(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.
|