Montana § 33-32-109 Biologic Prescriptions For Minors

Montana Statutes

§ 33-32-109 — Biologic Prescriptions For Minors

Montana § 33-32-109

Title 33INSURANCE AND INSURANCE COMPANIES

Ch. 32HEALTH UTILIZATION REVIEW

Part 1General Provisions

This text of Montana § 33-32-109 (Biologic Prescriptions For Minors) is published on Counsel Stack Legal Research, covering Montana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook

Mont. Code Ann. § 33-32-109 (2026).

Text

33-32-109 . (Effective January 1, 2026) Biologic prescriptions for minors.

(1)Biologic therapies may be prescribed by a treating provider for individuals under 18 years of age as provided in this section. The biologic therapies must meet the following requirements:

(a)the biologic therapies must be approved by the U.S. food and drug administration for use on adults but need not be approved for use on persons under 18 years of age; and

(b)the biologic therapies must be medically necessary, covered benefits and supported by medical literature in at least two peer-reviewed journals demonstrating that the off-label use is both safe and effective for use on persons in the following comparable phases of life age ranges:

(i)infancy, between birth and 2 years of age;

(ii)childhood, from 2 to

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33-32-109 . (Effective January 1, 2026) Biologic prescriptions for minors. (1) Biologic therapies may be prescribed by a treating provider for individuals under 18 years of age as provided in this section. The biologic therapies must meet the following requirements:
(a) the biologic therapies must be approved by the U.S. food and drug administration for use on adults but need not be approved for use on persons under 18 years of age; and
(b) the biologic therapies must be medically necessary, covered benefits and supported by medical literature in at least two peer-reviewed journals demonstrating that the off-label use is both safe and effective for use on persons in the following comparable phases of life age ranges:
(i) infancy, between birth and 2 years of age;
(ii) childhood, from 2 to 12 years of age; and
(iii) adolescence, from 12 to 18 years of age.
(2) Upon receipt of the request for prior authorization and medical records supporting the request and the literature described in section (1)(b), an entity covered under the provisions of this chapter performing a utilization review must approve or deny a request for prior authorization for biologic therapies under subsection (1) in the timeframe set forth in this chapter.
(3) For the purposes of this section, the term "biologic therapies" means a treatment that uses substances made from living organisms to treat disease. These substances may be made in a laboratory or occur naturally in the body.