Dialysis from the sharp end of the needle

Finish line crossed

By Bill Peckham

I made it to the health insurance finish line, but not until the finish line had moved. After consulting with the Carpenter's Trust of Western Washington I came to understand that there is a whole new system for qualifying for healthcare benefits, which will be an advantage going forward, and now getting initial access is the odd number of 358.05 hours in a three month period ... basically 360; maybe it's just as well I didn't know what I needed at the beginning but as of today I have 364+ hours worked Jan - Mar.

54 hours, about a seventh of that total, was overtime of one kind or another, either hours over eight in a day/forty in a week or working a weekend (a lot were all three: long weekend shifts after a long week). It's the nature of the job that the work load ebbs and flows, so you have to be able to clock the hours when they are there to be worked. One thing is for sure, there is no way I would have been able to get across the health insurance finish line if I had been doing any other type of hemodialysis.

It is only by dialyzing at home, more frequently, while I slept, that I was able to cover all my shifts and earn insurance to supplement my Medicare coverage.

Now it is on to step two, Travel. DSEN will follow my planning for a trip to Argentina. During the trip I will dialyze incenter, in Buenos Aires and near Iguazu Falls (after which I will have dialyzed on six of the seven continents - watch out Antarctica). My Mom is going to go too! We're aiming to go in the second half of August, towards the end of their rainy season, hoping to catch the falls in maximum flow and during what is normally a particularly slow period at work.

The five month countdown begins ... Now.

Live blogging the 2011 Home Hemodialysis Symposium - morning session

By Bill Peckham

We're due to get started in about 10 minutes. You can see the program here, I'll try to blog the full day.

Session 1: Home Hemodialysis: Update Leonor Ponferrada, BSN, RN, Presiding 
8:00 - 9:30am

• 8:00
  Introduction - Christopher Blagg, MD, Leonor Ponferrada, BSN, RN:  
  Run down of details of attendance. Blagg: HHD US census is starting up from a very low level, PD use is declining. HHD interest increasing in many countries, e.g. India, Turkey, South Korea
• 8:15
  NIH Study Update: Short Daily and Long Nightly HD, Christopher Chan, MD
  Speaking about the Frequent Hemodialysis Network Daily and Nocturnal Clinical Trials (FHN). Reviews observational trials that show improved results with higher doses of dialysis. 245 patients randomized to daily incenter dialysis and 87 pt randomized to the nocturnal group. Reviews the statistical means used and average outcomes.
  
  For 6x/week short dialysis: Measured outcomes in survival were not powered (not enough people enrolled) but it did show some advantage. The outcome of change in left ventricular mass showed more pronounced improvement for those doing 6x/week. SF-36 scores also showed a statistically significant improvement. Downside: higher rate of first time vascular access interventions among people doing 6x/week.
  
  Nocturnal outcomes suffer from being under powered. There was a significant reduction in phosphorus and blood pressure.  Analysis is continuing. There was a trend to more access interventions and improved survival.
• 8:35
  Benefits of Daily Home HD:  Freedom Study Update, Brigitte Schiller, MD
  These are very exciting times for short daily hemodialysis (SDHD). The primary hypotheses of the Freedom study is lower annual hospitalizations and non treatment related healthcare expenses among those who dialyze >6x/week. Target stdKt/V = 2 -2.2
  
  There are many of the same study limitations noted with the FHN, 150 patients have completed 1 year of treatments. The Freedom Study showed that there is a reduction of depressive symptoms that is sustained for > one year. SDHD reduces recovery time from, on average, 7 hours to 1 hour. SDHD improves sleep issues. SDHD improves Restless Legs Syndrome. SDHD reduces the need for hypertension meds. Presents new data showing improvements in SF36 measures; SDHD improves SF36 results.
• 8:55        
  Patient Technique Survival - Robert Lockridge, MD
  The Home Training Nurse is the critical determinate of technique survival, but patient perceptions of the burden effects their willingness to continue at home. For PD after one year 65% are still using PD. For NxStage there is not much written but one study showed 60% are still using NxStage after one year. Lockridge shows data from his nocturnal program as well as Canadian nocturnal results with over 90% still on nocturnal after one year and the "stickiness" continues in future years.
  
  Presenting six case studies, talking about the importance of informed consent, one component is the danger of the three day gap that comes with 3x/week incenter, another is the overall mortality risk among people using incenter conventional dialysis, another is the waiting time for a transplant and the risk inherent in waiting for a TX while using incenter dialysis. Speaks to the question can people aged 80+ do HHD? Mortality outcome may not vary but quality of life often improves.

Question time. Dr. Lockridge mentions that his program does require home nocturnal to be accompanied and that this is a change due to University of Virginia policy. I ask if this policy was the result of an event, the answer is no. I find this shocking. After over an hour extolling the benefits of more frequent home nocturnal dialysis - a significant mortality advantage - how can you simply exclude a large segment of the population ie single people living alone, from the benefits of nocturnal dialysis at home. It would have to hugely more dangerous to justify a prohibition yet there are no few examples of the danger of solo HHD.

Session 2: Home Hemodialysis Experience Worldwide John Agar, MD, Presiding 
9:45 - 11:10am

• 9:45 
  Australian Experience - John Agar, MD
  A program exists in the context of the nation's demographics - aging population, fewer workers per retirees and increasing incidence of CKD - are some of the factors that must be acknowledged to understand the proviision of dialysis and the choices that must be made. The federal government and state health departments fund all expenses related to CKD with a 600/year beneficiary contribution. The economic benefit of having people on home dialysis is recognized by the state which has resulted in three different incentives based on patients being at home - particularly for those on HHD. One of the incentives reimburses patients for expenses related to dialyzing at home - mostly utilities.
  
  Use of HHD varies geographically in Australia - some units have over half of their patients at home while other units have far fewer. About 60% remain on HHD after five years (transplant excluded), Data show HHD is significantly cheaper, the Australian system captures hospitalization savings.
• 10:00
  New Zealand Experience - Kelvin Lynn, MBChB
  New Zealand is the largest Polynesian Island (hadn't ever heard it put that way). HD is the preferred modality on the South Island, Dr Lynn is from Christchurch on the South Island. All hospital and specialist care is free, emphasis is on community based care. HHD program started in NZ in 1969, in 2000 29% of hemodialysis patients were using HHD. NZ has the largest percentage of patients at home, 52% are at home on either PD or HD.
  
  It can take up to a year to train people to go home, on average 5 weeks. HHD costs much less when total costs are computed, lower costs to provide the treatments and lower yearly hospitalization costs. Success rates due to a number of factors, (most important factor presented, in my view, is that incenter staff must believe HHD is a superior modality).
• 10:15
  UK Experience - Nick Hoenich, PhD
  HHD was pioneered in the UK (meh), but has declined to about 2% today. Pointing to increase in the median age of patients who use dialysis to explain the decline in HHD use. PD users comprise the vast majority of HD patients - about 29% of patients start at home. Presents a number of socio demographic. technical and other reasons for the decline in HHD use.
  
  Current, updated dialysis guidelines promote HHD use, there are a number of initiatives and some increase in use but numbers remain low. Barriers remain and may increase due to changing government policies.
• 10:30
  Canadian Experience - Andreas Pierratos, MD
  Healthcare is provided by the Provinces in Canada, mostly single payer but is a hybrid in regard to medications. About 22,000 people using dialysis, over 5,000 started dialysis last year, the prevalence is lower than the US. PD is the primary HD modality. There is variability among the provinces and there is variability among units in a given province - units specialize with a focus on PD or HHD, not both.
  
  New initiatives continue to be launched to increase the use of HHD. There is a home first initiative but use varies by province. Nocturnal HHD is the preferred therapy.
• 10:45
  US Experience - Robert Lockridge, MD
  HHD was the primary modality for years but HHD declined to nearly to less than 1%; SDHD was used in the US by one or two providers throughout the 20th century but it wasn't until this century that SDHD became a widely available.
  
  Reviews the various home machines that have come and gone (Aksys (sigh)) in the last 10 years. New machines are on the way. Shows results of his own survey that covered about 77% of those using dialysis in the US. See the attached blurry picture for results. I was surprised to see that nearly 2,800 (of a sample of about 77% of all dialyzors) are doing incenter nocturnal.

Session 3:  The Home Hemodialysis Patient Christopher Blagg, MD, Presiding 
11:30am - 12:15pm

• 11:30     
  Who Are the Candidates and What Do We Tell Them? Lisa Koester, MSN, RN
  Over the last 10 years there has been a change from choosing the patients via a comprehensive screening process ie ten years ago they were saying no for many patients. They required medically stable patients, capable of home modifications - underscoring the requirement that patients need to compliant.
  
  Today there is an understanding that compliance is not the primary criteria. Gives an example of a long term dialyzor who is ornery incenter but thrives after giving control back and going home. Over the last ten years her thinking has changed to see that all patients can be successful at home. "If you educate, they will come" you have to tell people: patients, physicians and staff need to know that HHD is a superior modality. It is the right thing to do and it is required by the Conditions for Coverage.
  
  "Incenterize" meaning the learned dependence inherent in incenter dialysis is a primary barrier. Other barriers are the needles and fear of being alone at home. After 10 years the lesson is that you should let patients choose you - ie patients who want to go home should be facilitated without regard to superficial markers such as age, economic status or size. Two questions are all that is needed: Why do you want to do this? Who is your family support?
• 11:50    
  The Patient’s Decision to Go Home: Overcoming the Barriers - Peter Laird, MD (www.hemodoc.com)
  Wide range of HHD use across the globe. Doctor knowledge of HHD is critical to patient uptake of HHD. Peter thought it was crazy to use HHD when he first heard about it predialysis. Reviews some of the fears associated with going home - shows picture I use for my avatar on IHD, its meant to remind people that it isn't enough to catch the frisbee you have to think about what comes next. Peter misidentified a picture of me rafting the Wenatchee River as me rafting the Rogue. The Wenatchee has bigger water but his point about NxStage facilitating life stands.
  
  Peter is getting a lot of laughs but he is also driving home hard points particularly about infection control. Reviewing data that he found convincing when he selected dialyzing more frequently at home. Reviews transplant results vs more frequent dialysis. There is not one right modality for all dialyzors, the length and frequency should be matched to the person's needs and what their family situation allows.

Break for lunch - I didn't run out of the room at the end of Peter's talk and as result missed out on the provided lunches. grrr. I'm off to find food hopefully I can make it back for the afternoon program.

Wall Street Journal spotlights home dialysis options

By Bill Peckham

Wall Street Journal Health Journal columnist Melinda Beck has an upbeat article available online, A Dialysis Treatment For The Busy Patient. The article reports on home dialysis, peritoneal dialysis (PD) and home hemodialysis (HHD), and gives a fair assessment of the current situation.  I'm quoted, along with friends of DSEN MEI's Dori Schatell and Northwest Kidney Centers' CEO Joyce Jackson, and several other dialyzors and MDs. 

It's a pretty complicated topic to cover within the confines of a news story, even harder covering both PD and HHD in the same article. While both are home modalities, they really are very different. The modalities are different with regard to the new bundle and they have different clinical advantages. Though I was glad to see mention of one clinical advantage they share:

experts worry that getting dialysis at a center makes patients more complacent about their treatment, and less careful with their health.

This is the learned dependence that is the bane of incenter dialysis.

Also confusing is that some of the details in the article don't apply to both modalities - for instance the need for a helper - and some of the info is not true for the featured devices. The NxStage System One and all PD cyclers can run on a normal 110 circuit. It's only the standard hemodialysis machines (the type used incenter) that need dedicated power.

From a financial point of view (it is the WSJ) the world does get complicated when it comes to the financial incentives and it would have been hard to adequately cover them in the space available (it's hard to explain in the nearly unlimited space of this blog). One complication is that the new PPS promotes both types of home dialysis but in different ways. The medically justified additional payments aren't available for those doing PD, and it is unlikely (though it does happen) for a person to start HHD in the first 120 day of starting dialysis.

Still considering the interest level of a typical WSJ reader and the space constraints, it's a great article.

Glenn Chertow, MD to give ADC 2011 Keynote Address

By Peter Laird, MD

The Annual Dialysis Conference is the best place to watch and learn about optimal dialysis trends not only in America but from around the globe. The tone of the conference is often highlighted in the key note address by one of many leading researchers and dialysis advocates. Past key note addresses in prior conferences still resonate in the lecture halls as data and information is not only presented but at times debated with great passion. Carl Kjellstrand spoke with great conviction two years ago in his keynote address against randomized controlled dialysis trials (RCT) and how they were not needed nor ethical in dialysis patients with over 40 years of solid evidence from observational studies showing great benefit of longer and more frequent dialysis schedules.

The legacy of Dr. Belding Scribner's dedication to bringing about optimal dialysis in America is often the subtext of the keynote address. Perhaps no where else is optimal dialysis championed as eloquently than at the Annual Dialysis Conference put on by the University of Missouri for over 30 years. I recently reviewed the upcoming program for the ADC meeting in February 2011 in Phoenix and found that the keynote address will come from Dr. Glenn Chertow. Dr. Chertow is a renowned nephrologist now at Stanford University and researcher involved in many of the dominant studies of the last two decades.

The HEMO study is a randomized, controlled trial that showed no benefit to high flux, high intensity hemodialysis maximizing Kt/V in conventional hemodialysis regimens. The result of this study and it's negative outcome led to questioning of the entire optimal dialysis strategy that was just gaining ground at that time with the the results of the Toronto group's nocturnal dialysis program. Dr. Chertow vocally championed the cause of further randomized and controlled trials to prove all aspects of optimal dialysis before adopting more frequent and longer duration sessions in America. In fact, DSEN has written several posts (here, here and here) in opposition to his dependence on randomized and controlled trials before going forward with the same type of programs that are already used with great success in Japan, Europe, Australia and New Zealand.

Dr. Chertow's upcoming keynote address is based on another study published in Kidney International earlier this year titled: Shorter dialysis times are associated with higher mortality among incident hemodialysis patients. The interesting aspect of this study is not only the astounding conclusion that shortened dialysis times less than 4 hours/session resulted in over 42% increased mortality, but that the conclusions were obtained not from a RCT, but from an observational trial. The simple fact that the Keynote address is by Dr. Chertow using an observational trial and not waiting for confirmation from a RCT is in my opinion big news for the dialysis industry.

Are the winds of time changing in the American dialysis community? Is this also prognostication of the results of the soon to be released Frequent Hemodialysis Network studies on short daily hemodialysis as well as daily nocturnal dialysis in which Dr. Chertow is a principle investigator? Perhaps my optimism for implementing optimal dialysis is overwhelming me with hope, or perhaps we are about to experience the paradigm shift that Mel Hodge wrote about so eloquently earlier this year. The path to a paradigm shift in hemodialysis:

About 1 out of 4 American conventional dialysis patients die in the first year and 3 out of 5 die within 5 years with no favorable trend in sight. Largely ignored in practice is the evidence accumulated over decades that longer, more frequent dialysis can immediately slash this grim result in half or more. Pierratos has called for a paradigm shift—a disruptive change—in dialysis practice from conventional treatment to daily nocturnal dialysis, performed at home, to realize this dramatic improvement. We examine here how such a paradigm shift might be brought about and suggest that changes in 3 perspectives must occur. First, new dialysis guidelines must be recast from the old goal of minimally adequate to a new goal of best possible. Second, the body of dialysis research must be interpreted through the lens of best possible patient survival and well being, and the near-impossibility of demonstrating dialysis survival advantage through randomized clinical trials must be acknowledged. Finally, dialysis modality must be seen as, most importantly, a survival and well-being choice, not merely a “Lifestyle” choice; hence, it must be the nondelegatable responsibility of the physician, not dialysis center personnel, to advise and prescribe. Many old perspectives, which might stand in the way of this sorely needed paradigm shift are also examined. These old perspectives make up a fabric of excuses that has delayed—and, if not discarded, will continue to delay—progress toward a survival and well-being outlook for dialysis patients just as favorable as might be achieved through kidney transplant.

Whatever the outcome of Dr. Chertow's keynote address, I believe that a true paradigm shift is in the making. The standard of dialysis care can no longer be that of minimum standards but instead that of maximizing patient survival and rehabilitation which are precisely the goals of therapy long advocated by Dr. Scribner. It is time to come full circle and realize that the pioneers of dialysis did it right by focusing on patient rehabilitation as the objective measure of dialysis adequacy instead of reliance on the laboratory based Kt/V. Dr. Chertow's keynote address on length of dialysis sessions is a welcome addition to the Annual Dialysis Conference not only for the data and evidence that he shall present, but more importantly because of the underlying message that he will send loud and clear in presenting evidence from an observational study as the basis of the 2011 ADC keynote address.

Vindication for the Hemodialysis Product

By Peter Laird, MD

RenalWeb's Gary Peterson posted a recent article that in many ways is a vindication of the HemoDialysis Product proposed several years ago by Dr. Scribner and Dr. Oreopoulos in an article titled: The Hemodialysis Product (HDP) A better index of dialysis Adequacy than Kt/V.  

The underlying premise for the HDP is Babb's Middle Molecule theory of dialysis which is not accounted for by the Kt/V concept of adequacy.  Scribner and Oreopoulos argued that the Kt/V measurement is inadequate in that it only deals with the fast diffusing urea, arguably a nontoxic molecule, and it fails to take into account time dependent molecules such as B-2 microglobulin and phosphorus which acts like a middle molecule.  

Removal of these time dependent middle molecules depends on the duration of exposure to the dialysis membrane. Removal is independent of blood flow rates, ultrafiltration rates and even, to an extent, the clearance rates of the artificial kidney. Time is the key variable and this is what allows for the elegant simplicity of the HDP.

HDP = (hours of dialysis per session) x (sessions per week)²

However, despite the theoretically application of the Hemodialysis product as a measure in support of the Middle Molecule time and frequency dependent theory, it never caught on in the dialysis community and in fact was widely rejected for the widely used Kt/V adequacy measurement. However, a recent article in Hemodialysis International by Kjellstrand, et, al brings the Hemodialysis Product back to the forefront of dialysis measurements:

Survival with short-daily hemodialysis:  Association of time, site, and dose of dialysis

Short-daily hemodialysis can be too short. In this series of patients, every extra hour spent on dialysis was associated with better survival. This finding is in agreement with those of others analyzing thrice-weekly dialysis and interestingly is seen in patients treated by long night hemodialysis, where the weekly dialysis hours are 2 to 4 times long than in our patients on SDHD.

The dose of dialysis as expressed by Kt/V was not associated with survival. This finding is in agreement with similar results reported in patients on long-nightly dialysis.  I has to be tempered with the fact that theses daily hemodialysis patients, except for 2, had weekly stdKt/V of 2 or higher and almost one-third had a Kt/V of 3, much above that recommend Kt/V of 2, to for "adequate dialysis" in the United States. Particularly in the United States, Kt/V, while reasonable to compare dialyzer efficiency, has taken too much precedence over the fact that a very important role of the kidneys is to maintain homeostasis. . .

We have over forty years of experience with SDHD with all of the studies revealing more frequent and longer weekly duration of dialysis reduces morbidity and mortality as well as promoting patient rehabilitation.  The goal of the pioneers of dialysis was quite simple, to render a fatal disease treatable at last and to return the patient back to a productive life.  The greed based, American style, short, rapid and violent hemodialysis sessions as practiced in the majority of incenter dialysis units is the cause of our excessive mortality in the last three decades as compared to Japanese, European and Australian/New Zealand providers that offer longer duration dialysis as the common standard.

It is time to put Kt/V into its proper perspective and adopt instead the Scribner/Oreopoulos Hemodialysis Product as our basic objective measure in combination with the most important measure of all, rehabilitation of the dialysis patient.  Time and time again, the practices of the dialysis pioneers with longer sessions in the comfort of the patients home is the only manner in which America shall once again mitigate the shame of our excessive mortality rate among dialysis patients. Indeed, it is not only the excessive mortality rate that cries out to us from studies such as this, but the loss of quality of life that could easily be restored within the framework of "cost effectiveness" in the savings from preventing the prevalent complications of dialysis.  The spirit of Dr. Scribner sounds out loud and true to do that which is right and just for our patients.

Under the bundle why can't home dialyzors self administer iron and Vitamin D?

By Bill Peckham

Before MIPPA was passed, when bundling was talked about as a concept, one of the benefits of an expanded bundle was imagined to be that people using home hemodialysis (HHD) would be able to self administer neccessary injectable drugs, besides EPO:

One point always offered in defense of expanding the bundle is that it will increase the dialysis provider's flexibility in providing care ... I currently have to go incenter to receive iron and I cannot receive IV activated vitamin D at home only due to reimbursement rules. Under a bundle I assume that I would be able to avoid the trip incenter to get iron. Whether I would receive IV Active Vitamin D (calcitrol - Rocaltrol (Roche), Zemplar (Abbott)) or continue to receive Active Vitamin D in pill form 

would now be up to my physician. Post bundle, reimbursement would be neutral as to the form of my activated vitamin D. Or so I thought.

On page 150-151 of CMS-1418-F 151 the ESRD PPS (900+ page PDF) there is this comment and response (my emphasis):

Comment: Some commenters suggested that CMS allow for self-administration of injectable ESRD-related drugs at home by home dialysis patients. The commenters indicated that home dialysis patients would prefer to self-administer all injectable ESRD-related drugs at home to include EPO, rather than traveling to the dialysis facility to receive the injectable drugs. The commenters reasoned that since injectable drugs such as EPO, Vitamin D, and IV iron are included in the ESRD PPS bundle, patients should have the option to self-administer these drugs at home. 

Response: Under section 1861(s)(2)(O) of the Act, selfadministration of erythropoietin (EPO)is permitted for dialysis patients who are competent to use such drug without medical or other supervision with regard to the administration of such drug. If a dialysis patient meets this requirement, then he or she can self-administer erythropoietin at home. Payment for erythropoietin and supplies needed to self-administer the drug would be included in the ESRD PPS payment. The ESRD PPS does not fundamentally alter how other injectable drugs are administered under Part B. Thus, under CMS-1418-F 151 the ESRD PPS, home dialysis patients would continue to go to the dialysis facility for the administration of other injectable drugs.

Really?

I've always assumed that the rule limiting HHD reimbursement, and thereby access, to injectable Vitamin D and iron was an inadvertent quirk of the payment system. I've always assumed it was just something that came with doing home dialysis in an incenter dialysis world. This response suggests otherwise. This response suggests that CMS was purposeful in excluding those using HHD under the previous reimbursement rules and plans to continue the practice.

I can't think of a reason for CMS to take this position. I would think that under the expanded bundle this practice of medicine - which drug, in what form, where it is administered, by whom - should be left up to the provider working with nephrologists. It may be that providers and docs will decide that iron should be administered during clinic visits or that an oral version of vitamin D is best, but why is CMS taking a position?

Live blogging the Comprehensive Course in Hemodialysis - morning session

By Bill Peckham

The program is just starting:

Session I
Christopher Blagg, MD and Leonor Ponferrada, BSN, RN, Presiding
8:00 - 9:50am

8:00 Leonor Ponferrada, BSN, RN is giving an overview of the program. It is meant to present information from successful programs

8:10 Introduction - Home Hemodialysis Today: Update Christopher Blagg, MD

Decline in PD is still occurring but has slowed. Home hemo is growing but from a very lo base, we're above 1% for the first time since 1998 (in '98 it was a percent of a smaller number). The greatest increase has been from short daily (basically the growth of NxStage), nocturnal has declined slightly. Washington and Indiana have the greatest percent on home hemo.

According to MedPAC 22% of all units offer home hemo (or say they offer) which would mean that about 4 patients per program. The suspicion is that some are  home programs in a name only. Legislative changes are coming - bundling, changes in Conditions for Coverage.

Davita has about 1.6% on HHD. FMC is also committing to HHD. Internationally PD dominates Australia has about 10% on HHD NZ about 16%. Interest in HHD is growing in Asia: China, Hong Kong, etc.

8:20 Rick Berkowitz Why I Chose Home HD

Rich is relating his experience transitioning to HD. Needed to start HD with a catheter incenter, was stuck there for three years. Found the incenter renal diet a burden while waiting for the unit to start their HHD program. Presents the symptoms of conventional incenter HD, including a heart attack on the way home from a conventional treatment.

Tried nocturnal incenter, found it too hard to sleep. Did not like the comfort of the unit or the staff. A change in insurance forced a change in provider. Nephrologist suggested to self advocate did so by writing everyone involved. Was finally granted chance to go home using the NxStage.

HHD and now doing extended overnight HHD has been a sea change - allowing him to have a normal day. The term ESRD starts people off on the wrong foot - first impressions matter. sommerville would object to his transplant take; need optimal for people who won't get a transplant.

Asks why there is a disconnect - the Patient, Provider, Physician or Payer. Surprise - it's all four. The demand for RCTs are a problem too.

8:45 Jim Manning Home Hemodialysis, My steps taken to become a Home Hemo Patient

Jim relates his transition to CKD5. Has cat named Peaches - his third love behind his wife at number one and his Doctor Bonnie Collins, second. His sister's passing focused his mind on his own health. Has a long family history of insulin dependent diabetes, he believes by listening to his docs he'll be able to outlive the experience of his siblings.

Was able to explore treatment possibilities through the Northwest Kidney Centers. Narrowed his choices down to B Braun or Aksys PHD - he chose the PHD. Had his first treatment six years ago, this month, incenter. Hard to see the illness of the other patients coming incenter. Gets a good laugh by saying that the renal nurses remind him of first Sergeants in the military - you want to control everything.

When Aksys went out of business he went on NxStage first with PureFlow, now with bags, wants PureFlow back.

9:00 Robert Lockridge, MD, Selling the Therapy: Informed Consent 

It's our job to offer this modality (HHD) - What does informed consent mean? Provides a case study of a man who shows up at the ER needing dialysis. What do you tell him? Runs through the AMA definition of Informed Consent. It's a legal and ethical responsibility.

A 1.1 Kt/V is equivalent to a 8 GFR, a 1.5 Kt/V equates to 10% GFR. Follows up with a graph showing the minimal movement of standard mortality despite achieving the clinical performance measures that have been established. Phosphorus needs time for removal, conventional dialysis can't do the job.

There are not RCTs but there are studies that can help to provide informed consent. Good data showing home dialysis provides an advantage, aside from higher frequencies. New data shows frequency improves mortality even better.

To the question of selection bias in the data the comparison should be to people looking for a cadaveric transplant an even more selected group. HHD measures up well, cites three studies showing HHD survival rivals cadaveric transplant.

Given this information what should you tell people? What do you tell the case presented at the start? Home. Home is the most appropriate venue for many people even as they wait for the call for transplant.

9:20 Brent Miller, MD, Why More is Better: Benefits -

Explains what Lockridge was saying - he was giving the finger to people who question the meaning of informed consent in the context of enrolling people in the Nocturnal Study. Heh

Wants to get beyond the data to look the benefits of more frequent dialysis. Surrogate markers may not have clinical significance. What is the role of costs? Consider the hidden costs. Rapid changes may be a significant reason for poor conventional dialysis outcomes. Cites the Freedom Study - very good outcomes. Other studies show reduction in a range of symptoms - including sleep apnea. Mortality risk of not dialyzing over the conventional dialysis weekend is about 3 (three times more likely to have sudden death), more frequent dialysis allows you to avoid the deadly weekend.

Study shows that when people are doing their own dialysis at home there are half the adverse events as they would have incenter. Study had people using the NxStage incenter with treatment run by staff, compared to 8 weeks at home with patient/care partner  running treatment. Half the adverse events at home.

Session II
Lisa Koester, MSN, RN, John Moran, MB, Presiding
10:05am - 12:00pm

10:10 Leslie Wong, MD Bridges to Home Hemodialysis: PD 

Shows data showing that when informed about options 50% will choose home, the majority will choose PD. No needles, easier, less intimidating. Data s showing that HHD draws from what would otherwise be incenter conventional HD. No data showing a strong HHD program cannibalizes a strong PD program - see NKC experience.

PD doesn't last forever, after four years data shows a big drop off. Reviews data showing where PD patients transition once they need to stop using PD. Only 1% make the transition to HHD within the first two years, transplant rates are high, of those going to HD the vast majority go incenter.

"Dialysis is an adjustable rate mortgage" you start off with a low interest rate but over time the price increases - may lead to foreclosure without a lot of work. For PD patients that face the foreclosure on their choice of modality they aren't ready to get back on the home market - most go incenter.

CKD education has to continue once someone starts PD to prepare them for the next renal replacement transition. Placement of a fistula in PD patients is marker for good CKD education. PD patients should be prepared to transition to HHD.

10:28 Debbie Brouwer, RN Self-Cannulation Practices

Incenter mostly staff cannulate, should be patient self cannulation. Patients can become the most expert cannulators of their own arm - it's all about the biofeedback. The staff push back is that it is just easier to have staff do it rather than take the time to teach. Need to start early with vessel preservation - as soon as you are identified with CKD you have to start protecting your arm vessels.

Staff misinformation is a barrier to patient use of self cannulation - "You don't need a self care certification to offer patients the option to self cannulate" it's in the conditions for coverage that patients have the right to put in their own needles. There are resources - see Home Dialysis Central for self cannulation and buttonhole information.

10:40 Susan Bray, MD, In-Center Self-Care

Offering self care is an important way to offer patients back control. Selfcare centers have to be separate from full care stations. One barrier identified as patient laziness (?, I'd say leaned dependence not laziness) it can take time but there are incremental steps. Staff and physicians need to understand the importance of self-care.

Observational data to suggest clinical benefits. Similar benefits to returning home or transplant. Successful self-care has been seen among diverse and challenging patients.

Questions: should be "care partner" vs "care giver", should fistulas be placed at the same time as PD catheters (Wong: maybe but not sure it should be a given); why the big PD drop off at 3-4 years (Wong: not clear, experience abroad is better); testimony from dialyzor who started hemo in 1966  "everything the speakers said is true); is age a barrier to HHD? (Moran I don't think so, anyone benefits from HD); testimony on the power of self care/self cannulaton

11:00 John Agar, MBBS, Designing Optimal Dialysis: Use of Kt/V and if not, What Should Replace It?

45 to 50% at home in Agar's program, 30% using HHD. What should be used instead of Kt/V? Everything else. The problems started with the NCDS study which informed the Gotch approach. THe fluid compartments of the body complicate the removal of any molecule including urea. Bottom line using Kt/V is crap naive.

The V in Kt/V is the total body water and the approach would only work if all the fluid were in a single compartment. Another definition of Kt/V (K=Killer; Treatment in fiVe years). Kt/V was useful in establishing the minimum, the bare floor of dialysis dose.

Reviews data he presented in a two part article on Home Dialysis Central (part 1; part 2)  Fluid and solute removal: how and why. I wrote three posts inspired by the articles: Dr. Agar on fluid and solute removal; More on fluid and solute removal; Optimal dialysis - beyond Kt/V; I think Dr. Agar's papers offer a great insight into a key concept. Fun to hear him present the data live.

Offers a Dialysis Key Performance Measure: 20 questions worth 1 point (example e.g. how do you feel, are you using a fistula, Hgb in range, Ca x PO in range) I scored a 20, Yes!

11:20 Bessie Young, MD, Clinical and Practical Challenges

Provides the NKC HHD experience. 63 at home (two in training) out of about 1,300 on HD. This is my experience so is very familiar. They encourage home dialysis, allow extended overnight treatments with the NxStage, allow people to dialyze alone. Provides a clear eyed view of program expectations so that patients understand what the trade offs are - it's worst to over sell then to not sell at all.

Dry weight evaluation is a challenge at home but can be accommodated during monthly clinic visits. The NKC commitment is to keep people at home but problems need to be addressed, the key is keeping communication open.

Lunch

UK Prime Minister Brown endorses wider use of home hemodialysis; NxStage is ready to help

By Bill Peckham

RenalWEB links to some exciting dialysis news out of the UK. Gordon Brown, Prime Minister of the United Kingdom and Leader of the Labour Party will promise a "personalised" revolution in health and social care in an upcoming speech. Aside from the possibility Brown won't win the election to retain his Prime Ministership this suggests that home hemodialysis (HHD) will become more widely available in the UK.

I was recently discussing what I thought it would take to get more people on HHD in England and I went through the usual suspects: the need to explain the benefits of HHD to dialyzors and their docs, over coming dialyzor needle fears and nephrologist's inertia, but I failed to mention that it would be very helpful if the Prime Minister identified HHD as a national priority:

Addressing an audience at health think-tank The King's Fund, Mr Brown will pledge a broad reform of community healthcare, giving people the option of chemotherapy and dialysis without having to travel to a clinic or hospital.

It would also be easier to access palliative care and care for the elderly at home.

Committing to ensure that within the next five years 1.6 million cancer sufferers have access to one-to-one nursing care in their homes, Mr Brown is to say: "When faced with the fears and uncertainties of a serious illness, dedicated nursing, such as that provided by Macmillan nurses, has the potential to transform the experience of care for the patient and their family too.

"Not just improving the outcomes of care, but helping them to understand their choices and options.

The timing of this is ideal.

NxStage has recently announced a partnership to provide the System One to dialyzors in the UK. Their goal is to increase the number of NHS dialysis patients on HHD to over 10%, from currently 2%. Before this announcement I was thinking it would take a lot of leg work to reach the 10% threshold, but now it sounds like the challenge will be keeping up with demand. That's a good problem for NxStage to have.

Is Evidence Based Medicine the Main Barrier to Optimal Dialysis in America?

By Peter Laird, MD

Since the advent of hemodialysis availability in the 1960’s, practitioners have searched for the most optimal way to utilize this life saving technology.  Historical reviews of the pioneering days of hemodialysis reveals experimentation on how frequent and how long we should administer dialysis to patients in need of renal replacement therapy to optimize outcomes.  Surprisingly, the modalities that we now refer to as new and novel were actually described and utilized very early in the course of dialysis experimentation.  Dr. Shaldon was the first nephrologist to prescribe home, nocturnal hemodialysis in 1964 both in London and in Germany followed shortly by Dr. Scribner in Seattle. Dr. Bernard Charra continued overnight hemodialysis in Tassin, France in the 70’s and 80’s with excellent results that were largely overlooked for decades.

The modern era of home, nocturnal hemodialysis reemerged in 1993 in Toronto, Canada by Drs Robert Uldall and Andreas Pierratos. The published observational data from multiple centers utilizing home, nocturnal hemodialysis 3-7 times/week reveals improved anemia control, normalized blood pressure, normalized mineral bone metabolism, normalized functionality and reduced mortality and morbidity compared to conventional incenter dialysis. A recent study with twelve years of follow up showed equal survival with daily, nocturnal hemodialysis as compared to cadaveric transplant. Despite an abundance of observational data and practical experience from Canada, Australia, New Zealand and other nations that have adopted the concept of optimal hemodialysis modalities, America continues to view optimal dialysis modalities with skepticism.

Today, America stands alone as the only developed nation not convinced of the overwhelming evidence that more frequent and longer duration dialysis saves lives.  America also stands alone with an alarming mortality rate among dialysis patients 2.5 times higher than Japan. American healthcare continues to insist on randomized, controlled trials showing the benefits of these alternative dialysis strategies over conventional incenter care even though they readily admit that it is impossible to randomize the 3000 to 5000 patients needed for such a study.  The Frequent Hemodialysis Network is actually unable to recruit even 250 patients for their ongoing nocturnal dialysis study let alone a study with enough statistical power to show a 30% difference in mortality from conventional incenter dialysis. Patients that are knowledgeable of the benefits of extended dialysis are routinely denied access to these life changing home therapies by their insurance companies who allege a lack of evidence of their benefit.

Group Health - Clinical Review Criteria:

Frequent Home Dialysis, Nocturnal or Short Daily
There is insufficient evidence that home nocturnal dialysis improves important health outcomes compared to in-center dialysis. An RCT found improvement in LV mass and phosphate level, intermediate outcomes, and mixed findings in QOL. There is weak evidence from a single cohort study that nocturnal dialysis lowers the rate of dialysis-related or cardiovascular- related hospitalizations. In this cohort study, all-cause hospitalizations did not decrease significantly.  

To date, we have the benefit of only one small RCT on nocturnal hemodialysis which confirmed many of the findings of prior observational studies showing significant benefits of more frequent and longer duration dialysis. America continues to stand alone in it’s call for the highest academic standards of dialysis healthcare, while paradoxically delivering the worst dialysis outcomes anywhere in the civilized world.  America’s search for the holy grail of dialysis evidence based medicine with an optimal randomized  controlled trial that is admittedly impossible to ever complete is nothing but tilting at windmills. 

While America charges ahead with protests of academic purity before accepting the proven benefits of optimal dialysis, patients are needlessly dying at the hands of our own nephrologists who blindly forgo these lifesaving treatments.  While the world embraces optimal dialysis, America instead worships at the altar of optimal randomized controlled dialysis trials which shall never be completed.  It is time to end this quixotic quest, we must stop fighting the windmills of academic purity. Instead let us be inspired by the great pioneers of dialysis in the fight against our true foe, the uremic milieu of too little dialysis and simply ask the dialyzed what frequency and duration of dialysis makes them feel better.

Best PPS comment, nonDialyzor catergory

By Bill Peckham

No new PPS comments were posted today (you can view the comments here or download the continuously updated Excel file), but I am expecting at least a few more. I haven't seen one from KCC or from FMC, I expect they'll be posted early next week.

So far I have 1,115 comment on my PPS spreadsheet. They run the gamut from the actionable to those that can be summarily dismissed. I'll have a more in depth analysis once I think all the comments are posted. There were a lot of great comments from dialyzors. Dialyzors using the NxStage are vastly over represented. I can't wait to count up the comments from people using the NxStage (and NxStage family members). I think home dialyzors really came through to improve this rule for everyone. If CMS really listens to their beneficiaries they'll get rid of medical justification and pay fairly for home training.

I'll compile and post from the best dialyzor comments soon, until then here is my favorite comment out of all that were submitted, in the non-dialyzor category.

It's the 1,112^th comment I read. Maybe I'm just loopy from all the previous multipage entries, but I thought this one broke through in an engaging way, to tell a story that made the author's point, in fewer than 2,000 characters. (The submission was through the website interface so it was limited to 2,000 characters (the web interface also strips paragraph breaks, I've made a guess where to add them to improve the comment's readability.)):

I will never forget the first time a dialysis patient was upset with me. It was 15 years ago. I was an undergraduate Dietetic Student at the University of Vermont. I was interviewing dialysis pts on their calcium/phosphorus intake. One Saturday morning 2 pts absolutely refused to participate.

I had interviewed each of them 15 times before, but today, interviews were not going to happen. Why? The pts refused, saying; "we're trapped here in a chair. we're prisoners. We're going to sit here for 4-5 hours on a Saturday, and then spend most of our weekend trying to recover. You're going to ask a bunch of questions and then run off to enjoy your day. We don't want to help you".

What they were really saying is that they wanted to be free. They wanted to recover faster and feel better. They wanted a more "normal life". Why do i remember these 2 pts? Having now worked with many home hemodialysis pts, I know that these 2 pts should NOT have been in that center, not these 2.

They should have been treating at home, they should have been enjoying the benefits of daily home hemodialysis. Clinical evidence tells us that pts performing more frequent, home hemodialysis, realize faster recovery times post-treatment, a reduction in BP meds, increased levels of energy, less depressive symptoms, improved mental and physical capabilities, etc...

I applaud CMS for including in the proposed rule a stated goal of encouraging more home dialysis, and for allowing providers the opportunity to bill for more frequent therapy, which has been proven to improve the lives of patients. Unfortunately, because the stated rule fails to appropriately capture the costs associated with providing the essential HHD training required for home patients, I fear you are working against your stated goal.

Please reconsider the elimination of separate payments for home hemodialysis training. You are so close to hitting the mark, improving cost of care and quality of life. Help keep pts home and free.

That's a great comment. If you're the renal dietitian from CA congratulations, you won the best comment nonDialyzor award.

In your honor I went through and corrected the spelling of "Dietitian" in Column P across all 19 page of the spreadsheet.

Baxter takes first steps towards home hemodialysis 510K

By Bill Peckham

On Thursday Baxter reported third quarter results and activity highlights including:

Filing an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) to begin a clinical study to collect safety and effectiveness data required for a 510(k) application for a new home hemodialysis system.

A new home hemodialysis system. How exciting.

How does the proposed expanded bundle effect home dialysis?

By Bill Peckham

Sign up for Nephrology News & Issues' webinar on Wednesday October 21, 3PM EDT -  Can home dialysis survive in the bundled payment era?: 

With dialysis payment reform approaching, some concerns have been raised in the renal community about how home therapies will be reimbursed. Will the proposed "bundled"payment provide enough financial incentive for dialysis providers to offer home therapies? This hour-long Webinar will examine the value of home vs. in-center therapy, how to set up and manage such programs, and how Medicare plans to compensate providers.

It's going to be an action packed hour and I'll be one of the people talking.

It's a new format from the webinars I've been a part of at Home Dialysis Central, this will be my first webinar panel. Mark Neumann, Executive Editor, Nephrology News & Issues will moderate essentially a panel of five: four people from industry and me. After you sign up to attend the webinar check out the E-Poll on the NN&I home page - the results are only surprising in that nearly 10% would choose incenter hemodialysis. I'll assume they were thinking of incenter nocturnal.

Light-Shielded Hemodialysis Or, Why my blood doesn't see the light

By Miriam Lippel Blum

As with any information you find on the internet do not do this experiment unless you have shown the research to your physician, discussed it thoroughly, and have his or her permission.

Hemodialysis (HD) is usually performed in bright, clinic rooms using transparent tubing to move blood from person to machine and back again. This means during every dialysis session the dialyzor’s blood is exposed to harsh fluorescent lighting. This adds up to more than 450 hours a year (156 treatments x 3-5 hours).  Uniquely during HD blood is exposed to light while it is in use, normally circulating blood is never exposed to light. This, I think, raises a question: does light have an impact on circulating blood?

Research done in Japan, and published in 2005 in the journal Clinical Chemistry, showed that light does have an impact. In Light-Shielded Hemodialysis Prevents Hypotension and Lipid Peroxidation by Inhibiting Nitric Oxide Production, Japanese researchers chronicle an experiment to measure the impact of light on circulating blood. The researchers simply covered the  dialysis tubing and measured changes in nitric oxide (NO) and lipid peroxidation.

Why are these two blood measures important? Together, both are involved in stimulating inflammation which can contribute to a host of problems, e.g. atherosclerosis, decreased epo response, amyloidosis. Individually, too much nitric oxide in the bloodstream can cause hypotension, while lipid peroxidation is a prime suspect for causing vascular damage.

In their experiment, the authors decreased the circulating blood's light exposure by covering the tubing with aluminum foil for the duration of the run. The authors found that the levels of NO were decreased and blood pressures stabilized. And they found the decreased NO inhibited plasma lipid peroxide generation. The implication of this research is that light is not good for blood that is in use. This routine light exposure during HD is likely contributing to dialyzor cardiovascular problems.

This research has had a big impact on me.  When I was on in-center HD, I had terrible intradialytic hypotension that was not related to fluid issues.  No matter how much saline or hypertonic was pumped into me, my blood pressures still would fall dramatically. Often my treatments had to be suspended because my BP was too low to continue.  I also developed severe cardiovascular disease within 9 months of starting in-center HD.  (I was on PD before that.)

My husband, always on the lookout for things that will help my health, happened to come across the Clinical Chemistry article.  I talked with my nephrologist and he agreed, why not see what would happen if we covered my tubing during treatment.  We had some hassles with the clinic but since my doctor wrote an order allowing it, the clinic eventually gave in, after making me address some safety issues (I had to make sure my coverings could be removed quickly in case the machine had an air alarm sound, and the pump needed to be visible).  So I made coverings with fabric and velcro so they could come off quickly and fashioned a little window for the blood pump with polarized plastic (like sunglasses) that would block light but still allow visibility.

The result was remarkable.  My blood pressures stabilized allowing me to have treatment runs uninterrupted by drastic blood pressure drops.  It worked so well that my nephrologist wanted to do some more research, unfortunately there was no funding.

Since that first effort I've fashioned reusable covers out double layers of heavyweight dark fabric. I use these covers along with strategically placed aluminum foil every run. I make sure to fully cover the tubing and dialyzer so that each time I hook up to NxStage I only briefly expose my blood to light. The only time my circulating blood is exposed is during the start and finish of treatments.

I recently talked to Dr. John Agar, about my light avoidance techniques and shared the Clinical Chemistry paper that led my husband and I down this road. Agar had never seen the research and found it very interesting.  He said that some current Australian research showed a heretofore unexplained lower level of NO in patients on nocturnal dialysis.  Perhaps this is because doing dialysis at night, in the dark, reduces the blood's light exposure. Light exposure that would be routine during conventional HD.  This may also be another reason why nocturnal HD seems to be so much better and less damaging to dialyzors.

There is much more research that needs to be done in this area and many questions to be answered.  For example: is there a particular wavelength of the light spectrum that causes the damage?  Or is all light equally damaging?  Does the source of the light matter i.e. fluorescent vs. incandescent vs sunshine?  Does it have to be direct light? Would indirect lighting solve the problem?

Research on blood light exposure could have implications for the provision of dialysis. That the cardiovascular damage seen in dialyzors could be mitigated by something as easy and noninvasive as preventing light exposure is something that should be seriously considered. Research may show that the blood tubing needs to provide shielding or the research may show that redesigning the unit's lighting would solve the problem.

Whatever the solution the dialysis industry needs to address this remarkably uncommented on issue. As for me I have seen (and felt) enough to continue my habit of covering the blood lines and dialyzer.

US News & World Report article reports benefits of nocturnal hemodialysis

By Bill Peckham

Okarol at IHD links to an article in US News & World Report For Some Kidney Patients, Home Dialysis Is Better Evidence suggests nighttime treatment yields better results. My experience matches the results reported in the article which is generally very good. The article does a good job backing most statements with references to current research. However, starting with the title it is clear that the writers at US News aren't completely sold on the nocturnal option.

"For Some Kidney Patients ..." why just for some? In the article they claim in regard to nocturnal home hemodialysis:

Experts say it's not for everyone, particularly people with other serious medical problems, such as cardiovascular disease.

What experts say that? What study showed that?

If anything frequent nocturnal home hemodialysis should be the first choice of people with cardiovascular disease and CKD5. One of the ways nocturnal hemodialysis is healthier is that is let's you remove fluid slowly, this combined with higher frequencies makes the modality the most heart friendly form of dialysis. With frequent nocturnal hemodialysis fluid buildup/rapid removal does not routinely strain the heart, which can happen with conventional dialysis. Change that sentence to "Experts say it is for everyone, particularly people with other serious medical problems, such as cardiovascular disease" and you would have an A+ article.

KidneyTalk explains the significance of the dialysis bundle & CMS's rule making process

By Bill Peckham

A new KidneyTalk is up with Lori Hartwell and Mike Paget talking about the pending change to the way Medicare reimburses for dialysis. This KidneyTalk gives a good overview of the history of Medicare reimbursement for dialysis and the process that will unfold over the next few months. While reading the dialysis bundling Q&A, listen to the podcast:

Congress passed legislation last year that will require CMS to write the rules on the payment policy for dialysis services. Mike Paget, who has many years experience in the dialysis community will explain how the renal community can be sure to be involved in the process. Any day now CMS will publish a "proposed rule" on the new payment policy for dialysis care, in the Federal Register. The community will have 60 days to comment, after which CMS will review the comments to establish the final rule. Listen to the show and learn how you an make an impact and what some of the key issues are.

It's a good show. There is a lot to cover. At the 6:30 minute mark Lori gets into the meat of the process by asking how Centers for Medicare & Medicaid Services (CMS) and Congress interact. Mike outlines the point of interaction: the comment period after the rule change has been published in the Federal Register.

At the 15:40 Lori outlines the changes around how quality measures are used. These changes are meant to create incentives for quality care by threatening to deduct 2% from payments. An important question for CMS to decide is what has to happen for 2% of reimbursement to be withheld? There are about 6 quality measures. The rule making will establish the quality targets and the repercussions for not meeting the targets. Mike and Lori do a good job explaining the process and putting CMS's pending action in the context of legislation, HR 6331, the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008.

The MIPPA legislation is the framework that will guide CMS through their process of crafting rules to implement the legislation. You can scroll through the whole MIPPA, or just check out the tiny bit that directly impacts the provision of dialysis: Section 152 and Section 153. The legislation left these key issues for CMS to sort out through its rule making process:

• Unit of payment: Will the bundle be per treatment, per week, or per month of services? Most in the renal community would prefer payment to be made per treatment.
• Scope of services: Exactly which lab tests, drugs, and other services will be included in the bundle? This is not yet clear, but will be included in the Proposed Rule from Medicare expected this summer.
• Home training: Training is a resource-intensive, one-time patient course. Home dialysis supporters want training payment to stay outside of the bundle. If included in the bundle, there is a risk that clinics will not want to go to the expense of training patients and caregivers to go home with their dialysis.
• More-frequent dialysis: Will Medicare continue to let providers be paid for treatments beyond three per week? Current Medicare policy allows extra treatments to be paid for when there is a medical reason. It is unclear whether this will still be the case under the new bundle.
• Home treatments: Congress passed a law that requires Medicare to encourage home dialysis. It is vital that when they create a new bundle, they don't accidentally make it harder for clinics to offer home treatments or for people to choose them.

Mike makes the point that these structural changes to reimbursement do not come along very often, it's been 26 years. This is going to be a one time opportunity to advocate for reimbursement that supports the care you want. There are choices that have to be made, if we get up to speed on the process and the issues, we can help CMS make the right choices.

Q&A to prepare for the implementation of Medicare's expanded dialysis payment bundle

By Rich Berkowitz, Bill Peckham and Dori Schatell

Dori, Rich and I have been participating with a diverse group of Home Dialysis advocates for a few months to prepare information for dialyzors so that we can all present feedback on the pending changes to dialysis reimbursement. I think the letter below stands on its own. We all expect that CMS will be publishing a notice this summer which then opens a 60 day comment period. This will be a chance for dialysis advocates to provide feedback

Start with this letter and then follow the link at the bottom of this post to read the Q&A. DSEN will be tracking this issue for the foreseeable future. Stay tuned for updates as this develops.

Dear Patient/Care Partner,

As you may know, the Centers for Medicare & Medicaid Services (CMS) is now working on making changes to the way dialysis is paid for. Congress passed a law last summer that requires Medicare to make a plan to improve the quality of dialysis care and reduce costs of dialysis treatment.

This will have a direct impact on YOUR dialysis. It is vital for you to stay informed and get involved to ensure that your treatment will not be affected.

While details of the new bundle are not yet known, the issues that could affect your treatment include:

• Whether the cost of dialysis will be looked at per treatment, per week, or per month
• Which lab tests, drugs, and other services will be part of the payment bundle
• Whether the cost of home training will stay outside of the payment bundle
• Whether Medicare will still allow providers to be paid for treatments beyond three per week based on medical reasons

We expect the new draft plan for dialysis to come out this summer. Medicare, which pays for most people's dialysis, wants to hear from YOU to help them finalize the plan.

Congress and the leaders in Medicare are not experts on the needs of people with kidney disease. YOU are the expert and YOUR input can give these leaders the chance to make better-informed decisions.

To help you better understand the policy issues that can affect people with kidney failure, we have written the Q&A. We hope this will help you to get involved and share your stories and ideas. After the proposal is released, we will have a follow-up letter with next steps.

Thank you for your efforts to ensure that the needs of people on dialysis are addressed in the new bill.

Sincerely,
Dialysis from the Sharp End of the Needle
Medical Education Institute, Inc. (Home Dialysis Central)
NxStageUsers

Click here to read the QA

Bill “Epoman” Halcomb and Rita

By Peter Laird, MD

photo by Trina Halcomb

Sitting on my “throne” here at the Kaiser Permanente Sunset Home Dialysis training room, the topic of other people with renal disease who write on a blog came up. Rita my training nurse, stated she had one other patient who wrote on a website as well. She couldn’t recall the title exactly but it was “I hate” something or other. Being a fan of I Hate Dialysis (IHD), I immediately stated, “you mean you trained Bill “Epoman” Halcomb right here in this chair?” Of which Rita immediately stated, "yeah that’s it."

I never met Epoman before his much untimely death, but like so many others, Bill Halcomb has touched my life by the legacy he left all renal disease patients on IHD. I had only seen a couple of the pictures of Epoman on IHD, and only briefly reviewed some of the tributes to Bill Halcomb after his death in 2007 at the age of 35, but sitting in the same chair where he had trained touched me to learn more of this life cut short, yet he still lives in the minds and memories of those that knew him. Interestingly, the most touching tributes to Epoman may have come from those that joined IHD after his death:

monrein
I'm sitting here bawling my eyes out for someone I never met, not even in cyber-space as he left before I found IHD, but someone for whom I am profoundly grateful. Grateful for Bill's vision, his spirit, his courage, his values and above all his "realness". He was a true "mensch". May he Rest in Peace and my condolences go out to his family.

annabanana
When I first found this site a few months ago I read a lot...but missed that Epoman had passed on. I read practically everything he had written and when I found out he had passed on it was such a shock. I cried like a baby. I felt as if I'd lost a family member and I hadn't even joined this forum yet. He has left such an incredible gift! Here's to you, Epoman!

My heart goes out to “Epokid and Epowife” as I read the tributes to Bill “Epoman” Halcomb. Not only has he left a loving legacy to a family that I am sure misses him with all of their hearts, yet Epoman lives on in my own life as I daily read over all of the new posts added since the last time I was on IHD, which is usually at least two or three times a day. Epoman is a daily part of my life and an inspiration to all those who suffer with renal disease. Epoman not only made a difference, he still is making a difference even after his death. What a legacy of love, caring and sharing from a man I will never meet on this side of eternity, yet I seem to know him any way as a close and dear friend.

Let this be just one more loving tribute to a man that will continue to make a difference in my life and many others that never had the pleasure to know Epoman in person . The influences in life that one man can have over those that he has never met is a legacy that we all in one way or another leave for those that are left behind. Rita remembers fondly her time training Epoman and Epowife and regrets the life cut short by such a prevalent disease. As I was bombarded with all the different people doing intakes for my home dialysis training, I was asked a simple question of “How tall are you?” My answer was, “Much shorter than before I started my training, because every time I turn around, Rita is tapping her hands and telling me “chop/chop” to get a move on.” I wonder how many times Rita told Bill “Epoman” Halcomb “chop/chop” as I sit atop my “throne” here in this somewhat cramped training room.

Bill, you have touched my life through IHD in so many countless ways, and now through Rita and the same dialysis chair that you sat in for your NxStage training, I am drawn even closer to you, may your soul rest in peace. Your friend and fellow renal disease sufferer, Peter, aka Hemodoc.

NxStage: My Initial Experience - The Good, The Bad, The Ugly

By Peter Laird, MD

After an exceedingly long wait, I have now completed my first week of home dialysis training on the NxStage machine. My conclusion after this week, is that I have proven with my own experiment that daily dialysis is FANTASTIC and I never want to go back to to usual incenter hemodialysis no matter how well done. However, there are several issues that I have either observed or experienced in my first week which I will relate as the Good, the Bad and the Ugly.

First, the Good. As I began above, the differences of cognition and general well being can never be achieved with usual care in center that I have experienced with 5 days of continuous HD therapy. I ate my first orange, my first orange juice, my first banana and my first sliced tomato in over 3 years. Wow, I have been deprived is all I can say.

I must make a special note of how fantastic my trainer at Kaiser Sunset is. Her name is Rita and she makes me almost, but not quite forget that it took nearly nine months from the time of my request for NxStage until I started my home training. My wife and I felt a kindred spirit with her immediately, and she is the first dialysis person to give me a hug and peck on my cheek at the end of my first week of training. She is a breath of fresh air after over two years of some very unpleasant experiences at the hands of dialysis staff and I look forward to learning as much as I can from this kind lady.

There is much more that I will state over time on the "Good" of home dialysis, but for now let me turn to my criticisms. The Bad:

1. (NxStage) No air chamber in the system. It is impossible to get all of the micro-bubbles out of the system before the first pass is giving to me. I went through the snapping step very carefully 3 times and still after sitting for a few minutes, several grew back onto the tubing again. My question is what effect does this have on accumulated pulmonary function tests over years of use. Patients on the cardio-bypass machine have significant cognitive declines after Coronary Artery Bypass Grafting (CABG) from this simple issue of micro-bubbles going to the brain. I am left with an open question of what will the long term effect of micro-bubbles be on my pulmonary system? Why not eliminate this issue with air chambers that will reduce this issue during the priming stage.


2. (Kaiser) My long wait. It appears that some of the problem is in the referral practices where many patients are referred before they have a mature access or have any experience with self cannulation. This leads to training times of over 2 months in some cases. I believe that an upfront self cannulation and access maturation in the referring unit will improve the training times dramatically. With the integrated health care system of Kaiser, requiring this prior to referral will secondarily improve buttonhole use across the system. Nevertheless, Rita has made me forget almost all of my frustration on waiting so long. I wouldn’t trade her for anyone.


3. (Kaiser) I became aware that Kaiser has contracted with some excellent outside units for over a year now specifically for access to the NxStage only three weeks before I started my own training. It is a shame for Kaiser to lose the good press it deserves for going forward with this NxStage access system wide by not having adequate communication to all involved, especially to the patients. For issues 2&3, I will give my input to those that can make a difference at Kaiser that I know personally. Kaiser has a long history of improving dialysis care for all patients, so with Rita by my side, I will move on and hope that my own experience makes it a better experience for those that will follow me.

Now, for the Ugly!!! Within 30 seconds of hooking up to the NxStage and cranking the system up to speed, I experienced the onset of an overwhelming “taste” that I have never experienced before. In addition over the next minute, I developed nausea, a mild burning in my chest which was followed by 24 hours of chest congestion without phlegm production and mid abdominal discomfort lasting for the majority of my dialysis session. I did a progressive rinse protocol the rest of the week and was able to eliminate the physical side effects with 2.5 L rinse on Friday, but I still had a fairly strong plastic taste that reminds me of Nitrous Oxide.

I have looked into this on the internet and found several people who have complained of this on Home Dialysis Central and on IHD. However, I have yet to find any references to this on a PubMed and Google search. But to my surprise, after reviewing my NxStage handbook from cover to cover today (OK, I skipped a lot of the alarm section) I came across the following discussion in Appendix D, Synopsis of Clinical Study in their discussion on Unanticipated Adverse Device Effects (UADE):

One UADE, a plastic taste in mouth, was reported during the study. This was later independently adjudicated as dysgeusia and did not meet the definition of a UADE. This event was further classified as mild in severity, therapy-related, seemed to be quite transient and not associated with any serious or lasting consequences. The full analysis was provided to the FDA during the study.

As a physician who has observed many adverse reactions to medications, I would not define my experience as simple dysgeusia. It was by all accounts an Unanticipated Adverse Device Effects (UADE). With the severe and overwhelming taste resulting in nausea, abdominal discomfort, burning in the chest with congestion lasting for several hours, I would report this as an adverse reaction to therapy if any of my own patients had experienced this sort of reaction after I prescribed a therapy for them. I am aware that not all patients even notice the taste, and even fewer have such adverse physical complaints. It brings to a head the entire issue of BPA/Phthalates in dialysis equipment. I will spend more time on this issue over the course of my training. However, in preparation for this, I would recommend reading a few quick links on the adverse effects of BPA (here, here and here)

So, in summary, I am quite excited about feeling somewhat like a real person again with NxStage. Aside from the issues above, I will adapt my own habits to minimize any adverse effects and stay on the NxStage until perhaps someone else invents a better mousetrap. I look forward to gaining my independence that has been sorely tested in the last two years of incenter care. NxStage is a step foreword, but I believe that there are several issues that need to be addressed to improve it more.

Northwest Kidney Centers offers all incenter patients opportunity to try frequent dialysis

By Bill Peckham

The Northwest Kidney Centers May/June patient newsletter, Output, has an article announcing a new program that allows people to "test drive" more frequent dialysis:

What is the main benefit of dialyzing five days a week? You will feel much better. That's why the Home Hemodialysis department at Northwest Kidney Centers would like to give you a chance to take home hemodialysis for a "test drive." Starting in May in NKC's Eastside centers, daily hemodialysis is available on a trial bases, with no strings attached.

I hope this is very successful. It's a challenge to get people already incenter to consider going home, and dialyzing more frequently. The hope is that after two weeks of frequent dialysis along with first hand experience with the equipment they will be better informed to evaluate the home hemodialysis option.

If all dialyzors were fully and accurately informed about their dialysis options how many would choose to dialyze at home frequently? It's an open question but I do think being fully informed does include first hand experience with how it feels to be frequently dialyzed. With out that first hand experience I don't know how you could be fully informed to make the comparison to a conventional incenter dose.

Do it yourself hemodialysis - the Chinese model

By Bill Peckham

Today RenalWEB linked to an interesting story out of China. A hemodialysis co-op was being used by 10 people to manage their stage 5 Chronic Kidney Disease (CKD5). A couple dialyzors bought a machine, which they shared, and where no doubt able to provide themselves dialysis for less than $30US a treatment (excluding the initial expense of buying a machine and water treatment system). This compares to the cost of a dialysis treatment in neighboring Chinese Taipei where dialysis is reckoned to cost about $127US per treatment.

The article indicates that the police are unsure how to proceed:

"They were ordered to stop their treatments. Considering the fact that a direct ban could threaten their lives, the enforcement is a little different for these patients, but the place will still be shut down in a few days."

The health authorities have asked the ten patients to contact their own local governments and return home to find a solution to their problems.

At 5 pm, officials from the district Health Department and Public Security Bureau visited them again. They said they would continue to talk with the patients to find a solution.

The patients refused to return home.

I hope the Chinese authorities decide to allow the experiment to continue. Absent an entitlement for dialysis or a wide availability of healthcare people with (CKD5) should be allowed to find their own way to pay for their treatment. In this situation it is hard to see the State's interest in preventing true dialysis co-ops.

Meet me in Naples, FL March 31 - April 1, 2009 10:00 am - 2:00 pm

By Harvey Wells

For anyone that lives in the SW area of Florida, I’m going to be doing a home dialysis demonstration in my motor home at the:

ARA Dialysis Center
4529 Executive Dr
Naples, FL 34119
(239) 566-7180

Tuesday March 21 and Wednesday April 1, 2009 from 10 am – 2 pm or when the last person leaves. The ‘Main Event’ (self-cannulation) as I bill it, occurs around 11:00 – 11:15. Get your questions answered, look at the equipment, see how easy the setup procedure is and observe for yourself the freedom and flexibility of travel and staying active on more frequent daily dialysis. If you have any questions please feel free to contact me or call the center. See you in Naples!

How Dialysis Fits into My Daily Routine?

By Bill Peckham

The third question I was asked to address at the conference on Saturday How Dialysis Fits into My Daily Routine? gets to the issue of logistics. There is of course some overlap with the answers to the previous two questions here and here but rather than answer as I did on Saturday I'll recount my day today.

Last night's dialysis treatment finished about 7:15 this morning. I was making coffee by 7:45. I have a four hour shift today but it's a flexible start so I'll go in after I receive my monthly NxStage supply order. While waiting I write a blog report, feed my internet habit, do a load of laundry and take care of emails. 72 boxes of dialysate arrive and it's off to work.

Before starting I walk the dog along the river (the dog works when I work and he'll be at work Thursday and Friday while I'm in LA - he has way more hours than me). Work is an easy day - I'm training to use a new piece of equipment - a very elaborate flat bed printer and there aren't any real signs to produce - I print Watchmen posters for the walls and over thirty posters for NKC that I'll cut out next week. At the end of the shift I can operate the new printer. It's pretty cool - it can print directly on Plexiglas.

After work I am busy on the internet and the phone, posting about the petition and returning calls. The dog eats and with daylight savings time there is about an hour of daylight so the dog and I head to the beach to watch the sun set behind the Olympic mountains. We take a 20 minute walk up into a green belt and then loop back to Duke's as the sky turns red. I order a bowl of crab chowder to go, down a strawberry lemon drop while watching Seton Hall and Syracuse and head home.

Back on the internet while eating delicious chowder and then about an hour of TV. I set up my NxStage for tonight's treatment with the TV on and the my second load of laundry in the wash. After the machine is set up I figure out what to pack and now I'm writing this post. In about 30 minutes I'll walk the dog and then I'll finish the day watching the Daily Show as I get on dialysis. 

The trade off is the more I work the less I blog and I give volunteer activities a high priority so all of this is scheduled around meeting commitments. This week is also different because of the travel. Tonight will be my forth treatment in a row. Normally I go 3 on one off, 2 on one off. If I wasn't dialyzing tonight I would, ideally, have spent more time on life chores - bills, the yard, the kitchen, etc. - some nights it turns into more time on the internet, or eating at the bar and a second drink.

If I wasn't dialyzing overnight I would have had to walk the dog on the way home from work, pack and make myself something to eat. I'd get on dialysis by 7 if all went well. For the next three+ hours, during the six + years I was on short daily (9/2001 - 1/2008) I'd watch TV, and idly surf the internet. Maybe a friend would come over, or I would be on the phone, or slowly typing out one handed responses to emails or discussion board posts. DSEN would not exist or would be very different. There would be no petition effort.

Home extended overnight hemodialysis fits well into my busy and enjoyable life. As I wrote my dialysis gives me the freedom to struggle and it is what has opened the door for me to provide a new view.

How Does Home Hemodialysis Influence My Quality of Life?

By Bill Peckham

As I said yesterday I did well while I was on incenter dialysis but at home I am doing better, particularly now that I am doing frequent extended overnight hemodialysis. At the conference I reported that my Quality of Life (QoL) improved every time I increased my dose. Now 18+ years after taking up hemodialysis to manage my stage 5 chronic kidney disease (CKD5) I am enjoying my highest QoL yet. Dialyzing over night gives me both better clinical results and more free time. My already high QoL improved when I switched to extended treatments overnight. 

By improving my clinical experience of dialysis, frequent home hemodialysis has eliminated the post dialysis feeling of being hung over. After incenter dialysis I often felt literally hung over - headache, food doesn't sound good, dry mouth, weariness - I coped with this by going to bed. I'm fortunate to dialyze through the Northwest Kidney Centers which operates each one of their units with shifts starting after 5PM; dialyzing after work meant by the time I got home from dialysis it was time to go to bed.

When my dialysis frequency increased the hangovers went away. In place of nausea I felt hunger. I've gained 14kg since switch from incenter to frequent home hemo. I was under weight incenter, spicy food made me nauseous - mild salsa only. Dialyzing at home has made food more appealing while removing nearly all my dietary restrictions. I can have cereal with milk in the morning; with my nachos I love the hottest salsas. Getting more dialysis at home ended the hangovers and it also cleared the uremic fog.

I could think more clearly. My reading comprehension improved. I could win more consecutive games of Freecell once I started dialyzing frequently at home. These are solvable card puzzles that come with the Windows operating system. While I was incenter it was rare for me to be able to complete five games at a time. Once I was getting more dialysis I became bored with the game as I was able to win again and again. My ability to concentrate had returned.

Then with my latest increase in dose, provided by moving to extended overnight dialysis using the NxStage System One, not only have those areas improved once again but I have my evenings free. I haven't had my evenings free for over 18 years. This blog is due to my having my evenings free. As someone who self dialyzes I am very aware of the time and effort home dialysis requires - extended overnight dialysis requires less time and effort then any other modality I have tried - incenter included. Less effort. Feel better. Live longer. Extended overnight dialysis at home is a positive influence on my Quality of Life.

Why Did I Make the Transition to Home Hemodialysis?

By Bill Peckham

For my part on Saturday I was given three question to answer: Why Did I Make the Transition to Home Hemodialysis? How Dialysis Fits into My Daily Routine? How Does Home Hemodialysis Influence My Quality of Life? I was the last to speak after a long day on Saturday so I tried to keep it brief. That was the idea here too; in three parts.

I dialyzed incenter for 11 years, from 1990 to 2001. I did well on incenter dialysis. After an initial rocky start I've been a dialysis success story. I learned to mange my CKD with regular 4:45 minute dialysis treatments, diet and exercise, fitting it all into a busy life. While dialyzing incenter I joined the carpenter's union and worked my way to the top of the union pay scale. I actively volunteer with my provider, joining their board in December of '97 as patient association president. And I traveled extensively. I had friends. I had a dog. It seemed like enough.

I was identified as a good candidate for home hemodialysis early on in my dialysis journey but I didn't see the advantage of taking dialysis home, I had compartmentalized dialysis. The only time I thought of it was when I was actually dialyzing. It was a freedom of resignation ... I had been down so long that being down didn't bother me. I accepted the CKD burden e.g. the nausea, the cramping, the weariness, the dialysis milieu. I resigned myself to coping with the new normal and couldn't see an advantage to doing at home the same thing as I was doing incenter.

The calculus changed in 2001. It was that year that NKC decided to offer people dialyzing at home more frequent dialysis. As a trustee I heard the thinking behind the change - it was in direct response to the feedback from participants in a more frequent dialysis trial the center was conducting - participants, to a person, never wanted to go back to incenter dialysis again. They felt better. They looked better. They wanted to continue to dialyze frequently. NKC was convinced and I was convinced. If it was that much better then conventional dialysis I had to give it a try.

Once I went home and started dialyzing 6 days a week, I knew I made the right choice. I used the B Braun with an R/O and a helper (a buddy from college who I traded rent to), then a year later in 2002 I started dialyzing by myself first on the Aksys PHD and now on the NxStage System One. It was the promise of feeling better that got me to take dialysis home; it is a promise that's been kept.

Why aren't home dialysis modalities more popular? Why should they be more popular?

By Bill Peckham

Renal and Urology News has a new article up by Delicia Honen Yard, Why Use of Home-Based Dialysis Lags. It's a good article mainly focusing on peritoneal dialysis (PD) but I think at least two important points are left unsaid. The article quotes Dr. Rajnish Mehrotra, associate professor of medicine at the David Geffen School of Medicine, University of California-Los Angeles (UCLA) and associate chief and director for peritoneal dialysis in the division of nephrology and hypertension at Harbor-UCLA Medical Center. He lists four reasons that PD isn't used as much as he reckons it should be, one of his reasons is "Lack of infrastructure".

I think he is thinking of the number of programs offering PD and the number of skilled trainers available to teach patients how to safely do PD in the home. Patient access to PD programs and PD training slots. Left unsaid is that there is another piece of missing infrastructure that decreases the number of people using PD. The lack of inpatient PD availability.

Many hospitals can provide inpatient hemodialysis (HD) for people with stage 5 chronic kidney disease (CKD5) who are in the hospital for any reason, however, at some of these same hospitals PD is a complete mystery. I've heard stories of family members having to stay with their loved one in order to do the exchanges, bringing supplies from home. Alternatively the hospital might place a catheter, and do HD if the patient is too ill to do the treatments and there is no one else able and willing to step up. I am sure a doctor doesn't have to deal with this problem too many times before manifesting a bias away from PD  and towards HD.

I think Dr. Blagg professor emeritus of medicine at the University of Washington in Seattle, executive director emeritus of Northwest Kidney Centers in Seattle, and editor-in-chief of Hemodialysis International, charts the best transition into CKD5:

Dr. Blagg has some important advice on preparing for this eventuality [when PD no longer provides enough dialysis]: “To do hemodialysis you need blood access, which means undergoing surgery to put in a fistula in your arm. I believe very strongly that if somebody starts on peritoneal dialysis, once they're stable and doing well, they should have surgery so that they have an access.”

Dr. Blagg theorizes that because a fistula can take several weeks or even two to three months to mature, having it ready well in advance will enable PD patients to go much more safely and simply to HD.

The idea would be that even if the CKD is diagnosed late in the disease process and dialysis has to be started - PD can be used right away and the person can be sent home to manage their own treatments after as little as a week of training. Then, while managing their CKD5 with PD the patient can have a fistula placed so that when it is time to transition to HD there will be a mature fistula ready to be used from day one. Left unsaid is the thread that runs through this optimal transition and connects the two modalities - selfcare at home.

Taking dialysis home avoids the infantalization that often happens when a person spends as little as a few months on incenter HD. This has been a much remarked on process which was first described in The Patient with Chronic Renal Failure: "A Marginal Man" by Melanie K. Landsman, ACSW, published in the "Annals of Internal Medicine" in 1975. The learned dependency inadvertently instilled incenter compounds the burden of CKD. For this reason alone home should be the dialysis venue of first resort. I think all the docs quoted in the article could agree with that.

Babb made home hemodialysis possible

By Bill Peckham

Two new interviews are available through the Nephrology Oral History Project, Richard J. Hamburger, MD and Louis H. Diamond, MBChB. These continue to expand the record of the early years of dialysis. I've listened to a couple snippets of the new material. I enjoy listening to the doctors tell their stories but this December, 2000 interview of Albert "Les" Babb conducted by Frederik Nebeker for the IEEE History Center, is excellent reading. Babb gives a clear first person account of the early days of chronic dialysis in Seattle.

Babb's involvement was to develop a way to mix dialysate on a large scale simplifying the dialysis process and making it less expensive (Babb's central dialysate delivery system for multi-patient dialysis cut the per year, per patient cost of dialysis from $20,000 to $10,000). Starting here in the interview Babb explains how a bunch of engineers who were working on the University of Washington's nuclear reactor ended up making home hemodialysis a reality. It's a pretty amazing story.

As Babb explains his involvement he gives a thorough overview of hemodialysis circa 1962 and the state of the process that he came to understand in those early days. Babb brings an engineer's understanding to dialysis. First Babb created a system to serve an entire dialysis unit - 5 stations at the time; then Scribner gave him a tougher challenge. He needed Babb to take what he had created for a unit, and shrink it down so that someone could use it in their home. And he needed the device in 4 months.

Babb and his team of engineers met the four month deadline. This photo from the HDC Dialysis Museum is of an early dialysate proportioning system developed from the prototype "Mini-1" machine designed by Babb. It was this device that made home hemodialysis a reality. In one of the twists of fate that weave through the early days of dialysis, Babb and his team were working for the benefit of someone he knew well. Babb's original Mini-1 prototype was used on an experimental basis to provide dialysis in the home of his good friend for a daughter. A daughter that had been turned down by the Seattle selection committee.

Later in the interview it's mentioned that a paper Babb wrote received landmark status, Google suggests that it was Hemodialysis International that bestowed the honor. He and Scribner were trying to figure out "how many hours a week a patient should be dialyzed." I was struck by one passage:

A lot of the work we did after that [creating the dialysate proportioning systems] was mathematical and we tried to model this process to see if it could be optimized. We suggested three 8-hour treatments per week rather than two 12-hour treatments were more optimal and convinced the medical staff to switch to this practice. By the beginning of 1964 I was feeling somewhat relieved that this was done.

The phrasing "somewhat relieved" suggests that he thought that three days a week wasn't quite right. I wonder if it ever crossed his mind to suggest every other day dialysis? It was a unique time here in Seattle. A time when Scribner could pick up the phone and get a team of nuclear engineers on a dialysate job and a nuclear engineer could call Scribner and make hemodialysis dose recommendations.

Reading this and listening to the Oral History Project interviews you get a sense of the pragmatic, problem solving group of men (definite gender bias evident) that launched ongoing dialysis. They pushed forward, solved problems, made it work. Back when you could just make it work. Today the red tape has caught up with interest.

Kaiser Permanente: Leading By Example

By Peter Laird, MD

During the summer of 2005, I was confronted with the certainty that my IgA nephropathy would eventually lead to complete renal failure and I would then need renal replacement therapy. The latest creatinine level of 2.1 triggered this reality and I finally resigned myself to seek expert advise as early as possible to prepare for this progression to renal failure. Fortunately, as a physician at Southern California Kaiser, I had the ability to consult with some of the nations top nephrologists at Kaiser’s Los Angeles Medical Center (LAMC).

Zach recently sent a link to a 1995 NY Times article about LAMC, praising the advances that their dedicated doctors had made and Kaiser's lead role in improving dialysis outcomes during the 1990’s. Kaiser is unique in that it is an integrated health care system with continuity of care between outpatient and inpatient clinics with Kaiser Foundation serving as the single payer for both. The advantages that Kaiser can thus capitalize upon is in capturing savings from pharmaceutical expenses as well as reduced hospitalizations when care is improved in the outpatient setting. From the NYT article Making the System Work In Kidney Patients' Favor by Kurt Eichenwald:

In June Kaiser announced what dialysis providers said was the first comprehensive effort to establish broad-based standards to measure the quality of care. Those standards, which every dialysis company contracting with Kaiser would have to meet, are based on 450 objective indicators, from blood-pressure level to the amount of urea in patient's blood. The standards are by far the strictest in the industry, providers said. No comprehensive standards have been set by the Government.

Dr. Hannah of Kaiser's Southern California division said that a number of university kidney specialists had reacted to the proposed standards with dismay, saying that they were impossible to meet. But at the same time, a number of doctors from dialysis companies have told him they will meet the standards, if Kaiser gives them a contract to serve its patients.

Kaiser set lofty goals at that time that have come to fruition in many ways. Six years ago, in an ongoing collaboration with Fresenius Medical Care (FMC), Kaiser jointly started another dialysis unit in the Antelope Valley teamed by FMC employees but headed by a Kaiser physician, Dr. Philip Tuso. Dr. Tuso receives only his usual Kaiser compensation and thus has no personal financial interests in the delivery of care to his patients which is a key element of this arrangement. With an eye on total care throughout our system, Dr. Tuso has achieved a 7% mortality statistic for 2008. This was achieved with increased dialysis duration to a standard 4 hours, special attention to food insecurity which is widespread in the Antelope Valley even among our own patients and flexible protocols where patients in special need would have even higher levels of dialysis. By example, one of the patients in my unit is currently on dialysis for 5 hours duration, 4 times a week to help him overcome recent setbacks.

The goals set forward by Dr. Hannah nearly 15 years ago have been greatly realized with at least two of the joint Kaiser/FMC units in Southern California reaching a 3% annual mortality statistic for 2008 (unpublished data) and almost all of them achieving less than 10% mortality. In such, Kaiser’s usual dialysis care in these centers far exceeds reported national mortality rates in Japan, Europe and Australia.

Kaiser is also venturing into the realm of home hemodialysis at its Los Angeles Medical Center. Today, I met with the home hemodialysis training nurse and social worker as I prepare for my own NxStage training which will hopefully occur in the next couple of months as they go through their wait list. My nephrologist at LAMC is Dr. Scott Rasgon, Chief of Nephrology at LAMC who has a special interest not only in providing home dialysis through NxStage but also in researching outcomes. (here and here) I look forward to embracing home hemodialysis soon especially with such a dedicated team. Dr. Rasgon and his colleagues offer only short daily dialysis at this time, but it is my fervent hope to be one of their first patients to begin extended sessions to realize the long term survival seen in Australian patients dialyzing over 20 hours/week. Kaiser truly is leading by example not only in usual dialysis care in center, but also in research and implementation of a viable home dialysis program which I hope will be generalized to all Kaiser medical centers soon.

The time has come for not only leadership, but also for strong actions by all American dialysis programs. Kaiser will continue to serve as an excellent model of what can be achieved when total patient care throughout all levels is considered. Truly the best medicine is the cheapest medicine.

It’s Time to Go Home

By Peter Laird, MD

In November of last year, I went to Los Angeles for my evaluation for home hemodialysis with the NxStage cycler. It seemed like an eternity while I waited for the call to set up my home evaluation which finally came last week. Tomorrow afternoon, I will meet with the nurse, the social worker and the technician who are involved with my home care. Strangely, the day after I received the call, I returned to my dialysis unit feeling as if a large burden had been lifted from my shoulders. Of a certainty, I dialyze in an extraordinary unit where the annual mortality statistics have fallen from about 20% down to 7% last year in just a few short years. The care is exceptional, yet in many ways, simply dialyzing in unit means that I have lost much of my independence that I so greatly cherish.

I will frankly admit that after spending nine years in the Army and being promoted to the rank of major, as well as nearly 20 years as a practicing physician, I am not use to following house rules, especially having people tell me what to do when I know what I'm doing. Perhaps it is unresolved adolescent authority issues which I resolved by becoming an authority myself, but in fact, in the last two years since starting in center hemodialysis , I have had staff mock me in front of other patients, abandon me to go home while a needle was hanging out of my arm but still needing assistance to hook up to the machine as I was learning to do self care in center, and then I had an RN become incensed when I refused to use a blood collection tube that had fallen on the floor. It had accidentally fallen on then floor and I then threw it in the trash. She picked it up out of the trash can and told me to use it after she wiped it off with alcohol. After fuming for about 30 seconds silently, I firmly asked the lead RN to get me a new tube and threw the contaminated tube away once and for all.

In Idaho last summer on my first trip since starting dialysis in February of 2007, the unit director scolded me not to use the sink across from my chair and to use the patient sink out in the hallway. I dutifully proceeded out into the hall and found out that she had locked the unit door behind me when I returned. On my second day at my unit in Cape Cod later that summer the lead RN greeted me at the door as I came in within five minutes of my scheduled time saying “Come in, come in, you’re, late, Hurry up and get in here.” I heard that same scold with several other patients over the 5 weeks that I was there.

I could keep going on with my own encounters, but I have also heard my fellow dialyzors advising the techs to reduce the UF rate because they believed their dry weight was too low only to see them become hypotensive later because the tech refused to consider their input. Having been involved in medicine since the mid 1980’s, I am keenly aware of the ethical concept of patient autonomy. I am also keenly aware that since I have entered into incenter hemodialysis , I have had to fight hard to keep any semblance of patient autonomy. I will frankly admit that I am not an easy patient to contain due to my bull headed nature at times, yet that seems apt considering the last two years experimentation in cattle call lines. It is time to go home. But what about all those fellow dialyzors that I will leave behind? Those that can't go home.

I remember a classic experiment I read about years ago on what happens to prison guards and how the authority that they have can get out of control with their prisoners who must get permission for all of their needs and are shackled and placed in confined spaces. Is it possible that we have a similar psychological paradigm where dialysis patients are completely at the mercy and control of their staff who also inflict pain on a daily basis? I will leave it for others to answer such a loaded question, but I would firmly advise all of my medical colleagues to get tough skin if they ever end up in my position. I will ask a further question: what is the cause of all of the stress and depression that dialysis patients undergo? Perhaps it is not all related to the underlying renal disease nor the dialysis treatment itself.

Unless dialysis staff work diligently to engage patients with respect for their autonomy, it is easy to see why so many of my fellow patients become very passive and do not participate in their care. Bill has used the term sheeple for these passive patients. I wonder how many have simply given up after being subdued by staff that treat us as one more anonymous body in the cattle call line that many dialysis centers have entrenched.

Who needs to approve self dialysis?

By Bill Peckham

Can/should people dialyze alone? Who makes the determination? I believe that it should be the decision of the person doing dialysis in consultation with their doctor. However, dialysis providers operate in a regulatory intensive environment and have to follow both federal and state regulations.

The Centers for Medicare and Medicaid Services has pages of dialysis provider regulations called the Conditions for Coverage (CfC). The CfCs don't speak to the need for a trained partner for home hemodialysis but states can have their own regulations that are in addition to the CfCs. Anna famously had issues (I would have driven supplies to her had it become necessary) and indeed the State of New York has their own regulations . These I think are the relevant State of New York regulations regarding home dialysis, Section 757.2 (my emphasis):

OFFICIAL COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 10. DEPARTMENT OF HEALTH
CHAPTER V. MEDICAL FACILITIES
SUBCHAPTER C. STATE HOSPITAL CODE
ARTICLE 6. TREATMENT CENTER AND DIAGNOSTIC CENTER OPERATION
PART 757. CHRONIC RENAL DIALYSIS SERVICES
Text is current through February 29, 2008.Section 757.2.

General requirements.
The operator shall comply with the following requirements:

(a) A physician or a registered professional nurse who has had at least three months of training and experience in hemodialysis under the close supervision of a qualified physician, shall be in attendance at all times during the provision of hemodialysis services by center or facility staff to patients at home; provided, however, that upon the certification of the medical director that the patient's condition is sufficiently stable, a licensed practical nurse with equivalent training and experience may attend a patient during dialysis treatment at home.

(b) Provision of chronic hemodialysis service in the home, by a patient and/or the patient's assistant shall be based on a recommendation for such home treatment as a result of the coordinated evaluation of each patient's treatment in an approved center or facility and after the patient and the assistant have been properly trained at an approved center or facility. The center or facility assumes the responsibility to supervise the patient's home treatment and to act as backup for the patient's emergency needs.

(c) Provision of chronic renal dialysis services in a patient's home by center or facility staff shall be based on a recommendation for such home treatment as a result of the coordinated evaluation of each patient's treatment in an approved center or facility and the recommendation of the patient's physician. The center or facility shall assume the responsibility to provide the patient's home treatment and to act as a backup for the patient's emergency needs. In addition to the specific requirements of this Chapter, chronic renal dialysis shall be provided by an approved center or facility in a patient's home in accordance with generally accepted standards of professional practice.

(d) Approved centers or facilities treating pediatric patients, on other than emergency basis, must have the consultation services of a qualified pediatric nephrologist.

(e) Approved centers or facilities shall furnish all types of home dialysis training and supervision either directly or under an agreement or by arrangement in writing with another center or facility.
... [continues with water quality guidance]

The problematic language are the highlighted phrases in section (b). From a strict reading one might conclude that the state of New York is specifying that someone on dialysis can be a passive participant in their care but they can not be the only person responsible for their care.That is not an optimal framework.

It isn't clear what the rule writers had in mind. Is the intent of the language to take a position on self dialysis? Or rather is it describing current practices when the rule was written? It is my guess that the rules are based on the dialysis of yesteryear. These dialysis regulations need to be revisited by the State of NY Department of Health to reflect modern dialysis machines and the clinical stability that comes from more frequent hemodialysis. Access to high dose dialysis should not depend on a willing helper. Adults, even adults with CKD5, should, in consultation with their doctor, be left to make their own decisions about how to meet their renal replacement needs.

Creatively improving the provision of dialysis: the Hana, Maui model of communial home hemo

By Bill Peckham

In March of last year I wrote about the effort to provide dialysis in the remote community of Hana Maui. On Saturday The Maui News posted an article, Hana home dialysis sets a Feb. 20 start announcing the launch of an innovative home hemodialysis program. The innovative feature of this program is the home hemodialysis will be provided in a neutral location, a home donated for the use of all the dialyzors in the community (currently 2 but the number ebbs and flows, 5 additional people have been identified with CKD).

The Maui News article announces that a building, formerly a residence for the community doctor, has been turned over to the community for the use of as a communal home hemodialysis center. This is a final step; the most critical step was taken in October when the Centers for Medicare and Medicaid Services (CMS) approved a first-of-its kind arrangement. The dialyzors in Hana will go to a local home, where their own machine (provided by Liberty Dialysis) will be set up by trained community volunteers (trained by Liberty Dialysis) and these volunteers will serve as dialysis helpers. You can read the letter from CMS Regional Administrator Deborah Romero authorizing Liberty dialysis to provide communal home dialysis, it's exhibit C on page 8 of this pdf.

I think this could be a model for care in other rural communities without enough dialyzors to support a small unit. Beyond economics an advantage of co-locating home dialysis machines would be to address some of the reasons people are reluctant to choose home hemodialysis. A dialysis co-op would preserve the social atmosphere of going through dialysis incenter, the space issue related to storing home hemo supplies and equipment would no longer be an issue and family members would not have to be be exposed to the treatment or have to provide support so they could continue to avoid dealing with their loved one's condition. Kudos to CMS and Liberty Dialysis for supporting this innovative program.

The group that has been formed to provide support and advocate for all this is called Hui Laulima O Hana. I'll be interested in following the co-op's progress.