Purpose

The bill would generally prohibit requiring prior authorization (PA) or step therapy for FDA-approved drugs used to treat opioid use disorder (OUD) under Minnesota’s medical assistance (Medicaid) program. It amends Minnesota Statutes to outline how PA is reviewed, when it can be used, and specific exceptions, with the goal of improving access to medications for OUD while preserving some clinician and program considerations.

Main Provisions

• Formulary Committee role and criteria

  • The Formulary Committee will review and recommend which drugs require PA and set general criteria for PA of brand-name drugs when a generically equivalent drug exists.
  • The committee is not required to review every brand-name drug that has a generically equivalent option.
  • The committee must consider medical data, information from the commissioner, public input, and must hold a public forum with a 15-day comment period.

• Commissioner authority and PA process

  • The commissioner may require PA for certain formulary drugs; must provide information on impact to patient care and program costs, misuse potential, and relevant Medicaid data before requiring PA.
  • A 15-day notice is required before implementing PA.

• Exceptions and specific rules

  • Not require PA for atypical antipsychotic drugs used to treat mental illness if:
  • there is no generically equivalent drug, or
  • the drug was first prescribed before July 1, 2003, or
  • the drug is part of the recipient’s current course of treatment.
  • Automatic 60-day PA exemption for brand-name drugs used to treat mental illness if a generically equivalent drug becomes available and the brand-name drug was part of the recipient’s course when the generic became available.
  • Liquid methadone: no PA if only one version exists; if more than one version exists, ensure at least one version is available without PA.
  • For oral liquid forms, PA may be required, but:
  • automatic PA within 24 hours is allowed when the drug is FDA-approved for a condition and the patient uses an enteral tube.
  • if multiple liquid versions exist, the commissioner may select the version compatible with enteral-tube use.
  • a streamlined PA form must be used for patients with enteral tubes.
  • Brand-name drugs may still face PA if a generically equivalent product is available, even if a prescriber requests “dispense as written,” as allowed by law.

• Automatic PA timelines and applicability

  • The commissioner may automatically require PA for up to 180 days for any drug approved by the FDA on or after July 1, 2005; the 180-day period starts when the drug is first available for shipment in Minnesota.
  • To continue PA beyond 180 days, the provisions above must be followed.

• Compliance and cross-references

  • PA and related actions must comply with the state’s PA and step-therapy rules (section 62Q.184 and 62Q.1841 for step therapy).
  • Notwithstanding other laws, PA or step therapy shall not be required for:
  • any FDA-approved drug class for HIV/AIDS treatment or prevention, or
  • any FDA-approved drug class for the treatment of opioid use disorder.

Notable Changes to Law

• Broad shift toward reducing PA/step therapy for OUD medications under Medicaid, with explicit exceptions and administration rules to manage access and costs.
• Establishment of a formal process (Formulary Committee) to determine when PA is needed, including requirements for public input and data-driven decision-making.
• Specific exemptions for certain mental health medications (with conditions on generics and timing) and for liquid methadone to protect access.
• New procedures to ensure rapid PA decisions for enteral tube patients and selective management of liquid oral formulations.
• A default 180-day automatic PA window for newly FDA-approved drugs, creating a limited period of fast-track access before full PA review.
• Explicit protection against PA/step therapy for HIV/AIDS and OUD medications, reinforcing access to essential therapies.

Practical Impact

• For people with OUD, access to necessary medications under Medicaid could become more straightforward, with fewer PA hurdles in many cases.
• Clinicians may have clearer rules about when PA is required and when it is automatically granted or avoided, particularly for enteral-tube patients and certain liquid formulations.
• States’ Formulary Committee processes and public input requirements could slow or guide decisions about drug coverage in a transparent way.
• Some protections remain in place for other conditions (e.g., HIV/AIDS, mental health drugs) under specific exceptions.

Terminology and Definitions (Key Terms)

• prior authorization (PA)
• step therapy
• Formulary Committee
• medical assistance / Minnesota Medicaid
• opioid use disorder (OUD)
• FDA-approved drugs
• brand-name drugs vs generically equivalent drugs
• generically equivalent
• atypical antipsychotic
• liquid methadone
• enteral tube
• oral liquid drug forms
• public forum
• notice period (15 days)
• FDA approval timing (180-day automatic PA window for post-2005 drugs)
• HIV/AIDS
• dispenses as written / brand necessary (prescriber directive)
• 62Q.184 and 62Q.1841 (PA and step-therapy standards)

Relevant Terms prior authorization; step therapy; Formulary Committee; medical assistance; Minnesota Medicaid; opioid use disorder; FDA-approved; brand-name; generically equivalent; atypical antipsychotic; liquid methadone; enteral tube; oral liquid; HIV; HIV/AIDS; 62Q.184; 62Q.1841; public forum; notice; auto-authorization; dispensing as written