To be eligible for coverage of a CGM and related supplies, the beneficiary must meet all of the following initial coverage criteria (1)-(5):
- The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); and,
- 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,
- The CGM is prescribed in accordance with its FDA indications for use; and,
- The beneficiary for whom a CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:
- The beneficiary is insulin-treated; or,
- The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following (see the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS section of the LCD-related Policy Article (A52464)):
- Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L)) that persist despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,
- A history of one level 3 hypoglycemic event (glucose <54mg/dL (3.0mmol/L)) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia 5. Within six (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.
The effective date for the new LCD and Policy Article is April 16, 2023, a few weeks before the anticipated May 11 COVID-19 PHE end date. You can view the DME MAC’s response to the comments here. AAHomecare thanks the DME MACs for finalizing the CGM coverage prior to the end of the PHE. This addresses concerns with CGM patients that qualified under the PHE waivers but would not have under the currently effective LCD.