HF4852

Purpose

• Establish a formal Formulary Committee to guide which drugs are covered and how prior authorization works for Minnesota’s public health programs.
• Increase transparency, public input, and expert guidance (including input from the Minnesota Rare Disease Advisory Council) in drug coverage decisions.
• Strengthen conflict-of-interest safeguards and ensure diverse professional representation on the committee.
• Align drug coverage practices with advanced hearings, public comment, and open-government principles.

Key Provisions and What They Do

• Formulary Committee creation and structure

  • The commissioner must designate a Formulary Committee to handle duties related to drug coverage and prior authorization.
  • Composition includes at least five physicians (one practicing psychiatrist, one specializing in rare diseases, one pediatric specialist, one provider for persons with disabilities, and at least one hospital pharmacist; plus additional pharmacists with rural and urban practice representation) and at least two consumer representatives. One member is to be chosen by the Minnesota Rare Disease Advisory Council, and the remainder come from licensed health care professionals with relevant expertise.
  • Members cannot be employed by the Department of Human Services or have a substantial financial interest in pharmaceutical companies, PBMs, health plans, or related entities. The department’s medical director serves as an ex officio, nonvoting member.
  • Terms are three years, with the option to be reappointed twice. The committee must elect a chair and a vice chair.
  • The committee must meet at least three times per year (the commissioner can require more).
  • An honorarium ($100 per meeting) and mileage reimbursement are provided to attending members.
  • The committee expires June 30, 2029 (with an indication that 2030 is also referenced, suggesting possible extension).

• Conflict of interest and transparency

  • Members must disclose any potential conflict of interest and recuse themselves from related discussions or votes.
  • A conflict-of-interest form must be publicly disclosed on the Department of Human Services website at least 48 hours before relevant meetings.
  • The panel may remove members for cause, but disagreement or dissent on a clinical issue is not cause for removal.
  • The committee is subject to the Open Meeting Law; staff may still consult with Rare Disease Advisory Council representatives and external experts, as long as a quorum is not present during those consultations.

• Open process, public input, and expert input

  • The committee must seek expertise from the Minnesota Rare Disease Advisory Council and may encourage public comment.
  • After the committee makes a recommendation, staff must share related work and documents with the Rare Disease Advisory Council; the Rare Disease Advisory Council may conduct public outreach related to proposed actions, provided no quorum of the committee is present during those outreach activities.
  • Public notice requirements apply to Formulary Committee meetings, including drug discussions and proposed actions.

• Prior authorization (13f) framework changes

  • The Formulary Committee will review and recommend drugs that require prior authorization and set general criteria for brand-name drugs when generics exist.
  • The commissioner may request a prior-authorization review from the committee, which must include a public forum and a 15-day public comment period. Public comments must be posted publicly within 48 hours of receipt and kept on file.
  • Certain exemptions and timelines:
  • Some atypical antipsychotics may be exempt from prior authorization if specific conditions apply.
  • Automatic 60-day prior authorization for certain brand-name mental health drugs when a generic becomes available if the drug was part of the patient’s treatment plan.
  • Automatic 60-day approvals for certain brand-name drugs when no generic equivalent exists and the drug is part of the patient’s treatment.
  • Automatic 24-hour prior authorization for an oral liquid drug when prescribed for a patient using an enteral tube (with version selection if multiple liquids exist).
  • A streamlined prior-authorization form for enteral-tube patients using oral liquids by August 1, 2026, including a box to verify tube use, which permits automatic approval without extra documentation.
  • A 180-day automatic prior authorization window may be used for drugs approved by the FDA on or after July 1, 2005, after which the regular process applies.
  • HIV/AIDS drugs are exempt from prior authorization and step therapy.
  • The Formulary Committee must establish general criteria for prior authorization but does not have to review every individual drug.

• Preferred drug list (PDL) framework (13g)

  • The commissioner must adopt and maintain a preferred drug list (PDL) and may contract with a vendor to help administer the PDL and related rebate programs.
  • The PDL must be published annually, archived, and publicly accessible. Changes may be made after consulting the Formulary Committee and the Rare Disease Advisory Council, especially for orphan drugs.
  • The commissioner must consider public notice and provide opportunities for public comment and compliance with applicable requirements when modifying the PDL, including public hearings for deletions or modifications.
  • The PDL is integrated with the state’s supplemental drug rebate program; drugs not on the PDL may be subject to prior authorization.
  • The terms “appropriate medical specialist” and “preferred drug list” are defined, and federal waivers or approvals may be sought to implement these provisions.
  • Before deleting or modifying a drug on the PDL, the commissioner must assess impacts on public health and health disparities and publish the analysis and evidence 30 days before a public hearing.

• Public notice and communication requirements

  • Public notice must be provided at least 30 days in advance of Formulary Committee meetings, with the drug(s) to be discussed and the proposed actions listed in the notice.

• Additional governance and compliance provisions

  • The commissioner must avoid entering into or renewing a contract with a pharmacy benefit manager (PBM) if it would limit the committee’s ability to seek expertise and input.
  • Guidance and definitions related to orphan drugs, expert input, and the open-government framework aim to improve accountability and public trust.

Significant Changes from Current Law

• Creates a formal, multi-disciplinary Formulary Committee with explicit conflict-of-interest safeguards, public reporting, and open-meeting requirements.
• Places explicit emphasis on seeking expertise from the Minnesota Rare Disease Advisory Council for orphan drugs and rare-disease-related decisions.
• Expands the role of public comment and public notice in formulary decisions, including prior authorization and orphan-drug placement.
• Links the prior-authorization process to transparent criteria, public forums, and recorded public input; introduces automatic approvals and streamlined forms for specific scenarios (e.g., enteral tube use).
• Establishes a formal process to maintain and publish a preferred drug list with a vendor contract, while requiring public hearings and public analysis before deletions or changes that could affect health disparities.
• Tries to limit PBM influence by prohibiting contracts that would curb the committee’s ability to obtain external expertise.

Relevant Terms - Formulary Committee - Minnesota Rare Disease Advisory Council - prior authorization - orphan drug - preferred drug list (PDL) - pharmacy benefit manager (PBM) - Open Meeting Law - conflict of interest - recusal - ex officio - public comment / public forum - Department of Human Services (DHS) - medical director (DHS) - novel streamlined prior authorization - public notice - public health disparities - open government / transparency - vendor for PDL and rebates - critical terms: Medicaid context, drug coverage, and prior authorization criteria