Independent review must be conducted under an independent review plan that is consistent with standards developed with input from appropriate health care providers, and reviewed and approved by the IRO's medical director. The independent review plan must include the following components:
  (1) a description of the elements of review that the IRO provides;
  (2) written procedures for:
    (A) notification of the IRO's determinations provided to the patient or a representative of the patient, the patient's provider of record, and the utilization review agent, under §12.206 of this chapter;
    (B) review, including:
      (i) any form used during the review process;
      (ii) time frames that must be met during the review;
    (C) accessing appropriate specialty review;
    (D) contacting and receiving information from health care providers under §12.205 of this chapter;
  (3) required use of written medically acceptable review criteria that are:
    (A) based on medical and scientific evidence and use evidence-based standards, or if evidence is not available, generally accepted standards of medical practice recognized in the medical community;
    (B) established and periodically evaluated and updated with appropriate involvement from physicians, including practicing physicians, and other health care providers;
    (C) objective, clinically valid, compatible with established principles of health care, and flexible enough to allow for deviations from the norms when justified on a case-by-case basis;
    (D) developed based on consideration of the treatment guidelines, treatment protocols, and the pharmacy closed formulary as provided in orders issued or rules adopted by TDI-DWC, including Chapter 134 and Chapter 137 of this title for health care provided under Labor Code Title 5;
    (E) used only as a tool in the review process; and
    (F) available for review, inspection, and copying as necessary by the commissioner or the commissioner's designated representative so the commissioner can carry out the commissioner's lawful duties under the Insurance Code;
  (4) independent review determinations that:
    (A) use review procedures that are established and periodically evaluated and updated with appropriate involvement from physicians, including practicing physicians, and other health care providers;
    (B) are made with medically accepted review criteria, taking into account the special circumstances of each case that may require a deviation from the norm; and
    (C) are made by physicians, dentists, or other health care providers, as appropriate.

Source Note: The provisions of this §12.201 adopted to be effective November 26, 1997, 22 TexReg 11363; amended to be effective December 26, 2010, 35 TexReg 11281; amended to be effective July 7, 2015, 40 TexReg 2538