I 
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 de-
termined 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 Defi-
ciency Disorder treatment under part B of such title, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives 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’’. 
VerDate Sep 11 2014 
22:16 Aug 01, 2023
Jkt 039200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H4438.IH
H4438
pbinns on DSKJLVW7X2PROD with $$_JOB
SEC. 2. MEDICARE COVERAGE OF ALPHA-1 ANTITRYPSIN 
DISORDER TREATMENT. 
(a) IN GENERAL.—Section 1861 of the Social Secu-
rity Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (II); 
(B) by inserting ‘‘and’’ at the end of sub-
paragraph (JJ); and 
(C) by inserting at the end the following 
new subparagraph: 
‘‘(KK) Alpha-1 Antitrypsin Deficiency Dis-
order treatment (as defined in subsection 
(nnn));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(nnn) ALPHA-1 ANTITRYPSIN DEFICIENCY DIS-
ORDER TREATMENT.—(1) The term ‘Alpha-1 Antitrypsin 
Deficiency Disorder treatment’ means augmentation ther-
apy (as defined in paragraph (2)(C)) furnished by quali-
fied home infusion therapy suppliers (as defined in para-
graph (2)(D)) which are furnished in the individual’s 
home (as defined in paragraph (2)(B)) to an individual— 
‘‘(A) who is under the care of an applicable pro-
vider; 
VerDate Sep 11 2014 
22:16 Aug 01, 2023
Jkt 039200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H4438.IH
H4438
pbinns on DSKJLVW7X2PROD with $$_JOB
‘‘(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 de-
fined 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 resi-
dence 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 chron-
ic 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 sub-
section (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. 
VerDate Sep 11 2014 
22:16 Aug 01, 2023
Jkt 039200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H4438.IH
H4438
pbinns on DSKJLVW7X2PROD with $$_JOB
1395m) is amended by adding at the end the following 
new subsection: 
‘‘(aa) PAYMENT
FOR INTRAVENOUS ADMINISTRA-
TION
KITS
AND
NURSING
SERVICES
FOR
ALPHA-1 
ANTITRYPSIN DEFICIENCY DISORDER TREATMENT.—The 
Secretary shall implement a payment system under which 
payment is made under this title to a qualified home infu-
sion 
therapy 
supplier 
(as 
defined 
in 
section 
1861(nnn)(3)(D)) for intravenous administration kits and 
nursing services for up to 2 hours of care by a qualified 
home infusion therapy supplier in coordination with the 
furnishing of augmentation therapy (as defined in section 
1861(nnn)(2)(C)).’’. 
(c) CONFORMING AMENDMENTS.— 
(1) 
PAYMENT
REFERENCE.—Section 
1833(a)(1) of the Social Security Act (42 U.S.C. 
1395l(a)(1)) is amended— 
(A) by striking ‘‘and’’ before ‘‘(HH)’’; and 
(B) by inserting before the semicolon at 
the end the following: ‘‘, and (II) with respect 
to intravenous administration kits and nursing 
services described in section 1834(aa) for 
Alpha-1 Antitrypsin Disorder treatment (as de-
fined in subsection (nnn)(1)), the amount paid 
for such kits and services shall be an amount 
VerDate Sep 11 2014 
22:16 Aug 01, 2023
Jkt 039200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H4438.IH
H4438
pbinns on DSKJLVW7X2PROD with $$_JOB
equal to 80 percent of the lesser of the actual 
charge for the services or the amount deter-
mined 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 in-
travenous administration kits and nursing serv-
ices 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
SERV-
ICES.—Section 1861(m) of the Social Security Act 
(42 U.S.C. 1395x(m)) is amended, in the first sen-
tence, 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))’’. 
VerDate Sep 11 2014 
01:47 Aug 03, 2023
Jkt 039200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H4438.IH
H4438
pbinns on DSKJLVW7X2PROD with $$_JOB
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply to items and services furnished on 
or after January 1, 2025. 
Æ 
VerDate Sep 11 2014 
22:16 Aug 01, 2023
Jkt 039200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6301
E:\BILLS\H4438.IH
H4438
pbinns on DSKJLVW7X2PROD with $$_JOB