Affordable Inhalers and Nebulizers Act of 2025
- Bill Number
- H.R. 5278
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-09-10: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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
- 2025-12-02T08:46:00Z
AI-Generated Summary
Purpose of the Legislation
The Affordable Inhalers and Nebulizers Act of 2025 aims to make prescription inhalers and related equipment more affordable for people with breathing disorders like asthma and chronic obstructive pulmonary disease (COPD). It does this by limiting out-of-pocket costs for patients and ensuring coverage without high upfront fees, applying to private insurance, Medicare, and uninsured individuals.
Key Provisions
- Coverage for Private Insurance Plans:
- Amends the Public Health Service Act (PHSA), Internal Revenue Code (IRC), and Employee Retirement Income Security Act (ERISA) to require group and individual health plans to cover all "specified inhaler products" (defined below).
- No deductibles (the amount patients pay before insurance kicks in) can be applied.
- Cost-sharing (like copays or coinsurance) is capped at $15 per 30-day supply.
- Any cost-sharing paid counts toward the patient's overall out-of-pocket maximum and deductible limits.
- "Specified inhaler product" includes maintenance, reliever, or rescue inhalation drugs (e.g., aerosols, metered-dose inhalers, dry powder inhalers, solutions, bronchodilators, and corticosteroids) approved for treating asthma or COPD. It also covers related equipment like masks, tubing, spacers, nebulizers, and valve-holding chambers.
- Includes "safe harbor" rules: High-deductible health plans (HDHPs, which encourage using health savings accounts) and catastrophic plans (basic coverage for major medical events) won't lose their status for waiving deductibles on these products.
- Coverage for Medicare:
- Under Medicare Part B (outpatient services), patients pay no more than $15 per 30-day supply after Medicare covers 100% of the approved amount (with no deductible applied).
- Under Medicare Part D (prescription drugs), plans must cover these products with no deductible and cost-sharing capped at $15 per month's supply. This applies to standard plans and alternative coverage options.
- Low-income Medicare beneficiaries get the same $15 cap on copays for these products.
- Effective for services starting January 1, 2026.
- Support for Uninsured Individuals:
- Creates a new payment program under the PHSA, run by the Secretary of Health and Human Services (HHS).
- Starting January 1, 2026, licensed healthcare providers (e.g., doctors or pharmacies) can register and submit claims for providing these products to uninsured people.
- HHS reimburses providers an amount it deems appropriate (subject to available funding), and patients pay no more than $15 per month's supply.
- "Uninsured" means not covered by federal programs (like Medicaid or Medicare), employer/group plans, individual insurance, or federal employee health benefits.
- Providers agree not to charge uninsured patients more than $15 if reimbursed.
- Implementation:
- HHS can use guidance, instructions, or other methods to put these changes into effect without full rulemaking.
Significant Changes to Existing Law
- Adds new sections to PHSA (Section 2799A-11), IRC (Section 9826), ERISA (Section 726), and Social Security Act (for Medicare Parts B and D).
- Modifies Medicare payment rules (e.g., Section 1833 for Part B fees and deductibles; Section 1860D-2 for Part D benefits) to eliminate deductibles and cap costs specifically for inhalers.
- Updates low-income subsidy rules in Medicare Part D to align with the $15 cap.
- Introduces a first-of-its-kind reimbursement program for uninsured patients under PHSA (new Section 399V-8), which doesn't exist in current law.
- Provides exceptions (safe harbors) for HDHPs under IRC Section 223 and catastrophic plans under the Affordable Care Act (ACA), preventing these plans from being disqualified for the new rules.
- All changes apply to plan years beginning on or after January 1, 2026.
Potential Impacts
- On Citizens: Improves access to essential medications and devices for the estimated 25 million Americans with asthma and 16 million with COPD, reducing financial barriers that could lead to skipped treatments, emergency visits, or worsened health. Uninsured patients gain a safety net, potentially lowering overall healthcare costs from untreated conditions.
- On Government Agencies: HHS and the Centers for Medicare & Medicaid Services (CMS) will need to oversee implementation, process claims for the uninsured program, and update Medicare systems, which may require new funding or administrative resources. Medicare spending could rise due to full coverage but might be offset by fewer hospitalizations.
- On Health Insurers and Employers: Plans must redesign benefits to comply, possibly increasing premiums slightly to cover the waived deductibles, though it standardizes costs for a common chronic condition.
- On International Relations: No direct impact, as the bill focuses on domestic U.S. health policy.
Main Stakeholders Affected
- Patients: Primarily those with asthma or COPD, including children, seniors on Medicare, and low-income or uninsured individuals who rely on inhalers for daily management or emergencies.
- Healthcare Providers: Pharmacies, doctors, and clinics that dispense or administer these products, especially those serving uninsured patients through the new reimbursement program.
- Health Insurers and Employers: Insurance companies and self-insured employer plans must adjust coverage, potentially facing compliance costs.
- Pharmaceutical Manufacturers: Companies producing inhalers (e.g., makers of albuterol or steroid inhalers) may see steady demand but could experience pricing pressures if costs shift more to payers.
- Government Entities: HHS and CMS for administration; Congress for funding the uninsured program.
Notable Legal, Constitutional, or Political Implications
- Legal: Builds on the ACA's essential health benefits framework by mandating coverage for a specific category of drugs/devices, which could invite lawsuits from insurers claiming it exceeds federal authority over private plans. However, it mirrors existing mandates (e.g., for insulin cost caps) and includes coordination across ERISA (for employer plans) to avoid preemption issues. The uninsured program relies on appropriations, so funding disputes could delay rollout.
- Constitutional: No major challenges expected; it regulates interstate commerce in healthcare (a well-established federal power) without infringing on states' rights, as states can still regulate provider licensing.
- Political: Sponsored by a diverse group of House members (mostly Democrats from urban districts), it advances affordable care priorities amid ongoing debates on drug pricing. If passed, it could set a precedent for capping costs on other chronic disease treatments, influencing future healthcare reform, but faces potential opposition over added costs to Medicare and private plans.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (13)
Rep. Johnson, Henry C. "Hank" [D-GA-4], Del. Norton, Eleanor Holmes [D-DC-At Large], Rep. Thanedar, Shri [D-MI-13], Rep. Elfreth, Sarah [D-MD-3], Rep. McIver, LaMonica [D-NJ-10], Rep. Fields, Cleo [D-LA-6], Rep. Davis, Danny K. [D-IL-7], Rep. Figures, Shomari [D-AL-2], Rep. Olszewski, Johnny [D-MD-2], Rep. Ivey, Glenn [D-MD-4], Rep. McClain Delaney, April [D-MD-6], Rep. Foushee, Valerie P. [D-NC-4], Rep. Lynch, Stephen F. [D-MA-8]
Recent Actions
- 2025-09-10: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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.
- 2025-09-10: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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.
- 2025-09-10: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Workforce, 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.
- 2025-09-10: Introduced in House
- 2025-09-10: Introduced in House
Bill Versions
- Affordable Inhalers and Nebulizers Act of 2025 — issued 2025-09-10 — PDF (14 pages)