I 119THCONGRESS 1 STSESSION H. R. 2343 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 MARCH25, 2025 Ms. S ALAZAR(for herself, Ms. PINGREE, Mr. SMITHof New Jersey, Mr. J OHNSONof Georgia, Mr. OWENS, Ms. NORTON, Mrs. KIM, Mr. ROUZER, and Mr. T ONKO) 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 Defi- ciency Disorder treatment under part B of such title, and for other purposes. Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘John W. Walsh Alpha- 4 1 Home Infusion Act of 2025’’. 5 VerDate Sep 11 2014 21:30 Mar 31, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H2343.IH H2343 ssavage on LAPJG3WLY3PROD with BILLS 2 •HR 2343 IH SEC. 2. MEDICARE COVERAGE OF ALPHA-1 ANTITRYPSIN 1 DISORDER TREATMENT. 2 (a) I NGENERAL.—Section 1861 of the Social Secu-3 rity Act (42 U.S.C. 1395x) is amended— 4 (1) in subsection (s)(2)— 5 (A) by striking ‘‘and’’ at the end of sub-6 paragraph (II); 7 (B) by inserting ‘‘and’’ at the end of sub-8 paragraph (JJ); and 9 (C) by inserting at the end the following 10 new subparagraph: 11 ‘‘(KK) Alpha-1 Antitrypsin Deficiency Dis-12 order treatment (as defined in subsection 13 (nnn));’’; and 14 (2) by adding at the end the following new sub-15 section: 16 ‘‘(nnn) A LPHA-1 ANTITRYPSINDEFICIENCYDIS-17 ORDERTREATMENT.—(1) The term ‘Alpha-1 Antitrypsin 18 Deficiency Disorder treatment’ means augmentation ther-19 apy (as defined in paragraph (2)(C)) furnished by quali-20 fied home infusion therapy suppliers (as defined in para-21 graph (2)(D)) which are furnished in the individual’s 22 home (as defined in paragraph (2)(B)) to an individual— 23 ‘‘(A) who is under the care of an applicable pro-24 vider; 25 VerDate Sep 11 2014 21:30 Mar 31, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2343.IH H2343 ssavage on LAPJG3WLY3PROD with BILLS 3 •HR 2343 IH ‘‘(B) who is enrolled under both parts A and B 1 of this title, and is not enrolled in an MA plan under 2 part C of such title; and 3 ‘‘(C) who requires augmentation therapy (as de-4 fined in paragraph (2)(C)). 5 ‘‘(2) For purposes of this subsection: 6 ‘‘(A) The term ‘applicable provider’ means— 7 ‘‘(i) a physician; 8 ‘‘(ii) a nurse practitioner; and 9 ‘‘(iii) a physician assistant. 10 ‘‘(B) The term ‘home’ means a place of resi-11 dence used as the home of an individual (as defined 12 for purposes of subsection (n)). 13 ‘‘(C) The term ‘augmentation therapy’ means 14 an Alpha-1 Proteinase Inhibitor indicated for chron-15 ic augmentation and maintenance therapy in adults 16 with clinical evidence of emphysema due to severe 17 hereditary deficiency of Alpha-1 Antitrypsin. 18 ‘‘(D) The term ‘qualified home infusion therapy 19 supplier’ has the meaning given such term in sub-20 section (iii)(3)(D)(i).’’. 21 (b) P AYMENT FOR INTRAVENOUS ADMINISTRATION 22 K ITS AND NURSING SERVICES FOR ALPHA-1 23 A NTITRYPSINDEFICIENCYDISORDERTREATMENT.— 24 Section 1834 of the Social Security Act (42 U.S.C. 25 VerDate Sep 11 2014 21:30 Mar 31, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2343.IH H2343 ssavage on LAPJG3WLY3PROD with BILLS 4 •HR 2343 IH 1395m) is amended by adding at the end the following 1 new subsection: 2 ‘‘(aa) P AYMENT FOR INTRAVENOUS ADMINISTRA-3 TIONKITS ANDNURSINGSERVICES FOR ALPHA-1 4 A NTITRYPSINDEFICIENCYDISORDERTREATMENT.—The 5 Secretary shall implement a payment system under which 6 payment is made under this title to a qualified home infu-7 sion therapy supplier (as defined in section 8 1861(nnn)(3)(D)) for intravenous administration kits and 9 nursing services for up to 2 hours of care by a qualified 10 home infusion therapy supplier in coordination with the 11 furnishing of augmentation therapy (as defined in section 12 1861(nnn)(2)(C)).’’. 13 (c) C ONFORMINGAMENDMENTS.— 14 (1) P AYMENT REFERENCE .—Section 15 1833(a)(1) of the Social Security Act (42 U.S.C. 16 1395l(a)(1)) is amended— 17 (A) by striking ‘‘and’’ before ‘‘(HH)’’; and 18 (B) by inserting before the semicolon at 19 the end the following: ‘‘, and (II) with respect 20 to intravenous administration kits and nursing 21 services described in section 1834(aa) for 22 Alpha-1 Antitrypsin Disorder treatment (as de-23 fined in subsection (nnn)(1)), the amount paid 24 for such kits and services shall be an amount 25 VerDate Sep 11 2014 21:30 Mar 31, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H2343.IH H2343 ssavage on LAPJG3WLY3PROD with BILLS 5 •HR 2343 IH equal to 80 percent of the lesser of the actual 1 charge for the services or the amount deter-2 mined under section 1834(aa)’’. 3 (2) D IRECT PAYMENT.—The first sentence of 4 section 1842(b)(6) of the Social Security Act (42 5 U.S.C. 1395u(b)(6)) is amended— 6 (A) by striking ‘‘and’’ before ‘‘(J)’’; and 7 (B) by inserting before the period at the 8 end the following: ‘‘, and (K) in the case of in-9 travenous administration kits and nursing serv-10 ices described in section 1834(aa), payment 11 shall be made to the qualified home infusion 12 therapy supplier (as defined in section 13 1861(nnn)(2)(D))’’. 14 (3) E XCLUSION FROM HOME HEALTH SERV -15 ICES.—Section 1861(m) of the Social Security Act 16 (42 U.S.C. 1395x(m)) is amended, in the first sen-17 tence, by inserting the following before the period at 18 the end: ‘‘and intravenous administration kits and 19 nursing services described in section 1834(aa) for 20 Alpha-1 Antitrypsin Deficiency Disorder treatment 21 (as defined in subsection (nnn)(1))’’. 22 VerDate Sep 11 2014 21:30 Mar 31, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2343.IH H2343 ssavage on LAPJG3WLY3PROD with BILLS 6 •HR 2343 IH (d) EFFECTIVEDATE.—The amendments made by 1 this section shall apply to items and services furnished on 2 or after January 1, 2027. 3 Æ VerDate Sep 11 2014 21:30 Mar 31, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6301 E:\BILLS\H2343.IH H2343 ssavage on LAPJG3WLY3PROD with BILLS