SF2645

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

This bill seeks to amend Minnesota statutes concerning the operations and responsibilities of the Formulary Committee, which advises on drug formularies and prior authorizations. The bill aims to enhance transparency and public involvement in the committee’s decision-making processes, particularly concerning rare diseases.

Main Provisions

Conflict of Interest Guidelines: Formulary Committee members with potential conflicts of interest are now allowed to participate in discussions but must publicly disclose conflicts. They cannot vote or communicate on matters where conflicts exist unless publicly disclosed 48 hours before relevant meetings.
Public Comment Process: The commissioner of human services is tasked with developing a public comment process for the Formulary Committee’s recommendations. This includes informing the public about meetings and allowing public comments which must be published within 48 hours.
Involvement of Rare Disease Council: The Formulary Committee is required to seek expertise from the Minnesota Rare Disease Advisory Council, especially concerning orphan drugs, which are drugs developed for rare diseases.
Prior Authorization Changes: The bill dictates stricter regulations on when drugs, especially brand-name drugs with generic equivalents, can require prior authorization. It mandates a 15-day public comment period before implementing such authorizations.
Preferred Drug List Modifications: Changes to the preferred drug list, like drug deletions or modifications, must now consider state public health policies and health disparities and require public hearings and disclosures.

Significant Changes to Existing Law

The Formulary Committee is now required to meet at least three times a year, extending its expiration from 2027 to 2030.
The act introduces a 30-day notice requirement before meetings, allowing experts and the public to contribute comments.
The commissioner must publish the terms of contracts related to the preferred drug list and maintain a public archive of previous lists.
Automatic prior authorizations for newly FDA-approved drugs are limited to 180 days unless further formal review occurs.

Relevant Terms

Formulary Committee
Conflict of Interest
Public Comment Process
Minnesota Rare Disease Advisory Council
Prior Authorization
Orphan Drugs
Preferred Drug List
Health Disparities

Bill text versions

Introduction PDF file

Actions

Date	Chamber	Where	Type	Name	Committee Name
March 16, 2025	Senate	Floor	Action	Introduction and first reading
March 16, 2025	Senate	Floor	Action	Referred to	Health and Human Services

Citations

[
  {
    "analysis": {
      "added": [
        "A provision requiring the Formulary Committee to seek expertise from the Minnesota Rare Disease Advisory Council.",
        "A mandate for the commissioner to develop a public comment process."
      ],
      "removed": [],
      "summary": "This legislative bill amends section 256B.0625 regarding the Formulary Committee's roles and procedures.",
      "modified": [
        "Clarified conflict of interest procedures for committee members.",
        "Updated terms of service and procedural rules for committee operations."
      ]
    },
    "citation": "256B.0625"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "The bill refers to section 473.121 to define the geographic scope of metropolitan counties for the Formulary Committee's pharmacist representation.",
      "modified": []
    },
    "citation": "473.121"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "This bill makes indirect references to section 62W.02 in the context of pharmacy benefit manager regulations related to the Formulary Committee's obligations.",
      "modified": []
    },
    "citation": "62W.02"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Section 151.21 is cited as a reference for prescription writing instructions related to generic drugs and prior authorization.",
      "modified": []
    },
    "citation": "151.21"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "The bill mentions section 62Q.184 in reference to prior authorization requirements.",
      "modified": []
    },
    "citation": "62Q.184"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Section 62Q.1841 is mentioned to address compliance regarding step therapy protocol requirements.",
      "modified": []
    },
    "citation": "62Q.1841"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "The bill references section 152.01 to define orphan drugs, affecting the Formulary Committee's drug placement decisions.",
      "modified": []
    },
    "citation": "152.01"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Section 256.4835 is cited for establishing the Rare Disease Advisory Council, which the Formulary Committee must consult.",
      "modified": [
        "Updated procedures for consulting with the Rare Disease Advisory Council."
      ]
    },
    "citation": "256.4835"
  }
]