I 118th CONGRESS 1st Session H. R. 4438 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.

1. Short title This Act may be cited as the John W. Walsh Alpha-1 Home Infusion Act of 2023 . 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.