Creating a Hot Seat for CMS approval for the Guardian Sensor 3

#1

I’ve had type l DM for 60 years. I currently use a Medtronic 670G pump(used a pump for 20 years) I’m incensed that medicare will not cover Medtronics Guardian Sensor 3. Likewise,they refuse to be transparent on their rational, even when members of congress ask them.
It would appear that congressional representatives only get involved when they receive a lot of mail about a topic and when a DC newspaper runs an article. I would propose the following:

  1. A “mass” mailing to all members of the Congressional Diabetes Caucus(6), chaired by Congresswoman Diana DeGette and copies to each individuals rep/senator.
  2. Same letter to Two Representatives with Type l …Kim Schrier and Daniel Lipinski.
  3. Same letter but addressed to the editor of the Washington Post.

I will be happy to write such a letter which others may use to create their own.
However, it will not be successful and a waste of time without large numbers doing it. Let me know if there is any significant interest
Steve 59

#2

Perhaps I am confusing the technologies, but my recollection is that Medtronic has not obtained the required FDA approvals on the cgm system.

#3

The FDA approval is a confusing issue. Here’s the March FDA approval statement:
(https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm600603.htm)

Note the following sentence that was added just before approval.
“The CGM component of the MiniMed 670G System is not intended to be used directly for making manual insulin therapy adjustments, but rather to provide an indication of when a glucose measurement should be taken.”
So this statement is what needs to be amended by the FDA.(I just learned this since my post.) The FDA wanted more research done, which is already exhaustive. According to my source PBS is going to do a documentary on the 670G, its benefits and questions why it hasn’t received approval. The more public exposure the more likely the more likely approval will come before year end.

I’ve had type l DM for 60 years. I currently use a Medtronic 670G pump(used a pump for 20 years) I’m incensed that medicare will not cover Medtronics Guardian Sensor 3. Likewise,they refuse to be transparent on their rational, even when members of congress ask them.
It would appear that congressional representatives only get involved when they receive a lot of mail about a topic and when a DC newspaper runs an article. I would propose the following:

  1. A “mass” mailing to all members of the Congressional Diabetes Caucus(6), chaired by Congresswoman Diana DeGette and copies to each individuals rep/senator.
  2. Same letter to Two Representatives with Type l …Kim Schrier and Daniel Lipinski.
  3. Same letter but addressed to the editor of the Washington Post.

I will be happy to write such a letter which others may use to create their own.
However, it will not be successful and a waste of time without large numbers doing it. Let me know if there is any significant interest
Steve 59
[/quote]

But note the following statement which was added very late in the process and what the FDA needs to change to allow medicare to cover.(I was just appraised of this since my last post), I was also told that PBS is doing a documentary on the 670G and will question why all approval hasn’t been issued. The more publicity the better according to my source.

#4

IMHO - No.

This is the FDA Approval that Medtronic needs to apply for and have granted.

It is not up to the FDA to be picking which companies to make label changes for.

It is up to the manufacture to apply to the FDA for a label change based on proper procedure.

It is 100% on the responsibility of Medtronic to apply to the FDA for a label change for non-adjunctive use for the Medtronic cgm system. My opinion obviously.

1 Like
#5

Perhaps, we should have a mass mailing to Medtronic “threatening” not to purchase future Medtronic CGMSs if FDA/Medicare Advantage approval is not obtained.