Tandem t:slim X2 and Dexcom G5:  It takes Flexibility

Last Wednesday I received my email from Tandem with the upgrade code to add Dexcom G5 integration to my pump. A great feature of the t:slim X2 is the ability to perform software updates at home rather than need a hardware replacement every time new capabilities are added to the pump. This first X2 software update adds Dexcom G5 receiver functions to the pump in anticipation of future updates adding threshold suspend and other insulin dosing algorithms. Tandem has a catchy slogan for the X2: “The pump that gets updated, not outdated.”

My Upgrade Experience

I followed the instructions for the upgrade and for the most part, it went well. I had one glitch where an error code indicated that my pump was communicating with another device. I restarted the upgrade and everything went fine. I had not been using my Dexcom receiver and I was assured by other X2 users on Facebook that I could leave the G5 app running on my iPhone and Apple Watch. (Note: the Dexcom G5 transmitter can only communicate with one receiver and one smart device. You cannot use the X2 and the G5 receiver at the same time.)

For the first hour I received an unbroken every-5 minute tracing of my Dexcom readings. After that it went haywire and I got only 2 readings in the next hour. I continued to get multiple Out of Range alerts as the day went on.

When you use a tubed pump, your pump is never far away from your CGM transmitter. My Tandem pump was in a pocket. My Dexcom transmitter was on my arm. My iPhone was on the table, in a pocket, in the kitchen, in my purse and not missing a dot. The pump was struggling with 12 inches.

I called Tandem twice over the next couple of hours and with a little troubleshooting it was apparent that I shouldn’t be having such problems. As always, the Tandem reps were helpful and the second rep indicated that many similar problems had been solved by a new transmitter. My current transmitter has been in use for a month and seemingly fine, but I wasn’t going to argue with trying a new transmitter.

I received the new transmitter on Saturday and will begin using it with my next sensor.

Meanwhile I have begun to get better communication with my Dex sensor, but it is not because the pump is better at picking up the signal. It is because I am making changes. I initially kept my pump in my left front pocket with the sensor on my right arm. I am now wearing the pump clipped to my waistband on the right side. I still lose signal when I sit in my normal “easy chair” and my arm is against the back cushion. (My phone does not lose signal in this scenario.) But I am getting better at moving to the right side of the chair and keeping my arm on the armrest so that the transmitter is not obstructed. I prefer my pump in my pocket, but I can get used to the waistband.

Basically I am being flexible to make things work.

Pump Case

Somehow every change I make impacts something else. Wearing the pump on my waistband has brought back the problem that the clip on the new case is neither tight enough nor long enough to keep the pump secure in the vertical position. Over two days it fell off 5 or 6 times and was saved from hitting the floor only by yanking on my infusion set. Miraculously the infusion set never ripped off. I decided to do a hack of adding a piece of Velcro to the tip of the clip. Bad hack. The Velcro made it difficult to slide the pump onto my waistband. Ultimately I broke the clip off the case by trying to open it wide to pull onto my pants. Definitely user error and because I was given the case for free, I will eventually just order another one.

Second hack. I am back to using a Nite Ize Hip Clip that is attached directly to the pump. When I used this clip a few months back, it also tended to fall off my waistband but not as badly as the Tandem case. This time I put a small piece of Velcro on the pump side of the clip and it hasn’t fallen off once. Of course so far it is only a 3-day experiment.

I am not done yet with figuring out a case hack and think it will involve a Nite Ize clip attached to the Tandem case and a small piece of Velcro. Or maybe just Velcro attached to the case using the Tandem clip. Although the Hip Clip attached directly to the pump is working OK, I prefer the protection of a case. My false occlusion alarms were eliminated by using a case and I am hesitant to go without one. I’ll definitely write another blogpost once I decide on an ultimate fix.

Summary

I like having my G5 information on my pump and I will continue to be as flexible as possible to make it work. Although there is some frustration that my relationship with the X2 is a bit temperamental—first due to occlusion alarms and now to CGM reception—I am still very happy with the pump. In general if I go back and look at the  various pumps and CGMs that I have used since 2005, they have all required me to learn, change, and be flexible to ensure success.

Medicare?

Now I get to the nitty-gritty of this newest update. What are the Medicare repercussions??? I’m flexible, but I can’t say the same thing for Medicare.

I have discussed more than once the stupidity of the Medicare ban on smartphone use for Dexcom G5 users. I’m not going there today. However, I have been hoping that because the Tandem X2 is durable medical equipment (DME) and not a smartphone that I will be able to use it as my CGM receiver instead of the Dexcom receiver.

When I read the Noridian Medicare coding and coverage document released in March, I do not believe that the X2 violates the guidelines:

“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.”

Unfortunately I have heard from several sources that Dexcom is instructing Medicare customers that current Medicare instructions mandate use of the Dexcom receiver. I suppose justification for that comes from the first sentence of the Noridian document: “The Dexcom G5® Mobile CGM System is currently the only FDA-approved device with a “non-adjunctive” indication.” Although my Tandem pump works with the G5 Mobile CGM System, it is technically not part of the system according to Medicare. Some Tandem pumpers have also been told by Tandem that the X2 is currently not approved by Medicare to be used as a Dexcom G5 receiver.

I continue to be optimistic that Medicare regulations regarding the Dexcom G5 will be changed to allow use of a smartphone and use of the Tandem X2. I have no predictions for a timetable for those changes. In the short run I am still using Dexcom supplies purchased before Medicare and continue to use my iPhone, Apple Watch, and Tandem X2 pump. In the long run I will follow Medicare regulations because CGM coverage is too valuable to risk losing that coverage.

As always with diabetes, I will be flexible.

 

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.

Dexcom G5 and Medicare:  What’s Going On?

History

On January 12, 2017, the Centers for Medicare & Medicaid Services (CMS) released a ruling indicating that the Dexcom G5 CGM was a therapeutic medical device and eligible for reimbursement as Durable Medical Equipment (DME). I published a blogpost on 1/15/17 discussing this ruling and I urge you to read it as background for what has been going on (or not going on) in the last six months.

On 6/1/17 Mike Hoskins of Diabetes Mine published an article titled “Stuck Waiting for Medicare CGM Access” and this is good background for connecting the dots from January to June. Yours truly (Laddie Lindahl in Minnesota!!!) was one of the seniors highlighted in the article. Mike summed up the last six months pretty well by writing:

“but so far CMS has not proposed a national coverage policy. As a result, many PWDs on Medicare who previously had coverage or are trying to get CGM coverage are being told they can’t get the devices and supplies they need because “nothing is finalized yet.”

I found the end of the Diabetes Mine article to be quite alarming as Mike suggested:

“Insurance companies send out their contracts to medical supply distributors during the summer months, leading up to open enrollment periods that typically start in the Fall months. So right now is a critical time. Contracts are being crafted and finalized, and with all this Medicare CGM confusion, insurers and third-party distributors may very well simply leave out any language about Dexcom G5 coverage. Effectively, Medicare CGM’ers could face no coverage for their Dexcom supplies for 2018 because so much is up in the air right now.”

I transitioned to Medicare in April anI have been able to continue using my Dexcom CGM due to an extra G4 transmitter saved from my free upgrade to the G5 and from a couple of boxes of stockpiled sensors. Everything I am using is out of warranty, but it works. I am okay….but only for a while. This spring it was announced that Liberty Medical was going to be the authorized Medicare supplier for the Dexcom G5. They were quickly overwhelmed by the demand. (Who knew that it was so complicated?) I placed an order with Liberty and canceled it within a few days of shipping. It had become common knowledge that Liberty was not being reimbursed by Medicare and those of us placing orders might be responsible for the out-of-pocket cost. Meanwhile Liberty withdrew from supplying G5 supplies under Medicare as of 5/28/17.

Where are We Now?

I have had no reliable information source during the last weeks and months, but I have managed to piece together some news. Here is some info with the source and I’ll let you judge the reliability.

Dexcom: Some people on Facebook have mentioned email updates from Dexcom and I have called the company several times and was assured that I was on “The List.” I’ve never received an email. Yesterday I called Dexcom and learned a few new things.

1) Dexcom has set up a Medicare link in their phone menu. Call the Customer Service number at 888-738-3646. Select Option #1 for placing an order. Within that menu, select Option #1 for Medicare Help. Please note that Dexcom is experiencing high call volume about Medicare and I waited almost 10 minutes on hold.

2) If you are desperately out of supplies, call Dexcom and in some cases they are providing supplies.

3) I suggest that you call Dexcom to ensure that your account has the correct insurance information. On Tuesday mine was showing private insurance and Edgepark as my supplier. It has now been corrected to show Medicare as my primary and BCBS as my supplemental.

4) I was told on Tuesday that we each have a “Reorder Specialist” assigned to our account. I found out the name of my specialist and got his contact information. I was told that these specialists are sending out the informational emails and I had not received any because I was not “in his pipeline.”

Facebook: I am in a Facebook group called Seniors with sensors (CGM’s) where members share their experiences and opinions. Of course a lot of the info is “my endo told me” or “the Dexcom email said” or “the letter from Liberty said.”  We all know that the world will collapse into a black hole when Facebook is the source of all knowledge, but here are some things that I have learned:

“I heard from my endo this morning that Dexcom will be doing their own distribution for their Medicare CGM products. No third party like Liberty Medical (thank god.) The hang up at the moment is they are looking for a supplier for meters/strips which Medicare is requiring.” 6/21/17

“Dexcom also told me this week that they will be distributors.” 6/21/17

“I just got off the phone with a very nice Dex Customer Service Rep. Still many unanswered questions from Medicare but she says they expect to be alerting those on the waiting list by end of June” (The rep I spoke with yesterday was unwilling to give me any timetable.) 6/19/17

‘Did you get the email today from Dex with updated requirements from Medicare? They are ” working on it .” Still no way we can use phone / watch combo. I think that ageist and unfair.” 6/15/17

Diabetes Mine: In a 6/15/17 article about the ADA Scientific Sessions, Mike Hoskins and Amy Tenderich shared an update from Dexcom executives:

“If you’re wondering what’s going on with Medicare coverage of Dexcom CGM, here’s the rub: CMS has mandated that Dexcom ship out to Medicare patients “everything they would need” to use the product. Since calibrations with a fingerstick meter are required, that means Dexcom has to find a traditional meter company to partner with to actually ship meters and test strips in the package with their CGM. Kinda crazy, and definitely creating delays for the company and its customers!”

The Part We Hate!

It is becoming increasingly clear that unless things change, Medicare users of the Dexcom G5 will be forbidden from using their smartphones in any form. I understand and previously wrote about the importance of the receiver in allowing the G5 to be designated as DME. The idea that one cannot use a smartphone in conjunction with the receiver is absurd. The dollar value of Medicare reimbursement is significant enough that I can go back to using my receiver, but I hate the idea of abandoning my phone and especially the ability to see my Dexcom numbers on my Apple Watch.

For me it is an inconvenience. But how about those seniors who benefit from someone using the Follow app to monitor their BG trends. How about those seniors who use the accessibility features of their iPhone to access their BG numbers?

It is a stupid requirement. At the same time, my personal feeling is that we need to establish Medicare CGM coverage before we fight this battle. If you read the original CMS ruling, the only reason that the Dexcom G5 qualifies as DME is because of the receiver. If we don’t need the receiver, then unfortunately the G5 is no longer DME. So we need to be careful. That is my 2 cents!!!

What Others Are Saying?

When I began writing this blogpost, I asked my fellow seniors from the Seniors with sensors (CGM’s) Facebook group to share their thoughts. I learned a lot.

“Although it will be a inconvenience for most of us, which will hopefully be temporary, those using the Tandem X2 insulin pump or an Apple Watch series 2 should still be able to connect directly to the Dexcom G5 via Bluetooth by this fall with expected software upgrades from both Apple and Tandem”  —Larry

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. He had a severe car accident due to a low blood sugar which the initial 4 months of hospitalizations and rehabilitation cost almost 2 million dollars. If he would have just had a CGM it would have saved all that money, he would still be working and not on disability, and I would still be working. Every diabetic at diagnosis should get a CGM and certainly should not get them taken away at medicare age. He got his after coming out of rehab. We as caregivers near and far need to be able to assist our diabetic family and friends with the features Dexcom has like Share and Follow. —Barry and Kim.

As a type one diabetic who lives alone, it is mandatory to have a CGM that is 100% covered by Medicare. This is a lifesaver. As much as I would hate to be without either my Tandem pump or my Dexcom CGM, my Dexcom is crucial to my daily survival. I will be eligible for Medicare in September, 2017, and I am so very disappointed to find that I will have fewer benefits than I do with private insurance now.  —Cindy

Laddie, my biggest concern is with the exclusion of phones, and especially smart watches from Medicare’s program. In my opinion the use of a Smartwatch to manage Bg and treat T1D is a major advance in T1D care. It is a real time process. No phone need come out of a pocket, no receiver from same or elsewhere. Tap your watch,see your Bg, make treatment decisions in real time. I have been absolutely amazed by this one simple process and the impact it’s had on my life and T1D management. Somehow we must get Medicare to recognize this and allow the use of this technology for treatment. Either that or Dexcom has to build a receiver/watch.  —Dave

I am a Therapist. The watch being important to my work. It is not possible for me to check my blood sugar on a receiver or even a phone at this point during office visits. This restriction on app use is going to cause a problem for me .  —Deidre

Two Medicare people in my household. Repeatedly denied CGM coverage despite multiple appeals and documented Certificates of Medical Necessity the app by my PCP/Endo. Brittle Type 1 46 years with history of severe hypos with seizures and one incident of Nocturnal hypoglycemia leading to coma. One incident of severe DKA requiring 5 days in ICU.  —John

I haven’t experienced a coma yet, but that’s what happens when you have no cgms or no partner to watch over you.  —Dianna

I know, Dianna. Before my CGM I was almost afraid to go to sleep at night.  —Cindy

Signed up for the CGM in January. Now middle of June. Still waiting. Yesterday, another low where I crawled to kitchen for OJ. Made it again. Every time, I wonder when the time will come when I don’t make it.  —Camille

Summary

I think that Camille said it all:  “Yesterday, another low where I crawled to kitchen for OJ. Made it again. Every time, I wonder when the time will come when I don’t make it.”

One Month of Medicare with Type 1 Diabetes

I thought it was going well.

Some of it is great.

I’m learning that maybe not everything is going so great.

I haven’t screamed at a phone menu yet.

I officially started Medicare on April 1. I seem to have figured out how to pay my bills through auto payment. I have received a box of pump supplies and have an order in place for CGM supplies. I have received my insulin at no cost through Medicare Part B and had another prescription covered at no charge through Part D. I belong to a new health club through a program offered by my supplemental insurance. On the surface all of this looks great and some of it is. Unfortunately not everything is going smoothly and Medicare is not approving everything.

What’s Going Great:

Silver&Fit:  This fitness program is a benefit of my BCBS Supplemental policy. It provides a membership at a participating fitness facility, an instructor-led class, or access to Home Fitness kits. I joined a club five minutes from home that has a huge number of work-out machines, weights, a spa, nutrition and fitness programs, locker rooms, and free fitness classes. I have been attending numerous strength and cardio classes and having a great time. No charge at all. My only limitation is that I can only use the club I joined and not the other branches around Minneapolis. I literally walked in the door and was a member 10 minutes later.

Doctor Visits: In April I had two routine doctor appointments. It was easy to provide my Medicare information and as far as I can see, they are being covered with no issues. I feel bad seeing how low the Medicare reimbursement is for my doctors.

Not Perfect but On the Right Track:

Insulin for Pump: As I explained in a previous Medicare blogpost, insulin for an insulin pump is covered under Part B DME. With my supplemental plan coverage that means I get my insulin at no cost. I am not bound by formulary restrictions nor does my insulin require a copay or put me into the Part D donut hole. The new prescription from my endocrinologist contained the required information and I spoke to a pharmacy tech to remind them to file it with Part B. Very quickly I got an email that the prescription was ready; it had been charged to my Part D plan with a charge of $481 for 3 vials.

The next morning I went to Walgreens and fortunately the pharmacist on duty knew how to correct the problem. She told me that it would be referred to the central Walgreens Medicare department and it might take 2 days to set up. That afternoon I got a call from the Medicare department and was asked for information such as my pump brand, model, serial number, purchase date, and whether it was paid for by Medicare or private insurance. That all made sense and was easy to provide. She finished our conversation with two questions. How tall are you? What do you weigh? Huh??? She said that my insulin would be ready for pick-up in an hour and it was.

Pump Supplies: In March I contacted Tandem Diabetes to learn my Medicare supplier for pump supplies. I was told that according to my supplemental insurance, I should use CCS Medical and Tandem would set up the account for me. CCS has been great so far and has contacted me and my endo’s office several times to get the necessary information. One requirement was a C-Peptide test which I had never had before in my diabetes career. As expected, I passed or failed the test depending on your criteria. I failed because I produce minimal to no insulin. I passed because I qualify for a pump and supplies under Medicare.

My pump supplies arrived quickly and were exactly as ordered. Last evening I went into the Medicare site to check my claims and was stunned to see that my pump supplies were denied. I called Medicare this morning and got no good answers as to why. It was suggested that maybe I was using the wrong supplier and I was given the name of another supplier who doesn’t even provide supplies for insulin pumps. I called CCS and the rep indicated that they were already working with Medicare to get it straightened out. She said that it was very common for supplies to be denied on the first go-round for patients new to Medicare. She assured me that everything is OK and I am choosing to believe her.

A Total Mess:

All of us on Medicare were thrilled when the Centers for Medicare and Medicaid Services (CMS) announced in January 2017 that the Dexcom G5 was now covered as a therapeutic CGM under Medicare DME. Soon after that CMS released a document with preliminary coverage criteria and Liberty Medical was identified as the sole Medicare-approved supplier for the G5. Liberty was deluged with calls but managed to start shipping supplies to some customers. One caveat however. In order to receive supplies, you had to sign that you would be responsible for the cost of the supplies if you were not approved by Medicare. Meanwhile it was announced that more specific coverage criteria were still to be released and Medicare was not approving orders filled by Liberty.

Last week it became apparent that Liberty is not going to continue to supply G5 supplies for Medicare beneficiaries. All along Dexcom has indicated that it will not (cannot?) sell G5 supplies out-of-pocket to people covered by Medicare. Please note that the cash price from Liberty is much higher than the previous cash prices from Dexcom. Dexcom will sell G4 supplies to Medicare beneficiaries out-of-pocket. On Monday I received a letter from Liberty officially indicating that they are not going to provide Dexcom supplies after May 28. At this time there is no other supplier.

I placed an order at Liberty about a month ago. I was called last week to indicate that they had everything required to process my order and that it was under medical review. Today I canceled the order because I do not want to be stuck with the responsibility of getting an initial denial by Medicare, having to pay cash for the order, and then filing an appeal. I think I’ll wait to see what happens in coming weeks or months.

Dexcom has been quiet and provided little help to seniors. Today some people received a form letter from Dexcom indicating that they are working on the problem and stating: “If you have an immediate, critical need for Dexcom G5 Mobile CGM supplies, please contact Dexcom at 888-738-3646.” I did not receive the email.

So currently the Dexcom G5 is covered by Medicare, but not really. I am choosing to be patient and optimistic that everything will be worked out soon. Many other seniors on Facebook are angry and less optimistic.

Summary:

Some of my diabetes needs are being met through Medicare and other things are being worked out. So far I have had no problem reaching customer service reps at Medicare, CCS Medical, Walgreens, Dexcom and Liberty. Everyone has been polite and helpful to the best of their ability. Unfortunately no one at Dexcom or Liberty really seems to know what is going on and I believe them when they say the delay is with CMS. The Medicare Help Line was answered promptly but they could give me no reason for my supply denial and then nicely gave me inaccurate information. CCS Medical has been very responsive and so has Walgreens.

Right now I have everything that I need, but that won’t be true for the longterm. In the past I have often had problems when switching insurance plans and suppliers. I am hopeful that most of my Medicare problems are in the same category. I expect the pump supply problem to be resolved fairly quickly. I am less optimistic about CGM coverage.

So that’s today’s story about Medicare and Type 1 diabetes. Stay tuned for more. 😀

 

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!

 

Back to the Future:  Dexcom G4 Share and Apple Watch

Laddie_Head SquareIn the last 10 days, my diabetes technology world has changed. On one hand I have reverted to an older tech platform. On the other hand I have zoomed into the future with a modern and cool-for-a-64-year-old-woman device.

Stepping Back:  After getting my free(!) upgrade to the Dexcom G5 last fall, I was lucky to be left with an unused G4 transmitter. I didn’t start using the G5 until March when my previous G4 transmitter passed its 1-year anniversary. It was still working fine, but I abandoned it to transition to the G5 platform. A bit wasteful, but gee whiz, that transmitter was never going to die! I used two G5 transmitters and for the most part was happy with G5.

That unused G4 transmitter did not disappear and kept sending “Use Me! Use Me!” messages to my brain inbox. If I were not moving to Medicare and no CGM coverage in 6 months, I probably would have used my “privileged diabetes patient” status to stay with G5 and give the unused G4 transmitter to a  needy DOC friend.

Last weekend my second G5 transmitter timed out and I bit the bullet to go back to G4. My CGM warranty expired in early September and I was able to order a new G4 Share receiver. Although it had only been 6+ months since I had last used Share, I panicked as it seemed totally foreign to me. Also because I am using the mySugr logbook, I needed to be sure that my CGM information would continue to sync to the app. Miraculously I figured everything out and it is working correctly.

Onward to the Future:  Earlier this fall I decided that I would use my #firstworldprivilege to order an Apple Watch so that I could see my current blood sugar just by raising my wrist. Please remember that I started my diabetes career in the days of urine testing and things like this are magical to me.d-tech-privilege-circle

My Apple Watch 2 arrived last week. I have not worn a wristwatch in 12+ years since I got my first insulin pump, aka pocket watch. It wasn’t terribly difficult to add the Share app to the watch and it works okay. Unfortunately it cannot be used as a watch face “complication” like the G5 app. There is another app called “Watch Sugar” that allows me to add the Dexcom number to my watch face, but it is so time-delayed that I don’t find it helpful.

Basically I leave the Dexcom Share app open on the watch all of the time and it is usually what I see first when I raise my wrist. When Share is not the wake-up screen, it is easy to find the app in the dashboard and restore it. My difficulty with this whole set-up is that occasionally it just doesn’t work. If I am using other Bluetooth devices such as headphones or a speaker, I think the phone gets confused and occasionally loses the signal from the Dexcom receiver. There are also user-error problems such as leaving the receiver upstairs or closing out the Share app on my phone.

Clash of the Past and Future:  The bad part about these D-tech changes is that now I have two more devices to carry, coordinate, and charge than I did two weeks ago. The G4 requires a receiver and of course the watch is added. The blood glucose number that I see on my wrist starts with the transmitter beaming info to the receiver which communicates with the phone that sends it to the watch. There is definitely some mental fatigue and data overload with this set-up. At the same time I love not having to reach into my pocket to retrieve Dexcom data.

Life is good. It might would be nice if I didn’t diabetes but that horse left the barn a long time ago. So today I give thanks for access to technology that make my life with diabetes a little bit easier and a lot more interesting. 😀

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!

 

Subtracting the Adjunct from Dexcom G5

I will preface this blogpost by reminding you that I am not a medical professional and I am not suggesting that you do what I do.

Laddie_Head SquareSetting the Scene:  On July 21 Dexcom will have an Advisory Panel hearing with the FDA to discuss whether Dexcom’s G5 CGM should be officially approved for dosing insulin. (This Diatribe article gives information on the meeting and how to provide comments or attend in person.) Currently the G5 has “adjunctive” labeling which means that it is approved by the FDA to be used with confirmatory finger stick testing. Non-adjunctive labeling will help CGM’s receive approval for Medicare coverage as well as justify CGM use for more people with diabetes. In September 2015 the G5 was approved with proper calibration for insulin dosing in Europe.

Background:  Three years ago I wrote a blogpost about how frequently I dose off of my Dexcom. In that post I mentioned bolstering my Dexcom confidence with an average of 8 meter tests a day. Not much has changed since then except I now back up my Dexcom with only 4-6 daily finger sticks. Two of those BG tests are for calibration so it is evident that I am relying on Dexcom for most of my BG information.

Dexcom Blindman’s Bluff:  Earlier in June I decided to test my confidence in the Dexcom G5 and play a game that could be called Dexcom Blindman’s Bluff. The purpose was to experiment with reducing the number of meter tests even further and to consider whether I have enough trust in a CGM to allow it to be the basis for all insulin dosing as it might be in an artificial pancreas (AP) system.

Articles about improvements in AP technology seemed to be published daily. Many clinical trials report average blood glucose numbers in the high 120’s to the low 140’s. For the vast majority of people with Type 1 diabetes, those numbers would be a significant improvement.

I am a T1 who has managed to have lower averages than that for many years. Would I be willing to trade a higher A1c for a huge decrease in the mental burden of diabetes alongBlindFolded Woman with a significant reduction in variability and the number of lows? I suspect that I would although I know some T1’s who definitely would not. Secondly, would I trust a Dexcom sensor to give sufficiently accurate results to dose insulin without my input?

For 48 hours on June 7-8, I decided to accept all numbers in my Dexcom target range of 70-160. The rule was No peeking at my G5 screen for any reason other than to act on prompts for calibration and alerts for out-of-range BG’s. I would use my Freestyle meter only for calibrations. I would rely on Dex alert numbers as the basis for correcting lows and highs and no meter tests for confirmation were allowed. Before eating I would not check my Dex for my current BG status and I would dose insulin based only on the carb count of the food I was eating and my anticipated activity level. If I hadn’t received an alert, I knew that my BG was somewhere between 70 and 160 and that was it.

Because I had Dexcom alerts and calibrations, I didn’t believe that I was doing anything horrendously dangerous. After all, those of us diagnosed with Type 1 diabetes before the mid-1980’s had no home blood glucose monitoring and played “chicken” with diabetes every day.

Results: I had no problems blindly following my Dexcom G5 for 2 days and I was comfortable letting Dexcom run the show. That confidence came with a couple of caveats. The sensor was a week old and had already proven itself to be reasonably accurate. I was close to home both days and not climbing mountains, playing golf, or eating chocolate-covered donuts.

I am the first to admit that my results were skewed for the experiment because I tried to avoid anything that would push my BG out of range. It was two days of the best diabetes numbers that I have seen in ages. But good numbers weren’t the purpose of the experiment and when I got a couple of low alerts overnight, I treated them with no meter confirmation and the same with an afternoon high.

Dexcom Clarity Graphs

This experiment reinforced how little I can feel differences in my blood sugar. Most of the time I had no clue where my BG was in my range. 75 or 155? I had no idea.

Although a two-day test is not sufficient to prove that I would trust the Dex as the compass for an artificial pancreas, it did show me how quickly I could adjust to accepting all numbers in a target range and letting a tech device deal with the minutiae. The idea of not thinking about blood sugars all of the time was very enticing and a slightly higher A1c, especially with less BG variability, might be a small price to pay for a more “normal” life.

Longterm:  Two days was only a toe in the water of using a CGM as my primary blood glucose guide. I thought about doing a longer test, but I couldn’t think of any reason to continue using a CGM blinded. Trends, spot-checks, and pre-meal info are crucial features of CGM use and it is an artificial, somewhat silly game to do without them.

Even when personal experiments aren’t scientific and don’t prove a lot, they definitely relieve the tedium of diabetes and that is something I need. A more apt experiment for testing the G5 as a non-adjunctive device would be where I used my meter only for calibrations and as Dexcom recommends in Europe, when BG is low or changing rapidly. I don’t need to do that test because that’s close to what my life is right now.

Choosing the Dexcom G5—Again

Laddie_Head SquareIn September I wrote a blogpost about the pros and cons of upgrading from the Dexcom G4 CGM to the Dexcom G5. Since my upgrade was free and I did not have to return the new and still-unused G4 transmitter, the decision to accept the G5 transmitters was a no-brainer.

Two weeks ago my transmitter warranty expired and I was once again faced with the G4/G5 decision. Most of the arguments from my September post are still valid, but probably my biggest concern was whether I liked the positives of the G5 enough to outweigh the increased cost of the transmitters. As most of you know, G4 transmitters are warrantied for 6 months but operate until they die—sometimes as long as a year after initial use. G5 transmitters are sold in pairs with each transmitter programmed to shut-off after 108-112 days (90 days + 18-22 days grace period).

Around the DOC I have seen many CGM users who have chosen to remain with the G4 for various reasons. Read Mike Hoskins’ post at Diabetes Mine for a good description of valid reasons for not changing. Recently on Facebook there have been discussions where some users are considering going back to the G4 as their G5 warranties expire. In most cases the motivation is financial although some users have been dissatisfied with the transmission range and signal reliability of the G5 system.

I have been using the Dexcom G5 since late February. Initially I was quite frustrated by the alert sound options on my iPhone and in typical fashion wrote a rant blogpost. At that point I was too new to the system to evaluate other pros and cons of the G5 platform.

Fast forward a few weeks and when once again faced with the G4/G5 decision, I chose without hesitation to remain with the G5 system. So what changed and why am I totally on board with the G5?

Dexcom G5 Choice

1. Although I never really minded carrying the Dex receiver, I quickly fell in love with not carrying it. I appreciate having one less thing in my pockets and one less expensive device to keep track of. I like how my BG numbers are displayed on the phone and how the G5 app allows me to key in calibration numbers rather than scrolling on the receiver wheel. I like the use of color in the app and the ability to see graphs in landscape mode. I appreciate the new iPhone “complication” that allows me to see my BG number without unlocking my phone.

2. When I use the receiver, I find the screen with the white background easy to read unlike the G4 screen with colored numbers and tracings on a black background. As someone who spends a lot of time hiking in bright sunlight, I found the G4 receiver impossible to read at those times when I needed it the most. (See “Sunlight and the Dex G4: A Bad Mix.”) I will admit that I dislike the glaring spotlight of the G5 screen when checking it in the middle of the night.

3. Although I am still not happy with the sound profiles on the iPhone, it is not bothering me very much. I am experimenting with using the receiver at night and my phone during the day. When I combine the musical Dexcom alerts with my Lantus reminder alarm in the evening, I feel like a digital music box.

4. Because I am a year away from Medicare and no CGM coverage, it is easy to argue that I should be hoarding transmitters and continuing with the extended life of the G4 transmitters. A great idea in theory, but it ignores the probable release of the Dexcom G6 in 2017 or early 2018. The G6 promises improved accuracy and reliability and I suspect it will quickly leave the G4 and G5 platforms in the dust. Because the G5 does not require a receiver, maybe it will be more economical than the G4. Or are you required by the FDA to purchase a new receiver every year?

Right now Medicare is a huge “unknown” in my life and I will soon be writing about my preparations and guesswork as I move closer to April 1, 2017. I hate the idea of hoarding supplies and technology that will become obsolete and possibly unused. But I am not optimistic about a change in Medicare CGM policy and am I crazy not to stock up on G4 transmitters?

5. I have not been bothered by things that could be considered flaws of the G5 system. I have experienced very few dropped data points. I have occasionally lost the signal on my phone, but that also happened periodically with my G4 receiver. The battery of my almost 3-year old iPhone 5 runs down more quickly due to the Dex G5, but not enough to be a real problem. I am still not satisfied with the lack of a robust vibrate alert on my phone, but I’m losing no sleep over it.

Summary:  As I am reminded whenever I write technology blogposts, I am indeed one of the “Diabetes Privileged.” I would of course prefer not to have diabetes and it is certainly not a “privilege” to live with this difficult-nagging-frustrating-serious-chronic health condition. But given that I do, I have many things in my favor. I am educated. I have good health insurance and am able to buy insulin and other required medications/supplies. I have a computer, an iPhone, and a connection to the Internet and the Diabetes Online Community. I have access to good food and a safe environment in which to walk and exercise. I am the beneficiary of the newest diabetes technologies and able to debate whether I want to live with the fabulous Dexcom G4 CGM or the newer and fabulous Dexcom G5 CGM.

And today I choose the Dexcom G5.

Dexcom G5: Alerts & Sounds?

Laddie_Head SquareIn September I wrote a blogpost “Considering the Dexcom G5 Upgrade” which continues to be one of my most-read posts ever. My upgrade was free and it was a non-brainer to accept the two G5 transmitters. Because the G4 transmitter that I began using last March was still working fine until now, I have only just begun using a G5 transmitter. I am due to order a new transmitter next week (definitely trying to stock up before I transition to Medicare!)and I am glad to get some experience with the G5 before deciding whether to order a G4 or G5 transmitter.

So far I hate the G5 or at least how it functions on my iPhone 5.*** Maybe one of you canDexcom Sound Menu give me some help. As far as I can tell, there is no way to set Dexcom alerts to vibrate without having my whole phone on Vibrate Only. I find it hard to believe that “Vibrate” isn’t one of the sound choices on the phone as it is on the Dex receiver. But if it’s there, I don’t see it. If I turn off sounds for the Dex app in the phone notification settings, then it doesn’t vibrate either and losing alerts negates the major reason for using a CGM.

I like having a ringtone for my phone and I especially like a ding when I receive texts. So I don’t really want my phone on Vibrate Only. I find the Dexcom alerts incredibly loud and they don’t seem to respond to the volume adjustment of my ringer. I don’t want my day interrupted with diabetes sound blasts and I think that my husband, dog, golfing partners, and hiking friends would agree.

So unless I am missing something, I have 3 choices.

  1. Embrace the loud Dexcom alerts.
  2. Keep my phone on Vibrate Only with the risk of missing calls, texts, and calendar alerts.
  3. Use the Dexcom receiver instead of my phone or addition to my phone with phone alerts disabled.

I am not willing to go with Option 1. Diabetes intrudes into almost every moment of my life and I don’t want it accompanied by beeping, dinging, and babies-crying alerts.

I suspect that I can get used to Option 2 and that is what I am using today.

If I am going to use Option 3 then I should definitely just stay with the Dexcom G4 for my next transmitter with the longer battery life and no drop-dead date. Plus, I thought that the purpose of the G5 was to eliminate the receiver and use my smartphone instead!

So am I crazy and missing something obvious? Or is this another instance of “improved” medical devices taking a step backwards?

***Actually I like the Dexcom app on the phone and the ease of reading data and entering calibrations. But the lack of a Vibrate option is a big issue for me.