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History and Legal Regulation Of Medicine
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Shamanism
Oldest Medicine Primitive Tribes Alternative Medicine Integrates Religion And Medicine Persists Even Today In So Called Modern
Cultures
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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
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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
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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
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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
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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
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Scientific Medicine
Not The Philosopher's Scientific Method The Imperative To Disprove Theories The Full Disclosure Of Information Science Is Constantly Questioning And
Rethinking
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Paracelsus
Philippus Aureolus Theophrastus Bombastus Von Hohenheim
Early 16th Century Transition From Alchemy Experiments And Systematic Observations Antimony
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Anatomy And Function
Andreas Vesalius Mid 16th Century Accurate Anatomy
William Harvey Early 17th Century Flow Of The Blood And Operation Of The
Heart
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Edward Jenner
Smallpox Major Killer Wiped Out The Indigenous Peoples 1798 – Published His Book On Cowpox
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John Snow
Cholera In London Broad Street Pump Proved Cholera Is Waterborne 1854
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Ignaz Philipp Semmelweis
Childbed Fever Fellow Medical Student Died Controlled Studies 1849
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Louis Pasteur
Scientific Method Germ Theory Vaccination For Rabies Pasteurization 1860s-1880s
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William Morton
Dentist Ether Anesthesia 1846
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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
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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
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Tuberculosis Control - 1900
The Major Killer Koch And Pasteur Sanatoria Pasteurization Of Milk Disease Control Of Dairy Herds Effective Drugs Came Later
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Governmental Interests
Cross-Subsidize Government Programs Tax the Profession Political Influence of Professionals Draw on Professional Expertise
Traditional Public Health Traditional Mental Health
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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?
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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
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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
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Constitutional Limits on the Police Power
Civil Rights Chinese Laundry Cases Other Shams for Discrimination
Contraception Sterilization and Abortion Access to Adequate Pain Relief?
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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
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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
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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
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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
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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
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Post WW II Technology
Ventilators (Polio) Electronic Monitors Intensive Care Shift From Hotel Services to Technology
Oriented Nursing Became capital intensive
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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
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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
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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
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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
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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