The patient pool for people using continuous glucose monitors is set to get a little bit bigger starting in April.
The Centers for Medicare & Medicaid Services has published a final coverage determination that could increase access for about 1.5 million people using basal-only treatment in the U.S. covered by Medicare.
CMS said if other payors follow suit that number could swell to between three million and four million people.
The modified proposal first popped up in October of 2022 and could benefit Dexcom and Abbott Laboratories, two huge players in the CGM space.
Most recently, Dexcom made some noise in the space by winning a nod from FDA for its G7 CGM. The technology was once called one of medtech’s most highly anticipated technologies.
Abbott Laboratories had its breakthrough moment in the CGM market when the Freesyle Libre won a nod from FDA in 2017.
The Libre’s FDA clearance was considered a major win for Americans with diabetes because it eliminated routine finger sticks, which have been the standard of glucose testing for more than 40 years.
In an email sent to MD+DI, Kevin Sayer, Dexcom’s CEO, president, and chairman said, “The expanded Medicare coverage for CGM to all insulin-treated people or people who have a history of problematic hypoglycemia is the biggest single expansion of CGM coverage. We are proud that our 2021 MOBILE study, using Dexcom CGM, was the primary piece of clinical evidence that led to this monumental decision. In light of this landmark ruling and the recent Medicare approval of Dexcom G7, we are excited to bring Dexcom CGM to even more people with diabetes to help them take control of their health.”
BTIG Analyst Marie Thibault wrote, “This comes sooner than the July timeframe Dexcom estimated on its last earnings call. The finalized version had a slight change in language for one of the eligibility criteria: “The beneficiary is insulin-treated with at least one daily administration of insulin” was changed to “The beneficiary is insulin-treated.”
Thibault added, “In our view, this is a significant catalyst that will increase CGM adoption in this patient population, benefiting both Abbott and Dexcom.”