| (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.
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