HR5278-119

1. Short title This Act may be cited as the Affordable Inhalers and Nebulizers Act of 2025.

2. Reducing patient cost sharing for prescription drug inhaler products used to treat breathing disorders such as asthma and chronic obstructive pulmonary disease Part D of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–111 et seq.) is amended by adding at the end the following new section: A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide benefits under such plan or coverage (as applicable) for all specified inhaler products and, with respect to such a product, may not— apply any deductible; or impose any cost-sharing requirement in excess of $15 per 30-day supply of such product. A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall count any cost-sharing requirement described in subsection (a)(2) incurred by an individual enrolled under such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such individual and product. For purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodilators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment for lung diseases such as asthma and chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers). Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section: A group health plan shall provide benefits under such plan for all specified inhaler products and, with respect to such a product, may not— apply any deductible; or impose any cost-sharing requirement in excess of $15 per 30-day supply of such product. A group health plan shall count any cost-sharing requirement described in subsection (a)(2) incurred by a participant or beneficiary of such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such participant or beneficiary. For purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodialators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment of asthma or of chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers). The table of sections for such subchapter is amended by adding at the end the following new item: Subpart B of part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 is amended by adding at the end the following new section: A group health plan, and a health insurance issuer offering group health insurance coverage, shall provide benefits under such plan or coverage (as applicable) for all specified inhaler products and, with respect to such a product, may not— apply any deductible; or impose any cost-sharing requirement in excess of $15 per 30-day supply of such product. A group health plan, and a health insurance issuer offering group health insurance coverage, shall count any cost-sharing requirement described in subsection (a)(2) incurred by a participant or beneficiary of such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such participant or beneficiary and product. For purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodialators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment of asthma or of chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers). The table of contents in section 1 of such Act is amended by inserting after the item relating to section 725 the following new item: Section 223(c)(2) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph: For plan years beginning on or after January 1, 2026, a plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for specified inhaler products (as defined in section 2799A–11 of the Public Health Service Act). Section 1302(e)(1)(B)(i) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(e)(1)(B)(i)) is amended by inserting or 2799A–11 of the Public Health Service Act after section 2713. The amendments made by this paragraph shall apply to plan years beginning on or after January 1, 2026. Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended— in subsection (a)(1)(S)— in clause (i), by inserting or (iii) after clause (ii); and by adding at the end the following new clause: and (iii) with respect to a specified inhaler product (as defined in section 2799A–11 of the Public Health Service Act) furnished on or after January 1, 2026, the amounts paid shall be 100 percent of the lesser of the actual charge or the payment amount established in section 1842(o) (or, if applicable, under section 1847, 1847A, or 1847B), less, per 30-day supply of such product, $15,; and in subsection (b), in the first sentence— in paragraph (12), by striking , and; and by striking .. and inserting , and (14) such deductible shall not apply with respect to a specified inhaler product (as defined in section 2799A–11 of the Public Health Service Act) furnished on or after January 1, 2026.. Section 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w–102(b)) is amended— in paragraph (1)(A), by striking paragraphs (8) and (9) and inserting paragraphs (8), (9), and (10); in paragraph (2)(A), by striking paragraphs (8) and (9) and inserting paragraphs (8), (9), and (10); in paragraph (4)(A)(i), by striking paragraphs (8) and (9) and inserting paragraphs (8), (9), and (10); and by adding at the end the following new paragraph: For plan year 2026 and subsequent plan years, the deductible under paragraph (1) shall not apply with respect to any specified inhaler product. For plan year 2026 and subsequent plan years, the coverage provides benefits for any specified inhaler product with cost sharing for a month’s supply that does not exceed $15. For purposes of this paragraph, the term specified inhaler product has the meaning given such term in section 2799A–11 of the Public Health Service Act. Section 1860D–2(c) of the Social Security Act (42 U.S.C. 1395w–102(c)) is amended by adding at the end the following new paragraph: The coverage to provided in accordance with subsection (b)(10). Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended— in paragraph (1)— in subparagraph (D)(iii), by adding at the end the following new sentence: For plan year 2026 and subsequent plan years, the copayment amount applicable under the preceding sentence to a month's supply of a specified inhaler product (as defined in section 1860D–2(b)(10)) dispensed to the individual may not exceed $15.; and in subparagraph (E), by inserting or under section 1860D–2(b)(10) in the case of a specified inhaler product (as defined in such section) after (as defined in subparagraph (C) of such section); and in paragraph (2)(B), by striking paragraphs (8) and (9) and inserting paragraphs (8), (9), and (10). Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following new section: Beginning January 1, 2026, the Secretary shall establish a program under which— program-registered providers submit claims to the Secretary with respect to the furnishing of specified inhaler products (as defined in subsection (b)) to uninsured individuals; and the Secretary, subject to the availability of appropriations, pays each such provider for such products in an amount determined appropriate by the Secretary. In this section: The term program-registered provider means a health care provider that— is licensed or otherwise authorized to administer or dispense specified inhaler products in the State in which such provider so administers or dispenses such products under the program established under this section; and enters into an agreement with the Secretary under which the provider agrees not to hold an uninsured individual liable for the cost of any such product administered or dispensed to such individual in an amount exceeding $15 for a month’s supply of such product if a payment is made under subsection (a)(2) with respect to such product so administered or dispensed. The term specified inhaler product has the meaning given such term in section 2799A–11. The term uninsured individual means, with respect to an individual furnished a specified inhaler product, an individual who is not enrolled in— a Federal health care program (as defined in section 1128B(f) of the Social Security Act); a group health plan or health insurance coverage offered by a health insurance issuer in the group or individual market (as such terms are defined in section 2791); or a health plan offered under chapter 89 of title 5, United States Code. The Secretary of Health and Human Services may implement the amendments made by this section by program instruction, subregulatory guidance, or otherwise. 2799A–11.Coverage and cost-sharing requirements for specified inhaler products(a)In generalA group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide benefits under such plan or coverage (as applicable) for all specified inhaler products and, with respect to such a product, may not—(1)apply any deductible; or(2)impose any cost-sharing requirement in excess of $15 per 30-day supply of such product.(b)Counting cost sharing towards deductible and out-of-Pocket maximumA group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall count any cost-sharing requirement described in subsection (a)(2) incurred by an individual enrolled under such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such individual and product.(c)Specified inhaler product definedFor purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodilators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment for lung diseases such as asthma and chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers).. 9826.Coverage and cost-sharing requirements for specified inhaler products(a)In generalA group health plan shall provide benefits under such plan for all specified inhaler products and, with respect to such a product, may not—(1)apply any deductible; or(2)impose any cost-sharing requirement in excess of $15 per 30-day supply of such product.(b)Counting cost sharing towards deductible and out-of-Pocket maximumA group health plan shall count any cost-sharing requirement described in subsection (a)(2) incurred by a participant or beneficiary of such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such participant or beneficiary.(c)Specified inhaler product definedFor purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodialators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment of asthma or of chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers).. Sec. 9826. Coverage and cost-sharing requirements for specified inhaler products.. 726.Coverage and cost-sharing requirements for specified inhaler products(a)In generalA group health plan, and a health insurance issuer offering group health insurance coverage, shall provide benefits under such plan or coverage (as applicable) for all specified inhaler products and, with respect to such a product, may not—(1)apply any deductible; or(2)impose any cost-sharing requirement in excess of $15 per 30-day supply of such product.(b)Counting cost sharing towards deductible and out-of-Pocket maximumA group health plan, and a health insurance issuer offering group health insurance coverage, shall count any cost-sharing requirement described in subsection (a)(2) incurred by a participant or beneficiary of such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such participant or beneficiary and product.(c)Specified inhaler product definedFor purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodialators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment of asthma or of chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers).. Sec. 726. Coverage and cost-sharing requirements for specified inhaler products.. (H)Safe harbor for absence of deductible for specified inhaler productsFor plan years beginning on or after January 1, 2026, a plan shall not fail to be treated as a high deductible health plan by reason of failing to have a deductible for specified inhaler products (as defined in section 2799A–11 of the Public Health Service Act).. (10)Treatment of cost sharing for specified inhaler products(A)No application of deductibleFor plan year 2026 and subsequent plan years, the deductible under paragraph (1) shall not apply with respect to any specified inhaler product.(B)Application of cost sharingFor plan year 2026 and subsequent plan years, the coverage provides benefits for any specified inhaler product with cost sharing for a month’s supply that does not exceed $15.(C)DefinitionFor purposes of this paragraph, the term specified inhaler product has the meaning given such term in section 2799A–11 of the Public Health Service Act. . (7)Treatment of cost sharing for specified insulin productsThe coverage to provided in accordance with subsection (b)(10).. 399V–8.Specified inhaler product payment program(a)In generalBeginning January 1, 2026, the Secretary shall establish a program under which—(1)program-registered providers submit claims to the Secretary with respect to the furnishing of specified inhaler products (as defined in subsection (b)) to uninsured individuals; and(2)the Secretary, subject to the availability of appropriations, pays each such provider for such products in an amount determined appropriate by the Secretary.(b)DefinitionsIn this section:(1)Program-registered providerThe term program-registered provider means a health care provider that—(A)is licensed or otherwise authorized to administer or dispense specified inhaler products in the State in which such provider so administers or dispenses such products under the program established under this section; and(B)enters into an agreement with the Secretary under which the provider agrees not to hold an uninsured individual liable for the cost of any such product administered or dispensed to such individual in an amount exceeding $15 for a month’s supply of such product if a payment is made under subsection (a)(2) with respect to such product so administered or dispensed.(2)Specified inhaler productThe term specified inhaler product has the meaning given such term in section 2799A–11.(3)Uninsured individualThe term uninsured individual means, with respect to an individual furnished a specified inhaler product, an individual who is not enrolled in—(A)a Federal health care program (as defined in section 1128B(f) of the Social Security Act);(B)a group health plan or health insurance coverage offered by a health insurance issuer in the group or individual market (as such terms are defined in section 2791); or(C)a health plan offered under chapter 89 of title 5, United States Code..

2799A–11. Coverage and cost-sharing requirements for specified inhaler products A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall provide benefits under such plan or coverage (as applicable) for all specified inhaler products and, with respect to such a product, may not— apply any deductible; or impose any cost-sharing requirement in excess of $15 per 30-day supply of such product. A group health plan, and a health insurance issuer offering group or individual health insurance coverage, shall count any cost-sharing requirement described in subsection (a)(2) incurred by an individual enrolled under such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such individual and product. For purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodilators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment for lung diseases such as asthma and chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers).

9826. Coverage and cost-sharing requirements for specified inhaler products A group health plan shall provide benefits under such plan for all specified inhaler products and, with respect to such a product, may not— apply any deductible; or impose any cost-sharing requirement in excess of $15 per 30-day supply of such product. A group health plan shall count any cost-sharing requirement described in subsection (a)(2) incurred by a participant or beneficiary of such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such participant or beneficiary. For purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodialators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment of asthma or of chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers).

726. Coverage and cost-sharing requirements for specified inhaler products A group health plan, and a health insurance issuer offering group health insurance coverage, shall provide benefits under such plan or coverage (as applicable) for all specified inhaler products and, with respect to such a product, may not— apply any deductible; or impose any cost-sharing requirement in excess of $15 per 30-day supply of such product. A group health plan, and a health insurance issuer offering group health insurance coverage, shall count any cost-sharing requirement described in subsection (a)(2) incurred by a participant or beneficiary of such plan with respect to a specified inhaler product towards any out-of-pocket maximum and any deductible that, but for application of subsection (a), would have applied to such participant or beneficiary and product. For purposes of this section, the term specified inhaler product means any maintenance or reliever or rescue inhalation drug (including inhalation aerosols, metered dose inhalers, dry powder inhalers, inhalation solutions, bronchodialators, and corticosteroids) with a medically accepted indication (as defined in section 1927(k)(6)) for the treatment of asthma or of chronic obstructive pulmonary disease. Such term includes any equipment used in the administration of such drug (such as masks and tubing, spacers, nebulizers, and valve-holding chambers).

399V–8. Specified inhaler product payment program Beginning January 1, 2026, the Secretary shall establish a program under which— program-registered providers submit claims to the Secretary with respect to the furnishing of specified inhaler products (as defined in subsection (b)) to uninsured individuals; and the Secretary, subject to the availability of appropriations, pays each such provider for such products in an amount determined appropriate by the Secretary. In this section: The term program-registered provider means a health care provider that— is licensed or otherwise authorized to administer or dispense specified inhaler products in the State in which such provider so administers or dispenses such products under the program established under this section; and enters into an agreement with the Secretary under which the provider agrees not to hold an uninsured individual liable for the cost of any such product administered or dispensed to such individual in an amount exceeding $15 for a month’s supply of such product if a payment is made under subsection (a)(2) with respect to such product so administered or dispensed. The term specified inhaler product has the meaning given such term in section 2799A–11. The term uninsured individual means, with respect to an individual furnished a specified inhaler product, an individual who is not enrolled in— a Federal health care program (as defined in section 1128B(f) of the Social Security Act); a group health plan or health insurance coverage offered by a health insurance issuer in the group or individual market (as such terms are defined in section 2791); or a health plan offered under chapter 89 of title 5, United States Code.