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SF2645 (Legislative Session 94 (2025-2026))

Formulary Committee members with a potential conflict of interest participation in committee communications and discussions authorization provision, public comment process for recommendations to the Formulary Committee development by the commissioner of human services requirement provision, and Minnesota Rare Disease Advisory Council expertise sought by the Formulary Committee requirement provision

AI Generated Summary

Purpose of the Bill

The bill aims to update the operations of the Minnesota Formulary Committee with enhanced transparency and efficiency in its processes, particularly concerning drug recommendations and public involvement. It ensures committee decisions are informed by specific expertise and public input while maintaining ethical standards and addressing rare diseases.

Main Provisions

  • Formulary Committee Composition and Ethics: The committee will include physicians with varied specialties, pharmacists, consumer representatives, and a member from the Minnesota Rare Disease Advisory Council. Members with potential conflicts of interest must disclose these and recuse themselves where necessary, but having a conflict doesn't automatically disqualify them from participation.

  • Expertise and Public Input: The committee must seek expertise from the Minnesota Rare Disease Advisory Council for relevant drug recommendations and hold public forums for input on drug prior authorizations.

  • Public Comment Process: The commissioner of human services will develop a public comment process to allow external input into the committee's recommendations.

  • Membership and Operations: The committee will have at least three meetings per year, and members will be compensated with an honorarium and travel reimbursements. The committee is subject to the Open Meeting Law to ensure transparency.

  • Prior Authorizations and Preferred Drug List: The bill clarifies procedures for requiring prior authorizations and managing the preferred drug list, including the inclusion of orphan drugs and the maintenance of an accurate archive of the drug list available to the public.

Significant Changes to Existing Law

  • The bill broadens the inclusion of professional and public input into the drug formulary process and prevents conflicts of interest from influencing committee decisions.
  • It mandates a structured process for incorporating public and expert opinions from the Rare Disease Advisory Council, particularly before decisions impacting orphan drugs and drug authorizations are made.
  • The bill extends the expiration date of the Formulary Committee to June 30, 2030, and changes the way automatic and streamlined prior authorizations are handled, especially for those using an enteral tube for medication.
  • It introduces specific frameworks for handling new drugs and changes the prior authorization process while ensuring these procedures don't contribute to health disparities or negatively impact public health initiatives.

Relevant Terms

  • Formulary Committee
  • Rare Disease Advisory Council
  • Prior Authorization
  • Conflict of Interest
  • Orphan Drugs
  • Preferred Drug List
  • Public Comment Process
  • Open Meeting Law

Bill text versions

Actions

DateChamberWhereTypeNameCommittee Name
March 17, 2025SenateFloorActionIntroduction and first reading
March 17, 2025SenateFloorActionReferred toHealth and Human Services

Citations

 
[
  {
    "analysis": {
      "added": [
        "A requirement for the Formulary Committee to include representatives with specific specialties such as rare diseases and disabilities."
      ],
      "removed": [],
      "summary": "Amendments to the structure and operation of the Formulary Committee, including conflict of interest guidelines and composition.",
      "modified": [
        "Clarification on the conditions under which members with conflicts of interest can participate."
      ]
    },
    "citation": "256B.0625",
    "subdivision": "subdivision 13c"
  },
  {
    "analysis": {
      "added": [
        "New criterion for automatic approval of oral liquid drugs for patients with enteral tubes."
      ],
      "removed": [],
      "summary": "Adjustment to prior authorization processes for drugs, including public comment requirements.",
      "modified": [
        "Standards for prior authorization notification and public comment disclosure on the DHS website."
      ]
    },
    "citation": "256B.0625",
    "subdivision": "subdivision 13f"
  },
  {
    "analysis": {
      "added": [
        "Requirements for public notice and analysis disclosure prior to deleting or modifying drug listings."
      ],
      "removed": [],
      "summary": "Updates to the preferred drug list management, transparency, and public engagement processes.",
      "modified": [
        "Procedures for consulting with the Rare Disease Advisory Council on orphan drug entries."
      ]
    },
    "citation": "256B.0625",
    "subdivision": "subdivision 13g"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Defines metropolitan counties as part of the guidelines for the practice locations of Formulary Committee members.",
      "modified": [
        "References to practice locations for pharmacist members of the Formulary Committee."
      ]
    },
    "citation": "473.121",
    "subdivision": "subdivision 4"
  }
]

Progress through the legislative process

17%
In Committee

Sponsors