The following words and terms, when used in this subchapter,
have the following meanings, unless the context clearly indicates
otherwise:
(1) Brand name drug--A drug marketed under a proprietary,
trademark-protected name.
(2) Certified workers' compensation health care network
(certified network)--An organization that is certified in accordance
with Insurance Code Chapter 1305 and department rules.
(3) Closed formulary--All available Food and Drug Administration
(FDA) approved prescription and nonprescription drugs prescribed and
dispensed for outpatient use, but excludes:
(A) drugs identified with a status of "N" in the current
edition of the Official Disability Guidelines
Treatment in Workers' Comp (ODG) / Appendix A, ODG Workers' Compensation Drug Formulary, and
any updates;
(B) any prescription drug created through compounding
prescribed before July 1, 2018 that contains a drug identified with
a status of "N" in the current edition of the ODG
Treatment in Workers' Comp (ODG) / Appendix A, ODG Workers' Compensation Drug Formulary, and
any updates;
(C) any prescription drug created through compounding
prescribed and dispensed on or after July 1, 2018; and
(D) any investigational or experimental drug for which
there is early, developing scientific or clinical evidence demonstrating
the potential efficacy of the treatment, but which is not yet broadly
accepted as the prevailing standard of care as defined in Labor Code §413.014(a).
(4) Compounding--As defined under Occupations Code §551.003(9),
the preparation, mixing, assembling, packaging, or labeling of a drug
or device:
(A) as the result of a practitioner's prescription
drug order based on the practitioner-patient-pharmacist relationship
in the course of professional practice;
(B) for administration to a patient by a practitioner
as the result of a practitioner's initiative based on the practitioner-patient-pharmacist
relationship in the course of professional practice;
(C) in anticipation of a prescription drug order based
on a routine, regularly observed prescribing pattern; or
(D) for or as an incident to research, teaching, or
chemical analysis and not for selling or dispensing, except as allowed
under Occupations Code §562.154 or Occupations Code Chapter 563.
(5) Generic--See generically equivalent in definition
of paragraph (6) of this section.
(6) Generically equivalent--As defined under Occupations
Code §562.001, a drug that, when compared to the prescribed drug,
is:
(A) pharmaceutically equivalent--Drug products that
have identical amounts of the same active chemical ingredients in
the same dosage form and that meet the identical compendia or other
applicable standards of strength, quality, and purity according to
the United States Pharmacopoeia or another nationally recognized compendium;
and
(B) therapeutically equivalent--Pharmaceutically equivalent
drug products that, if administered in the same amounts, will provide
the same therapeutic effect, identical in duration and intensity.
(7) Medical emergency--The sudden onset of a medical
condition manifested by acute symptoms of sufficient severity, including
severe pain that in the absence of immediate medical attention could
reasonably be expected to result in:
(A) placing the patient's health or bodily functions
in serious jeopardy; or
(B) serious dysfunction of any body organ or part.
(8) Nonprescription drug or over-the-counter medication--A
non-narcotic drug that may be sold without a prescription and that
is labeled and packaged in compliance with state or federal law.
(9) Open formulary--Includes all available Food and
Drug Administration (FDA) approved prescription and nonprescription
drugs prescribed and dispensed for outpatient use, but does not include
drugs that lack FDA approval, or non-drug items.
(10) Prescribing doctor--A physician or dentist who
prescribes prescription drugs or over the counter medications in accordance
with the physician's or dentist's license and state and federal laws
and rules. For purposes of this chapter, prescribing doctor includes
an advanced practice nurse or physician assistant to whom a physician
has delegated the authority to carry out or sign prescription drug
orders, under Occupations Code Chapter 157, who prescribes prescription
drugs or over the counter medication under the physician's supervision
and in accordance with the health care practitioner's license and
state and federal laws and rules.
(11) Prescription--An order for a prescription or nonprescription
drug to be dispensed.
(12) Prescription drug--
(A) A substance for which federal or state law requires
a prescription before the substance may be legally dispensed to the
public;
(B) A drug that under federal law is required, before
being dispensed or delivered, to be labeled with the statement: "Caution:
federal law prohibits dispensing without prescription;" "Rx only;"
or another legend that complies with federal law; or
(C) A drug that is required by federal or state statute
or regulation to be dispensed on prescription or that is restricted
to use by a prescribing doctor only.
(13) Statement of medical necessity--A written statement
from the prescribing doctor to establish the need for treatments or
services, or prescriptions, including the need for a brand name drug
where applicable. A statement of medical necessity shall include:
(A) the injured employee's full name;
(B) date of injury;
(C) social security number;
(D) diagnosis code(s);
(E) whether the drug has previously been prescribed
and dispensed, if known, and whether the inability to obtain the drug
poses an unreasonable risk of a medical emergency; and
(F) how the prescription treats the diagnosis, promotes
recovery, or enhances the ability of the injured employee to return
to or retain employment.
(14) Substitution--As defined under Occupations Code §551.003(41),
the dispensing of a drug or a brand of drug other than the drug or
brand of drug ordered or prescribed.
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| Source Note: The provisions of this §134.500 adopted to be effective January 3, 2002, 26 TexReg 10970; amended to be effective January 17, 2011, 35 TexReg 11344; amended to be effective April 22, 2018, 43 TexReg 2275 |
