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 1867-1880s Listerine

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Koch - 1880s

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

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Sanitation Movement in Public Health

Food Sanitation Water Sewage Life Expectancy Goes from 25 – 50+ fast Slowly Rises to 76.5

20

Tuberculosis Control - 1900

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 - 1850

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 - 1870s

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

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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