On October 6, the Medicare Administrative Contractors (MACs) that oversee durable medical equipment announced proposed changes to the Medicare coverage policy (called a local coverage determination (LCD)) for CGMs, including removing the requirement that people must be on multiple (3) daily injections of insulin per day to be eligible for CGM. These changes would expand access to CGM for Medicare beneficiaries with diabetes.
In July 2021, the MACs updated the CGM policy to remove the requirement that people check their blood glucose 4 times per day to be eligible for a CGM. They also changed “inject” insulin to “administer” insulin. Since then, ADCES and our advocacy partners have been urging CMS to make additional changes to the LCD to further expand coverage. We sent letters, met with CMS, engaged the Congressional Diabetes Caucus both as an organization and through our coalition work. The proposed LCD for CGMs reflects the important changes we advocated for including allowing people using basal insulin (only) to be eligible for a CGM.
Below are the proposed coverage criteria.
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 with at least one daily administration of insulin; or,
- The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:
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.
- Recurrent level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L) that persist despite multiple (2 or more) 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
This LCD is open for public comment between 10/6/2022-11/19/2022. The open meeting will be held 11/15/2022. After that, they will finalize the policy. ADCES will do a thorough review of the policy and we'll be discussing our plan of action with our advocacy partners, but this is a very big win on the advocacy front! ADCES members are encouraged to submit comments in support of these proposed changes.