28 Tex. Admin. Code § 134.540 - 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.
(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; 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 that 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 under the certified
network's treatment guidelines and preauthorization requirements in Insurance
Code Chapter 1305 and Chapter 10 of this title (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 regimen proposed by the prescribing doctor
differs from the medications, dosage or range of dosages, or drug regimen
previously preauthorized by that prescribing doctor; or
(B) there is a change in prescribing
doctor.
(d)
Treatment guidelines. The prescribing of drugs must be under the certified
network's treatment guidelines and preauthorization requirements in 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 under subsection (g) of this
section.
(e) Appeals process for
drugs excluded from the closed formulary.
(1)
When 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 requester, or
injured employee must request approval of the drug in a specific instance by
requesting preauthorization under the certified network's preauthorization
process established in Chapter 10, Subchapter F of this title (Utilization
Review and Retrospective Review) and applicable provisions of Chapter 19 of
this title (Licensing and Regulation of Insurance Professionals).
(2) If an injured employee or a requester
other than the prescribing doctor requests preauthorization and a statement of
medical necessity, the prescribing doctor must provide a statement of medical
necessity to facilitate the preauthorization submission under §
134.502 of this title
(Pharmaceutical Services).
(3) If
preauthorization for a drug excluded from the closed formulary is denied, the
requester may submit a request for medical dispute resolution under §
133.308 of this title (MDR of
Medical Necessity Disputes).
(f) Initial pharmaceutical coverage.
(1) Drugs included in the closed formulary
that are prescribed for initial pharmaceutical coverage under 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 that are prescribed for initial pharmaceutical coverage
under 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 under §
133.230 of this title (Insurance
Carrier Audit of a Medical Bill), §
133.240 of this title (Medical
Payments and Denials), Insurance Code Chapter 1305, and applicable provisions
of Chapters 10 and 19 of this title.
(1) 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 on request under §
134.500(13) of
this title (Definitions) and §
134.502(e) and
(f) of this title.
Notes
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