The following words and terms, when used in this chapter, will
have the following meanings unless the context clearly indicates otherwise.
(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) 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) Best evidence--Evidence based on:
(A) randomized clinical trials;
(B) if randomized clinical trials are not available,
cohort studies or case-control studies;
(C) if subparagraphs (A) and (B)of this paragraph
are not available, case-series; or
(D) if subparagraphs (A), (B), and (C) of this paragraph
are not available, expert opinion.
(4) Biographical affidavit--National Association of
Insurance Commissioners biographical affidavit to be used as an attachment
to the IRO application form.
(5) Case-control studies--A retrospective evaluation
of two groups of patients with different outcomes to determine which
specific interventions the patients received.
(6) Case Series--An evaluation of a series of patients
with a particular outcome, without the use of a control group.
(7) Cohort studies--A prospective evaluation of two
groups of patients with only one group of patients receiving a specific
intervention(s).
(8) Commissioner--The commissioner of insurance or
designee.
(9) Control--The power to direct, or cause the direction
of, the management and policies of a person, other than power that
results from an official position with or corporate office held by
the person. The power may be possessed directly or indirectly by any
means, including through the ownership of voting securities or by
contract, other than a commercial contract for goods or nonmanagement
services. A person controls another if the person possesses the power
described above with regard to the other person. The commissioner
presumes control to exist if any person, directly or indirectly, or
with members of the person's immediate family, owns, controls, or
holds the power to vote, or if any person other than a corporate officer
or director of a person holds proxies representing 10 percent or more
of the voting securities or authority of any other person. A person
may rebut the presumption by showing that control does not exist in
fact. The commissioner may determine that control exists in fact,
despite the absence of a presumption to that effect, where a person
exercises, either alone or under an agreement with one or more persons,
such a controlling influence over the management or policies of an
IRO as to make it necessary or appropriate in the public interest
that the person be deemed to control the IRO.
(10) Department--Texas Department of Insurance.
(11) Dentist--A licensed doctor of dentistry holding
either a D.D.S. or a D.M.D. degree.
(12) 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.
(13) 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.
(14) 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 not yet broadly accepted as the prevailing standard
of care.
(15) Expert opinion--A belief or an interpretation
by a specialist with experience in a specific area about the scientific
evidence on a particular service, intervention, or therapy.
(16) 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.
(17) Health care provider or provider--A person, corporation,
facility, or institution that is:
(A) licensed by a state to provide or otherwise lawfully
providing health care services; and
(B) eligible for independent reimbursement for those
services.
(18) Health insurance policy--An insurance policy,
including a policy written by a corporation subject to Insurance Code
Chapter 842, that provides coverage for medical or surgical expenses
incurred as a result of accident or sickness.
(19) Independent review--A system for final administrative
review by a designated IRO of an adverse determination regarding the
medical necessity and appropriateness or the experimental or investigational
nature of health care services.
(20) Independent review organization or IRO--An entity
that is granted a certificate of registration by the commissioner
to conduct independent reviews under the authority of Insurance Code
Chapter 4202. An IRO must have the capacity for independent review
of all specialty classifications and subspecialties contained in the
two-tiered structure of specialty classifications set out in §12.402
of this chapter.
(21) Independent review plan--The review criteria and
review procedures.
(22) IRO application form--A form for an original application
for, renewal of, or reporting a material change to a certificate of
registration as an IRO in this state.
(23) Legal holiday--A holiday:
(A) as provided in Government Code §662.003(a),
includes 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
(B) as provided in §102.3(b) of this title.
(24) 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.
(25) Medical and scientific evidence--Evidence found
in the following sources:
(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;
(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);
(C) medical journals recognized by the Secretary of
Health and Human Services, under Section 1861(t)(2) of the federal
Social Security Act;
(D) the following standard reference compendia:
(i) the American Hospital Formulary Service Drug Information;
(ii) Drug Facts and Comparisons, current edition as
published by Lippincott Williams & Wilkins;
(iii) the American Dental Association Accepted Dental
Therapeutics; and
(iv) the United States Pharmacopoeia--Drug Information;
(E) findings, studies, or research conducted by or
under the auspices of federal government agencies and nationally recognized
federal research institutes including:
(i) the federal Agency for Healthcare Research and
Quality;
(ii) the National Institutes of Health;
(iii) the National Cancer Institute;
(iv) the National Academy of Sciences;
(v) the Centers for Medicare & Medicaid Services;
(vi) the federal Food and Drug Administration; and
(vii) any national board recognized by the National
Institutes of Health for the purpose of evaluating the medical value
of health care services;
(F) peer-reviewed abstracts accepted for presentation
at major medical association meetings;
(G) for independent review of adverse determinations
of health care provided under 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 under Labor
Code §408.028 and §413.011, including Chapter 134 of this
title and Chapter 137 of this title; or
Cont'd... |
