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H. R. 5278

Affordable Inhalers and Nebulizers Act of 2025

Shown here: Introduced in House (2025-09-10)

To amend title XXVII of the Public Health Service Act, the Internal Revenue Code of 1986, and the Employee Retirement Income Security Act of 1974 to reduce patient cost sharing for prescription drug inhaler products used to treat breathing disorders such as asthma and chronic obstructive pulmonary disease, and for other purposes.

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

(a) Coverage and cost-Sharing requirements

(1) Private insurance

(A) PHSA

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:

2799A–11. Coverage and cost-sharing requirements for specified inhaler products
(a) In general
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—
(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 maximum
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.
(c) Specified inhaler product defined
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).

(B) IRC

(i) In general

Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:

9826. Coverage and cost-sharing requirements for specified inhaler products
(a) In general
A 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 maximum
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.
(c) Specified inhaler product defined
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).

(ii) Clerical amendment

The table of sections for such subchapter is amended by adding at the end the following new item:

Sec. 9826. Coverage and cost-sharing requirements for specified inhaler products.

(C) ERISA

(i) In general

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:

726. Coverage and cost-sharing requirements for specified inhaler products
(a) In general
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—
(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 maximum
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.
(c) Specified inhaler product defined
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).

(ii) Clerical amendment

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:

Sec. 726. Coverage and cost-sharing requirements for specified inhaler products.

(D) Conforming amendments

(i) HDHP safe harbor

Section 223(c)(2) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:

(H) Safe harbor for absence of deductible for specified inhaler products
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).

(ii) Catastrophic plan safe harbor

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”.

(E) Effective date

The amendments made by this paragraph shall apply to plan years beginning on or after January 1, 2026.

(2) Medicare

(A) Part B

Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended—

(i) in subsection (a)(1)(S)—

(I) in clause (i), by inserting “or (iii)” after “clause (ii)”; and

(II) 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

(ii) in subsection (b), in the first sentence—

(I) in paragraph (12), by striking “, and”; and

(II) 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.”.

(B) Part D

(i) In general

Section 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w–102(b)) is amended—

(I) in paragraph (1)(A), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”;

(II) in paragraph (2)(A), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”;

(III) in paragraph (4)(A)(i), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”; and

(IV) by adding at the end the following new paragraph:

(10) Treatment of cost sharing for specified inhaler products
(A) No application of deductible
For 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 sharing
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.
(C) Definition
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.

(ii) Conforming amendment for alternative prescription drug coverage

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:

(7) Treatment of cost sharing for specified insulin products
The coverage to provided in accordance with subsection (b)(10).

(iii) Conforming amendments to cost sharing for low-income individuals

Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended—

(I) in paragraph (1)—

(aa) 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

(bb) 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

(II) in paragraph (2)(B), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”.

(b) Payment program for uninsured individuals

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:

399V–8. Specified inhaler product payment program
(a) In general
Beginning 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) Definitions
In this section:
(1) Program-registered provider
The 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 product
The term specified inhaler product has the meaning given such term in section 2799A–11.
(3) Uninsured individual
The 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.

(c) Implementation

The Secretary of Health and Human Services may implement the amendments made by this section by program instruction, subregulatory guidance, or otherwise.

Workspace/Typeset/Bill

H. R. 5278

Affordable Inhalers and Nebulizers Act of 2025

Shown here: Introduced in House (2025-09-10)

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

(a) Coverage and cost-Sharing requirements

(1) Private insurance

(A) PHSA

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:

2799A–11. Coverage and cost-sharing requirements for specified inhaler products
(a) In general
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—
(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 maximum
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.
(c) Specified inhaler product defined
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).

(B) IRC

(i) In general

Subchapter B of chapter 100 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:

9826. Coverage and cost-sharing requirements for specified inhaler products
(a) In general
A 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 maximum
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.
(c) Specified inhaler product defined
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).

(ii) Clerical amendment

The table of sections for such subchapter is amended by adding at the end the following new item:

Sec. 9826. Coverage and cost-sharing requirements for specified inhaler products.

(C) ERISA

(i) In general

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:

726. Coverage and cost-sharing requirements for specified inhaler products
(a) In general
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—
(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 maximum
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.
(c) Specified inhaler product defined
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).

(ii) Clerical amendment

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:

Sec. 726. Coverage and cost-sharing requirements for specified inhaler products.

(D) Conforming amendments

(i) HDHP safe harbor

Section 223(c)(2) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:

(H) Safe harbor for absence of deductible for specified inhaler products
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).

(ii) Catastrophic plan safe harbor

(E) Effective date

The amendments made by this paragraph shall apply to plan years beginning on or after January 1, 2026.

(2) Medicare

(A) Part B

Section 1833 of the Social Security Act (42 U.S.C. 1395l) is amended—

(i) in subsection (a)(1)(S)—

(I) in clause (i), by inserting “or (iii)” after “clause (ii)”; and

(ii) in subsection (b), in the first sentence—

(I) in paragraph (12), by striking “, and”; and

(B) Part D

(i) In general

Section 1860D–2(b) of the Social Security Act (42 U.S.C. 1395w–102(b)) is amended—

(I) in paragraph (1)(A), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”;

(II) in paragraph (2)(A), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”;

(III) in paragraph (4)(A)(i), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”; and

(IV) by adding at the end the following new paragraph:

(10) Treatment of cost sharing for specified inhaler products
(A) No application of deductible
For 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 sharing
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.
(C) Definition
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.

(ii) Conforming amendment for alternative prescription drug coverage

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:

(7) Treatment of cost sharing for specified insulin products
The coverage to provided in accordance with subsection (b)(10).

(iii) Conforming amendments to cost sharing for low-income individuals

Section 1860D–14(a) of the Social Security Act (42 U.S.C. 1395w–114(a)) is amended—

(I) in paragraph (1)—

(II) in paragraph (2)(B), by striking “paragraphs (8) and (9)” and inserting “paragraphs (8), (9), and (10)”.

(b) Payment program for uninsured individuals

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:

399V–8. Specified inhaler product payment program
(a) In general
Beginning 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) Definitions
In this section:
(1) Program-registered provider
The 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 product
The term specified inhaler product has the meaning given such term in section 2799A–11.
(3) Uninsured individual
The 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.

(c) Implementation

The Secretary of Health and Human Services may implement the amendments made by this section by program instruction, subregulatory guidance, or otherwise.