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RULE §195.4Operation of Pain Management Clinics

(a) Purpose. The purpose of these rules is to identify the roles and responsibilities of physicians who own pain management clinics and to provide the minimum acceptable standards for such clinics.

(b) Exemptions. The rules promulgated under this title do not apply to the following settings:

  (1) a medical or dental school or an outpatient clinic associated with a medical or dental school;

  (2) a hospital, including any outpatient facility or clinic of a hospital;

  (3) a hospice established under 40 TAC §97.403 (relating to Standards Specific to Agencies Licensed to Provide Hospice Services) or defined by 42 CFR §418.3;

  (4) a facility maintained or operated by this state;

  (5) a clinic maintained or operated by the United States;

  (6) a nonprofit health organization certified by the board under Chapter 177 of this title (relating to Certification of Non-Profit Health Organizations);

  (7) a clinic owned or operated by a physician who treats patients within the physician's area of specialty and who personally uses other forms of treatment, including surgery, with the issuance of a prescription for a majority of the patients; or

  (8) a clinic owned or operated by an advanced practice nurse licensed in this state who treats patients in the nurse's area of specialty and who personally uses other forms of treatment with the issuance of a prescription for a majority of the patients.

(c) Ownership. A pain management clinic may not operate in Texas unless the clinic is owned and operated by a medical director who is a physician who practices in Texas, has an unrestricted medical license, and holds a certificate as described in §195.2 of this title (relating to Certification of Pain Management Clinics). A clinic may be owned by more than one physician licensed in Texas, but a non-physician may not hold any ownership interest.

(d) Operation of Clinic. The medical director of a pain management clinic must operate the clinic in compliance with Drug Prevention and Control Act, 21 U.S.C.A. 801 et. seq. and the Texas Controlled Substances Act, Chapter 481 of the Texas Health and Safety Code, relating to the prescribing and dispensing of controlled substances.

(e) Personnel and Physician Requirements. The medical director of a pain management clinic must, on an annual basis, ensure that all personnel are properly licensed, if applicable, and that all personnel and physicians complete at a minimum 10 hours of continuing medical education related to pain management, and qualified consistent with §195.2(b)(1) of this title.

(f) Standards to Ensure Quality of Patient Care. The medical director of a pain management clinic shall:

  (1) be on-site at the clinic at least 33 percent of the clinic's total number of operating hours;

  (2) review at least 33 percent of the total number of patient files of the clinic, including the patient files of a clinic employee or contractor to whom authority for patient care has been delegated by the clinic;

  (3) establish protocols consistent with Chapter 170 of this title (relating to Pain Management); and

  (4) establish quality assurance procedures to include at a minimum:

    (A) a practice quality plan that requires the medical director to complete as part of the 48 credits of CME completed every 24 months as a prerequisite for registration of the physician's permit, at least 10 hours of CME in the area of pain management from formal courses that are:

      (i) designated for AMA Category 1 credit by a CME sponsor accredited by the Accreditation Council for Continuing Medical Education or a state medical society recognized by the Committee for Review and Recognition of the Accreditation Council for Continuing Medical Education; or

      (ii) designated for AOA Category 1-A credit required for osteopathic physicians by an accredited CME sponsor approved by the American Osteopathic Association;

    (B) documentation of the background, training, and certifications for all clinical staff;

    (C) a written drug screening policy and compliance plan for patients receiving chronic opioids; and

    (D) performance of periodic quality measures of medical and procedural outcomes and complications that may include questionnaires or surveys for activities of daily living scores, pain scores, and standardized scales.

(g) Patient Billing Procedures.

  (1) The medical director of a pain management clinic must ensure that adequate billing records are maintained for all patients and made available to the board, upon request. Billing records shall include the amount paid, method of payment, and description of services.

  (2) Billing records shall be maintained for seven years from the date of last treatment of the patient.

Source Note: The provisions of this §195.4 adopted to be effective May 2, 2010, 35 TexReg 3281; amended to be effective June 28, 2011, 36 TexReg 3922; amended to be effective December 4, 2011, 36 TexReg 8033; amended to be effective January 23, 2014, 39 TexReg 298; amended to be effective July 2, 2020, 45 TexReg 4339

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