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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5397 Introduced in House (IH)]

<DOC>

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.

    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 ``Joe Fiandra Access to Home Infusion 
Act of 2023''.

SEC. 2. MEDICARE COVERAGE OF EXTERNAL INFUSION PUMPS AND NON-SELF-
              ADMINISTRABLE HOME INFUSION DRUGS.

    (a) Clarifying Appropriate for Use in the Home Criteria for DME 
Definition.--Section 1861(n) of the Social Security Act (42 U.S.C. 
1395x(n)) is amended by adding at the end the following new sentence: 
``An external infusion pump and associated infusion drug or other 
associated supplies shall be treated as meeting the appropriate for use 
in the home requirement applied to the definition of durable medical 
equipment under section 414.202 of title 42, Code of Federal 
Regulations (or any successor to such regulation) and shall be covered 
as durable medical equipment under this title if each of the following 
criteria (as described in the Notice of Proposed Rulemaking titled 
Expanded Classification of External Infusion Pumps as Durable Medical 
Equipment published in the Federal Register on November 4, 2020 (85 
Fed. Reg. 70404)) is satisfied:
            ``(1) The Food and Drug Administration-required labeling 
        requires the home infusion drug associated with the pump to be 
        prepared immediately prior to administration or administered by 
        a health care professional or both.
            ``(2) A qualified home infusion therapy supplier (as 
        defined in subsection (iii)(3)(D)) administers the drug or 
        biological in a safe and effective manner in the patient's home 
        (as defined in subsection (iii)(3)(B)).
            ``(3) The labeling described in paragraph (1) specifies 
        infusion via an external infusion pump as a possible route of 
        administration, at least once per month, for the drug.''.
    (b) Implementation.--Notwithstanding any other provision of law, 
any home infusion drug associated with an external infusion pump that 
satisfies the criteria described in each of paragraphs (1), (2), and 
(3) of section 1861(n) of the Social Security Act (42 U.S.C. 1395x(n)), 
as added by subsection (a), shall be included in the Local Coverage 
Determination on External Infusion Pumps made under title XVIII of such 
Act (42 U.S.C. 1395, et seq.) (LCD number L33794) (and any successor 
LCD), and payment shall be authorized for home infusion therapy 
services provided in association with any such drug, effective as of 
the date of the enactment of this section or the Food and Drug 
Administration's approval of the drug, whichever comes later.
                                 <all>
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