28 Tex. Admin. Code § 12.5 - Definitions
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
(H) any other medical or scientific evidence
that is comparable to the sources listed in subparagraphs (A) - (F) of this
paragraph.
(26) Nurse--A
registered or professional nurse, a licensed vocational nurse, or a licensed
practical nurse.
(27) 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 under Labor Code Title 5.
(28) Payor--
(A) an insurer that writes health insurance
policies;
(B) a preferred provider
organization, health maintenance organization, or self-insurance plan;
or
(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 Insurance Code §
4201.054, to persons
treated by a health care provider in this state under a policy, plan, or
contract.
(29)
Person--An individual, corporation, partnership, association, joint-stock
company, trust, unincorporated organization, any similar entity, or any
combination acting in concert.
(30)
Physical address--Location of the IRO's primary office where personnel are
reasonably available by telephone at least 40 hours per week during normal
business hours in both Central and Mountain time zones to discuss or respond to
requests for independent review.
(31) Physician--A licensed doctor of medicine
or a doctor of osteopathy.
(32)
Primary office--The place where an IRO maintains its physical address in Texas,
and where its books and records about independent reviews assigned by the
department are maintained and accessible.
(33) 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.
(34)
Randomized clinical trial--A controlled, prospective study of patients who 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.
(35) Review
criteria--The written policies, medical protocols, previous decisions, and
guidelines used by the IRO 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.
(36) TDI-DWC--The Texas Department of
Insurance, Division of Workers' Compensation.
(37) Utilization review agent--A person
holding a certificate under Insurance Code Chapter 4201.
(38) Working day--A weekday that is not a
legal holiday.
Notes
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