Section 1 Short title
This Act may be cited as the “Joe Fiandra Access to Home Infusion Act of 2023”.
Joe Fiandra Access to Home Infusion Act of 2023
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.
Sec. 2 Medicare coverage of external infusion pumps and non-self-administrable home infusion drugs
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:
“(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.”
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.