The following words and terms, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise.

1. (1) Adverse determination--A determination by a utilization review agent made on behalf of any payor that the health care services provided or proposed to be provided to a patient are not medically necessary or appropriate, or are experimental or investigational.
2. (2) Affiliate--A person who directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with the person specified.

3. (3) Best evidence--Evidence based on:

   1. (A) randomized clinical trials;
   2. (B) if randomized clinical trials are not available, cohort studies or case-control studies;
   3. (C) if subparagraphs (A) and (B) are not available, case-series; or
   4. (D) if subparagraphs (A), (B) and (C) are not available, expert opinion.
4. (4) Case-control studies--A retrospective evaluation of two groups of patients with different outcomes to determine which specific interventions the patients received.
5. (5) Case-series--An evaluation of a series of patients with a particular outcome, without the use of a control group.
6. (6) Cohort studies--A prospective evaluation of two groups of patients with only one group of patients receiving a specific intervention(s).
7. (7) Commissioner--The Commissioner of Insurance.
8. (8) Department--Texas Department of Insurance.
9. (9) Dentist--A licensed doctor of dentistry holding either a D.D.S. or a D.M.D. degree.
10. (10) Evidence-based medicine--The use of current best quality scientific and medical evidence formulated from credible scientific studies, including peer-reviewed medical literature and other current scientifically based texts, and treatment and practice guidelines in making decisions about the care of individual patients.
11. (11) Evidence-based standards--The conscientious, explicit, and judicious use of evidence-based medicine and the current best evidence based on the overall systematic review of the research in making decisions about the care of individual patients.
12. (12) Experimental or investigational--A service or device for which there is early, developing scientific or clinical evidence demonstrating the potential efficacy of the treatment, service, or device but that is not yet broadly accepted as the prevailing standard of care.
13. (13) Expert opinion--A belief or an interpretation by specialists with experience in a specific area about the scientific evidence pertaining to a particular service, intervention, or therapy.
14. (14) Health benefit plan--A plan of benefits that defines the coverage provisions for health care offered or provided by any organization, public or private, other than health insurance.

15. (15) Health care provider or provider--A person, corporation, facility, or institution that is:

    1. (A) licensed by a state to provide or otherwise lawfully providing health care services; and
    2. (B) eligible for independent reimbursement for those services.
16. (16) Health insurance policy--An insurance policy, including a policy written by a corporation subject to the Insurance Code Chapter 842, that provides coverage for medical or surgical expenses incurred as a result of accident or sickness.
17. (17) Independent review--A system for final administrative review by a designated independent review organization of an adverse determination regarding the medical necessity and appropriateness or the experimental or investigational nature of health care services.
18. (18) Independent review organization or IRO--An entity that is certified by the commissioner to conduct independent review under the authority of the Insurance Code Chapter 4202. Such entity must have the capacity for independent review of all specialty classifications and subspecialties thereof contained in the two tiered structure of specialty classifications set forth in §12.402 of this chapter (relating to Classification of Specialty).
19. (19) Independent review plan--The review criteria and review procedures of an independent review organization.

20. (20) Legal holiday--A holiday:

    1. (A) as provided in the Government Code §662.003(a), including New Year's Day; Martin Luther King, Jr. Day; Presidents' Day; Memorial Day; Independence Day; Labor Day; Veterans Day; Thanksgiving Day; and Christmas Day; and
    2. (B) as provided in §102.3(b) of this title, (relating to Computation of Time), the Friday after Thanksgiving Day; December 24th; and December 26th.
21. (21) Life-threatening condition--A disease or condition for which the likelihood of death is probable unless the course of the disease or condition is interrupted.

22. (22) Medical and scientific evidence--Evidence found in the following sources:

    1. (A) peer-reviewed scientific studies published in or accepted for publication by medical journals that meet nationally recognized requirements for scientific manuscripts and that submit most of their published articles for review by experts who are not part of the editorial staff;
    2. (B) peer-reviewed medical literature, including literature relating to therapies reviewed and approved by a qualified institutional review board, biomedical compendia and other medical literature that meet the criteria of the National Institute of Health's National Library of Medicine for indexing in Index Medicus (Medline) and Elsevier Science Ltd. for indexing in Excerpt--Medicus (EMBASE);
    3. (C) medical journals recognized by the Secretary of Health and Human Services, pursuant to Section 1861(t)(2) of the federal Social Security Act;

    4. (D) the following standard reference compendia:

       1. (i) the American Hospital Formulary Service Drug Information;
       2. (ii) Drug Facts and Comparisons, current edition as published by Lippincott Williams & Wilkins;
       3. (iii) the American Dental Association Accepted Dental Therapeutics; and
       4. (iv) the United States Pharmacopoeia--Drug Information;

    5. (E) findings, studies, or research conducted by or under the auspices of federal government agencies and nationally recognized federal research institutes including:

       1. (i) the Federal Agency for Healthcare Research and Quality;
       2. (ii) the National Institutes of Health;
       3. (iii) the National Cancer Institute;
       4. (iv) the National Academy of Sciences;
       5. (v) the Centers for Medicare & Medicaid Services;
       6. (vi) the federal Food and Drug Administration; and
       7. (vii) any national board recognized by the National Institutes of Health for the purpose of evaluating the medical value of health care services;
    6. (F) peer-reviewed abstracts accepted for presentation at major medical association meetings;
    7. (G) for independent review of adverse determinations of health care provided pursuant to the Labor Code Title 5, the treatment guidelines, treatment protocols, and pharmacy closed formulary as provided in applicable orders issued or rules adopted by the TDI-DWC pursuant to the Labor Code §408.028 and §413.011, including Chapter 134 of this title (relating to Benefits--Guidelines for Medical Services, Charges, and Payments) and Chapter 137 of this title (relating to Disability Management); or
    8. (H) any other medical or scientific evidence that is comparable to the sources listed in subparagraphs (A) - (F) of this paragraph.
23. (23) Nurse--A registered or professional nurse, a licensed vocational nurse, or a licensed practical nurse.
24. (24) Patient--The enrollee or an eligible dependent of the enrollee under a health benefit plan or health insurance policy, or an injured employee entitled to receive workers' compensation benefits pursuant to the Labor Code Title 5.

25. (25) Payor--

    1. (A) an insurer that writes health insurance policies;
    2. (B) a preferred provider organization, health maintenance organization, or self-insurance plan; or
    3. (C) any other person or entity that provides, offers to provide, or administers hospital, outpatient, medical, or other health benefits, including workers' compensation benefits as provided under the Insurance Code §4201.054, to persons treated by a health care provider in this state under a policy, plan, or contract.
26. (26) Person--An individual, corporation, partnership, association, joint stock company, trust, unincorporated organization, any similar entity, or any combination of the foregoing acting in concert.
27. (27) Physician--A licensed doctor of medicine or a doctor of osteopathy.
28. (28) Primary office--The place where, based upon the totality of the business activities related to independent review performed under this chapter, an independent review organization's books and records pertaining to independent reviews assigned by the Department are stored.
29. (29) Provider of record--The physician or other health care provider that has primary responsibility for the care, treatment, and services rendered or requested on behalf of the patient; or the physician or health care provider that has rendered or has been requested to provide the care, treatment, or services to the patient. This definition includes any health care facility where treatment is rendered on an inpatient or outpatient basis.
30. (30) Randomized clinical trial--A controlled, prospective study of patients that have been randomized into an experimental group and a control group at the beginning of the study with only the experimental group of patients receiving a specific intervention, which includes study of the groups for variables and anticipated outcomes over time.
31. (31) Review criteria--The written policies, medical protocols, previous decisions and/or guidelines used by the independent review organization to make decisions about the medical necessity or appropriateness of a treatment, procedure, or service or the experimental or investigational nature of a treatment, procedure, or service.
32. (32) TDI-DWC--The Texas Department of Insurance, Division of Workers' Compensation.
33. (33) Utilization review agent--A person holding a certificate under the Insurance Code Chapter 4201.
34. (34) Working day--A weekday that is not a legal holiday.

Source Note:The provisions of this §12.5 adopted to be effective November 26, 1997, 22 TexReg 11363; amended to be effective December 26, 2010, 35 TexReg 11281.