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HR 5278S 2756119th CongressIntroduced

Affordable Inhalers and Nebulizers Act of 2025

Introduced: Sep 10, 2025
Healthcare
Chamber Versions:
Standard Summary
Comprehensive overview in 1-2 paragraphs

The Affordable Inhalers and Nebulizers Act of 2025 aims to significantly reduce what patients pay out of pocket for prescription inhaler products (including devices used to administer them) used to treat asthma and COPD. The bill would establish a uniform $15 cap for cost-sharing per 30-day supply and eliminate deductibles for these products across private insurance (through the Public Health Service Act, Internal Revenue Code, and ERISA), and would apply similar protections in Medicare. It also creates a program to reimburse providers who furnish these inhaler products to uninsured individuals, so patients do not face higher costs. The measure defines “specified inhaler products” to include both the drugs (maintenance, reliever, or rescue inhalers) and the associated administration equipment (spacers, nebulizers, masks, etc.). The changes would begin to take effect for plan years starting in 2026 and include safe harbors to preserve certain plan designs (like high-deductible plans) and adjustments to Medicare costs and coverage. In short, the bill seeks broad, cross-cutting cost-sharing relief for inhaler therapies and related devices, expanding protections to insured private plans, Medicare, and uninsured individuals through a payer/provider program, with a focus on asthma and COPD treatments.

Key Points

  • 1Coverage and cost-sharing cap: Requires private group health plans, health insurance issuers, and related coverage to cover all specified inhaler products without a deductible and with cost-sharing not exceeding $15 per 30-day supply; applies across PHSA Part D, IRC, and ERISA plans (with parallel provisions in each respective statute).
  • 2Counting toward deductibles and out-of-pocket maximums: Any cost-sharing for specified inhaler products must be counted toward an enrollee’s deductible and out-of-pocket maximum, as if the standard cost-sharing rules applied.
  • 3Medicare and Part D/D-2 adjustments: Creates similar $15-per-30-day cap and no-deductible rules for specified inhaler products under Medicare Part B and Part D, including adjustments to payment amounts and deductible rules for these products (with applicable conformity across the Medicare statute sections cited).
  • 4Uninsured patient payment program: Establishes a program under Part P to reimburse program-registered providers for specified inhaler products furnished to uninsured individuals, with the provider agreeing not to bill the uninsured patient beyond $15 per 30-day supply if a payment is made under the program.
  • 5Definition and scope of specified inhaler products: Defines “specified inhaler product” to include maintenance, reliever, or rescue inhalers (in various formulations) and any equipment used to administer them (e.g., masks, tubing, spacers, nebulizers, valve-holding chambers), with medically accepted indications for asthma or COPD.

Impact Areas

Primary group/area affected- Individuals with asthma or COPD who use inhaler therapies and related administration devices, including both insured and uninsured populations.Secondary group/area affected- Private employers, health plans, and insurers ( plan sponsors and issuers) due to changes in benefit design, deductible structure, and cost-sharing caps.- Medicare beneficiaries (Part B and Part D) who rely on inhaler therapies, with changes to cost-sharing and pricing mechanics.Additional impacts- Potential reduction in patient out-of-pocket costs and fewer barriers to access for inhaled therapies.- Encouragement of coverage expansion for inhaler products in employer-sponsored plans and in Medicare, which could affect premium patterns and formulary design.- Creation of a new funding/operational pathway to support uninsured patients through provider reimbursements, with oversight by the Secretary of Health and Human Services.- Administrative changes for plans to implement the new caps, counting rules, and safe harbors, plus the need for plan documents and member communications reflecting the new requirements.- Clarification of definitions to ensure inclusion of inhaler devices and administration equipment in the protections.Out-of-pocket maximum: the most a patient would pay out of pocket in a given period; once reached, the plan covers 100% of covered benefits.Deductible: the amount a patient must pay before the plan starts to pay.Cost-sharing: includes copays, coinsurance, and similar patient payments.Safe harbor: protections that help certain plans (like high-deductible health plans) maintain favorable tax or regulatory treatment while offering the new benefits.30-day supply: standard unit for measuring a month’s worth of medication, used to cap costs.Medically accepted indication: a recognized therapeutic use defined by existing laws, ensuring the inhaler products are legitimately prescribed for asthma or COPD.
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