Allosure DNA test

[Cupcake]

Any other transplant patients getting the Allosure test to check for donor DNA floating around in your body? It requires a different blood test that gets sent to California-they fed ex me a kit and I fed ex it back. Supposed to be better at detecting early rejection. I have had it 4 times so far and all have been 'fine' but since I am an over achiever I want to know if they are 'fine' or 'fabulous'! last one was 0.19; they get nervous if you are greater than 1 so I guess that's good.

So far I haven't gotten a bill--my Humana denied it but Medicare might have picked it up.

[iolaire]

Yes, once when they were worried about inflammation they were seeing, here are the results:
http://ihatedialysis.com/forum/index.php?topic=34003.msg525444#msg525444

I was able to see the results on the website.  My nephrologist team might have had to grant me access.  Or maybe they sent me the PDF results.

Medicare covers it but 4 test seems sort of excessive to me unless you have other tests causing concerns, but I don't know the timeframe.  One thing they cautioned me is a that a good result is good, a bad one doesn't really give you any specific information of the problem if any - but I guess that would allow them to know they need to increase surveillance via lab work.

My Nephrologist recommended the test company CareDx Inc NASDAQ: CDNA as an investment and I agreed with him so I put a $1k in it.  Its more than doubled and I probably should put a lot more into it. (Actually I did buy more in another account so I'm happy.) I feel like the company was probably trying to fundraise from the Nephrologists.

Except I see this in my stock portal!!!
On July 16, 2019, Kerrisdale Capital Research released a report alleging, among other things, that the Company's diagnostic test, AlloSure, is "fundamentally incapable of identifying the most common type of kidney rejection." Moreover, the report stated that AlloSure revenues are derived from "protocol usage in clinical testing, which is suffering 20-30% quarterly attrition."
Here is their press release, keep in mind Kerrisdale makes its money shorting stocks so any negative news for a company is a plus for them, its in their best interest to exaggerate things.  But if its true its worrisome, on the stock from its down a bit but still fairly high relative to last August so maybe people don't believe this too much.
https://www.kerrisdalecap.com/investments/caredx-inc-cdna/

[Cupcake]

Thanks Iolaire! I guess if I'm 0.19, that's as low as they register so great! The protocol says monthly x 6 months, then quarterly (or something like that) so Barnes thinks I should have had more by now (10 months after Tx)

Disappointing to read that the Allosure may be a bunch of hooee anyway. Sorry you invested. this up and down with the stock market overall is annoying for sure.

[iolaire]

Dang they are hitting the test hard!  I wonder if your center is one of the centers with active studies on the effectiveness of the test.

But maybe your center bought into the test long ago. The company was just demonstrating the test at GE last August so I was one of the first to do the test there.

I still think it’s a great innovation and investment. But more importantly a few other similar tests are coming out so we will have a range of options beyond biopsy’s.

[iolaire]

Just received a call from a Allosure coordinator GW Transplant Center now wants people like me (2.5 years post transplant) to be doing the test quarterly.  The options are basically a mobile blood draw where they come to you or do it in a doctors office.  I scheduled the draw at the clinic despite not having been in there for about two years now as that's more convenient then meeting someone at my home.  They don't yet have contracts with LabCorp or Quest to do the blood draws.

[kristina]

Any other transplant patients getting the Allosure test to check for donor DNA floating around in your body? It requires a different blood test that gets sent to California-they fed ex me a kit and I fed ex it back. Supposed to be better at detecting early rejection. I have had it 4 times so far and all have been 'fine' but since I am an over achiever I want to know if they are 'fine' or 'fabulous'! last one was 0.19; they get nervous if you are greater than 1 so I guess that's good.

So far I haven't gotten a bill--my Humana denied it but Medicare might have picked it up.

Hello cupcake,
Reading your question gave me quite a surprise because I have never ever thought about the possibilities of Donor DNA "floating around my body" ! But it does make sense !
Are you being informed about the results of this blood test as well ?
Does it make you wonder ?
.... What about young couples who wish to have children after one of them had a  transplant ?
Thanks for the information about it, it is very much appreciated.
 .... And many thanks for answering my questions and I send you my best wishes from Kristina.
 

[MooseMom]

Kristina, I've just posted the link to a podcast on Renal Support Network's website that addresses the issue of pregnancy after transplant, including whether or not the father's antibodies can cause rejection.  (Basically, no.)

[MooseMom]

OMG, how are you all getting this Allosure test paid for?  I am really having trouble over the past 3 years getting a regular DSA test paid for and am now having to get a separate referral for it (I am on an HMO and my tx clinic is out of network).  I wish I had a dollar for every time I had to explain TO SOMEONE ALREADY IN THE MEDICAL FIELD what the test is for and why the lab needs my donor's tissue for the test to be performed.

I have had people in my medical group give me a referral for just my annual appointment and then take a year to actually pay for it, in the meantime lying about why they won't pay ("The referral wasn't really a referral, rather, it was just an in-office memo." , or "We have not received a statement/claim from your transplant clinic."  Lie, Lie, Lie.)

It has become so bad that I went to see my Congresswoman this past weekend to complain.  She must have made a few phone calls because I just got off the phone with the case nurse at the medical group where once again I had to explain the oh so fascinating facts of the DSA test.  Geez. 

So, really, how are you all paying for this Allosure thingy?  Especially if you're having it 4 times a year??

[iolaire]

OMG, how are you all getting this Allosure test paid for?  I am really having trouble over the past 3 years getting a regular DSA test paid for and am now having to get a separate referral for it (I am on an HMO and my tx clinic is out of network).
So, really, how are you all paying for this Allosure thingy?  Especially if you're having it 4 times a year??

Its Medicare Approved so that covers it for me right now. Second answer is also that all cost controlled insurances like HMO's probably fight the tests (and all costs) as much as they can to lower plan costs. 

I worry about it as I transition to my wife's insurance January 1 and loose Medicare in July.  I'm hoping that by going with a higher cost non HMO BlueCross Plan they might pay it once off Medicare.  I'm hoping that since we get to pick her insurance from the Federal Government plans I can pick a good plan and move between plans yearly if I make a bad choice.  For example looking at the Aetna and Blue Cross plans I see Envarsus is not covered on the Aetna plans so I'm looking more at Blue Cross.

Also this is probably VERY profitable for Allosure so they will work for you to get pre approvals: http://www.allosure.com/insurance-information/  You might try that once and see if they have some sort of magic to get it approved under plan.

[MooseMom]

iolaire, as if we transplant patients didn't have enough to worry about!  I get so mad because truth be told, I am a model patient and do whatever is necessary to take care of myself.  I do whatever my team tells me, and more!  I am my own advocate, so I resent it when there are outside forces working against me.

When you go to choose your plan, be particularly attentive to how plans respond to medication costs.  My husband is a city attorney and deals with the city's insurance broker when choosing the plans that the city employees will have to choose from.  BCBS-IL HMO is by far the most responsive when it comes to costs for my tx meds.  That's the only reason we've not changed to the PPO.  To be fair, I've never had anything denied by the actually insurance company, rather, it is the umbrella medical group that gives me fits.  I'm sure their eyes would glaze over if I came to them with a referral request for something brand-spanking new like Allosure!!

Of course, you may have a completely different experience since you live in a different state.

And yep, of course an HMO will want to fight, but they never have before, and I do not know why they are choosing to do so now.  I'm sure they think I will just give up, but they don't know me.

Anyway, I have the same concerns as I transition the other way, from private insurance onto Medicare, if it even exists by the time I need it!  I'll be very interested to hear which plan you pick once the time comes, so keep me posted!

It's all just a real pain in the butt.  The stall tactics are just so predictable and irritating.

[Cupcake]

MooseMom-you go, Girl! taking it to a congressperson! I send the occasional snarky email to mine and I've gotten on his newsletter list. Me: let the children out of cages! Him: Look at me, I'm at the State Fair! 

Medicare is paying for the Allosure, but my transplant center doesn't seem to care about the results. I did it 2 weeks ago and had to call for result-its 0.16, the lowest its ever been. My creatinine is 0.86 one year post transplant so I am feeling pretty happy. The Allosure company sends me the kit, I have a nurse friend draw my blood and then I put it in the prepaid Fedex envelope and drop it off at Kinko's. I agree that's easier than scheduling someone to come here. I'm too busy out running around.

I had a lot of trouble with Humana not covering some charges for my transplant and related wound infection, even though Barnes was approved ahead of time. Every time I called they gave me a different reason, etc. For the first 6 months after transplant I spent about an hour or two a week, on the phone with Humana or one office or the other at Barnes. I think its all settled now and its been a year. I asked for an itemized statement and tried to correlate charges and payment with Humana and Medicare and almost went nuts. I get easily frustrated with that sort of nonsense, but made it my mission to grind them down. I hadn't thought of calling my Congressman, but he's probably driving a firetruck or cutting a ribbon someplace.

[iolaire]

Medicare is paying for the Allosure, but my transplant center doesn't seem to care about the results.

I hope they are extremely responsive for the bad test results.  It seems that a good test means your are fine, but a bad test means they need to do more to figure out if its a problem.  I also didn't really hear back on the good result from my neph.  I'm not holding my breath that the center will reach out to me with my next good result.  But I do think I might be able to see the results online as after the first (and only test) I setup an account on their site to see the results.

[MooseMom]

What really gets up my nose is the fact that I'VE HAD A KIDNEY TRANSPLANT FOR SEVEN YEARS and never had trouble getting this stuff approved until about 3 years ago.  Every year I'd get my big long list of labs done (through Quest, which is local and network approved, so no referral necessary) and the courtesy draw done, have the DSA thingy done at my tx center, and then go and have my annual checkup.  Easy peasy lemon squeezy.  And now suddenly I'm having to sing and dance while jumping through the hoops to infinity and beyond to get approval to even whisper the word "transplant".  OMG, it's unbelievable!  I swear on all that's holy that a few years ago when my tx team wanted me to have a biopsy, the very first thing I thought was, "OMG, the paperwork is going to be colossal!"  I was on holiday in California and the tx center called me with a "courtesy call" to tell me that they had not received the proper documentation (ie, referral) from my PCP yet.  This is why our healthcare is so damn expensive.  How much money is being paid to all of the bright sparks who assassinate entire forests for all of this paper?

Luckily for me, my Congresswoman worked in health care and is a registered nurse, so she gets it.  I've been to her town halls, and despite the deluge of swamp water we're seeing in DC nowadays, I can tell you that health care is the most discussed topic.  Sometimes I feel like I'm having to do everybody's thinking for them.  The whole concept behind developing antibodies is not exactly rocket science; I mean, that's the concept behind vaccinations, yeah?

I know this has nothing to do with Allosure specifically, and I apologize for my rant, but I have my annual checkup tomorrow and I'm very stressed about it.  I just want to go and live my life, and while I accept the responsibility that comes with being a compliant transplant patient, I vastly resent having to be constantly reminded of the precarious nature of my condition every damn time I have to discuss insurance or payments or referrals or any of this crap that I shouldn't have to think about because I am not being paid to do other people's jobs for them.

[MooseMom]

I had a whole "nuther rant all written out, but luckily for all of you, it got gobbled up in the ether of the internet.  LOL!

[Cupcake]

Keep ranting, its unfortunately necessary for your care and maybe it helps someone less able to advocate for themselves. Best of luck at your checkup.

[iolaire]

You can now get your AlloSure test results in the AlloCare phone app (iOS for me). Under the Health Stats icon the top results is Test Results which shows Allograph function -> AlloSure-Kindey with the last result, then click on that and it shows history back to 2018 for me.  My results from older to newer: <0.19%, <0.15%, 0.16%, 0.14%.