H.R. 4993 — Joe Fiandra Access to Home Infusion Act of 2025

This section deems external infusion pumps and associated home infusion drugs (as defined in SSA §1861(iii)(3)(C)) or other supplies as meeting the Medicare durable medical equipment (DME) "appropriate for use in the home" requirement under 42 CFR §414.202 (or successor regulation)—notwithstanding that they may not otherwise qualify—beginning with the first calendar quarter at least one year after enactment, if (1) FDA-approved prescribing information for the drug requires administration by or under the supervision of a health care professional, (2) a qualified home infusion therapy supplier (as defined in SSA §1861(iii)(3)(D)) administers or supervises administration in the patient's home (as defined in SSA §1861(iii)(3)(B)), and (3) FDA prescribing information requires infusion at least 12 times per year intravenously or subcutaneously, or at rates the HHS Secretary determines necessitate an external infusion pump. (As background, Medicare Part B covers home infusion therapy for certain parenteral drugs using DME such as infusion pumps, but items requiring professional—not patient self—administration have previously been ineligible as DME.) The section also requires the HHS Secretary to notify patients of Medicare cost-sharing for home infusion therapy compared to other care settings for infusion drugs.