Epinephrine’s Pharma Inflated Price Ends Now Act; EPIPEN Act
Summary
H.R. 5139, the "Epinephrine's Pharma Inflated Price Ends Now Act" or "EPIPEN Act," aims to amend the Public Health Service Act, the Employee Retirement Income Security Act of 1974, and the Internal Revenue Code of 1986. The bill seeks to establish cost-sharing requirements for epinephrine delivery systems under group health plans and individual and group health insurance coverage. It was introduced in the House of Representatives on September 4, 2025, and referred to multiple committees for consideration.
The core provision of the bill mandates that health plans provide coverage for epinephrine delivery systems without deductibles. It also caps cost-sharing at $60 per package of two delivery systems. The bill defines 'epinephrine delivery system' broadly to include auto-injectors, nasal sprays, and sublingual delivery systems approved by the FDA.
The amendments made by this section will apply with respect to plan years beginning on or after January 1, 2026.
Expected Effects
The bill will likely reduce the out-of-pocket expenses for individuals who require epinephrine delivery systems, such as those with severe allergies. This could lead to increased access to life-saving medication.
Health insurance plans will need to adjust their coverage policies to comply with the new cost-sharing requirements. This may lead to adjustments in premiums or other cost-containment measures.
The bill could also incentivize pharmaceutical companies to re-evaluate the pricing of epinephrine delivery systems.
Potential Benefits
- Reduced Out-of-Pocket Costs: Caps cost-sharing for epinephrine delivery systems at $60 per package, making it more affordable.
- Increased Access to Medication: Eliminating deductibles and limiting cost-sharing improves access for individuals with allergies.
- Financial Relief: Cost-sharing payments count toward deductibles and out-of-pocket maximums, providing additional financial relief.
- Comprehensive Coverage: Includes various epinephrine delivery systems like auto-injectors, nasal sprays, and sublingual options.
- Improved Health Outcomes: Timely access to epinephrine can prevent severe allergic reactions and improve health outcomes.
Potential Disadvantages
- Potential Premium Increases: Health insurance plans may increase premiums to offset the cost of mandated coverage and cost-sharing limits.
- Limited Out-of-Network Coverage: The bill does not require plans to provide benefits for out-of-network providers, potentially limiting choice.
- Cost Shifting: Insurers might shift costs to other areas of coverage to compensate for the mandated epinephrine coverage.
- Administrative Burden: Health plans will incur administrative costs to implement and manage the new requirements.
- Uncertain Impact on Innovation: Reduced profitability for epinephrine delivery systems could potentially disincentivize future innovation in this area.
Constitutional Alignment
The bill appears to align with the general welfare clause of the Constitution (Preamble), as it aims to improve public health by increasing access to life-saving medication. Congress has the power to regulate interstate commerce (Article I, Section 8), which includes health insurance and pharmaceutical products.
The bill also falls under Congress's authority to enact laws necessary and proper for carrying out its enumerated powers (Article I, Section 8, Clause 18). By regulating health insurance plans and cost-sharing for essential medications, the bill seeks to ensure that individuals have access to affordable healthcare.
There are no apparent conflicts with individual rights or liberties protected by the Constitution or its amendments.
Impact Assessment: Things You Care About ⓘ
This action has been evaluated across 19 key areas that matter to you. Scores range from 1 (highly disadvantageous) to 5 (highly beneficial).