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SB 2076

AN ACT to amend and reenact section 50-24.6-04 of the North Dakota Century Code, relating to prior authorization and certification of medically necessary medication.

69th Legislative Assembly (2025-26)

ND Medicaid will require prior authorization for many drugs, with a new certification program for five or more concurrent psychotropic meds to verify medical necessity.

Filed with Secretary Of State 04/16
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Bill Summary · SB 2076

Summary — SB 2076 (North Dakota)

Act to amend and reenact NDCC § 50-24.6-04 — Prior authorization and certification of medically necessary medication

Status & sponsors
- Introduced: March 7, 2025 (at the request of the Department of Health and Human Services)
- Committee action: Human Services Committee adopted committee report March 24, 2025; reported favorably April 22, 2025.
- Filed with Secretary of State: April 16, 2025.
- Companion bill: HB 3114.

Purpose
- To revise the state Medicaid (medical assistance) prior authorization rules and to establish a provider certification program aimed at verifying medical necessity for certain polypharmacy regimens, while preserving access to clinically necessary medications and enabling the department to pursue additional manufacturer rebates.

Key provisions
1. Prior authorization program (meets federal requirement 42 U.S.C. §1396r‑8(d))
- The Department of Health and Human Services must develop and implement a prior authorization (PA) program for drugs identified as requiring PA.
- Mandatory approval criteria: PA must be granted if (a) preferred/no‑PA drug has failed or is expected to fail, (b) causes or is expected to cause harmful reactions, or (c) the prescribed drug is for a medically accepted use supported by an approved compendium or product labeling, unless a therapeutically equivalent no‑PA drug exists.
- The department must work with prescribers when no compendia‑supported medication exists for a diagnosis.

  1. Drug placement review

    • For any drug placed on the PA list, the department must supply medical/clinical criteria, cost data, and utilization information to the Drug Use Review Board, which may consider other inputs when deciding placement.

  2. Classes generally protected from broad PA

    • For adults (18+) and minors (<18), the department may not require PA for “substantially all” drugs in these classes (with limited exceptions): antipsychotics, antidepressants, anticonvulsants, antiretrovirals (HIV), antineoplastic agents, and immunosuppressants (transplant prophylaxis).
    • Exceptions include: quantity limits (no less than manufacturer insert), cases where post‑rebate costs favor a different product, line‑extension drugs (new formulations but not abuse‑deterrent forms), and manufacturer actions that exclude the department from supplemental rebate/value‑based offers.

  3. Definition clarifications

    • “Line extension drug” = new formulation (excludes abuse‑deterrent formulation).
    • “Substantially all” defined with four listed exceptions (e.g., multisource brands, extended‑release when immediate‑release is included).

  4. Contractor use and rulemaking

    • The department may use contractors to collect/analyze documentation and must consult the Drug Use Review Board when adopting implementing rules (including processes to allow prescribers to submit documentation without disrupting patient care and to convene expert panels).

  5. Manufacturer rebates

    • The department may negotiate supplemental rebates, join a multistate rebate pool, and allow other manufacturers to match negotiated rebates.

  6. Certification program for polypharmacy regimens

    • The department shall develop a certification program to verify medical necessity for any regimen with five or more concurrent prescriptions from a specified set of classes: antipsychotics, antidepressants, anticonvulsants, benzodiazepines, mood stabilizers, sedative‑hypnotics, or ADHD medications.
    • Each prescriber of a medication in such a regimen must annually certify the medication is medically necessary.
    • Payments may be denied until certification is provided.
    • The program applies to individuals under age 22 and may be extended to others at the department’s discretion.
    • For minors, prior authorization to exceed limits for five or more concurrent psychotropic prescriptions requires prescriber consultation with a department‑approved board‑certified child & adolescent psychiatrist.

Who is affected
- Medical assistance (Medicaid) recipients — especially children and young adults (under 22) receiving multiple psychotropic or related medications.
- Prescribers — new documentation, annual certifications, and required psychiatrist consultation in certain pediatric polypharmacy cases.
- Pharmacies and Medicaid program administrators — implementation of PA and payment denials pending certification.
- Drug manufacturers — potential impacts from rebate negotiations and PA placement decisions.
- Department of Health and Human Services and Drug Use Review Board — expanded rulemaking, oversight, and program administration responsibilities.

Potential impacts (practical considerations)
- Intended to increase clinical oversight of high‑risk polypharmacy, reduce inappropriate prescribing, and preserve access to essential medications for conditions where PA would otherwise be a barrier.
- May create additional administrative burdens for prescribers and the department; timely certification and consultation processes will be important to avoid disruptions in patient access.
- Enables the department to pursue additional cost containment through supplemental rebates and multistate purchasing arrangements.

Procedural notes
- The bill amends and reenacts NDCC § 50‑24.6‑04 and requires the department to adopt implementing rules in consultation with the Drug Use Review Board.

Compiled from official sources — confirm details with the bill’s official record.

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