Ed Tepper: Fighting Against Dexcom Medicare Restrictions

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)

Ed’s Presentation:

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.  

For example:

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.

Feel Good Stories about Medicare CGM Coverage

Although those of us on Medicare are thankful that CMS now covers the Dexcom G5, many online discussions are angry and focused on the frustrating regulation that we are not allowed to use our smartphones, smart watches, and pumps as receivers. I wrote a blogpost about this in August and unfortunately there have been no changes to the policy. In fact the most recent news indicates that legislative action might be required to pull Medicare into the 21st century and mobile health technology.

Today I don’t want to write about gloom and doom. I want to focus on good things and how CGM coverage is improving the lives of many Medicare beneficiaries with diabetes. Without fail D-people are finding the Dexcom G5 to be a life-changing device that helps them monitor blood sugar trends along with receiving warnings of highs and lows. Universally CGM users are learning new things about their diabetes and several have experienced huge improvements in average blood glucose levels and A1c’s. Those who are using a Dexcom CGM for the first time mention a reduction in fear and a new ability to feel “almost normal.”

One thing that I have learned in recent months is that I need to stop saying “seniors” in connection to Medicare. Several people I’ve communicated with about this article are on Medicare due to disability and are not yet 65 years old. At the same time, most of us in the Seniors with sensors (CGM’s) Facebook group are 65+ and have lived with diabetes for a long time.

Here are some stories.

Carol W

Carol W and I are email friends—the digital age version of pen pals. She has had Type 1 diabetes for 55 years since age 5 and qualified for Medicare 12 years ago due to diabetes-related vision loss. For many years Carol has lived in the no-win zone where she needs tight control to manage current and avoid future complications while trying to avoid life-threatening lows. Carol lives alone and in February had a severe overnight hypo resulting in a hit to her head, two black eyes, and severe leg seizures. She doesn’t remember the fall. Her only recourse at that point was to begin setting an alarm for 3 AM to ensure that she was okay. Although Carol and her doctor knew that a CGM would greatly benefit her, she was unable to afford the device without coverage by Medicare.

Fast forward to today. Carol received her Dexcom G5 kit in September. Unable to get training at her diabetes clinic for at least two months, she overcame her fear of the insertion needle and started her first sensor with a Dexcom trainer coaching her over the telephone. Some of Carol’s remarks illustrate the life-changing benefits of CGM coverage.

In Carol W’s words:  “Tiny victory yesterday doing all the things I always need to do and made it through the entire day without any lows/highs or ALL THE TESTING with the meter.   Glorious to feel more “normal” – like the days when I didn’t have to test so often. I paid dearly for those days before tight glucose control though. I lost most of my eyesight…. I was able to go play with my neighbor’s one year old yesterday and didn’t have to think about testing. I just checked the receiver. It is truly amazing! I can go outside and garden and just check the receiver. So happy.”

Nolan

I met Nolan through Facebook and we chat periodically through Messenger. Nolan has had Type 1 diabetes for over 50 years. He has used an insulin pump for 25+ years and a CGM for 8+ years. CGM’s have protected Nolan from severe overnight lows and allowed him to sever his relationship with the local EMS and fire department. Because of the importance of a CGM for his safety, Nolan was self-funding his Dexcom for the last two years. This was stressful for the household finances because he is retired with a limited income.

Nolan has experienced the gamut of Medicare CGM experiences. He was one of the few seniors who received G5 supplies from Liberty Medical in the few months that it was the Medicare supplier. Because of no Medicare reimbursement for the starter kit, Nolan was afraid to use the supplies until October when Liberty assured him that he would not be responsible for the cost. A few weeks later Nolan sounded the alarm that “Big Brother is watching” as he got a call from Dexcom indicating that he was on the list of non-compliant seniors using the G5 mobile app. Although he had been using supplies purchased prior to Medicare coverage and thought that was allowed, Nolan learned that we must delete the G5 app from our phone as soon as our Medicare G5 kit is shipped. Violators were warned that if they were flagged again, Dexcom would no longer provide them with Medicare supplies.

In Nolan words:  “Some of the CMS / Medicare bureaucratic issues are just plain ‘non-sensical’ but it certainly is not the end of the world…. Due to my age, length of time I’ve had T1D I just can’t sense the very low BG situations and my CGM has been simply a Godsend for me and my wife in that regard. Simply put I consider the G5 CGM to be a lifesaver for me.”

Carol G

Diagnosed at age 41, Carol G has lived with Type 1 diabetes for 31 years. She uses multiple daily injections and had never used a sensor prior to Medicare CGM coverage. She knew that she was losing her ability to sense low blood sugars but was uncomfortable with paying out of pocket for a Dexcom.

Carol has been blown away by what she has learned since starting to use a Dexcom G5 in late August. She immediately began to see rollercoaster highs and lows that she had no idea were happening between finger pricks. Although disappointed that the Omnipod is not covered by Medicare, she is seriously looking at pumps as the best way to smooth out her blood sugar. Carol had an unhappy learning experience twelve days after starting her CGM. She accidentally dropped her receiver into the dishwasher where it irreversibly died! Dexcom offered a one-time receiver replacement cost of $200 and after nine very anxious days, she was back to using her G5.

In Carol G’s words:  “My first few days with the G5 were a real eye-opener for me.  I couldn’t believe how many spikes and dives my receiver was showing. And how many alerts I received—at all hours of the night. My mind was going a mile a minute. What changes could I make to stop the alerts, and even-out my “hills and valleys”? I had a long phone conversation with my Dr., but realized that I was mostly in charge of this journey…. I met with my PCP recently—the first appointment since getting the G5…. I was thrilled my A1c had dropped two points since my last appointment.”

Lloyd, Kathy, and Sharon

Lloyd has had Type 2 diabetes for 23 years and I shared his story in an October blogpost. Lloyd has been amazed at the accuracy of his new Dexcom G5 and has identified previously unrecognized lows. He finds that the “load” of managing diabetes seem heavier as a senior.

In Lloyd’s words:  “Decades of experience, great tools, and the load seems heavier to me. I really wasn’t frustrated when you interviewed me, BUT I AM NOW!… I used to be able to manage D in my sleep, now I’d settle for being successful period.”

Kathy is on Medicare due to disability and has lived a nightmare trying to get CGM coverage since Dexcom does not have a contract with her Advantage plan. She is grateful to have access to supplies comped by Dexcom and is looking for a new insurance plan for 2018. Kathy is the poster child for learning a lot about “her diabetes” through CGM use.

In Kathy’s words:  “As a benefit, my bs has dropped from avg 166 down to 127 in 30 days, pretty exciting. The numbers are not as significant to me as the trends: how much to correct highs, dose correctly at the start, toss problem foods, add more protein to each meal. Also a walk uphill drops me 70 points on a straight down double arrow, so its good for me to start a little high.”

Sharon lives with diabetes because of the surgical removal of her pancreas 20 years ago. It took 3 months for her to receive a Dexcom due to the distributor asking for BG logs and doctor notes, then signed logs and signed notes, and finally dated signed logs and dated signed notes. After starting to use a G5, Sharon quickly lowered her A1c from 8.3 to 6.8. She personally is not bothered by the inability to use a smartphone but feels strongly that Medicare beneficiaries deserve access to current technology.

In Sharon’s words:  “But there are people who are reliant on family and friends, although going into a nursing home is not a good alternative, cause they’ll just take away our pumps and cgms and put us on a sliding scale. I hope Medicare will get enlightened about Diabetes so we can get to a closed loop solution. Older people can really benefit from this coverage. It is a life-saver.”

Summary

Medicare coverage of continuous glucose monitoring is not perfect. There are wrinkles and delays in obtaining coverage. The inability to use mobile technology is nonsensical. It is frustrating not to be able to use a Tandem X2 pump as a receiver and to not have access to the Dexcom touchscreen receiver. At the same time CGM coverage is life-changing for Medicare beneficiaries with diabetes. Every person who contributed to this post is living with less fear, more safety, and the ability to live a more normal life. Many people are seeing immediate improvements in their diabetes numbers along with a new understanding of the journey that is “their diabetes”.

Yes, there is work to be done. But we are on the right path.

Medicare and CGM Coverage: Swirling Emotions

If you’ve been following the saga of Medicare coverage for the Dexcom G5 CGM, you know that Medicare beneficiaries will be forced to use the Dexcom receiver while being absolutely forbidden from using smartphones and the G5 and Follow apps. Coding and Coverage information released by Noridian Medicare in March 2017 clearly states this Medicare policy:

“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.”

Few people in the diabetes community think that this makes sense, but for now it is the rule. Most of us on Medicare are grateful for the thousands of dollars we will save annually by having our Dexcom G5’s reimbursed, but emotions are swirling. JOY for coverage. ANGER at the restrictions. ANTICIPATION that sensors will be shipped soon. DISGUST that seniors are being treated differently. FEAR that no longer can our caretakers track our numbers in real time. SADNESS that we are losing access to our phones and watches. TRUST that this policy will change.

Lately I have been waking up in the middle of the night and stewing about being forced to abandon my smartphone and Apple Watch as Dexcom receivers. I worry about whether I will be able to integrate my G5 into my t:slim X2 insulin pump once the the Tandem software is approved. In the light of day I try to sort through my feelings knowing that I shouldn’t lose sleep over this. Mostly I feel frustration because it is a stupid ruling that I have little recourse to challenge. There is sadness because I really like my having CGM number on my watch. There is the sense of loss taking away something that I once had. And not to be ignored is the spoiled-child syndrome that “I want what I want when I want it!” and it’s unfair that others have it and I can’t.

For the most part anger about this situation is not one of my emotions, but others are frustrated, furious, and ready to do battle. A couple of quotes from Facebook:

“This is a ridiculous and ageist policy and I have said it many times. It’s not right.”

“I find it abhorrent that Dexcom G5 is MEANT to be used with smart technology and ANYONE not on MEDICARE has this option.”

“There is no way I can sign that form. It’s aggressive and hostile and incredibly ageist.”

Another emotion I do not have is fear. I currently neither use the Share app nor need someone alerted to my highs and lows. But others are dependent on a caretaker monitoring their BG levels and their safety is jeopardized with the denial of cell phone use.  Some Medicare recipients have disabilities such as low vision that make the larger screens and adaptability features of smartphones a better choice than the small screen of a Dexcom receiver.

“My T1D husband has a traumatic brain injury. So it is invaluable to me, his 24/7 caregiver for 3 1/2 years to be able to use the share/follow app.”

“Share has saved my life a couple of times on the G4 when I was mowing grass and didn’t hear the Dexcom alarm, but I did hear my phone when my wife called.”

“I don’t feel my Lows and my guy gets the alarm on his phone….This is a *safety issue* in my opinion. If we were totally able to feel things and get through without the chance of conking out we wouldn’t even need the darn CGM.”

“I have retinopathy of prematurity and have always had bad vision. Seeing my Dexcom readings on the iPhone is much easier than on a small receiver.”

My Thoughts and Things to Remember:

When my reasonable brain takes control, I know that I will survive using my Dexcom receiver. That is all I had for the first seven years of my nine years using a CGM.

I don’t have medical reasons that my iPhone and Apple Watch are better than my receiver. In fact I prefer dismissing alerts on the receiver because I can just push the button and not even look at the number! BTW that is a bad thing…. On the phone, I need to scan my fingerprint, tap on the alert, and go to the Dex app to dismiss it. I will miss automatic syncing of my G5 numbers to Dexcom Clarity, Tidepool, mySugr, and other apps, but I will survive.

My blog was started in the spring of 2013 and quickly became known for advocacy for Medicare Coverage of CGM’s. If at any point we had been offered the possibility of CGM reimbursement contingent on no smartphone use, we would have jumped at the chance. What we’ve got now is not perfect but it is thousands of dollars per year better than nothing.

Right now I think a lot of my stress comes from just not knowing what is going on. Through the early months of working out the logistics of Medicare, Dexcom did not do a good job of communicating with seniors. Some people were getting email updates. Others of us called Dexcom numerous times to be put on “The List” and never received any information. Seniors are still being told different things by different representatives from Dexcom, DME suppliers, pump companies, and medical professionals. Fortunately there is now some information on the Dexcom website but it does not answer all of my questions. I will definitely have an easier time coping once I know the rules of the game along with hardware and software modifications.

For the most part I am resigned to the Medicare restrictions and am working to accept them. In the short run I think we need to get Medicare reimbursement established before fighting the smartphone ban. Others disagree with me and are making calls, writing letters, starting petitions, and even hiring lawyers. And that is good because although patience is sometimes the best strategy, other times anger and in-your-face advocacy are the only way to force change.

Right now I know that whatever the policy ends up being, I will adapt. I haven’t used a receiver in years, but I’ll get used to it again. I can’t live in fighting mode all of the time and right now need to find acceptance. Although I know that I will eventually take my place on the battlefield fighting Medicare CGM policies, at the moment I am choosing to let things take their course and trust that Dexcom and JDRF will get this changed. At the same time I am cheering on those actively opposing Medicare. One online friend sums up my views perfectly:

“A year or two ago we were all writing letters to our Congressmen to get on board with a bill to have Medicare pay for the Dexcom. Now that is is approved, I’ve decided to let go of any anger and resentment (never does a diabetic good anyway) and am thankful for the approval and the fact that I won’t be paying out of pocket anymore, despite the absurdity of Medicare’s restrictions. However, I will still work in any way I can to change those restrictions if possible.”

Another senior stated it even more succinctly:

“It is what it is. You want Dexcom through Medicare? You sign the form.”

Amen.

 

Note: This blogpost only addresses the smartphone ban for Medicare coverage of the Dexcom G5. There are other problematic policies such as only 2 test strips per day being provided to CGM users. Those issues are in the wait-and-see category and worthy of discussion another time.

Medicare and CGM Coverage: Love Your Receiver!

Laddie_Head SquareI was surprised, thrilled, elated, stunned, relieved, and every other adjective that you can think of when I received Friday’s mass email from Derek App, JDRF President, with the breaking news:

CMS Labels Continuous Glucose Monitors as Durable Medical Equipment

JDRF is pleased to share that the Centers for Medicare & Medicaid Services (CMS) decided today to recognize continuous glucose monitoring (CGM) devices approved for use in making diabetes treatment decisions as durable medical equipment, a significant step toward making them eligible for coverage under Medicare. Today’s decision lays a pathway toward extension of Medicare coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers. Although the significant benefits of CGM use have been known since 2008, CMS had previously refused to consider covering the devices under Medicare, saying they did not meet the statutory definitions of durable medical equipment or any other category the agency could cover. Today’s decision removes that impediment.

In recent years I have wavered between optimism and pessimism as I advocated, hoped, and prayed for Medicare coverage of continuous glucose monitors. Now it looks as though the day is coming! I don’t know how long it will be before procedures are in place for receiving reimbursement, but it will be soon. Soon may mean later in 2017. Soon may mean 2018. But there is finally a path in sight for Medicare reimbursement of CGM’s.

Today I read through the 15-page CMS Ruling with a yellow highlighter. You will find some of the specifics of the report well-described in Mike Hoskins’ Diabetes Mine article:  NEWSFLASH: Medicare Will Cover Some CGMs Now! Below I will expound on a couple of Mike’s points and then talk more about the specifics of durable medical equipment.

Dexcom Only: This ruling only applies to the Dexcom G5 because it is the only CGM approved by the FDA for insulin dosing. Therefore the G5 is the only system that fits the definition of a “therapeutic CGM.” Currently CGM systems by Medtronic have not been approved for insulin dosing and are considered “non-therapeutic.” They do not fit the definition of Durable Medical Equipment (DME).

No Guarantee of Coverage: This ruling only states that therapeutic CGM systems fall within the scope of Medicare Part B DME. There has not yet been a national coverage determination to guarantee approval if one satisfies still-to-be-determined coverage criteria. Right now MAC’s (Medicare Administrative Contractors) have the option of issuing local CGM coverage determinations or coverage may be obtained on a claim-by-claim basis. What does this mean? We will learn as Medicare beneficiaries begin filing claims for CGM coverage. You can bet that I will apply for coverage as soon as possible after starting Medicare in April.

All Types of Diabetes: Just as people with all types of diabetes are able to receive coverage for home BG monitoring, all PWD will be eligible for CGMs according to this ruling. Don’t get too excited because IMO the coverage criteria will most likely restrict reimbursement to some people with Type 1 diabetes and some insulin-using Type 2’s. Just as it is more difficult for Type 2’s to obtain coverage for insulin pumps, it may be more difficult for them to obtain CGM coverage. But this is still an improvement over the 2015 congressional bills (S.804 and H.R.1427) that specified Type 1 diabetes.

One thing not addressed in Mike’s article is how the Dexcom G5 fits into the Medicare definition of Durable Medical Equipment (DME).

According to the CMS ruling, there are 5 criteria which must be established in order for a device to considered as DME:

  • Can withstand repeated use;
  • Effective with respect to items classified as DME after January 1, 2012, has an expected life of at least 3 years;
  • Is primarily and customarily used to serve a medical purpose;
  • Generally is not useful to a person in the absence of an illness or injury; and
  • Is appropriate for use in the home.

Home blood glucose meters and supplies have been in this category for a long time. Technically the meters are “durable” and have an expected life of at least 3 years. For “multicomponent” systems, the other components are covered as long as one component (the meter) is “durable.” Therefore test strips are covered because they are an integral part of the system.

Looking at the Dexcom G5 system, CMS quickly specifies that sensors with an expected life of 1 week are not durable. Neither are transmitters with an expected life of 3 months. So we are left with the receiver. According to CMS, “reliability analysis data from an engineering firm that evaluated the receiver component of the recently approved therapeutic CGM predicts a lifetime of greater than 3 years for the receiver.” CMS goes on to say that the receiver “is the only component of the therapeutic CGM that can be considered durable and satisfy the 3-year MLR criterion of the definition.”

What does this mean? It means Love Your Receiver!!! Without the receiver, the Dexcom G5 system does not satisfy the criteria for DME.

dexcom-love-your-receiver

The FDA approval of the G5 system required the purchase of a receiver and many people complain about that requirement since they use their phones as the receiver. Just know that CMS is never going to classify your phone as a reimbursable medical device, so cherish your receiver even if you never take it out of the box. If you’re not on Medicare, still cherish your receiver so that seniors can receive CGM coverage! Also Medicare coverage of CGM’s is important for everyone because it is a vital component to coverage of artificial pancreas systems.

In the coming weeks and months, we will learn more about the implementation and impact of this CMS ruling. If you’d like to learn more, here are a few links.

Text of CMS Ruling

Diabetes Mine Analysis  

Diatribe’s Preliminary Analysis

Expanded Statement from JDRF

And no matter what, don’t forget to Love Your Receiver!

 

Healthy Lunch Day

Laddie_Head SquareI have been a quiet blogger this November and done little to advertise or celebrate diabetes month. I was an active participant in the Big Blue Test but that was all behind the scenes. I have read the wonderful blogposts by other diabetes advocates and  chosen not to feel guilty for my lack of participation.

This morning I received an email from Chelsea at the American Diabetes Association asking me to participate in the second annual Healthy Lunch Day which is celebrated today. Easy enough because I eat lunch almost every day and it is usually a “healthy” meal!

A salad is my most common lunch and today was no exception. The base was a Mann’s Power Blend containing Brussels sprouts, Napa cabbage, kohlrabi, broccoli, carrots, and kale. I topped it with raspberries, leftover cooked broccoli, a hard-boiled egg, and a yogurt-based dressing. I guessed the carb count to be 18 grams and bolused accordingly.

fullsizeoutput_1a22I tend to spend two or three hours each afternoon at my kitchen table “desk” and like to avoid BG spikes with a lowish carb lunch. I go heavy on vegetables and berries to make up for my oatmeal breakfast that has nothing green or colorful.

So here’s to #HealthyLunchDay and the ADA’s November theme of #ThisIsDiabetes. My lunch was healthy and I have diabetes, so it’s a perfect fit!

Countdown to Medicare with Type 1 Diabetes:  5 Months / Anxiety

Laddie_Head SquareThere are frequent online discussions about addressing mental health issues along with physical concerns when living with diabetes. I am lucky to be mostly immune from things like diabetes burnout and depression. I don’t like diabetes but it doesn’t haunt or slow me down much. I come from a family with a history of depression but its dark clouds have never settled over me for very long. Still…

I have a tendency towards anxiety. The kind of worry that radiates in my chest and aches in my belly. It has never been so crippling that I have felt the need for professional help and I have been helped by progressive relaxation tools I learned from a book many years ago. Deep breathing and exercise also help.

I am very in tune with my anxiety. It surfaces when I need to make a decision or address a problem and I don’t feel in control. Sometimes the issues are trivial or at least very fixable, but my rational brain can’t convince my gut that I shouldn’t be stressed. I won’t call them silly, but my anxiety worries are not life-or-death. Maybe it is a leaky roof. Maybe it is a grandchild getting her feelings hurt. Maybe it is Christmas. Maybe it is thinking about what needs to be done to sell our house and we don’t even plan on selling the house.

Maybe it is Medicare.

I have been trying to get a handle on Medicare options for several months. I haven’t decided whether I know too much or not enough. I wake up many nights at 2:00AM and start thinking about Supplemental versus Cost* plans. I walk the dog and my stomach cramps thinking of Competitive Bidding. Part B insulin and test strip brands are a constant concern. This stuff is important, but not so important that I should be losing sleep.

But anxiety does not always make sense.

I finally have premium costs and plan information for 2017 and I am making worksheets to compare my options. I have only one decision that could have an impact beyond my first year on Medicare and that is the Supplemental versus Cost plan decision. Supplemental (Medigap) policies are only required to accept me (a person with pre-existing conditions)countdown-to-medicare-5-months during the first 6 months that I am on Medicare. After that I can be denied coverage or charged higher rates. At the same time there are guidelines about having guaranteed Medigap rights and some of those scenarios will grant me needed flexibility in the future.

The things that stress me are discrepancies like one plan agreeing that insulin for a pump will be covered under Part B and a similar plan saying it won’t. (That can be a big deal because Part B insulin does not go into donut hole calculations.) I think the plan saying no is wrong, but what do I do about it and do I dare risk signing up with that company? I need to consider that company because it happens to offer CGM coverage. Yes, I am lucky to have the option of CGM coverage with one plan! But I need to consider the whole package, not just one thing. More homework to do.

Another thing that is stressful is trying to figure out what pump and testing supplies cost. For the most part I have been using the negotiated prices from my current BCBS policy. But one friend shared his test strip cost info with me and it looks as though he is paying 20% of what I consider a high retail price compared to what a negotiated price should be. Am I right? Right or wrong it certainly makes me wonder what prices I should be using to figure out my anticipated costs.

Another thing that kicks me in the gut is competitive bidding. This is only relevant if I choose a Supplemental plan because Cost plans use their own suppliers. DPAC has published a couple of blogposts recently that scare the bejesus out of me. One post was written by a person with diabetes on Medicare and the other was written by someone who owns a durable medical equipment company. These are great articles to spur advocacy, but frightening for those of us anticipating Medicare.

One benefit of participating in the DOC is that I have support from other people affected by diabetes. A downside is that I read stories of people having nightmare experiences with Medicare. As a blogger, I get emails from readers sharing their stories and problems. At the same time I know many people with Type 1 who are doing fine on Medicare but those people don’t write much about their experiences. I mostly hear the bad stuff.

anxiety

I have anxiety. Some of it is unreasonable. I live in Minnesota and have several good (not perfect) options for Medicare. My husband still works and his income will provide a buffer from the shortcomings of Medicare. At the same time some anxiety might be reasonable because healthcare reimbursement at all levels in the United States is under siege and people with diabetes are getting hit particularly hard.

I expect that my next Countdown to Medicare post in December will outline some specifics of my choices. Obviously cost is a major concern, but so are things like drug formularies, test strip brands, and requirements for getting pump supplies. I have already eliminated choices that do not network my current doctors and I am looking at the plans of two different companies. It is likely that I will choose a plan that allows me to avoid competitive bidding because anyone with a tendency towards anxiety might not survive that disaster.

More to come. 😀

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**Minnesota is one of very few states that offers Cost plans. These plans are hybrids that combine features of traditional Medicare and Advantage plans. Most people reading this post will not encounter Cost plans in their Medicare journey.

A Diabetes Data Machine

Laddie_Head SquareI am currently involved in a couple of projects that require tracking my diabetes data. The good part is that some of the data is automatically logged with little or no input from me. The bad part is that I am using 3 different apps on my phone and must enter food information twice. The good part is that I have learned new things about my diabetes. The bad part is that I am uber-involved in the input of data and not paying much attention to the output.

Big Blue Test

Most of you are familiar with the Big Blue Test sponsored by the Diabetes Hands Foundation. Every test logged between October 14 and November 14 will result inBig Blue Test Logo a $3 donation to support people with diabetes. Three charities will receive $5000:  Diabetes Sisters, We Are Diabetes, and the Riverside Community Diabetes Collaborative.

The Big Blue Test is by far the easiest of my current data projects. I use the app on my phone and it’s a quick 30 seconds to record my exercise. Although participation is easy, I am no Big Blue Test slouch. Yesterday I managed to input 5 (!) tests. Dog walk. Gym session. Rake. Rake again. Dog walk. That translates into a $15 donation for diabetes.

If you are participating in the Big Blue Test, keep up the good work. If you are not involved, check out this link to learn more. It’s not just walking and running. You can include housework, yard work, weight work, and dancing. You can help a couple of diabetes groups while receiving the physical and mental benefits of moving your body. Sounds like a win for all.

mySugr Consulting

I continue to be a beta-tester for the mySugr consulting module. As outlined in my September post, mySugr is launching a feature to allow virtual coaching from Gary Scheiner and the team at Integrated Diabetes Services. You can learn more about themysugr-copy program here and here.

Today I am not addressing the coaching experience except to say that Gary Scheiner does a better job of understanding my D-data than I do. Instead I am writing to share that amazingly I am still logging after 3 months!

I am still learning shortcuts for entering my data and have reduced the number of data points I am tracking. I continue to enter food and carb counts, but don’t classify the food anymore as vegetable, meat, etc. Similarly I am not distinguishing between food and correction bolus amounts, just total insulin. What I like about mySugr is the ability to customize my logbook to show only the data points that are important to me and to list them in an order that makes sense to me.

My newest “cool” discovery about mySugr is that if I use the workout app on my Apple Watch, it automatically transfers the activity to mySugr. Another diabetes/life datapoint automatically logged!

Glu and T1D Exchange

Glu is the patient community of the T1D Exchange and provides an easy way to participate in research relating to type 1 diabetes. I am currently part of a study about blood sugar results and treatment satisfaction for T1 adults using pumps or multiple daily injections.blip_logo

The logging requirements of this study are not difficult because most of my data goes into Tidepool’s Blip. If you don’t know about Tidepool and their innovative diabetes apps, check it out here. I download my Animas pump and Freestyle meters once a week. My Dexcom CGM automatically links with the Blip Notes app on my iPhone. My only daily responsibility is to create a Blip note whenever I eat. I click on #food and record the meal with the carb count. To make it easy, I copy and paste the meal info just entered into mySugr. Takes 30 seconds or less.

Where to from here?

The Big Blue Test ends November 14.

The mySugr logging has no end date and I’ll keep at it a while longer. But not forever.

The T1D Exchange study lasts 4 weeks.

I have learned a lot from this intensive logging. I tend to eat a little bit all of the time and now have visual proof that my BG is better when I eat more at meals and reduce snacking. I have done some basal testing and am seeing better CGM tracings. Better basals allow for less snacking.

But I am tired of logging. My head is exploding with numbers and my brain is drowning in data. I am thinking about diabetes too much and will be happy to quit recording my life in a couple of weeks. Being a diabetes data machine is fine for a while, but for me the benefit gets lost when I do it too long. For sure I will quit before Thanksgiving because there is no way I want to start the holiday season being accountable for my food decisions….

 

Thoughts on Patient Empowerment

Laddie_Head SquareI recently read two articles by Dr. Niran S. Al-Agba, a pediatrician in Washington State and blogger at MommyDoc. I discovered her posts through KevinMD.com and have added her blog to my Feedly list. As a grandmother with 40 years of Type 1 diabetes, you might wonder why I plan to follow the writings of this young pediatrician. I think it is because her thoughtful views on the roles of patients and physicians in our healthcare system (or lack thereof?) give voice to some of my opinions and experiences.

The first article I read was titled “Building Better Metrics: Focus on Patient Empowerment.” Mid-article Dr. Al-Agba writes something that many of us who use insulin believe is essential: “Patient-centered care is often talked about as a virtue worthwhile to attain because it puts them at the heart of their healthcare team. Empowerment goes one step further by actually giving power and authority to the patient.”

She goes on to share the characteristics of an “empowered activated patient” as listed by ENOPE (European Network on Patient Empowerment):

  • Understands their health condition and its effect on their body.
  • Feels able to participate in decision-making with their healthcare professionals.
  • Feels able to make informed choices about treatment.
  • Understands the need to make necessary changes to their lifestyle for managing their condition.
  • Is able to challenge and ask questions of the healthcare professionals providing their care.
  • Takes responsibility for their health and actively seeks care only when necessary.
  • Actively seeks out, evaluates and makes use of information.

I don’t know about you, but I believe this list describes me and many of us living with diabetes. At least most of the time.

The second article by Dr. Al-Agba is titled “Building Better Metrics: Patient Satisfaction Can Be Done Right!” Building on the first article, she writes that physicians are often more comfortable with “standards of care” and need to become more comfortable in the role of giving information, sharing options, and empowering patients to take more control. She goes on to discuss that sometimes that means disagreeing with a patient’s decision while respecting the right of the patient to make that decision.

That idea really hit home for me based on a recent experience with a new physician. My longtime internist retired this summer and suggested that I follow one of his younger partners to a nearby clinic that is part of a large provider system. Until now all of my doctors have been part of independent clinics. Such practices are starting to be an anomaly in big cities and I was not opposed to moving into a “system.” I knew that it wasdoctor-patient-respect probably a good idea to narrow my network of doctors as I look to future health insurance and Medicare restrictions.

In August I had my annual physical with the new internist. He asked several questions and for the most part seemed to accept my answers. Many queries seemed to be coming from a computer-generated checklist which I suspect was labeled “Old Lady with Diabetes.” I had to fight the urge to say “Hey, that’s not me!”–because of course that is me. Our only area of conflict was over statins which I have resisted up until now. In May I wrote about my previous doctor’s support for my decision to avoid that class of drugs. I felt a bit bullied by the new doctor but given that it was his first week in the new system, our first meeting, and already an overly long appointment, I decided to let it go. And I agreed to give statins a try.

Two months later I am experiencing clear side effects from the statin drug and have chosen to stop taking it. One thing that I love about my new medical system is a complete online health record along with the ability to send secure messages to my health team. I was able to share my statin decision without talking to anyone or feeling that I was hiding something from the new medical team. I wrote several drafts of the email and believe that I ended up with a respectful but confident and empowered message.

I did not get a reply to the message nor did I expect one. I am sure that it will be a item of discussion next time I see this doctor. I am very comfortable with the idea that he can strongly disagree with my decision. However, I need to feel that he respects my right to make that decision. If not, I will look for a new internist. However, based on most of the August appointment, I am optimistic that as we get to know each other, we will do just fine. Fingers crossed.

Friday Notes

Laddie_Head SquareYesterday was a busy diabetes day. In addition to just having diabetes (and believe me, that’s enough!), I attended an advocacy training program sponsored by the American Diabetes Association (ADA) and there was a vote by an FDA Advisory Committee regarding the Dexcom G5.

Number #1: My DiabetesNothing momentous to say about my diabetes except that yep, I’ve still got it. I had a big unexpected BG spike after a restaurant salad lunch. Maybe there was hidden sugar in the salad dressing. Maybe my glass of wine decided to be a problem. Maybe it was the mid-morning peanut snack dosed with an extended bolus. Maybe it was because it was 90+ degrees outside with off-the-chart humidity even though I was comfortable inside with air conditioning. Maybe it was because it was Thursday. This is the sort of stuff that makes it a miracle that those of us dealing with Type 1 even have a modicum of sanity left in our lives.

Number #2: ADA Advocacy Training:  I attended a late afternoon Advocacy Training seminar sponsored by the American Diabetes Association. I found it to be very empowering and in a moment of bravado, I signed up to be available for in-person office visits to my congressional representatives. I am a confident advocate when writing, but speaking and putting myself “out there” border on terrifying.

The ADA has a good app for advocacy and I suggest that you check it out. It provides information on national and state advocacy priorities and links to easily become involved in ADA advocacy. Search for “Diabetes Advocacy” in the app store.IMG_0298

Because Scott Johnson was the reason that I knew about this seminar, I can’t say that it was a surprise to run into him by the Diet Coke cooler. But it’s always a pleasure to see Scott.IMG_0295

Number #3: FDA and Dexcom G5:  I was pleased to receive an email from Bennet Dunlap of DPAC sharing news from yesterday’s FDA Advisory Committee meeting on Dexcom G5 labeling. The panel voted 8-2 to recommend approval of a G5 labeling change to allow insulin dosing without a confirmatory BG meter test. The FDA will have to make the final approval, but it is likely that the advisory committee’s recommendation will be accepted. This change should help justify Medicare coverage for CGM’s as well as expand the use of CGM to more patient populations.IMG_0932

That’s it for today. Have a good weekend!

 

Consistent Inconsistency

Laddie_Head SquareIt’s now Day 4 of Diabetes Blog Week and the homestretch is in sight. I am starting to fade a bit when it comes to daily writing and reading about diabetes. Fortunately I’ve read some great blogposts this week and am inspired to make it to the finish line. Today the subject is healthcare and our fearless DBW leader, Karen Graffeo of Bitter-Sweet™, has given us permission to get grouchy. Right now I have good doctors and good insurance. Not everyone else is as lucky.

Today’s Topic:  Most people who live with a chronic illness end up with a lot of experience when it comes to dealing with healthcare. How would you improve or change your healthcare experience? What would you like to see happening during medical visits with your healthcare team? How about when dealing with your health insurance companies? What’s your Healthcare Wish List or Biggest Frustration? Today is the day to share it all!

Wow. I think that those of us with diabetes could write an encyclopedia on this topic. The thing that bothers me the most about the healthcare system in the United States is the consistent inconsistency of it.

New year ==> New Insurance plan ==> Used Humalog last year. Forced to switch to Novolog.

New job ==> Different insurance company ==> Current endocrinologist is now out-of-network.

Same year ==> Same insurance plan ==> Won’t cover my brand of pump anymore.

Next-door neighbors with Type 2 diabetes  ==> My insurance reimburses diabetes education ==> Yours doesn’t.

Next-door neighbors with same income ==> You work for a large corporation and pay $500/month for health insurance ==> I am self-employed and pay $1000/month for similar insurance.

An insurance company pays my dentist $75 for an office visit ==> I don’t have dental coverage and must pay $135 for the same visit.

I have my 65th birthday ==> When I was 64 I had full insurance coverage for a CGM ==> Now it is considered “precautionary” and not reimbursable.

I could go on and on but it would drive me crazy. What worries me most about our healthcare system is that it is going to get worse before it gets better:-(

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To read more posts on this topic, click here.