Maine § 24-A §4320-N Step therapy (REALLOCATED FROM TITLE 24-A, SECTION 4320-M)

Maine Statutes

§ 24-A §4320-N — Step therapy (REALLOCATED FROM TITLE 24-A, SECTION 4320-M)

Maine·Title 24-A MAINE INSURANCE CODE·Ch. 56-A HEALTH PLAN IMPROVEMENT ACT

1.Definitions. As used in this section, unless the context otherwise indicates, the following terms have the following meanings.

2.Clinical review criteria. Clinical review criteria used to establish a step therapy protocol must be based on clinical practice guidelines that:

3.Absence of clinical practice guidelines. In the absence of clinical practice guidelines that meet the requirements in subsection 2, peer‑reviewed publications may be substituted.

4.Consideration of atypical populations and diagnoses. When establishing a step therapy protocol, a utilization review organization shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria.

5.Construction. This section may not be construed to require carriers or the

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1.
Definitions.
As used in this section, unless the context otherwise indicates, the following terms have the following meanings.
2.
Clinical review criteria.
Clinical review criteria used to establish a step therapy protocol must be based on clinical practice guidelines that:
3.
Absence of clinical practice guidelines.
In the absence of clinical practice guidelines that meet the requirements in subsection 2, peer‑reviewed publications may be substituted.
4.
Consideration of atypical populations and diagnoses.
When establishing a step therapy protocol, a utilization review organization shall also take into account the needs of atypical patient populations and diagnoses when establishing clinical review criteria.
5.
Construction.
This section may not be construed to require carriers or the State to set up a new entity to develop clinical review criteria used for step therapy protocols.
6.
Exceptions process.
When coverage of a prescription drug for the treatment of any medical condition is restricted for use by a carrier or utilization review organization through the use of a step therapy protocol, the enrollee and prescriber must have access to a clear, readily accessible and convenient process to request a step therapy override exception determination from that carrier or utilization review organization.
7.
Rules.
The superintendent may adopt rules to implement this section. Rules adopted pursuant to this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2‑A.
8.
Step therapy for metastatic cancer and associated conditions prohibited.
Notwithstanding subsection 6, paragraph B, with respect to coverage of a prescription drug on a carrier's formulary for the treatment of metastatic cancer and associated conditions, a carrier or utilization review organization may not require that the enrollee use a step therapy protocol before the carrier provides coverage of a prescription drug approved by the United States Food and Drug Administration.

Maine § 24-A §4320-N (Step therapy (REALLOCATED FROM TITLE 24-A, SECTION 4320-M)) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

Legislative History

PL 2019, c. 295, §1 (NEW). PL 2019, c. 295, §2 (AFF). RR 2019, c. 1, Pt. A, §26 (RAL). PL 2021, c. 345, §§2-5 (AMD). PL 2021, c. 345, §6 (AFF). PL 2025, c. 448, §§1-3 (AMD).