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Bigfoot Biomedical CEO hits back against CMS over data-sharing decision

November 15, 2017 By Sarah Faulkner

Bigfoot BiomedicalBigfoot Biomedical CEO Jeffrey Brewer has spoken out about a recent data-sharing decision made by CMS, saying that he plans to lobby Medicare to reverse its latest move.

Earlier this year, CMS said it would begin covering the use of particular continuous glucose monitors for people with diabetes. But since that decision, the agency has said that if a beneficiary uses a non-durable medical equipment device, like a smartphone, separately or in combination with a device classified as DME, it will not be reimbursed.

In other words, according to Brewer, Medicare will not reimburse for Dexcom‘s (NSDQ:DXCM) G5 smartphone app. The chief executive said that people who use Dexcom’s glucose monitor have reported that they can’t use the company’s share function that allows a family member or another person to remotely monitor the user’s glucose levels.

“CGM’s sharing capability is the type of innovation that can head off adverse events and save lives, especially among elderly people with diabetes who are at increased risk for recurrent and/or symptom-free hypoglycemia. CMS’s decision seems heartless to me at worst, short-sighted at best. It reflects a lack of understanding about the future of digital health and stifles innovation in an industry where smartphone integration is truly essential to making life easier for people with intensively managed chronic disease,” Brewer wrote.

“As a result, I will be joining medical technology innovators and advocacy groups to lobby for the reversal of this CMS decision. It’s a setback for remote monitoring of chronic health conditions in general, and also seems to suggest that the smartphone has no place in the world of medical technology. I could not disagree more strongly with this premise.”

Brewer noted that some believe CMS is concerned that the agency will be required to buy smartphones for Medicare beneficiaries if it allows glucose readings to be accessed remotely.

“This is not going to happen because this was never the point in designing a solution to be used with a smartphone,” he explained.

He added that he sees this latest decision by CMS as a blow against remote monitoring, which is often used by elderly and young people with diabetes, as well as those at risk of hypoglycemia.

“I’m looking forward to the day when CMS reverses this decision, and I believe that day will come,” he said. “Once CMS understands that no one is trying to argue that an app should be considered ‘durable medical equipment’ the way a CGM receiver is. No one is trying to get the agency to buy smartphones for millions of Medicare beneficiaries.

Once we make this clear to them, and once they begin to understand that smartphone integration is a fundamental part of forthcoming innovations in digital health, they will begin to rethink this decision.”

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Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Bigfoot Biomedical, DexCom Inc.

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