Cal. Code Regs. Tit. 8, § 9792.27.5 - Mtus Drug Formulary - off-Label Use

(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).

Notes

Cal. Code Regs. Tit. 8, § 9792.27.5

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.

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