CMS Updates CGM Eligibility to Broaden Coverage for Beneficiaries

Recently, CMS announced significant changes to how it would cover continuous glucose monitoring (CGM) devices for Medicare beneficiaries with diabetes. Specifically, it permanently eliminated the 4 times or more per day testing requirement for devices to qualify as CGM, and broadened coverage for those who use inhaled insulins by permitting multiple daily “administrations” of any insulin. Previously, this guidance was restricted to insulin “injections.”

According to the Local Coverage Determination (LCD), no evidence exists to support that frequent self-monitoring blood glucose (SMBG) over 4 times per day “as a prerequisite for initiating CGM use is predictive of improved health outcomes.” This stance is also supported by several diabetes organizations including the Endocrine Society, Diabetes Canada, and the Chinese Diabetes Society, all of which do not endorse a prerequisite baseline SMBG frequency before using CGM.

Revisions will become effective on July 18, 2021. The changes mark a significant step forward for many diabetes advocates, including the Association of Diabetes Care & Education Specialists (ADCES).

“This updated Local LCD was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities,” said Kate Thomas, the chief advocacy and external affairs officer at ADCES.

Additional updates included:

• Removing “Medicare-covered” from continuous subcutaneous insulin infusion (CSII) pump criterion language for CGMs
• Clarification of coding verification language for products billed as K0554
• Revision of 5 minutes for measuring interstitial fluid of glucose content by a CGM devise to 1 minute

CMS coverage of CGM devices has been a hotly contested issue for years, both in and outside of the courtroom. Currently, around one-third of Medicare beneficiaries have diabetes.

These new revisions come after a rule proposed in 2020 would expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as durable medical equipment under Medicare Part B.

Despite these recent gains, advocates note that more work needs to be done. “We know there are more changes that must be made and ADCES is working with the Diabetes Technology Access Coalition to push for additional improvements, including removing the requirement for multiple daily injections of insulin to qualify for a CGM device,” Thomas said.

The American Diabetes Association (ADA) also praised the announcement, calling it a “big win for the diabetes community” and tweeting, “The removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes.”