California Code of Regulations
Title 8 - Industrial Relations
Division 1 - Department of Industrial Relations
Chapter 4.5 - Division of Workers' Compensation
Subchapter 1 - Administrative Director-Administrative Rules
Article 5.5.2 - Medical Treatment Utilization Schedule
Section 9792.27.5 - Mtus Drug Formulary - off-Label Use

Universal Citation: 8 CA Code of Regs 9792.27.5

Current through Register 2024 Notice Reg. No. 38, September 20, 2024

(a) Off-label use of a drug shall be in accordance with the MTUS Treatment Guidelines and rules and the MTUS Drug Formulary.

(b) Authorization through prospective review is not required to dispense an Exempt drug for an off-label use if the MTUS Treatment Guideline recommends the off-label use of the drug to treat the condition.

(c) Authorization through prospective review is required prior to dispensing the following drugs for an off-label use:

(1) Non-Exempt drug, or

(2) Unlisted drug, or

(3) Exempt drug lacking recommendation in the MTUS Treatment Guideline for the intended off-label use.

(d) When a physician believes it is medically necessary to prescribe a drug for an off-label use not recommended by the MTUS Treatment Guidelines or not addressed by the MTUS Treatment Guidelines, the permissibility of the treatment outside of the guidelines is governed by section 9792.21 subdivision (d) (condition not addressed by MTUS or seeking to rebut the MTUS), section 9792.21.1 (medical evidence search sequence), section 9792.25 (quality and strength of evidence definitions) and section 9792.25.1 (MTUS methodology for Evaluating Medical Evidence).

1. New section filed 12-7-2017; operative 1-1-2018 pursuant to Government Code section 11343.4(b)(3) (Register 2017, No. 49).

Note: Authority cited: Sections 133, 4603.5, 5307.3 and 5307.27, Labor Code. Reference: Sections 4600, 4604.5 and 5307.27, Labor Code.

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