Medicare Program Integrity Manual (Pub. 100-08), Ch. 10 § 10.2.3.16
Manufacturers of Replacement Parts/Supplies for Prosthetic
10.2.3.16 – Manufacturers of Replacement Parts/Supplies for Prosthetic
Implants or Implantable Durable Medical Equipment (DME) Surgically
Inserted at an Ambulatory Surgical Center (ASC)
(Rev. 11859; Issued: 02-16-23; Effective: 03-17-23; Implementation: 03-17-23)
Part A/B MACs make payments for implantable prosthetics and DME to hospitals,
physicians, or ASCs. A manufacturer of non-implantable prosthetics and DME and
replacement parts and supplies for prosthetic implants and surgically implantable
DME may enroll in the Medicare program as a DMEPOS supplier via the Form
CMS-855S if it meets the definition of a supplier as well as the requirements of 42
CFR § 424.57.