Iowa Admin. Code r. 653-13.13 - Standards of practice-experimental treatments for patients with a terminal illness
(1)
Exemption from discipline . To the extent consistent with state
law, the board shall not revoke, fail to renew, suspend, or take any action
against a physician 's license based solely on the physician 's recommendations
to an eligible patient regarding access to or treatment with an investigational
drug, biological product, or device.
(2)
Eligible patient. A
physician shall ensure that a patient meets all of the following conditions
prior to the use of an investigational drug, biological product, or device
pursuant to this rule :
a. The patient has a
terminal illness, attested to by the patient's treating physician .
b. The patient has considered and rejected or
has tried and failed to respond to all other treatment options approved by the
U.S. Food and Drug Administration (FDA).
c. The patient has received a recommendation
from the patient's physician for an investigational drug, biological product,
or device.
d. The patient has given
written informed consent for the use of the investigational drug, biological
product, or device.
e. The patient
has documentation from the patient's physician that the patient meets the
requirements of this rule .
(3)
Investigational drug, biological
product, or device. A physician may recommend access to or treatment
with an investigational drug, biological product, or device that has
successfully completed phase 1 of an FDA-approved clinical trial but has not
yet been approved for general use by the FDA and remains under investigation in
an FDA-approved clinical trial.
(4)
Terminal illness. A physician shall ensure that a patient has
a terminal illness prior to the use of an investigational drug, biological
product, or device pursuant to this rule . A terminal illness is a progressive
disease or medical or surgical condition that entails significant functional
impairment and that is not considered by a treating physician to be reversible
even with administration of treatments approved by the FDA and that, without
life-sustaining procedures, will result in death.
(5)
Written informed
consent. A physician shall obtain written informed consent prior to
the use of an investigational drug, biological product, or device pursuant to
this rule . Written informed consent is a written document that is signed by a
patient, a parent of a minor patient, or a legal guardian or other legal
representative of the patient and attested to by the patient's treating
physician and a witness and that includes all of the following:
a. An explanation of the products and
treatments approved by the FDA for the disease or condition from which the
patient suffers.
b. An attestation
that the patient concurs with the patient's treating physician in believing
that all products and treatments approved by the FDA are unlikely to prolong
the patient's life.
c. Clear
identification of the specific proposed investigational drug, biological
product, or device that the patient is seeking to use.
d. A description of the best and worst
potential outcomes of using the investigational drug, biological product, or
device and a realistic description of the most likely outcome. The description
shall include the possibility that new, unanticipated, different, or worse
symptoms might result and that death could be hastened by use of the proposed
investigational drug, biological product, or device. The description shall be
based on the treating physician 's knowledge of the proposed investigational
drug, biological product, or device in conjunction with an awareness of the
patient's condition.
e. A statement
that the patient's health plan or third-party administrator and provider are
not obligated to pay for any care or treatments consequent to the use of the
investigational drug, biological product, or device, unless the patient's
health plan or third-party administrator and provider are specifically required
to do so by law or contract.
f. A
statement that the patient's eligibility for hospice care may be withdrawn if
the patient begins curative treatment with the investigational drug, biological
product, or device and that hospice care may be reinstated if treatment ends
and the patient meets hospice eligibility requirements.
g. A statement that the patient understands
that the patient is liable for all expenses consequent to the use of the
investigational drug, biological product, or device and that this liability
extends to the patient's estate unless a contract between the patient and the
manufacturer of the investigational drug, biological product, or device states
otherwise.
(6)
Assisting suicide. This rule shall not be construed to allow a
patient's treating physician to assist the patient in committing or attempting
to commit suicide as prohibited in Iowa Code section
707A.2.
(7)
Grounds for discipline .
A physician may be subject to disciplinary action for violation of rule
653-13.13 (144E,147,148,272C) or 653-Chapter 23. Grounds for discipline include, but are
not limited to, the following:
a. The
physician recommends access to or treatment with an investigational drug,
biological product, or device to an individual who is not an eligible patient
pursuant to this rule .
b. The
physician fails to obtain appropriate written informed consent prior to
recommending access to or treatment with an investigational drug, biological
product, or device pursuant to this rule .
c. The physician assists the patient in
committing or attempting to commit suicide as prohibited in Iowa Code section
707A.2.
This
Notes
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