Appointments Limits on Ability to Influence the Process Allow Use of Outside Reviewers

The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 6. Clear Parameters for Informal Investigations 7. Procedures for Single Hearing after MEC makes its Determination 74

The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 8. Appeal Process After Hearing. • Single Appeal • Limited Review without New Information • Short Time Frame for Decision • Automatic Denial if Physician Does Not Participate 75

The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 9. Databank Reporting. • Mandatory Timeframe for Submission • No Approval Rights by Practitioner 76

The Top 10 Most Important Things to Include in Your Medical Staff Bylaws: 10. Reappointments and Suspensions – No Automatic Reappointments – Mandatory Release – Requirement of Additional Information 77

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QUESTIONS 79

Reporting Requirements to the National Practitioner Data Bank By Jo Moore 80

Creation of the National Practitioner Data Bank (“NPDB”) The Health Care Quality Improvement Act of 1986 (the “Act”) • Final Regs published in Fed Reg Oct. 17, 1989 • Codified at 45 CFR Part 60 • US Dept. of Health & Human Services is responsible for implementation • NPDB opened Sept. 1990 81

Specific Concern • Congress believed that physicians and dentists were unreasonably discouraged from participating in effective peer review due to potential personal liability arising from peer review participation. • Through the Act, Congress provided incentive and protection for physicians engaging in effective professional peer review. 82

Incentive and Protection - Immunity • Hospitals and other entities subject to the Act are immune from private damages in civil suits under Federal and State law where the professional review action is conducted: • With the reasonable belief of furthering the quality of health care and with proper regard for due process (typically governed and provided by Hospital medical staff bylaws). • This immunity is extended to reporting to the NPDB. 83

Creation of the NPDB • Is an information clearinghouse relating to the professional competence and conduct of physicians, dentists and certain other health practitioners • Meant to serve as a resource to assist State licensing boards, Hospitals, and other health care entities in conducting independent investigations of the qualifications of the healthcare practitioners they seek to license, hire or grant clinical privileges 84

Purpose of the NPDB “To improve the quality of healthcare by encouraging State licensing boards, Hospitals, and other healthcare entities and professional societies to identify and discipline those who engage in unprofessional behavior and to restrict the ability of incompetent physicians, dentists and other practitioners to move from State to State without disclosure or discovery of previous medical malpractice payment and adverse action history. ” 85

NPDB Reporting Statistics • As of September 30, 2006, there were a total of 403, 310 reports on 235, 942 practitioners since the inception of the NPDB – – 73% malpractice payments 15% licensure actions 4% adverse clinical privileges actions 8% exclusion actions • The NPDB is encouraging use of the NPDB and increasing its enforcement actions – Form letters have been sent to Hospitals and other healthcare entities with no or few queries/reports to the NPDB reminding those Hospitals of their NPDB obligations. 86

Reporting to the NPDB The following entities must report information to the NPDB: • An entity that makes a medical malpractice payment • A board of medical examiners or a state licensing board taking an adverse action against a physician or a dentist • A professional society that has a peer review process and qualifies as a “health care entity” which takes an adverse membership action as a result of professional review • A health care entity that takes an adverse clinical privileging action as a result of professional review 87

Hospitals Are Required to Report to the NPDB • Medical malpractice payments made on behalf of a physician • Adverse clinical privilege actions taken by the Hospital 88

Reporting Medical Malpractice Payments • A Hospital must report to the NPDB all payments for the benefit of a physician or other healthcare practitioner in settlement of, or in satisfaction in whole or in part of, a claim or a judgment demanding monetary damages against the practitioner. • A Hospital must also report the payment to the appropriate state licensure board. 89

NPDB’s Interpretation of Medical Malpractice Information “[A] payment in settlement of a medical malpractice action or claim shall not be construed as creating a presumption that medical malpractice has occurred. ” NPDB Regulations 60. 7(d) 90

When Appropriate to Report • Where the Hospital pays a malpractice payment on behalf of physician who is named in the complaint or claim and also named in the settlement, release or final adjudication • Where the Hospital refunds a practitioner fee due to a written complaint or claim demanding monetary damages against the physician • Where the Hospital pays loss adjustment expenses (legal fees and costs) as part of the medical malpractice payment 91

Not Reportable • An individual person, who out of personal funds, makes a medical malpractice payment on his or her own behalf of on another’s behalf • Malpractice payments made solely for the benefit of a business entity such as a clinic, group practice, or Hospital • Medical malpractice payments made on behalf of unlicensed student providers • Dismissal of physician prior to the settlement or a judgment • Inclusion of a physician in a settlement agreement who was not named in the complaint or claim 92

Table E-2. Medical Malpractice Payments Determining Reportable Action 93 NPDB Reporting Responsibility A malpractice settlement or court judgment includes stipulation that the terms are kept confidential Must file report. Malpractice settlement is structured so that claimant receives an annual sum for each year he or she is alive Report the initial payment after NPDB opening; identify as multiples payments. Malpractice settlement involves five practitioners. Must file a separate report on each of the five practitioners. Payment is made based only on oral demands. No report is required. Payment made by an individual. A professional corporation or other business entity comprised of sole practitioner must file a report. No report is required for an individual making payment out of personal funds. Payments made for corporations and hospitals. Payments made for the benefit of a corporation such as a clinic group practice or hospital are not currently reportable. Payment is reportable when made for business entities comprised of sole practitioners. Payments made for licensed residents and interns. Must file report. Practitioners fee refund. Must file report of refund is made by an entity (including so incorporated practitioners). No report is required if refund is made by an individual. Dismissal of defendant from lawsuit. No report required if defendant is dismissed prior to settlement or judgment. Report is required if dismissal results from condition in settlement or release.

Time Period to Report Medical Malpractice Payments Within 30 days that the payment is made • If multiple payments made, 30 days from the date of the first payment. 94

Penalties for Failure to Report Medical Malpractice Payers • Civil money penalty of up to $11, 000 for each payment not reported. • If the Hospital has failed to report, the failure will be printed in the Federal Register and the Hospital will lose its immunity for professional review activities for three years. 95

Reporting Adverse Clinical Privileges Actions • Hospitals must report adverse clinical privileges actions based upon a physician’s professional competence or professional conduct that adversely affects, or could adversely affect, the health or welfare of a patient. • Only applies to physicians • The Hospital may but is not required to report adverse clinical privileges actions taken against other health care practitioners (i. e. CRNA or nurse practitioner) 96

Adverse actions based on the practitioner’s professional competence or professional conduct include: • Reducing, restricting, suspending, revoking, or denying privileges • Hospital’s non-renewal of privileges or denial of expansion of clinical privileges • Physician’s non-renewal or withdrawal of clinical privileges while under investigation. 97

“Investigation” • Not defined by the Act • Case law and the NPDB Guidebook provide that there is an “Investigation” if – Investigation is carried out as a precursor to a professional review action – Investigation is carried out by the Hospital, not an individual – There is written evidence (minutes, notices, or orders) that an investigation was initiated at the time of the physician’s resignation or non-renewal. – Investigation complies with the medical staff bylaws – Investigation focuses on the specific physician and is not routine 98

Adverse Clinical Privilege actions do not include: • Censures, reprimands or admonishments • Adverse actions relating to the physician’s business practices rather than patient care – For example, adverse actions relating to the physician’s advertising practices, fee structure, salary arrangement, or competitive business acts are not reportable. • Denial of clinical privileges relating to eligibility 99

Adverse Clinical Privileges Action NPDB Rules specify that Hospitals and other health care entities must report • Professional review actions that adversely affect a physician’s clinical privileges for a period of more than 30 days. • Acceptance of a physician’s surrender or restructure of clinical privileges while under investigation by the entity for possible professional incompetence or improper professional conduct or in return for not conducting an investigation on professional review action. • Summary suspension of physician based upon professional competence or conduct for more than 30 days by Hospital. 100

Table E-3. Determining Reportable Actions for Clinical Privileges Action Reportable Based on assessment of professional competence, a proctor is assigned to a physician or dentist for a period of more than 30 days. The practitioner must be granted approval before certain medical care is administered. Yes Based on assessment of professional competence, a proctor is assigned to supervise a physician or dentist, but the proctor does not grant approval before medical care is provided by the practitioner. No As a matter of routine hospital policy, a proctor is assigned to a physician or dentist recently granted clinical privileges. No A physician or dentist voluntarily restricts or surrenders clinical privileges for personal reasons; professional competence or professional conduct is not under investigation. No A physician of dentist voluntarily restricts or surrenders clinical privileges; professional competence or professional conduct is under investigation. Yes A physician or dentist voluntarily restricts of surrenders clinical privileges in return for not conducting an investigation of professional competence or professional conduct. Yes A physician’s or dentist’s application for medical staff appointment is denied based on professional competence or professional conduct. Yes A physician or dentist is denied medical staff appointment or clinical privileges because the health care entity has too many specialists in the practitioner’s discipline. No A physician’s or dentist’s clinical privileges are suspended for administrative reasons not related to professional competence or professional conduct. No A physician’s or dentist’s request for clinical privileges is denied or restricted based upon assessment of clinical competence as defined by the hospital. Yes 101

Time Period to Report an Adverse Clinical Privilege Action Within 15 days from the date the adverse action was taken or clinical actions were voluntarily surrendered 102

Adverse Clinical Privileges Action Reporting to State Licensure Board • Must also mail a copy of the report sent to the NPDB and NPDB verification of receipt to the appropriate state licensure board 103

Penalty for Failure to Report Adverse Clinical Privilege Actions • HHS will conduct an investigation • Hearing rights are offered to the Hospital • If the Hospital has failed to report, the failure will be printed in the Federal Register and the Hospital will lose its immunity for professional review activities for three years. 104

Reporting Requirements Under Alabama Law • The CEO of each Hospital must report to the Alabama State Board of Medical Examiners any disciplinary action taken concerning any physician when the action is related to professional ethics, negligence or incompetence in the practice of medicine, moral turpitude, sexual misconduct, abusive or disruptive behavior, or drug or alcohol abuse. Disciplinary action shall include termination, revocation, probation, restriction, denial, failure to renew, suspension, reduction, or resignation of Hospital privileges for any of the above reasons. • The report must be in writing and be made within 30 days of the date of the action. • Failure to file a report may in the State Board of Health's discretion, result in a civil monetary penalty in an amount not to exceed $2, 500. 00 for each violation. Ala. Code § 34 -24 -59 105

Section 1921 of the Social Security Act • Section 1921 expanded the government’s authority to collect information concerning sanctions taken by State licensing authorities against health practitioners. • To date, final rules have not been promulgated, but Section 1921 will require Hospitals and healthcare entities to report all adverse actions (not limited to conduct and competence) to the NPDB 106

Queries to the NPDB A Hospital must request information from the NPDB • When a physician or other healthcare practitioner applies for medical staff appointment or clinical privileges (including courtesy, non-clinical, or temporary) • Every two years thereafter on all physicians or other healthcare practitioners who are on the medical staff (including courtesy, non-clinical, or temporary) or who hold clinical privileges • To add or expand existing staff or clinical privileges of a physician or other health care practitioner. 107

Queries Cont’d • Hospital’s queries are not limited by these mandatory requirements. In addition to these mandatory requirements, Hospitals may query about a physicians or other healthcare practitioner at any time. • In 2007, the NPDB launched its Proactive Disclosure Service (PDS) which allows the Hospital to receive any new reports of the Hospital’s physicians within one day of the filing of the report. Participation of the Hospital in PDS satisfies the Hospital’s query requirement for its existing physicians and other practitioners. 108

Penalties for Failure to Query • Results in a presumption that the Hospital knew the information provided by the NPDB which can be detrimental to the Hospital. 109

Resources The NPDB Website www. npdb-hipdb. hrsa. gov The NPDB Guidebook www. npdb-hipdb. hrsa. gov/pubs/gb/ NPDB_Guidebook. pdf 110

Questions 111

THANK YOU! 112

Responding to Recommendation Requests Regarding Difficult Physicians Colin Luke Presentation to Alabama Hospital Association November 3, 2009 113

Key Points to Remember: • You do not have to complete the recommendation form. • If you complete the reference or recommendation form, it must be accurate and complete. • Do not allow references to be submitted without appropriate review. • Do not allow the requesting physician to review the response or to submit a suggested response. 114

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) 115

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) • Kadlec Medical Center, in Richland, Washington, brought suit against LAA, the LAA shareholders, and Lakeview Regional Medical Center (“defendants”) because they failed to disclose Dr. Berry’s on-duty use of narcotics in response to Kadlec’s reference request. • Dr. Robert Berry, an anesthesiologist and former shareholder of LAA, worked at Lakeview Medical until he was caught using Demerol at work. He failed to answer a page while on-duty at the hospital and he was discovered in the call-room, asleep, groggy, and unfit to work. He was fired soon thereafter. 116

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) 117 • After being terminated by Lakeview Medical and LAA, Dr. Berry sought work at Kadlec Medical Center through Staff Care. • Upon receiving his application, Kadlec began its credentialing process and examined a variety of materials, including referral letters from LAA and Lakeview Medical. • LAA’s Dr. Preau and Dr. Dennis, two months after firing Dr. Berry for his on -the-job drug use, submitted referral letters for Dr. Berry to Staff Care, with the intention that they be provided to future employers.

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) • The letter from Dr. Dennis stated that he had worked with Dr. Berry for four years, that he was an excellent clinician, and that he would be an asset to any anesthesia service. • Dr. Preau’s letter said that he worked with Berry at Lakeview Medical and that he recommended him highly as an anesthesiologist. • Dr. Preau’s and Dr. Dennis’s letters were submitted on June 3, 2001, only 68 days after they fired him for using narcotics while on-duty and stating in his termination letter that Dr. Berry’s behavior put “patients at significant risk. ” 118

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) • • Kadlec also sent Lakeview Medical a request for credentialing information about Dr. Berry. The request included a detailed confidential questionnaire, a delineation of privileges, and a signed consent for release of information. Lakeview Medical responded to the requests for credentialing information about 14 different physicians. In 13 cases it responded fully and completely to the request; however, the response concerning Dr. Berry was handled differently. Lakeview Medical drafted a short letter that stated: This letter is written in response to your inquiry regarding [Dr. Berry]. Due to the large volume of inquiries received in this office, the following information is provided. Our records indicate that Dr. Robert L. Berry was on the Active Medical Staff of Lakeview Regional Medical Center in the field of Anesthesiology from March 04, 1997 through September 04, 2001. If I can be of further assistance, you may contact me at (504) 867 -4076. 119

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) • The letter did not disclose LAA’s termination of Dr. Berry; his on-duty drug use; the investigation into Dr. Berry’s undocumented and suspicious withdrawals of Demerol that “violated the standard of care”; or any other negative information. • Kadlec then credentialed Dr. Berry, and he began working there. • Shortly thereafter, Dr. Berry was in a car accident and suffered a back injury. After the accident, nurses began to notice he appeared sick and exhibited mood swings. • Several months later, Dr. Berry gave a patient too much morphine during surgery, and she had to be revived using Narcan. The neurosurgeon was irate about the incident. 120

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) • On November 12, 2002, Dr. Berry was assigned to the operating room beginning at 6: 30 a. m. He worked with three different surgeons and multiple nurses well into the afternoon. • According to one nurse, Dr. Berry was “screwing up all day” and several of his patients suffered adverse affects from not being properly anesthetized. • Kimberley Jones was Dr. Berry’s fifth patient that morning. She was in for what should have been a routine, fifteen minute tubal ligation. When they moved her into the recovery room, one nurse noticed that her fingernails were blue, and she was not breathing. Dr. Berry failed to resuscitate her, and she is now in a permanent vegetative state. 121

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) • Dr. Berry confessed he had been using Demerol since his car accident and that he had become addicted to Demerol. • Jones’ family sued Dr. Berry and Kadlec, and both Dr. Berry’s and Kadlec’s insurers settled the claims. • In this case, Kadlec and its insurer have filed suit against LAA, Dr. Dennis, Dr. Preau, Dr. Parr, and Lakeview Medical alleging intentional misrepresentation, negligent misrepresentation, strict responsibility misrepresentation, and general negligence. 122

Kadlec Medical Center v. Lakeview Anesthesia Associates (“LAA”) 123 • In the lower court, a jury found Lakeview Medical and the three shareholders/doctors of LAA liable. The court held that, in order to protect future patients of an impaired physician, Lakeview Medical and its physicians had a duty to disclose Dr. Berry’s impairment to a second hospital where the physician relocated and applied for privileges. • On appeal, the Fifth Circuit Court of Appeals held that: – the defendants, after choosing to write referral letters, assumed a duty not to make affirmative misrepresentations in the letters. – the doctors’ reference letters were misleading, while the letter from Lakeview Medical was not. – the defendants had no affirmative duty to disclose negative information about Dr. Berry in their referral letters. – Lakeview Medical did not breach any duty owed to Kadlec, and therefore the judgment against it was reversed.

Additional Pointers: • Do not feel the need to stay within the form used for the reference request; • Do not respond to verbal requests for references or provide information via email or telephonically; • Confirm every answer made with documentation in file; and • Do not rush to complete the reference request and do have it reviewed before it is submitted. 124

Questions? 125

Strategies to Avoid Litigation/Settlement Options 126

CASE STUDIES 127

“MOTIVATED BY CONCERN ABOUT THE PATIENT” Hospital receives a complaint about Physician A from Physician B who competes with Physician A was reported to have approached patient in hospital bed to tell patient that patient’s primary care physician, Physician B, was no longer accepting Medicaid patients because Physician B was only concerned about money. Since Physician A was “motivated by concern about the patient”, Physician A was willing to accept responsibility for the patient and move the patient over to his service. Patient moved over to Physician A. 128

“EVERYONE NEEDS A LITTLE HELP” Hospital nursing supervisor received complaints from three operating room nurses regarding new Surgeon X. These nurses alleged that Surgeon X was not familiar with even the most basic operating room supplies and asked them to download and read out loud instructions from the internet during a surgical procedure. Surgeon X reportedly asked the operating room nurses several questions about what to do next during operating room procedures. As part of a routine review for new physicians, Surgeon X was found by an outside reviewer to have violated the standard of care during several surgical procedures. Surgeon Y, the only other surgeon in Surgeon’s X’s specialty on the medical staff, refuses to participate in the peer review process. 129

“I CAN’T BE EVERYWHERE AT ONCE” Physician 1, the hospital’s only neurosurgeon, receives a consult request from hospital for an inpatient in serious condition in the ICU. Physician 1 learns that request for consult was initiated by Physician 2 who was his former partner. Hospital’s medical staff bylaws require that active members of the medical staff accept consults if they are available. Physician 1 reports that he is unavailable as he is out of the area. Physician 1 later that day arrives at hospital to see one of Physician 1’s patients. Physician 1 states that he cannot see Physician 2’s patient as the two physicians do not get along. 130

“KEEP YOUR HANDS TO YOURSELF” Hospital nursing supervisor received a complaint from an R. N. in the Labor & Delivery unit that one of the Ob-Gyn doctors approached her in the medicine room, pulled her to him in a bear hug, rubbed his upper body against her breasts, and then pulled her scrub top away from her body and looked down her shirt. Another R. N. who happened to be in the medicine room observed the incident. Nurse number two told Nurse number one that this is not the first time that the Ob-Gyn doctor has behaved in this way. 131

“THE CASE OF THE ABUSIVE SURGEON” (OR “MY FIRST NAME IS GOD”) Surgeon X, the hospital’s most prominent cardiothoracic surgeon, has a reputation for yelling at nurses and support staff during procedures and for throwing sutures, bandages, and other items in the O. R. The hospital nursing supervisor received a complaint from an O. R. nurse that Surgeon X became enraged during a procedure when his favorite brand of staple gun was not available. The O. R. nurse presented Surgeon X with one of the staple guns that the hospital currently stocked. Surgeon X closed the patient’s incision and then used the staple gun on the O. R. nurse and stapled her shoulder and scalp. The O. R. nurse left the operating room in tears. Surgeon X completed the procedure. Patient care was not compromised. 132