how do we get started doing extended daily therapy (Nocturnal)

[Maggie and Jeff]

We would love any info as to how to get started doing extended daily therapy (Nocturnal) on our NxStage system one.  As I understand it we would need a heparin pump and car 171.

And a clinics cooperation. This is the one we seem to need the most help with at the moment.

[Wallyz]

You got it.  Have them Contact the Northwest Kidney Centers, as they are doing a lot of it.

[Roadrunner]

DaVita won't do nocturnal until it is FDA approved.  I bet then they will need state approval.  It's probably a legal issue, they are covering themselves and you.

Some not-for-profit clinics will offer nocturnal.  I don't know why they aren't afraid of the legalities but seem more concerned with the health of the patients.

[swramsay]

Maggie & Jeff,
I just saw this thread. I began home hemo training last week with Davita. My goal is to go to nocturnal home when I am comfortable with the short daily. Davita is aware of this. If they aren't willing to work with me on this, I will switch to Northwest Kidney when it's time to go to nocturnal.

What have you found out since your post here in December? Are you doing the nocturnal and if so, with whom?

[Adam_W]

My nurse told me that NxStage has just applied for FDA clearance for nocturnal, and they are hoping for approval in six months. However, I'm still skeptical, because we were being told the same thing for the last year and a half. Unfortunately for me, there are no other clinics that offer "extended dialysis" with NxStage. I do have the option of doing NHHD with Fresenius, but I don't think I'd be able to store all those extra supplies, plus a huge dialysis machine and RO unit. I also like to do weekend trips and take my machine with me so I don't miss more than one day's treatment. Well, maybe we'll be lucky and NxStage really will get FDA clearance in six months, and Duh-Vita will offer it.

Adam

[Sunny]

My Insurance Blue Shield of California told me they cover 4 treatments per week on home hemodialysis machines. If I need any more than this, my nephrologist has to have it pre-authorized and deemed medically necessary. I haven't started treatment yet and am pre-dialysis. My questeion is: How do you go about getting the extended therapy approved for NxStage?What have you NxStage users done to get the approval you need so that you have coverage from your iinsurance company?

[Maggie and Jeff]

What have you found out since your post here in December? Are you doing the nocturnal and if so, with whom?

We have searched and called all of the clinics within 100 miles and some across the country basically the only way we can do NHHD is with a Fresenius and if we work with Davita (fight with them) they will let us keep the NX-stage since we travel about 20 weeks a year.

I have talked to many of the higher up's in Davita, Head of the Region, ect.  and no one knows when Davita will allow NHHD with the NX-stage but it will be after FDA approval some time after 12/31/2009. 

We could become part of the FDA study group except the closest study to us is 350mi one way and they would want to see Maggie quite often so we are trying to spread the word we want to be the first as soon as it is available.

To the best of my Knowledge and searching the only clinic one can go through to do NHHD with the NX-stage is part of the FDA trial groups.

I'll let ya'll know when we start NHHD.

My Insurance Blue Shield of California told me they cover 4 treatments per week on home hemodialysis machines. If I need any more than this, my nephrologist has to have it pre-authorized and deemed medically necessary. I haven't started treatment yet and am pre-dialysis. My questeion is: How do you go about getting the extended therapy approved for NxStage?What have you NxStage users done to get the approval you need so that you have coverage from your insurance company?

Hi Sunny

It is great you are learning this stuff before you need to know it. 

Here Is was I have learned, the day you have you first dialysis you will be ESRD and eligible for medicare.  You will need medicare because dialysis is expensive and your insurance most likely has a lifetime max of around 3 million. Davita billed about 60,000 per mouth to Maggie's insurance and they maxed out after about 18 months we were then forced to take medicare and Medicaid for the first month.  As for the # of treatments per week it was just some more paper work for the doctor to do.  We started with 6 days a week and are still doing it 6 days a week. 
As far as extended therapy for the NxStage the answer is the same as for NHHD with the NX-Stage. 
Good luck and God Bless

[Sunny]

Thanks. That helps to understand the process a little.
It sounds like it's a matter of getting my nephrologist to fill out appropriate paperwork showing I need more than just 4 treatments per week.

[Maggie and Jeff]

Thanks. That helps to understand the process a little.
It sounds like it's a matter of getting my nephrologist to fill out appropriate paperwork showing I need more than just 4 treatments per week.

Maggie's nephrologist filled out the appropriate paperwork without any hassle at all.
good luck let us know how it goes.

[sueq123]

It is interesting that you say that Nxstage won't do extended treatment. We have been doing Nxstage for almost 2 years through a Davita clinic.  We were the first home hemo clients for this clinic--you are right about making a pain in the *** to get what you want.  Anyway, two shipments ago, Nxstage sent me the 170 cartridge filters and the warming bags with 9 lines instead of our usual 6.  When I called to find out about the change, the customer service said they were for "nocturnal" treatment and Oops!  they would send the right ones.  I got to keep the 170's, and I was going to ask about trying extended
at our next visit with the doctor.  Hmmm

[Wallyz]

no- 171's are for nocturnal  170's don't have  a heparin line..  9-line warmers are just for people who use more than 30l/treament

[sueq123]

you are right-my keyboard mistyped.  They are Car 171's.

[Bill Peckham]

To the best of my Knowledge and searching the only clinic one can go through to do NHHD with the NX-stage is part of the FDA trial groups.

No there are a number of clinics offering extended overnight dialysis using NxStage - as Wallyz said - there is NKC in Seattle. I know the Rubin Center in NY does. I think the big home program in Lincoln Nebraska does. Well Bound does. The largest (or second largest) NxStage program in the country the one in Indianapolis does.

Hmmm what do all those providers have in common? cough cough nonprofit cough cough

[Maggie and Jeff]

Well, we moved to FMC a few years ago but still no Nocturnal on our NxStage system one.

[swramsay]

I know this thread has been going for a while. There was a comment about 'non-profits' offering nocturnal. Davita at Home in Federal Way, WA is where I have been doing home nocturnal for several years. I was told they gave the official approval for nocturnal home over a year ago.
Federal Way Davita has an excellent home dialysis program.

[Simon Dog]

no- 171's are for nocturnal  170's don't have  a heparin line..  9-line warmers are just for people who use more than 30l/treament

171's don't have a pressure pod and have longer bloodlines to give you more room to nocturnalize.

[Maggie and Jeff]

Car 172's have a heparin port and a pressure pod. 

[Simon Dog]

Car 172's have a heparin port and a pressure pod.

Long like like the 171 or short like the 170?

[Maggie and Jeff]

Car 172's have a heparin port and a pressure pod.

Long like like the 171 or short like the 170?

Short

[Maggie and Jeff]

I know this thread has been going for a while. There was a comment about 'non-profits' offering nocturnal. Davita at Home in Federal Way, WA is where I have been doing home nocturnal for several years. I was told they gave the official approval for nocturnal home over a year ago.
Federal Way Davita has an excellent home dialysis program.

I have called every center I could find in a 250 miles radius.  38478 Pulaski TN.  I am willing to drive.

If anyone Knows where I can find a clinic or support that my current clinic could use.  I ask every month.

[Maggie and Jeff]

http://www.stockhouse.com/news/press-releases/2014/12/22/nxstage-receives-fda-clearance-for-home-nocturnal-hemodialysis

NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis
NXTM | 7 hours ago
First-ever clearance of its kind in the US creates an important new option for patients and providers to perform home hemodialysis overnight while sleeping
LAWRENCE, Mass., Dec. 22, 2014 /PRNewswire/ -- NxStage Medical, Inc. (NASDAQ: NXTM), a leading manufacturer of innovative dialysis products, announced today that the U.S. Food and Drug Administration (FDA) has cleared its System One™ to perform hemodialysis overnight while the patient is at home sleeping, known as home nocturnal hemodialysis. NxStage's® System One is the first and only hemodialysis machine cleared by the FDA for this indication.

NxStage Medical, Inc.
Home nocturnal hemodialysis is an important patient option associated with a number of lifestyle and clinical advantages. By doing therapy while sleeping, the patient frees up their day to pursue other activities therefore reducing the overall burden of therapy.  A longer, overnight therapy also allows greatly expanded flexibility in dialysis dose and schedule, better enabling physicians to match the dialysis prescription to individual patient needs.

"For years, patients and physicians in the United States have been asking for an FDA-cleared home nocturnal hemodialysis option for the improved outcomes and quality of life the modality can deliver," stated Brigitte Schiller, M.D, Chief Medical Officer of Satellite Healthcare and Principal Investigator of NxStage's home nocturnal hemodialysis trial. "I, along with my fellow investigators in this trailblazing trial, am pleased that we were able to demonstrate the NxStage System One can safely and effectively deliver this important treatment option."

"We are delighted with this milestone achievement, which we believe will open home hemodialysis therapy to new segments of patients, and improve patient care for ESRD patients by expanding therapeutic options and flexibility," stated Jeffrey Burbank, Founder and Chief Executive Officer of NxStage. "This 'first of its kind' clearance is the culmination of significant product innovation, ongoing collaboration with the FDA, a rigorous clinical  trial and our experience in delivering over 10 million treatments with the System One around the world."

The Company is actively preparing for a full U.S. market launch in support of this expanded indication in 2015.  The System One also is CE-marked for home nocturnal hemodialysis.

About the NxStage System One
The NxStage System One is the first and only portable hemodialysis machine cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage Pureflow SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid. Unlike conventional hemodialysis systems, the System One requires no special infrastructure to operate. Under the guidance of their physician, patients can use the NxStage System One, with their trained partners, where, how and when it best meets their needs, including while they are sleeping - at home or on vacation and at a medically appropriate treatment frequency. The System One is also used to provide a range of flexible therapy options in more traditional care settings such as hospitals and dialysis centers. Its safety and efficacy have been demonstrated by experience with more than 10 million treatments with thousands of patients around the world. http://www.nxstage.com/.

About NxStage Medical
NxStage Medical, Inc. (Nasdaq: NXTM) is a medical device company, headquartered in Lawrence, Massachusetts, USA, that develops, manufactures and markets innovative products for the treatment of ESRD and acute kidney failure. For more information on NxStage and its products, please visit the Company's website at www.nxstage.com.

Forward-Looking Statements
This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this release that are not clearly historical in nature are forward-looking, and the words "anticipate," "believe," "expect," "estimate," "plan," and similar expressions are generally intended to identify forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those that are discussed in NxStage's filings with the Securities and Exchange Commission, including the Quarterly Report on Form 10-Q for the quarter ended September 30, 2014. NxStage is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Kristen K. Sheppard, Esq. 
VP, Investor Relations 
ksheppard@nxstage.com

Logo- http://photos.prnewswire.com/prnh/20110503/MM94799LOGO

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nxstage-receives-fda-clearance-for-home-nocturnal-hemodialysis-300012964.html

SOURCE NxStage Medical, Inc.


PR Newswire
December 22, 2014 - 7:07 AM EST

[Maggie and Jeff]

 

Final started nocturnal with the nxstage. 7 years after the original post

Starting with buying a dinamap to take bp like the hospitals do.

Then we bought a medfusion 2010 to pump the heparin.

We modified a enuresis alarm for blood leaks at the access.  (around the needles)

We started doing it without a heparin line and told the DR. about the clotting we got.

And what cartridges we needed to fix the clotting.

We got car 172-c

this is our 2nd night.

Next step 7 days per week

[PrimeTimer]

That is wonderful news! Good luck! Please keep us posted on your progress and the pros/cons you encounter and if not too personal, how you actually feel doing nocturnal. God Bless! 

A brave hero shared this with me today, thought I'd share it...

"But they that wait upon the Lord shall renew their strength; they shall mount up with wings as eagles; they shall run, and not grow weary; and they shall walk and not faint." Isaiah 40:31

[Maggie and Jeff]

Thank you for the quote.


Con
Maggie says the needle (button hole) sites and skin the tape was on hurt a bit more.

It has taken time to get the various alarms set right.

Cost about $700 and had to research and apply what I learned while standing ground with the reluctant doc.

There is a learning curve ( I'd be happy to help anyone any way I can I'm not a doc.)

Here in the beginning I find it hard to sleep as we work the last few bugs out.  Well, the bugs are mostly gone.

Pro
Full day but took a nap.

Can remove 2+ liters of fluid per night

Doc acted like it was his idea

So far she feels fine but has had some water on as we have not established her new dry weight.  Maggie's bp is regulated by her fluid so much so that I'm sure 3/per week would put her under the ground.

8 hours per night is better for Maggie than the short daily was.

We have our days back as soon as I learn to sleep.







Maggie hopes to move from her chair to the bed soon I'm praying  about that.



Here is another good word form our author.

 And we know that in all things God works for the good of those who love him, who have been called according to his purpose.




On a personal note:

I make wine Maggie likes to drink the wine and so do I.

Fact is Maggie's Potassium runs low so we may be switching to a 3k bath from the 2k she is on now.  Most folks are on 1k potassium.

She takes a protein pill (ok 6 of them) to keep her albumin up.  And I don't think she eats much.

[iolaire]

Final started nocturnal with the nxstage. 7 years after the original post

Darn, that took some time.  What made it finally happen, was it the FDA approval?