I have been using a Dexcom G4 CGM and a Tandem t:Slim pump for 1 1/2 - 2 years. I have been waiting for two things:
Medicare coverage of CGM … which I have recently been allowed and have just received a new G5 transmitter and receiver from Dexcom. Hooray!
I then thought that I should be able to get the $399 upgrade of my t:Slim to the recently FDA-approved t;Slim X2 G5. However, Tandem told me that they will not allow me to upgrade my t:Slim (even if I pay for the upgrade myself) because Medicare does not allow a pump to be upgraded.
I have been unable to find what Medicare will/won’t allow in the way of pump upgrades on Medicare.gov … but, also can’t understand why Medicare would care/know if I paid for the upgrade, they never got a claim, and the ongoing pump supplies of cartridges and infusion sets did not change.
Does anyone have any knowledge of this issue to know whether what Tandem is telling me is right or wrong? While Medicare probably doesn’t care that I will now have to once again carry the Dexcom receiver, it shuts me out from future zero-cost software upgrades to the t:Slim system, would cost Medicare nothing extra in terms of pump supplies (if I pay for the actual upgrade), and locks me out of future safety enhancements such as the Predictive Low Glucose Suspend.
Any insights, comments, or relevant experiences would be greatly appreciated.
@John_S2 - Some others can likely answer the Medicare questions better. @Laddie is really good with that information.
But I will take a crack at it anyway - but still using info from Laddie.
My understanding with some of this is if a distributor (or if using the manufacturer as the distributor) has a contract with Medicare than they are legally not allowed to charge a Medicare recipient outside the allowed reimbursement. Dexcom ran into this with some of its G5 patients earlier this year. Here is a quote from a VP of Dexcom from May 2, 2017:
“In addition, because of the January CMS ruling, we’re prohibited by law from balance billing our existing cash-pay Medicare eligible patients, which we estimate accounted for approximately $2 million to $3 million in lost sales during the quarter.”
So if you wanted to do something outside of Medicare and pay for it yourself (which would by all accounts appear to be perfectly legit for you even if it was an issue for a company with a Medicare contract), I would think you would have to do it through a distributor with which you have never done business such that they have no idea you have Medicare. Or a distributor who simply has no contract with Medicare although I doubt such exists.
On the bright side, if you have 2 years into your pump now and if Medicare allows a new pump after 5 years and if the Tandem upgrades are delayed (seems like most things get at least minor delays) such that it is maybe 2 years before the Tandem software updates are actually released than potentially you might only end up having to wait one year or so from when all the Tandem updates are available and when you can upgrade to the newest Tandem pump that would take advantage of these.
Laddie does discuss this topic on her blog:
“Unfortunately I will be on Medicare by the time the 670G is released and Medicare beneficiaries are not allowed to participate in manufacturer upgrade programs. I have been told that this rule is part of anti-fraud regulations, but it truly makes no sense to me. It is not as though there is any cost to Medicare to allow me to upgrade if I pay the out-of-pocket cost (if any) and I don’t see how anything about it is fraudulent.”
My understanding is that Medicare recipients are not allowed to participate in upgrade programs. Usually the manufacturers have that in the small print when advertising upgrade deals.
At the same time, one woman who has been on Medicare a while indicated to me that Medtronic told her that if she bought the 630G (which she did) that after the first year when Medicare recipients are technically “leasing” their pumps, that she could upgrade. That doesn’t fit with what I know about Medicare, but I can’t begin to pretend that I am an expert. Right now the 670G isn’t approved by Medicare anyway although the 630G is.
I was able to do the recent software update of my t:slim X2 pump to integrate the Dexcom G5. It was free and a software change so Medicare rules didn’t forbid it. When I purchased my X2 pre-Medicare, my local rep indicated that Tandem was not completely sure how the later software updates (most of which will not be free) will be viewed by Medicare. To be determined…
I just received an email from Tandem and one of the blurbs says:
“Medicare doesn’t cover CGM if integrated with an insulin pump.
The Dexcom G5 integration feature should not be used on the t:slim X2 Pump by people with Medicare coverage. Medicare will not cover CGM supplies for people using the integration. Dexcom is working with CMS regarding this decision, but for the time being, exclusive use of the Dexcom G5 receiver, not an insulin pump, is the requirement for Medicare reimbursement. FOR MORE INFORMATION >”
The more information link just goes to the Dexcom Medicare FAQ page:
Thank you for this information. Hopefully, Medicare will soon begin to approve the FDA-approved integration of the Tandem t:Slim G5.
When I went through the process of getting Medicare approval for a Dexcom G5, I had so sign a “on penalty of death …” form saying that as a Medicare-covered person I would not use the Smart Phone capabilities of the G5. Dexcom told me that this was because a Smart Phone is not a FDA-approved device. However, at that time, Dexcom thought that there would be no problem using it with the t:Slim X2 G5 … but they apparently didn’t understand the Medicare constraints.
So Tandem is not going to get into the fight on the G5 Medicare ruling? They’re just going to sit back and hope the wonderful negotiators at Dexcom can get a better deal the second time around? This is madness. The only way to get that ruling changed, is to have as many people and entities involved as possible. My prediction is that this ruling will not be changed until Medtronic starts throwing their billions into the ring to get their sensors covered, but there are variables to consider. Even if Medtronic gets their sensors covered, it doesn’t guarantee the ruling will be changed, because the Dexcom receiver is the wildcard. Medtronic doesn’t have an extra peripheral, just the sensor /transmitter and pump. The Medicare G5 crowd can say hey their pump is allowed to be paired with the transmitter, why not ours? Unfortunately, in comes the receiver again. What a mess this turned into
I think that all of this stuff is so new that nobody really knows the answers. I do think that it is unlikely that we would get caught using our X2 pumps, because I don’t think that Medicare would be auditing Tandem. But of course we would never download our receivers to Clarity and maybe that absence would be noted.
As I have said in many posts, I just went on Medicare in April and have enough hoarded supplies to get me through until February. So I will continue to use my X2 and my iPhone and Apple Watch. But once I get supplies from Medicare, I will follow those regulations.
But maybe we need to have a resort-like prison in some place nice like San Diego for Medicare PWD who violate the rules and use our smartphones… I would have said Florida, but don’t want to subject us to hurricanes.
Yes, it is early in the process. At least Tandem is already upgrading older pumps to the t:Slim X2 G5 for non-Medicare folks and seemed ready to go with that almost immediately after receiving FDA approval.
While I don’t know who is doing what, as Tandem has now received this FDA approval, I’m hopeful that it won’t take too long for Medicare to get this updated so that they WILL allow GGM integration and not preclude using the pump to view CGM data.
Note: Based on the wording of the document that I signed with Dexcom to get the Medicare-approved G5, I don’t plan to use a phone to monitor my CGM … but hope that the t:Slim situation gets resolved soon.
I too am anxious for Medicare to fix this. I was very excited that I could avoid the smartphone issues when I learned that I could get my data from the t slim x2 into Tidepool with a new driver. Then i received the official email from Tandem that asked how the update went and by the way if on Medicare use is forbidden.
I’m thinking now that I can live with this for a while as it just means having to wear clothes with extra pockets (and maybe spaced just right since my old G4 had issues if close to the pump!) However this is going to be a real serious problem once we get the G6 and a low glucose suspend feature.
Jason, perhaps Medicare knows how unreliable MM CGM is. I hope they don’t cover the Enlite system because it can cause more grief and wasted time than many people can endure.
Medtronic will most likely push to get the Guardian 3 covered. The accuracy is about the same as the G5, I can’t think of any reason why it shouldn’t be covered. But, with what we’ve seen in the last few months, nobody can possibly predict what Medicare is going to do.
I’ve heard through my doctor’s office that the 3 is less than 25% better in accuracy than the awful Enlite. I’ve no personal knowledge, but my doc goes to conferences on this stuff, and speaks with the principals who get these things approved. Reports of accuracy aren’t good. MM is always claiming that they have wildly better equipment than they do–look how they touted ahttps://www.medtronicdiabetes.com/blog/fda-approves-minimed-670g-system-worlds-first-hybrid-closed-loop-system/ C’mon, would YOU trust a “closed loop system” that uses a MM sensor, of any generation? That’s a serious question. Even if it’s only intention was to turn OFF one’s basal during a supposed low. Heck, I had so many “lows” with the Enlites at night, that I would ACTUALLY be sky-high it if turned off my basal for hours, at night thanks to the propensity of the Enlite to erroneously read LOW when I’m sitting or lying down. There are plenty of complaints about the Enlite that I don’t feel as if I have to “prove” my point with further with more of my own anecdotal evidence.
I’m not a Medtronic supporter at all. I was with them for a long time and never liked any of their sensors. I know exactly what you by hype with them. I did get the 630g and was not impressed at all. That huge pump with a tiny color screen was pathetic. When the trainer told my fiancé and I that the pump had no Bluetooth or smartphone connectivity, no access to their version of Dexcom’s share app, like my 530g had, we both looked at each other and told the rep to take it back. I did receive a call a few days later and was promised to be one of the first people to get a 670g if I stayed with Medtronic. It seems that every one of Medtronic’s patients were promised to be on that fast track list. In the end I chose Tandems’s X2 along with Dexcom and haven’t looked back.
Jason, do you mean that Carelink doesn’t work with the 630G? If that’s the case, did they offer any valid reason? Is there some other replacement method for viewing the raw data, and charts?
I have lots of gripes about MM, but the biggest one is the very slow pace of innovation. Look how long it’s taken to get a color screen. And the orientation of the screen? Ugh. And then the sad performance of their sensors. That is unforgivable. We’ll see what pumps are available in 2 years when my pump is out of warranty.
Is the Tandem waterproof? Not just claims, but is it ACTUALLY waterproof?
ah, I misread Jason’s comments. He DID say that there was no version of the SHARE app. My bad for reading that in my haste, as it having no Carelink-type app.
Dave- no, it connects to care link. I think it’s called mini med connect. The 530g uses a separate little thumb drive looking thing that converts the pumps radio signal into Bluetooth so it can connect to an iPhone. They have an app that talks to the pump, just like Dexcom. The app has the ability to share your alerts via text messages and care link, because it uploads your data in real time just like the clarity app. This system has saved my life more than once. The rep said they omitted this feature on the 630g because they wanted to get the pump released as fast as possible and they didn’t have time to incorporate those features. Same line of bs with the 670g as well. There’s no excuse that the 670g does not have Bluetooth built in.
I believe Tandem states the X2 is watertight, up to 3ft for 30 minutes. No swimming with it like an Animus pump. I absolutely love it, except for the cases. The old style case is ok, the newly released case sucks. I went back to my old white one, which just happens to match my iPhone perfectly.
Maybe you don’t have to “prove” anything, but I also wonder if you HAVE TO continue unsubstantiated hate for Medtronic. What exactly is the point of that?
The Guardian3 is actually very accurate (from my own anecdotal evidence, if you think that’s better than the systematic tests companies have to run) and yes, lots of 670 users DO trust it for their hybrid systems.
There are multiple factors that lead people to choose one system over another and while pointing out the trade-offs which always exist in a neutral manner is helpful, I don’t find this type of comment is.
I hope they don’t cover the Enlite system because it can cause more grief and wasted time than many people can endure.