A physician's treatment of a patient's pain will be evaluated by considering whether it meets the generally accepted standard of care and whether the following minimum requirements have been met:

(1) Evaluation of the patient. (A) A physician is responsible for obtaining a medical history and a physical examination that includes a problem-focused exam specific to the chief presenting complaint of the patient. (B) The medical record shall document the medical history and physical examination. In the case of chronic pain, the medical record must document: (i) the nature and intensity of the pain; (ii) current and past treatments for pain; (iii) underlying or coexisting diseases and conditions; (iv) the effect of the pain on physical and psychological function; (v) any history and potential for substance abuse or diversion; and (vi) the presence of one or more recognized medical indications for the use of a dangerous or scheduled drug. (C) Prior to prescribing opioids, benzodiazepines, barbiturates, or carisoprodol for the treatment of chronic pain, a physician must review prescription data and history related to the patient, if any, contained in the Prescription Drug Monitoring Program in accordance with Section 481.0764 of the Texas Health and Safety Code and §170.9 of this Chapter (relating to Prescription Monitoring Program Check). In addition, a physician must consider obtaining at a minimum a baseline toxicology drug screen to determine the presence of drugs in a patient, if any. If a physician determines that a baseline toxicology drug screen is not necessary, the physician must document in the medical record his or her rationale for not requiring the screen.

(2) Treatment plan for chronic pain. The physician is responsible for a written treatment plan that is documented in the medical records. The medical record must include: (A) how the medication relates to the chief presenting complaint of chronic pain; (B) dosage and frequency of any drugs prescribed; (C) further testing and diagnostic evaluations to be ordered, if medically indicated; (D) other treatments that are planned or considered; (E) periodic reviews planned; and (F) objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function.

(3) Informed consent. It is the physician's responsibility to discuss the risks and benefits of the use of controlled substances for the treatment of chronic pain with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is without medical decision-making capacity. This discussion must be documented by either a written signed document maintained in the records or a contemporaneous notation included in the medical records. Discussion of risks and benefits must include an explanation of the: (A) diagnosis; (B) treatment plan; (C) anticipated therapeutic results, including the realistic expectations for sustained pain relief and improved functioning and possibilities for lack of pain relief; (D) therapies in addition to or instead of drug therapy, including physical therapy or psychological techniques; (E) potential side effects and how to manage them; (F) adverse effects, including the potential for dependence, addiction, tolerance, and withdrawal; and (G) potential for impairment of judgment and motor skills.

(4) Agreement for treatment of chronic pain. A proper patient-physician relationship for treatment of chronic pain requires the physician to establish and inform the patient of the physician's expectations that are necessary for patient compliance. If the treatment plan includes extended drug therapy, the physician must use a written pain management agreement between the physician and the patient outlining patient responsibilities, including the following provisions: (A) the physician may require laboratory tests for drug levels upon request; (B) the physician may limit the number and frequency of prescription refills; (C) only the primary pain management physician or another physician covering for the primary pain management physician in compliance with Chapter 177, Subchapter E of this title (relating to Physician Call Coverage Medical Services), may prescribe dangerous and scheduled drugs for the treatment of chronic pain. For any prescriptions issued for medications to treat acute or chronic pain by a person other than the primary pain management physician or covering physician, the terms of the agreement must require that at or before the patient's next date of service, the patient notify the primary pain management physician or covering physician about the prescription(s) issued. The terms of the agreement must require that such notice include at a minimum the name and contact information for the person who issued the prescription, the date of the prescription, and the name and quantity of the drug prescribed; (D) only one pharmacy designated by the patient will be used for prescriptions for the treatment of chronic pain, with an exception for those circumstances for which the patient has no control or responsibility, that prevent the patient from obtaining prescribed medications at the designated pharmacy under the agreement. For such circumstances, the agreement's terms must require that at or before the patient's next date of service, the patient notify the primary pain management physician or covering physician of the circumstances and identify the pharmacy that dispensed the medication; and (E) reasons for which drug therapy may be discontinued (e.g. violation of agreement).

(5) Periodic review of the treatment of chronic pain. (A) The physician must see the patient for periodic review at reasonable intervals in view of the individual circumstances of the patient. (B) Periodic review must assess progress toward reaching treatment objectives, taking into consideration the history of medication usage, as well as any new information about the etiology of the pain. (C) Each periodic visit shall be documented in the medical records. (D) Contemporaneous to the periodic reviews, the physician must note in the medical records any adjustment in the treatment plan based on the individual medical needs of the patient. (E) A physician must base any continuation or modification of the use of dangerous and scheduled drugs for pain management on an evaluation of progress toward treatment objectives. (i) Progress or the lack of progress in relieving pain must be documented in the patient's record. (ii) Satisfactory response to treatment may be indicated by the patient's decreased pain, increased level of function, and/or improved quality of life. (iii) Objective evidence of improved or diminished function must be monitored. Information from family members or other caregivers, if offered or provided, must be considered in determining the patient's response to treatment. (iv) If the patient's progress is unsatisfactory, the physician must reassess the current treatment plan and consider the use of other therapeutic modalities. (v) The physician must periodically review the patient's compliance with the prescribed treatment plan and reevaluate for any potential for substance abuse or diversion. In such a review, the physician must consider obtaining at a minimum a toxicology drug screen to determine the presence of drugs in a patient, if any. If a physician determines that a repeat toxicology screen is not necessary, the physician must document in the medical record his or her rationale for not completing it.

(6) Consultation and Referral. The physician must refer a patient with chronic pain for further evaluation and treatment as necessary. Patients who are at-risk for abuse or addiction require special attention. Patients with chronic pain and histories of substance abuse or with co-morbid psychiatric disorders require even more care. A consult with or referral to an expert in the management of such patients must be considered in their treatment.

(7) Medical records. The medical records shall document the physician's rationale for the treatment plan and the prescription of drugs for the chief complaint of chronic pain and show that the physician has followed these rules. Specifically, the records must include: (A) the medical history and the physical examination; (B) diagnostic, therapeutic and laboratory results; (C) evaluations and consultations; (D) treatment objectives; (E) discussion of risks and benefits; (F) informed consent; (G) treatments; (H) medications (including date, type, dosage and quantity prescribed); (I) instructions and agreements; (J) periodic reviews; and (K) documentation of the mandatory PMP review.

Source Note: The provisions of this §170.3 adopted to be effective January 4, 2007, 31 TexReg 10798; amended to be effective August 4, 2015, 40 TexReg 4898; amended to be effective July 7, 2016, 41 TexReg 4824; amended to be effective July 13, 2020, 45 TexReg 4748