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Health Law
St. Louis University School of Law
Watson, Sidney D.

Watson – Health Law Outline – Fall 2013
            A. Access, Quality, Cost and Choice
            B. Allocating/Rationing Medical Care
                        1. What Factors Are Important? (Where Should Law Look?)
                                    a) Medical opinion/judgment
                                    b) Medical and scientific factors
                                    c) Social science data
                                    d) Ethical factors
                                    e) Ability to pay
                                    f) Patient’s choice
                        2. Who Should Decide?
                                    a) Doctor
                                    b) Independent medical organization
                                    c) Federal (or state) agency
                                    d) Judge
                                    e) Hospital ethics committee
                                    f) Private organizations
                                                1) God Squad in Seattle
                                    g) Multi-disciplinary blue ribbon panels
                                    h) Market competition (Greaney)
3. Role of Law
            a) Law vs. Medicine v. Social Science
C. Challenges in Defining “Good” Quality Care
                        1. Limited knowledge
                        2. Local practice variations
                        3. Historical reliance on “custom” in medical community as “quality”
                        4. Measuring quality by its impact on population health
            D. Law and Public Health
                        1. Standard of Review
                                    a) Decision-Maker
                                    b) Standard
                                    c) Role of Medical Review
                        2. History as Coercive Law
                                    a) History, Use and Effectiveness
                                    b) Potential of Misuse against Stigmatized Groups
                        3. Focus on Population Health
                                    a) Collective Measures of Outcomes
                                    b) Risks/Benefits
4. Organ Transplants vs. Childhood Vaccinations
                                    a) Sarah Murnaghan
b) Jacobsen v. Massachusetts (1905)
                                                1) Requirement of vaccination to stop smallpox epidemic
2) Constitutional law question – state has power to enact laws for the health of the population
3) But also provides legislature power to make judgments on scientific questions relating to public health
E. Medical vs. Public Health Problem
                        1. Obesity
                        a) Public health = forcing people to do something…
                        b) Medical = paying for care through insurance; able to discuss with Drs.
2. ACA more about population and public health
                                    a) preventative medicine, rather than only when a person is “sick”
            A. Professionals’ Licensing, Certification and Registration
                        1. Introduction
                                    a) Allopathic
                                                1) Western medicine
2) MD, DO, RN, NP, PA, primary care, specialties
                                    b) Alternative/Complementary
                                                1) Homeopathic
                                                2) Midwives
                                    c) State Licensing Boards
                                                1) Board of Healing Arts
                                                2) Nursing Board
                                    d) Layers of Law
                                                1) Fed. Constitution
                                                2) State Constitution
                                                3) Licensing Statute
                                                4) Agency/Board Regulations
                                                            i) Promulgate Regulations
                                                            ii) Adjudicatory Authority
                                                            iii) Subregulatory Policies
                        2. Overarching Legal and Policy Issues: Professionals
                                    a) READ THE STATUTE!
1) What does it say you have to be licensed for and what can you do under the license?
2) FDA and DEA Authority
b) Licensing vs. Board Certification vs. Registration
                                                1) License = public, state statute, general
                                                            **insurance only pays for licensed professionals/providers
                                                2) Board Cert = private, practice for a few years, specialized
                                                3) Registration = don’t have to pass exam, sign up; not licensed
                                    c) Standard of Review – Agency Hearing Decisions
1) In an appeal from an admin agency, a reviewing court is bound to uphold the agency’s order if it is…supported by reliable, probative and substantial evidence, and is in accordance with the law; deference standard
2) In Re Williams (1991)
i) Whether a Dr. prescribing drugs later banned can be punished for being below the Board’s standard of care
ii) When there are two established schools of thought, cannot use its own preference/opinion as evidence of standard of care
iii) In order to get “deference” need to present expert testimony because the judge is NOT an expert
iv) Board needed to present evidence of violation
                                                3) In Re Guess (1990)
i) Whether practice of homeopathy falls outside acceptable state practice
ii) Did not qualify as acceptable medical practice because it was not developed through acceptable methods of research and approval by medical board
iii) Statute will be upheld, unless it has no rational relationship to legitimate public purpose (police power)
iv) Strict construction, deference to state legislature
                                                4) In Re Hoover, Hoover v. Agency for HCA (1996)
i) Agency filed an admin complaint against Hoover for excessively prescribing controlled substances
ii) Must admin review board give substantial weight to a hearing officer’s findings before supplanting the findings and revoking a license to practice medicine?
                                    d) Standard of Review – Agency Rule Making
1) Are the rules such a failure of duty/violation of the law as to be arbitrary and capricious? (abuse of discretion?)
2) Smith v. Heckler (1984)
i) Whether trial court erred in finding that Secretary does not have statutory duty to develop and implement a system of nursing home review and enfo

  b) Licensing vs. Accreditation vs. Payer Certification
1) Licensing = mandatory state grant allowing you to practice or operate, requires meeting certain criteria
2) Accreditation = nongovernmental, voluntary, typically conducted by not-for-profit organizations; private review for quality purposes
3) Payer Certification = certain minimum standards required to receive funding
                                    c) Scope of Judicial Review
                                                1) Agency Hearing Decisions – Arbitrary and Capricious
                                                2) Agency Rule Making – Deference, Substantial Evidence
                                                3)  Fairfax Nursing Home v. HHS (2002)
i) Nursing facility sought judicial review assessing civil monetary penalty for facility's failure to comply with Medicare regulations
ii) Determination that state of immediate jeopardy to resident health existed at facility; supported by substantial evidence
                        3. Issues in Licensing of Institutions
                                    a) Allocation of Federal/State Authority in Medicaid
1) cooperative federalism – in order to receive funds, states must comply with federal regulations
                                    b) What should licensing standard measure?
                                                1) patient focused (Smith)
                                                2) patient-centered care (ACA)
                                                3) structure/process/outcome (Donabedian)
                                                4) technical, interpersonal, amenities
                                                5) patient satisfaction
                                    c) How do you draft standards?
                                                1) Nursing Home Compare Problem
                                                            i) site is an example of market accountability
ii) give the public the most information possible for decision-making
                                                            iii) transparency and accountability
                                                2) Setting Standards for Staffing Problem (154)
i) increasing staffing is likely to raise costs, but should it also raise payment levels by Medicare and Medicaid?
ii) as the payer, how do I make sure the extra money goes towards staffing and not extra profit?
                                    d) How do you comply with standards?
                                                1) Residents’ Right Problem (155)
                                                            i) requirements relating to residents' rights and quality                                                                      ii) tension between QUALITY and CHOICE