The following words and terms, when used in §§21.3010 - 21.3011
of this subchapter (relating to off-label drugs) shall have the following
meanings, unless the context clearly indicates otherwise:
(1) Chronic illness--A disease, syndrome, or condition of expected
long duration, showing little change or slow progression.
(2) Contraindication--As defined in Insurance Code Article
21.53M.
(3) Disabling illness--A disease, syndrome, or condition determined
by an enrollee's health care practitioner to have caused or have the potential
to cause:
(A) a physical or mental impairment that substantially limits,
or may limit, one or more of the activities of daily living of the enrollee
including, but not limited to, eating, bathing, dressing, grooming, routine
hair and skin care, meal preparation, exercising, toileting, and transfer
and ambulation;
(B) an impairment substantially limiting an enrollee's cognitive
acuity;
(C) an impairment substantially limiting an enrollee's ability
to work, home-make, or engage in leisure or educational activities; or
(D) a condition regarded as an impairment by an enrollee's
licensed health care practitioner.
(4) Drug--As defined in the Texas Pharmacy Act, Occupations
Code §551.003.
(5) Enrollee--A person covered by a health benefit plan.
(6) Health benefit plan--As described in Insurance Code Article
21.53M. This term includes health benefit plans providing coverage for pharmacy
benefits only.
(7) Health care practitioner--An advanced practice nurse, doctor
of medicine, doctor of dentistry, physician assistant, doctor of osteopathy,
doctor of podiatry, or other licensed person with prescriptive authority.
(8) Impairment--Any loss or abnormality of psychological, physiological,
or anatomical structure or function.
(9) Indication--As defined in Insurance Code Article 21.53M.
(10) Issuer--Those entities identified in Insurance Code Article
21.53M, §2(a)(1)-(8).
(11) Life-threatening illness--A disease or condition for which
the likelihood of death is probable unless the course of the disease or condition
is interrupted.
(12) Off-label drug use--The use of a drug that is approved
by the Food and Drug Administration for the treatment of one medical condition,
but is used to treat another medical condition, or at different dosage forms,
dosage regimens, populations, or other parameters not mentioned in the approved
labeling.
(13) Peer-reviewed medical literature--A published scientific
study in a journal or other publication in which original manuscripts are
published only after they have been critically reviewed by unbiased independent
experts in the same field, for scientific accuracy, validity, and reliability,
and have been determined by the International Committee of Medical Journal
Editors to have met the Uniform Requirements for Manuscripts submitted to
biomedical journals. Peer-reviewed medical literature does not include publications
or supplements to publications that are sponsored to a significant extent
by a pharmaceutical manufacturing company or an issuer of a health benefit
plan.
(14) Standard drug reference compendia--
(A) The American Hospital Formulary Service-Drug Information;
or
(B) The United States Pharmacopoeia-Drug Information.
|
