Negotiations between Dexcom and CMS addressing the requirement that Medicare beneficiaries use only the Dexcom receiver have reportedly not been going well. Diabetes Patient Advocacy Coalition (DPAC) has organized a campaign to lobby our congressional representatives to have this policy changed through legislative action. To read an overview of the issue and easily contact your members of Congress, download the DPAC app on your phone or tablet or go to the DPAC website.
Ed Tepper of Glen Allen, Virginia is affected by the smart device restriction and has chosen to advocate for change. Coming from a family with a strong history of Type 2 diabetes, Ed was diagnosed with T2D 11 years ago. After developing neuropathy in his feet, Ed worked with his endocrinologist to intensively manage his blood sugars using insulin therapy in conjunction with a CGM. In addition to being an outspoken advocate for people with diabetes, Ed is an active cyclist and triathlete.
Here is Ed in his own words followed by the informative presentation he shared with one of Senator Tim Kaine’s staffers.
Ed Tepper: This morning I had a 10 minute meeting with one of the staffers for Sen. Tim Kaine (D-VA). The attached file is the presentation I left with him. It was a good meeting. There is a strong history of diabetes in the staffer’s family and he was genuinely interested in the technology. He promised me that he would forward the document to Sen Kaine’s health lead and would email me within a few weeks. I’ll follow up if I don’t here from him by year-end. By the way, Sen. Kaine is on the senate heath committee so he may have some influence there. Keep bugging your senators and representatives about this issue. (11/28/17)
Medicare’s restrictive policies regarding Continuous Glucose Monitors put seniors at risk and potentially raise the overall cost of diabetes management.
Meeting with Marc Cheatham, Staffer for Senator Tim Kaine of Virginia. November 28, 2017.
Disclosure: I am an individual who is living with diabetes and is concerned that Medicare’s restrictive policies regarding the use of CGM’s will adversely impact my ability to stay healthy. I am not employed or otherwise associated with any company that manufactures or distributes CGM’s or related items. I am currently covered by Medicare Part A, Part B and Part D and have a Medicare Supplement policy.
What is a Continuous Glucose Monitor (“CGM”)?
A CGM is an FDA approved device that provides continuous insight into glucose levels throughout the day and night. The device displays information about current glucose levels and the direction and speed of change, providing users additional information to help with their diabetes management. The CGM consists of three components: the sensor that is inserted subcutaneously, the transmitter that sends data from the sensor to a receiver, and the receiver.
To Medicare’s credit, in 2017 they started covering the cost of one model of CGM, the Dexcom G5. However, they have place restrictions on how we must use the CGM that causes undue inconvenience and creates dangerous situations for Medicare recipient users.
I have been using the Dexcom G5 CGM for about 2 years now (before being covered by Medicare starting September 1, 2017). I started using the CGM because I developed neuropathy in my feet and in consultation with my endocrinologist decided that I needed to maintain better control over my blood glucose levels. Using the CGM has helped me understand how insulin, food, & exercise affect my glucose levels and I’ve learned to adjust the three to maintain a more equal levels of blood glucose throughout the day. It also alerts me when my glucose levels are lower or higher than I want or are falling or rising too fast.
Medicare Prohibits the Use of Available FDA Approved Technology
Before being covered by Medicare, I used the FDA approved Dexcom smart phone app and an FDA approved integrated insulin pump to read the CGM data. Medicare has taken those options away from me and now I can only use the receiver that comes from the CGM manufacturer. In addition to the inconvenience of having to carry and care for another piece of equipment, not being allowed to use smart phone and integrated pump technology can create health hazards for Medicare recipients using a CGM.
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, such 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.
These restrictions have already caused life threatening situations in real life.
Kim H. of Pennsylvania reported to me: “My t1[Type 1 diabetic] husband has a traumatic brain injury. He doesn’t remember how to use the receiver and I must let him keep it at times if I am more than 30 feet from him. He pushes buttons and has entered incorrect bg [blood glucose] numbers making the CGM data incorrect! I need to have control using my iPhone for proper data and effectiveness as I am his 24/7 caregiver.”
Jenny S. of California told me: “I have been legally blind from premature birth & although I can still see I am extremely nearsighted. Seeing a smart phone screen is a whole lot easier than the Dexcom receiver. I already have a phone, so why should I be forced to use a $700 receiver that is very hard to see?”
For me being restricted to using the Dexcom receiver is a real issue when I’m outside. I’m an avid cyclist and triathlete and I’m very hypoglycemic unaware. That means that I cannot feel having low blood glucose levels until the levels approach being dangerously low. Pre-Medicare I used the phone app because it sync’d to my sports watch which vibrated when the app triggered low glucose alerts giving me advanced warning that my blood glucose levels were falling and I needed to eat. The Dexcom receiver is difficult to read in bright daylight and its alarms are not as noticeable when exercising. Since being on Medicare, I’ve been surprised by low glucose levels more than once while cycling. That’s a very dangerous situation because I could lose the ability to control the bike and … well the results wouldn’t be pretty.
CGM’s Can Reduce Overall Costs.
The Economic Cost of Diabetes is Staggering and Growing.
According to the Centers for Disease Control & Prevention, National Diabetes Statistics Report, 2017, (“CDCP Report”) the cost of diabetes care in 2012 was $245 Billion. The American Diabetes Association (“ADA”) estimates the current cost at $322 Billion per year.
Emergency room visits in 2014 included 245,000 cases for hypoglycemia (low blood sugar) and 207,000 visits for hyperglycemia (high blood sugar). That’s almost one-half million emergency room visits for diabetes care. (Source: CDCP Report).
The ADA estimates that 30 million Americans are affected by diabetes, that’s 1 in 11 Americans.
Complications people living with diabetes can suffer include: Stroke, Blindness, Kidney Disease, Heart Disease and Loss of Toes, Feet or Legs.
Use of a Continuous Glucose Monitor (“CGM”) can reduce the onset of complications and reduce overall cost of diabetes care.
The Consensus Statement of the American Academy of Clinical Endocrinologists & the American College of Endocrinology (Vol. 22, Issue 8, August 2016) states:
“CGM improves glycemic control, reduces hypoglycemia and may reduce the overall cost of diabetes management. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes.”
As reported by the National Institute Health, the report “The Impact of Real-Time Continuous Glucose Monitoring in Patients 65 Years and Older” concluded that “restrictive access to … CGM in the Medicare age population may have deleterious health, economic, and QOL [Quality of Life] consequences.”
HERE’S THE ASK:
Medicare must change its restrictive, dangerous policies regarding the use of CGM’s. It must allow the use of available technology approved by the FDA, including smart phones and watches and integrated insulin pumps. It must cover all CGM’s approved by the FDA, not only the Dexcom G5. It must make the changes NOW.
Restricting use of smartphone has reduced the
Protection of CGM. NOT expecting Medicare to pay for smartphone just give us option of using.
Smartphone use greatly increases advantage of CGM. Not asking Medicare to par for smartphone just give us the option.
Thanks for the post and ability to easily contact our reps to get this badly-informed policy changed.
Well stated; thank you…..
it is a ridiculous regulation by people who can only read the rules, not understand them.
Great letter! Wish someone with experience as a diabetic helped make these decisions at MEDICARE. I wrote my senatorsand only one read the letter. The other one wrote back thanking me for writing about the Omnipod! Okay, Ding Dong….I wrote about the Dexcom CGM. And Medicare’s STUPID decision to not allow the use of the smartphone technology placing patients at risk!
Great letter, thank you as I sent to my “Representatives”. While the phone would be nice, I would rather have it on my tslim pump. The phone app for some reason is VERY selective on Android phones (which is a joke considering Android is the OS not the phone). If Medicare manages to change this rule next step will be having to concentrate on Dexcom to make a true Android application and not a per phone application for everyone to be able to utilize it. But once again, thanks for your time and guidance/assistance on this.
Great post, great advocacy. I hope this makes the impact on the insurance companies that diabetics deserve.