Optimal Dialysis: Are we losing the Battle in America?

By Peter Laird, MD

A little over a week ago I had my home dialysis monthly check-in with a nephrologist that I was meeting  for the first time.  I found him very knowledgeable and supportive of alternative dialysis strategies including the NxStage System One as well as nocturnal dialysis in its various forms.  He recently opened his unit to incenter nocturnal dialysis patients, achieving excellent results with several of those patients who transferred from conventional dialysis care.  Unfortunately, one of those patients is now at jeopardy of returning to conventional dialysis care by the decision of their HMO. This, despite the widespread acceptance of the benefits of incenter nocturnal dialysis especially in Canada just to the north and down south in Australia, America continues to dismiss the overwhelming evidence of improved outcomes with this modality.

Remarkably, despite the widespread knowledge that dialysis pioneers originally used eight hour sessions nearly fifty years ago instead of the conventional 3-4 hours sessions we are now familiar with, many health insurance providers perversely consider these alternative strategies unproven and experimental and will not pay for them.  They continue to insist upon randomized controlled trials as the only standard of proof which at this time still do not exist.  They fail to acknowledge that the current standard of care, 3-4 hours sessions thrice a week, was a business decision unsupported by any randomized controlled trials as well.  

A little over a year ago, I contacted the physician overseeing the committee at Southern California Kaiser that evaluates new and evolving technologies after hearing that they were considering nocturnal hemodialysis at that time.  After reviewing the available literature mainly from Canada and Australia, they determined that that data was insufficient to support adopting it as a covered benefit for all patients, but they did recommend setting a pilot study which is now in progress.  Yet there are many such as Dr. Carl Kjellstrand and Dr. Christopher Blagg who have advocated  for optimal dialysis here in America for decades citing the improved outcomes in several other nations that have been able to incorporate this in dialysis practice.

The case of my fellow patient at my center now battling for coverage of optimal dialysis through a well run incenter nocturnal dialysis program takes me back to the current status of many patients in America who still do not have access to these life saving modalities.  After observing the positively changing mindset among many in the nephrology community over the last two years that I have been involved in dialysis advocacy, this case reminds us that the battle is not yet won here in America.  With the uncertainties that the new prospective payment system could bring to American dialysis patients and these alternative treatment options, I can only wonder whether we are winning or losing this battle.  Dr. Belding Scribner spent the last two decades of his life fighting this battle only to tragically die in 2003 before he saw it come to fruition. 

Certainly, in the nearly seven years since Dr. Scribner death, dozens of studies have brought forth the profound benefits of daily hemodialysis, especially in regard to daily nocturnal hemodialysis. Many who support these modalities continue to wage the battle against this American dialysis hegemony hoping that we shall never again hear that a patient was denied access to these life changing treatments.  It is a battle that one of our fellow dialyzors is waging today, unfortunately it seems, with very little chance of success.  A vocal dialysis advocate that I asked to assist in this case summed it up by simply saying, “That's truly appalling!”  I agree.  The battle continues locally and nationally.

Comments

[roberta mikles]

I agree with the person who said, "That's truly appalling!" It is actually more than appalling to think that our health care system of which many believe is the best in the world continues to deny patients that which would be in their best interest and well being in order to live a life of quality. One has to ask the question "Why?" does this continue if there are proven studies, etc. That is the question, WHY?

Roberta Mikles
Patient Safety Advocate

[Peter Laird, MD]

Roberta,

Thank you for your continued support in the many ways you help those with ESRD. Unfortunately, this is a uniquely American problem where they set up the catch 22 of only accepting randomized controlled trials as the level of evidence to establish the effectiveness of optimal dialysis modalities. Thus, from their perspective, there is not any evidence to justify these treatment options. However, Canada, France, Australia, Japan and New Zealand all recognize the obvious that more frequent and longer duration dialysis does save lives completely vindication Dr. Carl Kjellstrand who proposed the un-physiology theory of dialysis in the late 70's.

In brief, this theory states that patients on conventional dialysis care show up for treatment with high potassium, acidotic and volume overloaded. When they leave, they have low potassium, low blood volume and are alkalotic thus never reaching a steady state of physiology. The cure is quite simple, longer, slower and more frequent dialysis. Correcting these biochemical abnormalities results in improved clinical effects. Unfortunately, here in America, the obvious is ignored to the detriment of the majority of dialysis patients.

When people discuss this from the other side of sensibility, they often refer to the decades of experimentation with longer and more frequent dialysis. Sorry, but in my mind, the theories of why people do poorly on conventional dialysis are compelling and the treatments to remedy this are proven. Yet, here in America, what is standard care for the rest of the developed world is called experimental. It is appalling to say the least. It is time for America to step into reality and treat dialysis patients with the same adherence to sensibility as the rest of the world. They continue to look upon our approach with disdain for all of the patients that suffer and die needlessly. Optimal dialysis truly deserves a trial of life in America.

[Linda Gromko, MD]

In reference to "more frequent dialysis," i.e. daily or nocturnal, the most telling question is this: what type of dialysis would health care providers want for themselves? (Or perhaps even more telling: what type of dialysis would our legislators require?) I know of no physician colleague who would preferentially dialyze In-Center - if only because of the soul-sucking ambience! Home is clearly the most optitmal, because nobody cares more about that quality of your dialysis than you or your partner! Linda Gromko, MD; www.LindaGromkoMD.com.

[Lori Hartwell]

It is so clear that more dialysis is needed for patients to thrive and yet why can't the kidney community make it happen? At least we should let the patients who want to dialyze longer - dialyze longer. It would be a start.

[Peter Laird, MD]

Thank you Lori,

I believe that there are only two ways for optimal dialysis to happen in America. FIrst, that we get a randomized controlled trial with enough power that shows that these are the most effective treatment options. The difficulty with this approach is it will never happen since you will need an estimated 3,500 to 5000 patients to randomize which is beyond the number of HD patients dialyzing at home at present.

Secondly, and perhaps more realistically is the fact that the nephrology community can establish optimal dialysis as the community standard. In the medical/legal community, this is the measure of standard treatment options where the medical community sets the standards. There are many in the nephrology community who recognize several aspects of conventional dialysis care that is suboptimal and needs to be changed. On the other hand, it is CMS and the insurance organizations that have set the standard of care for the dialysis community. In this sense, business values perversely supersede the medical values.

For those who wish to wait until we have a completed RCT showing the efficacy of optimal dialysis modalities, they shall not be moved despite the overwhelming observational data we have to date.

Lastly, all trial results must meet the final test of an RCT or well done cohort study. That is generalizing the results of the study to the general population involved in the study. In many ways, the accomplishments of countries such as Canada and Australia already establish these modalities as an effective and desirable treatment option. The shortsighted nature of our dialysis decisions are the source of much derision in all of the other nations who have successfully implemented optimal dialysis modalities. Yet, the egocentric nature of American medicine supplants the worldwide condemnation of our failed policies.

Perhaps all that we need in America is for the nephrology community to grow ears to hear the international condemnation of our backward conventional dialysis treatments. As an American trained physician and now as a fellow dialyzor, I am indeed ashamed of our uniquely American approach to dialysis due to the thousands of patients who have needlessly suffered and died. Until the American nephrology community stands up and embraces optimal dialysis practices, only the holy grail of an impossible to accomplish RCT will prevail. It is in the hands of the nephrology community to stand up and establish the international standard as our standard.

My only question is whether my nephrology colleagues have the courage to do what is right? Only time will tell, but it is my prayer that it is done soon.

[Peter Laird, MD]

Thank you Dr. Gromko for your kind comments here as well as those on your blog. It has been established many times over that conventional incenter dialysis is not the treatment option that physicians would choose for themselves if they could not obtain a preemptive transplant. Isn't it time that they encourage their colleagues to offer what they would choose for themselves to their patients? Not to do so is the ultimate hypocrisy.

[Roberta Mikles]

Peter,

As a new dialysis patient safety advocate, (5 years) not new to hospital safety advocacy, I am just shaking my head as I read your post and become even more educated to this system that one has to wonder how could this have happened? My question is “What would it take to change this system of only accepting randomized controlled trials?” As you stated “the obvious is ignored to the detriment of the majority of dialysis patients” perhaps shows that those who make up these guidelines, rules, etc., do not have a clear understanding, or a being pressured by an underlying system perhaps of profit???? When other countries “….look upon our approach with distain…………” one has to also wonder how these who set rules, guidelines, etc. can hold their heads up. Sorry to have to state it that way, however, I have been stating for my time in advocacy that perhaps those who deliver care and those who set rules, etc, should place themselves in the dialyzor’s shoes. As long as I have been doing advocacy (twenty years plus) my first and foremost question to physicians, nurses legislators, etc. is “What would you want if this was for you or a loved one?” (that which Dr. Gromko also stated).And, going back to my pet-peeve --- all one has to do is to review ‘some’ dialysis survey findings to certainly understand that it is SAFER to do home than incenter.

It is sad that the nephrology community can establish the community standard for optimal dialysis when aware of the complications, problems, etc. and not acting in the best interest of their patients (not all providers, of course) So, if the insurance companies and CMS set the standards for the dialysis community, then we advocates need to reach out to the insurance companies. For example, many do not reimburse for certain avoidable errors, therefore, showing they may support safe care. Why can’t this happen for dialysis as well. To recall, I have made suggestions, on various levels, to many individuals, that insurance companies that pay outrageous amounts for dialysis should be receiving not only dialysis facility survey reports, but data on complications, hospitalizations, preventable errors, etc. Insurance companies could save millions if they adopted the same thinking for dialysis facilities as they do for hospitals, e.g. non-reimbursement for preventable errors (some). Would this force providers to support and encourage home dialysis more by setting up more and more home dialysis programs??
As far as CMS, at this point in my advocacy I understand that the intent is there to set guidelines for quality safe care, however, it just not seem to be working.

How can many of our legislators profess (and providers) that the delivery of dialysis care is so outstanding when other countries proved different?

As you said, will your nephrology colleagues have the courage to do what is right…. That is the question and what prevents them from doing so? I remember once saying to a family member’s cardiologist, in a medical emergency, “what would you do if this was your father?” And, that I say to all the nephrologists and providers, “what would you want for yourself, or a loved one?

Perhaps if we had all those celebrities who received a kidney transplant, who were on dialysis a short time support advocating for improved delivery of care incenter e.g. every other day dialysis, and to support home dialysis, we would see some change???? Just a thought.

Lori, I agree with what you said also. If the kidney community knows this, and we all know they are aware of such, then why haven’t they pushed harder for what is best for patients? It is my belief that if providers, over the last many years, would have spent their lobbying fortunes of monies on supporting home dialysis perhaps lives would have been saved, patients would have continued to work longer and those doing home would have had the opportunity to have that quality of life as those of us who do not need dialysis of which occupies hours of our lives.

Peter, Lori, Bill, Dr. Gromko.. thank you all for your efforts and continued advocacy,,, perhaps we will make a difference in lives in this new year........saving lives.
Roberta

[Roberta Mikles]

all one has to do is to review ‘some’ dialysis survey findings to certainly understand that it is SAFER to do home than incenter.

The above --- correction.......All one has to do is review 'some' dialysis survey findings to certainly understand that it is SAFER and PROVIDES IMPROVED QUALITY OF LIFE when patients do home dialysis.

roberta

[Sally Burrows-Hudson]

Sometimes neither history nor science can stand on it's own. Yet we have both as strong evidence that supports outcomes that may benefit the person with CKD on dialysis. So what is/are the barrier(s)? Politics? Money? Fact is there is no ground swell of people - patients, families, caregivers - making loud informed noise. We need more people who are experiencing the sharp end of the needle to engage in and further the dialog - questioning the policy makers, the insurance companies, the politicians, the scientists and academicians. Healthcare providers, as a whole, are not going to try to change the status quo without an RCT - some will, but the majority will not step out of line. The voices that will be listened to are those coming from all patients demanding more effective treatment and care. Will those people speak out?

[Roberta Mikles]

Sally, I am always willing to work with other advocates to address insurance companies, legislators, etc....
Roberta