Current through Register Vol. 63, No. 9, September 1, 2024
(1) The
Board may examine any diagnostic and/or therapeutic examination, test,
substance, device or procedure (ETSDP) to determine its acceptability for
patient care. The Board may require a chiropractic physician to provide
information on any ETSDP for determination of its status, taking into account
all relevant factors and practices, including, but not limited to: the
practices generally and currently followed and accepted by persons licensed to
practice chiropractic in the state, the teachings at chiropractic schools
accredited by the Council on Chiropractic Education or its successor, relevant
technical reports published in recognized journals, and the desirability of
reasonable experimentation in the furtherance of the chiropractic arts and
sciences.
(2) A chiropractic
physician may use any diagnostic and/or therapeutic ETSDP which is considered
standard. A standard diagnostic and/or therapeutic ETSDP is one in which one or
more of the following criteria have been satisfied:
(a) Is taught or has been taught by a
chiropractic school accredited by the Council on Chiropractic Education or its
successor, or health professions' courses taught by regionally accredited
colleges with subject matter that is within the scope of chiropractic practice
and has not been disapproved by the Board; or
(b) Has been approved by the Board through
the petition process:
(A) The petition
requires a formalized agreement of 10% or more of the chiropractic physicians,
holding an active chiropractic license in Oregon, attesting to the safety and
efficacy of a particular ETSDP. The petition shall be submitted in writing to
the Board by any party wishing to establish any ETSDP as standard. It is the
responsibility of the petitioner to gather the required evidence and supporting
statements. It is the sole responsibility and discretion of the Board to review
the sufficiency of the evidence in the petition and to make a determination
whether to concur and affirm the ETSDP as standard or to deny the petition. The
Board may, but is not required to, hold a public hearing on any petition. The
Board shall make its determination and reply to the petitioner within 180 days
of receipt of the petition unless the Board and the petitioner mutually agree
to extend the deadline.
(B) The
petition shall specifically address the following issues:
(i) The kind of ETSDP that is the subject of
the petition, i.e., whether it is an examination, a test, a substance, a
device, a procedure, or a combination thereof;
(ii) A detailed description of the proposed
ETSDP;
(iii) The clinical
justification for the ETSDP;
(iv) A
method for determining appropriate termination of care and/or consultation with
other providers with special skills/knowledge for the welfare of the
patient;
(v) Whether the proposed
ETSDP is to be used by itself or used in addition to any other generally
accepted or standard ETSDP;
(vi) A
description of known or anticipated contraindications, risks, and
benefits;
(vii) A description of
any subpopulations for which greater risk or benefit is expected;
(viii) A description of any standard ETSDP
for the equivalent condition together with its relative risks and benefits;
and
(ix) An assessment of the
expected consequences of withholding the proposed ETSDP.
(c) Is supported by adequate
evidence of clinical efficacy as determined by the Board. In determining
adequacy, the Board may consider whether the ETSDP:
(A) Has clinical justification;
(B) Has valid outcome assessment
measures;
(C) Is supported in peer
reviewed literature;
(D) Is
consistent with generally recognized contraindications to chiropractic
procedures; and
(E) The potential
benefit outweighs the potential risk to the patient.
(3) A chiropractic physician may
use any diagnostic and/or therapeutic ETSDP that has not met the criteria of
subsections (2)(a) - (c) of this rule as investigational. It must show
potential merit for effectiveness and be of acceptable risk. Documentation
requirements are based on potential risk to the patient. All investigational
diagnostic ETSDPs must include or be accompanied by standard diagnostic
procedures until full Board approval is attained under the criteria cited in
subsections (2)(a) - (c) of this rule. Nothing in this section is intended to
interfere with the right of any patient to refuse standard or investigational
ETSDPs. In determining risk, the Board may use the following criteria:
(a) For minimal risk procedures, defined as
those which, when properly or improperly performed on the general population,
would have a slight chance of a slight injury and, when properly performed on
select populations, have an extremely remote chance of serious injury:
(A) Informed consent is suggested but not
required; and
(B) The chiropractic
physician is recommended, but not required, to participate in or conduct a
formal investigation of the procedure.
(b) For low risk procedures, defined as those
which, when properly performed on the general population have a slight chance
of mild injury; when improperly performed on the general population have a mild
chance of mild to moderate injury, and when properly performed on select
populations have a remote chance of serious injury:
(A) Informed consent is required;
and
(B) The chiropractic physician
is recommended, but not required, to participate or conduct a formal
investigation of the procedure.
(c) For moderate risk procedures, defined as
those which, when properly performed on the general public have a significant
chance of mild injury and a slight chance of moderate injury; when improperly
performed on the general population have a slight chance of severe injury; and
when properly performed on select populations have a slight chance of serious
injury:
(A) Written informed consent is
required; and
(B) The chiropractic
physician is recommended, but not required, to participate or conduct a formal
investigation of the procedure.
(d) For high risk procedures, those which,
when properly performed on the general population have a significant chance of
moderate injury and a slight chance of serious injury; when improperly
performed on the general population have a significant chance of serious
injury; and when properly performed on select populations have a significant
chance of serious injury:
(A) Written informed
consent is required; and
(B) The
chiropractic physician is required to participate in or conduct a formal
investigation of the procedure under the auspices of, or in conjunction with,
any other health care professionals knowledgeable and competent in the care and
treatment of potential serious injuries.
(e) Board approval is required of all
moderate or high risk procedures.
(4) The Board shall maintain a list of ETSDPs
which have been reviewed and have been determined to be unacceptable or
approved as investigational.
(5) A
chiropractic physician may not use any diagnostic and/or therapeutic ETSDPs
which have been determined by the Board to be unacceptable.
