Lyumjev Insulin & Medicare Part B Coverage for Pumps

@Robyn_H , In regard to your reply, there are several jurisdictions where licensees of the medical licensure board are censured or have licensure revoked, cancelled, or otherwise nullified. The jurisdiction of your residence may be less restrictive than others. The caution to all may be prudent.

I am aware of some insurance companies revoking coverage for off label leaving the user to pay large amounts because of these issues.

@SLYDoggie , see the comment to Robyn above. The use of off label products is nuts.

@SLYDoggie & @Robyn_H the ultimate “in all our faces” is the most recent off label is caused by ERs reporting to CPS (Child Protective Services or jurisdictional equivalent) when children have been transported because of car crashes, school injuries, etc.

The information about CPS involvement came from Child Welfare Information Gateway (https://www.childwelfare.gov)

The insurance chargebacks & CPS meddling are crazy. My thought is to get insurance to pay (& me not to pay back) & keep CPS’s nose out of my friends & my business.

Hope this helps.

Are you suggesting that a 20% mix of Humalog with Fiasp prevents the development of insulin resistance due to the niacin in Fiasp?

To be honest, I have read your post multiple times and don’t know that I have much of a clue on most of your statements. What are you calling “off label”? The CPS paragraph makes little sense to me as well.

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Off label: Tandem says to only use Humalog or Novolog. Anything else is off label.

CPS, some ERs are repotting off label to CPS.

Thoughts?

SLYDoggie
January 10

Jay6:

@Robyn_H , In regard to your reply, there are several jurisdictions where licensees of the medical licensure board are censured or have licensure revoked, cancelled, or otherwise nullified. The jurisdiction of your residence may be less restrictive than others. The caution to all may be prudent.

I am aware of some insurance companies revoking coverage for off label leaving the user to pay large amounts because of these issues.

@SLYDoggie , see the comment to Robyn above. The use of off label products is nuts.

@SLYDoggie & @Robyn_H the ultimate “in all our faces” is the most recent off label is caused by ERs reporting to CPS (Child Protective Services or jurisdictional equivalent) when children have been transported because of car crashes, school injuries, etc.

The information about CPS involvement came from Child Welfare Information Gateway (https://www.childwelfare.gov)

The insurance chargebacks & CPS meddling are crazy. My thought is to get insurance to pay (& me not to pay back) & keep CPS’s nose out of my friends & my business.

Hope this helps.

To be honest, I have read your post multiple times and don’t know that I have much of a clue on most of your statements. What are you calling “off label”? The CPS paragraph makes little sense to me as well.

No I was suggesting mixing them so it won’t clog in the tubing

Off-label use is the prerogative of physicians, upon discussion with their patients. That is why you have a medical license. It needs to make medical sense however.
As long as you don’t go whacky and start giving deworming drugs for a viral infection, for example.

The term “off label” is used to describe any use of a medicine or medical tool for anything other than the usage documented when it was approved by (in the US) the FDA. For example, the use of a Dexcom G6 sensor on your upper arm is “off label” because Dexcom’s approval studies only “indicated” that the G6 could be used on the abdomen. (Yes?)

Another example. Several years ago, I used the Medtronic Enlite CGM system with a Medtronic Paradigm 723 pump. This was an “off label” use because Medtronic never “indicted” that the Enlite CGM worked with the Paradigm 723 pump. Technically Medtronic’s studies only supported using the (at the time) new Enlite CGM with their newer 530g pump

I am treated for my diabetes at the VA. Both the 723 pump and Enlite CGM were mailed directly to me either from the VA or at VA request. So I had no probable actually using the Enlite with the 723.

What I could not do, however, was call Medtronic customer support to report/replace a bad sensor. Because my use was off label, Medtronic wouldn’t work with me because they didn’t have a prescription in their records documenting that a physician was supporting what I was doing.

Since the VA does prescriptions electronically, I had to convince the physician I was working with at the VA to write a paper prescription that I could then mail to Medtronic. After I did this, I could call the Medtronic hotline and get support.

At any rate, that was how I gained greater insight into what both “off label” and “Indicated for use” can mean in day to day life. :roll_eyes: :upside_down_face:

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I really wonder. So many people think of off label as different things.

I don’t think insulin is off label because you inject it or pump it.

I think if you are taking insulin for arthritis it would be off label.

Not that anyone would do that.

Years ago I heard men were taking prostate medication to prevent hair loss. That’s what I think of when I think of off label.

My feeling from my limited experience of “off label” restrictions is that it can too easily become ensnared in bureaucratic quicksand.

My particular situation with the Paradigm 723 and Enlite CGM stemmed from a bureaucratic oddity. I am certain that almost all of Medtronic’s users have prescriptions on file with Medtronic demonstrating that they are working with & supported by a physician. I was one of the rare few who not only did not have a script in Medtronic’s records but also went to the trouble of calling their hotline to request a replacement when my CGM sensor failed.

I am sure it just felt “strange” to the Medtronic customer reps I spoke with.

By contrast Dexcom could demand the same documentation from me, but never has.

I think a large part of whatever path is taken is decided by the corporate culture of the company you are attempting to work with. :man_shrugging:

If I stuck with the “yada yada” about “don’t use off label” I would have hav ended up with complications and issues with several pumps over my 51 yrs of T1D and 27 yrs using a pump. Because the new FDA products, dugs and processes cannot keep up the the current drugs and processes available to improve our lives, there is no barrier to using a current “pump approved” insulin in the Tandem pump now.

Luymjev is the most consistent and predictable insulin I’ve used in 51 yrs and 27 pump years. Luymjev, pre-FDA approval, has been used in clinical trials for several years and when the T:Slim with CIQ, and no issues were indicated. There is not a way of getting Luymjev FDA approved with Tandem unless new clinical trials are done, particularly since the new CIQ software is undergoing clinical trials, maybe Luymjev will be included with the new FDA approval of the new T:slim and Tandem pumps in he future.

Luymjev is “FDA pump approved” and is noted in the Lilly use document for 7+ days use in a pump cartridge.

Personally, I will not suffer or compromise my quality of life to wait for FDA approval for the drugs FDA approved for use in my pumps, ever!

FDA approvals have never been in alignment with the pumps and drugs in the 27 yrs on a pump.

Luymjev is a fantastic pump insulin and it is more consistent and predictable that any other on the market. Stinging is possible and location can overcome this issue easily.

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Thanks for this thoughtful reply! Your thoughts on this are definitely more in line with my thoughts as well. Also, you are definitely in line with my 2 vial trial of Lyumjev in my Tandem X2 t:Slim with BIQ as well. It’s good to know that it works well with the CIQ software as well.

Now if I could just get it covered under Medicare Part B insurance as they do for Fiasp. I’m going to keep trying every 6 months as you never know when Medicare will start covering it. It took less than a year after the FDA approved Fiasp for pump use. I’m hoping the same will be the case for Lyumjev.

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