Dexcom, Abbott have 'massive opportunity' with new CGM coverage proposal: analysts – MedTech Dive

The CMS coverage currently applies to patients who take at least three doses of insulin a day, limiting CGM reimbursement to people with intensive Type 1 and 2 diabetes. The proposed coverage will expand CGM use beyond that limited population if finalized in its current form.
The CMS is proposing to cover CGMs in all patients who use insulin at least once a day. If a patient does not take insulin each day, they will still be covered if they have a history of problematic hypoglycemia. A patient who has recurrent level 2 hypoglycemic events, despite treatment changes, will receive coverage as will a person who has experienced at least one level 3 event that required third-party assistance, according to the CMS. 
Neither the insulin nor hypoglycemia criteria for coverage differentiate between Type 1 and 2 diabetes. Analysts at J.P. Morgan interpreted the proposal as a positive for the push to access the Type 2 market.
“It’s a step in the right direction and points to [a] clear path to coverage for all insulin using diabetic patients, opening up a massive opportunity for both Dexcom and Abbott over the next 1-2 years,” the analysts wrote in a note to investors. “Penetration rates in the Type 2 population remain exceptionally low, with our forecast across the intensive patients at ~25%+ in 2022.” 
The analysts wrote that they are bullish on the impact of expanding CMS coverage to people who take insulin once a day, calling the expansion into the basal insulin population “a major near-term driver for growth” that “doubles [the] market opportunity of 2M US Type 1 patients and 2M US Type 2 insulin intensive patients.” 
The proposal is open for comment until Nov. 19. The analysts said they expect a final coverage decision next year.
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The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start. 
President Joe Biden's executive order calls for SBOMs, and the FDA wants to require premarket submissions to have an inventory of third-party device components. AdvaMed is concerned the data could be exploited by hackers.
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