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[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.
<all>
Introduced in House
Introduced in House
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.
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.
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.
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