119-hr5278

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5278 Introduced in House

    (IH) ]

<DOC>

119th CONGRESS
 1st Session
 H. R. 5278

 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.

_______________________________________________________________________

 IN THE HOUSE OF REPRESENTATIVES

 September 10, 2025

 Mr. Mfume (for himself, Mr. Johnson of Georgia, Ms. Norton, Mr. 
Thanedar, Ms. Elfreth, Mrs. McIver, Mr. Fields, Mr. Davis of Illinois, 
 Mr. Figures, Mr. Olszewski, Mr. Ivey, and Mrs. McClain Delaney) 
 introduced the following bill; which was 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

_______________________________________________________________________

 A BILL

 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.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Affordable Inhalers and Nebulizers 
Act of 2025''.

SEC. 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:

``

SEC. 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:

``

SEC. 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:

``

SEC. 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:

``

SEC. 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.
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