Continuous Glucose Monitoring (CGM) is life-saving technology for people with diabetes. The ability to view glucose trending data and set alarms to prevent dangerous high and low blood glucose levels has changed the way many of us manage our diabetes.Multiple studies have shown the positive benefits of CGM usage; of particular note was the significant reduction of severe hypoglycemia in those who are higher risk due to hypoglycemic unawareness (the inability to "feel" a low blood glucose level or show symptoms of hypoglycemia):

For individuals experiencing a high risk of hypoglycemia, real-time CGM usually resulted in significant clinically meaningful reductions in risk of hypoglycemia by 33% to 50%. (https://www.ncbi.nlm.nih.gov/pubmed/18779236/)

Medicare Refused to Cover CGM

Despite the overwhelming data showing the positive impact of CGM technology and the widespread reimbursement of this system by private insurers, the Centers of Medicare and Medicaid Services (CMS) refused to cover it, claiming it was "precautionary," "not medically necessary," and that it would not replace fingersticks for blood glucose checks.The diabetes community and many members of Congress attempted the legislative route, beginning in 2014 with the Medicare CGM Access Act of 2014 (and then 2015) in an effort to ensure Medicare beneficiaries would be reimbursed for CGM coverage.The reasons listed above were shattered with the FDA's December 20, 2016 announcement that beyond the two calibration fingersticks needed each day, FDA approved the Dexcom G5 for:

"...replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes. This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test."

Less than a month later, on January 12, 2017, CMS issued Ruling 1682R, which finally brought reimbursement for the CGM system for our Medicare community. While there were restrictions and exclusions, there was cause for celebration. Access to this life-saving technology was now available to those who never had access or had lost access to it by becoming Medicare eligible.

NO SMARTPHONE, WATCH, OR TABLET ACCESS TO VIEW CGM DATA?

But the cause for celebration was quickly muted due to the following statement set down by CMS under Miscellaneous:

"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-DMEdevice (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."

Why? Because CMS believes that if someone on Medicare doesn't use the receiver that is required by FDA to be shipped as part of the system, then they shouldn't have to pay for the system at all. The receiver is considered Durable Medical Equipment (DME) and so the only way they can be sure it is used is to prevent any other method of viewing the data. This includes smartphone, watches, and tablets.

Unintended Safety Consequences

By denying access to the CGM data generated by the transmitter to any device except the receiver, the ability to remotely monitor or alternately alarm the person with diabetes is prohibited. This becomes a significant safety issue, as:

Caregivers cannot use the Dexcom Follow App, which allows up to 5 people to remotely view CGM data. The Dexcom Follow App can alarm the caregiver when blood glucose levels are out of the accepted safe range so that the caregiver can immediately contact the person with diabetes (or emergency personnel) to prevent severe hyper- or hypoglycemia.
People with diabetes cannot use the Dexcom G5 Mobile App, which shows real-time data on a smartphone or tablet with the ability to create custom volume alarms and vibrations.
People with diabetes cannot use a smartwatch to access either app. The smartwatch will vibrate on an individual's wrist when the blood glucose is outside of a safe range. For individuals who are deaf, hard-of-hearing, or asleep, the haptic (small vibrations on the wearer's wrist) is needed to ensure that they respond to the alarm.
Integration of CGM data into insulin pumps is prohibited for people on Medicare, which is currently available for the rest of the diabetes community. As the pathway to hybrid- or closed-loop artificial pancreas technology needs CGM data to be effective, CMS is preventing Medicare beneficiaries from using CGM integrated insulin delivery devices to stay safe.

Who Decided This Safety Restriction?

Administrators at the Centers of Medicare and Medicaid Services (CMS). Not Dexcom. Not people with diabetes. Not caregivers.

CMS ADMINISTRATORS.

Dexcom has met with CMS several times, submitting multiple suggested language proposals that would allow our Medicare community to use alternate methods of viewing CGM data taken from the transmitter to share with their family, friends, and care team.There is continued dialogue but as patients we need to raise our voice to the safety concern this is causing. Patients not covered by Medicare can use the full system without restrictions, so why are Medicare beneficiaries with diabetes (which include Seniors, children with disabilities, and people with End Stage Renal Disease) who are often most at risk denied the full functionality?

WHAT CAN WE DO RIGHT NOW?

The phrase: "It will take an act of Congress!" is true in this case.CMS is not listening to patients. It's not listening to Dexcom. (And, companies who will use CGM technology for insulin dosing in the future will add their voices in the near future...)

CMS must listen to Congress.

If an individual in Congress calls CMS to ask a question regarding a ruling,

CMS must respond with a phone call.

[fullwidth menu_anchor="" backgroundcolor="" backgroundimage="" backgroundrepeat="no-repeat" backgroundposition="left top" backgroundattachment="scroll" bordersize="0px" bordercolor="" borderstyle="solid" paddingtop="20px" paddingbottom="20px" class="" id=""]It's our responsibility to tell Congress to call CMS and ask why they are putting our Medicare community in harm's way by preventing access to CGM data on devices other than receivers.[/fullwidth]

How?

Here are some easy steps:

If you haven't downloaded the DPAC Mobile App, you can do so here. You can call your Senators and Representative, Tweet your Congressional reps, and even email your request to them straight from the app. (A few clicks and you're done!)
You can click here and send an email to your reps.
You can post to your Congressional representative's Facebook page (NEW!) to let them know they must call CMS and ask about this safety issue.
SHARE THIS POST and ask your community circles to contact their Congressional representatives, too!
Tweet this message out:

[bctt tweet="Contact Congress re:CMS ruling denying smart device CGM data access. Serious safety issues for #diabetes!" username="DiabetesPAC"]