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RULE §195.3Inspections

(a) The board may conduct inspections to enforce these rules, including inspections of a pain management clinic and documents and records of a physician(s) and mid-level practitioner(s) practicing at such a clinic, as set out in subsections (b) and (c) of this section.

(b) The board may inspect a pain management clinic certified under this chapter, including the documents of a physician practicing at the clinic, to determine if the clinic is being operated in compliance with applicable laws and rules. If violations of the Medical Practice Act or board rules are found during an inspection, the board may bring an enforcement action for such violations. The board may utilize the services of another state or local agency, as needed, in carrying out inspections under this section.

(c) The board may inspect a clinic or facility that is not certified under this chapter, including the documents of a physician practicing at the clinic or facility, to determine whether the clinic or facility is required to be certified under §168.101 of the Medical Practice Act. After an inspection, the Board may bring a disciplinary action for failure to certify the clinic as required by Chapter 168 of the medical practice act and board rules. In addition, to certification violations, if any, the Board may bring a disciplinary action for any other violation of the Medical Practice Act or board rules found during the inspection.

(d) The following criteria will be reviewed and evaluated in determining whether an inspection of a clinic or facility pursuant to subsection (c) of this section should be conducted. If, after evaluation of the criteria described below, the board reasonably believes that a clinic or facility has not been properly certified under §168.101 of the Act, the board may inspect such clinic or facility.

  (1) the patient population of a clinic or facility includes multiple patients from outside the geographical area of service for which the clinic or facility provides service, based on a review of the Texas Prescription Monitoring Program (PMP) reports;

  (2) the patient population of the clinic or facility includes several patients at the same address who are all being treated for chronic pain;

  (3) data from the PMP indicating that the volume of prescribing of a physician, or mid-level provider(s )supervised by the physician at a clinic or facility, who has not been subject to an inspection under subsection (c) in the previous 12 months, places them in the top 50 prescribers in the state at any time in the preceding 12 months for prescriptions of opioids, benzodiazepines, barbiturates, or carisoprodol, excluding prescribers at certified pain management clinics, clinics or facilities engaged in treating cancer patients, and certified hospice facilities;

  (4) information from the PMP that a physician or mid-evel provider(s) supervised by the physician is prescribing to multiple patients, opioids in combination with one, or all of the following: benzodiazepines, barbiturates, or carisoprodol in a clinic or facility;

  (5) complaints and/or information, from non-anonymous complainants related to inappropriate prescribing practices, including those from law enforcement agencies or health care regulators, regarding a clinic or facility, or a physician or midlevel provider(s) supervised by the physician, working at the clinic or facility;

  (6) A patient overdose death related to controlled substances opioids, benzodiazepines, barbiturates, or carisoprodol, prescribed by a specific physician or a physician's mid-level provider(s);

  (7) arrest of a physician or a mid-level provider related to improper or fraudulent prescribing of controlled substances;

  (8) information developed during the course of a board investigation of a physician or a physician's mid-level provider indicating that the physician or mid-level provider is prescribing to a majority of patients opioids, benzodiazepines, barbiturates, or carisprodol in a clinic or facility.

(e) Unless it would jeopardize an ongoing investigation, the board shall provide at least five business days' notice before conducting an on-site inspection under subsection (b) of this section.

(f) When inspecting clinics or facilities that are not certified, the board may utilize a subpoena instanter requiring immediate production, inspection and copying of medical and billing records. Board staff will consult with the board's medical director prior to utilizing a subpoena instanter. If immediate production is not made in compliance with the subpoena, the board, acting through the attorney general, may file suit to enforce the subpoena in a district court in Travis County.

(g) This section does not require the board to make an on-site inspection of a physician's office.

(h) The board shall conduct inspections of pain management clinics certified under this chapter if the board suspects that the ownership or physician supervision is not in compliance with board rules.

Source Note: The provisions of this §195.3 adopted to be effective May 2, 2010, 35 TexReg 3281; amended to be effective February 18, 2018, 43 TexReg 768

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