HEALTH LAW
MONAHAN
SPRING 2013
a) General
i) World Health Organization (WHO) defines health as “[a] state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” and states that “Gov'ts have a responsibility for the health of their peoples which can be fulfilled only by the provision of adequate health and social measures.” Health can also be viewed in a more limited sense as the performance by each part of the body of its “natural” function.
ii) These definitions tend to be more descriptive and less value-laden. Ex: “Disease is then a biological malfunction, a deviation from the biological norm of natural function.”
iii) Illness can be viewed as a subset of disease. An illness must be, first, a reasonably serious disease with incapacitating effects that make it undesirable
iv) There are, then, two sense of “health.” In one sense it is a theoretical notion, the opposite of “disease.” In another sense it is a practical or mixed ethical notion, the opposite of “illness.”
v) Illness is thus a socially constructed deviance. Something more than a mere biological abnormality is needed. Defining a condition as an illness to be aggressively treated, rather than as a natural condition of life to be accepted and tolerated, has significant economic effects. Impacts of defining a condition as an “illness”
(1) Treatment options; Financing; Life style; Financial consequences; Research; Moral/Normative
vi) General sense that things have been over-medicalized.
vii) Katskee medical syndrome is one where P bears no responsibility. What about “diseases” when those conditions or syndromes within the control of the individual. Ex: alcoholism, obesity, etc.
b) KATSKEE v. BCBS – NEBRASKA, (S.Ct. of NE, 1994) – pg. 3
i) Determination of what constitutes an illness within the meaning of a health insurance policy issued by BCBS
ii) Facts/Procedure: P diagnosed with genetic syndrome that makes it more likely the woman will develop breast and/or ovarian cancer. P decided to have despite surgery, BCBS determination that it would not cover the surgery. P filed this action of breach of contract to recover $6,022.57
iii) Analysis
(1) What is covered by the policy:
(a) Find: language is not ambiguous. The plain and ordinary meaning of the terms “bodily disorder” and “disease” as they are used in the policy to define illness, encompasses any abnormal condition of the body or its components of such a degree that in its natural progress would be expected to be problematic.
(2) whether appellant's condition constituted an illness:
(a) BCBS – no illness b/c P did not have cancer
(b) Find: Record establishes that a woman who suffers from this condition has a physical state which significantly deviates from the physical state of a normal, healthy woman and the surgery was covered
(3) When a condition is such that in its probable and natural progression it may be expected to be a source of mischief, it may reasonably be described as a disease or an illness. On the other hand . . . If the condition is abnormal when tested by a standard of perfection, but so remote in its potential mischief that common speech would not label it a disease or infirmity, such a condition is at most a predisposing tendency. (Chief Justice Cardozo in Silverstein v. Metro. Life Ins. Co., 1930)
c) Problem: The Couple's Illness; pg. 10
i) Infertility issues: defining illness
d) What Medical Care is and isn't – Some misconceptions about medical care (pg. 10-15)
i) All knowing doctor myth
ii) Best treatment myth
iii) Medicine as an exact science myth
iv) Standardized products myth
v) Life/Death/Serious Pain Myth
vi) More medical care is better than less care Myth
II DISTRIBUTIVE JUSTIVE
a) Should health care goods be distributed on a different basis than other consumer goods?
b) Bases for distribution:
i) Market allocation: consistent with libertarian approach to health care. If people value healthcare, they will allocation resources, if they don't, they won't and that is there prerogative and their burden.
ii) Equal opportunity: consistent with liberal re-distribution of wealth approach to healthcare. Saying that people have a right to a basis level of health and wealth should be redistributed to the extent necessary to have the population meet this basic level of health.
iii) There are hints of both of thes approaches in the health care system. Mostly free-choice but there are safety-nets
c) Allocation and Rationing
i) Through allocation, a society determines what portion of its resources to devote the a particular purpose. (ex: Health care v. defense v. education, etc.)
ii) Through rationing, a community decides which specific individuals receive available resources.
iii) Allocation and rationing decisions often treat the loss of human life inconsistently, with greater tolerance for “statistical lives” lost and much less tolerance for the loss of “identifiable lives”
iv) Allocation deals mostly will statistical lives, while rationing most often deals with identifiable lives.
v) US relies on the market to allocate most, but not all, health care resources
d) RATIONING SCARCE HUMAN ORGANS
i) Human organs are a good case study of how we ration scare resources. No amount of funds will fix the problem.
ii) What criteria should be used to ration available organs?
(1) Medical indications relating to survivability with and without transplant neutral standards?
(2) Age? Children, family?
(3) Regional v. national pools?
(4) Who can get on what waitlists
iii) Problem: Selecting an Organ Transplant Recipient (Pg. 76-78)
e) The Organ Procurement Transplant Network
i) National Organ Transplant Act (NOTA) requires that the HHS establish an Organ Procurement Transplant Network (OPTN) to organize the retrieval, distribution and transplantation of human organs.
ii) HHS contracts with the United Network for Organ Sharing (UNOS), a private nonprofit organization, for management of the federal OPTN.
iii) new regulation in 1999 intended to ensure OPTN policies complied with NOTA requirements. UNOS revised a good number of policies post 1999 regulations.
iv) Geographic Distribution of Organs
(1) Prior to 1999 regulation, UNOS policy was to keep organs in the geographic area where they were recovered. Median waiting times varied considerably by region. (Rationale = reduce damage to organs from preservation during transport; improve organ quality' reduce costs incurred; increase donations)
(2) Now, all organs (except thoracic organs) are allocated based on medical urgency rather than geography. Despite this change, geographic disparities in waiting times exist.
(3) Multiple listings
(4) Several states have enacted laws which favor intra-state distribution by placing restriction on out-of-state organ transfers.
(5) Global market in organs; condemned by UNOS Ethics Committee
v) Listing Patients for Transplantation
(1) Individual doctors and hospitals decide who get on the UNOS registry and when. physicians exaggerated their patient's medical condition to move them up higher on the list
(2) Prioritizing criteria varies by the organ. Common examples: time on list; medial status; greatest survival benefit.
(3) Psychosocial factors traditionally have played large role in considering which patients receive organs. UNOS Ethics Committee has expressed concern over the use of nonmedical transplant candidate criteria but still justifies the use of certain non-medical criteria based on the shortage of available organs for transplantation.
(a) Patients contribution to condition; compliance with medical recommendations; repeat transplantation; availability of alternative therapies
vi) Kidney Matching and Disparate Impact by Race
vii) Problem: Setting Priorities – Pg. 83
III PUBLIC HEALTH (PG. 95-114)
a) What is public health?
i) What we as a society do collectively to ensure the conditions in which poeple can be healthy (ION definition)
ii) Using law, through a state's police power, to enhance health.
iii) State's ability to act to protect the health, safety and welfare of its citizens.
b) 8 areas of public health
i) Environmental health laws
ii) Reporting of disease and injury
iii) vital statistics
iv) Disease and injury control
v) Involuntary testing
vi) Contact tracing
vii) Immunization and mandatory treatment
viii) Personal restrictions
c) Problem: Obesity as Epidemic? (pg. 98-99)
d) Constitutional Issues
i) Pressures between individual liberty and good of society
ii) JACOBSON v. MASSACHUSETTS, 1905
(1) Enforced vaccination of all inhabitants (free) and tax on those that refuse to comply ($45)
(2) The liberty secured by the Constitution does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. Real liberty could not exist under the operation of a principle which recognizes the right of each individual person to [do what he wants] regardless of the injury
hnology, and the substantial history of conflict between medical and other approaches to child birth.
c) SCOPE OF PRACTICE REGULATION
i) Scope of practice regulation focuses on boundary-setting between the professions and attempts to separate medicine from nursing from other health care disciplines. In doing so, it faces an inherent difficulty, as you saw in Ruebke.
ii) Modern health care delivery regularly consists of multi-professional groups including nurse practitioners, doctors, physician assistants, and others.
iii) One compromise position that is often taken on the regulatory front in expanding the scope of practice of non-physician health care professionals is to require that they practice only under the supervision of a licensed physician.
iv) SERMCHIEF v. GONZALES, S.Ct Missouri, 1983. (pg. 151)
(1) Petition for a declaratory judgment that the practices of the Agency nurses are authorized under the nursing law of this state and do not constitutes the unauthorized practice of medicine.
(2) Analysis
(a) Reading of the laws affect nursing profession show legislative desire to expand the scope of authorized nursing practices. Most apparent is the elimination of the requirement that a physician directly supervise nursing functions.
(3) Conclude: the acts of nurses clearly fall within this legislative standard & “we” see nothing in the stature purporting to limit or restrict their continued use.
v) Authority to prescribe medication has been a major issue in debates over the appropriate scope of practice of nurses and physician assistants as well as other non-physician providers.
(1) Most states now authorize nurses to prescribe medications, at least under a doctor's supervision.
vi) PAs and nurses have assumed different professional identities.
vii) States handle delegation and licensure of PA differently
viii) Negligence and malpractice litigation forms the greatest volume of litigation involving scope of practice.
ix) Problem: Physicians, Physician Assistants, and Nurses – Pg. 156-158
V INSTITUTIONAL QUALITY CONTROL (pg. 159-176; Text 191-194)
a) New focus on data: State and federal gov'ts are making efforts to strengthen the influence of the market over the quality of health care facilities. Most of these efforts are focused on collecting and posting quality data to allow consumers to select among facilities and to encourage facilities to take action to improve their performance. Serious barriers to timely, accurate and helpful data still exist.
b) In face of market failure, state and federal gov'ts often use a “command-and-control” system of licensure or certification for many key health care organizations through which the gov't sets standards, monitors compliance, and imposes sanctions for violations.
c) Debate over market versus direct gov't regulation of performance
d) Private nonprofit organizations also offer a voluntary accreditation process through which facilities can measure their compliance with standards accepted by their own segment of the industry
e) Facilities themselves also engage in internal quality assurance and improvement efforts
f) Private tort and related litigation also raises the cost of poor quality facilities
g) rapidly changing structure of health care organizations (Hospitals; long term care facilities; home health agencies; full hospice; ambulatory surgical treatment center; etc)
i) MAUCERI v. CHASSIN, (S.Ct., Albany County, NY, 1993)
(1) Plaintiff operates a business out of her home providing patients and their families with the names of home health aides. P does not conduct any investigation into the qualifications of the aides
