HF3444

Purpose

This bill aims to improve access to medications used to treat opioid use disorder (OUD) by prohibiting the use of prior authorization and step therapy for those drugs under medical assistance. It also makes related changes to how prior authorization decisions can be made and reviewed for other drugs.

Main provisions

• Prohibition for OUD meds: Prior authorization and step therapy cannot be required or used for any drug approved by the FDA to treat opioid use disorder.
• Public review process for other drugs: For drugs that may require prior authorization (generally brand-name drugs when a generic exists), a Formulary Committee must review and set general criteria, hold a public forum, and allow a 15-day public comment period before the commissioner can implement prior authorization. A 15-day notice is required before implementing prior authorization.
• Exceptions and special rules for other drugs:
  • Atypical antipsychotics: Prior authorization may be avoided if there is no generically equivalent drug, or if specific grandfathered conditions apply (e.g., initial prescription before a certain date or part of the recipient’s current course of treatment).
  • Automatic 60-day or automatic approval rules: In certain situations, brand-name drugs may receive a 60-day automatic authorization when a generically equivalent drug becomes available, provided the brand-name drug was part of the patient’s treatment. For liquid methadone, if only one version exists, no prior authorization is required; if multiple versions exist, at least one must be available without prior authorization.
  • Oral liquid forms: Prior authorization may be required, but automatic approval within 24 hours is provided if the drug is for an FDA-approved condition and the patient uses an enteral tube. If multiple liquid versions exist, the commissioner may select the version that fits the enteral-tube scenario.
  • Streamlined forms: The commissioner must create streamlined prior authorization forms for patients who use enteral tubes.
  • Dispense-as-written flexibility: The commissioner may require prior authorization for brand-name drugs even if the prescriber indicates “dispense as written.”
  • FDA-new drugs: The commissioner may automatically require prior authorization for up to 180 days for any drug approved by the FDA on or after July 1, 2005.
  • General criteria: The Formulary Committee will develop broad criteria for prior authorization but is not required to review every individual drug after the initial guidance.
• Compliance and related program rules: Any prior authorization or step-therapy requirements must align with existing statutory provisions and relevant sections governing the program (e.g., requirements for step therapy and related processes).
• Overrides for certain conditions: The bill explicitly states that prior authorization or step therapy shall not be required for HIV/AIDS drugs and for opioids-use-disorder drugs, despite other rules.

How this changes existing law

• Removes or restricts prior authorization and step therapy for FDA-approved OUD medications, making it easier for recipients to access these treatments under medical assistance.
• Maintains a framework for evaluating and imposing prior authorization on other drugs, but requires public input and a formal process, including notice and comment periods.
• Introduces specific automatic-approval timelines and exceptions for certain drug forms (liquid forms, enteral-tube patients) and drug types, while preserving the ability to require prior authorization in other cases.
• Keeps some automatic-authorization concepts (e.g., 60-day/180-day timeframes) for non-OUD drugs, but explicitly carves out the OUD and HIV/AIDS drug classes from these requirements.

Significant changes to existing law (at a glance)

• OUD drugs: No prior authorization or step therapy required.
• HIV/AIDS drugs: No prior authorization or step therapy required.
• For other drugs: A structured process with formulary review, public forums, comment periods, and notice before implementing prior authorization; potential automatic approvals in specific scenarios; streamlined forms for enteral-tube patients.

Implementation notes

• Public involvement: The bill requires a public forum and a 15-day public-comment period before any prior authorization decision is implemented.
• Timelines: Settlement of automatic-authorization timelines (60 days, 180 days) and conditions for continuation beyond those periods are spelled out.
• Oversight and criteria: The Formulary Committee provides general criteria for prior authorization; the commissioner determines when to apply it, with information about impact on care quality and costs.

Relevant Terms prior authorization step therapy Formulary Committee Minnesota Medical Assistance (medical assistance) opioid use disorder (OUD) HIV/AIDS atypical antipsychotic generically equivalent brand-name drug enteral tube liquid methadone automatic approval FDA (U.S. Food and Drug Administration) public forum public comment dispense as written 62Q.184 (statutory reference) formulary review drug formulary automatic authorization period (60 days, 180 days)