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

Joint DME MAC Publication
Posted January 25, 2024

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.

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