Lots of information to share from an ex-Director of one of the Big 2 Dialysis Co

[dialysisinsider]

Hi Everyone,

I'm not a dialysis patient, but I do know a lot about dialysis, dialysis patients and what they go through. For the last 4 years I have been a Regional Operations Director for one of the two large dialysis companies (you know them as FMC and DaVita). What this means is that I oversaw 15 programs (10 hemodialysis centers, 4 PD programs and one home hemo program). I had roughly 200 employees and was responsible for the care of over 1,000 patients, just like you.

I've joined this forum to share information about what I learned during this time. I am no longer with a dialysis company, so I feel more free to share my true thoughts about how dialysis centers are run, how they make money, and how they treat their patients.

I would be very interested in hearing questions that you have regarding dialysis. I'm not a doctor or even a nurse, so I won't have all the answers, especially the clinical questions. But I do have a lot of knowledge about how the dialysis system works and want to share.

I really care about this community and want to patients live full lives. I think the more information dialysis patients have, the more empowered they can be to live longer and be happy.

Nice to meet everyone!

[thegrammalady]

  to the board, this could get interesting..................

[dialysisinsider]

Actually, I hope it does. I hope my honesty can lead to dialysis patients getting better care and leading better lives.
 

[MooseMom]

I would very much like to know if it is really true that the FDA has not given approval for use of the NxStage System One for nocturnal/extended use for home hemodialysis.  I've asked the FDA about what their concerns are, and they don't seem to know what the hell I'm talking about.

Oh, and welcome to our community!!

[boswife]

welcome to our happy home   I too hope lots of open questions get asked.  My head is spinning trying to think of some, but right now.... blank..lol   Nice of you to join us!

[carol1987]

Welcome!!

[greg10]

..
I've joined this forum to share information about what I learned during this time. I am no longer with a dialysis company, so I feel more free to share my true thoughts about how dialysis centers are run, how they make money, and how they treat their patients..

Welcome to the forum, insider.

I think there has been many threads in this forum about how much dialysis really cost.  Many patients routinely receive a monthly billings of $50k "retail" prices and then they see an adjusted price paid by the primary then another portion to the secondary and/or patient's own out of pocket bill.  I know from past experience with one of the two big chain centers is that the secondary or patient's portion can be $800 per month or more.

So how much does dialysis really cost in center and how much does that compare to in home dialysis?

Do big centers really want to support home dialysis?  Another way of putting this is do they make less or more money with home dialysis?

Another obvious question would be whether the new Medicare bundling rule will affect the profitability of big centers and would that also affect the treatment of patients.

Thanks in advance for you insights.

[tyefly]

Welcome....      I would like to know why you have left the dialysis community.....  we need caring people to help change the mindset with the clinics....  Tech.... nurses..... and esp   upper management...   

[Rerun]

Maybe we should start a thread in Dialysis General Discussion called Questions to Dialysis Insider?

Rerun, Moderator   

Woo Hoo!  I love this site!   

[paris]

Welcome to our incredible community.  I think we can learn from you, but you may also learn from the other "insiders" -- those with the needles in their arms.  This is a great site for sharing.  And a wonderful place for support.  Looking forward to more posts so we can learn more about you.  Welcome to IHD.   




paris, Moderator

[ardyce]

Insider,

First and for most welcome to the site!  I think you opened up a can of worms!

My grip is the “cost of dialysis” and since you are on the management end you probably have somewhat of an idea of how costs are charged out.  I know now there is the bundling factor in play also.
When I started dialysis three and half years ago I first started on in-clinic hemo and was charged $1635.00 each session.  I soon changed to home peritoneal dialysis after a dialysis employee told me I had that option.  The doctor did not tell me anything, in fact when I was in the hospital I said to him that I knew nothing about dialysis.  He walked out of the room without answering my question.  That was the first mark against him and showed me that I should not trust him.
But on to the really issue “cost of dialysis”.  On peritoneal dialysis I am on the Baxter Pro Home choice system.  I use two 6000ml bags a night.  I found the Baxter web site that they have listed out the cost of their products.   So I added up what I used per each day with all the tubing and cassettes and I came up with a grand total $104.97 of product a day.  I know the clinic has more cost such as Labs and rental space and salaries for the employees and overhead.  But I am charged $600 to $680 dollar a day.  I have had labs drawn elsewhere and it did not cost me $400 some dollars for a lab drawn.  But I only go into the clinic twice a month and the PD nurse only does a lab draw once a month all the manual labor I do myself at home I give myself the epogen shots.  I guess the twice monthly clinic visits with the lab draw equates to about $495.00.  It does!!!!   I asked the PD nurse about the cost and she did not want to answer my question so she got the social worker (what an idiot!!).  I just said that I had figured up the cost of the products I used from the Baxter web site and I came up with using $104.97 a day and since I am being charged $600.00 a day I would like to know where the other $495.00 a day is going.  She hmm and hahed around and finally came up with, will the PD nursed is on call 24 hours a day.  LOL  LOL  I told her so is the doctor but I don’t pay him $600 a day.  She did not have an intelligent came back.  I went to other dialysis clinics and when I asked about cost they had the exact same reaction.
But now my 30 months are up and Medicare is primary and my insurance is secondary. The dialysis clinic is still charging that $600 to $680 a day but Medicare does not pay out like the insurance company did during the first 30 months.  Now what the dialysis clinic is getting is around $2800 and month which equates to about $94 a day.  Which is more in line with what it should be.
See why I did not trust these people.  I just think they are all a bunch of crooks!  Now I am trying to get extraneal for my long daytime dwell and they tell me it is too expensive.  They were just fine when they were over charging the insurance company but when there is a product that could help a patient it’s suddenly too expensive.  As I said they are all bunch of crooks!

[WishIKnew]

Hi insider!

I do PD and am shocked at the cost.  So, as others have asked, why so much $$$$$ when I do it all here at home??

What I have always wondered is why there is NO connect between transplant centers and dialysis units?  I mean I get NO info from my nurses/care team and am left to fuddle through on my own.  Frequently I tell them what I have learned about the surrounding transplant centers and they seem so interested and say they will pass my info on to others in my unit, yet they have been NO HELP for me.....  Frustrating!

I' sure I'll think of more questions, but that's my starting point.

Welcome!

[dialysisinsider]

Wow! First, thank you for all the welcomes. I'm glad to be a part of the dialysis community and am very happy to help.

Let me start off by saying why I left my position. I left because I did not feel I was a good fit for what I was doing anymore. I have worked in health care for most of my career, but what I found myself doing at my job was trying to cut costs while improving quality of care. I did all I could to try to do both, but at a certain point I felt that I could not do both. That is not to say someone else could not do better.

Let me start off a quick financial lesson in dialysis with a disclaimer. I am not all knowing. I am a pretty smart guy, but I do not know the specifics of every situation. I will try to the best of my knowledge to answer all questions though 

Ok, so a quick run down on questions:

MooseMom - I am not certain about NxStage System One for nocturnal/extended use for home hemodialysis. Are you getting push back from your provider about using the system longer at home? Are you currently a HH patient? Tell me more and I will give you what I know.

greg10 - PD, Hemo, and then Home Hemo. From lowest cost to provider to highest in that order. Yes, the providers do want to push home, but will have to have the costs of Home Hemo go down a lot for them to make money on everyone. The govt is pushing PD because it costs the least and the outcomes are still good (the same or better than in center in almost all cases).

paris - I agree. I know nothing compared to you, the patients. I admire your strength You are the true insider.

ardyce - Ok, there's a lot of questions here, so I'm going to put together a video to give some information out on how reimbursement is done for dialysis. Basically, for 33 months, if you have insurance, your insurance will be billed. This is called Coordination of Benefits (COB). After that, Medicare, Medicaid and usually a secondary insurance will kick-in. So the rate that Medicare pays is much less because they pay for all dialysis patients after the COD. Basically, if there were no insurance patients, then dialysis centers would not be able to make much profit, if any at all. So it is a pay upfront with insurance and break-even or make only a small amount going forward. Oh yes, and this is all for the US of course.

For your PD questions, the costs are confusing. So asking your PD nurse will not help. Most people, even your manager at your facility (FA) will not know the answers to these questions. The costs may seem high, but the cost of healthcare is very high in the US.

WishIKnew - if your team is not getting you on a list... them shame on them! Talk to them again and message me here if you need help.

Ok, I'm running out of time here, but I'm going to put together some basic videos so I can explain some of this stuff since there seems to be confusion.

Hope this helps!

[MooseMom]

Dialysisinsider, thanks for your reply.  Re NxStage for home nocturnal use...I am not on dialysis yet so have been using this time to research modalities.  I plan to do home hemo with NxStage and my neph agrees this will be good for me.  I know that it is generally used for short daily home hemo, but more and more patients are asking to use the machine for home nocturnal use.  I have asked my clinic about this, and their reply has been "We are not aware that NxStage has been approved by the FDA for home nocturnal."  Some NxStage users have nephs who will write prescriptions for extended use but still some clinics do not want to know.  Here is a thread by an IHD member that speaks to the problem...

http://ihatedialysis.com/forum/index.php?topic=21873.msg357893;boardseen#new

I am getting the feeling that "The FDA has not approved NxStage for nocturnal dialysis" is either a lie or an urban myth.  Like I said, I contacted the FDA's medical devices unit, and they said they found nothing in their database to suggest NxStage is contraindicated for nocturnal use.  Can you enlighten us in this regard?  A LOT of dialysis patients would be ecstatic if their clinics would support the use of the System One for home nocturnal.  It would be wonderful!  Thanks for any info you may have!!!

[carol1987]

I want to know why ,when  started Dialysis... the social worker asked me if I wanted to sign up for Medicare instead of informing me of my options and helping me decide my best option?   I know nothing about medicare and their policies... my private insurance has been great so far... but I know nothing about the 30 months.. etc...

 

[dialysisinsider]

MooseMom- I don't know enough about the current situation to give any more help on this topic. I can ask around, but it might take me a bit to get you an answer. I will answer though

carol1987 - They are signing you up because after the COD or about 30-33 months your primary insurance will be medicare. Trust me, the dialysis company will do everything in their power to keep you on your insurance. It is very, very, very important for profitability that they see you stay on your insurance so don't worry.

[greg10]

I would very much like to know if it is really true that the FDA has not given approval for use of the NxStage System One for nocturnal/extended use for home hemodialysis.  I've asked the FDA about what their concerns are, and they don't seem to know what the hell I'm talking about.

Oh, and welcome to our community!!

MM, Please see the response to this thread from February 26, 2008 by Dori Schatell:  http://forums.homedialysis.org/showthread.php/1740-how-clinics-cover-nocturnal-txs

Dori Schatell
Moderator
 
 Originally Posted by Jane 
1. I have read that none of the existing machines are FDA approved for nocturnal length txs- is this accurate?
I'm not sure it's accurate to say that the FDA has not approved any machines for "nocturnal-length" treatments. As far as I'm aware, any machine currently on the market could be used for a 7 or 8-hour treatment that is done during the day. The issue comes in when nocturnal treatments are done at night while folks (and presumably home HD partners) are sleeping. The FDA has not yet looked at any machines for this specific purpose yet. It is certainly our fervent hope that when and if they do, that they will take into consideration a safety record that dates back 40 years--and compare it to the known risks that occur each year in dialysis centers where patients are "supervised" and yet incidents still occur.

2. If the machines are not FDA approved, how are clinics offering nocturnal txs?
At this point in time, the issue is not whether a machine is FDA approved for nocturnal treatments--none of them are. The issue is whether machines are FDA approved for home, which requires studies in addition to those needed to just get a machine on the market. The Renal Solutions Allient Sorbent machine, for example, is undergoing this research right now. It will be very flexible as to treatment length once it is available for home use--which can be handy for switching between short daily and long nocturnal.

[texasstyle]

Gee, I 'm learning smething new here. I did not know that you need FDA approval before starting NX stage. Is this with all dialysis done at home?

[greg10]

Gee, I 'm learning smething new here. I did not know that you need FDA approval before starting NX stage. Is this with all dialysis done at home?

Hi TS.  NxStage cycler has been approved for home use, it is just that no dialysis machines are specifically approved by the FDA for nocturnal home use:  Lawrence MA, - (June 29, 2005) - NxStage Medical, Inc. today announced that it has received expanded Section 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its System One™ portable daily hemodialysis device for home use.

As Dori Schatell wrote in another forum: "The FDA approves medical devices (e.g., dialysis machines) and drugs--that's its job. The FDA does not approve types of HD therapy. That's the doctors' job"

[MooseMom]

Greg, that thread is two years old, but I will assume that what held true then holds true now.  So what is being said is NO machine is specifically approved for HOME NOCTURNAL use despite the fact that we all know that people are doing home nocturnal even as we speak.  This is different from saying that NxStage or any other machine has been contraindicated for NHHD or from implying that we are all supposed to be waiting around for FDA approval that is never even on the agenda in the first place.

If you want to dialyze for an extended period while you and/or your partner sleep, what is the FDA or someone going to do, call the sleep police?  All of these machines have all sorts of alarms that go off if you just breathe funny, so I would think that falling asleep while dialyzing isn't a problem unless your clinic decides it's a problem.

So, with that in mind, I am assuming that if your neph prescribes nocturnal home hemo with NxStage, a dialysis center can't deny that treatment to you, quoting "Sorry, but the FDA hasn't approved that."

I then have to wonder what the legal implications are for denying a patient a treatment prescribed by a physician.  A clinic now has no reasonable grounds for denial.  Say with Tyefly...she is concerned that if she begins nocturnal/extended HHD with NxStage now, once DaVita completes its purchase of her clinic, they may try to deny her her treatment of choice and force her into a treatment that is not as clinically effective (if you are of the belief that NHD offers virtually the same clinical results as cadaveric transplantation).  Is that a legally sustainable course of action?  I'd investigate that.

I'm thinking that clinics have purposely created the impression that this modality is unavailable because of the FDA when in fact, the FDA has no say in the matter.  Am I missing something here?  I suspect that those patients who want to do NHHD now have some ammunition; the whole argument against is a bit of a con.

[cariad]

Is anyone trying to get it approved for home nocturnal?

I think the FDA does in fact have a say, and that home nocturnal may need someone to advocate for it? As has been mentioned, there are really two departments to the FDA that the medical community works under - the drugs and the devices. I know the trial I underwent was put on hold for nearly 6 months because of the stem cell separating device not being FDA approved for the trial. There was an old machine that the company said they would no longer support so they could not use that, and a new machine from Baxter (yes, THAT Baxter) that used magnets and was supposed to be much better. Stupidly, it was approved for stem cell separation, just not in kidney patients, or something like that. It was incredibly nitpicky, and even with my well-funded and well-connected surgeon furiously filling out the documentation, the trial could not go forward until this issue was resolved. And for flips sake, it's not like the stem cell separation machine presents any danger whatsoever to the patient.

So, I completely believe that the FDA could be part of the problem. But is anyone out there fighting for FDA approval? That might be the bigger problem. I don't know, I am just speculating. All of the FDA talk from my surgeon made my head spin and made me wonder how he ever had any time to perform transplants.

[MooseMom]

Yes, of course people are fighting to get this elusive approval.  I have been in contact with the medical devices department of the FDA, and they are completely clueless and have told me that they don't have any opinion on what time of day NxStage is used.  You see, they don't even understand the QUESTION, which leads me to believe there IS no real question!

If you look at the NxStage Users website, you will see that loads of people are awaiting approval because their clinics keep fobbing them off, saying "Oh no we can't let you do that because the FDA hasn't approved it yet."  However, no one seems to be able to point to any documentation at all that says anything about the FDA looking into this use of NxStage.  Based on my own investigation of the FDA's website and on my correspondence with the medical devices dept, I don't think the FDA is the problem at all.  However, it seems that some clinics are CLAIMING that the FDA is the problem.  I suspect that we patients are fighting for this approval in a battle that doesn't even exist.  If I am wrong, someone please tell me and direct me to some concrete evidence.  Life is hard enough without having to fight nonexistent battles.

[Rerun]

Can we please leave the introduction section.  Not enough people read this section.  Someone Please go to general discussion and start a questions thread for Dialysis Insider.

Thanks.....

Rerun, Moderator   

[cariad]

Yes, of course people are fighting to get this elusive approval.  I have been in contact with the medical devices department of the FDA, and they are completely clueless and have told me that they don't have any opinion on what time of day NxStage is used.  You see, they don't even understand the QUESTION, which leads me to believe there IS no real question!

I meant any doctors, any people with the expertise to file for approval.

I don't know that the people who answer the phone are necessarily going to be the right people to ask. Did you ask what their role at the FDA is?

Since the assumption is that everyone will be asleep during nocturnal, and since dialysis can turn deadly if problems are not addressed immediately, it may be something that the FDA is never willing to approve. In that case it will be up to patients to either take the initiative themselves or doctors to prescribe it and let it be their heads if something goes wrong. I think the easiest question to ask is How do we get FDA approval? What are the steps? I would guess that someone, a doctor, would need to take the time to prove the safety of home nocturnal using NXStage.

Anyhow, I probably should not even have joined this discussion. It just triggered a memory for me of something that I had begun to forget, but that I thought might give some insight into the process. I remember Aleta considering nocturnal and saying that the lack of FDA approval was one obstacle, but it did not seem to be an insurmountable one. This seems like something Meinuk would know loads about.

Sorry, Rerun. I don't mean to ignore you, I just wanted to clarify my earlier remarks. If I had questions for dialysisinsider, I would start that thread, but I intend to leave this topic alone now.

[okarol]

Please take your questions and comments over to a new thread http://ihatedialysis.com/forum/index.php?topic=22034.0

This is for introductions/welcomes only.

Thanks.

okarol/admin