Laws and Regulations

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• Laws and Regulations
• Donna Smith

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Laws and Regulations

• This section will focus on your knowledge of the
• Effects of government policy on healthcare
  operations
• Opportunities for and restrictions on lobbying
  activities and other contact with government
  officials
• Implementation of laws pertaining to healthcare
• Legal responsibilities and liabilities of
  organizations and professionals
• Identification of restraint-of-trade situations
• Identification of healthcare-related fraud and
  abuse

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Laws and Regulations

• Law is a system of principles and rules devised
  by organized society for the purpose of
  controlling human conduct.
• Southwick, A.F. The Law of Hospital and Health
  Care Administration (2nd ed). 1988 page 3.

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Laws and Regulations

• Types of Law
• Constitutional
• Statutory
• Judicial
• Administrative

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Laws and Regulations

• Know the trends and pitfalls in legal fields
• Criminal law
• Contracts
• Antitrust
• Negligence
• Fraud abase
• Taxation
• Administrative Law
• Law of Corporations
• Environmental regulation
• others

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Laws and Regulations

• Contract Law
• Private agreements give rise to certain duties
  that are enforceable in a public forum (court
  system)
• All physician-patient and institution-patient
  relationships are founded in contract the
  patient requests treatment and the provider
  agrees to provide it in return for payment
• This establishes certain legally enforceable
  duties and expectations

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Laws and Regulations

• Contract Law
• Contractual aspects exist in relationships
  between a healthcare organization and
• Physicians
• Nurses
• Other employees
• Suppliers
• Payors
• Government
• others

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Laws and Regulations

• Corporation Law
• Because a corporation has a charter from the
  state, it receives certain benefits
• Perpetual existence
• Legal personality
• corporate veil that shields the individual who
  created it and those who operate it

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Laws and Regulations

• Corporate charters also create legal obligations
• Government licensure
• Regulation
• Oversight merely to virtue of its corporate status

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Laws and Regulations

• Criminal Law
• Prosecution and conviction for
• Assault
• False imprisonment
• Violation of civil rights
• Defamation (libel and slander)
• Environmental pollution
• murder

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Laws and Regulations

• Negligence/Tort Law
• Violation of some proven standard of care or
  failure to exercise due care under the
  circumstances.
• Alleged medical malpractice
• Healthcare organizations were once protected by
  the doctrine of charitable immunity, this is no
  longer the case

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Laws and Regulations

• Negligence failure to
• Determine the qualification of a physician prior
  to granting or renewing staff privileges
• Failure to monitor the qualifications of nurses
  or healthcare workers
• Failure to maintain and implement adequate
  institutional policies
• Failure to follow the organizations own bylaws
• Failure to maintain adequate facilities and
  equipment
• Failure to comply with anti-dumping laws
  regarding emergency room patients

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Laws and Regulations

• Negligence failure to
• Supervise the performance of contractors
  (including hired physicians)
• Maintain appropriate peer review and quality
  assurance functions
• Prevent the unauthorized disclosure of
  information from patient records
• Protect patients from healthcare workers who
  carry communicable or infectious diseases
• Protect the identities of AIDS or substance abuse
  patients

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Laws and Regulations

• Negligence failure to
• Follow standard orders and protocols
• Inform the patient or family when injuries result
  from known deviations from the standard of care
• Counsel persons regarding known or knowable
  genetic conditions that would affect their
  children

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Laws and Regulations

• Fraud and Abuse
• False claims
• Kickbacks for referrals or Medicare patients
• Physician self-referrals
• Huge potential for penalties fines and
  expulsion from the Medicare program

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Laws and Regulations

• Antitrust Laws(Clayton Act and Sherman Act)
• Physicians and healthcare organizations were once
  exempted from antitrust statutes because of their
  learned profession status
• However we are now subject to antitrust laws of
  both federal and state governments.
• Mergers
• Consolidations
• Acquisitions
• Reduction of services
• Joint Ventures

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Laws and Regulations

• Antitrust Laws
• The incentives of antitrust laws (to preserve and
  promote competition) seem counter to the policy
  imperatives of healthcare reform (efficiency,
  lower cost, reduction of duplication of services).

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Laws and Regulations

• Antitrust Laws
• Litigation is brought by
• U.S. Department of Justice
• Federal Trade Commission
• State antitrust agency
• Antitrust action
• Can take years to litigate
• Cost millions of dollars to defend
• Can cost millions or more in damages and penalties

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Laws and Regulations

• Tax Laws
• Tax-exempt organizations must comply with tax
  laws limitations and requirements regarding
• Lobbying activities
• Political campaigning
• Community benefits
• Charitable purposes
• Private inurement
• Unrelated business income

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Laws and Regulations

• Other Legal Obligations
• Admission and discharge procedures
• Hill-Burton Act
• EMTALA Emergency Medical Treatment and Active
  Labor Act
• Involuntary Commitment of Mentally Ill persons

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Laws and Regulations

• Informed Consent
• Know the circumstances when consent can be
  refused
• Procedures needed to secure and document informed
  consent
• Legal aspects of medical records
• Forms and consents
• Standards for retention/disposal
• Rights of ownership and control
• Use as evidence in litigation

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Laws and Regulations

• Informed Consent
• Know the legal principles affecting consent for
  treatment of
• incompetent adults
• Young minor children
• Mature minors
• Pregnant minors
• Seriously ill newborns whose parents refuse to
  consent to care

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Laws and Regulations

• Informed Consent
• Know the legal principles affecting consent for
• Abortion
• Sterilization
• Euthanasia
• Genetic therapies
• Other procedures having religious or ethical
  overtones
• Potential liability for wrongful life or
  wrongful birth

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Laws and Regulations

• Need more in-depth resources?
• Southwick, A.F. The Law of Hospital and Health
  Care Administration (2nd ed). Health
  Administration Press. 1988.
• J. Stuart Showalter, J.D. Southwicks The Law of
  Healthcare Administration, 3rd ed.
• Dean M. Harris, J.D., Contemporary Issues in
  Healthcare Law and Ethics, 2nd ed.
• Scott C. Withrow, J.D., Managing Healthcare
  Compliance

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Laws and Regulations

• Ready for some test questions?

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Laws and Regulations Test Questions

• A court may find in favor of an employee who has
  been dismissed, if the employers dismissed the
  plaintiff
• For cause, but without using progressive
  discipline
• Before the end of the plaintiffs probationary
  period
• For union organizing
• Without cause

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Laws and Regulations Test Questions

• All of the following are commonly recognized to
  be a right of each patient except the right to
• Receive considerate and respectful care
• Access protective services
• Communicate with a caregiver in the language of
  the patient's choosing
• Be informed about and participate in decisions
  regarding their care

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Laws and Regulations Test Questions

• All of the following statements about
  documentation in the medical record are true
  except
• Verbal orders must be authorized by the
  practitioner within a time frame to be defined by
  the medical staff
• Verbal orders can only be accepted by registered
  nurses
• Authentication may be made by actual written
  signatures, initials, rubber stamp signatures, or
  computer signatures
• That entries must be authenticated by the actual
  author only.

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Laws and Regulations Test Questions

• A non-legitimate reasons to release information
  from a patients medical record is when
• Subpoenaed by a court order
• Requested by the spouse or next of kin
• The patient becomes incompetent
• Reporting statistics for a research project

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Laws and Regulations Test Questions

• In the past, hospitals have been less effective
  in lobbying than physicians because
• Legislators like physicians more
• Physicians have better lobbyists
• The law prevents hospitals from lobbying
• Hospitals dont vote

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Laws and Regulations Test Questions

• In general, courts exhibit attitude regarding
  controversies over medical staff privileges?
• Human lives are at stake and the courts must
  intervene to protect physicians rights to save
  those lives.
• If the decision were supported by reasonable
  evidence, courts will not substitute their
  judgment for that of the hospital board.
• Hospitals must not be permitted to interfere with
  the doctor-patient relationship.
• Courts may not entertain suits regarding medical
  staff privileges.

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Laws and Regulations Test Questions

• Under federal law, whenever a patient comes to a
  hospital emergency department with an emergency
  condition
• With few exceptions, the patient's ability to pay
  may be considered in determining whether to
  provide treatment
• With few exceptions, the patients condition must
  be stabilized before he/she is transferred or
  discharged
• A police officer may be asked to authorize
  treatment
• The hospital has no duty to treat the person if
  he/she is not a patient or a member of the
  medical staff

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Laws and Regulations Test Questions

• In considering applications for medical staff
  privileges, hospitals receive reports from a U.S.
  Government clearinghouse on malpractice payments
  and adverse medical staff and licensure actions.
  In general, these reports have had which effect?
• Reports have rarely led hospitals to make
  privileging decisions they would not have made
  otherwise
• Reports have been timely and helpful and have
  reduced the complexity of the privileging process
• Had they not received the reports, most
  hospitals privileging decisions would usually
  have been different
• Hospitals usually receive significant information
  that neither the practitioner involved nor any
  other sources had provided.

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Laws and Regulations Test Questions

• Which of the following statements best summarizes
  the prevailing legal standard used to judge the
  actions of members of a not-for-profit healthcare
  organizations governing board?
• They must act in good faith, with reasonable
  care, and with the best interests of the
  corporation in mind.
• They must exercise the same high level of
  fiduciary duty as is applied to the trustees of a
  trust.
• The must avoid gross negligence and willful
  misconduct.
• They are immune from personal liability.

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Laws and Regulations Test Questions

• Which of the following is the clear trend
  regarding a hospital's liability for the actions
  of members of its medical staff?
• The hospital may be held liable for a physicians
  negligence even though the physician is an
  independent contractor.
• Hospitals are not liable for such actions because
  they are simply physical sites where patients
  receive treatment from privately retained
  physicians.
• Courts are becoming more reluctant to impose
  liability on hospitals for the negligence of
  physicians who use their facilities.
• The hospital is liable only if the physician is
  an employee.

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Laws and Regulations Test Questions

• A joint venture laboratory owned by a hospital
  and physicians on its medical staff would
  probably be in violation of fraud and abuse laws
  if it were to
• Market its services to both investors and
  non-investors
• Offer ownership shares at the same price to
  referrers and non-referrers
• Require investors to refer business to it
• Base its profit distributions on the amount of
  capital contributed, not on referrals.