Lymphedema Compression Treatment Items Requirement for Registration with the Food and Drug Administration

Joint DME MAC Publication

Suppliers are reminded that before billing the Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) for a medical device, the device, at a minimum, must be registered with the Food and Drug Administration (FDA). This requirement includes Lymphedema Compression Treatment Items.

Devices that are not registered as a medical device must be billed with A9270 (Noncovered item or service). [emphasis added]

Refer to the CMS Internet Only Manual Publication 100-2 Chapter 14 Section 10 and 21 CFR 880.578.