A licensed physician shall not be found guilty of unprofessional
conduct or be found to have committed professional failure to practice
medicine in an acceptable manner solely on the basis of employing
a health care method of complementary or alternative medicine, unless
it can be demonstrated that such method has a safety risk for the
patient that is unreasonably greater than the conventional treatment
for the patient's medical condition. The Texas Medical Board will
use the following guidelines to determine whether a physician's conduct
violates the Medical Practice Act, §§164.051 - .053 in regard
to providing complementary and alternative medical treatment.
(1) Patient Assessment. Prior to offering advice about
complementary and alternative health care therapies, the physician
shall undertake an assessment of the patient. This assessment should
include but not be limited to, conventional methods of diagnosis and
may include non-conventional methods of diagnosis. Such assessment
shall be documented in the patient's medical record and be based on
performance and review of the following listed in subparagraphs (A)
- (D) of this paragraph:
(A) an appropriate medical history and physician examination
of the patient;
(B) the conventional medical treatment options to be
discussed with the patient and referral input, if necessary;
(C) any prior conventional medical treatments attempted
and the outcomes obtained or whether conventional options have been
refused by the patient;
(D) whether the complementary health care therapy could
interfere with any other recommended or ongoing treatment.
(2) Disclosure. Prior to rendering any complementary
or alternative treatment, the physician shall provide information
to the patient that includes the following with the disclosure documented
in the patient's records:
(A) the objectives, expected outcomes, or goals of
the proposed treatment, such as functional improvement, pain relief,
or expected psychosocial benefit;
(B) the risks and benefits of the proposed treatment;
(C) the extent the proposed treatment could interfere
with any ongoing or recommended medical care;
(D) a description of the underlying therapeutic basis
or mechanism of action of the proposed treatment purporting to have
a reasonable potential for therapeutic gain that is written in a manner
understandable to the patient; and
(E) if applicable, whether a drug, supplement, or remedy
employed in the treatment is:
(i) approved for human use by the U.S. Food and Drug
Administration (FDA);
(ii) exempt from FDA preapproval under the Dietary
Supplement and Health Education Act (DSHEA); or
(iii) a pharmaceutical compound not commercially available
and, therefore, is also an investigation article subject to clinical
investigation standards as discussed in paragraph (7) of this section.
(3) Treatment Plan.
(A) The physician may offer the patient complementary
or alternative treatment pursuant to a documented treatment plan tailored
for the individual needs of the patient by which treatment progress
or success can be evaluated with stated objectives such as pain relief
and/or improved physical and/or psychosocial function. Such a documented
treatment plan shall consider pertinent medical history, previous
medical records and physical examination, as well as the need for
further testing, consultations, referrals, or the use of other treatment
modalities.
(B) The treatment offered should:
(i) have a favorable risk/benefit ratio compared to
other treatments for the same condition;
(ii) be based upon a reasonable expectation that it
will result in a favorable patient outcome, including preventive practices;
and
(iii) be based upon the expectation that a greater
benefit for the same condition will be achieved than what can be expected
with no treatment.
(4) Periodic Review of Treatment. The physician may
use the treatment subject to documented periodic review of the patient's
care by the physician at reasonable intervals. The physician shall
evaluate the patient's progress under the treatment prescribed, ordered
or administered, as well as any new information about etiology of
the complaint in determining whether treatment objectives are being
adequately met.
(5) Adequate Medical Records. In addition to those
elements addressed in paragraph (1)(A) - (D) of this section, a physician
implementing complementary and alternative therapies shall keep accurate
and complete medical records to include:
(A) any diagnostic, therapeutic and laboratory results;
(B) the results of evaluations, consultations and referrals;
(C) treatments employed and their progress toward the
stated objectives, expected outcomes, and goals of the treatment;
(D) the date, type, dosage, and quantity prescribed
of any drug, supplement, or remedy used in the treatment plan;
(E) all patient instructions and agreements;
(F) periodic reviews;
(G) documentation of any communications with the patient's
concurrent healthcare providers informing them of treatment plans.
(6) Therapeutic Validity. All physicians must be able
to demonstrate the medical, scientific, or other theoretical principles
connected with any healthcare method offered and provided to patients.
(7) Clinical Investigations. Physicians using conventional
medical practices or providing complementary and alternative medicine
treatment while engaged in the clinical investigation of new drugs
and procedures (a.k.a. medical research, research studies) are obligated
to maintain their ethical and professional responsibilities. Physicians
shall be expected to conform to the following ethical standards:
(A) Clinical investigations, medical research, or clinical
studies shall be part of a systematic program competently designed,
under accepted standards of scientific research, to produce data that
are scientifically valid and significant;
(B) A clinical investigator shall demonstrate the same
concern and caution for the welfare, safety and comfort of the patient
involved as is required of a physician who is furnishing medical care
to a patient independent of any clinical investigation; and
(C) A clinical investigator shall have patients sign
informed consent forms that are compliant with federal regulations,
if applicable, and that indicate that the patients understand that
they are participating in a clinical trial or investigational research.
(8) If the provisions set out in paragraphs (1) - (5)
of this section are met, and if all treatment is properly documented,
the board will presume such practices are in conformity with the Medical
Practice Act, §§164.051 - .053.
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Source Note: The provisions of this §200.3 adopted to be effective November 22, 1998, 23 TexReg 11653; amended to be effective June 29, 2003, 28 TexReg 4635; amended to be effective March 15, 2016, 41 TexReg 1840; amended to be effective September 26, 2016, 41 TexReg 7485 |