42 C.F.R. § 414.1505
In order for home infusion therapy services to qualify for payment under the Medicare program the services must be furnished to an eligible beneficiary by, or under arrangements with, a qualified home infusion therapy supplier that meets the following requirements:
[84 FR 60643, Nov. 8, 2019, as amended at 85 FR 70355, Nov. 4, 2020]