§ 25-22.5-1-2.1 — Experimental or nonconventional treatment; protocols for treatment; causes of action

Indiana § 25-22.5-1-2.1

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 22.5: PHYSICIANS
• Ch. 1: Definitions and Exclusions

Text

1. (a) An individual who consents under IC 34-18-12 may receive any experimental or nonconventional medical
treatment if:
(1) a licensed physician has personally examined the individual
and agrees to treat the individual;
(2) the treating physician determines:
(A) there is no reasonable basis to conclude that the medical
treatment, when administered as directed, poses an
unreasonable and significant risk of danger to the individual
receiving the medical treatment; or
(B) the:
(i) individual has been diagnosed with a terminal disease or
condition and does not have comparable or satisfactory
treatment options that are approved by the federal Food and
Drug Administration and that are available to diagnose,
monitor, or treat the individual's disease or condition; and
(ii) probable risk to the individual from the experimental or
nonconventional medical treatment is not greater than the
probable risk from the individual's disease or condition; and
(3) the treating physician has provided the individual with a
written statement and an oral explanation of the medical treatment
that the individual has acknowledged by the individual's signature
or the signature of the individual's legal representative and that
discloses the following:
(A) That the medical treatment is experimental or
nonconventional.
(B) That the investigational drug, biological product, or device
(as defined in IC 16-42-26-2) has not been approved by the
federal Food and Drug Administration for any indication.
(C) The material risks generally recognized by a reasonably
prudent physician of the medical treatment's side effects.
(D) An explanation of the medical treatment, including
expected frequency and duration of the treatment.
(b) If the medical treatment is to be provided on an inpatient or
outpatient basis at a hospital licensed under IC 16-21, then that type of
treatment must have been approved by the governing board of the
hospital or by a committee of the hospital authorized by the governing
board to approve the types of experimental or nonconventional medical
treatments that may be provided at the hospital on an inpatient or
outpatient basis.
(c) The medical licensing board shall develop protocols for medical
treatments that are provided in a setting other than the inpatient or
outpatient hospital setting specified in subsection (b). A physician who
fails to comply with a protocol developed under this subsection shall
be subject to discipline by the medical licensing board.
(d) This section does not require any person or organization to
provide an individual with access to a medical treatment not otherwise
commercially available to that individual.
(e) This section does not require:
(1) an insurer;
(2) a fraternal benefit society;
(3) a nonprofit corporation;
(4) a health maintenance organization (as defined in IC 27-13-1-19);
(5) a preferred provider arrangement under IC 27-8-11; or
(6) a limited service health maintenance organization (as defined
in IC 27-13-34-4);
to provide coverage or make payment beyond the terms and conditions
of the contract for medical treatment authorized under this section.
(f) This section does not create a cause of action against a health
care provider involved in connection with the use of an investigational
drug, biological product, or device by a patient for any harm to the
patient from the investigational drug, biological product, or device.

Legislative History

As added by P.L.44-1998, SEC.2. Amended by P.L.49-1999, SEC.1; P.L.2-2015, SEC.4.