History and Legal Regulation Of Medicine

2 Shamanism Oldest Medicine Primitive Tribes Alternative Medicine Integrates Religion And Medicine Persists Even Today In So Called Modern Cultures

3 Explicitly Ministers To The Psyche And The Body Often Sophisticated Rituals And Herbals Driven By Myths Trial And Error And Careful Observation Some Cure, Most Do Not Leviticus Public Health Code Rules Reduce Food Poisoning

4 Useful Pharmacopeia Ethnobotany Study Of Plants Used By Ritual Healer Many Drugs Have Been Discovered This Way Witches Used Foxglove - Digitalis Medicinal Chemists Refine And Modify Botanicals

5 Greco-Roman Rationalism Galen And Successors Driven By Rational Theories Religion Is Left To Priests Observations Forced To Fit Into The Theory Plato Was Terrible About This Mistakes Are Not Corrected Persisted Until 16th Century

6 Hospitals as Religious Institutions Started in Europe in the Middle Ages Some of the Oldest Institutions in Continuous Operation Run by Nursing Sisters For the Poor More Egalitarian in the United States

7 Nursing Only Church Did Not Sanction Medical Care Goal Was to Alleviate Suffering Ease the Transition to Heaven Most Died From Their Illnesses Only the Very Sick Entered Excellent Environment for Infectious Diseases Changed With Technology in the 1880s

8 Scientific Medicine Not The Philosopher's Scientific Method The Imperative To Disprove Theories The Full Disclosure Of Information Science Is Constantly Questioning And Rethinking

9 Paracelsus Philippus Aureolus Theophrastus Bombastus Von Hohenheim Early 16th Century Transition From Alchemy Experiments And Systematic Observations Antimony

10 Anatomy And Function Andreas Vesalius Mid 16th Century Accurate Anatomy William Harvey Early 17th Century Flow Of The Blood And Operation Of The Heart

11 Edward Jenner Smallpox Major Killer Wiped Out The Indigenous Peoples 1798 – Published His Book On Cowpox

12 John Snow Cholera In London Broad Street Pump Proved Cholera Is Waterborne 1854

13 Ignaz Philipp Semmelweis Childbed Fever Fellow Medical Student Died Controlled Studies 1849

14 Louis Pasteur Scientific Method Germ Theory Vaccination For Rabies Pasteurization 1860s-1880s

15 William Morton Dentist Ether Anesthesia 1846

16 Joseph Lister Antisepsis s Listerine

17 Koch s Koch’s Postulates Agent Must Be Present In Every Case; Agent Must Be Isolated From The Host And Grown In Vitro [In A Lab Dish]; Agent Must Cause Disease When Inoculated Into A Healthy Susceptible Host; And Agent Must Be Recovered Again From The Experimentally Infected Host. Limitations

18 Organic Chemistry – 1880s German/Swiss Dye Industry Bayer Hoffman La Roche Ciba Became Drug Chemistry

19 Sanitation Movement in Public Health Food Sanitation Water Sewage Life Expectancy Goes from 25 – 50+ fast Slowly Rises to 76.5

20 Tuberculosis Control The Major Killer Koch And Pasteur Sanatoria Pasteurization Of Milk Disease Control Of Dairy Herds Effective Drugs Came Later

21 Antibiotics Sulfa Drugs In The 1930s Penicillin Alexander Flemming – 1928 Purified By Chain And Florey In 1939 Streptomycin – 1944 First Antituberculosis Drug Selman Abraham Waksman – 1944 (Coined The Term Antibiotic

State Regulation of Medical Practice

23 Pre-Constitutional Period Limited Occupational Licensing NY Passed Licensing Law in 1760s Not Enforced Extensive Public Health Regulation Old Notion of Dirt Nuisance Managing Fear People Terrified of Epidemic Disease Yellow Fever and the Constitution

24 Constitution - Post Civil War Jacksonian Populism and Distrust of Institutions Decline of Occupational Licensing Existing Laws Were Rescinded Doctors Lawyers Continued Growth of Public Health Regulation Driven by Snow’s Discoveries Shattuck Report – Boston

25 Schools of Practice – Mid 1800s Allopathy Opposite Actions Toxic and Nasty Homeopathy Same Action as the Disease Symptoms Tiny Doses Less Dangerous Naturopaths, Chiropractors, Osteopaths, and Several Other Schools

26 Legal Consequences of Schools of Practice No Testimony Across Schools of Practice Different from Medical Specialties Surgery, Internal Medicine, Pediatrics All Same School of Practice - Allopathy All Same License Cross-Specialty Testimony Allowed

27 Locality Rule Medicine was judged based on the community you were in If you were in the sticks, you had to show that the care was below the standard for the sticks, not for Boston Made it almost impossible to bring claims Provided little inventive to improve practice Still applies to hospitals in some situations

28 The Profession s Most Medical Schools are Diploma Mills No Bar to Entry to Profession Small Number of Urban Physicians are Rich Most Physicians are Poor Cannot Make Capital Investments Training Medical Equipment and Staff Physicians Push for State Regulation

29 The Role of Legal Regulation in Professionalizing Medicine Protection of Licensees Quality of Care Availability of Care Fair Pricing Governmental Interests

30 Protection of Licensees Critique from the Left Paul Starr - Social Transformation of American Medicine Critique from the Right Milton Friedman “Hostile” v. “Friendly” Licensing Not Incompatible with Other Goals

31 Quality and Availability of Care Require Training Exclude Unorthodox Practitioners Discipline Incompetent or Impaired Docs Subsidize Indigent Care with Required Treatment Mandates EMTALA Medicare/Medicaid Non-Discrimination Rules

32 Fair Pricing Sustain Prices to Assure Supply Prevent Monopoly Pricing Prevent Gouging Based on Patient’s Limited Bargaining Position Emergency Conditions Emotional Vulnerability Lack of Knowledge This never worked very well

33 Governmental Interests Cross-Subsidize Government Programs Tax the Profession Political Influence of Professionals Draw on Professional Expertise Traditional Public Health Traditional Mental Health

34 Medicine and Surgery Medicine Starts to Work Surgery Can Be Precise Patients Do Not Get Infected Professionalism Starts to Matter What is a Quack if Nothing Works? Why Train if Training Does Not Matter?

35 Authority to Regulate Medical Care and Public Health - The Police Power Historical Right of Societal Self-Defense Central Colonial Function Not Police Forces Public Health and Safety Left to the States by the Constitution Can Be Preempted by Federal Legislation Tobacco Labeling Medical Device Labeling

36 Constitutional Attacks on State Regulation of Medicine Equal Protection/Due Process Discriminating Based on Training Discriminating Based on Theory of Practice License as Property Right Inception of Licensing Laws Discipline of Licensees All Trumped by Police Power

37 Constitutional Limits on the Police Power Civil Rights Chinese Laundry Cases Other Shams for Discrimination Contraception Sterilization and Abortion Access to Adequate Pain Relief?

38 Licensing and Education Mid to Late 1800s Physicians are Solo Practitioners Most Make Little Money Have Limited Respect Effective Medicine Drives Licensing Licensing Limits Competition Physicians Start to Make Money Makes sense to invest in training

39 Consolidation of Power American Medical Association Gains Power Linked State and Local Societies to the National Society Linked Medical Staff Membership to Local and State Society Members Exclusionary Politics Blacks Women Jews

40 Reform of Medical Education Schools with High Standards Could not Compete Degree Cost More Took More Time Did not Affect Entry to Practice or Success Race to the Bottom Schools Were Closing Curriculum was Weakening

41 Outside Forces Carnegie Foundation “Flexner Report” Most Schools Failed Not Like US News and World Report Rankings Incentives to Change Foundation Money Student Selection Pressures

42 Effect of Licensing State Required Training in Approved Programs Some Programs Were Not Approved Some Unorthodox Practitioners Had Their Own Schools so They Cooperated Students Had an Incentive to Attend a Better School

43 How Did Medical Schools Change? Professionalism of Faculty Full-Time Salaried Positions Education Requirements Emphasis on Research Driven by Outside Money Reinforced by the Success of the Research Development of Modern Residency Training

44 What Happened to Unorthodox Practitioners? Homeopaths and Osteopaths Homeopathic Schools Closed Osteopathic Schools Evolved to be Much the Same as Other Medical Schools Osteopaths are Now Licensed and Treated the Same as Other Physicians Chiropractors Politically Very Powerful Got Their Own License and Allowed to Keep Practicing

45 Where Are We Now? All States Require A Medical School Degree Most Require One Year Post-Graduate Residency Training No States Have Separate Licenses for Specialties Private Certification of Medical Specialties Required by Most Hospital and Health Plans Extra Training and Examinations

46 Hospital-Based Medicine Started With Surgery Medical Laboratories Bacteriology Microanatomy Radiology Services and Sanitation Attract Patients Internal Medicine Obstetrics Patients

47 Reformation of Hospitals Paralleled Changes in the Medical Profession Began in the 1880s Shift From Religious to Secular Began in the Midwest and West Not As Many Established Religious Hospitals Today, Religious Orders Still Control A Majority of Hospitals

48 Post WW II Technology Ventilators (Polio) Electronic Monitors Intensive Care Shift From Hotel Services to Technology Oriented Nursing Became capital intensive

49 Post World War II Medicine Conquering Microbial Diseases Vaccines Antibiotics Shift to Chronic Diseases Better Drugs Better Studies Leukemia Chronic Diseases are much more lucrative

50 Hospitals Shift From Nuns to Paid Staff Advantages of Nuns Work Cheap Work Long Hours Well Organized and Disciplined Keep Physicians In Line Supply Plummets Replaced With Paid Staff Not Many Nuns Even In Religious Hospitals

51 Joint Commission on Accreditation of Hospitals 1950s Now Joint Commission on Accreditation of Health Care Organizations American College of Surgeons and American Hospital Association Split The Power In Hospitals Medical Staff Controls Medical Staff Administrators Control Everything Else Enforced By Accreditation

52 Legal Implications of Staffing Changes Old Days Charitable Immunity No Independent Liability for Nurses – who wants to sue a nun? No Liability for Physicians 1970s Demise of Charitable Immunity Liability for Nursing Staff Negligent Selection and Retention Liability for Medical Staff

53 Contemporary Hospital Organization Classic Corporate Organizations CEO Board of Trustees Has Final Authority Part of Conglomerate Medical Staff Committees Tied To Corporation by Bylaws Headed by Medical Director Constant Conflict of Interest/antitrust Issues

54 Hospital Economics - Old Days Patients Are Necessary More Patients Meant More Money Docs Admit Patients Insurance Was So Generous It Cross- subsidized Indigent Care

55 Hospitals Have High Fixed Costs Capital Costs Not Built on the Donations of the Faithful Anymore Ancillary Services Lab, Etc., Must Be up for Even One Patient Nursing Can Be Cut Back, but Only by Closing Units Pretty Hard to Get Excited About Malpractice Risks Unless You Can Fill Every Bed in the Hospital

56 Value of An Admitting Physician Only 2 Cases a Day, Average Stay a Week Each Case Is Worth $15,000 to the Hospital Over the Week 10 Beds Filled at Any One Time Take a Month Off, Have a Few Slow Days, Say Only 400 Patients a Year. $6,000,000 a Year If You Are Sloppy, They Just Stay in the Hospital Longer

57 Right to Die - Old Days Technological Imperative Every Day Every Procedure Every Increasing Stage of Intensive Care Big Money Just Making It Past Midnight Might Be Worth Another $2,000.

58 Physicians Owning Hospitals Originally Was Unethical to Own a Hospital Conflict of Interest Exception for Small Towns Changed When Hospitals Made Money Characteristic of Medical Ethics Lawyer Ethics Are Also Pretty Flexible HCA Was The Model - Interesting Times

59 Physician Practices Pre-1990 Sole Proprietorships Partnerships Mostly Small Some Large Groups First Organized As Partnerships Then As Professional Corporations Shaped by Corporate Practice Laws

60 Corporate Practice of Medicine Physicians Working for Non-physicians Concerns About Professional Judgment Cases From 1920 Read Like the Headlines Banned In Most States Real Concern Was Billing By A Non- physician Not as strict in Louisiana, but followed national staffing models

61 Impact of Corporate Bans Physicians Do Not Work for Hospitals Contracts Governed by Medical Staff Bylaws Sham of “Buying” Practices Physicians Contract With Most Institutions Charade of Captive Physician Groups Managed Care Companies Contact With Group Group Enforces Managed Care Company’s Rules Physicians Can Be As Ruthless As Anyone

62 Where Do Physicians Get Business? Just Like Lawyers Outside of Texas No Referral or Finders Fees Unlike Lawyers, Docs Generally Do Not Pay Them Because of Real Penalties Goodwill, No Grief on Peer Review Now Patients Are Controlled by Managed Care Organizations

63 Stark and Fraud and Abuse Cannot Pay Incentives for Referrals Cannot Have Ownership Interests That Give the Doc an Incentive to Refer Cannot Sell Patients to the Highest Bidder

Medical Staff Privileges Not covered in this lecture

65 Medical Staff Privileges Physicians are Independent Contractors Hospitals Are Not Vicariously Liable for Independent Contractor Physicians Hospitals Are Liable for Negligent Credentialing and Negligent Retention Hospitals Can Be Liable if the Physician is an Ostensible Agent

66 Medical Staff Bylaws Contract Between Physicians and Hospital Not Like the Bylaws of a Business Selection Criteria Contractual Due Process For Termination Negotiated Between Medical Staff and Hospital Board

67 State Actor Hospitals Special Concerns About Due Process and Equal Protection Cannot Delegate Some Decisions to Special Groups Cannot Require Medical Society Membership May Be Restricted on Requiring Board Certification All Hospitals Must Follow General Anti- discrimination Laws

68 Review Criteria Decision Rests With Board of Directors Review Is Done by Medical Staff Committee Increasing Pressure to Use Independent Reviewers Medical Education There Are Impostors Medical Licenses Verify With Every State Problem With Liars

69 Postgraduate Training Most Hospitals Require Board Certification Board Certified Physicians Control The Process Reduces Liability for Negligent Selection Letter From Residencies Evidence of Board Certification "Board Eligible”

70 References From Other Hospitals Every Hospital You Ever Applied to Circumstances of Terminations Withdrawn Applications Should Check

71 Review of Privileges Privileges Can Be Limited Can Require Supervision Can Refuse to Renew Privileges Can Terminate Privileges Can Do an Emergency Suspension

72 Acceptable Grounds for Termination Competence Judgment Getting Along With Others Economic Credentialing

73 What Is the Impact of Adverse Privilege Determinations? If Every One Uses the Same Criteria and Relies on Previous History, You Are Dead Parallel Action The National Practitioner Databank National Clearing House Why Have One? Problem of Liars Malpractice And Peer Review Will It Be Opened up?

Managed Care and DRGs

75 Managed Care Pressures on Hospitals DRGs Capitation Negotiated Reimbursement Still Need Butts in Beds Must Get Them Out Quick and Cheap Death Can Be Very Cheap Right to Die – Yes Please Do!!

76 Managed Care Pressures on Docs When is Denying Care Cheaper? What is the Timeframe Issue? Insurers Now Control the Patients Employee Model Contractor Model De-selection Financial Death No Due Process

77 New Challenges Aging Population Emerging Infectious Diseases Antimicrobial Failure New Agents (HIV, Ebola) How To Pay For Health Care How To Deliver Health Care Medical Business Organizations