Medtronic 670G Guardian 3 Sensors/Medicare Coverage Update

This is an update on the Guardian 3 Sensors used with the Medtronic 670G CGM. Medicare does not cover them. Nor does our secondary insurance company.

Many are in the same boat.

My husband currently has an appeal in process with Medicare and our secondary insurance company.

Cash price is 345. per box.

Some diabetics are extending their sensors for longer than a week. I encourage appeals.

Let’s hope FDA will approve soon.

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Bear in mind that Medtronic chooses when to file for approvals.

It has been known for a long time what the standard is for CMS to cover cgm systems.

Dexcom was the first but Abbott was pretty quick behind with their FreeStyle Libre.

It was a choice by Medtronic NOT to seek the required FDA approval. Previously.

(Medtronic has finally filed with the FDA for the required approval.)

EDIT: Even Senseonics which is much newer to the cgm market filed and has already received approval from the FDA (June 2019) to market and label their Eversense 90-day cgm as non-adjunctive which apparently makes the Senseonics Eversense also eligible for Medicare reimbursement under the well known CMS rules around cgm systems.

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I hope they’re approved soon, too. It baffles me why Medtronic put off this application for years with the FDA to recognize the Guardian 3 sensor’s ability to base treatment decisions without a confirmatory fingerstick.

I wonder if their initial success (180,000 670Gs sold) blunted their interest. Perhaps a recent report that many people stopped using that pump because of difficulties with staying in auto mode.

In any case, Med-T’s success with the FDA will help many people like you. Good luck with your appeal.


I hope more people will file appeals. Strength in numbers.

Medtronic is agreeable to submission.

DUBLIN, July 23, 2019 (GLOBE NEWSWIRE) – Medtronic global leader in medical technology, services and solutions, today announced its Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA) requesting approval for non-adjunctive labeling for its Guardian™ Sensor 3, as part of the MiniMed™ 670G system.

Thanks for your info.

Much appreciated.

I agree that Medtronic has finally decided to file with the FDA for the label change for non-adjunctive use.

My point was that it has been entirely Medtronic’s choice and decision up to this point NOT to file. Who knows what their reason was. They could have filed for such at any point assuming they felt their technology was good enough to be approved for what their were asking the FDA for.


Yes I see Tim. I totally see what you mean. I have thoughts on this.

And don’t like how it appears this has been handled. At least from my perspective.

Been thru a lot with this.

I would agree.


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From what I have read and recall, Medtronic needed to generate signifact research on how accurately the Guardian 3 maintained the 670G users’ BGs at or above 75% of the time within the“Target Range.” Accordingly, Medtronic waited until enough reasearch from actual users was developed to convince the FDA that the Guardian 3 sensor was safe enough to control insulin delivery without putting the user at risk.

Yes. Exactly and the newer transmitter may also play a role in getting the sensor approved.

Thankyou. Don.

I have read that if you are going with the cash price, you cannot appeal Medicare.
So much misinformation out there, mostly for us, exclusively through Medicare.
I did extensive research on coverage for CGM’s, was told by Medicare that Medtronic pump and insulin and CGM’s were covered; brands were not exclusive. Then we called when told by Medtronic’s that they were not covered by Medicare (therefore also not covered by our supplemental insurance). Called Medicare again, was told to go to the dmes page and choose a supplier with the M symbol next to there name, they will cover sensors we were told. Called Byram supplier, gave all my info, told the definitely covered guardian sensor 3, was so happy we had found a supplier who would cover the sensors! Waited 2 weeks for the approval from dr. Office to Byram, followed up with Byram only to find out they cancelled our order due to the fact that Medicare does not cover Medtronic guardian sensors…
This should not be this difficult! So much misinformation, so much wasted time, our first experience with Medicare non coverage, seems like you wait a lifetime, work hard to ensure you will have coverage when you reach Medicare eligibility age only to find you have no coverage. I am exhausted!
If anyone has a way to or has found coverage for CGM’s I would appreciate the info. A


Medtronic has not received the required FDA approval that will allow Medicare to cover the Medtronic sensors.

This was the choice of Medtronic not to apply (until now) for the required approval.

When CMS first made the ruling in January 2017 to allow certain CGM systems to be covered, they were quite explicit:

Medicare does not cover CGMs approved by the FDA for use as adjunctive devices to complement, not replace, information obtained from blood glucose monitors. In our view, such devices are not used for making diabetes treatment decisions, such as changing one’s diet or insulin dosage based solely on the readings of the CGM, and therefore, have not been covered under Medicare because they are not considered to serve the medical purpose of making diabetes treatment decisions.

Medtronic has only recently announced on July 23, 2019 that it has now submitted to the FDA for the non-adjunctive label change for its Guardian Sensor 3, as part of 670G system.

I could tell you stories and more stories about Medtronic. It’s terrible. And Medicare AND our secondary insurance.

They ARE not connecting the dots and looks like they are not going to.

I don’t trust anyone but just do the best I can.

I personally think that when Medtronic is selling their pump to Medicare customers they should inform people that the sensors are not covered. Hmmmmmm! I wonder why? Silly me!!!

And they have sure dragged their heels submitting approval to the FDA to get them covered.

I have an appeal in to Medicare and Anthem BCBS concerning coverage of the 670G Sensors.

It was well put together and comprehensive.

I will be hearing from Anthem by next week and Medicare by the beginning of September.

I think it will be a battle but we are going for it.

This is for my husband concerning the 670G Sensors. I will let everyone on this forum know how it goes. I have been discussing it here and there under other topics.

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I may not think highly of the Medtronic cgm equipment.
Regardless, IMHO I find it inconceivable that the FDA will not provide the label change for the non-adjunctive use which Medtronic is asking for. Further, I expect this to be approved and announced before Thanksgiving.

(I consulted my Magic Eight Ball for the date of approval.)

Tim I tend to agree with you. I do think they may very well be approved but I still went thru with the process of appealing.

Just before the July 23rd submission of approval for the Guardian 3’s was submitted to Medicare by Medtronic.

I believe in anticipating the worst in hopes that it will not be.

Ty. :smiley:

5Appeal all you want but Medicare will not approve the Guardian 3/670 G until the FDA issues it’s approvable for the use of the Guardian 3…

From what I have read, the FDA will not issue its approval until Medtronic can show that the Guardian 3 can control insulin flow of the 670G without causing any undue risk. Apparently, Medtronic has now submitted real world studies of actual 670/Guardian users that show that the system keeps its users within the safe target range at an acceptable time frame. Once the FDA confirms the accuracy of the studies. It will issue its approval.

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The sensor was already approved for automated bolusing.
It just was not approved for manual bolusing.

Now if you can explain to me how that makes any sense that would be awesome !!!

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Somewhere along the line “Cash” is the answer.

Yes I will appeal to both Medicare and my secondary insurance.

I am not one to not pursue our rights.

We know what the content of our appeal focuses on.

Thanks Don.:slightly_smiling_face:

Sally, you sound like me, persistent and just a little angry that Medicare cannot come right out and explain the products they do and do not cover.
I will share my thoughts with you though and it may save you some time. If Medicare does not cover, your secondary will also not cover because they follow Medicare guidelines for coverage. I hate to waste time. If you can get Medicare to cover through the appeals process, I believe your secondary will then cover the difference.
I believe you are right, Cash is the bottom line with Medtronics, Sad and greedy world we live in at the expense of someone’s health and existence.

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