The Centers for Medicare and Medicaid Services (CMS) yesterday published the LCD modifying coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.
Abbott and Dexcom both develop market-leading CGMs. The Dexcom G7 recently launched outside the U.S. and the company hopes for FDA clearance early next year. Meanwhile, Abbott recently announced positive data backing its FreeStyle Libre 2 system.
Two contractors that handle national durable medical equipment (DME) supplier services and claims processing published the LCD. It defines problematic hypoglycemia as either recurrent level 2 hypoglycemic events (glucose <54mg/dL) that persist despite two or more attempts to adjust medication(s) or treatment or a history of one level 3 hypoglycemic event (glucose <54mg/dL) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia.
Additionally, the proposal eliminates the requirement for frequent adjustments of the patient’s insulin treatment regimen. This is on the basis of glucose measurement testing. According to BTIG analyst Marie Thibault, the proposal doesn’t mark a blanket for all beneficiaries with type 2 diabetes not administering insulin. However, by eliminating the intensive insulin management requirement, it could be a “positive step.” This would potentially benefit those most at risk of hypoglycemic events.
She noted that both Abbott and Dexcom at ADA 2022 in June expressed hope for improved Medicare coverage. They aimed for coverage for CGM in type 2 diabetes basal-only patients as soon as 2023. Thibault cites an estimated 3 million U.S. basal-only patients as a representation of who could benefit from the decision.
Additionally, an expert call in March left BTIG analysts “encouraged” about potential greater payor coverage in the coming years. This proposal falls in line with those hopes.
“The comment period on the proposed LCD will run through November 19, after which a final determination will be made,” Thibault wrote. “We expect potential inclusion in the final determination will catalyze increased CGM adoption in this patient population, benefiting both [Abbott] and [Dexcom].”
This represents the latest potential step forward for CGMs with regard to Medicare. At the end of last year, CMS expanded coverage to include CGMs that integrate with Medtronic insulin pumps. Analysts said the new rule will likely bolster Medtronic’s Diabetes Business as a result of the expanded access to its diabetes technologies.