User:CheshireKatz/Health

Latest Reading
Notes to make up: 1/22 & 2/5
 * 2/12 - 877-99 & 920-33
 * 2/14 - 933-45
 * 4/15 - 1287-1325
 * 4/17 - 1325-1343

EMTALA Statute
EMTALA http://www.emtala.com/faq.htm
 * 1) Screening requirement
 * 2) Stabilization
 * 3) Transferring patients

You get to the hospital what next?
 * (a) Medical screening requirement
 * Courts ask did the screening differ? If its standard for the hospital to screen in one way, different standards are suspect.
 * What happens if they've an HMO that requires pre-authorization? Emergency takes precedence over authorization, care must be provided first.

What if an emergency medical condition is found?
 * 1) "Stabilized" →
 * 2) with respect to a [severe medical condition (see §(e)(1)(A))], that no material deterioration of the condition is likely, within reasonable medical probability, to result from or occur during the transfer of the individual from a facility, or,
 * 3) with respect to [labor (see §(e)(1)(B))], that the woman has delivered (including the placenta).
 * 4) "Transfer" →
 * By request of patient (or patient's representative) or after weighing of cost-benefit analysis of risking the patient's health per the transfer
 * See (c) Restricting transfers until individual stabilized

On call violation for lack of good faith effort

Medicare
Medicare - Care for the elderly, handicapped
 * Perception: Social insurance program (pooling risks)
 * Paid for through reduction from payroll
 * Who benefits & how?
 * Elderly (>65) + eligible for SS benefits
 * Disabled + eligible for SS benefits + 2yr wait
 * ESRD + eligible for SS benefits
 * 4 Parts of Medicare
 * A. Hospital (all automatically covered)
 * B. Outpatient (premiums; discounted for low & medium income beneficiaries)
 * C. (Managed Care)
 * D. Prescription Drugs - Unregulated (to evade gov't monopsony)

Hypo (pg. 742): LOL with $3000/yr drug costs. Plans:
 * 1) $35/month ($420/yr), change 2 drugs to equivs
 * Cost: $420 + $250 deductible + 25% of the next $2000
 * Really only good for people in excess of $3600 or approx $2250
 * 1) $23/month ($276/yr)
 * Cost: $276 + $250 deductible + 25% of the next $2000 + (tiered-copayment)
 * 1) $23/month ($276/yr), requires her to leave primary care provider
 * Cost: $276 + $250 deductible + (tiered-copayment - max of $40 on prescriptions)
 * 1) $30/month,
 * Cost: $360 + $250 deductible + 20% of the next $2000 + (tiered-copayment)

Diagnosis-related group (DRG) system
 * Pay is determined based upon the diagnosis
 * So if extensive care revealed simple diagnosis, then low pay
 * If minimal care revealed expensive diagnosis, then high pay
 * Thus risk shifted to care-provider
 * Exceptions: Hospitals providing education, care for underprivileged, hospitals in destitute or rural

Prospective payment formula for doctors (pg. 753)

Physicians may accept payment from patient, may accept medicare indemnification, or bill medicare directly. However they may not bill patients the balance of costs in excess of medicare.

Medicaid
Medicaid - Aid for the poor
 * Hybrid Cooperative Fed/State program
 * Federal matching funds for state medical assistance programs for the poor
 * Each state decides, but must comply with the mandatory fed standards
 * States have huge discretion in terms of what kind of program they want to create
 * Most states have chosen to provide a relatively comprehensive package
 * Perception: Government handout


 * Who's eligible?
 * 1) Economic Need (those in) (Controversy over Medicaid Estate Planning)
 * 2) Category
 * Mandatory (States must provide)
 * Children
 * Pregnant women
 * Disabled
 * Dual eligible - premiums/copays/cost sharing obligations
 * Optional (If States provide, Funds Matched by Fed)
 * Medically necessary
 * Controversy over funding of abortion in cases of rape or incest. (Constitutional, gov't cannot impede exercise of right, but need not pay for it)
 * States may not tighten restrictions (eg. only if woman's life is in danger) are not permissible, b/c discrimination injected on certain diagnoses. Limitations are for congress to determine. (Hern v. Beye)

INTRODUCTION
Costs → in 2002, we spend 14.9% of GNP on health care! Through the 1990s, health expenditures as a share remained fairly constant, since then, they have gone up again
 * Access
 * We spent over $5,000 per person on health care in the US. In recent decades, health care costs increase faster than consumer price index
 * What do we spend all that money on? 1/3 – hospital. services, 1/5 – physician services, 10% - prescription drugs (have doubled recently, services have gone down)
 * Who pays? In 2002, it was 36% private health insurance, 19% Medicare, 17% Medicaid, 16% out of pocket
 * In recent decades, Medicare has been bigger than Medicaid, but it’s expanding
 * We spend a lot more than any other country (Germany – 59% of what we spend per capita, Britain – 39% and they provide universal health care!)
 * Costs create huge problems!  For individuals, for businesses, for state gov’ts – can be the largest budget line, for fed, gov’t
 * Financing is incredibly complex, but also key to understanding the issues

Quality → sometimes magnificent, but often the quality of care provided is poor. Focus on alternative ways of defining and influencing quality

Managed care → claims review. Even if you are insured, sometimes you don’t get the $$!


 * Cost, Access, & Quality in relation to services at the beginning of life and at the end of life

Cost vs. Access vs. Quality ("Pick any two.")
 * Problems with today's system
 * High Administrative costs
 * No incentive to lower costs, because of limited alternatives
 * Vast discrepancies in Access & Quality, due to High Costs


 * Importance of Egalitarian Healthcare
 * Inalienable right to basic health, One cannot enjoy life, liberty, & pursuit of happiness if he is in perpetual fear of illness.
 * Preserve social order, stop spread of illness, assure folks are minimally well enough to work, live, etc.


 * Moral hazard
 * Theory that if risk is insured, more likely to incur it.


 * Tax System Healthcare
 * Those exceeding 7.5% of AGI are deductible (for those itemizing). Very limited.
 * Health insurance (through employment) is excluded from income. Yay! But limited based on employer. Boo!
 * Result is people take less wages for more tax-free health insurance
 * Bonus benefit from Highly Compensated Employees b/c more income not taxed at higher rate
 * Bush proposed alternative: Tax employer-provided health insurance, but provide a standard deduction for any health insurance premiums (unrelated to actual costs).
 * Result would be employers no longer providing health insurance and individuals shopping on their own without the benefit of negotiating as a group.

BARRIERS TO ACCESS

 * The Rise and Crisis of Provider-Dominated Health Care
 * 1887 – 1910 – The turn of the century
 * Physicians
 * Prior to the 19th century, healers were low status and low paid, often women (herbalists, midwives, abortionists)
 * Paid like barbers – service providers, not professionals
 * What happened to change that?
 * Stunning developments in technology and science and the understanding of germ theory
 * Allopath (germ guys) believed that their theories about treating people were so superior to the herbalists – they enlisted the power of the state to:
 * Prohibit practice by anyone not licensed by the state – confined the practice of medicine
 * Persuaded legislatures to put control in the hands of the allopath themselves
 * State should provide for general rather than specialized licensing
 * What kinds of problems were we trying to address?
 * Bad medical care
 * Why did we reject the other options?
 * The power of the allopaths was great.
 * Distrust gov’t control
 * The best deciders here were the doctors themselves
 * Hospitals
 * PGH and Bellevue were the first hospitals – established as the infirmary wards of almshouses
 * The only gov’t support we had for people who couldn’t work was the almshouses
 * When those people got sick, they were sent to the infirmary ward
 * Good place to students to get some practice
 * Only cared for poor people – the notion that a respectable person would go to a hospital. was crazy! They received care in their own homes
 * Private hospital. began to crop up; viewed with great distrust; served the teaching purpose
 * By 1873, there were only about 178 hospital., and most were mental
 * By 1910, there were over 4,300 hospital. in the US
 * Non-profit, charitable institutions, governed by the doctors who worked there
 * Medical education
 * In the 1880s, medical education was simple: entrance requirements were lower than that to a good high school
 * Other doctors trained as apprentices
 * Now oriented to acute specialty based hospital. care
 * Science, care, and professional power
 * Immense expenditures for sophisticated surgery, drugs, and diagnostic tests, and an astonishing inability to address the political, social, and behavioral causes of most illness and injury
 * Turned towards individualistic, procedure-focused services delivered by thousands or for-profit businesses and formally charitable but actually profitable larger businesses
 * The rise of public health insurance: 1930-1980
 * Government run health care fiercely opposed by profession
 * Restricted to inadequate programs for minorities, better programs for the armed services and veterans
 * 1935 – The Great Depression
 * Hospital. had proliferated, no health insurance, common for hospital. and doctors to offer a sliding fee scale for services
 * full pay ←→ charity and something in between
 * That worked until the GD, and then no one could pay
 * Hospital .were in desperate financial shape
 * Baylor model → school and hospital, no patients – began to contract with the local education system to say if every teacher pays x per month, then when they are sick, they can receive care from the hospital.
 * Three forms of private health insurance
 * Indemnity benefits (patient seeks reimbursement)
 * Service benefits (Blue Cross and Blue Shield, doctors and hospitals participate in plan and accept plan’s payments for services)
 * Direct services (services provided by the same organization to which a monthly premium is paid)
 * The struggle over private health insurance
 * AHA promulgated Blue Cross
 * Any licensed hospital could use symbol and accept patients and payments
 * The state authorized the creation of an insurance co that doesn’t need to meet the normal financial requirements that enable a firm promise of delivery
 * The hospital. that participated promised to provide care – less need for the financial reserve (insurance didn’t need level of security)
 * State must ensure that the system served the community → the plan would be open to anyone in the community, and everyone would be charged the same rate
 * Couldn’t charge more to higher risk patients
 * Guaranteed access at uniform price
 * Every hospital. in community that was licensed is entitled to join the plan
 * Unlike Baylor, you could pick any hospital. in the community
 * AHA owned the Blue Cross trademark
 * Must be controlled by hospital. community reps
 * Baylor had too much control over the doctors, under BC plan, doctors could choose where to send their patients
 * Hospital. themselves were collectively in control of the insurance plan
 * Blue Shield
 * Mixed indemnity and service benefit plan
 * Doctors agreed to accept plan payments for lower income patients, but retained the right to charge middle and high income patients more
 * National health insurance
 * 1935 – adopted social security, unemployment, AFDC, etc. to deal with the GD crisis
 * We didn’t adopt national health insurance
 * Opposition of medical profession very intense
 * Blue cross – it made the most sense at the time
 * Pattern continued well into the 50s
 * During WWII, we had wage and price controls – big demand for expanding
 * At the end of WWII, soldiers who had gotten good health care when in the services wanted to continue that level
 * Enter commercial insurers
 * Different attitude – they want to exclude high risks and charge different rates
 * Consequence – left the Blues to cover those rejected by commercial
 * Blues abandoned open enrollment and the commercial insurers continued to grow
 * Blues become more and more $$ -particular impact on the elderly – easy to ID as a bad risk
 * Politically motivated
 * 1965 → Medicare and Medicaid
 * How hospitals and doctors came to be paid
 * Developed in 1950s, by 1960s, provider-dominated health financing was firmly in place
 * Based on “reasonable costs”
 * Evolution of government’s role in health care
 * NIH – federally funded research
 * Medicare
 * Fed. program financed by payroll taxes
 * Universal eligibility for over 65 or sufficiently disabled
 * Provides basic coverage for medical services
 * Does not provide long term care, preventative care, prescription drugs
 * Administered by gov’t (formally) day to day admin delegated to local Blues offices
 * Part A → hospital insurance for the elderly
 * Part B → medical coverage for persons over 65
 * Medicare package is too meager for people who are really poor – more of a catastrophic coverage
 * As a practical matter, most Medicare people also purchase a gap filler
 * Medicaid
 * Federal matching funds for state medical assistance programs for the poor
 * For poor people
 * A bit of an afterthought
 * Not wholly fed – cooperative state-fed program
 * Each state decides, but must meet fed standards
 * Entitled to fed matching funds for whatever they spend
 * States have huge discretion in terms of what kind of program they want to create
 * Most states have chosen to provide a relatively comprehensive package
 * The crisis of the provider-dominated system
 * Rising costs
 * Costs were still determined in large part by the private sector itself
 * Advances in technology
 * Quality
 * Inefficient, unregulated, and often medically unnecessary
 * Responses to cost escalation and the emergence of managed care
 * Price controls, review of doctors’ decisions, and financial incentives
 * Managed care → the functions of insurance and delivery of health services are integrated into a single corporate arrangement that both insures groups and delivers covered benefits through a defined network of participating providers
 * HMOs, individual practice associations, PPOs, integrated service systems, POS plans, provider networks
 * Assumption of a contractual duty to furnish covered care and services
 * Provision of services through specified provider networks, which are themselves under contract to the managed care entity
 * Advance control over actual utilization of benefits by both providers and patients
 * Use of financial incentives in order to influence provider practice and resource utilization
 * Quality and cost control systems that include credentialing, practice reviews and guidelines, and the reporting of practice data which are used to control providers’ access to the market


 * National health care reform and the clash of fundamental values
 * A brief anatomy of national health care reform
 * Who will pay?
 * How will the vast sums of money that flow through the system be controlled, contained, and allocated to different types of providers, suppliers, managers, investors, and others?
 * 1994 – defeat of Clinton’s health care reform proposal
 * Very complex program – universal coverage administered by orgs., designed to appeal to a broad range of interests
 * Rejected fairly soundly
 * too complex for anyone to understand
 * Congress more generally has difficult time adopting complex legis.
 * Insurance industry that did not want the plan did a brilliant job through using the media (Harry and Louise commercials)
 * Things that they feared are perfectly legitimate!
 * Takes away choice
 * The truth → the fears and objections to the Clinton plan are precisely the issues that we are faced with today
 * Built on American tradition of relying on private corps to weave the safety net to provide basic health benefits, etc. then we have gov’t programs that come in to fill in the gaps (ERISA)


 * Conflicting values in American health care
 * Autonomy – professional control
 * Preferable to any other model – too complex to be legitimately subject to the forms of control that work in other areas (the market, bureaucrats)
 * Expertise and knowledge
 * Education and ethics provide a commitment to patient service
 * But that’s not their area of expertise!
 * Dominant way that the system was shaped
 * Remains very powerful today, particularly in response to the perceived excesses of managed care
 * Equality
 * It’s not a desired good – nobody wants to undergo surgery
 * Need is generally episodic and unpredictable
 * Emergency health needs are different
 * Market competition
 * Arose in the 70s in response to the other paradigms
 * There’s nothing special about health care! It’s not life or death; it’s optional and  .'. should not be treated any differently
 * People don’t confront financial barriers at the time of care and are not cost conscience shoppers

COMMON LAW BASELINE
Doctors have no duty to practice medicine on a non-patient

Where a relationship is established, notice (at least 30-day, preferably repeatedly) and referral are necessary to terminate the duty of medical care.


 * Hurley v. Eddingfield
 * F: The physician had been the decedent's family physician. When the decedent became dangerously ill, he sent for the physician. The decedent's messenger informed the physician of decedent's violent sickness, tendered him fees for his services, and stated to him that no other physician was procurable in time and that the decedent relied on him for attention. Without any reason the physician refused to render aid to the decedent. The decedent died. The wrongful act alleged against the physician was his refusal to enter into a contract of employment with the decedent. The trial court sustained the physician's demurrer to the complaint. The court affirmed. The court found that the act regulating the practice of medicine was a preventive, not a compulsive, measure. Thus, the physician, in obtaining the state's license to practice medicine, was not required to practice at all or on other terms than he might choose to accept.
 * “In obtaining the state’s license to practice medicine, the state does not require, and the licensee does not engage, that he will practice at all or on other terms than he may choose to accept”
 * Rejected analogy to common carrier or innkeeper
 * Court finds that the doctor has a right to refuse treatment under the no duty rule
 * The doctor had not undertaken to provide care in these circumstances


 * Campbell v. Mincey
 * F: When the mother arrived in labor at the emergency room she was instructed to go to another facility at which her physician practiced. She subsequently gave birth to her son in a car in the hospital's parking lot. The hospital then had her transported to the other facility by ambulance. The mother contended that the hospital's policy that resulted in the refusal of treatment was an unreasonable restriction upon the use of a public hospital by the mother and other similarly-situated individuals. The court dismissed the complaint. The court determined that the policy that required that a local physician authorize admission of a patient, except in true emergency situations, was intended to insure a doctor would be available for follow-up treatment of the patient. The court found that the mother had been a patient of the hospital on the occasion of a previous pregnancy and that the emergency room was used more frequently by blacks than by whites. The court also found that a large portion of the patients treated at the hospital were Medicaid patients. Thus, the court found no basis for the mother's contention that she was refused treatment because she was black or indigent.
 * Question: whether the hospital regulations requiring reference of incoming patients by local physicians except in true emergencies operates in a reasonable manner to further a legitimate state objective?
 * Holding: “In the absence of some proof that this regulation has or can operated in some manner to inflict an injury upon some individual, the court must accept the considered judgment of the medical specialists who are charged with the responsibility of administering the hospital
 * Needed a pre-existing relationship with a doctor in order to be admitted to the hospital
 * There was indeed an emergency .'. the hospital had a duty to admit the patient?
 * What’s the basis of that duty?
 * Detrimental reliance → they are operating an ER and .'. put themselves out there that they will take care of emergency medical situations!
 * ∆ → there was no emergency! But on these facts, that’s very difficult – giving birth in the parking lot!

‘’’Quasi-public institutions’’’ have an obligation to provide care in an emergency
 * Another theory is undertaking
 * This theory rarely adopted, in part b/c it’s a very broad theory – tough to figure out what makes it “public”


 * Analogy to common carriers/innkeepers
 * Services that hospital provides are much more complex, the courts ability to judge whether the hospital has a good reason to turn someone away is much different than that of a common carrier
 * But there are some similarities – public function, service people’s needs, recognition that when people are in need they should receive services


 * Assuming that the Πs can establish a duty, the ∆’s responses?
 * No emergency
 * Can’t accept everyone, or else they wouldn’t be able to function properly! Undermines ability to think intelligently about what we want to do and who we want to treat; hospital. have adopted a sensible policy that patients should have a doctor!
 * No causation


 * Conditioning
 * Lyons v. Grether
 * Walker v. Pierce
 * Payton v. Weaver
 * What do these three cases lead us to believe?
 * They allowed the doctor to make some conditions, but when the state law comes into play, the doctor can’t override that
 * Doctors have very broad freedom to condition the availability of their services, up to the point where it would violate some law.
 * Impose conditions on licenses
 * Place conditions on reimbursement
 * Competing issues re: hospital and doctor duty to care?
 * Contract principles
 * No duty principle
 * Detrimental reliance
 * Undertaking
 * Public function
 * Emergency
 * Proximate cause

STATE EFFORTS TO ASSURE ACCESS

 * Thompson v. Sun City Community Hospital
 * F:A minor was injured and taken to a private hospital, which later transferred the boy to a county hospital for financial reasons. He survived but with residual impairment of his left leg. His mother, as guardian ad litem, brought a malpractice action against the private hospital and the physicians alleging that her son was injured by the failure to admit and the consequent delay in repair of his damaged artery. On appeal, the mother alleged that trial court erred in misstating the law to be applied on the proper standard of care and in instructing the jury on the issues of breach of duty of care and causation. The court affirmed the decision in favor of the physicians because the physicians' actions did not cause refusal of medical treatment. However, the court found, as a matter of public policy, that licensed hospitals were required to accept and render emergency care to all patients who presented themselves in need, and that the patient was not to be transferred until all medically indicated emergency care was completed. This standard of care required private hospitals to provide emergency care that was medically indicated without consideration of the economic circumstances
 * Question: was the patient transferred for other reasons? Did the transfer cause new or additional injury or aggravate any pre-existing injury?
 * Holding: “The patient was transferred for financial reasons while emergency care was medically indicated.  As a matter of law, this was a breach of the hospital’s duty.”  Because the patient may have had a chance for improved recovery, the question of causation must go to the jury.
 * Reasoning:
 * “Charging hospitals with a legal duty to render emergency care to indigent patients does not ignore the distinctions between public and private hospitals. Imposition of a duty to render emergency care to indigents simply charges private hospitals with the same duty as public hospitals under a statutory plan which permits reimbursement from public funds for the emergency care.”
 * “Reasonable cause for transfer before completion of emergency care refers to medical considerations relevant to the welfare of the hospital. A transfer based in the forbidden criterion of economic considerations may be for the convenience of the hospital but it is hardly medically indicated.”
 * In the 70s, we began to impose statutes that hospital. did have a duty to provide emergency care
 * AZ was the only state not to join Medicaid until 1980; rather, they had a working system that required counties to pay hospital. for care provided to indigents and to provide emergency care by statute, tort damages
 * Statute says that you must provide emergency care – court merges the questions of whether this was emergency and whether this surgery was medically necessary
 * Third question of whether he was transferred for medical reasons
 * Is it a question of fact or law whether an emergency existed?
 * Court goes on to find that there was a breach as a matter of law – b/c he was transferred for financial reasons
 * That both allows a proof of a violation and allows a finding as a matter of law whether there was a factual emergency
 * Π can’t show that the transfer caused the injury → normal standard of proof

More likely than not that but for the ∆’s actions, the injury would have occurred
 * Does not show here, instead the court adopts an alternative standard that is based on whether the Π lost the chance


 * State emergency care requirements
 * TX, CA, MD adopted very broad laws with strong penalties which required permission from the transferee hospital
 * NY creates criminal liability
 * Anyakora → doctor made argument that doctor obligations are different than hospital obligations
 * Ford → sends woman to another hospital b/c they are on “diversion” – she’s convicted of a criminal action


 * Good Samaritan laws
 * Provide doctors with immunity from liability for negligence – is that likely to make a difference?
 * It doesn’t actually have any effect; the risk of being sued is just too great.
 * Nonetheless, they have been extended to immunize doctors in a hospital that responded to a STAT call to seek other people to come and help. If you respond, you’re entitled to immunity

Rational relationship standard

Staff Privileges and Hospital Physician K’s

 * Sokol v. Akron General Medical Center
 * P is a cardiac surgeon on staff at the hospital. He came under investigation because his patients had exceedingly high mortality rates.  As the result of some studies the hospital decided to revoke some of his privileges.  Question is were the Dr’s privileges wrongfully revoked?
 * Court said No, private hospitals (not gov owned/run) have broad discretion in determining who can enjoy staff privileges (function as a business judgment & quality control mechanism)
 * What count privileges? Dr’s access to hospital.  Admitting privileges—can I have my patients admitted here—and clinical privileges—what can I do there?

Hospital is organized as a corporation (profit or non-profit).
 * Basic corporate structure:
 * Shareholders form corporations, pool resources, and elect a Board of Directors to make decisions for the corporations
 * Board of Directors votes to appoint Officers & make major enterprise decisions
 * Officers manage the various affairs of the corporation
 * Fiduciary Duties - Loyalty & Care
 * Limited Liability
 * Not-for-Profit Corporate Structure
 * No Shareholders; Oversight provided by State Attorney General, Board of Directors, &, in some cases, Members (analogous to shareholders)
 * How are they financed? 1) Bonds, 2) Donations, 3) Grants, 4) Sell Goods, Services, & Membership (limitations on income from source)
 * Profit is allowed, BUT non-distribution constraint, profit cap, & expenditures must further mission of the NFP
 * Board of Trustees has legal responsibility to run the corp. Designate a hospital manager (CEO) to run day-to-day operations and maybe they will appoint department heads.
 * Physicians, nurses, & technicians run the medical services
 * Nurses & technicians are employees.
 * Most physicians, however, do not have employment K’s—rather they get paid by insurance companies instead of hospitals since they are independent contractors.
 * Medical staff is Drs organization that has by-laws and hires new physicians. Controls quality by determining who gets privileges.
 * Basically Sokol illustrated the role of the courts when called on to review hospital staff privileges decisions. 3 different views: 1) court will just make sure hospital complied with procedure (majority view) 2) another will look to see if there is a fundamental fairness  3) courts will look at substantive merits and basically conduct a  new hearing


 * Mateo-Woodburn v. Fresno Community Hospital (1990)
 * Anesthesiology doctors operated as an open staff. This was causing problems in patient care so the medical staff made the change from an open to closed system.  Several Drs refused to sign the new K’s because they didn’t like the terms.  Question is were the Drs medical staff privileges unlawfully terminated?
 * Court said No, if the justification is sufficient a Drs vested rights must give way to public and patient interest in improving the quality of medical services and here the best way to improve care was for the department to reorganize. Don’t need a hearing to restructure medical staff.
 * Privileges system performs a quality control measure at the institutional level.
 * Two themes: 1) what substantive rights do health care professionals have? 2) What procedures must organizations follow in creating and terminating relationships

Managed Care K’s for Professional Services

 * Potvin v. Metropolitan Life Ins Co.
 * Dr entered into an agreement with company to include him on their preferred provider list. A clause in the K said that either party could terminate without cause by giving 30 days notice. Company drops Dr because he wasn’t meeting their malpractice suit standards. The Dr is angry because he wasn’t given a hearing. Question is must insurance companies comply with common law idea of fair procedure before removing physicians from preferred provider list?
 * Court says it depends. Insurers must comply with fair procedure standards only when the insurer poesses power so substantial that the removal significantly impairs the ability of an ordinary competent physician to practice medicine in a particular geographic area thereby affecting an important and substantial economic interest.
 * Without cause termination clauses are unenforceable.

Integration and New Organizational Structures
Insurance has now become “managed care” –a term used to describe HMOs and other forms of health insurance that attempted not just to pay for, but also to control the cost of health care services.

Blue Cross (hospital insurance)/Blue Shield (physician insurance) arose as a result of the Depression; state based; in exchange for not-for-profit status they have to take everyone; these plans are usually not a good value because it has to accept everyone.

HMO is basis of managed care. Employes Drs (primary care physicians) and nurses to deliver health care. Differs form Drs office because it not only provides health service but insurance as well. Did away with deductibles. They didn’t take off—patients can only go to certain Drs and there is no incentives for Drs (they get paid the same salary no matter how many patients they see)

Purpose of insurance is to transfer risk.

Premium you pay is actually what co predicts its future losses will be.

Insurable risks must meet criteria  1) must be uncertain loss will occur  2) loss produced by risk must be measurable  3) must be large number of similar ?  4) loss must be significant

Hallmarks of Managed Care:
 * Capitation: partial or full risk bearing to primary care physician
 * Utilization Review: payer reviews utilization of service to determine level of care (usually to see if too much)
 * Primary Care Physician (PCP): have to choose a primary care physician who will determine when you do and don’t need to see a speacialist.
 * Protocols: cookbook medicine (standard care for certain illnesses)
 * Fuse Finance and Delivery
 * Integrated Delivery Systems

Drs agree to managed care organizations because they will have a pool of patients

US health care system moving steadily away from delivery of health care through independent practitioners and toward more integrated approaches.

IPA (Independent Practitioner’s Association): a physician organized entity that contracts with payers on behalf of its member physicians. Usually negotiates K’s with insurers and pays physicians on a fee for service basis with a withhold.
 * Physicians can maintain business outside the IPA.
 * Ex IPA—panel model HMO

PPO (Preferred Provider Organization): If you go to primary care physician, you will be 100% insured. If you get sent to specialist who is part of plan, will be fully covered. But of you choose your own specialist, only covered 75%.
 * This makes system more flexible.
 * More and more we are seeing this type of plan.

If hospitals are non-profit, why do prices keep going up?
 * Better quality (facilities and specialists)
 * Salaries
 * Ego (we have the biggest)

Now, consumer driven health care will hopefully level off skyrocketing prices but eventually, they will rise again

Why wouldn’t people like consumer driven health care? Have to pay fees out of pocket over allocated amount, higher co-pays, and deductibles.

Forms of Business Enterprises and Their Legal Consequences
Partnerships: associations of 2 or more persons acting as co-owners Ex—Family Medical Associates
 * All liable for each other’s debts
 * This isn’t a good organization type

Limited Liability Companies & Partnerships: liable for his or her own professional negligence
 * Better type of organization

What type of organization to choose often is influenced by tax considerations and retirement plans.


 * Stern v. Lucy Webb Hayes
 * Hospital was a charitable institution. 2 trustee ended up managing hospital themselves instead of executive committee.  1 of the trustees came under scrutiny and trustee refused to cooperate with the inquiries.  Patients field a complaint alleging trustees breached their fiduciary duty and conspired to enrich themselves.  Question is whether trustees breached their duty to the corporation?
 * Court said yes. Director of Bd had a duty to at least oversee the trustees and here director never did that.
 * Director breaches his fiduciary duty if it is shown that: 1) he fails to supervise activities of a committee that makes financial decisions. 2) he knowingly allows hospital to enter into business dealings with another organization in which he has an interest without disclosing the interests  3) he voted in decision to conduct business in himself
 * If in area of running business so operational responsibilities, usually run by director, he will be held to a lower standard of care. Must commit gross negligence.
 * If in area of running financial matters, usually by trustees, then will be held to high standard of care and will beliabel for simple negligence.
 * Insurance widely available for director liability.Attorney General is supposed to oversee non-profit orgs because they are actually trusts and Att Gen oversees all trusts


 * In re Caremark International
 * Hospital employees turned the hospital in for breach of fiduciary duty. The hospital was investigated and charged with felonies.  The hospital pleaded guilty and had to pay a significant amount in reimbursements.  Now the company is seeking to recover its losses from individuals of the Board.  Question is whether the directors adequately monitored what was going on in the corp soas to prevent liability to federal gov for wrongdoing?
 * Court said no. There is no evidence that they knew of the violations, Directors reasonably relied on expert reports.


 * Why would non-profit orgs want to convert to for-profit?
 * Stock options so co can get bigger and operate more efficiently
 * Advantages to insiders
 * Losing money


 * Manhattan Eye, Ear and Throat Hospital (MEETH) v. Spitzer
 * Not-For-Profit Hospital receives offer to purchase all hospital assets. BoD recognizes opportunity to abandon less profitable city hospital and instead build diagnostic treatment centers in suburbs. Amends NFP Corps mission to include creation of diagnostic treatment centers, submits to State AG for approval, and before response begins disassembling hospital. At issue is the fundamental change to the mission
 * (NFP) Duty of Obedience - Only as a last resort do you deviate from the mission.
 * Failure to Pursue Reasonable Compensation - In rush to take offer, did not pursue alternative bids, did not try to keep hospital running, did not disclose self-interest of consultants assessing hospital's value (commission on the sale).


 * Berlin v. Sarah Bush Lincoln Health Center
 * D nonprofit corp who employed P to practice medicine in hospital for 5 years. Drs K stated he couldn’t work within a 50 mi radius of hospital for 2 yrs after end of K.  Dr resigned and went to work for a clinic 1 mi away from hospital.  D sought injunction to keep P from practicing at the clinic.  Dr says corporate practice of medicine doctrine applies which prohibits corporations from providing professional medical services.  Question is does “corporate practice of medicine” prohibit corps which are licensed hospitals from employing physicians to provide medical services?
 * Court said no. When corp is licensed to operate a hospital it is allowed to hire physicians
 * Restrictive covenants will only be enforced if terms are reasonable

Contract Liability of Private Insurers and MCO’s

 * Lubeznik v. Helath Chicago
 * P diagnosed with ovarian cancer. P was referred to a DR who wanted to giver her a chemo/bone marrow treatment.  When Dr contacted P’s insurance for prepayment Dr was told her insurance doesn’t cover procedure because it is experimental.  P sought an injunction to force insurance to cover it.  Question is whether the procedure is a covered benefit under P’s insurance policy?
 * Court said yes. In determining whether a provision in insurance K is applicable court must 1st determine if specific provision is ambiguous.  Where a provision is ambiguous its language must be construed in favor of insured.  Here provision is ambiguous as to what appropriate medical tech Boards are.
 * In order to deny coverage based on exclusionary clause, clause must be clear and free from doubt.
 * Insurance companies will have a difficult time enforcing provisions that refuse payment for care that is “experimental” or “not medically necessary”

State Regulation of Private Health Insurance

 * States oversee financial solvency of insurers by imposing minimal requirements for financial reserves and for allowable investments.


 * Also through requiring annual statements and conducting periodic examinations of insurers.


 * States also regulate insurance marketing and claims practices.

State Regulation of Managed Care Practice
Enacted “any willing provider laws” which require MCOs to accept accept into their network any provider willing to accept its terms

In order to limit MCO’s ability to restrict access adopted laws guaranteeing MCO members access to particular specialties such as gynecologists and pediatricians.

Adopted “continuity of care” requirements. If provider drops a physician, you cann continue to see him for a period of time.

Enacted due process rights for termination of providers.

State law can ban gag clauses. Gag clauses tell Dr he can’t talk about other treatment options

Some state statutes will make certain services mandatory Ex—ER care, substance abuse treatment, coverage for newborns; length of stay

Strategies used by MCO’s to manage costs: 1) limiting members  2) utilization reviews  3) provider incentives  4) regulate quality

Utilization Review
 * Utilization review is when MCO does case by case evaluation to determine the necessity and appropriateness of medical care.
 * Some MCOs will use the review to determine which physicians to decertify from the plan.
 * A key factor in UR decisions is medical necessity.

Provider Incentives
 * Main financial incentive is capitation. Provider gets paid a fixed fee for providing care for MCO beneficiary for a fixed period of time.  If services beneficiary receive costs more than this payment, provider loses money.  If services cost less, provider makes money.

Non-Profit/Charity Status Standards
Nonprofit Hospitals and Other Health Care Providers
 * Revenue Ruling 69-545 – adopts “community benefit” standard over narrower “relief of the poor” standard for what makes hospital charitable
 * “In the general law of charity, the promotion of health is considered to be a charitable purpose.”
 * Hospital A is good where full time emergency room where no one denied treatment and “open” to all community doctors and open community board and excess revenue goes to paying off debt, capital improvements, medical training
 * Hospital B not exempt where closed emergency room, operated for benefit of limited group of doctors, not open to any doctor, not a community board
 * Requirements today: open emergency room, accept Medicare and Medicaid ( no ruling), plus +++
 * Eastern Kentucky Welfare Rights Organization v. Simon (DC Cir. 1974) Rev Ruling 69-545 is not inconsistent with 501(c)(3), definition of charitable is not static and covers more than relief of the poor
 * open emergency room (Court finds this quite significant), and must accept Medicare and Medicaid
 * IHC Health Plans, Inc. v. Commissioner (10th Cir. 2003) (Mormon HMOs not charitable) because operated primarily for benefit of members, not community -(pg. 933)-
 * Test: health care services available to all community plus provide additional community or public benefits that furthers public institutions or provides new service (see Public good), and public benefit must be primary purpose for which organization operates
 * Simply providing health care for fee (even discounted at adjusted community rating) is not sufficient to qualify for tax exempt status (need some “plus”, an additional benefit that society not providing
 * Not integral part doctrine, because 80% of services were not provided by Health Service (instead independent doctors)
 * No one really understands integral part doctrine
 * What if no emergency room because state health officials say duplicative or specialty hospital? Revenue Ruling 83-157 says specialty hospitals qualify if evidence of commitment to community health care (look at how broad base board of directors is, treatment of Medicare and Medicaid patients and application of operating surplus)
 * State Property Tax Exemptions: in leading case, Utah Supreme Court upheld denial of state property tax exemption to two nonprofit hospitals that failed to provide significant care to indigents, Utah County ex rel. County Board of Equalization v. Intermountain Health Care Inc. (Utah 1985) -(pg. 920)-
 * Intermountain insisted that they provided charity care, however, upon closer examination, charity care examples were limited to bad debts (emergency patients only revealed unable to pay after care provided) and some minor supplementary services to medicare. Intermountain also frequently carried a surplus of funds.
 * Dissent: Population density in area is too low to sustain gov't hospital. Serving gov't purpose by carrying that burden.
 * Coleman Standard - Substantial imbalance to exchange & lessens government benefit
 * IRS Examination Guidelines: guidelines for whether hospital qualifies under community benefit standard:
 * (1) governing board of civic leaders rather than hospital administrators and physicians
 * (2) if multi-entity, do minutes reflect corporate separateness?
 * (3) is admission to medical staff open to all qualified physicians?
 * (4) full-time emergency room open to everyone regardless of ability to pay?
 * (5) Does hospital provide non-emergency care to everyone in the community who is able to pay either privately or through third parties including Medicare and Medicaid?
 * Look for Medicare dumping, at emergency room manual and procedures
 * HMOs: IRS has been hostile, 14-factor test including free care for indigents, health education open to all, a broad board -> particularly targets HMOs that don’t actually provide services (instead contract it out to physicians)
 * But again look for integral part doctrine §1.502-1(b) – but only qualify here if the services provided would not constitute an unrelated trade or business?

501(c)(3) vs. 501(c)(4) (4) can lobby but can't accept donations or issue bonds

X-Hospital forms X-Corp. Physicians of X-Hospital form LP with X-Corp as a GP. The X-Corp held future profits of hospital investing in LP to benefit of partners.
 * General Counsel Memo 39862 (12/2/91)
 * Interest of Hospital: Under DRG, incentive get patients in & out as fast as possible with least cost.
 * Interest of Doctors: Perform more tests & prolong care to be paid more.
 * So tie the Hospital's profits to the Doctors' and the interests shift.

In Not-For-Profit context, dividend distribution is either Inurement (for insiders) or Private Benefit (for anyone)
 * X-Hospital's structure did not provide any additional benefit, but merely providing financing & private interests of hospital. -(pg. 963)-
 * By contrast if X-Corp had existed as a Research & Development or Educational Program

Physician recruitment
 * Hospitals offering bonuses, payment of Malpractice, et al. for purpose of attracting particular doctors as necessary to fulfill mission are acceptable to the extent that they are reasonable.

Excess Benefit Transactions (pg. 968)→ Private Inurement (insiders) & Private Benefit (anyone)
 * Non-fair market transaction
 * Unreasonable Compensation (Claims of competitive salaries)
 * Prohibited revenue-sharing agreement
 * Examples of those subject to sanctions
 * Disqualified persons (pg. 969) → Individuals with substantial influence (& family members)
 * Organization managers (pg. 970) → Safe harbor - disclose to professional advisor & rely
 * Rebutable if approved by disinterested board (pg. 970)
 * Exercises
 * Not a disqualified person (yet)
 * YES, look like dividends
 * Potentially
 * Offering discounted management services for:
 * Reaching out to rural society - YES
 * Incentivizing patients to join NFP Hospital for revenue stream (interest of hospital survival - NO

St. Andrew's Pt II (pg. 973)

False Claim
Laws designed to protect the gov from paying for goods or services that haven’t been provided or weren’t provided in accordance with gov regs
 * Many practices that are fraud and abuse in healthcare industry are perfectly legal outside the industry.

Statutes we’ll be dealing with are 1) False Claims Act (FCA) 2) Medicare/Medicaid Anti-kickback statute  3) Stark I & II
 * FCA has applicability to anyone dealing with gov. Other 2 deal specifically with healthcare claims.
 * FCA penalizes anyone who submits a false claim to the gov

United States v. Krizek
 * D is a psychiatrist and his wife who oversees the Drs billing operations. Practice consists in large part of Medicare patients.  Gov is suing Dr for providing medically unnecessary services and improper billing for services provided in that he changed the code so he would get higher reimbursement level.  Question is Did Dr engage in improper billing?
 * Court said no because statute was too ambiguous. However, court held Dr liable for billing irregularities because wife just assumed length of service and automatically billed for highest time.  This amounted to reckless disregard of truth so Dr liable under FCA.
 * Dr. liable because he failed to review billing practices and claims
 * Must have the mens rae of knowingly for FCA cases
 * Remedies available will be treble (triple) damages and 10,000 civil penalty per claim.

Luckey v. Baxter Healthcare
 * P former employee of D who is suing in name of the US gov under FCA because she says D is using improper testing procedures. Co refused to change testing procedures.  P maintains that representation that blood has been tested is fraud.  Question is whether the co is committing fraud?
 * Court said No. When supplier complies with existing regs it is entitled to represent to the gov that it has done so without facing a claim of deception.  In order for claim to be false there must be an attempt to deceive.

How does false claims act preclude malpractice actions? Because here act has to be done wrongfully and knowingly but malpractice standard is negligence.

Qui Tam Actions
 * Private person can bring a civil action for violation of FCA for person and for US Gov. Action will be brought in the name of the US Gov.
 * Gov can take over the action if it wants
 * How? P files a complaint and sends it to US Attorney’s office.  Complaint kept under seal until either gov intervenes or refuses and allows private attorney to take case.
 * Incentive for P is that if gov proceeds, P gets between 15-20% of award
 * Disincentive is high potential for retaliation
 * Other requirement is that you must learn from inside sources—not public info

Medicare/Medicaid Anti-Kickback Statute
Makes it a felony for false billing, illegal remuneration (bribes, kickbacks—paying and receiving payments for referrals), misrepresentation of compliance with conditions of participation
 * Not a strict liability statute. Must have scienter of knowingly and willfully.

US v. Greber, (3rd Cir. 1985) -pg. 1014-
 * DEF's Co provides physicians w/diagnostic services including a monitor device. Portion of Medicare payment to DEF's Co forwarded to the referring physician in violation of kickback statute.
 * Court agreed. If payments were intended to induce the physician to use the co’s services the statute is violated even if payments were also intended to compensate for professional services.
 * The purpose to induce referrals doesn’t have to be dominant purpose of scheme in order to fall under kickback laws.

Pre-Starks: McClarken(?)
 * Cannot claim relied upon lawyers advice if in seeking your attorney's advice you did not disclose all the facts.

US v. Starks
 * D operated drug addiction treatment programs. D contracted with hospital to run a drug program for pregnant women and in return hospital would pay D a share of hospital’s profits from program.  So D went to another local program and offered employees there money to make referrals.  Money dealings occurred in shady locations.  From referrals hospital received Medicaid payments.  Question is what is the scienter requirement for anti-kickback statute?
 * Gov only has to show that D knew it was acting unlawfully. Gov does not have to show the D knew the specific statute it was violating.  Here it’s clear D knew what is was doing was unlawful because payoffs were made in shady dealings.
 * Here the statute wasn’t vague and it gave fair notice that conduct is illegal.
 * Exception is if highly technical statute.

Penalties for violating statute include exclusion from participating in federal health care programs and monetary penalties.

HHS has promulgated Safe Harbor regs to describe conduct that isn’t criminal under fraud and abuse laws. Most of them deal with price reduction incentives.

Intent only requires that giver hopes to entice, even if receiver didn't know and/or no referrals resulted.

Statutory exception

Regulatory Safe Harbour

HHS Office of Inspector General (OIG) - Fraud

Hosp. MDs \      /   Ambulatory Service Center

Professional-Patient Relationship
Page 294

Informed Consent
Defining two forms of medical liability
 * 1) Negligent Medical Treatment / Malpractice
 * Treatment performed badly
 * 1) Lack of Informed Consent
 * Treatment performed without permission
 * Permission may require patient informed of risks, benefits, & alternatives

Lack of Informed Consent claims originated from battery claims (unwanted touching)
 * As a result some states only allow such claims for invasive procedures
 * Where assault or battery remains the legal theory applicable to situations where no patient consent at all has been given, most states now treat the issue of the adequacy of the consent – and of the disclosures preceding it – as an issue of negligence
 * LoIC can also extend to the wrong doctor performing the operation
 * No standard of care or reasonable person (would've consented) standard as it is a battery claim
 * However, once consent is granted, even having minimal information

Ordinary negligence standard
What about ordinary medical treatment?
 * Traditionally seen as an aspect of battery
 * Does battery provide an adequate standard for determining whether or not the doctor obtained consent?
 * Battery is simpler – in the medical context, we want to know if they patient was informed – there’s more going on here
 * In the 50s, took a negligence approach – what does that do?
 * Did this doctor fail to provide the information that a reasonable doctor would have provided under like circumstances; requires expert testimony
 * Today, that’s the standard in most jurisdictions

Reasonable patient standard
Canterbury v. Spence, (D.C. Cir 1972)
 * The district court granted directed verdicts to the physicians on the grounds that the patient had failed to produce any medical evidence indicating negligence on the physicians' part in diagnosing the patient's malady or in performing the operation. The court found that the trial judge did not specifically address the alleged breach of duty by the physician to divulge the possible consequences of the operation. On appeal, the court held that the patient, in his testimony and that of his mother, made out a prima facie case that the physician violated his duty to disclose the risk of paralysis from the operation. The court held that there was testimony from which the jury could have found that the physician negligently performed the operation. The record also contained sufficient evidence to submit to the jury the issues of whether and to what extent any such negligence causally related to the patient's post operative condition. The court held that these considerations entitled the patient to a new trial. Accordingly, the court reversed the judgment of the district court.
 * “We now find, as part of the physician’s obligation to the patient, a similar duty of reasonable disclosure of the choices with respect to proposed therapy and the dangers inherently and potentially involved”
 * “Respect for the patient’s right of self-determination on particular therapy demands a standard set by law for physicians rather than one which physicians may or may not impose upon themselves”
 * “In sum, the physician’s duty to disclose is governed by the same legal principles applicable to others in comparable situations, with modifications only to the extent that medical judgment enters the picture. We hold that the standard measuring performance of that duty by physicians, as by others, is conduct which is reasonable under the circumstances”
 * A risk is material if it is significant
 * Exceptions:
 * Unconscious patient
 * Risk-disclosure presents a serious threat of detriment
 * Not good to tell about all the bad things that could happen
 * How did Π win?
 * Climate of the times – patient’s rights, scholarly work impact on the law
 * Katz – wrote books describing the paternalism of doctors – med sociologist….in med literature then concrete findings
 * The court relies very heavily on all that scholarship
 * Why did court reject standard?
 * Not a consent case but a duty to disclose – is the focus on the patient or the actions of doctors?
 * Often there isn’t a professional standard re: the amount of info shared
 * Self determination is not a matter of medical expertise, it’s a matter of human values!
 * It’s not for the doctor to decide what’s best for the patient, but for an informed patient to decide what’s best for themselves
 * Attach significance in deciding whether or not to undergo the procedure
 * Defined exclusively in terms of the patient’s decision
 * Would it make someone change their mind?
 * Obvious need not be disclosed
 * What if the patient is unconscious
 * Does the doctor have reason to know that the patient wouldn’t consent
 * Presumption of consent
 * What if disclosure would make the patient worse off?
 * Patient would have nervous collapse or would reject necessary treatment
 * Therapeutic privilege
 * Allowing as a broad privilege could mean that the exception would swallow the rule
 * Court cabins the privilege – it’s never a therapeutic justification to say that it was to ensure that patient undergoes treatment
 * Doctor has burden to prove that there were reasons
 * Why is it objective rather than subjective?
 * Don’t want to enable patients to rely on idiosyncratic preferences unless they’ve made it plain to the doctor
 * Does Canterbury require that the doctor reveal personal characteristics that a reasonable person would want to know when working with this doctor?
 * Specifically rejects the notion that duty only arises when you ask
 * Do not require inexperience or a history of drug problems
 * In some cases, there is a duty to disclose HIV status
 * How does the doctor prove objectively that it was necessary?
 * Would a reasonable patient have objected the treatment?
 * Must show that no reasonable person would have undergone the treatment if they had known the risk
 * Why would the court adopt a causation standard that guts the core of the duty requirement?
 * The alternative (subjective standard) is unworkable
 * Not all that persuasive – it could have been workable
 * Are there other alternatives?
 * Causation is established where the Π can prove loss of chance theory
 * Does the duty to reveal extend beyond the treatment context?
 * An unrevealed risk must materialize or there’s no cause of action
 * But there can be an injury even if you fully recover
 * Duty to disclose that the patient is dying?
 * Yes – reasonable people would want to know that, BUT the case law shows that there is no duty to disclose this information
 * Confined to treatment cases
 * Exception Thurman → the doctor should have done more to inform her of the consequences of failing to follow his recommendation

Disclosure of Physician Conflicts of Interests
Moore v. Regents of UC
 * Facts: Patient subjected to liver tests which doctors are secretly profiting from

Malpractice
Iatrogenic Injuries
 * Encourages Defensive medicine & Coverups / Culture of Silence
 * ie. Ordering excessive unnecessary tests to cover liability AND avoiding useful, but riskier procedures

Professional Standard of Care (Reasonable MD)
 * Custom (different from ordinary negligence)
 * In Tort, must be well established & would've had an impact to be evidence of negligence (never dispositive)
 * In traditional malpractice, custom is dispositive (kinda), juries aren't meant to evaluate usefulness of that custom (though often do anyway).
 * The question is: What are the minimal standards of care and judgement?
 * Hall v. Hilbun
 * Facts: The patient complained of abdominal discomfort. The doctor diagnosed the problem and performed surgery with apparent success. The patient died 14 hours after the surgery. The husband brought a wrongful death action and argued that the doctor failed to provide adequate post-operative care. The P introduced experts who testified that the doctor did not provide the level of care that he should have.  The trial court excluded the expert’s evidence because he was not familiar with the local standards.
 * Holding: In light of the nationalization of medical education and training and the acknowledgement that reasonable expectations regarding a physicians skill and knowledge are the same everywhere, the court adopts a competence based national standard of care:
 * Given circumstances of each patient, each physician has non-delegable duty of care to use his or her knowledge and therewith treat through maximum reasonable medical recovery each patient, with such reasonable diligence, skill, competence, and prudence as are practiced by minimally competent physicians in same specialty or general field of practice throughout United States, who have available to them same general facilities, services, equipment, and options;
 * However, with respect to the medical facilities and equipment, the old locality rule still applies as in many rural areas certain facilities and equipment may not be available. Moreover, where expert lives or where he or she practices his or her profession has no relevance per se with respect to whether person may be qualified and accepted by court as expert witness.


 * Practice Guidelines as Codified Standards of Care
 * Substantial regional variations exist in the use of many procedures, with no apparent differences in outcome.
 * There have been recent substantial efforts toward standard setting and specifying treatments for particular diseases.
 * Clinical pathways/guidelines: interdisciplinary plans of care that outline the ideal sequence and timing of interventions for patients with a particular diagnosis, procedure, or symptom.
 * Critical pathways: describe what will happen to a patient every day that the patient is in the hospital
 * Such guidelines may reduce delays, reduce resource use and cut costs.
 * Since such guidelines might be evidence of the customary practice in the medical profession, a doctor conforming to the guideline might be shielded from liability (on the other hand, failure to conform to the guidelines could be negligence per se)
 * Plaintiffs have used such guidelines to their advantage in malpractice cases


 * Reasonable Physician Standard: Judicial Risk - Benefit Balancing
 * Generally: This is the standard to which the law is shifting, away from custom.
 * Helling v. Carey - Applies something like Learned Hand test = Burden < Probability of Loss
 * Important Note: For all the hype, this case is almost universally considered wrongly decided and is not followed by other courts.
 * Facts:
 * Relatively young patient (23 at the time of first treatment) complains of myopia, nearsightedness. She is given contacts.
 * Over the next nine years she complains of irritation and the doctor does nothing substantially. Finally, at the age of 32, she tests positive for glaucoma. Patient is nearly blind at this point.
 * Justification: Doctor justifies not giving the glaucoma test because it was not recommended for people under the age of 40 (incidence in that demographic is only 1 in 25,000).
 * Issue: Is defendants’ compliance with the standard of the profession of ophthalmology enough to insulate them from liability? (Does compliance with custom suffice?)
 * Hold: No. “We therefore hold, as a matter of law, that the reasonable standard that should have been followed…” was to give the glaucoma test. (334).
 * Failure to do so results in a finding of negligence.
 * Rationale: The doctor was wrong, and the entire profession was laggard (“…a whole calling may have unduly lagged in the adoption of new and available devices.” (Quoting from Justice Hand, T.J. Hooper case)). The custom should be changed to require glaucoma testing.
 * Historical Analysis:
 * Helling v. Carey made a huge splash when it was announced.
 * Demonstrates the limitations of judges in attempting to bypass experts in conducting cost-benefit analysis.
 * 1970s saw a huge exodus of private MedMal insurers from the market, and this case was often cited as a contributing factor.
 * Response from other jurisdictions:
 * The case has been widely disapproved of. Even the Washington state legislature tried to overturn the result with legislation, although they were rebuffed by the court.
 * But ophthalmologists nationwide did follow the court’s holding: there was subsequently a vast spike in glaucoma testing.
 * Explanation: Perhaps doctors were unaware that the case wasn’t good law. More likely, with fee-for-service insurance prevalent at the time, ophthalmologists could simply pass on the cost to insurers.
 * Important to preserve Informed Consent by expressing that this is not the standard.

Ostrowski v. Azzara
 * Contributory Fault of The Patient
 * Facts: Heavy smoker, insulin dependent diabetic sought treatment from D of a hurt toe. D cut off the toenail. The toe failed to heal and had to be cut-off. P alleges that the doctor acted negligently by cutting off the toenail w/o adequate consideration of P’s condition. D argued that P continued to smoke cigarettes and failed to maintain her diet; both of which contributed to the injury.
 * Holding: The jury concluded that D was negligent but since P was 51% at fault no recovery was allowed. The court discusses a number of doctrines and how they apply:
 * Comparative negligence: P can recover if his fault is less than 50%
 * Doctrine of avoidable consequences: a P who has suffered an injury as the proximate result of a tort cannot recover for any portion of the harm that by the exercise of reasonable care he could have avoided (comes into action when the injured parties carelessness occurs after the D’s legal wrong has been committed) this is a rule of damages not a defense
 * Doctrine of the particularly susceptible victim: a defendant must take the plaintiff as he finds him (i.e. with pre-existing conditions)
 * Doctrine of aggravation of a preexisting condition: a D whose acts aggravate a P’s preexisting condition is liable only for the amount of harm actually caused by the negligence
 * In a case like this where P already has a preexisting condition the doctrine of comparative negligence would not be appropriate. The pre-treatment health habits of a patient are not to be considered as evidence of fault that would have otherwise been pled in bar to a claim of injury due to the professional misconduct of a health professional. However, mitigation or apportionment of damages may be expressed in terms of the patient’s fault.
 * Rationale: Court basically says that if a doctor make a patient worse off than they already were, then the doctor is liable.
 * Notes: The theory of contributory negligence is typically invoked when a patient failed to follow physician’s instructions after a procedure was performed or while in the hospital.
 * The defense Assumption of risk has been successful when the patient decides to undergo unconventional treatment (as long as she was clear of the nature of the treatment and signed a consent form) and in cases of obvious defects of which the patient should have been aware, such as hazards in the hospital room (P tripped over TV cord in hospital room; she knew it was there, having previously pointed it out to the staff)
 * Eggshell patients: Self-imposed injuries prior to doctor visit are not contributory negligence. Only negligence after or during treatment can be included.
 * "Avoidable consequences" is not a defense, but a means of distributing consequences between responsible parties.

Hospital Liability

 * Sources of Vicarious Liability
 * Employment
 * Berel - Control test
 * Sword - Ostensible (apparent) agency: Hospitals must do something to hold out the belief that that doctors are hospital agents and can dispel such an illusion with a sign or notice to patients.
 * Simmons - Non-delegable duties/inherent functions: Hospitals still responsible for doctors liability during these actions


 * Sources of Direct Liability
 * equipment
 * record-keeping/procedures
 * policies - Muse discharge
 * staff supervision
 * duty extends to 3rd parties (douglass)


 * Washington v. Washington Hospital Center
 * Patient suffered permanent brain injury from oxygen deprivation in the course of general anesthesia for elective surgery. She sued the hospital for negligently failing to provide a device that allows for early detection of insufficient oxygen in time to prevent the brain injury. The plaintiff presented expert testimony and medical journals, which said such devices are an emerging standard. The hospital argued that the evidence was insufficient, that the procedure was not "mandated" and only reflects “recommendations,” in excess of the standard of care. The court held that a reasonably prudent juror could find that a reasonably prudent hospital, at the time of the injury, and according to national standards, would have supplied the device. A standard of due care necessarily embodies what a reasonable prudent hospital would do, and hence care and foresight exceeding the minimum required by law or mandatory professional regulation may be necessary to meet that standard.

A healthcare institution, whether a hospital, nursing home, or clinic, is liable for negligence in:
 * maintaining its facilities,
 * providing and maintaining medical equipment,
 * hiring, supervising, and retaining nurses and other staff, and
 * failing to have in place procedures to protect patients.
 * failing to provide adequate security
 * negligent credentialing

Basic negligence principals govern hospital liability.
 * The professional duty of a hospital is primarily to provide a safe environment within which diagnosis, treatment, and recovery can be carried out.
 * Hospitals must have minimum facility and support systems to treat the range of problems and side effects that accompany procedures they offer.
 * Staffing must be adequate.
 * Equipment must be adequate for the services offered, although it need not be the state of the art (there is a duty to transfer if the hospital lacks the necessary device)
 * Hospitals own safety rules or internal regulations may serve as a source of a standard of care.

Under the HCQIA, hospitals must check a central registry, a national database, before a new staff appointment is made. The database contains info on disciplined physicians, those who have been sued and those who have had their privileges revoked.
 * Darling v. Charleston
 * Facts: Patient broke his leg and went to emergency room for treatment. The doctor put the cast on wrong (cut off circulation) and when they took it off they cut his leg. The leg eventually had to be amputated. The patient sued the hospital and alleged that the hospital was negligent in failing to have a sufficient number of nurses for bedside care, failure of nurses to check on patients condition, failure to review docs work, failure to adequately supervise the doc. The court holds that a hospital is responsible to its patients for the quality of the docs allowed to practice within the institution.

Hospitals are held to certain standards; if there employees see incompetent care they have a duty to report it, plus the hospital has a duty to properly staff and supervise its employees.


 * Johnson v. Hillcrest Health Center
 * Facts: Husband sought treatment for chest pains at the hospital emergency room, and he was admitted to the hospital for further testing. The test results, which indicated the husband had myocardial injury, ordinarily were placed in the patient's chart and posted to the hospital computer system. However, the husband's test results were placed in the wrong chart. The data from the tests were available on computer terminals located throughout the hospital, but a doctor without checking the computer, concluded that the husband was not suffering from a heart attack and he was released. The next day, the husband was readmitted to the hospital again under the care of the same doctor, but was discharged again. The husband later died. The court held that summary judgment was precluded because: (1) sufficient evidence existed to raise material issues of fact concerning whether the hospital breached the applicable standard of care and the degree to which the breach may have caused or contributed to the patient's death; and (2) the summary judgment materials did not support a determination that the doctor's second discharge of the patient was an intervening cause of the patient's death.
 * Rationale: The court of civil appeals opinion was vacated. The trial court was reversed and the cause was remanded.

What happens when the patients insurance or other resources are exhausted but the staff physician believes that continued hospitalization is needed?
 * Duties to Treat Patients
 * Muse v. Charter Hospital of Winston-Salem
 * Facts: P argued that that the hospital was negligent in that, inter alia, it had a policy practice which required physicians to discharge patients when their insurance expired and that this policy interfered with the exercise of the medical judgement of his treating physician. The D argued that the theory is not a recognized theory of liability. The court held that the general duty of care owed by the hospital to its patients includes a duty not to institute a policy or practice, which required patients to be discharged when their insurance expired. However, it may be that insurance is checked early on systemically and limits are place on the care promised in advance. Remember stat obligs under EMTALA (Pg. 551)

Douglass v. Salem
 * Knowing affirmative representation

Abortion
Interests:
 * Harm - pregnancy
 * Having an unwanted child
 * Privacy (bodily autonomy & general autonomy)
 * Choice
 * Equal protections

Economic argument
 * Equality

or for those that are raped or for those that work in less secure employment

Sexual freedom in that men can walk away from sex w/o risk


 * Health of the mother
 * Potential life of fetus

Under Roe, Trimester Framework
 * 1st Trimester: Abortion less risky than pregnancy for woman & too early for viability (3rd trimester)
 * 2nd Trimester: In the interest of mother may regulate abortion method to reasonably preserve maternal health.
 * 3rd Trimester: In the interest of fetus or mother, State may proscribe, unless pregnancy health-threatening to woman.

Under Casey, Viability Threshold
 * Pre-viability → No Undue Burden or Substantial Obstacle
 * Post-viability → In the interest of fetus or mother, State may proscribe, unless pregnancy health-threatening to woman.

Roe v. Wade, H: Struck down anti-abortion law. Fundamental  right to privacy  exists & extends to a woman's  right to abort  her pregnancy  prior to viability  of fetus.
 * Roe's Viability Measure
 * 1st Tri → Individual fundamental right to decide whether or not (Strict Scrutiny)
 * 2nd Tri → Individual right, but state has compelling interest regarding health of mother
 * 3rd Tri → Viability of fetus, state has interest in protecting fetus life

Right to privacy is one of the Constitution's unenumerated implicit rights. Pregnancy is a great burden on a woman's personhood exclusively, thus the decision is hers. Right to privacy is not absolute, must be balanced against other interests, such as state’s protection over prenatal life. Planned Parenthood v. Casey, H: Affirms essential holding of Roe: State’s cannot prohibit abortion prior to viability. Trimester distinction overruled by new viability test. R: SDP protects a zone of privacy from gov't intrustion into one's most personal decisions (procreation, contraception, child-rearing, & education). Decision about whether or not to have a child is among the most profound decisions any human being can make, thus gov't cannot intervene. Protect Roe to preserve court’s legitimacy. Unlike, Plessy & Lochner, which were made intellectually obsolete by changes in perceptions & facts, the only thing that has changed since Roe is the USSC Justices. Responding to politics would undermines court's legitimacy. Fundamental right to abortion until 3rd trimester, prior to which state regulation is impermissible where it places undue burden on woman’s choice. State may inform or express preference so long as it doesn’t amount to undue burden.
 * Post-Roe Attempts at Regulation
 * 1) 24-hour Waiting Periods - Struck down because forced two trips, attenuated relation to woman's health, & burdens 1st trimester right w/o compelling interest.
 * 2) Informed Consent Requirements - Upheld as any other medical procedure until Casey
 * 3) Spousal Consent Requirements - Struck down because unnecessarily burdensome as woman gets final choice.
 * 4) Parental Notice/Consent Requirements - Upheld with condition of judicial bypass (minor could get judge's permission instead)
 * Substantive Due Process Argument
 * O'Connor's Equal Protection Arguments (Plurality):
 * 1) Burden is unique to women who have the right to shape their own destiny.
 * 2) Reliance interest: “Women have relied on Roe and Griswald…” forming relationships, making career & life decisions, knowing that abortion is an option. Blackmun: No justification to condem women back to darkness by overturning Roe & Griswold
 * 3) There has been no evolution in law rendering previous decisions obsolete
 * 4) There have been no factual changes in circumstances
 * New Undue Burden & Viability Framework
 * 1) 24-hour Waiting Period: Requirement of two visits is an undue burden;
 * 2) Informed Consent Requirement: Mere information (ie. suggesting there is life inside her womb) is NOT an undue burden.
 * 3) Spousal notification: Potential risk of domestic violence or divorce (eg. spouse is not the father) poses an undue burden on the subset affected that outweighs the subset of husbands' interests.

O'Connor: "Just because it's hard to adjudicate these cases, doesn't mean we can't or shouldn't. We must use reasoned judgment, while not mandating our own moral code. The liberty & burden of pregnancy on women is too unique & intimate to be regulated by the law."

Stenberg v. Carhart

Gonzalez v. Carhart

Fetal Rights
(pg. 1264)

In re A.C.: Cesarean section performed on terminally ill pregnant woman against her will in an attempt to save viable fetus. Court rules that there are no circumstances in which the right to bodily integrity can be infringed (and physically force them to be subjected to the surgery).

Argument: Voluntarily carrying the fetus to term creates a duty to child that could justify invasive procedure.
 * But no legal obligation for parent to donate kidney or blood if child requires it.
 * The threat of forced surgery (or increased criminal penalties for drug use while pregnant) could drive women away from medical system
 * Forced surgery results in wrongful imprisonment, assault, battery, et al.

Genetic Testing
Genetic tests are used for several reasons, including:
 * carrier screening, which involves identifying unaffected individuals who carry one copy of a gene for a disease that requires two copies for the disease to be expressed;
 * prenatal diagnostic testing;
 * newborn screening;
 * presymptomatic testing for predicting adult-onset disorders such as Huntington's disease;
 * presymptomatic testing for estimating the risk of developing adult-onset cancers and Alzheimer's disease;
 * confirmational diagnosis of a symptomatic individual; and
 * forensic/identity testing.

Genetic information can also be used unfairly to discriminate against or stigmatize individuals on the job. For example, people may be denied jobs or benefits because they possess particular genetic traits--even if that trait has no bearing on their ability to do the job. In addition, since some genetic traits are found more frequently in specific racial or ethnic groups, such discrimination could disproportionately affect these groups.


 * Problems of using Genetic Mutations as indicators
 * Incomplete penetrance → Heightened risk, but other things must happen for condition to express
 * Variable expressivity → Condition expresses itself in different levels of severity

BRCA 1 & 2: Initially, believed to be certain indicator of breast cancer. Study later revealed to examine only those with family history of breast cancer.

Insurers want information about identified genetic mutation for actuarial accounting. However, there are many concerns
 * They argue that the information asymmetries lead to adverse selection, impacting profitability of industry
 * Genetic mutations are immutable characteristics are unfair to penalize people for
 * Discourages people from doing genetic testing for fear of it being used against them


 * Life & Long term care insurance contrast
 * Necessity argument undermined by reality of investment
 * In NJ, actuarial justification necessary


 * Statutory protections:
 * State Law → NJ & others prohibit such discrimination for any employees in NJ
 * ERISA → Prohibits employment discrimination on the basis of predicted benefits consumption
 * Federal statute protecting Federal employees only


 * Mayfield, III v. Dalton
 * Facts: Marines challenge military policy of collecting DNA reference specimens for identifying bodies as unreasonable seizure.
 * Holding: Military has compelling interest (need to account for soldiers' fates & ensuring peace of mind to next of kin/dependents), which when measured against the minimal intrusion of taking samples for DNA registry is a reasonable "seizure."


 * Safer v. Pack
 * Facts: Doc treats P’s father for colon cancer (hereditary). P later develops colon cancer and brings suit alleging physician breached duty to inform those potentially at hereditary risk.
 * Holding (1): Physician has duty to warn those known to be at risk of avoidable harm from genetically transmissible condition; and
 * Holding (2): Physician's duty extends to members of immediate family of patient who may be adversely affected by breach of duty. However, liability determined on case by case basis (Doctor obliged to track down children given up for adoption?)
 * Holding (3): This is distinct from Tuberculosis case. Lower court application of that test (risk of infection occurred prior to doctor-patient relationship, therefore no duty) was rejected, due to doctor's unique position to prevent harm post-infection at limited cost to him.
 * Subsequent NJ patient confidentiality legislation (requiring court order to violate Dr./Patient confidentiality) overrides Holding (2), current status is unknown.

The only federal law that directly addresses the issue of genetic discrimination is the 1996 Health Insurance Portability and Accountability Act (HIPAA). HIPAA prohibits group health plans from using any health status-related factor, including genetic information, as a basis for denying or limiting eligibility for coverage or for charging an individual more for coverage.

Problem: All in the Family (Pg. 1300)
 * Sister may still benefit from knowledge even if abortion is a non-option

Greenburg v. Miami Children's Hospital Research Institute - (analogue to Moore(?) kidney/liver research case)
 * Facts: P (parents of children afflicted with Canavan disease & participating non-profit research groups) cooperated with Institute by donating & collecting tissue for researching disease and as aid in identifying other affected families. P sued D for patenting the genetic screening tests for it for the purpose of commercializing the results of charitable contributions.
 * Holding (1): Lack of informed consent, breach of fiduciary duty, fraudulent concealment of the patent, and misappropriation of trade secrets claims all dismissed.
 * Holding (2): Court upheld claim of unjust enrichment made by the donors of tissue, on the grounds that "the facts paint a picture of a continuing research collaboration that involved P also investing time and significant resources."

Death
Old Defs (practical determination based on a pretty certain guess) New Def is somewhere below 1st & above 3rd state Harvard Medical Committee Def Current Def
 * Irreversible cessation of heart/lung function (heart & breath stop)
 * Vent Dependent - quadriplegic
 * Vent Dependent - higher brain activity severely impaired (coma)
 * Dead - Breathing solely b/c of ventilator (organs can be kept alive this way for some time)
 * Irreversible Coma
 * Irreversible Cessation of H/L OR Whole Brain Death

Dead donor rule - Vital organs may only be retrieved from dead bodies.
 * Vital organs are most viable from bodies with beating hearts

In the event of brain death Non-Heart-Beating Cadavers (NHBC) possible, but a LOT harder.

The Anencephalic Baby (Unique situation - No higher brain ever existed)
 * In Re T.A.C.P. - Parents want baby's organs donated before death
 * Court applies Dead Donor Rule
 * In Re Baby K - Parents want baby kept alive as long as possible
 * EMTALA takes hold. Baby is brought in unstable, entitled to hospital care until stabilized.

COMMON LAW RIGHTS TO REFUSE TREATMENT

 * Competent patients
 * Lane v. Candura (Mass. 1978)
 * The mother, an elderly widow, suffered from gangrene in her foot and leg but refused to consent to amputation, even though that decision would in all likelihood lead shortly to her death. While she vacillated in her decision about whether to undergo surgery, she also spoke of her unwillingness to spend the remainder of her life as an invalid in a nursing home and said she welcomed death. The court held that the mother had the right to refuse surgery because the evidence did not warrant a finding of incompetence. There was no indication in the testimony that the mother's decision was made without an appreciation of its consequences, and the evidence failed to overcome the presumption of competence. The mother's refusal to consent to life-saving surgery was medically irrational, as indicated in her physician's testimony, but that decision did not justify a finding of legal incompetence. The state's interest in preserving life did not outweigh a competent person's right to refuse life-prolonging treatment, so long as the refusal was an informed decision made by a person capable of appreciating the nature and consequences of her act.
 * Competence can be defined in three ways
 * Outcome: actual decisions by patients which do not reflect community values are used as evidence of incompetence
 * Status: based solely on physical or mental status
 * Function: focuses on actual understanding and processes in decision-making situations
 * Hard questions are the human ones
 * The legal questions → are they competent? Do they understand?
 * In this case, the evidence was circular – no rational person would not want to the surgery
 * It’s a psychotherapist saying this
 * Per se incompetence
 * When the only evidence is rejection of doctor advice, that’s not sufficient
 * Distinguished in the matter of northern
 * That woman didn’t understand the outcome – she refused to acknowledge consequences
 * Nothing here about the constitution, this is all common law
 * This is the law in every jurisdiction
 * Competent people can refuse medical treatment even if the likely consequence is when they are going to die
 * Incompetent patients: common law rights


 * In re Quinlan (NJ 1976)
 * Appellant, father of an incompetent, initiated an action to be appointed guardian of person and property of his daughter who was in a coma, and respondent guardian at litem was appointed to protect the interests of the incompetent. Appellant expressed intentions to discontinue life support, if appointed. The trial court denied the request. On review, the court held that appellant's religious freedoms weighing against the state's interest in the preservation of life did not present a constitutional question. Appellant's daughter was not unconstitutionally subjected to cruel and unusual punishment because punishment was intended to cover criminal penalty. Appellant's daughter's right of privacy could be asserted on her behalf by her guardian under present circumstances. The court affirmed the refusal to authorize withdrawal of the respirator, but appointed a new guardian of the person of his daughter with power to make decisions with regard to the identity of her physicians. The court did not prohibit the physicians from concluding that life-support should be withdrawn, but took such decision out of the trial court's jurisdiction.
 * Employed the test: if the incompetent person were “miraculously lucid for an interval (not altering the existing prognosis of the condition to which she would soon return) and perceptive of her irreversible condition” what would she decide?
 * Not analogous to suicide
 * Suggest an in house Ethics Committee
 * Difference between brain dead and permanent vegetation state (PVS)
 * What do we want to ask ourselves in making this decision?
 * Subjective standard – what would she do in these circumstances?
 * www.compassionatechoices.org
 * Underscores that refusal to consent is protected by common law
 * Came down to what she would have wanted
 * The meaning depends on whether the patient is curable


 * Superintendent of Belchertown State School v. Saikewicz (Mass. 1977)
 * Respondent, a 67 years old with an I.Q. of 10 and a mental age of approximately two years and eight months, was diagnosed with a fatal form of leukemia. If the disease was untreated respondent was expected to die without discomfort. If respondent was treated with chemotherapy, although his life would have been extended, there were serious side effects that respondent would be unable to comprehend, and the treatment would not cure his disease. After a hearing, the probate court ordered that no treatment be administered. The court concluded that the probate judge acted appropriately because the decision was (1) in accord with the testimony of the attending physicians of respondent, and (2) in accord with the generally accepted views of the medical profession. Respondent's right to privacy and self-determination, even though he was an incompetent person, was entitled to enforcement. The court found no state interest sufficient to counterbalance the decision to decline life-prolonging medical treatment under the circumstances.
 * State’s interests: “(1) the preservation of life; (2) the protection of the interests of innocent third parties; (3) the prevention of suicide; and (4) maintaining the ethical integrity of the medical profession.”
 * Must be reconciled with the individual’s liberty interest
 * Posit that the Probate Court is the suitable body to make these decisions
 * Reject the NJ approach re: committee
 * “Finding no State interest sufficient to counterbalance a patient's decision to decline life-prolonging medical treatment in the circumstances of this case, we conclude that the patient's right to privacy and self-determination is entitled to enforcement. Because of this conclusion, and in view of the position of equality of an incompetent person in Joseph Saikewicz's position, we conclude that the probate judge acted appropriately in this case.”
 * Mentally retarded man diagnosed with leukemia
 * Decision purports to be relentless subjective
 * Taking into account the present and future incompetency – can you do that?
 * Not like a person who had a life and had conversations and has values and you can make a pretty good or bad guess were they able to speak
 * This man has never been able to articulate these wishes
 * Places a high priority on individuality
 * Standard is a very subjective one
 * Who should implement the standard?
 * The Jersey court cites a law review article that points out an ethics committee in the hospital could be a good way
 * Is that who’s supposed to make the decision?


 * How do we reconcile these two?
 * They pretty much never want to hear these cases
 * Only if otherwise justiciable controversy
 * Given the way the world is, we’re not willing to provide blanket immunity
 * Puts the hospital based committee in a very tough position
 * There hasn’t actually been much of that
 * Who decides in MA?
 * Probate judge
 * NJ and MA take very different approaches
 * MA wants you to petition judge, NJ doesn’t want these cases
 * Virtually all states have developed a subjective standard that seeks to effectuate the wishes of the patient even if they’ve never been competent


 * Living wills and power of attorney
 * One way is through living wills and powers of attorney
 * In a living will, the person tries to specify what they would or would not want done to them
 * Durable power of attorney avoids problems re: sufficient specificity
 * NY law is unusual in this regard
 * Hardest state (with MO) in which to effectuate your desire not to maintain life support
 * Need clear and convincing
 * Other states require only preponderance
 * All states have adopted laws where incompetent people can invoke the right to refuse treatment → subjective test to evaluate what the wishes of the patient would be


 * Quinlan court treated the issue before it as one of constitutional law, while the Saikewicz court treated the issue as one of common law and statutory guardianship

CONSTITUTIONAL RIGHTS TO REFUSE TREATMENT?

 * Cruzan
 * Petitioners, parents suing on their behalf and on behalf of their daughter, requested a court order directing the withdrawal of their daughter's artificial feeding and hydration equipment after she was rendered vegetative in an auto accident. The appellate court denied their petition holding that petitioners lacked authority to effectuate the request because there was no clear and convincing evidence of the daughter's desire to have life-sustaining treatment withdrawn as required under the Missouri Living Will statute, Mo. Rev. Stat. § 459.010 et seq. (1986). The United States Supreme Court affirmed. It said that the Due Process Clause, U.S. Const. amend. XIV, did not require the state to repose judgment on matters concerning the right to refuse treatment with anyone but the patient herself. The Court held that a state could choose to defer only to the patient's wishes rather than confide the decision to close family members.
 * Must be clear and convincing evidence
 * Why does it become a constitutional claim?
 * The state has expressed an interest in the preservation of life and insist on C & C evidence
 * In Cruzan, it becomes a constitutional case b/c the parents, the guardian at litem appointed, the state court judge → all agreed that if she could speak, she would want the feeding tube removed
 * Missouri SC acted in light of state’s interest – despite all that, we don’t think the feeding tube should be withdrawn
 * Brennan dissent
 * Applies a constitutional framework for these cases
 * More conventional way to look at intrusion on fundamental rights (pre-Casey)
 * This is a question that affects A LOT of people!
 * 70% of people who die in the hospital forego some sort of treatment
 * Applying the analysis: what’s the individual interest at stake in this case?
 * The same right protected by the common law right to refuse medical treatment (also protected by the constitutional prohibition on state interference on liberty)
 * Only through measures narrowly defined to serve compelling state interests
 * Rehnquist disagrees with all of this
 * Definition of individual interest: part of his more general approach to due process
 * Liberty protects a whole bunch of stuff, but not fundamental
 * If it’s just a liberty, then the state is entitled to interfere
 * Here, he assumes that there is an interest, not fundamental, so the state may override as long as the action is not wholly irrational
 * The state can demand C & C evidence and offers several reasons why
 * The state’s interest in preserving life
 * We often require C & C evidence when there are important rights at stake (terminating parental rights, mental commitment, BRD when we’re going to put someone in jail); .'. it’s okay to require C & C when the interest in important
 * Heart of dispute – Rehnquist sees this as a right to life; Brennan sees this as a right of choice
 * O’Connor concurrence: Serious invasion of bodily integrity
 * Artificial feeding burdens individual liberty – most people don’t in fact leave instructions
 * Individual ability to exert control over the end of their life
 * All the court technically says is that it’s okay to demand C & C, don’t say whether it’s okay to demand BRD
 * Terry Schiavo and the right to die cases
 * Federal right to privacy is much more explicit than state
 * Incompetent people have a constitutional right to end treatment
 * Case went up and down the courts
 * Jeb Bush persuades the legislature to appoint him as the guardian
 * His order was challenged as a violation of separation of powers
 * Appointing the governor was essentially performing a judicial task
 * This year, the tube is finally removed
 * Congress comes into the picture
 * Passes Terri’s law
 * Federal law
 * Is it constitutional or not?
 * It only applies to one person
 * Does that make it unconstitutional? On the one hand, Congress can adopt private bills for changing immigration or tax status, etc.  it’s ok to do that.  Only constraint is that you can’t pass a bill of attainder (difference is that one imposes a penalty and one does not)
 * Terri’s law is .'. constitutional
 * Authorizes federal court to ignore the fact finding of the state court
 * It’s a de novo review
 * Authorizes federal courts to review finding of state constitutional law
 * Schindler’s arguments
 * Denied 14th due process – substantive and procedural
 * Court rejects all these arguments – there has been a lot of process here – it’s all about the failure of the process
 * Implications of the whole incident?
 * This bill overwhelmingly passed
 * Supporters said we can expect to see more legislation stemming from this problem
 * Control of the federal courts?
 * As a practical matter, the fact that the judges did not take up the congressional indication, its hard to follow and hard to know what form it might be
 * More likely implications at the state level
 * Controversial role of people with disabilities
 * In context of treatment decisions made for infants
 * Substantive rules
 * Fairly straightforward in statement, if not always in application
 * Parents have wide latitude
 * Lots of discretion
 * Infants with very serious disabilities
 * 2 extraordinary articles
 * Duff and Campbell → pediatric intensive care nursery at Yale
 * Describes their process – essentially rapid evaluation, broad consultation, and making a judgment about whether to treat aggressively or basically not treat
 * While they want to respect parents’ desires, it was better not to say this is all up to you
 * Esp. if the decision is going to come out “don’t treat”
 * We’re not sure what society thinks, we’re not even sure if it’s legal, but here we are
 * Anorba from Britain
 * Pioneering techniques for treating kids with spina bifida – kids who otherwise would have died
 * In a wheelchair, incontinent, but didn’t affect their mental state at all – he thinks he made a mistake
 * He can save their lives, but it’s not a life worth living
 * Concludes: is this right? what do you as society think about this?
 * Baby Doe case
 * Unanimous agreement that the baby has Down’s Syndrome and an easily surgically corrective surgery – would you correct or not?
 * Doctor recommended not to correct, because the baby had Down’s. Parents agreed. Someone sued.
 * That case, unlike the earlier articles, generated a firestorm
 * Why?
 * Dove and Campbell weren’t dealing with Down’s, much more serious cases
 * People with disabilities have more of a voice
 * HHS § 504 of the rehabilitation act – federal remedy for withholding treatment on the basis of disability
 * Huge impact b/c it provided for a federal remedy (the baby doe hotline)
 * Every hospital had to put up a sign: if you think that a doctor or parent is withholding treatment on the basis that the baby is disabled, call that hotline
 * Courts held that HHS did not have the authority to pass those regulations
 * Key provision is § b → irreversible coma, virtually futile, inhumane, etc.
 * You can allow withholding if it would not effective in ameliorating, prevention of death, or futile

Life Sustaining Treatment
A Percentage Game (Perform treatment → 25% chance of success)

Is there a difference between refusing life-sustaining treatment and a lethal injection?
 * Letting nature take it's course vs. causing death/removing unwanted intervention
 * Consent argument is problematic because consent is never a defense to death
 * Withdrawal of treatment is not framed as right to die, but protection from unwanted bodily invasions

Removal of life-sustaining treatment under all circumstances, BUT... Capacity cases: NJ - Conroy
 * If request is suspect, capacity to make decision called into question.
 * In Re Eichner (NY) (Teacher with C&CEvid of his desire for LST withdrawal): Permitted
 * [Companion Case] (M.Handicapped whole life): Not Permitted since never could produce C&CEvid
 * Subjective - C&CEvid of P's decision
 * Limited objective - some evidence of intent/benefits of pain relief
 * Pure objective - no evidence of intent/severe pain
 * PVS - Family decides

NY - No living will statute NY - Health Care Proxy
 * If you write your wishes in a living will, that's C&CEvid
 * Spouse just as required to provide C&CEvid as anyone else
 * Agent must have reasonable knowledge of wishes (can't be guessing)

NJ - Living Will Statute

THE RIGHT TO ASSISTANCE IN DYING
Current battle moved beyond rejecting treatment to affirmative assistance in dying
 * Prohibitions against suicide are historic
 * Now, besides Oregon, it’s criminal to assist someone in suicide – either through regular homicide laws or through actual assisted suicide laws


 * Why has this issue emerged at this point in history?
 * Increases in technology
 * Attitude towards pain medication
 * Distance from the Holocaust – dangers of hastening death forgotten
 * Since Roe, both the pro-choice and the anti-choice movements gained power and momentum
 * Hemlock society has been around for a long time claiming that the terminally ill had a right
 * Out of that movement came a book called “Final Exit” that was published in 1990
 * Kevorkian gave a public face to these issues
 * HIV – entitled baby boomers wanted their choice!
 * 1991 – Quill wrote a piece in the NE journal of med described patients who he had helped to quicken death
 * He could give them the medicine but then not stay with them under ethics laws and that was horrible for him
 * Then he was brought up on charges and exonerated since he didn’t really know if the patients would take the drugs or not


 * Oregon passed the first assisted suicide law
 * Adopted in 1994, went into effect in 1997 after the SC Glucksburg decision
 * Define the right in the same way → legislation and Πs
 * Terminally ill, mentally competent, adults
 * Asking for the assistance – the doctor should be free to prescribe them medicines that they themselves can take
 * Difference between assisted death and euthanasia
 * Patient must make two requests, 48 hours apart, and that they be a resident of the state
 * Protection against coercion and limits on the substantive reasons for seeking death
 * Designed to assure that the choice is authentic
 * Must be terminal and must be able to self administer
 * Law does not require that the doctor certify that they are not depressed and that they are in chronic pain
 * Should the law require that the patient is not doing this for monetary reasons?
 * Requiring that the doctor can only do this if the patient’s whole family agrees?
 * Requirement that defines groups of vulnerable people barred from using this law?

WA v. Glucksberg (1997)
 * Respondents brought a suit seeking a declaration that Washington state's ban on physician-assisted suicide, Wash. Rev. Code § 9A.36.060(1) (1994), was unconstitutional on its face. On review, the United States Supreme Court held that history, legal traditions, and practice support criminalizing assisted suicide. The Court held that the assisted-suicide ban was rationally related to a legitimate government interest because Washington sought to preserve human life and also uphold the integrity and ethics of the medical profession. Additionally, Washington's statute sought to protect vulnerable groups, such as the poor, elderly, and disabled from abuse, neglect, and mistakes. Finally, the Court held that Washington's ban on assisted-suicide effectively prevented a broader license to voluntary or involuntary euthanasia. Thus, the Court reversed judgment in favor of petitioners.
 * Claims only made on behalf of competent adults
 * 9th and 2nd cir → the blanket ban on hastening death was unconstitutional as applied to competent terminally ill peeps
 * 9th went with liberty
 * 2nd went with equal protection
 * A unanimous SC reverses – Rehnquist
 * Always two questions → what’s the asserted individual liberty? What’s the state interest?
 * Right to bodily autonomy – but what’s the shape of that right? what’s the actual claim?
 * The Πs claim is whether mentally competent terminally ill people have a constitutional conizable right to control the circumstances of his or her imminent death
 * Rehnquist goes with right to commit suicide which itself includes a right to assistance → nothing to do with mentally competent terminally ill, but a more general right to commit suicide
 * Stevens characterizes is as a right to dignity in determining….avoiding indignity…..interest in deciding how rather than whether a critical threshold shall be crossed…choosing a final chapter that accords with her life story rather than one which demeans
 * Souter → beyond traditional liberty, to be free from arbitrary imposition or purposeless restraints
 * Less on substance on individual claim but whether the state has any justification
 * Rehnquist – as applied, Stevens – on its face
 * Stevens says the Πs have died! The doctors have never been prosecuted, so their claims might not be ripe
 * Both Rehnquist and Stevens want to characterize this as a very broad challenge so that it can be rejected (Stevens caveat that it doesn’t foreclose an as applied suit)
 * Tradition or simply a matter of common law
 * But if in 1997 every state criminalized it, how can the court go against this?
 * Interest doesn’t have the same force for a terminally ill patient -whether to live or whether to die
 * There’s a difference between a person who chooses to hasten the end of life and one who doesn’t
 * All lives are protected by the law
 * Undermine medical integrity


 * PAIN
 * Many recent large prestigious studies document that severe treatable pain is systematically undertreated in the US. Lots of people die in severe pain that could have been treated. Proposed solutions:
 * Education.
 * Enforcement of rules by state medical boards.
 * Availability of Pain-Relieving Drugs
 * Legal Remedies for Adequate Pain Care


 * FEDERALISM
 * The Supreme Court invites the states to experiment. But then Ashcroft questions whether the Oregon can experiment.
 * Controlled Substances Act
 * Asserts federal regulation over certain categories of drugs.
 * Category 1: drugs for which there are no medical uses (LSD, marijuana).
 * Category 2: drugs for which there are medical uses, but also have addictive properties.
 * You can’t prescribe a controlled substance without a federal license that you get from the DEA.
 * Does Congress have the power to do this, to tell the states what to do?
 * The Commerce Clause: does Congress have power under the Commerce Clause to adopt a rule telling states they can’t authorize doctors to assist hastening death.
 * Congress is allowed to regulate the channels and instrumentalities of interstate commerce, and those things that have a substantial relationship to interstate commerce.
 * So Congress could make a law regulating any drugs that have been sold in interstate commerce

HIPAA

 * THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996
 * Group reforms
 * Reduce time period by credible coverage
 * Pre-Existing Condition must be present → must broader definition!
 * Doesn’t have to have been diagnosed or treated, Can just be lurking…
 * Prohibition on excluding newborns, pregnant women, and genetics
 * Reforms for individual market
 * Prohibits from denying coverage – guarantees individuals access to the individual market if they meet the 18 month requirement, but only applies to companies that offer individual insurance and persons who have been insured; provides no limits on premiums that are charged
 * Bottom line – HIPAA provides a real benefit, but it’s not necessarily portability
 * Seeks to reduce practices by insurers and health plans that seek to bar entry by “bad risks” and thereby reduce the problem of “moral hazard”
 * Structure and scope of the act
 * Promotes entry into new groups by individuals with a PEC
 * Reaches both private employer health plans, heath plans offered to state and local employees, and group and individual insurance products sold by state-regulated insurance
 * The act “piggy-backs” on state insurance regulation schemes by establishing an enforcement process in the case of individual market reform provisions, that relies primarily on state enforcement schemes and that employs federal enforcement only in the case of default by the state
 * Group market reforms
 * Limits the ability of employer plans and group insurers to deny coverage to individuals with PECs; portability
 * Can only exclude a PEC if:
 * Relates to a condition diagnosed or treated in the past six months
 * Such exclusion does not last longer than 12 months
 * Period of exclusion is reduced by the aggregate of the periods of credible coverage
 * “Credible coverage” means coverage under another group health plan, any health insurance coverage, Medicare or Medicaid, etc.
 * Thus, an individual with one year’s credible coverage could not as a general rule by subject to any PEC exclusion in the event that he or she were to change jobs and timely enroll in a new employer group plan
 * “Special enrollment periods”
 * Individual must have turned down enrollment initially because he or she had other coverage at the time coverage was previously offered to the employee or dependent
 * Must state in writing at the time that enrollment was offered that his or her other coverage was the reason for declining new coverage
 * Other coverage must have been “under a COBRA continuation provision” and the COBRA coverage must either have been exhausted or else terminated as a result of the loss of eligibility for the coverage
 * Must request enrollment within 30 days after the date of exhaustion or termination
 * Thus, the existence of a PEC is not dependent on the individual’s having received treatment for a condition
 * Cannot use genetics, newborns, adopted children, or pregnancy
 * Several important caveats
 * Permits a group plan to elect what is termed an “alternative method” of calculating credible coverage
 * Credible coverage not counted if there was a 63 day period of non-coverage
 * Permits HMOs to impose an “affiliation period” of up to two months
 * Law prohibits employer plans and group insurers from discriminating in coverage against individuals; antidiscrimination
 * Cannot establish rules based on
 * Health status
 * Medical condition
 * Claims experience
 * Receipt of health care
 * Medical history
 * Genetic information
 * Evidence of insurability
 * Disability
 * Also prohibits higher premiums for these groups
 * Law regulates insurer practices in the area of small group coverage
 * “Guaranteed issue” in the small group market
 * Renewability
 * Can only deny on the basis of
 * Nonpayment of contributions
 * Fraud
 * Noncompliance with material plan provisions
 * Ceasing to offer coverage in a geographic area
 * No longer live, reside, or work in the covered area
 * The individual insurance market
 * Guaranteed availability
 * Limitations
 * Does not have to offer in the individual market at all
 * If it does, the insurer must offer entry to individuals who can satisfy five complex pre-conditions of eligibility which, taken together, exclude all persons other than individuals who, immediately prior to the purchase of individual coverage, were covered for at least 18 months by a health plan or a COBRA continuation plan
 * Can issue separate policies with separate premiums for the guaranteed issue population
 * Guaranteed renewal
 * Supplement article on criticisms of HIPAA