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CMS updates on criteria for Dexcom G5 coverage

March 24, 2017 By Sarah Faulkner

CMS updates on criteria for Dexcom G5 coverageShares in DexCom Inc. (NSDQ:DXCM) jumped 9% today after the Centers for Medicare & Medicaid Services updated the criteria for coverage of the company’s G5 Mobile continuous glucose monitor. The device is the only therapeutic CGM classified as durable medical equipment under Medicare Part B.

Patients covered by Medicare who have Type I or II diabetes and intensively manage their insulin will be able to obtain reimbursement, according to the updated criteria.

“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” president & CEO Kevin Sayer said in prepared remarks. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

According to CMS, therapeutic CGM could be covered by Medicare if a patient has diabetes mellitus, frequently uses a home blood glucose monitor, is treated with multiple daily insulin injections or uses a subcutaneous insulin infusion pump and if the patient’s treatment requires frequent adjustment based on therapeutic monitor testing results.

Dexcom’s G5 Mobile monitor is the only FDA-approved CGM that patients can use to make treatment decisions, according to the company.

Earlier this month, DexCom met expectations on Wall Street with its 4th quarter results.

The San Diego-based company posted a loss of -$7.4 million, or -9¢ per share, on sales of $171.2 million for the 3 months ended Dec. 31, for bottom-line loss of -593.3% on sales growth of 30.9% compared with the same period last year.

Adjusted to exclude 1-time items, earnings per share were -9¢, a penny ahead of consensus on The Street, where analysts were looking for sales of $167.3 million.

Filed Under: Diabetes, Drug-Device Combinations, Featured, Regulatory/Compliance, Wall Street Beat Tagged With: Centers for Medicare and Medicaid Services (CMS), DexCom Inc.

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