HF4349 (Legislative Session 94 (2025-2026))
Provisions governing hospital reimbursement for biological products to treat rare diseases modified.
Related bill: SF4521
AI Generated Summary
Purpose
This bill would change how hospitals are paid for certain biological products used in cell and gene therapies to treat rare diseases. It sets up a separate payment for these products in the inpatient hospital setting, but only if a drug maker enters a value-based payment arrangement with the state.
Main Provisions
- Establishes separate reimbursement to hospitals for biological products provided in the inpatient hospital setting as part of cell or gene therapy to treat rare diseases (as defined by current federal law), when the drug manufacturer signs a value-based arrangement with the state commissioner.
- Sets the reimbursement rate to follow the methodology used for drugs given in outpatient settings (the same approach used in another part of state law for outpatient drugs).
- Requires hospitals to be paid the actual acquisition cost (the exact price paid to obtain the biological product).
Effective Date and Requirements
- The changes take effect July 1, 2025, and depend on federal approval of the necessary documentation to enter into a value-based arrangement under another state program.
- The arrangement hinges on the drug manufacturer entering into a value-based agreement with the commissioner.
How this Changes Existing Law
- Adds a new subdivision focused on “Biological products for cell and gene therapy,” creating a specialized reimbursement process.
- Shifts inpatient reimbursement for these products to align with a value-based framework and with the outpatient drug payment methodology.
- Ties reimbursement to the manufacturer’s participation in a value-based agreement and requires federal approval of related documentation.
Key Concepts and Terms Encountered
- biological products
- cell therapy
- gene therapy
- inpatient hospital setting
- rare diseases
- value-based arrangement
- actual acquisition cost
- outpatient setting
- 256B.0625 subdivision 13k
- 256B.0625 subdivision 13e paragraph e
- United States Code title 21 section 360bb
- federal approval
- documentation required
Relevant Terms cell and gene therapy, biological products, inpatient, outpatient, value-based arrangement, actual acquisition cost, rare diseases, federal approval, documentation, 21 U.S.C. 360bb, 256B.0625, subdivision 13k, subdivision 13e, price methodology.
Bill text versions
- Introduction PDF PDF file
Upcoming committee meetings
- Health Finance and Policy on: March 23, 2026 13:00
- Health Finance and Policy on: March 23, 2026 13:00
Actions
| Date | Chamber | Where | Type | Name | Committee Name |
|---|---|---|---|---|---|
| March 16, 2026 | House | Action | Introduction and first reading, referred to | Health Finance and Policy |
Citations
[
{
"analysis": {
"added": [
"Creates a separate reimbursement mechanism for biological products in the inpatient setting as part of cell or gene therapy for rare diseases.",
"Links reimbursement to federal approval of documentation for a value-based arrangement under 256B.0625, subd. 13k.",
"Uses outpatient reimbursement methodology under 256B.0625, subd. 13e, para. e, to set the inpatient rate.",
"Requires payment of actual acquisition cost to hospitals for these products."
],
"removed": [],
"summary": "This bill amends Minnesota Statutes 2024 section 256.969, subdivision 32, to create separate inpatient hospital reimbursement for biological products used in cell or gene therapy to treat rare diseases, contingent on federal approval of documentation for a value-based arrangement under Minnesota Statutes 256B.0625, subdivision 13k. The rate is to be based on the outpatient reimbursement methodology under 256B.0625, subdivision 13e, paragraph e, and hospitals must be paid the actual acquisition cost.",
"modified": [
"Amends 256.969, subd. 32."
]
},
"citation": "256.969",
"subdivision": "subd. 32"
},
{
"analysis": {
"added": [],
"removed": [],
"summary": "The bill references Minnesota Statutes 256B.0625, subdivision 13k, as the basis for value-based arrangements related to hospital reimbursement for biological products. No specific statutory changes to 256B.0625, subd. 13k are included in this bill.",
"modified": [
"References 256B.0625, subd. 13k to authorize value-based arrangements for reimbursement of biological products."
]
},
"citation": "256B.0625",
"subdivision": "subd. 13k"
},
{
"analysis": {
"added": [],
"removed": [],
"summary": "The bill references Minnesota Statutes 256B.0625, subdivision 13e, paragraph e, for the outpatient reimbursement methodology that is applied to the inpatient reimbursement for biological products in cell/gene therapy.",
"modified": [
"Uses the outpatient reimbursement methodology described in 256B.0625, subd. 13e, para. e as the basis for setting the inpatient rate in this bill."
]
},
"citation": "256B.0625",
"subdivision": "subd. 13e, para. e"
},
{
"analysis": {
"added": [],
"removed": [],
"summary": "The bill references United States Code, Title 21, Section 360BB to define what constitutes a rare disease in the context of cell/gene therapy. The reference does not modify federal law.",
"modified": [
"Cites 21 U.S.C. § 360BB for the definition referenced in the bill."
]
},
"citation": "21 U.S.C. § 360BB",
"subdivision": ""
}
]Progress through the legislative process
In Committee