Allele fraction and Medicare

[sbs_patient]

I decided to see if I could find my Medicare Advantage provider's policy on allele fraction and came up with a page from their policies and procedures manual entitled "Janus Kinase 2 (JAK 2), CALR and MPL Gene Mutation Analysis". On this page, I found the following exclusion:

Testing for Janus Kinase 2 gene mutation is considered not medically necessary for any other indication including...

▪ Quantitative JAK 2V617F allele burden subsequent to qualitative detection of JAK 2V617F

Has anyone else in the US come across similar exclusions, and if so, how have you dealt with them?

[Meatloaf9]

I am 74 (PV) and on medicare with a part C Supplement (plan G) and I have had 3 AB tests since 2018. All of them have been paid for 100% so far. I have no idea if that has changed, my last one was in 2021. I also have no idea how much a Jak 2 AB test costs, do you?

I would like to have my AB checked again since I may switch from HU to Besremi or Pegasys. My counts have been well controlled so far (PV) so not sure I want to switch. My mpn specialist has told me that there is no concrete evidence that I would live one day longer on the interferons, he recommends to stay on HU but will switch me if I wish, so what to do?? I understand that besremi has about a 3500.00 total annual cap in 2024 on a medicare part D drug plan, only bad thing about that is it is all due the first month. I wonder if anyone has any further information on costs of besremi for medicare patients starting in Jan 2024.

I would think that is Medicare covers the AB test then both part C supplements and Medicare Advantage plans have to cover the procedure. When I have called the Medicare phone line all that they do is read from the Medicare manual so not worth the time. I don't know of a way to pre-authorize the test. Best to you.

[sbs_patient in reply to Meatloaf9]

Thanks for your interesting response. I'm 79, diagnosed with PV back in 2015. My initial hematologist called for blood work; I asked about the lab that did the work and was told that it was LabCorp, which was on my plan. It turned out that they had sent the genetic test out to an out-of-plan lab, and I eventually got a bill for $5K for a test that also reported the allele fraction. It took me a year to argue the bill down to $500. I have no idea what genetic tests cost now, but despite reports that tests are much cheaper now, my guess is that the actual bill sent out to an uninsured (or"coverage denied") person would still be very high.

Does the Medicare manual actually say that Medicare covers AB testing? If so, I canfind the source and pursue your argument with my Medicare Advantage insurer (Geisinger Health Plan, which now apparently belongs to Kaiser).

With respect to medication, I was on HU for about five years but developed skin ulcers and discolored nail beds. I switched to Ruxolitinib (Jakafi) in August 2022, and have been stable at 10 mg/day for a year now. The medicine has worked very well for me but has been very expensive at approximately $8K/year. You're right about the 2024 Medicare drug cost changes; what you say about Besremi will also be the case for Jakafi, and in 2025, the total annual cost is supposed to be $2K.

[hunter5582]

I have not had any trouble getting the JAK2 Quantitative Analysis covered on my Medicare plan. Note that I have a traditional Medicare part A-B plan with a higher-end Cigna secondary. It is important to understand that Medicare Advantage plans can vary widely regarding what they cover. These plans also vary widely in terms of the lab services that can be accessed. Had I switched to a Medicare Advantage plan, I would have lost access to all of my specialists, including my MPN Specialist. It is important to investigate these plans carefully when making a decision during open season,

It is possible to file an appeal to get a service approved. Note that it is often more effective for the patient to file the appeal, Doctors working under a HMO or Medicare Advantage plan may have a more limited ability to appeal on your behalf. In essence, the doctor answers to the payer, not to the patient in certain types of health care systems. Filing an appeal is an important and rather sophisticated skill. It is worth learning how. I had to file my own appeal for Besremi when it first came out. My doctor could not get it approved; however, I succeeded.

It is worth noting that catch phrases like "Not medically necessary" Investigational" and "Experimental" are just insurance company jargon for "We do not want to pay for it." They have no real meaning other than being a barrier to accessing care. Overcoming this kind of barrier requires understanding how to file an appeal. Sometimes, you do have to pay out-of-pocket.

The cost of lab tests and other procedures can vary widely between providers. It pays to shop around when paying out of pocket. The cast savings can be quite large. Here is one tool you can use to shop prices. findlabtest.com/lab-test/ge...

All the best moving forward.

[Mirror368 in reply to hunter5582]

Hunter,

I agree about Medicare Advantage plans. AT&T is dropping their $2,700 a year retiree health reimbursement account and only offering a Medicare Advantage PPO. We are choosing to pay for my husband’s Blue Cross supplement and Medicare drug plan out of pocket. If you switch to Advantage plans it is almost impossible to switch back to a supplement because of medical underwriting.

Eileen

[hunter5582 in reply to Mirror368]

I am sorry to hear that AT&T is limiting retirees to only a Medicare Advantage plan. There are many who are not well-served by this option. It sounds like you are making a good choice to stay in Traditional Medicare with a supplemental plan.

[sbs_patient in reply to hunter5582]

Thanks for the information and the link to the test pricing site. I will be speaking with my MPN specialist at our next televisit to get her opinion on whether this is worth doing. The information is certainly interesting, but the key question is whether it has any therapeutic implications.

Steve

[hunter5582 in reply to sbs_patient]

The "worth doing" answer will depend on who you talk to. There are many who now believe believe that JAK2 allele burden is a valid marker of treatment success due to the relationship to disease progression and symptom burden. My MPN treatment team agrees as do I. My MPN Specialists' assessment is that reduction in allele burden is definitely a good thing; we just do not how good it is - yet.

There is some good information on the significance of allele burden in the literature. the recent article by Moliterno et all does a nice job summarizing the information. ashpublications.org/blood/a...

If you decide that checking on the JAK2 allele burden, I hope you are able to get the lab paid for by your plan.

Wishing you success moving forward.

[SoledadBarcelona]

Can be it due to there is no guides to check the allelo burden? PharmaEssentia must say it. It is a big worldwide problem. There are some hematologists can decide, but others no.

[wrench69]

I have Tricare Prime insurance. They will not cover the Jak2 allele burden test because it is a "Lab Developed Test". At least, that is the reason they gave for denying the coverage. It's kind of strange, because they cover a bunch of other "Lab Developed Tests" (they have an approved list of them), but they refused to cover this one. Very odd. For reference, I had the test earlier this year and paid out of pocket.

Edit: After doing some more research, I think the reason this particular "Lab Developed Test" was denied is because it is not FDA approved.

[hunter5582 in reply to wrench69]

I had to look this one up. Per the FDA "A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory."

I wonder if this was a reference to a specific JAK2 Quantitative Analysis test at a specific lab. If, so, then there are a number of different JAK2 Quantitative Analysis labs available. Perhaps your plan would pay for some of them. Might be worth some research for future testing.