Texas Administrative Code
Title 28 - INSURANCE
Part 2 - TEXAS DEPARTMENT OF INSURANCE, DIVISION OF WORKERS' COMPENSATION
Chapter 134 - BENEFITS-GUIDELINES FOR MEDICAL SERVICES, CHARGES, AND PAYMENTS
Subchapter F - PHARMACEUTICAL BENEFITS
Section 134.530 - Requirements for Use of the Closed Formulary for Claims Not Subject to Certified Networks
Universal Citation: 28 TX Admin Code ยง 134.530
Current through Reg. 49, No. 38; September 20, 2024
(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 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).
(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.
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