Bill
SB 2249
Allows expedited, defined exceptions to step-therapy for certain meds with 5-day/72-hour review; sunset in 2027 unless extended.
Status: Filed with Secretary of State (03/31/2025). Passed both chambers (Senate 46–0; House 75–9). Sent to Governor 03/26/2025; signed 03/27/2025; filed with Secretary of State 03/31/2025.
Purpose
- Create time-limited (sunset) statutory requirements for step‑therapy protocol exceptions and require a legislative interim study of historical health‑care mandates. The intent is to standardize when insurers and benefit managers must grant exceptions to step‑therapy requirements and to evaluate the history, purpose, and effects of health‑care mandates.
Key provisions
1. Step‑therapy protocol exceptions (new section to NDCC chapter 54‑52.1)
- Definitions: adopts "step therapy protocol" as used in NDCC §19‑02.1‑16.3; defines a "step therapy protocol exception" as overriding the protocol in favor of the drug selected by a treating health care professional.
- Mandatory approval criteria: a carrier, health plan, pharmacy benefits manager, or utilization review agent must approve an exception request if any of the following apply:
- The protocol‑required drug is contraindicated per the manufacturer’s prescribing information.
- Due to a documented adverse event or medical/comorbid condition, the protocol drug is likely to (a) cause an adverse reaction, (b) reduce ability to perform daily activities, or (c) cause physical or mental harm.
- The protocol drug is expected to be ineffective for the individual based on clinical characteristics, peer‑reviewed literature, manufacturer information, clinician judgment, or the individual’s documented experience.
- The individual previously trialed an equivalent drug under step therapy and it was discontinued by the clinician for lack of effectiveness.
- The individual previously achieved a positive therapeutic outcome on the clinician‑selected drug.
- Coverage authorization and timelines:
- If the selected drug is covered under the plan, approval must result in coverage authorization.
- Non‑urgent requests: decision within 5 calendar days after receipt.
- Emergency/urgent requests: decision within 72 hours.
- Failure to respond within these timeframes = request deemed approved.
Reporting / Public Employees Retirement System (PERS)
Legislative management study — historical health‑care mandates
Application and sunset
- Applies to health benefits coverage beginning after June 30, 2025 and not extending past June 30, 2027.
- Act is effective through June 30, 2027; becomes ineffective after that date unless the Legislature acts (PERS has been tasked to propose repeal of the sunset).
Who is affected
- Insurers, health carriers, health benefit plans, pharmacy benefit managers, utilization review agents operating in North Dakota.
- Covered individuals (insureds) subject to step‑therapy requirements.
- Public Employees Retirement System (must report and consider extending coverage).
- State agencies and stakeholder groups participating in the mandated interim study.
Potential impacts (anticipated)
- Increased ability for clinicians to obtain coverage for prescribed medications without completing mandatory step trials when criteria are met, potentially improving timely access to treatment.
- Administrative and cost effects for carriers and PBMs due to expedited reviews and potential increases in use of higher‑step medications; PERS is required to report utilization and cost impacts.
- The interim study may inform future legislative changes to health‑care mandates and the permanence of these exception rules.
Compiled from official sources — confirm details with the bill’s official record.
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