No 5, 8, 10 and 20: Can you indicate the supporting evidence from the slide
5. Under common law, which of the following relationships was NOT considered privileged?
a. Doctor–patient
b. Attorney–client
c. Priest–penitent
d. Husband–wife
Proof of a patient’s consent is a defense against what type of lawsuit?
a. Harassment
b. Battery
c. False imprisonment
d. Negligence
10. Proof of a patient’s consent is a defense against what type of lawsuit?
a. Harassmentb. Batteryc. False imprisonmentd. Negligence
20. What is the major legal and philosophical problem with “wrongful life” cases?
a. Determination of the time of birth
b. How to measure damages
c. The statute of limitations
d. The Americans with Disabilities Act
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Chapter 10
Emergency Care
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Main Topics
• The common law and statutory duties
• The standards of federal law (EMTALA)
• The duty to exercise reasonable care
• Staffing the ED
• Good Samaritan statutes
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The Need for Emergency Care Facilities
• Number of ED visits increasing.
• Should acute care hospitals be required to have an ED?
• Where else can one get emergency treatment?
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Duty to Treat and Aid
• Common law rule: no duty to assist
• Childs v. Weis (Pregnant women case P.375)
• Later, more enlightened judicial decisions to
render ER care.
• Public employees have a duty to aid victims of
accidents and other emergencies.
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Statutory Requirements
• Some state laws have long required hospitals to treat emergencies.
• Discrimination may violate civil rights laws if based on race, creed, etc.
• Reports of “patient dumping” in the 1980s led to federal law.
• EMTALA (COBRA) 1985: Consolidated Omnibus Budget Reconciliation Act
known as (antidumping act) its purpose to provide adequate first response
to medical crisis for all patients.
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Statutory Requirements
• Hospitals, for example, under the Emergency Medical Treatment and
Active Labor Act (EMTALA) are required to first provide stabilizing
treatment and transfer to an appropriate healthcare facility when
necessary.
• The courts recognize a general duty to care for all patients presenting
themselves to hospital emergency departments. Not only must
hospitals accept, treat, and transfer emergency department patients
if such is necessary for the patients’ well-being, but they also must
adhere to the standards of care they have set for themselves, as well
as to national standards.
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EMTALA
• The term emergency medical condition under EMTALA has been
defined as:
(A) a medical condition manifesting itself by acute symptoms of
sufficient severity (including severe pain) such that the absence of
immediate medical attention could reasonably be expected to result in
(i) placing the health of the individual (or, with respect to a pregnant
woman, the health of the woman or her unborn child) in serious
jeopardy, (ii) serious impairment to bodily functions, or (iii) serious
dysfunction of any bodily organ or part.
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EMTALA
(B) with respect to a pregnant woman who is having contractions, (i)
that there is inadequate time to effect a safe transfer to another facility
before delivery, or (ii) that transfer may pose a threat to the health or
safety of the woman or the unborn child
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EMTALA
• EMTALA was not intended to be used as a federal malpractice statute
but, instead, was enacted to prevent patient dumping (the practice of
refusing to treat patients unable to pay for care).
• An EMTALA-appropriate medical screening examination is not judged
by its proficiency in accurately diagnosing a patient’s illness, but
rather by whether it was performed equitably in comparison to other
patients with similar symptoms.
• If a hospital provides an appropriate medical screening examination,
it is not liable under EMTALA even if the physician who performed the
examination made a misdiagnosis that could subject him or her and
the employer to liability in a medical malpractice action.
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EMTALA
• Hospitals are expected to notify specialty on-call physicians when
their particular skills are required in the emergency department.
• A physician who is on call and fails to respond to a request to attend
a patient can be liable for injuries suffered by the patient because of
his or her failure to respond.
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EMTALA (COBRA of 1985)
• EMTALA (COBRA of 1985)
• Duty to assess, stabilize if possible
• May transfer if benefits > risks
• Definitions are important
• Applies to everyone, whether Medicare-eligible or not
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Ambiguities in EMTALA
• What is an “appropriate” screening exam?
• When does duty begin?
• When has patient come to the hospital?
• Does motive matter? Pt inability to pay.
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Appropriate Screening Exam
• If the exam was negligent, is that inappropriate?
• What standard to apply?
• Summers case P. 379.
• Good faith, no improper motive
• Malpractice standard doesn’t apply
• Dangerous behavioral health patients
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When Duty Begins
• When known to have an emergency condition
• Subsec. (b)(1): Anywhere in the hospital, not just the ED
• Subsec. (c)(1)*: Restricts transfers before the patient is stabilized
unless certain conditions are met (patient request, MD
certification, etc.)
• Injured person outside the hospital entrance (Chicago case)
• Now by rule deemed to be anywhere within 250 yards
*Not quoted in the textbook
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Duty to Patients in Ambulances
• Arrington v. Wong—in ambulance and known to be on the way
• In a hospital-owned ambulance
• Beller v. Health and Hosp. Corp. of Marion County
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Motive
• Early cases held the hospital’s motive must have been related
to the patient’s economic status (uninsured, e.g.).
• Cleland case raised the issue.
• Supreme Court decision in Roberts v. Galen of Virginia holds
that an improper motive need not be proven.
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Other Considerations
• Duty of reasonable care—liability and negligence
• Admission or transfer
• Staffing the ED
• “Good Samaritan” statutes
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Chapter Discussion Questions
1. What is the common law’s traditional viewpoint concerning a bystander’s duty
to come to the aid of a person in need? How, if at all, is that duty different today?
How might it differ depending on who the bystander is? On the last point, if the
“bystander” is a lifeguard, an EMT, a law enforcement officer, etc., they might well
have a separate duty to attempt a rescue.
2. Discuss the Childs case with your classmates. Why do you suppose the hospital
did not have a physician present or immediately available to assist in its
emergency department? Why wouldn’t a physician come to the hospital and
personally examine a woman in labor? What were the motives of the parties
involved? It was rural Texas more than 50 years ago. At that time, most hospitals,
especially in rural areas, did not have full-time emergency physicians on call. As
for motives, one might suspect racial bias to have been a factor.
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Chapter Discussion Questions
3. Describe a hospital’s duty to a person who comes to the emergency department
requesting treatment. Is this duty the same if the person is indigent? The EMTALA
duty does not vary based on indigence.
4. In the Arrington opinion regarding what it means when someone “comes to the
hospital,” the US Court of Appeals for the Ninth District wrote approvingly of
HHS’s position. The HHS regulation states that “it would defeat the purpose of
EMTALA if we were to allow hospitals to rely on narrow, legalistic definitions of
‘comes to the emergency department’ or of ‘emergency department’ to escape
their EMTALA obligations.” Which is the more “legalistic” interpretation— that of
the regulation and the court or that of the person who reads into the plain
meaning of the statute? The case is an excellent example of how seemingly simple
language can create serious problems of interpretation. How might you have
written the statute to avoid the kinds of ambiguities seen in these cases?
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Chapter Discussion Questions
5. Is Arrington the work of “activist judges” who are “making law,” as some
claim about decisions they do not agree with?
6. What are the liability hazards of requiring all members of the medical
staff to take emergency department duty? See Law In Action on page 365.
7. What effects have Good Samaritan statutes had on the duty to render
aid in an emergency? Not much, I would argue.
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The Court Decides
• Moses v. Providence Hosp. and M.C., Inc.
• Beller v. Health and Hosp. Corp. of Marion
County
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Moses v. Providence Hospital and Med. Ctrs., Inc.
Discussion Questions
1. What additional information would you like to have about the facts of this
situation?
• Point out that the case will go back to the trial court for a hearing on the
merits. Facts need to be entered into evidence to address such questions
as: what did the psychiatrist think on day 5, not just the internist? Were
suicide precautions taken as instructed? Did Howard make other threats
against his wife while in the hospital for six days?
• 2. What is the EMTALA standard by which the decision to release this type
of patient should be made? Stabilize the patient.
• 3. According to the opinion of the court, was that standard met in this
case? Trick question. That wasn’t decided; it remains for the jury to decide
after a full hearing of all the facts.
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Beller v. Health and Hospital Corp. of Marion County
Discussion Questions
1. Do you agree that the 2003 amendment was a “clarification” and not a
substantive change to the EMTALA regulation?
2. Should the HHS denomination of the amendment be determinative?
3. Why is the named defendant the “Health and Hospital Corporation of Marion
County” and not Wishard Hospital? See if students know what “d/b/a” means.
It’s a county hospital doing business as “Wishard Memorial,” which was
probably its original name before being acquired by the government agency.
4. Had the outcome here favored the plaintiffs, what would the next procedural
steps have been and what would the likely outcome of the case be on its
merits? Had the decision been different, the case would then have gone to
trial on the merits. Students must understand that this decision concerned only
the correctness of the granting of summary judgment in favor of the
defendant.
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Chapter 9
Health Information
Management (HIM)
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Main Topics
• The purpose of HIM: to keep accurate records that aid in clinical
decision making
• Definitions of health information, covered entity, PHI, and deidentification
• Federal and state privacy laws including HIPAA, HITECH, and “red flags”
• The possible civil and criminal penalties for privacy breaches
• Use of records in legal proceedings
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HIM
• All organizations, regardless of mission or size, develop and maintain
information management systems, which often include financial,
medical, and human resource data.
• Information management is a process intended to facilitate the flow
of information within and between departments and caregivers.
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Health Information Management (HIM)
• The Form, Content, and Purpose of Records Health information
management (HIM) in the age of HIPAA concerns not only what we
traditionally think of as “medical records”—paper charts with physicians’
progress notes, nursing notes, lab results, etc.—but essentially any
information maintained about an individual having to do with their
healthcare in any way. So, for example, it includes billing records, which we
would not typically think of as being “medical records.”
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Health Insurance Portability and Accountability Act (HIPAA)
• Kassebaum-Kennedy bill, Aug. 1996 (HIPAA)
• New privacy and security standards
• New fraud provisions
• New definitions
• Health information
• Protected health information (PHI)
• Covered entity
• De-identified information
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Health Insurance Portability and Accountability Act (HIPAA)
• Covered entity is a health plan, healthcare clearinghouse, or healthcare
provider that transmits any health information in electronic form.
• Protected Health Information (PHI) is any health related information that
identifies or can be used to identify the individual to whom it pertains (name,
date of birth, address, email, URL, SS#…etc.
• De-identification: information can not reveal the identity of the individual.
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The primary purpose of medical records
• The primary purpose of medical records is of course to document the care
given, but there are other purposes too.
• The quality of documentation depends on the persons making the entries.
Liability increases if quality of documentation decreases. Entries must be
relevant to the clinical care. Suppositions, comments about other providers,
etc. are inappropriate.
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Medical Records: General Principles
• Primary purpose = documentation of care
• Other purposes:
• Medical necessity
• Ethical decision-making
• Protection of patients and providers
• Defense of litigation
• Coding and Billing
• Accreditation
• Per review and Quality Assurance
• Research
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Medical Records: General Principles
• Quality of documentation is important
• Improper changes = presumption of “guilt”
• What is “authentication”? The accuracy and correctness of
information.
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Medical Records: General Principles
• who owns the records (the provider) and who can have access (many people,
including the patient).
• HIPAA codifies the patient’s right to have access and a copy of their record and it
establishes these other patient rights under certain circumstances:
• A right to have a record corrected or amended, if wrong
• A right to limit the provider’s use and disclosure of information
• A right to obtain an accounting of the provider’s disclosures
• A right to a notice of privacy practices
• The right to file complaints with the secretary for privacy breaches
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General Principles (continued)
• Form and content
• Records retention: Records should be retained at least 5 years.
• Ownership and control
• Who owns the record?
• Who can have access to the information in the record?
• Patient matching errors▪ Record not belong to the right patient (False negative)
▪ Information in the record belong to another person (False positive)
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Access to Records
• The provider owns the record
• Patients have rights to access/copy of record
• Control over the use of their health information
• Request correction or amendment
• Limit use and disclosure
• Accounting of disclosures (other than normal treatment,
payment, healthcare operations)
• Notice of privacy practices
• Right to file complaint
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Medical Records (continued)
• Timeliness
• At time of treatment, observation, etc.
• Completed w/in 30 days of d/c
• Who can make entries?
• How to make changes?
• “Superconfidentiality” statutes: mental health,
HIV/AIDS, substance abuse
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Medical Records (continued)
• Entries must be legible.
• A “signature” can include rubber stamps (not preferred but okay if
permitted under state law and hospital policy) and electronic
signatures.
• The proper way to make a change in the record is to draw a single line
through the incorrect entry, write “error,” make the correct entry,
sign, and date; explain the change if not obvious. NEVER erase,
obliterate, use “white out,” etc. Examples of improper entries are
shown on pages 331 and 332. No
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Medical Records (continued)
• In most malpractice cases, the record is the most important
“witness.” Record entries must be timely, and an inpatient chart must
be completed with clinical résumé (“discharge summary”) signed by
the attending physician within 30 days of discharge. HIM department
can suspend the privileges of those physicians who are delinquent in
completing their charts.
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Medical Records (continued)
• There should be a hospital policy listing who can make entries in
medical records. These should include physicians and nurses, of
course, but others can make entries too: nursing and medical
students, if supervised; social workers; technicians; pastoral care;
case managers; etc.
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Medical Records (continued)
• Oral orders can be transcribed for certain things by persons given authority
to do so by hospital policy. Oral orders must be countersigned by the
physician within 24 hours.
• The hospital or physician owns the record itself, but the patient has an
interest in its contents. Under HIPAA, the patient has the right to review
and obtain a copy of their record or have a copy sent to someone of their
choice (a new physician, an attorney, etc.).
• There are federal and state “super-confidentiality” laws regarding mental
health, substance abuse, and HIV/AIDS records.
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HIPAA Privacy and Security Standards
• Due to electronic transactions/medical records
• Covers all patient-identifiable data if ever in electronic form
• Requires full-time security program
• Privacy/security officer, training, monitoring
• Huge civil and criminal penalties
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Release Of Information Without Patient Consent
• Treatment/payment/healthcare operations
• Court orders and subpoenas
• Statutory reporting requirements
• Abuse, neglect, etc.
• Criminal cases
• Other
• Duty to warn third parties (Tarasoff, e.g.) to prevent harm (case in the textbook
P.339).
• Peer review have the right to access medical records.
• Lien Statutes: the lien laws grants healthcare providers a legal claim under which
the cost of hospitalization is paid from damages that a patient recovers from the
person or entity whose civil wrong necessitated patients treatment. The tortfeasor
has the right to access patient record without consent to assess the legitimacy of
the medical bills.
*ROI = “release of information”
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Liability for Unauthorized Disclosure
• Defamation (libel/slander)
• Invasion of privacy
• Issues with photography and observation
• State and federal confidentiality laws
• “Superconfidentiality” of some types of records (mental health, HIV/AIDS,
substance abuse)
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HITECH Act and ID Theft Red Flags
• New requirements for business associates
• Notification of privacy breaches
• Medical ID theft red flags: using someone else medical record number,
information, and insurance.
• Adopt written ID-theft policy
• Educate employees what to look for
• Compliance, HIM, registration personnel are key in monitoring process
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Major HIPAA Security Risk Areas
• Shared passwords
• Inappropriate access
• Internet security
• Physical security
• Lax information habits
• Breach of confidentiality
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Other Issues
• Telemedicine
• Records used in legal proceedings—implicit waiver of
physician–patient privilege
• Government access to PHI
• Law enforcement requests for PHI
• State open meeting and public records laws—an issue for
government-owned providers
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Summary:
• Information management is the process of facilitating the flow of information
within and among departments and caregivers.
• The medical record is the principal means of communication among healthcare
professionals in matters relating to patient care.
• The contents of inpatient medical records provide evidence of a patient’s care
from admission to discharge (e.g., admission record, authorization for
treatment forms, advance directives, history and physical examination,
treatment plans, physicians’ orders, progress notes, nursing notes, diagnostic
reports, consultation reports, vital signs charts, anesthesia assessments,
operative reports, medication administration records, discharge planning
documentation, patient education, and discharge summary)
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Summary:
• Patient care documentation must be complete and accurate. Federal funding
can be denied for inaccurate record keeping.
• The Privacy Act of 1974 was enacted in part to safeguard individual privacy
from the misuse of federal records and to give individuals access to records
concerning themselves that are maintained by federal agencies.
• HIPAA requires the establishment of national standards for electronic
healthcare transactions and national identifiers for providers, health insurance
plans, and employers. HIPAA provisions also address the privacy and security of
health information.
• Medical records are maintained for the benefit of patients and are considered
the property of the healthcare provider. Patients, providers of care, and third
parties such as insurance carriers generally have access to patient records for
billing purposes. They are also available for criminal investigations.
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Summary
• The requirements for the length of time medical records must be retained
are based on statutory requirements, advice from legal counsel, patient
needs, future need for the records, and legal considerations.
• Although electronic medical records improve the ease and efficiency with
which data are compiled and shared, they also pose confidentiality risks.
• Records can be used as important evidentiary tools. The integrity and
completeness of a medical record can be crucial in reconstructing the
events surrounding alleged negligence.
• Falsification of medical or business records is grounds for both criminal
indictment and civil liability
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Chapter Discussion Questions
• Comments on some questions are provided below; other questions are rhetorical and for class
discussion.
• 1. Describe the nuances of the terms medical records and health information. Why does HIPAA
use the latter term? By definition, the latter is broader.
• 2. When might a patient’s favorite color or high school alma mater be considered health
information? When it could be used to identify the individual. I went to Garfield High School in
Terre Haute, Indiana. If I were living in Fairbanks, Alaska, and it became known that a certain
patient at Fairbanks Memorial Hospital went to that particular school, people could put two
and two together and identify me as the patient.
• 3. Describe some circumstances in which confidential health information may be disclosed
without the patient’s consent
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Chapter Discussion Questions
4. Why do you suppose a physician–patient privilege did not exist in common law but
had to be created by statute?
5. What is the proper way to make changes to a written health record?
6. Who owns physical health records, X-ray photography, and other items containing
health information?
7. How can the inability to predict dangerousness be reconciled with the emotional
issue of registering convicted sex offenders and preventing them from living in
proximity to schools and other places that children frequent?
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Chapter Discussion Questions
• This could prompt a good policy discussion. Is it “fair” or “reasonable”
or “justifiable” to assume that someone is prone to recidivism? Does
it matter what the crime was? If one gets a DUI, can we assume they
are more likely to get another? Does an instance of domestic violence
lead to repeated assaults? What if someone went to anger
management class? What if a sex offender has been to therapy and
purports to be “cured”? What if the person’s offense was having
“kiddie porn” on his computer?
• 8. Describe the provisions of the HITECH Act and the Red Flags Rule
and how they affect healthcare operations.
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The Court Decides
• Opis Management Resources, LLC v. Secretary,
Fla. Agency for Healthcare Admin.
• Tarasoff v. Regents of the Univ. of Cal.
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Opis Management Resources v. Secretary Discussion
Questions
• 1. Summarize in a succinct sentence (or two at the most) why this statute is
“contrary” to HIPAA. HIPAA regulations provide that, if an executor or personal
representative has legal authority to act on behalf of a deceased nursing home
resident, that person may have access to medical records; however, the mere
fact that someone is a surviving spouse does not qualify that person to act on
behalf of the deceased resident
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2. A similar Florida statute applicable to hospitals reads as follows: Any licensed facility shall,
upon written request, and only after discharge of the patient, furnish, in a timely manner,
without delays for legal review, to any person admitted therein for care and treatment or
treated thereat, or to any such person’s guardian, curator, or personal representative, or in
the absence of one of those persons, to the next of kin of a decedent or the parent of a
minor, or to anyone designated by such person in writing, a true and correct copy of all
patient records, including X rays, and insurance information concerning such person. . . . (Fla.
Stat. § 395.3025.)
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• What HIPAA-related infirmities do you see in this language, and how would the Opis
Management court decide a claim that this statute is preempted? The “only after discharge”
language is awkward in that HIPAA gives individuals (and their personal representatives) the
right of access to records during hospitalization, not “only after [their] discharge.” This issue can
be sidestepped by interpreting the language to be permissive—requiring access after discharge,
while permitting it before discharge as well. The fatal flaw in this provision, however, is: “in the
absence of one of those persons, to the next of kin of a decedent or the parent of a minor . . . .”
Such persons are not, solely by virtue of their status as next of kin or parent, automatically
entitled to access under HIPAA. The Florida legislature needs to revise various access-to-records
provisions in light of the Opis Management decision. Students could be asked to determine
whether this has ever been done.
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Tarasoff v. Regents of the University of California
Discussion Questions
1. This case was brought before the court on this procedural issue: whether the trial court was
correct to dismiss the complaint before a trial could be held. What do you suppose
happened after the case returned to the trial court? There is no further record of the case in
the reporter system. My suspicion is that the case was settled out of court.
2. What should the defendants have done differently? The case may prompt thoughts of
rampage shootings and other acts of violence in the news. Tarasoff and the other cases
demonstrate the difficult situation school officials and mental health personnel face when
trying to balance patients’ rights and the public welfare. There are no simple answers.
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Tarasoff v. Regents of the University of California
Discussion Questions
3. Why is the board (the Regents) of the University of California a defendant?
The regents (the university’s board of directors, in effect) are the corporate body
that is answerable for the university system. Note: Sovereign immunity relieves
the individuals of responsibility under California law. Note: California Civil Code
contains this provision: § 43.92. Psychotherapist’s duty to protect of patient’s
violent behavior; Immunity from liability; Legislative intent (a) There shall be no
monetary liability on the part of, and no cause of action shall arise against, any
person who is a psychotherapist … in failing to protect from a patient’s
threatened violent behavior or failing to predict and protect from a patient’s
violent behavior except if the patient has communicated to the psychotherapist a
serious threat of physical violence against a reasonably identifiable victim or
victims
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Tarasoff v. Regents of the University of California
Discussion Questions
(b) There shall be no monetary liability on the part of, and no cause of action shall
arise against, a psychotherapist who, under the limited circumstances specified in
subdivision (a), discharges his or her duty to protect by making reasonable efforts to
communicate the threat to the victim or victims and to a law enforcement agency.
(c) It is the intent of the Legislature that the amendments made by the act adding this
subdivision only change the name of the duty referenced in this section from a duty to
warn and protect to a duty to protect. Nothing in this section shall be construed to be a
substantive change, and any duty of a psychotherapist shall not be modified as a result
of changing the wording in this section.
(d) It is the intent of the Legislature that a court interpret this section … in a manner
consistent with the interpretation of this section as it read prior to January 1, 2013.
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Chapter 11
Consent for Treatment
and Withholding
Consent
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Main Topics
• The types of consent
• The hospital’s role in consent issues
• How “informed” must informed consent be to be valid?
• The role of a spouse or relative
• Consent and refusal of consent for minors and incompetent adults
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Definition:
• Patient consent is an agreement by the patient to allow something
proposed by another to be performed on his or her body.
• Informed consent is a legal concept that provides that a patient has a
right to know the potential risks, benefits, and alternatives of a
proposed procedure.
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Consent and Informed Consent
• Contrast the two
• Consent relates to assault and battery.
• Civil and criminal violation (potentially)
• Simple to prove
• Insurance might not cover
• Informed consent relates to negligence.
• Civil wrong only
• Standard malpracticelike case
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Types of Consent
• Express
• Oral or written
• Implied (“inferred” or “presumed”)
• Could be routine for vaccinations, physical exam, etc., but
written consent usually obtained anyway to be safe
• In emergencies (immediate treatment required to save life or
limb), treat emergency first; worry about consent later
• Consent issues when extending surgery
• An old issue
• Today’s consent forms usually cover this
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The Hospital’s Role
• Informed consent is primarily the physician’s
responsibility.
• Cannot delegate to nursing staff
• Hospital must have procedures in place.
• Forms for all procedures
• Ensure consent is documented before treatment
• Cancel procedure if IC not in chart
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Who May Consent?
• Competent adult
• Age of majority varies state to state
• Competency is a medical judgment
• Consent of spouse/family not required
• Psych. patients have rights to consent/refuse
• Can give meds against their will only if needed to prevent injury
to self/others, no lesser alternative, etc.
• Minor parents for their children
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Who May Consent?
• Minor women for the pregnancy Consent for a minor is usually
determined by a hierarchy of relationships under state law:
parent/stepparent; person holding power of attorney (loco parentis)
granted by the former; grandparent; adult sibling; adult aunt/uncle;
etc.
• For an incompetent adult, state laws may have a hierarchy too:
designated surrogate; guardian; spouse; adult child; parent; adult
sibling; adult relative; close friend; etc.
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Elements of Informed Consent
• Diagnosis and prognosis
• Nature/purpose of proposed treatment (in lay terms)
• Risks, consequences, side effects
• Probability of success
• Reasonable alternatives
• Prognosis w/o treatment (“informed refusal”)
• Type of recuperation likely
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Judging the Adequacy of Informed Consent
• What most doctors tell patients?
• What a reasonable doctor would disclose?
• What a reasonable patient would want to know?
• What this patient would have wanted to know?
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Potential Informed Consent Lawsuits
Three types of miscommunication and misunderstanding may lead to
informed consent lawsuits:
1. Misrepresentation of the facts
2. Lack of information about consequences
3. Lack of information about risks
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Defenses to claims that informed consent was lacking include:
▪ Risk not disclosed is commonly known and does not warrant
disclosure.
▪ Patient stated he would undergo the procedure regardless of the risk
involved.
▪ Consent was not reasonably possible by or on behalf of the patient.
▪ The practitioner, after considering all of the attendant facts and
circumstances, used reasonable discretion as to the manner and
extent as to which alternatives or risks should be disclosed.
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Examples of Risks Not Disclosed, But Consent Held to
Be OK
• When patient requests not to be informed
• Blood loss during surgery (common knowledge)
• Patient had the procedure before
• Risks that arise only when procedure is poorly performed
• 1-i-800,000 risk of aplastic anemia
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Who May Consent
• The patient, if competent
• Consent of a spouse or relative:
• Not required
• Ineffective if patient is competent
• Consult state law for incompetent patients
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Who May Consent (continued)
• Minor women for their
pregnancy
• Consent for a minor:
• Parent/stepparent
• Power of attorney
• Grandparent
• Adult sibling
• Adult aunt or uncle
• For incompetent adult:
• Designated surrogate
• Guardian
• Spouse
• Adult child
• Parent
• Adult sibling
• Adult relative
• Close friend
• Note: State law prioritizes who may consent for those who have
no legal capacity to consent for themselves.
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Withholding Treatment / Refusal to Consent
• When treatment is futile, “right to die” issues emerge
• Benefit/burden analysis (“ordinary” vs. “extraordinary”)
• State can intervene to protect innocent third parties
(children, usually)
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Refusal of Treatment
• Regardless of religious beliefs, patients have the right to refuse
medical treatment. If a patient refuses treatment: The refusal should
be noted in the patient’s medical record. A release form should be
executed that protects the provider from liability should the patient’s
refusal to accept care result in injury.
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Refusal of Treatment
• The right of self-determination provides that every human being of
adult years and sound mind has the right to determine what shall be
done with his or her own body.
• When there is uncertainty regarding a patient’s wishes in an
emergency situation, the dilemma should be resolved in a way that
favors the preservation of life.
• According to the Patient Self-Determination Act of 1990, healthcare
organizations have a responsibility to explain to patients, staff, and
families that patients have legal rights to direct their medical and
nursing care as it corresponds to existing state law.
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Incompetent Adults
• If patient’s wishes are known, follow them.
• Living will, durable P of A, etc.
• Conversations with loved ones, etc.
• Quinlan and Kruzan cases
• If not known:
• Review benefit/burden with family
• Involve ethics committee, if necessary
• Build consensus
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• Advance directives for health care are instructions, preferably executed in writing, by
individuals specifying what actions should be taken for their care in the event that they
become unable to make healthcare decisions.
• A living will is the instrument or legal document that describes those treatments an individual
wishes or does not wish to receive should he or she become incapacitated and unable to
communicate treatment decisions.
• A living will provides specific instructions as to a patient’s wishes, such as a desire not to be
maintained on a respirator.
• A healthcare proxy is a legal document that allows a person to appoint a healthcare agent to make
treatment decisions in the event he or she becomes incapacitated and is unable to make decisions
for him or herself.
• A durable power of attorney is a legal device that permits one individual, known as the principal,
to give to another person, called the attorney-in-fact, the authority to act on his or her behalf.
• A surrogate decision maker is an agent who acts on behalf of a patient who lacks the capacity to
participate in a particular decision.
• Guardianship is a legal mechanism by which the court declares a person incompetent and
appoints a guardian.
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Termination of Treatment
• Termination of treatment is legal in all states, under
the right circumstances.
• It’s a medical judgment re efficacy of treatment, but
there are moral, ethical, and emotional aspects.
• Advance directives
• “Living will”
• Healthcare surrogate
• POLST/MOST initiatives
• Physician aid-in-dying (“death with dignity”) laws
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Termination of Treatment
• Futility of treatment occurs when a physician recognizes that the effect of continuing
treatment will be of no benefit to the patient.
• Morally, there is a duty to inform the patient when there is little likelihood of success.
• The determination as to futility of treatment is based on the physician’s assessment and medical
judgment.
• Cardiopulmonary resuscitation (CPR) is an emergency procedure performed on
individuals who experience a cardiac arrest.
• Do-not-resuscitate (DNR) orders are those prescribed by a physician indicating that, in
the event of a cardiac or respiratory arrest, no resuscitative measures should be used to
revive the patient.
• Withholding and withdrawal of treatment:
• Withholding of treatment is a decision not to initiate treatment or medical intervention
for the patient.
• Withdrawal of treatment is a decision to discontinue treatment or medical interventions
for the patient.
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Aid-in-Dying Statutes
• Physician prescription for lethal medication
• Specific statutory criteria
• Not permitted in most states
• In Montana, permitted by judicial decision
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Physician-assisted suicide:
• The right to allow a physician to assist patients in dying who are
terminally ill and mentally competent to determine how they wish to
spend the remaining days of their lives.
• The Oregon Death with Dignity Act was the first statute allowing
terminally ill Oregon residents to obtain prescriptions from their
physicians for self-administered, lethal medications.
• Washington and Vermont now have similar statutes.
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Euthanasia:
• Euthanasia is the mercy killing of the hopelessly ill, injured, or
incapacitated. Euthanasia is complex, and the legal system must maintain a
balance between ensuring that the patient’s constitutional rights are
protected while protecting public interests in preserving life, preventing
suicide, and maintaining the integrity of the medical profession.
• Active euthanasia is the intentional commission of an act that will result in death.
• Passive euthanasia involves the withdrawal or withholding of lifesaving treatment.
• Voluntary euthanasia occurs when a suffering, incurable patient makes the decision
to die.
• Involuntary euthanasia occurs when a person other than the incurable person makes
the decision to terminate the life of an incurable person.
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Brain Death
• The Harvard Ad Hoc Committee on Brain Death published a report in 1968
describing the characteristics of a permanently nonfunctioning brain.
• Brain death = death in all 50 states
• Irreversible cessation of all functions of the brain, including the brain stem
• “He died 20 minutes later” is an oxymoron
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Questions
Health Administration Press
• 1. What are the two types of consent for medical treatment? When does each apply?
• 2. What is the standard for consent in an emergency? I would phrase it as follows: Treat emergency, and don’t
worry about consent unless the patient is clearly competent and vehemently objects. You might ask students to
invent scenarios in which someone would not treat the emergency and discuss how the answer may vary
depending on who the “someone” is (passerby versus off-duty EMT, for example).
• 3. What is the hospital’s role in obtaining informed consent?
• 4. What is required for informed consent to be valid?
• 5. What is the parallel between Helling v. Carey in chapter 5 and the cases in this chapter that disapprove of the
reasonable-doctor rule for informed consent? Like the Helling situation, the “reasonable doctor” standard might
leave patients subject to a professional standard of practice that is itself substandard if the custom of physicians is
to disclose too little.
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The Court Decides
• Cobbs v. Grant—classic case on consent
• Bush v. Schiavo—an unnecessary, tragic soap opera
• Baxter v. State—aid in dying by judicial decision
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Cobbs v. Grant Discussion Questions
• 1. How do you suppose the physician community reacted to this decision?
They were outraged, of course: “How dare a bunch of lawyers tell us how
to practice medicine!” I would like to have said, “You know, lawyers and
judges have been making these kinds of principled decisions a lot longer
than physicians. At a time when physicians were bleeding people to death
with leaches and straight razors, lawyers were writing the Constitution.”
But instead I would of course have said something more politic, like:
“That’s the role of the courts, and if you think it’s wrong you can get the
legislature to overturn it.” Of course, the profession’s level of resentment
has abated over time, and medical paternalism has nearly vanished in
favor of mutual respect between doctor and patient. (At least we can hope
that is the case)
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Cobbs v. Grant Discussion Questions
• 2. How would you explain the decision to someone who disagrees
with it?
One could explain it as the end of medical paternalism and the
beginning of the era of the enlightened and respected patient.
3. Is it fair for Dr. Grant to be held to a standard of care that did not
exist at the time of his patient’s treatment?
“Fair” is an interesting concept. Discuss.
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Cobbs v. Grant Discussion Questions
• 4. Can you explain why the reasonable-patient test is called “objective”
while testimony from the patient on the question of causation is
considered unreliable?
“Objective” is being used here in the sense of “undistorted by emotion or
personal bias.” Presumably, the jury makes an objective (unbiased) decision
as disinterested outsiders, but the patient’s opinion at the time of the trial
may be different than what her opinion would have been at the time of
treatment, and it is certainly affected by the events that are the basis of the
cause of action.
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Cobbs v. Grant Discussion Questions
• 5. The court said there was not enough evidence to support a verdict
of negligence, yet the original gastrectomy led to multiple hospital
stays and two follow-up surgeries. These complications were known
risks that can occur even if the surgeon performs the operation
flawlessly. If you were the patient and knew about these risks, would
you decide to consent to the first surgery? What factors would you
consider?
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Bush v. Schiavo Discussion Questions
1. Be prepared to describe the religious, political, and sociological factors
that may have influenced this drama.
2. On what grounds, if any, might Congress have jurisdiction over these
types of issues?
One might suppose a congressional interest (under the tax and spend
power of Congress) in regulation of these issues as they relate to federal
healthcare programs, but otherwise it is hard to conjure a legitimate
argument that federal jurisdiction exists for end-of-life decisions. The
Rehabilitation Act or Americans with Disabilities Act might be argued.
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Bush v. Schiavo Discussion Questions
3. If this kind of case were to arise at your healthcare facility, how might you
attempt to avoid this lengthy, contentious, and expensive conflict? Discuss the
use of a multidisciplinary approach to include ethicists, chaplains, social workers,
the patient’s pastoral or spiritual advisors, the hospital ethics committee (or IRB,
perhaps), and legal counsel. Stress that this is not primarily a legal dispute: It is a
profoundly personal human drama that may have legal overtones but cannot (or
at least should not) be solve solely or primarily with legal ratiocination.
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Baxter v. State Discussion Questions
1. In a concurring opinion, one of the justices quoted the affidavit of the
plaintiff, Robert Baxter (quoted in the text on p. 450). How are you
moved by such a statement? To the extent you can imagine it, what
would your desires be if you were in a similar situation at life’s end? Ho
2. In a second concurring opinion, another justice wrote, I join the opinion . .
. because the legislature has not plainly stated that assisting suicide is against
public policy. This court must not add such a provision by judicial fiat. . . . The
citizens of Montana have the right to have their legislature step up to the
plate and squarely face the question presented by this case, do their job, and
decide just what is the policy of Montana on this issue (354 Mont. at 252,
224 P.3d at 1222–23). w would your family and friends feel?
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Baxter v. State Discussion Questions
• It has been ten years since those words were written. Do you suppose
the legislature has responded? Why or why not? Not surprisingly, the
legislature has not addressed the issue and the Baxter decision
remains good law in Montana. A recent symposium held at the
University of Montana Law School confirmed that the practice is alive
and well (pardon the metaphor) in that state, although there is
continuing, low-level opposition by some rabid “right to lifers.”
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Chapter 12
Taxation of Healthcare
Institutions
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Main Topics:
• The nature of charity
• Federal tax issues
• Rules concerning lobbying and political campaign activity
• State taxation of real estate and other property
• The effect of the ACA on NFP status
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What is Charity?
• An organization that exists to help those in need or to
provide religious educational, scientific, or similar aid
to the public.
• Does not participate or intervene in any political
campaign on behalf of any candidate for public office.
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The Nature of a Charitable Corporation
• In a general sense, “charity” is:
• A virtue
• Benevolent giving and caring
• Not clearly defined in Internal Revenue Code (IRC)
• Dartmouth College case
• Compare/contrast 19th century and today
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Tax Law Issues
• Federal tax exemption—IRC § 501(c)(3)
• Organized and operated for charitable purposes
• No private inurement
• Insubstantial lobbying
• No political campaigning
• State tax exemptions
• Sales and income tax
• Ad valorem property tax
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Organized and operated for charitable purposes
• To be used in its generally accepted legal sense and is
therefore not to be limited by the separate
enumeration in section 501 © (3) of other tax-exempt
purposes.
• Healthcare was not explicitly stated but it involves
doing good work for the public.
• Help those in need or to provide religious educational,
scientific, or similar aid to the public.
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No private inurement
• Inure: A term used but not defined in IRC section 501 ©
(3), it means a charity’s income or assets may not
benefit, accrue to, or be distributed to private interests.
• A charity’s net earning must be permanently dedicated
to exempt purposes and may not be distributed to
private interests.
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Insubstantial lobbying and political campaigning
• Lobbying: Activity intended to influence the outcome of bending
legislation.
• Exempt organizations are prohibited from campaigning or
electioneering on behalf or in opposition to candidates for political
office.
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Lobbying
• Defined as “attempts to influence legislation”
• Does not include:
• Technical advice to the government
• Input on regulations of interest to the organization
• Meetings with executive branch officials
• Testifying at government request
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ACA New Requirements for Tax Code
1. Conduct a community health needs assessment at least once every 3
years.
2. Adopt an implementation strategy to meet health needs identified in the
assessment.
3. Publicize and implement a written financial assistance policy for services
to indigent patients.
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ACA New Requirements for Tax Code
4. Adopt a written policy on nondiscrimination in emergency services.
5. Limit the amounts charged for care to indigent patients.
6. Not attempt collection actions without determining whether patient
meets financial assistance criteria.
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FP/NFP vs. Taxable/Tax-Exempt
Corporations
Corp.
law
For profit
Tax law
(fed or
state)
Not-for-profit
Taxable
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Tax-exempt
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§501(c) Exempt Organizations
(1) Organized by act of
Congress
(2) Title-holder for EO
(3) Religious, educational,
charitable, etc.
(4) Civic leagues, etc.
(5) Labor, agricultural, etc.
(6) Bus. leagues, chamber of
commerce, realty boards
(7) Social/recreational clubs
(8) Fraternal beneficiary orgs
(9) Employee benefit
(10) Domestic fraternal
(11) Teachers retirement fund
(12) Certain life ins. cos.
(13) Cemetery companies
(14) State-charter credit
unions
(15) Mutual ins. cos.
(16) Certain farm coöps
(17) Unemployment benefit
trusts
(18) Certain employee pension
trusts
(19) Certain armed forces
organizations
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§501(c) – continued
(20) Group legal services plans
(21) Black lung benefit trusts
(22) Withdrawal liability payment
funds
(23) Veterans organization
(24) Sec. 4049 ERISA trusts
(25) Title holding corps.
(26) State orgs. For health coverage for
high-risk pts.
(27) State workers’ comp. reinsurance
orgs.
(28) National RR retirement investment
trusts
(29) Qualified NFP health insurance
issuers
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FP
NFP
+ Much broader range of activities
+ Raise capital through sale of
stock
+ Political campaigns
– Both shareholders and corp. pay
taxes
+ Most = exempt from taxes
+ Charitable deductions
+ May engage in some lobbying
– No political campaign activity
– UBI taxes possible
Others?
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State/Local Tax Issues
• What is “exclusive use” for charitable purpose?
• Mixed use in MOB?
• Vacant land?
• Building under construction?
• States/localities looking for revenue
• Conflicting public policies
• Intermountain Healthcare case
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Coming Full Circle
Compare and contrast . . .
• Christ Church Hospital and Provena
Covenant Med. Ctr.
• Greater Anchorage Area Borough and
Barnes Hospital
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Barnes hospital complex and Queeny Tower (circled)
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Chapter Discussion Questions
• I think these rhetorical questions are pretty straightforward as discussion
starters. Comments are included here for some of the questions.
• 1. How should the term charity be defined? What are the arguments against
and in favor of counting the provision of healthcare in and of itself as charity?
• 2. Compare the structure and financing of today’s “medical–industrial complex”
to your mental image of the nineteenth- and early twentieth-century hospital.
Outline your arguments—both pro and con—for this debate topic: “Resolved,”
that government shall eliminate all favorable tax treatment for not-for-profit
healthcare organizations.
• 3. Consider Genesee Hospital. Do you see any parallels between that case and
Charlotte Hungerford Hospital (discussed in Chapter 6)? Both cases concern the
use of hospital property for a medical office building. In Charlotte Hungerford
Hospital, the arrangement was upheld; in Genesee Hospital, it was not (in
effect). Why were the cases decided differently?
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Chapter Discussion Questions
Probe students for their understanding that, although there are some parallels in the cases (both
involve use of a medical office building), the similarities end there. Charlotte Hungerford Hospital
involved the charitable trust doctrine, “cy pres,” corporate powers, etc. In Genesee Hospital, the
issues revolve around interpretation of a tax statute.
4. Suppose the law requires that, for a property to be tax exempt, it must be used for exempt
purposes. Suppose also that January 1 is the assessment date, and the use of the property on
that date determines its exempt status for the coming year. In July 2016, a hospital buys a parcel
of land near its main campus to build a facility for housing and maintaining its fleet of
ambulances. Construction begins on December 1, 2016, and is completed in June 2017. The
hospital starts using the building as an ambulance station on June 30, 2017. Should the land be
considered exempt for 2016? What if construction had begun on January 2, 2014? Change the
hypothetical dates to suit yourself. Arguments can be made both ways concerning whether land
under construction is “being used” for a charitable purpose.
5. Discuss the future of property tax exemption in your state in the wake of decisions like Provena
(p. 479). Ask students to do some research in preparation for this class discussion. What is the
attitude of your state’s legislators and regulators toward exemption of hospital property? Are
state and local governments in such desperate need of revenue such that they might want to tax
that property as Illinois did in the Provena case?
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The Court Decides
• Greater Anchorage Area Borough v. Sisters of
Charity—tax status of medical office building
• Barnes Hospital v. Collector of Revenue—ditto,
with opposite result
• Provena Covenant Med. Ctr. v. Dept. of Revenue—
tax status of an entire health system
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Chapter 13
Competition and
Antitrust Law
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Main Topics:
• The Sherman, Clayton, and Federal Trade Commission acts
• Antitrust exemptions
• Sanctions and enforcement
• Rule-of-reason analysis and per se violations
• Antitrust application in healthcare
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What is a trust?
• In the business sense, a trust is a combination of companies
formed by a contractual arrangement that usually has the
effect of reducing or eliminating competition in the
particular industry.
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Why is it called “antitrust law”?
➢ Because it was used to break up the “trusts” created by competing
companies in the late 1800s.
➢The purpose of these laws is to preserve the private competitive
market system and eliminate practices that interfere with
competition.
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The Competition (Antitrust) Laws
• Sherman Antitrust Act: “Every contract, combination in the form of trust or otherwise, or
conspiracy, in restraint of trade or commerce among the several states, or with foreign
nations, is hereby declared to be illegal”.
• Section 1: Prohibits contracts, combinations, or conspiracies in restraint of trade
• Section 2: Prohibits monopolization/attempts to control
• Section 3: Prohibits “tying arrangements”
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Competition Laws (continued)
Clayton Act (1914):
“The labor of a human being is not commodity or article of commerce
and it is exempted from the antitrust laws”.
The Clayton Act’s protections for unions were a direct result of the
outcry from labor due to the Danbury Hatter’s Case.
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Clayton Act
• Prohibits acts that lessen competition or trend toward monopoly
• Enforced by Federal Trade Commission (FTC).
• Applies to both FP and NFP companies
(see Law in Action, p. 496)
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Competition Laws (continued)
• FTCA—unfair competition (FP only)
• Robinson-Patman—price discrimination: it is unlawful to
discriminate in price between different purchasers.
• Antitrust exemptions:
• Insurance
• Peer review
• State action
• Lobbying
• “Implied repeal”
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Competition Laws (continued)
• Authority of Congress to regulate competition
• The Commerce Clause
• Congress give power “to regulate Commerce with foreign Nations and
among the several States”
• Antitrust exemptions relative to healthcare
• Five main areas where federal antitrust law does not apply
• See exhibit 13.2
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McCarran- Ferguson Act
• The act exempts “the business of insurance that involves spreading
risk”.
• State governments are allowed to regulate the insurance business for
public good.
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Health Care Quality Improvement Act
• The act provides qualified immunity for persons conducting
professional review activities that affect a physician’s clinical
privileges.
• Peer Review Activities.
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State Action Doctrine
• State regulation sometimes restricts or restraints competition and thus appears
to run afoul (in conflict) of antitrust principles.
• The restraint of trade must be the result of a clear and affirmatively expressed
state regulatory policy.
• “The state made me do it” sometimes used as a defense to an antitrust claim.
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Noerr-Pennington Doctrine
• The doctrine provides that lobbying to influence legislation or
governmental regulation is exempt from the antitrust laws.
• The doctrine is based on the First Amendment’s provisions protecting
free speech, especially political speech.
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Implied Repeal Doctrine
• This common law principle that a new law prevails when it conflicts
with an earlier statute, especially when the older law is more general,
applies only if there is clear repugnancy between the two conflicting
statutes and only if necessary to make the subsequent law work.
• It is disfavored and rarely applied.
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Standard of Analysis
• “Rule of reason”
• Evidence of purpose and effect of the particular restraint
on competition
• Costly and complicated
• Per se violations (automatic violation)
• Agreements on prices (price fixing)
• Division of markets
• Group boycotts
• Tying arrangements
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Areas of Possible Concern
• Health planning
• Shared services
• Utilization review
• Med staff privileges
• Third-party contracts
• Managed care
• Mergers, consolidations
• State licensing
• Big Pharma
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Possible Antitrust Concern
• Restraint of trade
• Price fixing
• group boycott
• Monopolization(control)
• Tying arrangement
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Combinations under Sherman/Clayton Acts
• Growth and diversity, mergers and consolidations
• Combinations are not violations per se
• Two types of Combinations:
• Horizontal
• Vertical
• Rule of reason applies
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Combinations are not violations per se
• Proof of market power: Size and absent of competition alone do not prove
existence of an illegal monopoly.
• Definition of the relevant geographic and service market.
• Proof that the defendant has achieved or maintaining control power
willfully or unfairly.
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Evaluation Factors:
• Whether competing firms or potential competitors have been eliminated
from the market.
• Whether the acquisition will result in more dominant
• Whether the combination may lead to harm competitors.
• what happened in similar situations to the competitive environment.
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Horizontal Combinations:
• Horizontal: Mathematical formula (HHI) to measure market concentration.
• Herfindahl-Hirschman Index (HHI).
• Unconcentrated- HHI below 1,500
• Moderately concentrated- HHI between 1,500 and 2,500
• Highly concentrated- HHI above 2,500
• The agencies compare the pre and post combination HHI scores and based on the result
they make determinations in how to proceed.
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Vertical Combinations:
• The union of a vendor and customer do not directly eliminate a competitor.
• Ensure the availability of supplies to the customer and solidify (strengthen) sales of the
vendor’s product.
• Vertical combination may result in the following:
➢Foreclose the customer’s competitors from their source of supply
➢Foreclose the vendor’s competitors from access to the market
➢Force actual or potential competitors into vertical arrangements of their own which may
have anticompetitive effects.
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Rule of reason analysis:
• Factors that challenged the combinations:
• Ease of entry into a market
• Economic health of the particular industry
• Characteristics of the products involved
• Availability of substitute products
• Nature of consumer demand
• Possible procompetitive effects
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Antitrust Exemptions/Defenses
• State action exemption (incl. insurance)
• Noerr-Pennington exemption
• Failing business defense
• Learned professions—no longer a valid defense
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Antitrust Safety Zone:
• Safety zones describes conduct that the agencies will not challenged under the
antitrust laws, the safety zones for healthcare as follows:
• Combinations involving a small hospital
• Joint venture to purchase expensive or high-tech equipment or to provide certain
expensive services
• Collective efforts to share non-fee- related information
• Arrangements to provide fee-related information to purchasers of health services
• Participation in surveys regarding prices, wages, salaries and benefits
• Group purchasing arrangements that meet certain conditions
• Physician network joint ventures that involve certain types of risk sharing
• Certain multi-provider network arrangements
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Future Expectations
• Healthcare provider consolidations
• Collaboration with physicians
• State enforcement activities
• “Big Pharma” under scrutiny
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The Court Decides
• FTC v. Phoebe Putney Health System—state
action
• N. Carl. State Bd. of Dental Exam’rs v. FTC—
state action
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Federal Trade Comm’n v. Phoebe Putney Health
System Discussion Questions
• 1. Research and explain the community of Albany–Dougherty County and the
corporate structure involved in this case. Who do you suppose were the
officials in the various corporate entities? The county comprises a poor, rural
area of extreme southwest Georgia. Its population in the 2010 census was
about 95,000, two-thirds of whom were African American. No doubt the
officials in the various corporate entities did not reflect the demographics of
the community.
• 2. Explain how the transaction was structured, and why.
• 3. The federal trial court was the US District Court for the Middle District of
Georgia; the Court of Appeals was the Eleventh Circuit. Considering the
locations and compositions of these courts, why might the Supreme Court have
a different worldview and a different perspective on the policy aspects of this
issue?
• Compared to the justices of the Supreme Court, I suspect that many of the trial
and appellate judges in those jurisdictions were “good old boys” from the Deep
South
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North Carolina State Bd. of Dental Exam’rs v.
Federal Trade Comm’n. Discussion Questions
• 1. What does Justice Kennedy mean by the term “active market
participants”? He’s talking about people or organizations that are
engaged in competition with each other 2. What kind of “active
supervision” might the state have engaged in to yield a different
outcome to this litigation? Students could brainstorm this question.
Some top-of-the-head answers might include: having state officials
attend the board meetings or even serve as ex officio members;
having regulatory standards for board actions; or changing the state
law to set a state policy regarding teeth whitening.
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North Carolina State Bd. of Dental Exam’rs v.
Federal Trade Comm’n. Discussion Questions
• 3. In every state there are professional licensing boards similar to the
North Carolina dental board. How, if at all, does this decision hamper
state boards that license physicians, nurses, and other healthcare
professionals? I’m not sure that it does, but it might be an interesting
research project.
• 4. Compare this decision with that of the court in Phoebe Putney and
to the case of Patrick v. Burget in chapter 8 (see p. 292). How are they
similar, and where do they differ? Ask the students to speculate
about the motives involved in the cases.
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North Carolina State Bd. of Dental Exam’rs v.
Federal Trade Comm’n. Discussion Questions
• 5. By virtue of the HCQIA, which was passed in response to Patrick,
“active market participants” involved in peer review are immune from
liability. How are the actions of the members of the North Carolina
dental board different?
HCQIA requires that the actions taken be in the reasonable belief that
they would further the quality of care and only after due process. It
doesn’t seem from the opinion as though the North Carolina board
could meet that standard
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Chapter 14
Issues of
Reproduction and
Birth
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Main Topics
• Sterilization
• Wrongful birth and wrongful life
• Abortion
• The hospital’s role
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Sterilization:
• Sterilization is defined as the termination of the ability to produce offspring.
• Vasectomy is a surgical procedure performed on men in which the vas deferens is
severed and tied to prevent the flow of seminal fluid into the urinary canal.
• Tubal ligation is a surgical procedure performed on women in which the fallopian
tubes are cut and tied. This prevents the passage of the ovum from the ovary to
the uterus.
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Sterilization:
• Therapeutic sterilization is performed to preserve life or health.
• Eugenic sterilization is the involuntary sterilization of certain categories of
persons. It is often performed to prevent the transmission of hereditary
defects and, in some states, is performed to prevent procreation by
persons who would not be able to care for their offspring.
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Sterilization
• Voluntary sterilization is not legally controversial today
• Consent of spouse not required
• Connecticut law struck down by Supreme Court
• “Uncommonly silly”
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Eugenic Sterilization
• Rare and disfavored
• A “brutal and vicious” kind of law
• See Buck v. Bell
• “Three generations of imbeciles are enough” (OWH, Jr.)
• Universally criticized, never followed, but never overruled
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Wrongful Birth/Life Cases
• Wrongful birth
• Suit by parents for failed sterilization or failure to
diagnose/warn of handicap
• Routine malpractice-type case
• Wrongful life
• Suit by handicapped child for being born
• Disfavored by many states
• California and Washington permit them
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Wrongful Birth/Life Cases
• Wrongful birth, wrongful life, and wrongful conception have led to a
variety of lawsuits.
• Wrongful birth actions claim that, but for breach of duty by the
defendant, a child would not have been born.
• Wrongful life suits are those in which a parent or child claims to have
suffered harm as a result of being born—are generally unsuccessful.
• Wrongful conception actions claim that damages were sustained by
parents of an unexpected child based on the allegation that the
child’s conception was the result of negligent sterilization procedures
or a defective contraceptive device.
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WB/WL (continued)
Speck v. Finegold (p. 529)
Harbeson v. Parke-Davis (p. 536)
• Compare and contrast
• What are the arguments on each side?
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Duty, Breach, and Causation
• Malpractice case required a prove of duty care, a breach of that duty,
an injury caused by the breach and legally recognized damages.
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Other Reproduction Issues
• Stem cell research
• Assisted reproductive technology
• Artificial insemination
• Gestational surrogacy
• Uniform Parentage Act: “all children and all
parents have equal rights with respect to each
other” regardless of marital status.
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Other Reproduction Issues
• Artificial insemination most often takes the form of the injection of
seminal fluid into a woman to induce pregnancy.
• Homologous artificial insemination is when the husband’s semen is used in
the procedure.
• Heterologous artificial insemination is when the semen is from a donor other
than the husband.
• Surrogacy is a method of reproduction whereby a woman agrees to
give birth to a child she will not raise but will instead hand over to a
contracted party.
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Abortion
• Abortion is the premature termination of pregnancy. It can be classified as spontaneous
or induced.
• It may occur as an incidental result of a medical procedure, or it may be an elective
decision on the part of the patient.
• In addition to having substantial ethical, moral, and religious implications, abortion has
proven to be a major political issue and will continue as such in the future.
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Abortion
• Few restrictions until early 1800s; thus, the framers wouldn’t have
considered a fetus a “person” for constitutional purposes.
• Roe v. Wade probably correct on this point
• Status post Casey:
• Prior to viability, state cannot place “undue burden” on the woman’s right
to choose
• Post viability, can prohibit abortion except for life/health of mother
• What’s an “undue burden”? A rule is considered an undue burden
if its purpose or effect is to place a substantial obstacle in the path
of a woman seeking an abortion before the fetus is viable.
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Abortion
• Roe v. Wade is the Supreme Court’s ruling that, within certain
guidelines, women are allowed to make decisions regarding how their
pregnancies will end. According to Roe v. Wade:
• First trimester, an abortion decision is between a woman and her
physician.
• Second trimester, a state may regulate the medical conditions under
which an abortion is performed.
• Third trimester, a state can prohibit all abortions except those
deemed necessary to protect maternal life or health.
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Abortion
• States’ and women’s rights regarding reproductive decision have been further
shaped and defined by a number of landmark rulings.
• In 1992, in Planned Parenthood v. Casey, the Supreme Court nearly overturned
Roe v. Wade. It did reject the trimester approach in favor of the Court evaluating
the permissibility of state abortion rules based on whether they unduly burden a
woman’s ability to obtain an abortion.
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Abortion
• A partial-birth abortion is a late-term abortion that involves partial
delivery of the fetus prior to its being aborted. An Arkansas statute
failed to prohibit this manner of abortion largely as a result of its
broad coverage. The Act was determined to be unconstitutional
because it was unconstitutionally vague, imposed an undue burden
on women seeking abortions, and did not adequately protect the
health and lives of pregnant women.
• In Utah Women’s Clinic, Inc. v. Leavitt, the court determined that
imposition of a 24-hour waiting period—except in the event of a
medical emergency—does not impose an undue burden on the right
to an abortion.
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Abortion
• Individuals have a right to refuse to participate in abortions for reason
of conscience or religious or moral conviction.
• Several states have placed restrictions on abortions by reducing
funding.
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TRAP Laws and Other Tactics
• “Targeted restrictions on abortion providers”
• More and more state legislation
• Conscience protections to accommodate religious beliefs
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Restrictions to Abortion:
• Any tissue removed following an abortion be submitted to a
pathologist, because it placed insignificant burden on a women
decision on abortion.
• Record keeping and reporting requirements that protect
confidentiality.
• Statutes requiring that second trimester abortions to be
performed in licensed clinics.
• Written informed consent.
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Tactics (continued)
• Onerous record-keeping and reporting
• Licensure of facilities
• Written, detailed informed consent
• Requirement to use a hospital
• Waiting periods
• Counseling
• Ban on “partial birth abortion”
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The Hospital’s Role
• Government hospitals versus private
• State action versus no state action
• Receipt of $ is not “state action” to perform abortion
• Conscience clauses for physicians and
organizations (refusal to perform abortion on
moral or religious ground).
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The Court Decides
Skinner v. Oklahoma ex rel. Attorney General—sterilization
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Skinner v. Oklahoma ex rel. Attorney General
Discussion Questions
• 1. What does ex rel. mean in the caption of the case? “On the relation of.”
Skinner is a qui tam plaintiff (“private attorney general”) suing on behalf of the
state.
• 2. What does Justice Douglas mean when he talks about a “severability clause” in
the statute?
• 3. The opinion takes pains to distinguish Buck v. Bell from the present case. Are
you persuaded by Justice Douglas’s discussion, or has he effectively overruled
Buck without saying so? Buck v. Bell has never been expressly overruled—the
court is always reluctant to do so—but it has never been followed.
• 4. In the 1930s, Hereditary Health Courts were established in Nazi Germany to
enforce sterilization laws on individuals suspected of hereditary diseases and
other “defects.” See generally, Robert J. Lifton, The Nazi Doctors: Medical Killing
andthe Psychology ofGenocide, 22–44 (Basic Books 1986). Should forced
sterilization—whether for eugenic reasons or otherwise—ever be allowed? If so,
under what circumstances and controls? Discuss
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Used the slides to answer question
1. Legal requirements for maintaining medical records are most often found in which of the following?
a. State corporation laws
b. Regulations of state licensing agencies
c. Regulations of the Department of Labor
d. Federal charitable corporation law
2. Which of the following events is a hospital NOT normally required to report to public authorities for
statistical purposes?
a. Births and deaths
b. Diagnoses of infectious and communicable diseases
c. Gunshot wounds
d. A visitor’s slip-and-fall case
3. What does it mean for a physician to “authenticate” a record?
a. The physician has signed and dated it.
b. The physician has billed it.
c. The physician has filed it.
d. The physician has copied it.
4. Under HIPAA, a patient has a right to an “accounting.” This means that the patient
_________________________.
a. can get a copy of the bill
b. must file suit to get a copy of the record
c. can learn to whom his or her health information was disclosed
d. should hire a CPA to request an audit
5. Under common law, which of the following relationships was NOT considered privileged?
a. Doctor–patient
b. Attorney–client
c. Priest–penitent
d. Husband–wife
6. The federal law that requires evaluation of persons who come to a hospital emergency room is called
what?
a. OSHA
b. EMTALA
c. ERISA
d. EXCULPA
7. Which of the following is the best summary of the purpose of a Good Samaritan statute?
a. To require people to stop blind men from walking off cliffs
b. To provide protection from liability for people who render aid at the scene of an accident
c. To protect paramedics and other “first responders” from lawsuits
d. To provide financial incentives that encourage emergency response teams
8. Proof of a patient’s consent is a defense against what type of lawsuit?
a. Harassment
b. Battery
c. False imprisonment
d. Negligence
9. What type of consent is most commonly an issue in a medical malpractice case?
a. Death-bed consent
b. Express consent
c. Informed consent
d. Testamentary consent
10. Proof of a patient’s consent is a defense against what type of lawsuit?
a. Harassment
b. Battery
c. False imprisonment
d. Negligence
11. What type of consent is most commonly an issue in a medical malpractice case?
a. Death-bed consent
b. Express consent
c. Informed consent
d. Testamentary consent
12. Which of the following is NOT necessary for a valid informed consent?
a. Explanation of the nature of the treatment
b. Use of language the patient can understand
c. Quote for the approximate cost of the procedure
d. Discussion of possible alternative treatments
13. Which of the following is intended to convert patients’ preferences into enforceable physicians’
orders?
a. POLST/MOST
b. Patient Self-Determination Act
c. EMTALA
d. AMA Physician Order Form
14. Which of the following would disqualify a corporation from being tax exempt?
a. Being organized as a not-for-profit
b. Serving a charitable purpose
c. Paying dividends to shareholders
d. Serving a religious purpose
15. Which of the following is NOT typical of the courts’ attitude toward tax exemption?
a. Taxation is the rule; exemption is the exception.
b. The burden of proof is on the one seeking the exemption.
c. Providing free care to the poor justifies the exemption.
d. Any doubts should be resolved in favor of the exemption being denied.
16. Which of the following is NOT one of the major US antitrust laws?
a. Sherman Act
b. Clayton Act
c. Powell Act
d. Federal Trade Commission Act
17. A certain federal law prohibits unfair or deceptive practices, such as making false promises about a
product, sending billing for unsolicited merchandise, using high-pressure door-to-door sales methods,
and bait-and-switch techniques. What law is this?
a. Sherman Antitrust Act
b. Federal Trade Commission Act
c. Adam Clayton Powell Act
d. Interstate Commerce Act
18. Which of the following is most likely to be considered exempt by statute from the antitrust laws?
a. The business of healthcare
b. The business of insurance
c. The business of football
d. The business of railroads
19. For a case to be “justiciable” means it is _________________________.
a. being decided by a court of appeals
b. ripe for decision by a court of law
c. an advisory opinion
d. political in nature
20. What is the major legal and philosophical problem with “wrongful life” cases?
a. Determination of the time of birth
b. How to measure damages
c. The statute of limitations
d. The Americans with Disabilities Act