I 
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 Illi-
nois, Mr. FIGURES, Mr. OLSZEWSKI, Mr. IVEY, and Mrs. MCCLAIN 
DELANEY) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce, and in addition to the Committees on 
Ways and Means, and Education and Workforce, for a period to be sub-
sequently 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 pa-
tient cost sharing for prescription drug inhaler products 
used to treat breathing disorders such as asthma and 
chronic obstructive pulmonary disease, and for other pur-
poses. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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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 PRESCRIP-
TION DRUG INHALER PRODUCTS USED TO 
TREAT BREATHING DISORDERS SUCH AS 
ASTHMA AND CHRONIC OBSTRUCTIVE PUL-
MONARY DISEASE. 
(a) 
COVERAGE
AND
COST-SHARING
REQUIRE-
MENTS.— 
(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 REQUIRE-
MENTS 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 prod-
ucts and, with respect to such a product, may not— 
‘‘(1) apply any deductible; or 
‘‘(2) impose any cost-sharing requirement in ex-
cess of $15 per 30-day supply of such product. 
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‘‘(b) COUNTING COST SHARING TOWARDS DEDUCT-
IBLE AND OUT-OF-POCKET MAXIMUM.—A group health 
plan, and a health insurance issuer offering group or indi-
vidual health insurance coverage, shall count any cost- 
sharing requirement described in subsection (a)(2) in-
curred by an individual enrolled under such plan with re-
spect to a specified inhaler product towards any out-of- 
pocket maximum and any deductible that, but for applica-
tion of subsection (a), would have applied to such indi-
vidual and product. 
‘‘(c) SPECIFIED INHALER PRODUCT DEFINED.—For 
purposes of this section, the term ‘specified inhaler prod-
uct’ means any maintenance or reliever or rescue inhala-
tion drug (including inhalation aerosols, metered dose in-
halers, dry powder inhalers, inhalation solutions, broncho-
dilators, and corticosteroids) with a medically accepted in-
dication (as defined in section 1927(k)(6)) for the treat-
ment for lung diseases such as asthma and chronic ob-
structive pulmonary disease. Such term includes any 
equipment used in the administration of such drug (such 
as masks and tubing, spacers, nebulizers, and valve-hold-
ing chambers).’’. 
(B) IRC.— 
(i) IN
GENERAL.—Subchapter B of 
chapter 100 of the Internal Revenue Code 
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of 1986 is amended by adding at the end 
the following new section: 
‘‘SEC. 9826. COVERAGE AND COST-SHARING REQUIRE-
MENTS FOR SPECIFIED INHALER PRODUCTS. 
‘‘(a) IN GENERAL.—A group health plan shall pro-
vide benefits under such plan for all specified inhaler prod-
ucts and, with respect to such a product, may not— 
‘‘(1) apply any deductible; or 
‘‘(2) impose any cost-sharing requirement in ex-
cess of $15 per 30-day supply of such product. 
‘‘(b) COUNTING COST SHARING TOWARDS DEDUCT-
IBLE 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 bene-
ficiary of such plan with respect to a specified inhaler 
product towards any out-of-pocket maximum and any de-
ductible 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 prod-
uct’ means any maintenance or reliever or rescue inhala-
tion drug (including inhalation aerosols, metered dose in-
halers, 
dry 
powder 
inhalers, 
inhalation 
solutions, 
bronchodialators, and corticosteroids) with a medically ac-
cepted indication (as defined in section 1927(k)(6)) for the 
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treatment of asthma or of chronic obstructive pulmonary 
disease. Such term includes any equipment used in the ad-
ministration 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 fol-
lowing new item: 
‘‘Sec. 9826. Coverage and cost-sharing requirements for specified inhaler prod-
ucts.’’. 
(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 fol-
lowing 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 cov-
erage (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 ex-
cess of $15 per 30-day supply of such product. 
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‘‘(b) COUNTING COST SHARING TOWARDS DEDUCT-
IBLE AND OUT-OF-POCKET MAXIMUM.—A group health 
plan, and a health insurance issuer offering group health 
insurance coverage, shall count any cost-sharing require-
ment described in subsection (a)(2) incurred by a partici-
pant 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 prod-
uct’ means any maintenance or reliever or rescue inhala-
tion drug (including inhalation aerosols, metered dose in-
halers, 
dry 
powder 
inhalers, 
inhalation 
solutions, 
bronchodialators, and corticosteroids) with a medically ac-
cepted 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 ad-
ministration 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 re-
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lating to section 725 the following new 
item: 
‘‘Sec. 726. Coverage and cost-sharing requirements for specified inhaler prod-
ucts.’’. 
(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 DE-
DUCTIBLE
FOR
SPECIFIED
INHALER
PROD-
UCTS.—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 rea-
son 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 HAR-
BOR.—Section 1302(e)(1)(B)(i) of the Pa-
tient 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. 
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(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 fol-
lowing new clause: ‘‘and (iii) with re-
spect to a specified inhaler product 
(as defined in section 2799A–11 of 
the Public Health Service Act) fur-
nished 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 sen-
tence— 
(I) in paragraph (12), by striking 
‘‘, and’’; and 
(II) by striking ‘‘..’’ and inserting 
‘‘, and (14) such deductible shall not 
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UALS.—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 pre-
ceding 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 de-
fined 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 
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inserting ‘‘paragraphs (8), (9), and 
(10)’’. 
(b) PAYMENT PROGRAM FOR UNINSURED INDIVID-
UALS.—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 fur-
nishing 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 prod-
ucts in the State in which such provider so ad-
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ministers 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 dis-
pensed to such individual in an amount exceed-
ing $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 ‘un-
insured individual’ means, with respect to an indi-
vidual furnished a specified inhaler product, an indi-
vidual who is not enrolled in— 
‘‘(A) a Federal health care program (as 
defined in section 1128B(f) of the Social Secu-
rity Act); 
‘‘(B) a group health plan or health insur-
ance coverage offered by a health insurance 
issuer in the group or individual market (as 
such terms are defined in section 2791); or 
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‘‘(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 guid-
ance, or otherwise. 
Æ 
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