CHAPTER 134: BENEFITS – GUIDELINES FOR MEDICAL SERVICES,
CHARGES, AND PAYMENTS
Title
28 Texas Administrative Code (TAC) § 134.500, § 134.530 and § 134.540
§134.500. Definitions.
(a) 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 [any
compound 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]; and
(C) 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.
(b) This section will become effective for all
drugs that are prescribed and dispensed for outpatient use on or after MM/DD/YY
(intended to be a date certain approximately sixty days after the rule amendment
is finally adopted).
§134.530. Requirements for Use of the Closed Formulary for Claims Not Subject to
Certified Networks.
(a) Applicability.
The closed formulary applies to all drugs that are prescribed and dispensed for
outpatient use for claims not subject to a certified network on or after
September 1, 2011 when the date of injury occurred on or after September 1,
2011.
(b) Preauthorization
for claims subject to the Division's closed formulary.
(1) Preauthorization is only required for:
(A) drugs 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;
(B) any prescription drug created through compounding [any
compound 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]; and
(C) 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).
(2) When §134.600(p)(12) of this title (relating to Preauthorization,
Concurrent Review, and Voluntary Certification of Health Care) conflicts with
this section, this section prevails.
(c) Preauthorization
of intrathecal drug delivery systems.
(1) An intrathecal drug delivery system requires preauthorization in
accordance with §134.600 of this title and the preauthorization request must
include the prescribing doctor's drug regime plan of care, and the anticipated
dosage or range of dosages for the administration of pain medication.
(2) Refills of an intrathecal drug delivery system with drugs excluded
from the closed formulary, which are billed using Healthcare Common Procedure
Coding System (HCPCS) Level II J codes, and submitted on a CMS-1500 or UB-04
billing form, require preauthorization on an annual basis. Preauthorization for
these refills is also required whenever:
(A) the medications, dosage or range of dosages, or the drug regime
proposed by the prescribing doctor differs from the medications, dosage or
range of dosages, or drug regime previously preauthorized by that prescribing
doctor; or
(B) there is a change in prescribing doctor.
(d) Treatment
guidelines. Except as provided by this subsection, the prescribing of drugs
shall be in accordance with §137.100 of this title (relating to Treatment
Guidelines), the division's adopted treatment guidelines.
(1) Prescription and nonprescription drugs included in the division's
closed formulary and recommended by the division's adopted treatment guidelines
may be prescribed and dispensed without preauthorization.
(2) Prescription and nonprescription drugs included in the division's
closed formulary that exceed or are not addressed by the division's adopted
treatment guidelines may be prescribed and dispensed without preauthorization.
(3) Drugs included in the closed formulary that are prescribed and
dispensed without preauthorization are subject to retrospective review of
medical necessity and reasonableness of health care by the insurance carrier in
accordance with subsection (g) of this section.
(e) Appeals process
for drugs excluded from the closed formulary.
(1) For situations in which the prescribing doctor determines and
documents that a drug excluded from the closed formulary is necessary to treat
an injured employee's compensable injury and has prescribed the drug, the
prescribing doctor, other requestor, or injured employee must request approval
of the drug by requesting preauthorization, including reconsideration, in
accordance with §134.600 of this title and applicable provisions of Chapter 19
of this title (relating to Agents' Licensing).
(2) If preauthorization is being requested by an injured employee or a
requestor other than the prescribing doctor, and the injured employee or other
requestor requests a statement of medical necessity, the prescribing doctor
shall provide a statement of medical necessity to facilitate the
preauthorization submission as set forth in §134.502 of this title (relating to
Pharmaceutical Services).
(3) If preauthorization for a drug excluded from the closed formulary
is denied, the requestor may submit a request for medical dispute resolution in
accordance with §133.308 of this title (relating to MDR by Independent Review
Organizations).
(4) In the event of an unreasonable risk of a medical emergency, an
interlocutory order may be obtained in accordance with §133.306 of this title
(relating to Interlocutory Orders for Medical Benefits) or §134.550 of this title
(relating to Medical Interlocutory Order).
(f) Initial
pharmaceutical coverage.
(1) Drugs included in the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization and are not subject to retrospective
review of medical necessity.
(2) Drugs excluded from the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization, except as referenced in subsection (b)(1)(C)
of this section, and are subject to retrospective review of medical necessity.
(g) Retrospective
review. Except as provided in subsection (f)(1) of this section, drugs that do
not require preauthorization are subject to retrospective review for medical
necessity in accordance with §133.230 of this title (relating to Insurance
Carrier Audit of a Medical Bill) and §133.240 of this title (relating to
Medical Payments and Denials), and applicable provisions of Chapter 19 of this
title.
(1) Health care, including a prescription for a drug, provided in
accordance with §137.100 of this title is presumed reasonable as specified in
Labor Code §413.017, and is also presumed to be health care reasonably required
as defined by Labor Code §401.011(22-a).
(2) In order for an insurance carrier to deny payment subject to a
retrospective review for pharmaceutical services that are recommended by the
division's adopted treatment guidelines, §137.100 of this title, the denial
must be supported by documentation of evidence-based medicine that outweighs
the presumption of reasonableness established under Labor Code §413.017.
(3) A prescribing doctor who prescribes pharmaceutical services that
exceed, are not recommended, or are not addressed by §137.100 of this title, is
required to provide documentation upon request in accordance with §134.500(13)
of this title (relating to Definitions) and §134.502(e) and (f) of this title.
(h) This section will become effective for all
drugs that are prescribed and dispensed for outpatient use on or after MM/DD/YY
(intended to be a date certain approximately sixty days after the rule
amendment is finally adopted).
§134.540. Requirements for Use of the Closed Formulary for Claims Subject to
Certified Networks.
(a) Applicability.
The closed formulary applies to all drugs that are prescribed and dispensed for
outpatient use for claims subject to a certified network on or after September
1, 2011 when the date of injury occurred on or after September 1, 2011.
(b) Preauthorization
for claims subject to the Division's closed formulary. Preauthorization is only
required for:
(1) drugs 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;
(2) any prescription drug created through compounding [any
compound 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]; and
(3) 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).
(c) Preauthorization
of intrathecal drug delivery systems.
(1) An intrathecal drug delivery system requires preauthorization in
accordance with the certified network's treatment guidelines and
preauthorization requirements pursuant to Insurance Code Chapter 1305 and
Chapter 10 of this title (relating to Workers' Compensation Health Care
Networks).
(2) Refills of an intrathecal drug delivery system with drugs excluded
from the closed formulary, which are billed using Healthcare Common Procedure
Coding System (HCPCS) Level II J codes, and submitted on a CMS-1500 or UB-04
billing form, require preauthorization on an annual basis. Preauthorization for
these refills is also required whenever:
(A) the medications, dosage or range of dosages, or the drug regime
proposed by the prescribing doctor differs from the medications dosage or range
of dosages, or drug regime previously preauthorized by that prescribing doctor;
or
(B) there is a change prescribing doctor.
(d) Treatment
guidelines. The prescribing of drugs shall be in accordance with the certified
network's treatment guidelines and preauthorization requirements pursuant to
Insurance Code Chapter 1305 and Chapter 10 of this title. Drugs included in the
closed formulary that are prescribed and dispensed without preauthorization are
subject to retrospective review of medical necessity and reasonableness of
health care by the insurance carrier in accordance with subsection (f) of this section.
(e) Appeals process
for drugs excluded from the closed formulary.
(1) For situations in which the prescribing doctor determines and
documents that a drug excluded from the closed formulary is necessary to treat
an injured employee's compensable injury and has prescribed the drug, the
prescribing doctor, other requestor, or injured employee must request approval
of the drug in a specific instance by requesting preauthorization in accordance
with the certified network's preauthorization process established pursuant to
Chapter 10, Subchapter F of this title (relating to Utilization Review and
Retrospective Review) and applicable provisions of Chapter 19 of this title (relating
to Agents' Licensing).
(2) If preauthorization is pursued by an injured employee or requestor
other than the prescribing doctor, and the injured employee or other requestor
requests a statement of medical necessity, the prescribing doctor shall provide
a statement of medical necessity to facilitate the preauthorization submission
as set forth in §134.502 of this title (relating to Pharmaceutical Services).
(3) If preauthorization for a drug excluded from the closed formulary
is denied, the requestor may submit a request for medical dispute resolution in
accordance with §133.308 of this title (relating to MDR by Independent Review
Organizations).
(4) In the event of an unreasonable risk of a medical emergency, an
interlocutory order may be obtained in accordance with §133.306 of this title
(relating to Interlocutory Orders for Medical Benefits) or §134.550 of this title
(relating to Medical Interlocutory Order).
(f) Initial
pharmaceutical coverage.
(1) Drugs included in the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization and are not subject to retrospective
review of medical necessity.
(2) Drugs excluded from the closed formulary which are prescribed for
initial pharmaceutical coverage, in accordance with Labor Code §413.0141, may
be dispensed without preauthorization and are subject to retrospective review
of medical necessity.
(g) Retrospective
review. Except as provided in subsection (f)(1) of this section, drugs that do
not require preauthorization are subject to retrospective review for medical
necessity in accordance with §133.230 of this title (relating to Insurance
Carrier Audit of a Medical Bill), §133.240 of this title (relating to Medical
Payments and Denials), the Insurance Code, Chapter 1305, applicable provisions
of Chapters 10 and 19 of this title.
(1) In order for an insurance carrier to deny payment subject to a
retrospective review for pharmaceutical services that fall within the treatment
parameters of the certified network's treatment guidelines, the denial must be
supported by documentation of evidence-based medicine that outweighs the
evidence-basis of the certified network's treatment guidelines.
(2) A prescribing doctor who prescribes pharmaceutical services that
exceed, are not recommended, or are not addressed by the certified network's
treatment guidelines, is required to provide documentation upon request in
accordance with §134.500(13) of this title (relating to Definitions) and
§134.502(e) and(f) of this title.
(h) This section will become effective for all
drugs that are prescribed and dispensed for outpatient use on or after MM/DD/YY
(intended to be a date certain approximately sixty days after the rule
amendment is finally adopted).
