Use of step therapy protocols prohibition for the treatment of neurological conditions

2025-2026 Regular Session Introduced by Liz Boldon and 1 co-sponsor

Prohibits health plans from enforcing step therapy for neurological drugs that are FDA-approved and on the formulary when used per FDA indications and clinical guidelines.

Author added Boldon

#drugsandmedicine #healthandhealthdepartment #insurance-health

Summary of SF 5187 (2025-2026) – Minnesota

Title

Use of step therapy protocols prohibition for the treatment of neurological conditions

Purpose

To prohibit health plans from requiring step therapy protocols for treating neurological conditions when a drug is FDA-approved and listed on the plan’s formulary, provided the drug is used in accordance with FDA indications and a clinical practice guideline. The bill aims to ensure patient access to appropriate, guideline-concordant medications without being forced to try less appropriate or less effective therapies first.

Key Provisions

Section: 62Q.1842 – Prohibition on Use of Step Therapy Protocols for Neurological Conditions

Subdivision 1 – Definitions
“Clinical practice guideline” is defined as per Minnesota's 62Q.184, subdivision 1, paragraph (b).
“Neurological condition” means any disorder causing impairment in neurological function, whether due to injury or illness.
“Step therapy protocol” follows the definition in 62Q.184, subdivision 1, paragraph (e).
Subdivision 2 – Prohibition on Step Therapy for Neurological Conditions
Health plans that cover treatment for neurological conditions may not:
- limit or exclude coverage for a drug that is FDA-approved and on the plan’s prescription drug formulary,
- by requiring an enrollee with a neurological condition to follow a step therapy protocol,
- when the drug’s use is consistent with: 1) FDA-approved indication(s), and 2) a clinical practice guideline.

Effective Date

The prohibition becomes effective January 1, 2027.
Applies to health plans offered, issued, or renewed on or after that date.

Who Is Affected

Health plans (private insurers, as applicable in Minnesota) that cover treatments for neurological conditions.

Enrollees/patients with neurological conditions who would otherwise be subjected to step therapy prior authorization or tiered sequencing for FDA-approved drugs on the formulary.

Providers who recommend FDA-approved therapies aligned with clinical guidelines for neurological conditions.

Practical Implications

Patients with neurological conditions would have Medicare/FDA-approved drugs faster access if those drugs are on the formulary and recommended by guidelines, without mandatory stepwise escalation.

Payers would need to ensure formulary compliance and remove or adjust any step-therapy requirements for neurological drugs that meet FDA indications and guideline alignment.

Aligns coverage decisions with evidence-based practice guidelines to potentially reduce delays in effective treatment.

Procedural and Timeline Notes

Introduction and First Reading: April 21, 2026

Referred to: Senate Commerce and Consumer Protection

Next steps would include committee action, potential amendments, and floor considerations

Effective date: January 1, 2027, with applicability to plans renewed or issued on/after that date

Additional Context

The bill references Minnesota Statutes, chapter 62Q, for definitions related to clinical practice guidelines and step therapy, and it mirrors the broader policy framework governing patient protections against unnecessary treatment barriers.

No explicit exemptions or carve-outs for specific neurological conditions are stated; the prohibition applies broadly to neurological conditions where an FDA-approved drug is indicated and on the formulary.

If you’d like, I can provide a side-by-side comparison with current law or draft a one-page Q&A for patients and providers.