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.
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| 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 |
