SF3294 (Legislative Session 94 (2025-2026))

Prescription drug transparency provisions modifications

Related bill: HF3054

AI Generated Summary

Purpose of the Bill

The purpose of this bill is to enhance transparency in prescription drug pricing in Minnesota. It aims to modify the reporting requirements for entities involved in the 340B drug pricing program and to expand public access to information about drug pricing and increases.

Main Provisions

  • Reporting Requirements for 340B Entities: Entities participating in the 340B program must annually report detailed financial information regarding drug acquisition costs, payments for drugs dispensed, and direct costs associated with the program. These details need to be reported by payer type and at the national drug code level for frequently dispensed drugs by hospitals.

  • Enforcement and Exceptions: Non-compliant entities may be fined up to $500 per day for late reporting, though extensions or exemptions may be granted for good cause.

  • Annual Legislative Reports: The commissioner must report aggregated data about 340B entities to the legislature annually by November 15.

  • Definitions Updates: Definitions for terms like "biosimilar," "brand name drug," "generic drug," and "prescription drug" have been clarified in statute.

  • Prescription Drug Price Increase Reporting: Manufacturers have to report detailed information concerning price increases for drugs where such increases exceed specific thresholds over 12 to 24 months.

  • Public Posting of Drug Price Information: The commissioner is required to publicly post drug pricing information online in a comprehensible format, while protecting trade secrets and non-public data.

  • Notice of Drugs of Public Interest: A quarterly published list of drugs of substantial public interest will be made available, indicating those with significant price increases or public concerns.

Significant Changes to Existing Law

  • The amendments require more detailed reporting from 340B covered entities, enforcing stricter transparency on drug pricing and related costs.
  • The bill introduces the requirement for the commissioner to post certain prescription drug price information to increase public awareness.
  • It specifies public posting of a list of drugs defined as having substantial public interest, reflecting a stronger stance on price transparency.

Relevant Terms

  • Prescription Drug Pricing
  • Transparency
  • 340B Drug Pricing Program
  • Reporting Requirements
  • Biosimilar
  • Brand Name Drug
  • Generic Drug
  • Commissioner of Health
  • Public Posting
  • Price Increase Reporting

Bill text versions

Actions

DateChamberWhereTypeNameCommittee Name
April 06, 2025SenateFloorActionIntroduction and first reading
April 06, 2025SenateFloorActionReferred toHealth and Human Services

Citations

 
[
  {
    "analysis": {
      "added": [
        "A requirement for reporting by national drug code level for the 50 most frequently dispensed drugs."
      ],
      "removed": [],
      "summary": "This bill modifies reporting requirements for 340B covered entities under section 62J.461, subdivision 3.",
      "modified": [
        "The format and manner of reporting by payer type prescribed by the commissioner."
      ]
    },
    "citation": "62J.461",
    "subdivision": "subdivision 3"
  },
  {
    "analysis": {
      "added": [
        "An option for the commissioner to grant extensions or exemptions from reporting."
      ],
      "removed": [],
      "summary": "This bill addresses enforcement and exceptions for reporting by health care entities under section 62J.461, subdivision 4.",
      "modified": [
        "The provision related to fines for late data submission."
      ]
    },
    "citation": "62J.461",
    "subdivision": "subdivision 4"
  },
  {
    "analysis": {
      "added": [
        "Requirements for aggregation of data and specific reporting for significant net revenue entities."
      ],
      "removed": [],
      "summary": "The bill updates the reporting requirements to the legislature under section 62J.461, subdivision 5.",
      "modified": [
        "The format of reports to the legislature by November 15 each year."
      ]
    },
    "citation": "62J.461",
    "subdivision": "subdivision 5"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Classification of data reported by 340B entities as nonpublic under section 13.02, subdivision 9 is reiterated.",
      "modified": []
    },
    "citation": "13.02",
    "subdivision": "subdivision 9"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Reference to trade secret information under section 13.37, subdivision 1.",
      "modified": []
    },
    "citation": "13.37",
    "subdivision": "subdivision 1"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Definition of prescription drug referenced under section 151.441, subdivision 8.",
      "modified": []
    },
    "citation": "151.441",
    "subdivision": "subdivision 8"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "The bill references the licensing requirements for pharmacy benefit managers under section 62W.03.",
      "modified": []
    },
    "citation": "62W.03",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Reference to the licensing of wholesale drug distributors under section 151.47.",
      "modified": []
    },
    "citation": "151.47",
    "subdivision": ""
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Reference to standards for contracting with private entities under section 62U.04, subdivision 6.",
      "modified": []
    },
    "citation": "62U.04",
    "subdivision": "subdivision 6"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Federal reference for biologics license application under section 262.",
      "modified": []
    },
    "citation": "United States Code title 42",
    "subdivision": "section 262"
  },
  {
    "analysis": {
      "added": [],
      "removed": [],
      "summary": "Federal reference for new drug applications under section 355.",
      "modified": []
    },
    "citation": "United States Code title 21",
    "subdivision": "section 355"
  }
]