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HR 5139119th CongressIn Committee

EPIPEN Act

Introduced: Sep 4, 2025
Healthcare
Standard Summary
Comprehensive overview in 1-2 paragraphs

The EPIPEN Act would require group health plans and health insurance issuers offering group or individual coverage to cover epinephrine delivery systems (FDA-approved devices for administering epinephrine, such as auto-injectors, nasal sprays, or sublingual systems) with no deductible and with cost sharing capped at $60 per package that contains two delivery systems (or an equivalent packaging). Any cost-sharing paid for these devices would count toward the plan’s deductible and out-of-pocket maximums. The bill maintains that plans are not required to cover out-of-network epinephrine delivery systems, and may charge higher cost sharing for out-of-network devices. It applies across the Public Health Service Act (PHSA), ERISA, and the Internal Revenue Code (IRC), and defines the term “epinephrine delivery system” as FDA-approved delivery methods. The effective date is for plan years beginning on or after January 1, 2026. The bill’s title frames this as a measure to counteract high and rising prices for epinephrine products.

Key Points

  • 1Requires coverage of epinephrine delivery systems with no deductible and a cap on cost sharing at $60 per package of 2 delivery systems (or the equivalent).
  • 2Cost sharing for these devices must be counted toward any deductible and out-of-pocket maximums.
  • 3Out-of-network coverage is not guaranteed, and higher cost sharing can apply for epinephrine delivery systems delivered out-of-network.
  • 4Defines “epinephrine delivery system” as FDA-approved delivery methods for epinephrine, including auto-injectors, nasal sprays, and sublingual systems.
  • 5Applies the requirements to PHSA Part D, ERISA, and IRC, with a stated effective date for plan years beginning on or after January 1, 2026.

Impact Areas

Primary group: Individuals and families with access to group health plans or individual/group coverage who rely on epinephrine delivery systems (e.g., those with severe allergies or at risk of anaphylaxis) who would face lower out-of-pocket costs.Secondary group: Employers, health insurers, and health plans that would need to adjust coverage and cost-sharing structures to comply; manufacturers of epinephrine delivery systems.Additional impacts: Potential changes in consumer access and adherence during emergencies, administrative changes for plan administrators (tracking deductible/out-of-pocket accrual), and possible effects on pricing dynamics if plans adjust formularies or network practices to manage costs.
Generated by gpt-5-nano on Oct 8, 2025