EPIPEN Act
- Bill Number
- H.R. 5139
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-09-04: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- Last Updated
- 2025-09-23T16:08:55Z
AI-Generated Summary
Purpose
The legislation, titled the "Epinephrine's Pharma Inflated Price Ends Now Act" or "EPIPEN Act," aims to reduce financial barriers for individuals needing epinephrine delivery systems (devices used to treat severe allergic reactions, such as anaphylaxis). It does this by limiting out-of-pocket costs under group health plans and individual health insurance, ensuring more affordable access to these life-saving medications.
Key Provisions
- Coverage Requirements: Group health plans and health insurance issuers must cover epinephrine delivery systems without applying any deductibles (the amount patients pay before insurance kicks in). Cost-sharing (like copays or coinsurance) is capped at $60 per package of two delivery systems (or an equivalent amount for other package sizes).
- Application to Deductibles and Limits: Any allowed cost-sharing payments count toward the plan's overall deductible and out-of-pocket maximum (the yearly limit on patient expenses).
- Out-of-Network Flexibility: Plans with provider networks are not required to cover out-of-network epinephrine delivery systems and may charge higher costs for them.
- Definition: An "epinephrine delivery system" includes any FDA-approved device for administering epinephrine, such as auto-injectors (e.g., EpiPens), nasal sprays, or sublingual (under-the-tongue) systems.
- Scope and Effective Date: Applies to group health plans under the Employee Retirement Income Security Act (ERISA) and Internal Revenue Code (IRC), as well as group and individual coverage under the Public Health Service Act (PHSA). Changes take effect for plan years beginning on or after January 1, 2026.
Significant Changes to Existing Law
This bill introduces new sections to three major federal laws (PHSA, ERISA, and IRC) that previously lacked specific cost-sharing limits for epinephrine delivery systems. It builds on existing requirements for essential health benefits under the Affordable Care Act by adding targeted protections, eliminating deductibles entirely for these devices and setting a fixed cost cap—changes not present in prior law.
Potential Impacts
- On Citizens: Improves affordability and access for the estimated 1 in 13 Americans with allergies who may need epinephrine, potentially preventing delays in treatment during emergencies and reducing financial strain on families.
- On Government Agencies: The Departments of Health and Human Services, Labor, and Treasury (which enforce PHSA, ERISA, and IRC) will need to update regulations and guidance to implement and monitor compliance, possibly increasing administrative oversight.
- On Health Insurers and Employers: Insurers and self-insured employer plans may face higher upfront costs but could see offsets through better preventive care and reduced emergency claims. No direct impact on international relations is evident.
Main Stakeholders Affected
- Patients and Families: Primary beneficiaries, especially those with severe allergies, asthma, or anaphylaxis risks, who gain lower costs for critical medications.
- Health Insurers and Plans: Must adjust coverage policies, potentially affecting premiums or reimbursements.
- Employers: Sponsors of group plans (including self-insured ones) will need to ensure compliance, impacting benefit design.
- Pharmaceutical Manufacturers: Indirectly affected, as the cost cap may pressure pricing strategies for epinephrine products without directly regulating drug prices.
- Healthcare Providers: Pharmacists and doctors may see increased prescriptions due to affordability, but face no direct changes.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens consumer protections under federal health laws by mandating specific coverage, with enforcement through existing penalties for non-compliance (e.g., fines under ERISA or IRC). It avoids mandating coverage for all plans by allowing out-of-network exceptions, reducing potential legal challenges.
- Constitutional: No apparent conflicts with federalism or individual rights, as it regulates interstate commerce in health insurance—a well-established congressional authority.
- Political: Aligns with broader efforts to address high drug costs and expand access to essential medicines, potentially serving as a model for similar legislation on other high-priced treatments. It may spark debate over balancing patient affordability with insurer costs, but remains narrowly focused without broader tax or spending implications.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (1)
Rep. Matsui, Doris O. [D-CA-7]
Recent Actions
- 2025-09-04: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-04: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-04: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Education and Workforce, and Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
- 2025-09-04: Introduced in House
- 2025-09-04: Introduced in House
Bill Versions
- Epinephrine’s Pharma Inflated Price Ends Now Act — issued 2025-09-04 — PDF (7 pages)