I 

118TH CONGRESS 

1ST SESSION H. R. 5397 

To amend title XVIII of the Social Security Act to provide coverage of 

external infusion pumps and non-self-administrable home infusion drugs 

under the Medicare program. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 12, 2023 

Mr. FITZPATRICK (for himself and Mr. DUNN of Florida) 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 

coverage of external infusion pumps and non-self-administrable home infusion drugs under the Medicare program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Joe Fiandra Access 

5 to Home Infusion Act of 2023’’. 


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•HR 5397 IH

1 SEC. 2. MEDICARE COVERAGE OF EXTERNAL INFUSION 

2 PUMPS AND NON-SELF-ADMINISTRABLE 

3 HOME INFUSION DRUGS. 

4 (a) CLARIFYING APPROPRIATE FOR USE IN THE

5 HOME CRITERIA FOR DME DEFINITION.—Section 

6 1861(n) of the Social Security Act (42 U.S.C. 1395x(n)) 

7 is amended by adding at the end the following new sen8 tence: ‘‘An external infusion pump and associated infusion 

9 drug or other associated supplies shall be treated as meet10 ing the appropriate for use in the home requirement ap11 plied to the definition of durable medical equipment under 

12 section 414.202 of title 42, Code of Federal Regulations 

13 (or any successor to such regulation) and shall be covered 

14 as durable medical equipment under this title if each of 

15 the following criteria (as described in the Notice of Pro16 posed Rulemaking titled Expanded Classification of Exter17 nal Infusion Pumps as Durable Medical Equipment pub18 lished in the Federal Register on November 4, 2020 (85 

19 Fed. Reg. 70404)) is satisfied: 

20 ‘‘(1) The Food and Drug Administration-re21 quired labeling requires the home infusion drug as22 sociated with the pump to be prepared immediately 

23 prior to administration or administered by a health 

24 care professional or both. 

25 ‘‘(2) A qualified home infusion therapy supplier 

26 (as defined in subsection (iii)(3)(D)) administers the 


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•HR 5397 IH

1 drug or biological in a safe and effective manner in 

2 the patient’s home (as defined in subsection 

3 (iii)(3)(B)). 

4 ‘‘(3) The labeling described in paragraph (1) 

5 specifies infusion via an external infusion pump as 

6 a possible route of administration, at least once per 

7 month, for the drug.’’. 

8 (b) IMPLEMENTATION.—Notwithstanding any other 

9 provision of law, any home infusion drug associated with 

10 an external infusion pump that satisfies the criteria de11 scribed in each of paragraphs (1), (2), and (3) of section 

12 1861(n) of the Social Security Act (42 U.S.C. 1395x(n)), 

13 as added by subsection (a), shall be included in the Local 

14 Coverage Determination on External Infusion Pumps 

15 made under title XVIII of such Act (42 U.S.C. 1395, et 

16 seq.) (LCD number L33794) (and any successor LCD), 

17 and payment shall be authorized for home infusion ther18 apy services provided in association with any such drug, 

19 effective as of the date of the enactment of this section 

20 or the Food and Drug Administration’s approval of the 

21 drug, whichever comes later. 

Æ 


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