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 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 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;
(3) any prescription drug created through
compounding prescribed and dispensed on or after July 1, 2018; and
(4) 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.
