nocturnal home hemo question

[russ9320]

I am wondering what machines offer nocturnal home hemo. Currently I am using the nxstage and it isn't approved in the US for nocturnal use. My home nurse doesn't know if it can be done here.

[obsidianom]

I do know of some people doing Nxstage nocturnal but it is not common yet.

[ianch]

sad, sad, sad.  Fresenius do nocturnal.  I push their 4008B to 10 hours per treatment.  Getting more toxin removal than a person who doesn't qualify for dialysis (by time), but then i'm in New Zealand where home is the new centre

[amanda100wilson]

Currently in the US, there are no machines FDA approved for nocturnal home hemo.  The only way to do it, is to have a progressive nephrologist willing to agree to sign for it off label.  The key thing when asking, is not to call it nocturnal.  Call it extended, since it is approved for extended use.  Go armed with knowledge about the benefits of doing longer, more frequent dialysis.

[ianch]

That's crazy, how can something such as time not be approved.  4hrs, 6hrs, 8hrs, 10, whats the difference. I guess the system is vastly different and I'm thankful we don't follow the US.  Surely if a person is stable enough to be independent and is trained then the hours they do is up to them.  I can do 4 hrs every day if i want, but i chose after research to to 10 hours every 2 days.  The point is that it was my choice.

Night time is easy, the QB should be low, the UF per hour should be low, so all of those risky components that keep nurses on their toes in centre should be minimized or even eliminated because there are less complications with longer hours.  Find a good wrapping technique and its as safe as houses.  I can tug on my lines and they don't budge.

I've actually pushed the 4008B to 12 hours in one session and think it will go to 13 before the Bibag runs out.  I haven't tried because the concentrate may not have had enough potassium to sustain the required equilibrium.  I.e. might need to change formula for >10 hours and I wont get approval for that as >10 exceeds the operational threshold of the 4008b.

I think the FDA needs to take a look around and see what other countries are doing.

[obsidianom]

Dr. Agar in Australia has written on this extensively. He beleives the US is in the dark ages with dialysis compared to you guys down under. The home program in Australia runs circles over the US .  You are correct we are way behind here in the US..   It is a combination of our legal system, the FDA , medicare, and how our nephrologists are trained.  Someday we may finally catch up but not now. 

[amanda100wilson]

Lanch, I agree completely.  More dangerous to run fast and hard than run slow and long.

[ianch]

Good to see there are extended supporters here.  I see so much suffering on this site and i recall that much of it I too experienced with a 12hr per week schedule.  Now on a 40hr per week schedule and its almost normal life with virtually none of the issues before.

John also provided expert feedback into the RKF calculator we have just launched as I emailed a quite a few doctors around launch time.  His recommendations were added.

https://kiwimedtec.com/pub/rkf_calculator.php   

[carson]

Ii live in Canada and have been on nocturnal home hemo using the Bellco Formula machine for 7 yrs now. I had previously been on PD for 10 yrs but feel much, much better this way. I do about 7.5 hours x 6 days. New machines for the home market are being developed all the time. the US really needs to do right by their people and allow home nocturnal - it really is the only way to go. All the best to you.

[Simon Dog]

NxStage makes a cartridge specifically for nocturnal (#171) - longer lines; heparin port; no pressure pod.

[amanda100wilson]

Is that different from the 171B?

[Simon Dog]

Is that different from the 171B?

Not sure (my guess is no).  My point is home hemo is supported by NxStage as evidenced by specific products to support it.

[Hemodoc]

NxStage already completed the required FDA nocturnal study with excellent results. There is NO reason medically not to allow and FDA approve a nocturnal indication for NxStage.

Amanda is right that no machine is approved for nocturnal usage in the US, but that does not stop anyone from using it in that manner as many nephrologists do. Unfortunately, most US nephrologists are completely unaware of the history of dialysis in the US where in the 1960's, nocturnal dialysis at home was the preffered treatment with vastly primitive machines. The US is in the dark ages and I suspect shall remain there for much time to come.

The last thing CMS wishes to do is to prolong the lives of dialysis patients which would mean they would have more patients remaining on dialysis. I cannot prove this, but that is the only rational answer for why CMS does what it does in the dialysis arena in my opinion since their policies are completely counter to good medical outcomes. Time after time and again and again, CMS over the last 40 years has hindered home hemodialysis, especially home nocturnal hemodialysis with the best outcomes. Even the recent bundle penalized home hemo options especially training. They made some recent adjustments, but not enough to become another New Zealand where home is the preferred modality.

This will only end, I believe, when the American dialysis patient collectively addresses this agregious disparity in resource allocation for dialysis services. Sadly, there are only a minority of dialysis patients who will speak up and for those that do, retalitation is often the result.  In some ways, I feel as if I have been 7 years a slave and counting.

[amanda100wilson]

Hemodoc, doesn't the Hippocratic Oath (do doctors over here have to abide by the in the US?) say something about doctors not doing the patient harm?  How that that sit with dialysis if they do, since conventional dialysis does just that.

[Hemodoc]

Hemodoc, doesn't the Hippocratic Oath (do doctors over here have to abide by the in the US?) say something about doctors not doing the patient harm?  How that that sit with dialysis if they do, since conventional dialysis does just that.

Yes, it does but as far are nephrology goes they are in some sort of time warped delusions about dialysis. For some reason they completely dismiss the data on "optimal" dialysis modalities and state that they have not been proven to date. I believe that is how they justify in their own minds "not doing any harm."

[Bill Peckham]

I think it is important to understand the FDA controls how a product is marketed, it does not control how a device or medication is used. NxStage can't talk about nocturnal per se because it could be construed as promoting the product, aka marketing. The 171B is designed to be used for extended dialysis, which is the semantic tipoff that this is a bunch of BS. The FDA decided that the word nocturnal can't be used but that is ridiculous because what exactly constitutes nocturnal? The length? The amount of ambient light? People in Alaska could only dialyze for a couple hours each day during the winter.

However, no one can stand up and call it BS  - no one at NxStage or associated with NxStage - because that would be promoting its nocturnal use.

CMS carries out the edicts of Congress. Congress has said many fine things about home dialysis but when it comes to money reimbursement at one time disadvantage HHD. But Peter it is my understanding that the majority of MACs - the people who actually write the checks for Medicare reimbursement - are reimbursing for every dialysis treatment. The old argument was that based on 13 reimbursements a month it would take 18 months to recover sunk training costs. Based on reimbursement for every treatment 18 to 30/month, and the slight training bump, recovery is now much faster. As of today, in most of the country, reimbursement hugely advantages more frequent HHD.

The economics that work against NxStage are that compared to incenter dialysis the variable cost of a NxStage treatment are much higher. At a center the cost of providing one more treatment is on the order of $10 to $20. For NxStage the costs are higher, the per month supply cost +lease are said to be in the $2,000 range putting the marginal cost of a treatment in the $100 range. It's more lucrative in the short run to provide the treatment incenter.

The way dialysis works is that the whole edifice, all the industry, is there to serve the private payers but once you have this all in place you might as well serve Medicare beneficiaries too. You already have the building, machines and the nurses, just add some techs and you can provide a treatment at a very low marginal cost.

[Simon Dog]

For NxStage the costs are higher, the per month supply cost +lease are said to be in the $2,000 range putting the marginal cost of a treatment in the $100 range. It's more lucrative in the short run to provide the treatment incenter.

The actual marginal cost is the cost of adding an extra treatment, so the marginal cost of a NxStage treatment will not include amortization of the lease of the unit, but will include the cost of the supplies used for the individual treatment.   The marginal cost of a NxStage would be the cost of the cassette; portion of a PAK and SAK used; and misc supplies such as saline, gauze and tape. The $100 Mr. Bill quoted would be the average cost of a NxStage treatment.   Despite the seemingly high NxStage rental/support costs, NxStage is still posting quarterly losses.

Of course, the marginal cost of adding another NxStage patient for a month is indeed $2000 (using your numbers), so if you compare marginal cost on a "per month" rather than "per treatment" basis, your logic is sound.

The real comparison over the long run is the average cost of each, as you cannot infinitely add new patients at incremental cost - you hit staffing ratios requiring more RNs or techs on duty; need to buy more machines; have more room for chairs; etc.   The only time a marginal cost analysis doesn't break down when scaled is a home patient adding more treatments (leaving only supplies and machine wear to be accounted for).

For NxStage the costs are higher, the per month supply cost +lease are said to be in the $2,000 range putting the marginal cost of a treatment in the $100 range. It's more lucrative in the short run to provide the treatment incenter.

I expect that Medicare patients are profitable on an incremental basis, but don't cover the fully burdened cost.   This manner of cost allocation allows the clinic to say they "lose money" on Medicare patients, when in fact the make incremental money.   Similar logic plays out when a school grants a partial scholarship to a student and claims it is "costing" them money when in fact the partial scholarship students are profitable on an incremental basis and critical to the survival of the mid-tier schools who maintain an illusion of selectivity while struggling to fill their freshmen class each year.

I know I did my part for Davita - my insurance carrier paid over $9000 for two treatments I had at one of their clinics as a transient.