H.R. 5139: Epinephrine’s Pharma Inflated Price Ends Now Act

This bill, titled the "Epinephrine’s Pharma Inflated Price Ends Now Act" or "EPIPEN Act," aims to make epinephrine delivery systems more accessible and affordable for patients by amending several laws related to health insurance.

Key Provisions

• Coverage Requirement: The bill mandates that group health plans and health insurance issuers must provide coverage for epinephrine delivery systems, which include devices like auto-injectors and nasal sprays approved by the FDA.
• No Deductibles: Insurers may not apply any deductibles to these medications, meaning patients won't have to pay a set amount out of pocket before their insurance starts to cover the costs.
• Cost Sharing Limit: There is a cap on cost sharing, which is defined to not exceed $60 per package of two epinephrine delivery systems. This means that patients should only pay this amount for their medications, regardless of the total cost.
• In-Network vs. Out-of-Network Providers: The bill specifies that insurers are not obligated to cover epinephrine delivery systems when obtained from out-of-network providers. However, if patients do go out-of-network, the insurance companies can impose higher costs beyond the $60 limit.
• Application of Payments: Any payments made by patients for these delivery systems will count toward their annual deductibles and out-of-pocket maximums, helping patients avoid high costs over the year.

Legal Context

The bill modifies portions of three major statutes:

1. Public Health Service Act (PHSA): Adjustments are made to the health insurance framework established under this act to ensure that epinephrine delivery systems are covered according to the new guidelines.
2. Employee Retirement Income Security Act (ERISA): The provisions regarding employee benefits and health insurance coverage will similarly be updated to reflect the new coverage requirements for epinephrine delivery systems.
3. Internal Revenue Code (IRC): Adjustments here will address how health plans must cover these drugs in a way that is compliant with tax regulations, specifically ensuring that patients are not hit with high out-of-pocket expenses.

Implementation Timeline

The regulations set forth in this bill are set to take effect for health plans beginning on or after January 1, 2026.

Relevant Companies

• MYKAY - This company produces epinephrine auto-injectors. The new pricing regulations may impact their sales and pricing strategies significantly.
• EPI - As a manufacturer of epinephrine delivery systems, this company stands to be influenced by the cap on out-of-pocket costs imposed by the bill.