Senate Bill No. 85
(By Senators Blatnik and Walker)
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[Introduced January 17, 1996; referred to the Committee
on Health and Human Resources; and then to the Committee on
Finance.]
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A BILL to amend chapter sixteen of the code of West Virginia, one
thousand nine hundred thirty-one, as amended, by adding
thereto a new article, designated article thirty-five,
relating to the regulation of electroconvulsive therapy;
prohibited uses; necessary consent; withdrawal of consent;
administration by physicians; registration and maintenance
of equipment with the office of environmental services;
reporting of information to the health care cost review
authority; and use of reported information.
Be it enacted by the Legislature of West Virginia:
That chapter sixteen of the code of West Virginia, one
thousand nine hundred thirty-one, as amended, be amended by adding thereto a new article, designated article thirty-five, to
read as follows:
ARTICLE 35. ELECTROCONVULSIVE THERAPY.
§16-35-1. Application.
This article applies to the use of electroconvulsive therapy
by any person, including a private physician who uses the therapy
on an outpatient basis.
§16-35-2. Use of electroconvulsive therapy.
(a) Electroconvulsive therapy may not be used on a person
prior to the person reaching the age of emancipation.
(b) The use of electroconvulsive therapy shall be limited
for use only as a last resort in the treatment of severe mental
illness. Electroconvulsive therapy shall be utilized only when
appropriate and shall be administered within accepted standards
of practice for the diagnosis of severe mental illness. The
decision to use electroconvulsive therapy as a treatment of last
resort shall be accompanied by a concurring opinion of an
independent qualified physician who may not receive an economic
benefit from the administration of electroconvulsive therapy.
§16-35-3. Consent to therapy.
(a) Every health care provider utilizing electroconvulsive
therapy shall prepare a written consent form to be used when electroconvulsive therapy is being considered for use in the
treatment of a person.
(b) The written consent form shall clearly and explicitly
state:
(1) The nature and purpose of the procedure;
(2) The nature, degree, duration and probability of the side
effects and significant risks of the treatment commonly known by
the medical profession, especially noting the possible degree and
duration of memory loss, the possibility of permanent irrevocable
memory loss, and the remote possibility of death;
(3) That there is a division of opinion as to the efficacy
of the procedure; and
(4) The probable degree and duration of improvement or
remission expected with or without the procedure.
(c) Before a patient receives each administration of
electroconvulsive treatment, the hospital, facility or physician
administering the therapy shall ensure that:
(1) The patient and the patient's guardian, if any, receive
a written copy of the consent form that is in the patient's
primary language, if possible;
(2) The patient and the patient's guardian, if any, receive a written supplement that contains related information that
pertains to the particular patient being treated;
(3) The contents of the consent form and the written
supplement are explained to the patient and the patient's
guardian, if any:
(A) Orally, in simple, nontechnical terms in the patient's
primary language, if possible; or
(B) Through the use of a means reasonably calculated to
communicate with a hearing impaired or visually impaired patient,
if applicable;
(4) The patient and the patient's guardian, if any, sign a
copy of the consent form stating that the patient has read the
consent form and the written supplement and understands the
information included in the documents; and
(5) The signed copy is made a part of the patient's clinical
record.
(d) Consent given under this section is not valid unless the
patient and the patient's guardian, if any, understand the
information presented and consent voluntarily and without
coercion or undue influence.
§16-35-4. Withdrawal of consent.
A patient or guardian who consents to the administration of
electroconvulsive therapy may revoke the consent for any reason
and at any time. Revocation of the consent is effective
immediately.
§16-35-5. Physician requirement.
(a) Only a physician may administer electroconvulsive
therapy.
(b) A physician may not delegate the act of administering
the therapy. A nonphysician who administers electroconvulsive
therapy is practicing medicine in violation of the Medical
Practice Act as codified in article three et. seq., chapter
thirty of this code.
§16-35-6. Registration and reporting of equipment.
(a) A person may not administer electroconvulsive therapy
unless the equipment used to administer the therapy is registered
with the office of environmental services of the department of
health and human resources.
(b) A hospital or facility administering electroconvulsive
therapy or a private physician administering the therapy on an
outpatient basis shall file an application for registration under
this article. The applicant shall submit the application to the office of environmental services on a form prescribed by the
office.
(c) The application shall be accompanied by a nonrefundable
application fee. The office of environmental services shall set
the fee in a reasonable amount not to exceed the cost for the
office to administer this article.
(d) The application shall contain:
(1) The model, manufacturer and age of each piece of
equipment used to administer the therapy; and
(2) Any other information required by the office.
(e) The office of environmental services may conduct an
investigation as considered necessary after receiving the proper
application and the required fee.
(f) Any person, hospital or facility utilizing equipment for
the administration of electroconvulsive therapy shall maintain
current records and documentation regarding the maintenance and
repairs performed on the equipment. The records shall be made
available to the office of environmental services for its
inspection upon its request.
(g) The office of environmental services may promulgate
rules prohibiting the registration and use of equipment of a type, model or age the office determines is dangerous.
(h) The office may deny, suspend or revoke a registration if
it determines that the equipment is dangerous.
§16-35-7. Reports.
(a) A mental hospital or facility administering
electroconvulsive therapy for the treatment of severe mental
illness or a physician administering the therapy on an outpatient
basis shall submit to the health care cost review authority
quarterly reports relating to the administration of the therapy
in the hospital or facility or by the physician.
(b) The report shall state for each quarter:
(1) The number of patients who received the treatment,
including:
(A) The number of patients receiving mental health services
who consented to the therapy;
(B) The number of involuntarily committed patients who
consented to the therapy; and
(C) The number of patients for whom a guardian of the
patient consented to the therapy;
(2) The age, sex and diagnosis of the patients receiving the
therapy;
(3) The source of the treatment payment;
(4) The average number of electroconvulsive treatments
administered for each complete series of treatments, but not
including maintenance treatments;
(5) The average number of maintenance electroconvulsive
treatments administered per month;
(6) The number of fractures, reported memory losses,
incidents of apnea, cardiac arrests without death and suicides
(committed or attempted) occurring within fourteen days after
treatment;
(7) Autopsy findings if death followed within fourteen days
after the date of the administration of the therapy; and
(8) Any other information required by the health care cost
review authority.
(c) Each hospital or facility utilizing electroconvulsive
therapy and submitting a report in accordance with this article,
shall protect the privacy and confidentiality of the patients who
are receiving electroconvulsive therapy and shall adhere to all
federal and state confidentiality laws.
§16-35-8. Use of information; report.
(a) The health care cost review authority shall use the information received under this article to analyze, audit and
monitor the use of electroconvulsive therapy.
(b) The authority shall file annually with the governor and
the Legislature a written report summarizing by facility the
information received under this article. If the therapy is
administered by a private physician on an outpatient basis, the
report shall include that information but may not identify the
physician. The authority may not directly or indirectly identify
in a report issued under this section a patient who received the
therapy.
NOTE: The purpose of this bill is to provide for the
regulation of the administration of electroconvulsive therapy.
This article is new; therefore, strike-throughs and
underscoring have been omitted.