SF3294

SF3294 (Legislative Session 94 (2025-2026))

Prescription drug transparency provisions modifications

Related bill: HF3054

AI Generated Summary

Purpose of the Bill

This bill aims to enhance transparency in the pricing of prescription drugs within the state of Minnesota. It mandates specific reporting requirements for entities participating in the 340B Drug Pricing Program and requires manufacturers to report drug price increases. It also seeks to provide the public with accessible information on drug prices and factors affecting their costs.

Main Provisions

Reporting Requirements: The bill requires entities that participate in the 340B Drug Pricing Program to submit detailed annual reports to the state health commissioner. These reports must include acquisition costs, payment amounts, and the number of drugs dispensed.
Data Collection and Reporting: Each year, a report that aggregates data from the previous year must be submitted to legislative committees. This report focuses on entities with significant revenue from the 340B program.
Prescription Drug Price Increases: Drug manufacturers must report to the commissioner any significant price increases for brand name, generic, and biosimilar drugs. This includes price increases of 10% or more for brand drugs and 50% or more for generics over the past year.
Public Posting of Data: The commissioner is tasked with posting a list of drugs on a public website that have had significant price increases, providing insights into their pricing dynamics. This data should be accessible and presented in an easy-to-read format.
Enforcement and Fines: The commissioner can levy fines on entities that fail to report required data on time, although extensions may be granted for good cause.
Public Interest Drugs: The state will maintain a list of drugs that are of substantial public interest due to their price dynamics.

Significant Changes to Existing Law

Expanded Definitions: The bill introduces more comprehensive definitions related to drug pricing, including terms like biosimilars, brand name drugs, and generic drugs.
Increased Oversight: It significantly increases the state’s oversight of drug pricing by requiring comprehensive data submission from manufacturers and 340B covered entities.
Greater Transparency: The bill expands the types of drug price information that must be made publicly available and increases transparency on why prices rise.

Relevant Terms

Prescription drug transparency
340B Drug Pricing Program
Drug price reporting
Brand name drug
Generic drug
Biosimilar
Price increase reporting
Public posting of drug prices
Commissioner's role and enforcement

Bill text versions

Introduction PDF file

Actions

Date	Chamber	Where	Type	Name	Committee Name
April 06, 2025	Senate	Floor	Action	Introduction and first reading
April 06, 2025	Senate	Floor	Action	Referred to	Health and Human Services
April 08, 2025	Senate	Floor	Action	Author added

Citations

[
  {
    "analysis": {
      "added": [
        "New detailed reporting requirements for covered entities under the 340B program."
      ],
      "removed": [
        ""
      ],
      "summary": "This bill modifies reporting requirements to the commissioner for entities participating in the federal 340B program under section 62J.461, subdivision 3.",
      "modified": [
        "Clarification of data submission requirements by payer type, including commercial insurance, medical assistance, MinnesotaCare, and Medicare."
      ]
    },
    "citation": "62J.461",
    "subdivision": "subdivision 3"
  },
  {
    "analysis": {
      "added": [
        "An allowance for entities to apply for reporting extensions or exemptions for good cause."
      ],
      "removed": [
        ""
      ],
      "summary": "This amendment adjusts the enforcement provisions for non-compliance regarding reporting requirements under section 62J.461, subdivision 4.",
      "modified": [
        "Increased fines for late data submission and clarified the process for contested cases and judicial review under sections 14.57 and 14.69."
      ]
    },
    "citation": "62J.461",
    "subdivision": "subdivision 4"
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "The bill updates the annual reporting requirements to the legislature regarding the 340B program data under section 62J.461, subdivision 5.",
      "modified": [
        "The commissioner must submit a report by November 15 each year, including specific net revenue data for certain 340B entities in Minnesota."
      ]
    },
    "citation": "62J.461",
    "subdivision": "subdivision 5"
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "Reference to data classification standards impacting the reporting requirements in the bill under section 13.02, subdivision 9.",
      "modified": [
        "Clarified the classification of submitted data as 'nonpublic data' to align with the existing data privacy standards."
      ]
    },
    "citation": "13.02",
    "subdivision": "subdivision 9"
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "The bill modifies the definitions section related to prescription drug price reporting under section 62J.84, subdivision 2.",
      "modified": [
        "Updated definitions for consistency with related federal law terminologies, including 'Biosimilar', 'Brand name drug', and 'Generic drug.'"
      ]
    },
    "citation": "62J.84",
    "subdivision": "subdivision 2"
  },
  {
    "analysis": {
      "added": [
        "New detailed submission requirements for price increase factors, sales revenue, and manufacturer costs."
      ],
      "removed": [
        ""
      ],
      "summary": "Updates the reporting requirements for prescription drug price increases under section 62J.84, subdivision 3.",
      "modified": [
        "Adjusts thresholds for mandatory price increase reporting for brand name and generic drugs."
      ]
    },
    "citation": "62J.84",
    "subdivision": "subdivision 3"
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "References licensing requirements for PBMs that are relevant to the reporting entities under section 62W.03.",
      "modified": [
        "Incorporates licensing provisions for PBMs to be included in the broader reporting framework."
      ]
    },
    "citation": "62W.03",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "References licensing requirements pertinent to manufacturers as defined in section 151.252.",
      "modified": [
        "Ensures statutory compliance for manufacturers submitting drug price and cost data."
      ]
    },
    "citation": "151.252",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "The bill allows the commissioner to contract with entities satisfying standards set in section 62U.04, subdivision 6 for public posting of drug price information.",
      "modified": [
        "Facilitates collaboration with qualified entities to disseminate public information satisfying transparency goals."
      ]
    },
    "citation": "62U.04",
    "subdivision": "subdivision 6"
  },
  {
    "analysis": {
      "added": [
        ""
      ],
      "removed": [
        ""
      ],
      "summary": "The bill addresses trade secret information under section 13.37, subdivision 1 affecting the disclosure of prescription drug data.",
      "modified": [
        "Aligns public disclosure policies with existing trade secret protections for sensitive manufacturer data."
      ]
    },
    "citation": "13.37",
    "subdivision": "subdivision 1"
  }
]