Lyumjev Insulin & Medicare Part B Coverage for Pumps

I currently use Fiasp in my Tandem X2 pump and love how quickly it acts but hate that I have to change my infusion site every 2 days. If I try to extend the infusion set to the 3rd day, the effectiveness plummets and my BG is all over the place.

I recently tried a couple of vials of Lyumjev in my pump and it worked a little faster than Fiasp. In addition, I experimented with extended infusion set usage and could extend the infusion set to 4 to 5 days without any apparent drop-off of effectiveness. This was wonderful news for me!

That brings me to the reason for my post. Since I use insulin in my Tandem Pump, I get my insulin through Medicare Part B (rather than Part D). In my case, my supplemental insurance covers 100% of the Part B copay so the 90 day renewal of my insulin is zero cost to me. When my doctor sent in the Lyumjev prescription to my local CVS pharmacy in November of 2021, it got rejected because it isn’t in the Medicare Formulary so Medicare wouldn’t cover it.

I’ve searched everywhere for the Medicare drug formulary but can’t find it. My hope is that Lyumjev will get added in 2022 but I don’t know if that is realistic or not.

Anybody have any insight into how long it takes, after a new insulin is FDA approved, for the insulin to be covered by Medicare?

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It’s not a time issue, it is a money issue.
If the new insulin costs more than then old insulin and the old insulin costs less, they don’t approve the new one.

As for your 2 day issue, if you mix humalog 20% to the lumijev or fiasp it will work almost as fast and won’t clog or lose effectiveness.

@SLYDoggie , if you have a sharp team processing your claim you may or maynot have smooth sailing because there are issues here:
[1] Lyumjev has been approved for pump use by Medicare.
[2] IF ( BIG IF ) the pump manufacturer approves its system for Lyumjev
[3] TANDEM has NOT APPROVED the insulin for its X2 pump

So what?

If you fill the Rx with Lyumjev and the claim is reviewed, because Lyumjev is NOT APPROVED by Tandem for use in Tandem system, you could be looking at having to pay the claim yourself.

I had an Rx for a generic insulin in my X2 rejected as “insulin not approved” and my endo had to redo the Rx.

Be careful jumping the gun. There have been at least 2 posts in various forums about claims for unappoved insulins going thru and then bouncing back on review for the person to pay up because insurance rejected after the drug was dispensed and it could not be returned.

CAUTION!!!

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Thanks so much @Jay6 . This is good information and contrary to what I was assuming. I knew Lyumjev had been approved by the FDA for pump use but wasn’t aware that it had also been approved by Medicare. I wasn’t aware that each pump manufacturer had to also approve the insulin for use in their pump. In my case, I’m pretty sure it was also rejected for Medicare Part D insurance, which is where the “Formulary” comes in.

I have been getting Fiasp through Medicare Part B for some time now but had to go “round and round” with the CVS Pharmacy Team each time I refilled it until I finally convinced them to put notes in my record for what it finally took for them to get Fiasp through Part B for my Pump. I don’t know if Fiasp is officially approved by Tandem but I don’t think I have ever provided the pump manufacturer to the CVS who fills my prescriptions. Maybe the specific pump information is in the prescription but I haven’t provided it to CVS.

I will probably give it another try in a few months to see if I get a better result.

@SLYDoggie , WOW.

There are several issues in your pumping that are alarming based on the Tandem training I have had.
[1] Tandem material clearly states “ONLY use U-100 Humalog or U-100 NovoLog with your pump. Only U-100 Humalog and NovoLog have been tested and found to be compatible for use in the pump.” This statement or very similar wording appears on pages 19, 24, & 82 of the printed big, white, USER GUIDE (USA Edition). Link to Tandem’s PDF version below.

[2] a prescriber who deviates from this statement is either uninformed about the limitations of the Tandem system or is way too laissez-faire in their practice of medicine.

[3] as far as a “Medicare Formulary”, my discussions with pharmacy and multiple of my providers have never discussed such. However, I don’t use Part D as my secondary takes good care of me.

Here is the link to the PDF User Guide. It is searchable. This link was recovered at 10:58 AM EST (USA) 8 Jan 2022.

Having read many different social media sites, the best support is to stick to Humalog or Novolog and share this with your provider. Some other insulins have government approval for pump use, yet Tandem’s cartridges & tubing may cause occlusions or other malfunctions.

The difficulties you have encountered with CVS may have been someone trying to help you covertly.

My support would be to educate yourself and avoid unlabeled uses. Message me if you wish. There is more.

Seriously? I’ve been using Fiasp in my (Medtronic) pump for four years. No problems at all. Works way better than Novolog or Humalog. Two years ago my endo prescribed Jardiance, which is off-label for T1, and it has been enormously beneficial. Back 2000 or so they had me add Metformin, also off-label (or was then anyway) for T1 and I’ve used it ever since.

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@jay6 yes, I and my prescriber are well aware of the risks & impact of using Fiasp in the Tandem pump. I certainly understand the concerns you stated and I would agree for the typical pump user who is somewhat clueless on using the pump effectively.

Following are a few points:

  1. I would never use Fiasp or Lyumjev with the Control-IQ closed loop Tandem program as I don’t think the programming would work properly with the faster acting insulin. In my case, I stuck with the Basil-IQ program as the Control-IQ program would actually be a step backwards for my current Diabetes management. I’m having great success with Fiasp and Basil-IQ. I no longer have the big post meal peaks I used to have on either Humalog or Novalog and my A1C has dropped from the mid 6s to more in the 5.4 to 5.7 range by using Fiasp over the last couple of years.
  2. I am a very technical and precise person and have my pump programs very well tuned for the way Fiasp works with my pump and my body… Basil rates, Correction Ratios, Carb Ratios, and duration.
  3. With Fiasp, the only time I have post meal peaks above 200 (even on high carb meals) is when I miss my carb count or don’t bolus right at mealtime.
  4. My test with Lyumjev gave me the same benefits as Fiasp, with little tweaking to my pump programs. The advantage was that I didn’t need to change my site every 2 days with the Lyumjev like I’m having to do with Fiasp.

Just wanted to provide that additional insight. Thanks again for providing your input!

Or perhaps the exact opposite? Maybe the prescriber is better informed about current advances that have occurred since the pump received regulatory approval in 2016?

It’s long since established that Lyumjev is safe in the Tandem pumps and doesn’t crystallize like FIASP and Apidra. It just didn’t exist when the T:slim X2 was doing it’s clinical trials, so they legally cannot recommend it without paying for further regulatory approval. Tandem had also openly stated that they will be including other insulin formulations in future regulatory filings, so it’s not a blatant disregard of the manufacturer recommendations to do so.

Doctors are free to prescribe medications for use “off label” if they believe it is the best choice. That does not imply laissez-faire behavior, it’s to make up for lapses in the slow and expensive regulatory process. Some of the best treatments are off-label! I’m exceedingly grateful to have a doctor happy to write off-label prescriptions for me. I take low-dose Lisinopril off-label, like most diabetics, even though I don’t have high blood pressure, just to protect my eyes and kidneys. I also think off-label Trulicity has been the best thing that’s ever happened to me in my 32 years of dealing with Type 1. It feels like it’s fixed the rest of the metabolic problem that insulin alone doesn’t address. I want the best, not the outdated or most profitable.

Some people take comfort in the existence of governing bodies, while others see the shortcomings of the process. After dealing with the FDA professionally for most of my career, I’m firmly in the latter group.

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I’ve been using Apidra insulin in Animas and Medtronic pumps since about 2008. Apidra, in many pumps, is often contraindicated or limited by reduced infusion set duration. Yet my almost 14-year experience has not been troubled by occlusions or other delivery or absorption anomalies. I use my infusion sets for 72 hours and my insulin cartridge is only changed about once every 10 days.

I am not recommending that anyone disregard published policies from the insulin or pump manufacturers. What I am saying is that there exists some people who use insulin in pumps where the experts disagree with that use and yet they are enjoying incredible glucose control.

During that 14-year period, I have enjoyed in part due to Apidra insulin, some incredible measures of success. My time in range (65-130 mg/dL) went from about 40% to often over 90%. I lost 25 pounds and kept it off. I cut my insulin usage to less than half I was using prior. My average Bg dropped from about 120 mg/dL to less than 90 mg/dL and my standard deviation fell from about 40 mg/dL to less than 20 mg/dL. And my A1c fell from a high of 8.5% to under 5.7% or normal.

The manufacturers and regulators live with a more conservative position and their agenda is not your agenda. There is a fair amount of overlap but not complete congruency.

If I had been waiting for the permission of the manufacturers and regulators to approve my DIY Loop system, I would have missed the outstanding normal glycemia of the last five years. I view my “skin-in-the-game” authority as over-riding the manufacturers and regulators. I am grateful for the support of doctors who are willing to consider the facts and continue to write appropriate Rx’s.

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If you’re doctor thinks it is appropriate and you want to use it. You can get around those Rex come rations.
Your doc just writes the prescription “ for injection”
And it will be fine.
Many pumpers also inject insulin to improve performance.

I saw a couple of studies running including different insulins and the t2. So when those finish I assume they will open it up. It only makes sense

Because insulin for Tandem pumps is covered under Part B of Medicare and insulin for injections is covered under Part D, @SLYDoggie would be essentially asking his doctor to commit Medicare fraud if the prescription specified injections. I assume my doctor would say no to such a request and I would never ask her to write a prescription incorrectly.

I had a horrible experience with Lyumjev in my Tandem pump with the most painful and irritated pump site I have had in 20 years of pumping. My endo had given me samples so I never found out whether Medicare will cover it under Part B. I did get Fiasp covered but they wouldn’t give me a 90-day supply like Novolog. I got some occlusions with Fiasp and didn’t want to deal with changing out my cartridge more often. I go 5-6 days with Novolog.

I have also found that although I keep wanting to try new things, I tend to revert to what I know. At age 69 I have turned into an old fuddy-duddy! I find both Fiasp and Lyumjev to work faster than Novolog for injections but I didn’t use them enough in the pump to figure out if they were better.

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It’s all a game and a parsing of words in my opinion.

If I’m getting the best insulin for my needs and my doctor is prescribing it, then there is no fraud. There is no conflict in my opinion.

Maybe it would matter if I was on Medicare, but on regular insurance all insulin has the same copay.

Besides why is insulin cheaper because it’s in a pump? It’s really an arbitrary rule.

I wouldn’t suggest anyone defraud their insurance company, but I do believe you might have to do what ever you need to do to get the medicine that you need.

Now if he was getting 5 vials of insulin when he needs only 1 and was selling 4 online, well I would say that is fraud and I wouldn’t do something like that.

Medicare is quite different from private insurance. Insulin for tubed pumps is covered as DME by Medicare. Insulin for injections is covered by Part D prescription plans which are private companies. Definitely different pocketbooks paying for the insulin. Insulin for pumps is considered to be DME because it is part of equipment classified as DME. It is quite weird but is a huge benefit for those of us on tubed pumps. Mine is covered at No OOP cost because Medicare pays 80% and my Supplement Plan pays the remaining 20%. Insulin through Part D is in Tier 3 and has copays and Donut Hole ramifications. For a doctor to prescribe insulin to be covered differently than how it would be used would be fraudulent under Medicare.

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I get that there are weird rules. But there is no logic to it.

We pay into Medicare when we are working, and those dollars translate into insulin for those of us who need it.

So it’s a weird and arbitrary rule to charge more for injections and less for pumping the same drug that is needed the same way.

It might be against their rules and it might even be technically fraudulent.
In my opinion it is not. You need insulin, you get insulin. Everyone should pay the same for it.

Yes, that is a good argument. As someone who is getting great coverage for pumped insulin, I am not going to argue that I should pay more. Because for sure they are not going to switched injected insulin to the same rules as pumped insulin. According to Medicare rules, my pump is DME. Thus the supplies, including insulin, are also DME.

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@Robyn_H I couldn’t have said it better. My Endo is very experienced with pump usage, especially the Tandem X2 and would only go out of bounds when it is the right thing to do for the right patients.

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@Timothy the problem with this is that it defeats the purpose of my post. I am wanting Medicare Part B coverage for Lyumjev, which is only available for pump usage. If it is prescribed for Injections, then it has to go through part D. For me, that is a difference between getting a 90 day supply for Free (for Part B) vs. several hundred dollars (for part D).

I think @Laddie made the points on my behalf very well but I want to be clear about Medicare Part B vs Medicare Part D. It is all very confusing and vague until you get to the age where you have to use it and then it takes a lot of research and help to really figure it out.

Medicare Part B is similar to the private insurance that covers office visits, lab tests, and things like Insulin Pumps (Durable Medical Equipment… DME). Medicare Part D is done by private companies and is the Pharmacy Insurance. If you have a pump, then all the supplies (including covered insulin) are supposed to go through Part B. If you inject, then the insulin is covered by Part D, the pharmacy insurance.

Part B typically covers 80% of the cost but you can purchase extra Supplemental insurance (on your dime) to augment Medicare Part B and that covers some percentage of the 20% deductible. In my case, the Part B supplemental insurance I purchased covers 100% of the 20% deductible so I have no out of pocket cost for insulin used in my pump.

There is no fraud or “gaming” involved… This is how Medicare is set up.

My original question is not trying to game the system but rather just trying to understand when and if Lyumjev might be officially recognize by Medicare for Pump usage so it is covered under Part B. For Fiasp, this came about a year after Fiasp was approved for pumps. I’m hoping for the same kind of timeframe for Lyumjev. Until this happens, I’m sticking with Fiasp which the Medicare and Supplemental insurance I pay for covers at 100%.

For those far away from having to deal with Medicare I know this all seems foreign and twisted… Imagine that, a governmental program that seems foreign and twisted :wink:

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I have never found out how to access any list about what insulins are covered by Part B Medicare. I rely on anecdotal reports from other Medicare people on social media. I suppose I also rely on my pharmacy but sometimes they tell me things that aren’t true. (For example, one time they told me that Medicare now only covered insulin 30 days at a time. That was just wrong but that’s the result the pharmacy tech got when she filed with Medicare. Next time I was able to get 90-days.) That being said, I have not read of anyone on Facebook or at this site specifically saying that they were getting Medicare Part B coverage for Lyumjev.

Yeah, most of the Drug Store Chains are totally clueless about the Medicare Part B “stuff”. I’ve had to push back on them several times in the past before finally being successful with getting a 90 day refill.

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