Are Routine ECG checks Warranted for People With Type 1 Diabetes?

The US Centers for Medicare and Medicaid Services (CMS) has clarified the criteria for receiving insurance coverage for the Dexcom G5 System.  This is really big news!  Medicare may cover therapeutic continuous glucose monitoring (CGM) when ALL of the following conditions are met for a beneficiary:

• Has a diagnosis of diabetes
• Has been using a home glucose monitor, finger-stick testing at least four times per day
• Insulin treated with Multiple Daily Injections (MDI) or an insulin pump
• The regimen for insulin treatment necessitates that the patient make frequent adjustments based upon CGM testing results

To fall into this category, the system must be defined as “therapeutic CGM.”  This means that you are permitted to make treatment decisions based upon the CGM.  The FDA has only given this approval to the Dexcom G5.  No other CGM system has this approval.

There are instructions on the Medicare Administrative Contractor (MAC) website for adjudication of  individual claims.  Dates of service on or after January 12, 2017 are necessary for coverage to be effective.  For information on coding and coverage, visit: https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/coding-and-coverage-therapeutic-continuous-glucose-monitors.

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

However, there is a catch.  Medicare patients who want reimbursement have to use the receiver that comes with the system, rather than using a smartphone app to see their trend graph.  If they use the smartphone app, even if it’s in addition to the receiver, they will not be eligible for reimbursement.  Dexcom’s announcement of Medicare coverage did not include this information.

Dexcom’s G5 system is capable of transmitting to a smartphone app, so the patient doesn’t have to carry a separate device to display the glucose data.  There is also software that allows third party caregivers to see the glucose data remotely on their own smartphone.  However, the MAC article explains that because smartphones are not Durable Medical Equipment (DME)under Medicare, Medicare recipients cannot use smartphones and still qualify to get their CGM covered.  The MAC wording was, “If a beneficiary uses a non-DME device (smartphone, 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.” 

Back in December, the G5 system got an FDA indication that permitted users to make decisions about insulin dosing from the CGM, rather than taking a fingerstick.  Bear in mind, a fingerstick calibration of the CGM is still required every 12 hours.  But this decision did allow the Dexcom G5 System to qualify for Medicare’s definition of DME, which made it eligible for Medicare coverage.

Related to their age and the duration of time with a diagnosis of diabetes, people of Medicare age really need access to CGM because they are more likely to have hypoglycemia unawareness.  Hypoglycemia unawareness means that the patient doesn’t get the symptoms, which are warning signs, when BG levels are low (below 70 mg/dl).  If the patient’s BG is low, CGM alarms can alert the patient and family members or caregivers that the BG is too low and therefore unsafe.  This is especially important at night.  Imagine that you’re not waking up to your low alarms at 3 am.  Wouldn’t you be grateful if an off-site relative or caregiver could intervene on your behalf?       

This has been a long time coming, and we are thrilled that being of Medicare age will no longer be a barrier to benefitting from CGM.  However, the inability to use the smartphone app is a real disappointment.  It adds another layer of safety for a third party caregiver to have remote access to CGM data.  Let’s hope the next step will be to allow common sense to prevail.  As long as the receiver is used, why not let the smartphone be used to allow third party caregivers to have access to the data?