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SB 1638

Prohibitions Against Discriminatory Practices Relating to 340B Entities and 340B Drugs

2026 Regular Session Introduced by Shev Jones

The bill would prohibit discriminatory acquisition, contracting, and reimbursement practices by manufacturers and payors for 340B drugs, enforcing protections under FDUTPA.

Died in Banking and Insurance
#(adopted) #subjectindex
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Bill Summary · SB 1638

Overview

  • Bill: SB 1638 (2026) – Defending Affordable Prescription Drug Costs Act
  • Jurisdiction: Florida
  • Goal: Prohibit discriminatory practices by drug manufacturers and payors related to 340B drugs and 340B entities; establish enforceable protections under Florida’s Deceptive and Unfair Trade Practices Act (FDUTPA).
  • Status: Died in Banking and Insurance committee (Action History shows referral and eventual dissolution in committee).

Main purpose and intent

  • To protect access to 340B drugs by preventing discriminatory conduct in both acquisition and reimbursement processes.
  • Aims to ensure that 340B entities (covered entities and their contracted pharmacies) and patients are not disadvantaged in obtaining or paying for 340B drugs.
  • Seeks parity with non-340B entities in contracting, reimbursement, and network participation, and to deter unfair practices through FDUTPA penalties.

Key provisions and changes

1) Definitions (across sections 499.061, 626.8829, 627.64743, 627.65733, 641.31543)
- Clarifies terms: 340B drug, 340B entity, pharmacy, and related PBMs/insurers for purposes of the statute.
- Aligns definitions with federal 340B program references (42 U.S.C. 256b).

2) Prohibitions on manufacturers (Section 499.061)
- Manufacturers may not:
- Deny, restrict, prohibit, or interfere with acquisition or delivery of a 340B drug to a pharmacy contracted with a 340B entity (unless prohibited by federal law).
- Interfere with a pharmacy’s right to contract with a 340B entity.
- Violations are deemed FDUTPA violations, subject to its remedies and penalties.
- Limited distribution under risk mitigation strategies (REM) is not a violation.

3) Reimbursement protections for 340B entities (Sections 626.8829, 627.64743, 627.65733, 641.31543)
- Health insurance issuers, PBMs, and other payors (and their agents) may not:
- Reimburse a 340B entity at a lower rate for a 340B drug than for non-340B drugs.
- Impose terms/conditions on 340B entities that differ from non-340B entities solely due to 340B participation, including:
- Fees, clawbacks, or other adjustments not applied to non-340B entities
- Lower dispensing fees
- Restrictions in standard or preferred networks
- Audit frequency/scope requirements
- Requirements to indicate a drug is 340B on claims (unless required by CMS/AA)
- Other restrictions not imposed on non-340B entities
- Require reversal/resubmission/clarification of 340B-related claims outside normal pharmacy business
- Exclude 340B entities from networks for being 340B-participating or contract withholdings not applied to non-340B entities
- These provisions apply to:
- Individual health insurers (SB 1638 Sections 626.8829, 627.64743, 641.31543)
- PBMs and third-party payors, with respective statutory sections
- Medicaid exception: Section 4/Sec. 626.8829 acknowledges Medicaid as payor is exempt from certain provisions.

4) Enforcement and penalties
- Each prohibited act constitutes a FDUTPA violation.
- Violators may face FDUTPA remedies, including investigative demands and penalties.
- Provisions emphasize consistency with federal law; not intended to be less restrictive than federal law.

5) Effective date
- Effective July 1, 2026.

Who would be affected

  • Drug manufacturers: Prohibited from discriminatory acquisition/delivery practices and interfering with contracts with 340B entities.
  • 340B entities (and their contracted pharmacies): Protected from discriminatory reimbursement terms and network/exclusion practices.
  • Health insurers, health maintenance organizations, group/blanket/franchise insurers, PBMs, and other third-party payors and their agents: Must adhere to nondiscrimination standards in reimbursement for 340B drugs; changes extend to network participation and pricing terms.
  • Patients: Beneficiaries indirectly affected through protections against price- and contract-based discrimination impacting access to 340B drugs.

Procedural and timeline aspects

  • Legislative text sets a clear effective date: July 1, 2026.
  • Duplicative or parallel protections across multiple Florida statutes (FDUTPA framework) to ensure enforceability and consistency with federal law.
  • As an FDUTPA-based framework, enforcement could involve state investigations, civil actions, and penalties for violators.
  • Status indicates the bill did not advance past Banking and Insurance committee in 2026.

Notes for readers

  • The bill mirrors and expands protections around the federal 340B program to ensure fair contracting and reimbursement practices within Florida.
  • It creates a multi-statute framework to regulate both manufacturers and payors, with FDUTPA as the enforcement mechanism.
  • While the bill did not become law in the 2026 session, its provisions illustrate legislative focus on safeguarding affordable access to 340B drugs.

Compiled from official sources — confirm details with the bill’s official record.

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