Professor Katharine Van Tassel

1. Hospital Peer Review Standards and Due Process: Moving From Tort Doctrine to Contract Principles Based on Clinical Practice Guidelines Professor Katharine Van Tassel

2. Institute of Medicine, “To Err is Human” (1999) • 44,000 to 98,000 patients die each year in hospitals from medical mistakes • Number of casualties equivalent to one jumbo jet crashing every day for one year

3. Peer Review • State Licensing Boards • AMA / Professional Organizations • Hospital Peer Review

4. Summary of Presentation • How peer review hearings are conducted • Health Care Quality Improvement Act • Schism in the courts over the current standards • Problems inherent in the various vague categories of standards • Solution: Clinical Practice Guidelines (“CPGs”)

5. Stakeholders in Peer Review • Physician • ability to practice profession • Hospital • autonomy in staffing decisions, quality patient care, avoid liability • Patients • quality medical care + access to personal physician (Medicaid / Medicare)

6. Physician’s Interests Staff Privileges Property Right Access to hospital essential precondition to practice National Practitioners Data Bank Licensure Boards and Insurance Provider

7. 2. Medical Staff Executive Committee (MSEC) 2. Medical Staff Executive Committee (MSEC) 1. Department Chair Or Chief of Medical Staff Issues Complaint 3. Ad hoc Committee (AHC) Conducts Investigation 3. MSEC Conducts Investigation 4. AHC Issues Charges/ Corrective Action 4. MSEC Issues Charges And Corrective Action 5. Appeal to Board of Directors = Conducts Hearing 6. Appeal to Board Of Directors 5. Appeal to MSEC = Conducts Hearing

8. Role of the Courts • Judicial Review • High level of deference to evaluation of clinical competence • Application of basic principles of fairness and due process of law Fairness of Standards In Theory • Standards used to evaluate physician competency • Must be fair • Must be reasonable • Must not be subject to arbitrary/capricious application

9. “Misconduct” Standard Unconstitutionally Vague “[n]o one disputes the power of the university to protect itself by means of disciplinary actions against disruptive students. Power to punish and the rules defining the power are not, however, identical. Power alone does not supply the standards needed to determine its application to types of behavior or specific instances of “misconduct.” Soglin v. Kauffman, 418 F.2d 163 (7th Cir. 1969).

10. Procedures And Hearings

11. Procedures And Hearings Very Little Protection

12. Procedures And Hearings Very Little Protection Without Rules And Standards

13. Procedures And Hearings Very Little Protection Without Rules And Standards To Give Content To Proceedings

14. Procedures And Hearings Very Little Protection Without Rules And Standards To Give Content To Proceedings “The Idea of a hearing is fine. But what is to be heard?” Block v. Thompson (5th Cir. 1973)

15. Clearly Articulated Standing Rules Provides Fair Notice Of Conduct That Will Be Sanctioned

16. Clearly Articulated Standing Rules Avoids Arbitrary Capricious Decision-making Limits Allocation Choices Of Officials Provides Fair Notice Of Conduct That Will Be Sanctioned Choices Based On Principles Not Personal Preferences Of Officials

17. Are Clear Standards Possible? Small Minority Specific Criteria Objectively Applied Achievable and Necessary To Provide Notice To Avoid Decisions Based On Whim And Caprice

18. Are Clear Standards Possible? Large Majority Small Minority Specific Criteria Impossible /Undesirable Objectively Applied Standards Shift Rapidly Achievable and Necessary Human Lives At Stake To Provide Notice Better To Allow Unfair Denial Of Staff Privileges Than Harm To Patients By Unlimited Access To Hospitals To Avoid Decisions Based On Whim And Caprice

19. Majority Concedes • Common “procedure employed for appointment whereby members of the Active Staff (generally older, more established practitioners) hold the life line on the younger doctors by virtue of the fact that their recommendation is required for appointment.” • Grants the exclusive use of a tax supported institution to the doctors who agree among themselves that they are the most competent.

20. This Split Raises 3 Questions • 1. How vague are the standards ? • 2. Do they properly balance of the interests of the stakeholders while furthering the goals of peer review? • 3. Is it possible to create clearly articulated standards that both properly balance the interests at stake and further the goals of peer review?

21. Two Main Categories Of Standards • Grant absolute discretion to the decision-makers • Customary care in the “medical community”

22. Case of Stan and Dharva • Dharva= brilliant new comer + cutting edge practices

23. Case of Stan and Dharva • Stan = long timer/lags behind + political capitol • Dharva= brilliant new comer + cutting edge practices

24. Case of Stan and Dharva • Stan = long timer/lags behind + political capitol • Dharva= brilliant new comer + cutting edge practices Appoints as Department Chair

25. Standards Granting Absolute Discretion To The Hospital • Right to remove “whenever in [governing body’s] sole judgment the good of the hospital or the patients therein may demand it” • “Best possible care” or “adequate medical care” or “high quality medical care” or “unprofessional conduct”

26. Clearly Articulated Standing Rules Avoids Arbitrary Capricious Decision-making Limits Allocation Choices Of Officials Provides Fair Notice Of Conduct That Will Be Sanctioned Choices Based On Principles Not Personal Preferences Of Officials

27. Standard = Customary Care • Two Questionable Assumptions • That there are standards of care for the diagnosis and treatment of medical conditions that are commonly known, and agreed upon, in the medical community • That adherence to customs furthers quality of care

28. Herniated Disc

29. Is Surgery The Best Way To stop Back Pain? • Herniated Discs • Study of 1,200 patients: same result with or with out surgery • Surgery? • Depends on where you live • 20x more likely to have surgery if live in Idaho Falls, Missoula, and Mason City than if you live in Newark, Bangor and Terre Haute • “It is so interesting that geography is destiny.” Dr. James Weinstein

30. ‘Surgical Signature’ Phenomenon • In the absence of professional consensus based on outcomes (evidence-based medicine) • Individual or small groups of physicians can hold onto idiosyncratic clinical rules of thumb defining who needs surgery • In a given region, local physicians tend to apply their rules of practice consistently • This results in the ‘surgical signature’ phenomenon: rates for specific surgical procedures that are idiosyncratic for a region • Sometimes differing dramatically among neighboring regions

32. Surgical Signatures New York Chicago Detroit San Francisco Washington-Baltimore

33. Surgical Signatures • Rate of spine surgery in Bradenton, Florida 75% greater that in neighbors to the north, Tampa, Florida

34. Surgical Signatures • 50% more likely to get hip replacement surgery if live in Fort Lauderdale than if you live in Miami

35. Maine Hysterectomy 70 y.o. women One hospital Market = 20 % Equivalent Hospital Market = 70 % Iowa Prostatectomy 85 y.o. men Equivalent Hospital Market = 60 % One hospital Market = 15 % Vermont Tonsillectomy kids One hospital Market = 8 % Equivalent Hospital Market = 70 %

36. Failure to Deliver Essential Treatments for Common Causes of Death • Aspirin w/in the first 24 hours after a heart attack = 30%  rate of survival • 3,500 hospitals studied = physicians failed to give to 1/16 patients • Total of 12,000 patients in 2004 alone ≠ simple life saving treatment

37. Wide variation, from state to state, from hospital to hospital and from physician to physician within the same hospital, in whether it is customary treatment • Massachusetts hospitals provided treatment 100% of the time. • Arkansas provided the treatment only 85% of the time. • Most states, some hospitals provided treatment 100% vs others in the same community provided it only 50% of the

38. Assumption that adherence to customs furthers quality of care? • Custom to provide long-term hormone replacement therapy (HRT) in post-menopausal women to reduce coronary artery disease • Randomized trial showed that HRT resulted in a higher risk of heart attacks, strokes and blood clots • Custom to give anti-arrhythmia drugs to everyone who experienced irregular heartbeats after a heart attack because severely irregular heart beats could rapidly turn fatal • Randomized trial showed that patients with only mildly irregular heart beats were more likely to die if given anti-arrhythmia medication

39. Two Additional Problems • “Physician agreement regarding quality of care is only slightly better than the level expected by chance.” • Apply locality, the same or similar community, or national standard?

40. Clearly Articulated Standing Rules Avoids Arbitrary Capricious Decision-making Limits Allocation Choices Of Officials Provides Fair Notice Of Conduct That Will Be Sanctioned Choices Based On Principles Not Personal Preferences Of Officials

41. “In-house” Standards • Measured by the • “[Hospital’s] standard of competence” • “Standard of the hospital • “Standard of the medical staff” • “General standards of the surgical committee.”

42. ‘Super-locality Rule’ = In-house Measurement • Majority of states reject the locality rule • Resources available to keep pace with modern trends • Availability of experts • Insularity = sub-standard degree of care and skill

43. Clearly Articulated Standing Rules Avoids Arbitrary Capricious Decision-making Limits Allocation Choices Of Officials Provides Fair Notice Of Conduct That Will Be Sanctioned Choices Based On Principles Not Personal Preferences Of Officials

44. Vagueness = No Fundamental Fairness • No notice to physicians • No limit on the discretion of the decision makers • No opportunity for meaningful judicial review • Unlink decisions from quality of care concerns • No justification for limitation of access to judicial system

45. Alternative Contractual Language • ‘Expectations of performance’ + CPGs • Avoid pitfalls of standard of care measurements? • More equitable balancing of the stakeholders’ interests?

46. Clinical Practice Guidelines (CPGs) • Institute of Medicine • “Systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.” • Based on clinical outcomes and effectiveness research • Integration of powerful computer technologies + treatment data • Optimum treatment approach

47. CPGs • Enhance the quality of care • Reduce variation in practice • Encourage “best medical practice” • ↓cost of care (lower cost choices with same outcomes) • Examples: • American College of Physicians, Clinical Efficacy Assessment Project • American College of Obstetrics and Gynecologists (“ACOG”) • American Academy of Pediatrics • Harvard CPGs for anesthesia administration • The American College of Cardiology (ACC)

49. Cardiology Department Working Committee Reviews CPGS From ACC Accepts/ Rejects Modifies To Fit Practice Group Paternalistic Libertarian Model Cass Sunstein Richard Thaler U. of Chicago Proposes CPGs To Cardiology Department

50. Clearly Articulated Standing Rules Avoids Arbitrary Capricious Decision-making Limits Allocation Choices Of Officials Provides Fair Notice Of Conduct That Will Be Sanctioned Choices Based On Principles Not Personal Preferences Of Officials