Medicare Part B does not cover payment for purchase/rental and supplies/accessories of non-therapeutic continuous glucose monitors (CGMs). In a Proposed Rule, dated November 4, 2020, CMS has proposed to reclassify all non-therapeutic CGMs as DME, thus, qualified for Medicare Part B benefit payment.

Durable medical equipment (DME) suppliers face a variety of legal regulatory challenges in their businesses. Each year, state and federal agencies, including the Department of Justice (DOJ) and the Office of Inspector General (OIG) at the Health and Human Services Department charge many DME suppliers, including physician and non-physician suppliers, with fraud arising from regulatory violations.