Memorandum

CMS should allow use of CGM smartphone apps, per letter from Senate and House Diabetes Caucus leaders – April 23, 2018

Executive Highlights

  • House and Senate Diabetes Caucus leaders have sent a letter urging Medicare to allow use of CGM smartphone apps. The two-page letter, signed by Susan Collins, Jeanne Shaheen, Tom Reed, and Diana DeGette, notes that the current Medicare restriction “does not make sense” and CMS should work “expeditiously” to support the full spectrum of CGM use – i.e., receiver alone or receiver/smartphone app.

  • This has been a big issue ever since therapeutic CGM received coverage last March – if a beneficiary uses a app for viewing data, the CGM supplies are non-covered. Accordingly, Dexcom had to disable app communication for G5 Medicare users. Talks have been ongoing with CMS, and Dexcom’s call in February shared a “hope to resolve [this] in the next six months.” Will this letter move the needle?

In a CGM advocacy win, the co-chairs of the Senate and House Diabetes Caucus, US Senators Ms. Susan Collins (R-ME) and Ms. Jeanne Shaheen (D-NH) and US representatives Mr. Tom Reed (R-NY) and Ms. Diana DeGette (D-CO), recently wrote a succinct two-page letter to Hon. Seema Verma, the Administrator of the Centers for Medicare and Medicaid Services (CMS). The thoughtfully written letter criticizes the current CMS policy prohibiting use of CGM smartphone apps: “this restriction does not make sense and we are concerned that it will lead to poorer patient outcomes and less accessibility.” Yes!

The letter nicely argues two main points: (i) sharing CGM data, alerts, and alarms with others provides “an extra layer of defense,” especially in older patients at high risk of hypoglycemia; and (ii) the use of smartphone apps expands CGM accessibility to those with low-vision or blindness. The letter rightfully points out that commercial insurance plans allow use of smartphone apps – “the full spectrum of use” – meaning Medicare beneficiaries currently lose access to valuable features. We’re glad to see a clear takeaway: “We urge CMS to work expeditiously to revise its continuous glucose monitor Local coverage article, to clarify that beneficiaries may choose to use a smartphone app, in conjunction with their CGM receiver, without losing Medicare coverage for that device.”

We applaud the Diabetes Caucus for recognizing this critical issue and advocating for change – it’s been an issue for over a year now! On the 4Q17 call in February, Dexcom CEO Kevin Sayer said Medicare discussions were ongoing on this topic, with a “hope to resolve in the next six months.” Is this Congressional letter a piece of what he was referring to? Will CMS amend its Local Coverage criteria for therapeutic CGM? And if so, how quickly?

  • This has been a long saga ever since therapeutic CGM (i.e., insulin dosing claim) was classified under Medicare Part B in January 2017, and coverage for Dexcom’s G5 was announced two months later. In the local coverage decision, CMS was specific about use of smartphones: “If a beneficiary uses a non-DME device (smart phone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the supply allowance is non-covered by Medicare.” Presumably, this was aimed at preventing beneficiaries/companies from pursuing reimbursement for smartphones; ultimately, it has been a massive source of frustration. To ensure CMS reimbursement compliance, Dexcom had to turn off app communication for Medicare G5 transmitters, disabling remote monitoring and smartphone viewing.

  • As CGM systems move towards complete dependence on smartphone apps –  e.g., Medtronic’s Guardian Connect and Senseonics’ Eversense do not have receivers –  reversing this Medicare stipulation is more imperative than ever. Plus, doing so could arguably save CMS money over the long term, since eliminating the monthly receiver rental price could save the agency money. That said, the receiver is the critical “durable” component, so we’re not sure how simple that would be in this case.

  • Dexcom G5 and Abbott’s FreeStyle Libre are the only CGM devices with Medicare coverage – i.e., both are therapeutic CGMs approved as a replacement for fingersticks (insulin dosing). Abbott announced Medicare coverage for FreeStyle Libre in January, just over three months following FDA approval in September 2017. The status of FreeStyle Libre’s smartphone app, LibreLink, is unknown in the US for both the Medicare and non-Medicare populations. The Abbott-developed app launched on iPhone and Android in 12 EU countries in February, allowing FreeStyle Libre users to scan the sensor via NFC. No US timing has been given, though we’d imagine it’s a major priority.

 

--by Maeve Serino, Adam Brown, and Kelly Close