Table 2.

CMS Proposed LCD for Glucose Monitors. ²⁷

To be eligible for coverage of a CGM and related supplies, the beneficiary must meet all of the following initial coverage criteria 1-5: 1. The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and, 2. The beneficiary’s treating practitioner has concluded that the beneficiary (or beneficiary’s caregiver) has sufficient training using the CGM prescribed as evidenced by providing a prescription; and, 3. The CGM is prescribed in accordance with its FDA indications for use; and, 4. The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:  (A) The beneficiary is insulin-treated with at least one daily administration of insulin; or,  (B) The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following: • Recurrent level 2 hypoglycemic events (glucose < 54 mg/dL (3.0 mmol/L) that persist despite multiple (two or more) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or A history of one level 3 hypoglycemic event (glucose < 54 mg/dL (3.0 mmol/L) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia 5. Within 6 months prior to ordering the CGM, the treating practitioner has an in-person or Medicare-approved telehealth visit with the beneficiary to evaluate their diabetes control and determined that criteria 1-4 above are met.

Abbreviations: CMS, Centers for Medicare & Medicaid Services; LCD, Local Coverage Determination; CGM, continuous glucose monitoring; ICD, International Classification of Diseases.