[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4438 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 4438
To amend title XVIII of the Social Security Act to provide for coverage
and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under
part B of such title, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 30, 2023
Ms. Salazar (for herself, Ms. Pingree, Mr. Posey, Mr. Tonko, Ms.
Wasserman Schultz, Mr. Keating, Mr. Panetta, Mr. Connolly, and Mr.
Higgins of New York) introduced the following bill; which was referred
to the Committee on Energy and Commerce, and in addition to the
Committee on Ways and Means, 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 XVIII of the Social Security Act to provide for coverage
and payment of Alpha-1 Antitrypsin Deficiency Disorder treatment under
part B of such title, 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 ``John W. Walsh Alpha-1 Home Infusion
Act of 2023''.
SEC. 2. MEDICARE COVERAGE OF ALPHA-1 ANTITRYPSIN DISORDER TREATMENT.
(a) In General.--Section 1861 of the Social Security Act (42 U.S.C.
1395x) is amended--
(1) in subsection (s)(2)--
(A) by striking ``and'' at the end of subparagraph
(II);
(B) by inserting ``and'' at the end of subparagraph
(JJ); and
(C) by inserting at the end the following new
subparagraph:
``(KK) Alpha-1 Antitrypsin Deficiency Disorder
treatment (as defined in subsection (nnn));''; and
(2) by adding at the end the following new subsection:
``(nnn) Alpha-1 Antitrypsin Deficiency Disorder Treatment.--(1) The
term `Alpha-1 Antitrypsin Deficiency Disorder treatment' means
augmentation therapy (as defined in paragraph (2)(C)) furnished by
qualified home infusion therapy suppliers (as defined in paragraph
(2)(D)) which are furnished in the individual's home (as defined in
paragraph (2)(B)) to an individual--
``(A) who is under the care of an applicable provider;
``(B) who is enrolled under both parts A and B of this
title, and is not enrolled in an MA plan under part C of such
title; and
``(C) who requires augmentation therapy (as defined in
paragraph (2)(C)).
``(2) For purposes of this subsection:
``(A) The term `applicable provider' means--
``(i) a physician;
``(ii) a nurse practitioner; and
``(iii) a physician assistant.
``(B) The term `home' means a place of residence used as
the home of an individual (as defined for purposes of
subsection (n)).
``(C) The term `augmentation therapy' means an Alpha-1
Proteinase Inhibitor indicated for chronic augmentation and
maintenance therapy in adults with clinical evidence of
emphysema due to severe hereditary deficiency of Alpha-1
Antitrypsin.
``(D) The term `qualified home infusion therapy supplier'
has the meaning given such term in subsection
(iii)(3)(D)(i).''.
(b) Payment for Intravenous Administration Kits and Nursing
Services for Alpha-1 Antitrypsin Deficiency Disorder Treatment.--
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by
adding at the end the following new subsection:
``(aa) Payment for Intravenous Administration Kits and Nursing
Services for Alpha-1 Antitrypsin Deficiency Disorder Treatment.--The
Secretary shall implement a payment system under which payment is made
under this title to a qualified home infusion therapy supplier (as
defined in section 1861(nnn)(3)(D)) for intravenous administration kits
and nursing services for up to 2 hours of care by a qualified home
infusion therapy supplier in coordination with the furnishing of
augmentation therapy (as defined in section 1861(nnn)(2)(C)).''.
(c) Conforming Amendments.--
(1) Payment reference.--Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and'' before ``(HH)''; and
(B) by inserting before the semicolon at the end
the following: ``, and (II) with respect to intravenous
administration kits and nursing services described in
section 1834(aa) for Alpha-1 Antitrypsin Disorder
treatment (as defined in subsection (nnn)(1)), the
amount paid for such kits and services shall be an
amount equal to 80 percent of the lesser of the actual
charge for the services or the amount determined under
section 1834(aa)''.
(2) Direct payment.--The first sentence of section
1842(b)(6) of the Social Security Act (42 U.S.C. 1395u(b)(6))
is amended--
(A) by striking ``and'' before ``(J)''; and
(B) by inserting before the period at the end the
following: ``, and (K) in the case of intravenous
administration kits and nursing services described in
section 1834(aa), payment shall be made to the
qualified home infusion therapy supplier (as defined in
section 1861(nnn)(2)(D))''.
(3) Exclusion from home health services.--Section 1861(m)
of the Social Security Act (42 U.S.C. 1395x(m)) is amended, in
the first sentence, by inserting the following before the
period at the end: ``and intravenous administration kits and
nursing services described in section 1834(aa) for Alpha-1
Antitrypsin Deficiency Disorder treatment (as defined in
subsection (nnn)(1))''.
(d) Effective Date.--The amendments made by this section shall
apply to items and services furnished on or after January 1, 2025.
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