BASIC INFORMATION

HEALTH LAW CONCEPTS

1. Physician Authority/professionalism
a. Physicians influence medicine
b. Doctors receive pay for each service rendered (fee for service model)
c. Doctors control health care resources
d. Private practice of medicine (for profit)
2. Modest egalitarianism (patients have greater say in health care)
3. Market competition (competition between private insurers, doctors,
pharmaceutical companies)
BARRIERS TO HEALTH CARE
1. Lack of health insurance (5m lost through recession)
a. Under insurance
2. Lack of physicians
3. Poor adults who dont qualify for Medicaid w/o children
4. Legal and undocumented immigrants
a. 5 year wait period for legal immigrants
THEMES IN HEALTH CARE ACCESS
1. Distributive justice
2. Actuarial fairness or mutual aid?
3. Libertarian or egalitarianism
4. Role of government or market competition?
5. Political realities
LEGAL SOURCES OF RIGHT TO HEALTHCARE IN US
1. Federal Statutes: Medicare, Medicaid, ADA, EMTALA
2. State Statutes: anti-dumping laws, hospital licensure
3. Common law: malpractice, abandonment
4. ACA: increased access to insurance
5.
DOCTOR-PATIENT RELATIONSHIP
1. Medical ethics of doctor-patient relationship, defining characteristics:
a. First, do no harm
b. Power imbalance
c. Vulnerability of patient
d. Intimacy of relationship
e. Need for private info from patient (public health need)
2. Hurley v. Edington
a. Holding: Doctor has no duty to enter into contract with patient
i. Not responsible for everyones life just because D is doctor

b. Facts: Patient sends messenger to doctor with fee to pay doctor, tries to
get doctor to come provide care
3. Abandonment liability: once doctor-patient relationship established, doctor has
duty of care until cessation of necessity that gave rise to emergency
a. Ex: Ricks v. Budge
i. Holding: Doctor had duty of care to patient who he told come back
if finger gets worse
1. Dr must provide sufficient notice so patient can seek other
care
ii. Facts: Patient sues doctor for failure to provide care
1. Dr said come back if finger gets worse
4. State law duty to patient (hospital)
a. State CL: majority of hospitals recognize duty to treat patients in severe
emergency, regardless of patients ability to pay (See: Thompkins v. Sun
City)
i. Detrimental reliance: patient to ER, expecting treatment
ii. Undertaking: hospital takes on patient, and fails to treat or stabilize
(abandonment)
1. Ex: New Biloxi v. Frasierpatient in ER waiting room with
severe bleeding is refused treatment and no doctor will
attend to him
iii. Exceptions to duty to treat:
1. Diversion
5. Emergency Definition
a. Imminent risk of death or serious bodily harm
i. Includes labor (high risk of complications requiring immediate
treatment)
FEDERAL RIGHT OF PATIENT ACCESS TO ER (EMTALA)
1. Any patient who "comes to the emergency department" requesting "examination
or treatment for a medical condition" must be provided with "an appropriate
medical screening examination" to determine if he is suffering from an
"emergency medical condition". If he is, then the hospital is obligated to either
provide him with treatment until he is stable or to transfer him to another hospital
in conformance with the statute's directives.
a. Appropriate medical screening to determine whether patient suffers from
emergency medical condition
i. Within capacity of hospitals ER
ii. Not med mal standard
b. Stabilization of condition
i. Stabilizing medical tx OR
ii. Appropriate transfer to another hospital
c. Prohibit transfer until patient is stable, unless transfer is in accordance
with statute
i. Risk-benefit analysis

ii. Transport to appropriate facility

iii. Accepted by receiving facility
HISTORY OF EMTALA
1. Response to indigent patient dumping
2. Response to financial pressures from MCOs and DRGs
3. Development of Hill-Burton Act:
a. Hospitals that take on more patients who cant pay get more federal
money
b. Indigent women in labor
c. Stories about indigent women giving birth in hospital parking lots, after
hospital refuses to provide care
4. No federal remedy to patient dumping existed
a. Regulatory vacuum (no federal/state remedy)
5. Public policy
i. Reflect changing social expectations of egalitarianism
EMTALAS LEGISLATIVE HISTORY
1. Tied to Tax and Spend clause
a. Unfunded mandate (no EMTALA taxpeople pay more for hospital
services)
b. Linked to Medicaid participation
ii. Applies to all patients who seek care in emergency department, not
just Medicaid recipients
EMTALA CASE LAW
1. Power v. Arlington
a. Holding: Motive of hospital in not providing screening doesnt matter
i. Hospital must provide uniform screening to all patients
ii. Patient has burden of showing differential treatment
b. Facts: Patient comes to hospital with illness, doesnt receive screening
2. Summers v. Baptist
a. Holding: Hospital must only provide uniform screening to patients
i. Does not need to be reasonably calculated to detect an emergency
medical condition
ii. Court fears turning EMTALA into federal med mal remedy
b. Facts: Patient hears popping in chest
DUTY TO STABILIZE UNDER EMTALA
1. Definition of stabilized

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
2. Cherukuri v. Shalala (6th Cir. 1999)
a. Holding: transfer was appropriate, given lack of resources
b. Facts: Dr transfers patients with internal bleeding because hospital does
not have resources to perform necessary surgery
i. Accused of violating EMTALA (transfer before stabilization)
c. Compare with: Burditt v. HHSER physician refuses to come into ER to
treat woman who doesnt have insurance
2003 REGULATIONS
1. Obligations end once an individual is stabilized, appropriately transferred to
another hospital/facility or admitted to hospital as an inpatient
a. NB: Moses v. Providence Hospitalhospital that admitted patient to
psychiatric ward improperly transferred him, EMTALA obligations did not
end due to improper transfer
2. Hospital must maintain an on-call list of physicians and staff
a. Comprised in manner that best meets needs of patients who receive care
under EMTALA
b. In accordance with hospitals resources
3. Caveat:
a. Hospitals can permit physicians
i. To schedule elective surgery while they are on-call
ii. To be simultaneously on-call at different hospitals in the community
4. EMTALA applies when on hospital property
a. Main hospital campus
b. Includes parking lots, sidewalks, driveways
c. Does not included private physicians offices

EMTALA REMEDIES
1. Hospital subject to civil penalties levied by fed agency (HHS)
a. Loss of status as Medicare provider
2. Physician subject to civil penalties
3. Receiving hospitals may recover for their costs of treating individuals who were
improperly transferred to their facility in violation of EMTALA
4. Individuals may bring private CoA against hospital (damages governed by state
law)
EMTALAS RESULTS
1. No data on patient dumping prior to enactment, reportedly improving access
2. Concerns about added costs to hospitals have not materialized

a. Percentage of uncompensated care to hospital budget decreased slightly

from mid-1980s-1999
3. Increased usage of ER
a. Also consistent with increased to uninsured ppl
4. No decline in physicians refusing to participate in EW on-call panels
5. Violations continue to occur
ACA AND EMTALA
1. EMTALA will continue to govern ER case after ACA
a. Includes standard for charitable hospitals
2. Extra funding for trauma centers with disproportionate share of indigent patients
to states for ER physicians in underserved areas
3. Allows hospitals to make presumptive Medicaid eligibility determinations for
individuals
TEMPORING NO DUTY TO TREAT
1. Physicians can:
a. Refuse to accept new patients for any reason
i. Unless its an improper reason (race, gender, national orgin)
2. Health Care Facilities:
a. No racial discrimination
b. Title VI of CRA 1664
c. Meaningful steps to ensure access to interpreter
d. EMTALA
3. Social concernsdiscrimination on basis of race, disability and access to
healthcare in emergencies
a. Title VI of CRA
b. Section 504 of Rehabilitation Act
c. Americans With Disability Act
d. EMTALA
4. Physicians in MCOs voluntarily relinquish autonomy in selecting patients
5. NB: no duty to treat patients in need of care (outside exceptions)

REHABILITATION ACT ADA

1. Section 504: no otherwise qualified handicapped individualshall, solely by
reason of handicap be excluded from participation in, be denied benefits of, or be
subjected to discrimination under any program or activity receiving federal
financial assistance (link to 1964 CRA)
2. ADA: broader application e.g. to public accommodations including physicians
officers

WHAT IS A DISABILITY
1. ADA:
a. Physical or mental impairment that substantially limits one or more of the
major life activities of such individual
i. Record of impairment
ii. Being regarded as having such impairment
3. Ex) Bragdon v. Abbott
a. Holding: No direct threat to dentist
i. Providers cant refuse to treat HIV positive patients in their own
offices
ii. Universal precautions deemed to render care safe for provider
iii. No scientific reason to refuse surgery or other invasive procedure
iv. Segregtion within office not allowed
v. Public accommodation includes health care provider offices
b. Facts: Dentist refuses to fill cavity for patient with HIV
i. Would only treat her in hospital for extra precautions
c. ADA, Section 302: No individual shall be discriminated against on the
basis of disability in the full and equal enjoyment of the goods, services,
facilities, privileges, advantages, or accommodations of any place of
public accommodation by any person who operates a place of public
accommodation. 12182(a )
d. Nothing in this subchapter shall require an entity to permit an individual to
participate in or benefit from the goods, services, facilities, privileges,
advantages and accommodations of such entity where such individual
poses a direct threat to the health or safety of others. 12182(b)(3).
ADA REQUIREMENTS
1.
2.
3.
4.

Cannot deny participation in health care delivery

Cannot allow participation in an unequal manner
Cannot provider for different or separate participation on basis of disability
May be required to provide auxiliary equipment, personnel, etc

IMMIGRATION STATUS + ACCESS TO HEALTH CARE

1. Non-citizens more likely to be uninsured
a. Limited access to employment based insurance
b. Less likely to obtain needed care or preventative services
c. CHIP and Medicaid restrictions
2. ACA Impact
a. No changes to CHIP or Medicaid
b. Lawfully-present and eligible for Exchanges, no 5-year waiting period
c. Unlawfully present: not eligible to purchase insurance thru Exchanges at
full cost, and no subsidies
3. Continued role for safety-net providers
a. ACA sponsoring community health centers to treat

i. Uninsured
ii. Medicaid patients
iii. Vulnerable populations
b. Care without regard to ability to pay
c. Funding cuts regarding DHS allotments
i. Payments will fall even if number of uninsured ppl remains stable
ii. More pressure on safety net providers
4. Verification of status
a. Apply for benefit provide SSN and immigration citizenship status
b. Status will be automatically verified
FEDERAL LAW IMPACT ON STATE INSURANCE REGULATION
HIPAA INSURANCE REFORMS
1. Must limit pre-existing condition exclusions to increase portability of insurance
from job to job
2. Applies to individual and group plans
a. Individual plans: no exclusion for preexisting conditions if person had
insurance for 18 months (guaranteed renewal)
b. Group plans: limits on exclusions for preexisting conditions
i. Small group plans: guaranteed issue (policy is offered to any
eligible applicant without regard to health status)
3. Pre-existing conditions are physical or mental conditions that exist prior to
enrollment, regardless of whether tx sought
4. Coverage can be denied only if HIPAA reqs met, and is limited to 12 months
a. May exclude for HIV/AIDS
5. Plans can still establish restrictions on amount, extent, level and nature of
coverage for similarly-situated individuals enrolled on plan
6. Experience ratings permitted
7. NB: 2014, pre-existing conditions exclusions prohibited by ACA for group and
individual plans/policies
HIPAA NON-ENROLLMENT DISCIMINATION
1. Enrollment discrimination in GROUP PLAN cannot be based on health status,
health history, genetic information
2. Limitation on pre-existing conditions
3. Small group guaranteed issue
4. Less robust protections for individual market insureds
5. NB: health plans can still establish restrictions on amount, extent, level and
nature of coverage for similarly-situated individuals enrolled in plan (differentiate
from ACA)
a. May exclude for conditions (HIV/AIDS)
b. Group health plansguaranteed issue
c. No limit on premiums
i. Experience rating permitted
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d. Limited applicability to individual policies where there is continuous

coverage
i. Guaranteed renewal
ii. Individuals leaving group coverage
6. ACA prohibits coverage denials based on preexisting conditions
THE ACA
1. Applies to self-funded employers and insured
2. Triple Aim
a. Efficacy
b. Wellness
c. Patient-Centered health care Delivery
3. 10 Titles
a. Shared responsibility, state exchanges
b. Medicaid expansion 133% FPL
c. Payment incentives, delivery methods
d. Public health
e. PCP incentives
f. Elder abuse
g. Marketing biosmilars
h. CLASS (unsustainable)
i. Revenue provisions
j. HCERA
4. Additional landmarks
a. Medicaid expansion
b. Elder Abuse Prevention Act
c. National funding of public health measures
d. Patient Bill of Rights
e. Preventative Care Servics
f. Physician Payment Sunshine Act
g. Indian Health Care Improvement Act
5. Key features
a. Federal insurance market rules
b. Health Insurance exchanges
c. Individual and employer mandates
d. Affordability provisions and subsidies
e. Expanded access thru Medicaid and CHIP
6. Grandfathered Plans
a. Must comply with
i. Lifetime cap on benefits/annual limts
ii. No rescission of coverage, without fraud
iii. Cover kids up to 26
iv. No exclusion for pre-existing conditions
v. Summary of Benefits and Coverage
vi. Wellness rule

QUALITY CONTROL
1. Payment reforms eg quality measures, bundling payments, stronger primary care
foundation
2. Innovation center within CMS to reward cost effective quality improvement
3. Medical loss ratio and rate review
TITLE I: THREE-LEGGED STOOL
1. Insurance Reforms
2. Shared Responsibility
a. Individual, Emp. Mandates;
b. Medicaid expansion
3. Subsidies
RISK ADJUSTMENT UNDER ACA
1. Low risk individual and small group plans
a. Funds collected from non-grandfathered plans
b. Inside and outside exchange
2. Fed or state Risk Adjustment Program
a. Fed govt provides methodology
b. States operate exchanges may deviate from federal method
3. High Risk Individual and Small Group Plans
a. Funds redistributed to participating plans based on actuarial risk
ACA ROLLOUT
1. 14.1 m adults gained insurance (on exchanges or Medicaid expansion)
2. 2.3 m young adults on parents plan
3. Biggest gains in Blacks, Hispanics, Young Adults, Rural
4. CBO estimates premiums will be lower than expected
PROBLEMS WITH ACA ROLLOUT
1. Employer mandate DELAY
2. Family glitch
a. If an employer offers family plan that is too expensive, family doesnt
qualify for subsidies even if working parent is on individual plan
3. Medicaid expansion gap
a. Not all states expanded Medicaid
b. Some people left with no insurance because they earn too much for
Medicaid but not enough to qualify for subsidy on exchanges
4. Subsidy and state exchange litigation
a. Not all states enacted the exchanges
5. Contraception coverage mandate controversy
KING V. BURWELL
1. Validity of IRS reg that makes ACAs federal subsidies available to everyone who
purchases insurance thru a state or federal exchange
a. Are federal subsidies available to ppl who purchase insurance through
federally run exchanges?

b. Court (Roberts): prevent adverse selection in state insurance pools

intent of congress to compel ppl to buy insurance
i. Even though ppl buy plans run thru federal govt, they are still
shopping for plans on their states insurance market (that is the
point of the subsidy)
MEDICAID EXPANSION
1. Expanded to adults 133 percent of FPL
2. 30 states + DC expand
3. Fed govt pays 100% of costs until 2020 fed govt pays 90%
INDIVIDUAL MANDATE
1. Individuals must purchase health care plans or incur tax penalty
2. Subsidies for individuals who are between 133% and 400% FPL and who do not
have access to insurance through employer
EMPLOYER MANDATE
1. Employers must offer contraceptive coverage for individuals
2. King v. Burwellclosely held for profit corporations can use religious exemption
a. RFRA
b. Accomodation = least restrictive means to provide contraception coverage
3. Religious organizations must notify third-party administrator that they wont
provide coveragethird party administrator pays for it directly
4. Notre Dame v. Burwellproviding notice to enrollees = substantially burden the
plan?
a. Holding: no
ERISA (class 9)
REGULATION OF GROUP HEALTH PLANS
1. Employer/group plans may:
a. Provide coverage thru insurance k
b. Pay claims directly as they occur
2. Private sector self-insured group plans not subject to State health insurance
laws, and not subject to some of the provisions of the ACA (except some
consumer protections i.e. annual limit ban, prohibition on pre-existing coverage)
BACKGROUND OF ERISA
1. Passed in response to pension plan insolvencies
2. Covers health plans
3. Key features:
a. Does not require employers to offer health coverage
b. Reaches virtually all private employers
c. Uniformity across states
i. Preempts state law that relates to health benefit plans (express
preemption under 514)
ii. Saves state insurance laws from preemptionlimited by deemer
clause

10

d. Independent enforcement mechanism for beneficiaries wrongfully denied

benefits, preempting state law, including state tort law (implied preemption
under 502)
4. ERISA Plan Administration
a. Claims administrationdiscretion about coverage decisions
i. Ex) Mondryspeech therapy not covered initially by ERISAsponsored plan
1. Plan administrator furnishes information to beneficiaries
b. Medical services
i. What is medically necessary?
c. Actuarial services
d. Pharmacy benefit services
e. Utilization review
f. Claims appeal
i. Internal and external
g. **Settler Function: employer may decide what to cover and think about
their own interest, once plan set must be administered on behalf of ppl in
it
5. ERISA Provisions
a. Fiduciary duty
i. solely in interest of the participants and beneficiaries of the plan
ii. Weight interest of individual beneficiary against interest of all plan
participants
iii. Court will consider whether the plan breached fiduciary duty by
denying a participant plan benefits
b. Reporting requirements
c. Disclosure requirements
d. Claims policies and procedures
i. Full and fair review
e. COBRA, HIPAA requirements
f. Remedies and enforcements
i. DOL enforces penalties
ii. Equity remedies only
iii. De Novo standard of review for reviewing denials
REGULATORY VACUUM
1. Regulatory vacuum
a. All of state laws preempted but not replaced with federal remedies
b. State laws regulating health insurance not enforceable in any court
c. Does not prevent state from regulating underlying insurance coverage that
individual purchases in either commercial market or as provided to an
employer group plan
i. States can mandate insurance benefit coverage for non-ERISA
plans, but not for EPBs
2. ACA Impact on Regulatory Vacuum

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a. Apply to self-funded employers and insured

b. Essential Health Benefits (EHBs) are preempted
i. Individual and small group plans, self-funded and fully insured
ii. Does NOT apply to large group plans or small group self-insured
plans
c. Only fully insured plans
i. MLR
ii. Guaranteed issue and renewability
COURT INTERPRETATION OF ERISA
1. Interpret broadly
a. Legislative intent: Congress intended to preempt state law to allow
multistate employer offer nationally consistent plan to all of its workers
without cost and inconveniences of complying with contradictory state
regulations, legislation or litigation
i. Keeping cost low encourages employers to offer health plans
2. How to determine whether a state law is preempted?
a. Does the law relate to an EPB?
i. Does challenged law burden the administration of administration of
plan benefits, or only have remote impact?
1. ERISA preempts when state laws bind
employers/administrators to particular benefit choices, or
preclude uniform administration of EBP
2. Ex) state lawsuit challenging a benefit determination of
additional hospice coverage relates to employee health plan
because lawsuit requires court to interpret the plans benefits
and binds administrators to certain actions
3. Does the savings clause apply?
a. States are not preempted for enacting and enforcing state laws governing
the business of insurance (e.g. solvency requirements)
4. Does deemer clause apply?
a. Prevents states from deeming an ERISA covered plan as the business of
insurance
5. Interaction between relates to, savings, and deemer clauses
a. Law mandates certain health insurance benefits
i. Relates to ERISA plan since it involves structure of plan benefits
ii. Even though legislation would be saved from preemption when it
regulates EBPs that purchase traditional insurance policies, still
preempted when state attempts to apply statute to self-funded EBP
PLACEHOLDER FOR INFO FM SLIDES 8-11
ERISAS FULL AND FAIR REVIEW
1. Full and fair review of all denied claims to be performed by appropriately named
fiduciary
2. Ex) Shelby HCC v. The Majestic Star

12

a. Holding: de novo standard of review

3. Generally, courts deferential to plan administrator as long as plan expressly
grants discretion to plan administrator and decision was not arbitrary and
capricious
STATE LAW NOT APPLICABLE IF PREEMPTED BY:
502(a) [29 U.S.C. 1132(a)]
1. A civil action may be brought (1) by a participant or beneficiary(B) to recover
benefits due to him under the terms of his plan
514(a) [29 U.S.C. 1133(a)]
1. ERISA shall supersede any and all State laws insofar as they may now or
hereafter relate to an employee benefit plan
a. Savings clause
b. Deemer clause
FIRESTONE V. BRUCH
1. ERISA enacted to promote interests of employees and their beneficiaries in
employee benefit plans and to protect contractually defined benefits.
2. Firestones reading of ERISA would require court to impose standard of review
that afforded less protection to beneficiaries than they had before ERISA was
enacted
3. Impact of Firestone:
a. Give administrators fiduciary discretion to decide claims, interpret plan
documents, resolve ambiguities, and otherwise make eligibility and plan
determinations
i. Often, outcome determinative
b. Courts may account for conflicts of interest
i. E.g. employer/insurer who both evaluates and pays claim is a factor
to examine for biases
ERISA AND STOP LOSS INSURANCE
1. States may regulate insurance policies issued to plans or plan sponsors, if the
law regulates the business of insurance, and the insurance company
a. Includes stop loss plans
b. Otherwise, insurance companies could sell stop loss policies with low
attachment point essentially provide coverage which is not subject to
regulations
2. Insurance reg of group health plans limits insurance policy choices available to
third parties including EBPs

INFORMED CONSENT
DEFINING THE DOCTOR-PATIENT RELATIONSHIP
1. Basis in k law
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a. Modified by doctors fiduciary duty to patient

i. Power/info of doctor
ii. Illness, vulnerability of patient
iii. Intimacy of relationship
iv. Need for disclosure of personal information
2. Informed by ethics
a. Right to self-determination
b. Asymmetrical information (doctor knows more than patient)
c. Historical events
i. Nuremberg Code
ii. Tuskegee Syphilis Experiment
iii. Scholendorff (1917)
1. Every human being of adult years and sound mind has right
to determine what shall be done with his own body.
iv. Henrietta Lacks
3. Key case: Canterbury v. Spence
a. Holding: Doctor has duty to disclose all reasonable information and risks
to patients
b. Facts: Uninformed patient undergoes back surgery
i. Does not ask about risks of surgery
ii. Doctor does not disclose them
4. BoP: pl must show that if TARP knew risks, he would not have undergone
medical procedure
INFORMED CONSENT CAUSE OF ACTION
1. Duty: to reasonably disclose all material risks, facts, opinions
a. Scope of duty: TARP standard
i. Rejection of professional custom argument
1. Avoid self-regulation of physicians
ii. Objective standard: TAR(Patient) would not have undergone
medical procedure if informed of risks (remove the biases and
emotions of the patient)
2. Breach: failure to disclose the material risk
a. NB: substandard case not an issue
3. Causation: harm not warned about materialized
a. Thing doctor didnt tell patient about MUST happen
b. Proximate cause: must show that TAR(Patient) would have chosen the
other option if it had been disclosed (objective standard)
i. NB: small minority of jurisdictions permit subjective showing that
this patient wouldnt have undergone medical procedure
CASE LAW FOR INFORMED CONSENT
1. Mohr v. Williams
a. If operation performed on patient w/o consent, that constitutes A&B
b. Intentional tort
2. Cobbs v. Grant

14

a. Physician has duty to disclose to patient risks and benefits of proposed tx,
alternative tx, and of no tx, which HYPOTHETICAL REASONABLE
PATIENT would consider material
3. Culbertson v. Menditz
4. Johnson v. Kokemoor
a. Whether performance data should be disclosed depends on whether
surgeons experience presents an inherent risk factor for patient
i. Examine on case-by-case basis
b. No affirmative duty on physician to disclose lack of experience
i. Unless directly asked by patient
5. Compare Koremoor with Howard v. UMD
a. Howardwhen is physicians failure to accurately respond to patients
questions about credentials an informed consent case?
i. Misrep or exaggeration of credentials
ii. Pl must show:
1. Lack of experience is material (i.e. could substantively have
increased the risk of harm)
a. Need expert witnesses to establish
2. Increased risk would cause reasonable person not to
consent
Theory of
liability
Professional
(Culbertson,
majority of
courts)

Standard of
Disclosure
What
reasonably
prudent
physician
would disclose

Role of
Experts
SoC regarding
disclosure

Causation

Exceptions

Undisclosed
risk must
materialize;
reasonable
person would
not have
undergone if
risk known

-Common
knowledge
-Emergency
-Waiver
-Therapeutic
risk
-Additional
procedures
needed to
accomplish
procedure for
which there
was consent
Same

Material Risk

Risks
reasonably
prudent person
would have
taken in
making tx
decisions

Risks and
Same
harms of tx;
jury decides
whether
reasonably
prudent person
would have
considered
risks to be

15

material
DISCLOSURE REQUIREMENTS
1. What must be disclosed:
a. Patients condition
b. Nature of proposed tx
c. Benefit expected from proposed tx, AND material risks and dangers
d. Tx alternatives AND risks/benefits of alternatives
2. Who must disclose:
a. Physician NOT health care institution
i. Hospitals/institutions have no independent duty to obtain informed
consent
ii. Hospitals should still have policies requiring informed consent
1. Does this just mean that you cant hold hospital directly liable
for failure to obtain informed consent?
CONSUMER CONTROL, IMPROVEMENT AND INFORMED CONSENT
1. Hospital and Physician Compare
2. Report cards
3. Patient decision aids
FIDUCIARY DUTY + INFORMED CONSENT
1. Physician must disclose personal interests (research/economic) unrelated to
patients health that may affect physicians professional judgment
2. Failure to disclose may give CoA for perfoming medical procedures w/o informed
consent or breach of fiduciary duty
3. Ex) Moore v. Regents of Univ. of Calif.patient undergoes spleen removal, his
blood/tissue is valuable for physicians research
a. Patent issued to his physician about Mo cell lines
b. Potential value of patients blood cells=3b
PATIENTS RIGHT TO CONSENT TO TREATMENT
1. Adults who are competent:
a. Right to competent tx and
b. Right to be informed of the risks/benefits of proposed tx as well as
alternatives
c. Right to make this in private (confidentiality)
i. Respect of patients privacy = central to patients autonomy
ii. Ethical requirements since Hippocrates
iii. What is protected?
1. Decisional and informational elements
iv. Confidentiality is cornerstone of patient-doctor relationship
1. Full disclosure
2. Tx

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3. Protection of others (e.g. public health concerns, not traced

back to certain individual)
CONFIDENTIALITY
1. Confidentiality = cornerstone of patient-doctor relationship
a. Ex) McDonald v. Clingerpsychologist who discloses personal
information about patient to patients wife breaches fiduciary duty of
confidentiality and gives rise to CoA in tort
i. Pl must submit evidence
2. Exceptions to confidentiality
a. Public health
b. Infectious disease
c. Apprehension of individual by law enforcement officers
d. Child abuse
e. Other ethical obligations
i. Duty to third-parties
1. Contagious disease
2. Mental illness
3. Driving
4. Other foreseeable harm
5. Genetic information HIV/AIDS exceptionalism
ii. Existence and scope of this duty is often unclear (e.g. is warning to
patient sufficient?)
1. Breach one duty to fulfill another? Maybe
3. Applies to research subjects
4. Exceptions to right to consent:
a. Emergency when patient cannot consent, communicate, or have valid
healthcare agent
b. Minors or incompetent individuals have rights but those rights may be
exercised by others
5. NB: Statutory requirements may apply
a. HIV test
b. Abortion services
c. Mental health procedures (electro-shock)
d. Restraint and seclusion
6.
THE RIGHT TO REFUSE TREATMENT
SOURCES OF LAW TO DETERMINE PATIENTS WISHES
1. Common law
a. Informed consent
b. Bodily integrity
2. Statutory law
a. State laws re self-determination
i. Some states require clear and convincing evidence (Cruzen)
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ii. Other states require preponderance of evidence

3. Constitutional law
a. Religious freedom
b. Privacy
c. 14th Amendment Liberty Interest (no state shall deprive any person of life,
liberty or property without due process of law)
COMPETENCY
1. Every human being of adult years and sound mind has a right to determine what
shall be done with his own body
2. State interest in preserving life: 1) preservation of life; 2) protection of innocent 3 rd
parties; 3) prevention of suicide; 4) ethical integrity of the medical profession
3. Person may choose to withhold or withdraw medical treatment (hydration,
nutrition)
a. Terminally ill patients
4. Motives are irrelevant
a. Bouvia v. Superior Court: It is a moral and philosophical decision that,
being a competent adult, is hers alone.
5. Incompetent individuals
a. Never competent
i. Superintendent v. Sarkowitzmentally retarded man has cancer;
court applies substituted judgment in best interests of the patient
and decides that patient will not understand why hes suffering
(from tx) and has no concept of hope/remission
1. Patient cannot cooperative with tx
2. Quality of life
b. Formerly competent
i. In re Claire Conroynursing home resident with dementia, refuses
medical tx; somewhat alert
ii. Holding: an withhold tx if patient would want it withheld
1. Must show trustworthy evidence that patient would want to
stop tx
INCOMPETENT ADULT PATIENTS
1. Is patient capable of understanding her medical condition, prognosis, tx, and
risk/benefits of each?
a. Public Health v. WonsJehovahs Witness refuses blood transfusion, she
is mother of two young children (refuses while conscious/competent)
b. Holding: Competent adult has right to refuse tx for religious reasons, even
if that will cause her death
c. Lower court: held that children being raised by two parents=compelling
state interest
i. Compelling state interest: 1) preservation of life; 2) innocent third
parties; 3) prevention of suicide; 4) maintenance of ethical integrity
of medical profession
2. Was patient competent at earlier point?

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a. In re A.C.pregnant woman expresses desire to forego c-section to save

her life; hospital goes to court to get judgment
b. Holding: Substituted judgment must be used to determine wishes of
incompetent patient unless truly extraordinary/compelling circumstances
i. Must put bodily integrity of woman over the interest of the fetus
ii. Substituted judgment for the mother
iii. Family members usually best source of info about patient
iv. Lower court: flawed reasoning they did not find a competent
refusal to go ahead with surgery
3. **Dont forego right to make medical decisions
a. Exercise that right through other people
i. E.g. health care proxy or surrogate decision maker
ii. Durable power of attorney
iii. Less formal statements/oral directives made prior to incompetence
iv. Religious beliefs and tenants of patient
v. Consistent pattern of conduct with respect to medical care
b. Ex) United States v. Cruzenfamily wants to remove patients feeding
tube (patient in permanent vegetative state)
i. Evidence that she would want to end life: conversations with friends
and family at age 25
ii. Holding: MOs requirement that patients wishes proven through
clear and convincing evidence is constitutional
1. State has legit interest in protecting patietns lives
2. Due process clause does not require state to accept
conversations with friends and family as clear and
convincing evidence (substituted judgment)
iii. Brennens Dissent: lopsided standard of proof
1. Wouldnt be met without living will
2. Accede to Cruzans particularized and intense interest in
self-determination in her choice of medical treatment
3. Death with dignity
LEGAL LIABILITY AND REFUSAL
1. Negligence liability cant be ruled out when patient refuses tx and care is
rendered (tx against patients wishes)
2. Courts inconsistent about recovering damages for life that is preserved against
will of patient
a. Will probably consider quality of life
3. Physician may believe patient refuses tx but when patient dies, family dues for
negligence and/or abandonment
a. May be advantageous to seek preemptive judicial intervention before
withdrawing/withholding tx from competent patient who is not terminally ill
4. Factors court will consider in patients end of life decisions (est in Conroy)
a. Living willdirections concerning wishes about end of life care should one
be incompetent and faced with terminal illness
b. Oral directive made before incompetence
c. Durable power of attorneydocuments designating health care proxy

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d. Less formal statements

e. Deductions based on religious and beliefs
f. Consistent pattern of conduct regarding medical care
i. Active, thoughtful, maturity?
5. Advanced directives
a. Living will
b. Durable power of attorney
c. Patient Self-Determination Act (Federal): documents that patient can give
to family members outlining their end of life wishes
6. Do Not Resuscitate (DNR Orders)
a. State law permit physicians to write DNR orders
b. Part of patients medical record, patient wears or carries order (more
accessible)
c. Some states shield physicians against liability from following DNR orders
MEDICARE AND ADVANCED PLANNING
1. Doctors dont get reimbursed for end-of-life discussions with patients
a. ACA did not create death panels
2. 4/10 Americans do not have advanced directives
3. 30 cents per dollar is medical waste
4. 80% of individuals who die/year=Medicare beneficiaries
5. Dr. Donald Berwick: using unwanted procedures in terminal illness is form of
assault. In economic terms, it is a form of waste
6. More end-of-life intervention does not yield higher survival ates
OREGONS DEATH WITH DIGNITY BILL
1. Allows terminally-ill patients to end life through voluntary self-administration of
medication prescribed by doctor

MEDICAL MALPRACTICE
PROBLEM OF MEDICAL ERROR
1. Market controls (patients vote with feet)
2. Self regulation (internal review boards, accreditation, Joint Review Boards)
3. Regulatory approaches (medical/hospital licensure, state and federal regulations)
4. Medical malpractice suits (deterrence, NB: most ppl injured by med mal never file
a claim)
a. Pl must prove standard of care and negligence by preponderance of the
evidence
IOTRAGENIC INJURIES
1. Not every injury medical errorsome injuries begin with system of care
a. 3.7%: med error
b. 58%: system of care
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c. 28%: negligence
CULTURE CLASH
1. Lack of culture of openness in medical profession (doctors afraid to admit
mistakes, thus, hospitals cant implement systems to correct/prevent that same
error)
a. Cycle of inaction
2. IOM ReportRecommendations for preventing mistakes
a. New ways of creating and discussing knowledge
b. National mandatory reporting system
c. Encourage voluntary reporting efforts
3. Need for meaningful reform
a. Toll on profession (doctors have to see patients as adversaries,
incentivizes unneeded testing)
b. Patients suffer from malpractice injuries (can take years to get results)
4. Hall v. Hillbun
a. Holding: 1) doctor had obligation to perform all facets of surgery with level
of competence expected of minimally competent surgeon under the
circumstances; 2) pls expert witnesses should have been permitted to
testify even though they are from other parts of country
b. Facts: surgeon failed to provide post-op care to patient who died
STANDARD OF CARE
1. Degree of care and skill the average qualified practitioner, taking into account the
advances in the profession
a. Includes resources available to professional in her setting
PHYSICIANS AUTHORITY OF PROFESSIONALISM PARADIGM
1. Local standard of care: majority of jurisdictions
a. Customary practice under usual circumstances
2. Pl must prove that no doctor can ever do X action to prevail
a. Give jury power to decide what is/isnt negligence
b. Reasonableness=determining factor
3. Defenses to malpractice: Two Schools of Thought
a. Considerable number of professionals
b. Respected, reputable, reasonable
CLINICAL PRACTICE GUIDELINES
1. Based on growing importance of evidence based medicine
a. Important for Medicaid payment referrals and other quality measures
2. Cookbook method
3. Supports motion towards greater standardization of medical practice on national
level
4. Informs what standard of care is (brought in as evidence through expert witness
testimony)
5. Ex) pushing back screening requirements for mammograms

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a. Now, fewer mammograms can be part of new standard of care

b. Insurers may opt to cover fewer mammograms
6. Physicians may opt to not follow CPGs
DEFENSIVE MEDICINE
1. Practicing medicine with threat of lawsuit in mind
2. Overscreening for conditions
3. Inefficient, wasteful, drive up cost of care
4. Impose caps on damages
MYTHS ABOUT MED MAL
1. Med mal suits drive up cost of care
2. Expenses related to med mal suits are large portion of total heath care spending
3. Giant lottery (NOT unpredictable system rigged in favor of the pl)
RESEARCH AND NUMBERS
1. Cost of malpractice litigation: $55.6 billion annually
a. 45.6 bdefensive medicine
b. 5.7 bsettlements and judgments
c. 4.2 badministrative costs
d. 200mlost clinician time
2. 2.4% total health care spending
3. Texas v. Postimposes $250k liability cap
a. Outcome: after decision, TX doctors dont need to practice defensive
medicine anymore but no savings
4. 10% decline in malpractice insurance premiums reduced defensive medicine
costs by only 0.13% across all 35 medical specialties
a. Level of liability concern reported by doctors out of step with actual risk of
experiencing med mal
DR. BAKER REFLECTING ON MED MAL
1. Too much med mal is problem, not too much litigation
2. Costs of defensive medicine pale in comparison to costs incurred by individuals
who never bring claims
3. Med mal premiums rise and fall on financial trends and insurance industry
competition, not jury verdicts or aspects of litigation environment
4. Secrecy encourages filing of malpractice claims by individuals looking for
answers after unexpected, bad medical result
a. Encourage open culture to prevent repeat mistakes
5. 5% of physicians responsible for 54% of all med mal claims
FIRST GENERATION TORT REFORM CHOICES
1. Obstacles to Med Mal Suits
a. Attorney fee controls
b. Screening procedures, cert of merit
c. Mandatory arbitration

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d. Statute of limitations and repose

2. Doctrine Shift
a. Expert witness restrictions
b. Res ipsa changes (error that happened would not have occurred unless
the D was negligent e.g. amputating the wrong limb)
3. Reduction in recovery
a. Damage caps
b. Periodic payments (rather than lump sumif patient dies, dont have to
pay anymore)
c. Collateral source offsets
d. Reduce joint/several liability
OUTCOME OF 1st GEN. TORT REFORM
1. Largely unsuccessful
2. Reforms fail to account for health care industry and structure of insurance
industry
3. Ignored fact that malpractice exists
4. Recent attempts to federalize med mal reforms:
a. ACA does not address med mal
SECOND GENERATION REFORMS
1. Alternatives to litigation
a. Disclosure, apology, offer programs to prevent repeat incidents
i. Sorry Works (coalition of doctors and lawyers, promote full disclose
and apologies for medical error)
ii. Early Offer Program (make an offer to settle initially)
2. Greater emphasis on apology
a. Greater transparency when medical mistakes occur
b. Joint Commission requires disclosure (apology not required) in certain
sentinel events involving unanticipated outcomes
c. Require trusting element in doctor-patient relationship
d. Current tension between transparency and phycisian liability
e. Physicians may not be best judge of when negligence occurs (internal
review boards result in few sanctions)
f. Advisable for physician to consult with legal counsel before assuming
responsibility
g. Advisable for patient/family to consult with legal counsel before accepting
a payout
3. Enterprise liabilitylarger entity (hospital) bears liability for malpractice, rather
than individual physicians
4. Ex) Med Mal Reforms in Massachusetts
a. Notice and disclosure requirements to employees
b. Six month cooling off period
c. Apologies are not admissions at trial
i. Exception: inconsistencies introduced by D or Ds expert witness
d. Increased limitation of non-profit liability

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e. Overturn joint and several liability

5.
HOSPITAL LIABILITY
STANDARD OF CARE
1. The average reasonable hospital in similar circumstances
2. Regulations, standards, bylaws
3. NB: hospital not directly liable every time something goes wrong
VICARIOUS LIABILITY
1. Employee did something wronghold hospital liable
2. Physicians typically not employees of hospitalsonly have staff privileges
(independent contractors)
3. Test for VL
a. Represents that person is servant or agent
b. Induces reliance upon care or skill
4. Ex) Jackson v. Powerdoctor doesnt check patient who fell off cliff for internal
bleeding
a. Holding: Hospital had non-delegable duty to provide non-negligent care in
its emergency room
i. Non-delegable duty=exception to independent contractor
negligence
1. Such an important duty that principle shouldnt be allowed to
delegate it to another
ii. Hospital vicariously liable when patient who is conscious comes to
ER seeking emergency services
OSTENSIBLE AGENCY
1. Patient looks to institution, not provider for care
2. Hospital holds out physician as its employee
DIRECT LIABILITY
1. Four areas of duty for hospital (set forth in Thompson v. Nason)
a. Use reasonable care in maintainence of safe and adequate facilities and
equipement (Hall v. Hillbunwisdom teeth, anesthesiologist fails to check
vitals)
b. Select and retain only competent physicians
c. Oversee all persons who practice medicine within walls as to patient care
d. Formulate, adopt, enforce adequate rules and policies to ensure quality
care for all patients
2. Landmark care: Darling v. Charleston Memorial Hospital
a. Direct liability extends to hospital entities in their role as providers
i. Hospitals directly liable through their employees and independent
contractors (both owe patient duty of care)
b. National accreditation standards and state licensing regulations can define
standards of care
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c. Policy: hospitals like this decisiongives them leverage over their

physicians
3. Hall v. Hillbunduty to form, adopt, enforce, adequate rules and policies to
ensure quality care for all patients
a. Facts: patient dies when anesthesiologist fails to check vitals
EXPANDING HOSPITAL LIABILITY
1. Quality assurance
2. Cost containment
3. Increased technology, complexity of care
4. Expand liability to protect consumers
SPECIAL ISSUES IN HOSPITAL LIABILITY
1. Charter Hospitalmental health facility has policy that as soon as patients
insurance runs out, discharge them
a. Facts: physician discharges patient who kills himself
i. Abandonment?
b. Holding: Hospitals policy corrupted the doctors judgment, he was
browbeaten into submission

MCOs AND LIABILITY

THEMESHOW WILL LAW EMERGE?
1. New entities
2. Signficance of terms such as medically necessary
3. Do MCOs as arrangers and providers of care make medical decisions
a. Coverage decision=medical decision?
4. Is institutional MCO liability necessary given physicians autonomy, and ethical,
moral and legal obligations to the patient?
PAYORS AND DOCTORS
1. Wickline v. Calif.can payor be held responsible for a negligent discharge?
a. Holding: Nopayors goal of cost containment cannot override doctors
medical judgment
i. Doctor has duty to advocate to patients for coverage (appeal the
decision)
ii. Recognizes that payors play role in patient care but cannot replace
the role of the doctor
2. HMOs and Liability
a. May be held vicariously liable depending on relationship with doctors
i. Do patients look to HMO, not individual provider for service?
ii. Did HMO hold self out as provider of care?
b. What is the level of control exerted by the MCO?
i. How much control over providers?
c. Boyd v. Albert Einstein Medical Center
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i. Holding: HMO that selected and appointed doctors and limited

subscribers choices to those doctors can be vicariously liable for
negligent care
1. Gatekeeper function of PCP: pl cant see specialist until
goes thru her PCP
2. HMO directly paid the doctors (not indemnity service
retroactive reimbursement)
ii. Facts: complications from improperly performed biopsy
d. Petrovich v. Share Health Plan
i. Holding: HMO may be held vicariously liable for malpractice by
independent contractor physician under theory of apparent agency
and implied authority
e. Jones v. Chicago
i. Holding: Duty on HMO to conform to legal standard of reasonable
conduct in light of risk
1. Direct liability for MCO (breached standard of care by
assigning too many doctors to a provider)
2. HMOs must be accountable for their actions
3. Accountability must check HMOs goal of cost-containment
ii. Maybe not every HMO operates on the same institutional liability
available in this case
ROLE OF INSTITUTIONAL LIABILITY
1. Deterrence
a. Lawsuits and error reduction must work in concert
b. Increased managed care liability requires systems think

MEDICARE
OVERVIEWMEDICARE/MEDICAID
1. Passed under Titles XVIII of Social Security Act
2. Fed govt largest purchaser of healthcare
a. Administered through CMS
3. More ppl on Medicaid
a. Medicaid: 65 million
b. Mediare: 52.3 million
4. Medicare = more expensive
a. Medicaid: ppl younger, healthier
MEDICARE CRITERIA
1. 65 years +
2. US Citizen or permanent resident
3. Eligible for SSA payments
4. Disabled adults under 65
26

a. Must qualify for SSA payments

5. Carve out programs
a. End stage renal disease
b. ALS
POLITICAL DEVELOPMENT
1. 1960s: push back from physicians
a. Fear loss of authority to governmental regulation
2. Govt response: administer Medicare/Medicaid thru third-party administrators
a. Replicate familiarity of indemnity insurance
b. Administer benefits thru Medicare Administrative Contractors (MACs)
3. Does government interference hinder decision-making
a. Palchikpatient requires skilled nursing to recover from hip fracture, she
is depressed which hinders care, government refuses to pay for services
because she isnt making progress (Medicare excludes custodial care)
b. Court: Failure to account for entirety of patients condition (depression
hinders progress)
4. Positive influence of government
a. Quality control standards
i. Practices and guidelines
b. Federally funded research
i. E.g. determining never to reimburse never events
FOUR PARTS OF MEDICARE
1. Medicare Part A
a. Inpatient services (nursing facilities, home health, hospice care)
b. Free if you have paid taxes for 40 calendar quarters (payroll tax)
c. Monthly premium if you have not worked
d. Can qualify through spouse
2. Medicare Part B
a. Outpatient services
b. Medical services e.g. durable medical equipment, preventative care, xrays, mental health
3. Medicare Part C
a. Medicare Advantage
b. NOT separate benefitallows ppl to get Medicare coverage thru private
insurer
i. Must offer same benefits as original Medicare but may impose
different terms
ii. Generally HMOs/PPOs
iii. Enacted in response to growing political pressure from marketoriented Congress in 1997
iv. Disproportionately enrolled in by low-income ppl who cant afford
Medigap coverage
4. Medicare Part D

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a. Rx drugs, Medicare Modernization Act

b. Only provided thru private insurers that have contracts with government
c. Problem: doughnut hole
i. Combined cost of care (paid by you + insurer) exceeds $2840, you
start paying for all your drugs as if you have no insurance plus
paying for your premiums
ii. Once you reach $4550, you qualify for low-cost catastrophic
coverage to take you through the end of the year
iii. Then, insurance coverage starts over again from zero
MEDICARE FINANCING
1. Moving away from employee sponsored plans
2. Income based premiums
a. Previously, everyone paid same premium for Part B
b. Premium increases set at 85k
3. Gaps in financing
a. No eyeglasses, hearing aids
b. Custodial long term care (nursing home/institution)
4. Dual Eligibility
a. Medicare beneficiaries who are also eligible for Medicaid
b. Part Ano premium
c. Part BSpecified Low-Income Medicare Beneficiaries pay (state decision)
d. Part Ddeduction of premiums from monthly SS checks
CHALLENGES TO MEDICARE
1. Restrictive benefits and cost-sharing
2. First dollar Medicare coverage
a. High level deductibles
3. Raise eligibility age?
a. Need for preventative care at earlier age
b. Reduce healthcare costs once coverage starts
4. Shift from defined benefit to voucher
a. Get certain amount of money to beneficiary
b. When money gone, beneficiarys problem
c. Now, defined benefit = entitlement/constitutional right
DELIVERY REFORMS
1. Secretary of Health can require other states to make changes to delivery
methods for Medicare/Medicaid
a. High level of influence for private providers
b. Lot of political powerwill be shaped by next president
c. Ex) KY next governor will reverse Medicaid expansions under ACA once
Beshar leaves office

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