pg. 1-10; 21-37; 99-107
I. Defining Sickness
A. What is diff b/w sickness and disease? Abnormal feeling vs. normal feeling. People can have disease but may not know it, or even feel sick. Is aging a disease or just something we all inherently go through. Do we treat aging as disease? Can lead to expenditures in order to avoid “disease” of aging.
B. Katskee v. BC/BS:Ambiguous insurance policy will be construed in favor of the insured
1. “Condition” Cardozo – pg. 7
2. Technology in health care é early detect à Insurers: how remote a risk will activate coverage?
3. A deviation from the healthy normal state affecting the functions or tissues of the body is essentially an illness even though it is not yet diagnosed.
4. The next step is for insurance companies to have exceptions for the coverage. It is a contract and exclusions can be agreed to. There is a debate about what is disease. One definition of disease focuses on whatever the doctor says a disease is. It may also be defined on what a person’s gratification desires it to be.
C. “A disease, condition or illness exists within the meaning of a health insurance policy excluding preexisting conditions only at such time as the disease, condition, or illness is manifest or active or when there is a distinct symptom or condition from which one learned in medicine can with reasonable accuracy diagnose disease.”
II.Quality in Health Care
A. Assessing Quality – pg 21.
1. Structure, Process and Outcome Measures of Quality
i. Structure (tangible)
d. No direct correlation with patient; indicia of quality of care but not good measure
ii. Process (intangible)
a. Examination of care
b. Methodology of applying structure
c. No strong scientific basis
d. Emphasis on tech (overuse?); high cost; lack of interpersonal relationships
iii. Outcomes (both)
iv. Page 24 #5
a. MM – outcome
b. Adverse events – outcome; aspects of process and structure
c. Disciplinary actions – process
d. Mal litigation – process
e. MD specialties – structure
f. Patient self-assessment – outcome
g. Scope of services – ?
2. Medical Practice Variation and the Nature of Quality
3. Other Methods of Quality Improvement
i. Data Mining – pg. 25
a. Done mostly by insurance qualities
b. Helpful in reducing costs
iv. Medicare & Medicaid
v. Mechanisms of financing
vi. Judicial processes
4. Clinical Standards of Practice
i. Berry v. Cardiology
a. Off-label; Dosage
b. Informed consent
c. Π defined quality of care w/ manual as b/w structure and process
d. Δ defined QOC as b/w process and outcome
ii. Jost’s “Oversight”
III. Public Health
A. The Constitutional Foundation of Public Health Law – pg. 99
1. Jacobson v. Massachusetts: Scope of state’s police power inc. authority to enact reasonable regulations to protect public health and safety
i. Regulation must reasonably relate to the goal of the law
ii. If a specific population is the target of the law is will be deemed unconstitutional
iii. If the law is applied to all groups of people it is likely the law will prevail if challenged
iv. No liberty interest in conduct that may put others at risk
2. Childhood immunizations; HPV Note: Factors mandating legislation
i. Cost; Long-term effects; Mode of transmission; Pathology of disease; Behavioral affects
pg. 115-126; 140-156; 158
A. In re Williams – pg. 117
1. The board of medicine is not required in every case to present expert testimony on the acceptable standard of medical practice especially when the majority of the board is already practicing physicians who likely do not need the explanatory help of experts. The charges must be supported however with some reliable, probative and substantial evidence.
2. Standard of Care
i. Where there is a law setting forth standard of care, expert not needed to testify to standard
ii. Where there is not a law in place, an expert witness is needed to establish standard of care.
iii. When there is a statute, all the testimony in the world by doctors saying the practice is appropriate standard of care does not excuse physician.
B. Hoover v. The Agency for Health Care Admin. – pg.120: An admin review board must give substantial weight to a hearing officer’s findings before supplanting findings and revoking medical license
A. Unauthorized Practice: State medical board generally has primary responsibility to enforce prohibition against unauthorized practice of medicine. It is enforced by criminal sanctions against an unlicensed practitioner and license revocation against any physician who aids and abets the unlicensed practitioner.
B. State Board of Nursing and State Board of Healing Arts v. Ruebke
1. The practice of lay midwifery does not constitute the practice of nursing and medicine for the purpose of statutory professional regulation
2. Assistance in childbirth rendered by one whose practical experience with birthing provides comfort to the mother is not nursing under the nursing act, such that licensure is required.
3. The points to remember here include think about the actions of the midwife.
III. Scope of Practice Regulation
A. Practice: Theme of indeterminacy in what constitutes “practice.”
1. Licensed non-physician health care providers cannot legally practice medicine but practices that fall within their own licensure are not considered practice of medicine. (PAs & RNs) It isn’t until they exceed practices of their position that they become guilty of unauthorized practice of medicine.
2. Scope of practice regulation focuses on boundary setting b/w professions and attempts to separate medicine from nursing and other health disciplines.
3. The problem in defining the scope of practice is that regulation depends on identifying discrete activities that “belong” to each profession, it applies a notion that reflects neither overlapping competencies of health care professionals not nature of treatment for illness or injury.
B. Sermchief v. Gonzales – pg. 150
1. Nurse may perform certain medical procedures w/o engaging in authorized practice of medicine
2. Court found that statue permitted nurses to provide services “so long as those responsibilities are consistent with her or his specialized education, judgment and skill based on knowledge and application of principles derived from biological, physical, social and nursing sciences.”
C. Physician Assistants – Problem on 156. Drs’ want to set up an office and staff it with PA instead of always being there themselves. What they want to know is if they are going to get into trouble if they proceed with their plan. Typically the smart lawyer would structure the new partnership in order to classify out of liability under the current state laws, at least until the legislature makes a new requirement for the new entity.
1. What is diff between a physician assistant and a nurse midwife? P.A.s may not act without the supervision of a Dr. the nurse midwife works independently with the Drs’ availability as needed.
2. Physician assistants are educated in a medical model of care and view themselves as practicing medicine through physician delegation of tasks and under the supervision of physicians.
3. Nurse practitioners or advanced practice nurses view themselves as operating from a nursing model of care and acting independent practitioners who collaborate with physicians.
4. Currently, organized medicine says that they both operate under the supervision of Drs’ but the American Nursing Assoc. rejects that idea.
I. New Health Care Services Configurations
1. Agencies cannot exceed their scope of authority in regulating facilities.
2. Structures of healthcare organizations change in order to fall out from under regulation scope of agency, and then new regulation has to be promulgated.
3. Private in home care providers usually not licensed nor required to be
4. CLIA and OSHA may have some authority over DRs Offices.
5. ILCS defines a home health agency on pg 160. Home health agencies have not always been federally reimbursable UNLESS licensed by the state. So state’s implemented licensing requirements.
6. Independent assisted living facility: provide some sort of interface w/ health care professionals
7. Quest: what is appropriate level of regulation over these types of entities?
B. Mauceri v. Chassin
1. Provision of names of home health aides = arrangement of home health care services by statute
2. Construction given to § by agency charged w/ implementing it should be upheld if not irrational
3. Licensing used as oversight mechanism
4. Public Health Law: home care services agencies must comply w/ statutory licensing requirements
A. Differences Between Hospitals and Nursing Homes
1. Patient population and scope of services
i. Nursing homes treat chronically rather than acutely ill patients.
2. Impact of private litigation over quality
i. Characteristics of the nursing home population historically limited their ability to bring suit for harms
from a physician-patient relationship. Physicians who cannot fulfill their on call responsibilities must provide notice as soon as practicable once they learn of circumstances that will render them unavailable
vi. In a negligence action, if the harm is particularly foreseeable, a duty will be recognized
vii. Generally, a physician-patient relationship is created only where physician personally examines patient. However, under certain circumstances, courts have recognized a physician-patient relationship in absence of any personal contact b/w physician and patient.
viii.Absent an MD-PA relationship, no duty exists and a med mal claim must fail
ix. Where the consultant physician does not physically examine or bill the patient, a physician-patient relationship can still arise where the physician is contractually obligated to provide assistance in the patient’s diagnosis or treatment and does so.
B. Specific Promises and Warranties of Cure
1. Mills v. Pate
C. Partial Limitations on the Right to Sue
1. Protecting Patient Choices
II.Informed Consent: The Physician’s Obligation
A. Origins of the Informed Consent Doctrine
B. The Legal Framework of Informed Consent
1. Negligence as a Basis for Recovery
i. Canterbury v. Spence – pg. 233: Prior to a medical procedure, MD must disclose to PA all risks reasonable person would consider significant in deciding whether to undergo procedure
ii. Medical Community Standard (minority) applied in Canterbury
iii. Majority standard: Expert Testimony required in cases dealing w/ lack of informed consent
iv. Duty of Care: principle of negligence requiring individual to act in manner as to avoid injury to person to whom owes obligatory duty
v. Fiduciary Duty: person holding legal obligation to act for the benefit of another
2. Disclosure of Physician-Specific Risk Information: Johnson v. Kokemoor:
i. It is not an abuse of discretion for a trial court to admit physician-specific evidence in a case involving the doctrine of informed consent
ii. Failure to obtain informed consent can leave MD vulnerable to charge of battery
iii. Success on claim based solely on lack of informed consent extremely rare b/c difficult for Π to satisfy element that they would have refused treatment had they been fully informed of all the risks or the totality of the magnitude of the risks
iv. Success hinges on magnitude disparity assoc. b/w risks presented to PA v. actual risks
3. Damage Issues: Tisdale v. Pruitt, Jr. M.D. – pg. 279:
i. A patient’s acquiescence to a medical procedure may not be tantamount to consent
ii. Doctor is under an affirmative duty to tell PA, prior to serious medical case:
b. Nature of contemplated case
c. Risks involved
d. Probability of success
e. Risks of foregoing procedure
iii. There must have been affirmative communication b/w MD and PA
iv. Punitive damages usually only available when gross negligence or recklessness exist
4. Exceptions to the Duty to Disclose: Canterbury v. Spence – pg. 283:
i. MD bears burden of going forward w/ evidence pertaining to a privilege not to disclose
ii. PA establishes prima facie case à MD has to raise the issue of privilege
iii. Consent may be presumed in some cases of medical emergency
III. Informed Consent: The Institution’s Obligation
IV. Confidentiality and Disclosure in the Physician-Patient Relationship
A. Federal Medical Privacy Standards
1. Herman v. Kratche – pg. 302
2. Only electronically transmitted medical info, i.e. provider claims (faster payment is incentive)
3. Standards for Privacy of Individually Identifiable Health Information
i. PHI – 45 CFR § 160-164
ii. Covered entities