Omnipod

Diabetes Technology
21

Actually a phone is not even required. An iPod also works (proper version of course). As mentioned, for G5 it is Bluetooth communication from transmitter to smart device. To upload to the cloud into Clarity and for “follow” purposes, an internet connection is needed. Which again does not require a phone - an iPod on Wifi does just fine.

In terms of cost, an iPod touch 5 can be purchased for about $100 on ebay and requires no ongoing monthly subscription costs to anybody so it can be an economical approach. On the other hand if you already have a compatible smartphone then you would be all set.

I do like running the G5 with both the Dexcom receiver and the smartdevice app as it provides redundancy - particularly at night. Neither device depends on the other.

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22

Thanks Tim35, I realize that I am a bit far on one end of the spectrum from everybody else. I am frequently in an environment where digital devices are not an option - either because they are not permitted or because they will not function. If you don’t have an office job - if you, for instance, work in a group home or on an ambulance, where devices tend to get dropped or thrown across the room, its no good. Just for one example. (I also turn off my phone at ALL security conferences, for obvious reasons.) When I need my reciever most is in the outdoors, in -30 degree temps for eight hour periods, where digital devices tend to fail and there is no internet connection. Even pumps fail in those conditions. I haven’t really thought about what I’ll do when my receiver fails. Its something that you guys have reminded me to start planning for.

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23

:slight_smile: You buddy need the new 670G. It can survive a nuclear attack, you can use it as a self defense weapon, a mean of deterrance (since it’s so fulgy) or put it under the wheel of that ambulance in case you need to keep it safely parked on a hill - it’s that big.

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24

Great input man! easier to carry around than a phone as well. They weigh like nothing and I presume that the battery lasts forever considering that you are not downloading data over the mobile network.

25

According to the Dexcom User Manual, the Dexcom G5 transmitter has an operating temperature range of:
“Ambient temperature is 10° C-42° C (50° F-107.6° F)”

The Dexcom G5 receiver has “Storage/Operating Conditions” (ie - they are not distinguishing storage from operating in the case of the receiver whereas they do for the transmitter) of:
"Temperature: 32° F - 104° F "

Negative 30 (Celsius or Fahrenheit - lol) is likely far below what was tested and obviously below what is FDA approved and what would be under warranty by Dexcom. It would certainly be of academic interest to see how the system behaved under such extreme environmental conditions but I would not trust the numbers and certainly would never use readings under these environmental conditions for any treatment decisions.

26

The problem is, the new omnipod PDM does not cut down on a gadget. They are removing the BG meter. Since most people carry their phone anyway, and could get Dexcom CGM on their phone, removing the BG meter does not cut down on devices, it adds to them…

Before: 1) phone (has CGM, and people carry it anyway), and 2) PDM (has BG meter and insulin delivery)

After: 1) phone (people will still carry it, 2) PDM (insulin and CGM) and 3) BG meter

So the new system is 3 devices instead of 2.

And if you have a kid and want them to share their Dexcom data, they will still need a phone running Dexcom to be able to share it…

Exactly! Try working your insulin delivery on a touchscreen PDM when wearing gloves, or in the rain. The current PDM can be used even when driving, you don’t even need to look at it because of the push-buttons

This thread is now talking about two different things - a dedicated CGM receiver, and the omnipod PDM which won’t give you any hardware choices. For the omnipod PDM, the only choice will be their phone device.

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27

I presume that the received is kept in the pocket where the temperature is above 10C. The transmitter is usually around the body temperature.

28

From my reading, this is the primary reason that Medicare will not cover the Omnipod. Or at least the “stated” reason. So, perhaps the purpose of removing the BG meter functionality from the PDM is specifically to remove the Medicare objection and (potentially) allow coverage?

29

Makes sense.

Wicked cold for us is minus 10 F. I probably have never seen minus 30 (outside of a blast freezer - that job was real fun - not).

30

I don’t think it’s quite that simple. The part that delivers insulin is disposable, and the part that does not deliver it is non-disposable (DME- durable medical equipment).

In their brilliance, the fact that the non-disposable part is not attached to the disposable part makes the Mediclowns categorize it differently than a pump that has an attached tube. Even though both tubed and tubeless pumps have disposable and non-disposable components, the fact that it is not attached is what bothers them. I think the BG meter is irrelevant in the equation.

31

What disturbes me is that your clowns over there (FDA and Medicare) are setting standards for our clowns over here, sitting like ducks and waiting for the American side to agree and then share the products with Europe. 670G is rolling out in the US, albeit with 130 minimum range, and over here we have to wait for another 12-18 months before it’s even introduced on the market. Same story is to be expected with Dash.

32

I have often felt that the FDA is one of the biggest hurdles for diabetics. We don’t have Fiasp available in the U.S. yet, but it is available almost everywhere else. I feel your pain.

33

Read their decision. Sounds a bit crazy but I don’t think I misunderstood. I read it multiple times.

34

I read some stuff about it, which is what I referenced above. Perhaps not the same as what you read.

Share a link.

35

Medicare denied appeal to cover Omnipod

DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENTAL APPEALS BOARD
DECISION OF MEDICARE APPEALS COUNCIL
Docket Number: M-15-582

Date: May 11, 2015

Snippets:

“Further, we agree with CMS that Medicare does not cover the OmniPod pods, billed as A9274, as durable medical equipment and, therefore, we reverse the ALJ’s decision and hold the appellant liable for the non-covered charges.”

“According to the manufacturer, the pod integrates the insulin reservoir, cannula, infusion set, inserter, motor and power source of a conventional pump into one device that can be worn directly on the skin.”

“The second part is the Personal Diabetes Manager (PDM), which is portable and programmable, and sends dosing instructions to the pod, records data, and can be used to test blood glucose levels.”

“The Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC) initially denied coverage and on redetermination explained that the OmniPod pods are considered to be a disposable drug delivery system and, as a disposable system, the pods do not qualify under the definition of DME.”

“CMS has assigned the following codes to represent the two parts of the OmniPod system:
A9274 External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories; and
E0607 Home glucose monitor.”

“The programmable PDM, which sends dosing instructions to the pump, records data, and can be used to test blood glucose levels, is coded E0607.”

" … the pod cannot withstand repeated use. It is instead an expendable item designed to be disposed after no more than three days. Thus, the pod does not qualify as DME."

“In addition, the pods are for use with the PDM, which is also not coded as an external infusion pump, but rather a home glucose monitor.”

and it goes on. Certainly there are multiple way to read and interpret the decision. While removing the BG functionality from the PDM will not insure coverage by Medicare, it will obviously remove this particular objection. Should Medicare still refuse to provide coverage, they will have to have a different determination.

36

Well, I don’t think the BG meter is the problem…

" … the pod cannot withstand repeated use. It is instead an expendable item designed to be disposed after no more than three days. Thus, the pod does not qualify as DME."

It’s kinda stupid. A syringe is disposable. Infusion sets, like they use for Medtronic or Tandem pumps, are also disposable. All pumps perform the same function, you just throw a different part away with different pumps.

The up-front cost of the other pumps (for the part you don’t throw out) is several thousand, versus $300 for the omnipod. I’ve run the cost comparisons, using all kinds of accounting methods. Cost-wise, all of them are not too far apart.

The fault is ours - trying to apply logic to a decision for a government run agency…

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37

Compare this to the Dexcom Medicare coverage decision. I think it is very similar.

Not in the denial of Omnipod but more on how a successful appeal for Omnipod could happen. Follow the Dexcom success and try to replicate it. Find the items in the Omnipod rejection, eliminate the basis for those as possible and try to get Omnipod similar to Dexcom.

My thoughts…

38

@Tim35, thanks for looking that up. Thats interesting. The worst difficulty is when the old medtronic pump tubing would freeze solid. Data gets real erratic, but I always assume its because I’m doing a lot of physical work - climbing up and down hills in the deep snow, dragging things uphill, etc.

If I had to guess (just a guess), I would say that the temp doesn’t introduce a lot a noise into the system. The transmitter is on my body under my clothes, so its fine. If the receiver/receiver batteries are too cold the screens dim out and (for omnipod) I gotta take the batteries out and put them into my pocket for some time to warm up. Unfortunately, there’s a limit to how many things I can put into the pocket of my jeans at one time. Not everything is gonna work all the time. But, the Dex data is typically pretty continuous (although up and down). I, personally, haven’t noticed anything super strange - like ultra chaotic readings.

39

That could be. I just assumed that using the locked down Android device was to get a step closer to integrating the PDM into a phone, and you can’t reconfigure the Android device to include the bg meter. So by default, they needed to add a separate meter to the equation.

40

Ugh… don’t even say it.

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