Coming sooner than expected, Medicare recently clarified coverage criteria for the Dexcom G5, paving the way for Medicare to reimburse for people with both Type 1 and Type 2 Diabetes requiring intensive insulin dosing to use the Dexcom G5 mobile.

    Dexcom and the diabetes community heralded the exciting news, as the lack of CGM coverage for Medicare patients had previously been a glaring oversight. Dr. Steven Edelman, founder of TCOYD, often joked about this, saying, “Good news! According to Medicare, Type 1 diabetes is cured when you turn 65!”

    Despite the good feelings all around, a closer look at the Medicare document includes some concerning language that might forbid users to take advantage of one of the most useful features of the Dexcom G5: the ability to view sugars on your smartphone or smartwatch.

    First, the good news: Medicare reimbursement for both Type 1 and Type 2 Diabetes on Dexcom G5

    Dexcom proudly touted the fact that U.S. Centers for Medicare & Medicaid Services (CMS) issued guidelines that allowed for Dexcom G5 reimbursement for patients with either Type 1 or Type 2 diabetes who intensively manage their insulin. More specifically, they listed the following criteria that must all be met:

    • The beneficiary has diabetes mellitus; and,
    • The beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing; and,
    • The beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
    • The patient’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.

    Keep in mind these guidelines currently only apply to the Dexcom G5 Mobile system, as it is currently the only Continuous Glucose Monitor (CGM) to be FDA approved for “non-adjunctive use”, meaning it can be used for treatment decisions without a confirmatory fingerstick glucose measurement. (Calibrations with fingersticks are still required).

    The bad news: no smartphone usage?

    I’m admittedly not an expert when it comes to medical billing, but reading the CMS document more closely reveals some concerning information. In a section titled “Miscellaneous”, it states:

    Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a receiver classified as DME to display glucose data.  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

    By my interpretation of that phrase, it appears that Medicare would not cover users who use an iPhone or Apple Watch to view their blood sugars. I can understand why not using the dedicated Dexcom receiver might be discouraged by CMS since it’s solely built for medical use (unlike a smartphone, which can be less reliable), but the wording clearly also bans the use of a smartphone in combination with a receiver. That’s ridiculous.

    Your initial reaction might be that many elderly patients (most of the patients on Medicare are above the age of 65) are not tech-savvy enough to use their smartphone, but my experience has shown that a surprising amount of older patients are quite adept at using the latest tools.

    Now, the bigger question is this: can Medicare actually enforce this stipulation? Any patient receiving the Dexcom G5 System receives a separate receiver anyway, and how can Medicare police who is using the smartphone as the display device. Keep in mind, taking advantage of the Dexcom Share Cloud platform and Dexcom Clarity clinical tools require the app to be installed on a nearby smartphone, which may or may not fit the definition of using a “non-DME device as the display device.”

    Reassuringly, Dexcom doesn’t seem to be too concerned about this caveat, as their press release did not include any mention of this. We’ll continue to follow this as the real-world application of these guidelines unfold…