US-CONGRESS HR4993: Joe Fiandra Access to Home Infusion Act of 2025
HR4993, the Joe Fiandra Access to Home Infusion Act of 2025, has been ordered to be reported with amendments. It aims to expand Medicare coverage for home infusion therapy, potentially increasing demand for compounded sterile preparations and controlled substances used in home settings. Pharmacies must ensure compliance with USP 797 and DEA regulations for dispensing controlled substances to home patients.
Aforeworn detected this change in the Pharmacy & Controlled Substances space on July 28, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Independent pharmacies, retail chains, compounding pharmacies, long-term-care pharmacies should confirm how it applies to their specific situation before acting. There is a time constraint attached: Before the bill becomes law (likely within 6-12 months). Monitor congressional progress and final text.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmacy & Controlled Substances continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
The bill expands Medicare coverage for home infusion therapy, likely increasing prescriptions for compounded sterile preparations and controlled substances administered at home. Pharmacies may need to adjust compounding practices, dispensing protocols, and PDMP reporting for home infusion patients.
Who it affects
Independent pharmacies, retail chains, compounding pharmacies, long-term-care pharmacies
What you must do
Review current home infusion dispensing procedures for compliance with USP 797 and DEA controlled substance regulations. Ensure PDMP queries are performed for all controlled substance prescriptions, including those for home infusion. Update policies for suspicious order monitoring and diversion prevention in home delivery settings.
Deadline
Before the bill becomes law (likely within 6-12 months). Monitor congressional progress and final text.
Source: https://www.congress.gov/bill/119th-congress/house-bill/4993
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