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.

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