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October 15, 2010


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Anna Bennett

"Today, once again in America, under a government controlled program, dialysis patients are the subject of intense study..."

Peter, in this case, I am going to have to disagree with you.

From my POV, people on dialysis have been ignored, marginalized and written off. You are implying that the government is behind all of this, yet, when I look at outcomes and compare countries, the difference is that in the United States, dialysis is a profit center for LDO's. DaVita could not exist in Australia. I don't know enough about Japan and their payment structure for dialysis. France too, is government run, and now that the EU seems to be adopting High Dose Home Hemodialysis (at least the UK and Italy - France already does some good work in center), we just need to keep spreading the word.

The men of Tuskegee were victims of government sponsored medical trials, and it is a travesty. People suffering in center are at the hands of their provider, yes, eventually funded by medicare, but the budgeting, planning and hiring comes from the corporate level.

Bill Peckham

I agree that calling dialysis a government controlled program is a stretch however, I think it is an apt analogy in terms of consent.

The lack of informed consent is a key driver of the incenter production line. That's not due to government oversight, rather it is in spite of government oversight.

Peter Laird, MD

Dear Anna, Bill's response to me when he reviewed my post was simply one word: provocative. It is a post designed to be provocative and get people's attention. I do believe that ultimately, CMS who oversees the entire ESRD program and supervises through guidelines all of the dialysis units in America is a direct respondent in whatever is wrong in American dialysis units. In fact, CMS and their policy of not paying for optimal dialysis strategies while waiting for an RCT is one of the biggest factors in why it has not yet been implemented. DSEN has posted many responses on that issue alone as well as appeals directly to CMS and Dr. Straube to change that policy which to date they have not.

I do not in the least diminish the responsibility that corporate dialysis plays in this travesty. By simple numbers,the number of people actually harmed by the Tuskegee travesty is overwhelmed by what we suffer in just one week of conventional incenter care from what could be prevented by adopting today optimal dialysis in America.

Lastly, I lay the largest responsibility not on the government, not on the corporations, but on my colleagues in nephrology who could at the stroke of a pen improve care in America over night. Only nephrologists prescribe dialysis care, not CMS, not corporate America. It is time for my colleagues in nephrology to accept what all other industrialized nations accept and adopt longer, more frequent and gentler dialysis prescriptions. Ultimately, the nephrologist has 100% responsibility for their individual patients. Yet, they do not operate outside of the government run ESRD program but are a part of it, just as are the corporations.

As always, I appreciate and respect your opinions on all of these matters and further greatly appreciate Bill's courage to post articles that he does not always fully agree with himself. He should probably have a disclaimer preset just for me on some of my posts.

I do believe that there is a comparison between the present situation in America and not applying effective treatment options, not informing the majority of patients about these options and letting people die needlessly while waiting for knowledge to accumulate. If we wish to disagree on who is to blame for this mess, that is one issue, but I doubt that we disagree on the fundamentals of what is wrong.

Anna Bennett

"In fact, CMS and their policy of not paying for optimal dialysis strategies while waiting for an RCT is one of the biggest factors in why it has not yet been implemented."

Huh? Last time I checked, CMS/Medicare pays for HDHD. It pays for Nocturnal in center. (Why don't more centers offer it?)

Peter, you post is provocative, I would go so far as to say inflammatory - and slightly misleading. The tragedies of Tuskegee and Bill's mention of informed consent (the only time I see those words)are worlds apart from the strides that have been made.

I am advocating for dialysis patients not to be victims. You are writing with a using a very harsh example that they are victims. It is time to be proactive, empowering and to stop placing blame.

The government oversite is in place to maintain a MINIMUM standard for dialysis - for health and safety. It is just sad that the Business of Dialysis is only wanting to fulfill the minimum and profit from what corners it can cut. The profit should be health.

I would prefer less grandstanding with dramatic editorials, and more attempts at finding solutions. We don't need to manufacture drama, we see enough of it every day.

Peter Laird, MD

Bill, I agree with the informed consent issue, but I would hope we do not diminish the fight that has been ongoing for a long time over the requirement by CMS for an RCT before widespread implementation of optimal dialysis strategies in America.

Anna, as far as dramatic editorials, that is all that CMS, corporate America and the majority of practicing nephrologists leave us today. The data has been there for decades and they ignore it. Unfortunately, the majority of American dialysis patients undergoing conventional dialysis care are victims of the system. As Bill is fond of stating, your zip code determines your longevity probably more than anything else when you start dialysis.

The issue of an RCT for CMS is one at the heart of this discussion since most coroporate health providers mimic precisely the CMS standards in their programs. They can't do otherwise as the program is set up. Perhaps that could change over night as well, and that is my hope that it will soon.

Once again, there are many characters responsible for the travesty in American dialysis with the highest death rate in the industrialized nations. We have the information already on how to overcome this, yet it is not implemented to date on a wide circle, only in isolated pockets. The greatest obstacle to implementing this knowledge nationwide is the wall between part A and part B of Medicare. There is only one entity that can break down that wall, CMS themselves. The corporate impasse between these two government controlled entities is where the entire argument is at. The LDO's are not responsible for the hospitalizations that their money saving incentives lead to. This is the disconnect that I lay at the feet of CMS alone. Many have rightfully called for the wall between part A and part B to collapse, but it is still there.

Not to disagree for sake of disagreement alone, but in my opinion CMS is a great part of this impasse and shairs joint responsibility with corporate dialysis and nephrologists alike. The knowledge of how to do dialysis better is here already on a clinical basis. Yet it is not implemented do to beaurocratic payment schedules that corporate America maximizes to their profit. On that issue, there is no disagreement.

Anna Bennett

No Peter, we don't need dramatic headlines. This isn't Fox News. Why detract from something already dramatic enough?

If you want to change CMS, point out where the bottleneck is. What RCT study are you talking about? What extra payment are you asking for? We need action items, not pot stirrers.

What units aren't offering Home Hemo? The editorial that you wrote was simply pointing fingers. I hope that people who read the post above bother to read into the comments, as for me, my comments for this stop here. If you can illuminate an action point rather than just flame a fire of dissent, I'd appreciate it. Let's get to work - people are dying out there.

Peter Laird, MD

Dear Anna,

With all due respect, I already called for action from my nephrology colleagues at the stroke of their prescription pads to enact the simple type of changes that my nephrologist already did years ago in his unit. For instance, he dialyzes ALL patients for four hours with each dialysis session. In 2008, he already with NO additional payments improved annual survival from 20% to 7% over a seven year period of time. This is not yet enacted nationwide.

In addition, he has focused on anemia management with one of the top FMC outcomes in the nation. Added to that is a focus on overcoming malnutrition which is a known survival risk. These he did at the stroke of his pen without any additional payments whatsoever.

There are in fact many issues that the nephrologists, the corporate dialysis units and CMS together need to bring to fruition instead of continually placing them under study. The sad thing is that many of these reforms that we already know and understand will actually save not only lives, but money for the entire system as well.

As far as the NIH sponsored studies I am referring to, I would remind you of your own post on this same subject nearly two years ago that actually echos quite dramatically many of the same points I just brought up in my post. I am not sure how you completely divorce the government's involvement with corporate dialysis organizations and take offense to my analogy. There are many indeed that are to blame, as you pointed out in your own post. It is indeed time to enact many simple and affordable changes in dialysis practice that will actually save the ESRD program millions while at the same time saving lives.


Dori Schatell

Hi Anna. Per our database on Home Dialysis Central:
-- 899 clinics offer conventional (3x/week) home HD
-- 807 offer short daily home HD
-- 497 offer nocturnal home HD.
-- We also list 233 as having in-center nocturnal--but we are least certain of these (and relatively sure there are more.

The GOOD news is, these numbers are hugely up from 2004 when we launched our site:
-- 294 offered conventional home HD
-- 37 offered short daily home HD
-- 73 offered nocturnal home HD

The BAD news is...there are about 5000 dialysis clinics in the U.S. So, fewer than 20% of clinics offer ANY type of home HD.

The Medicare Conditions for Coverage now require clinics to educate patients about ALL of their treatment options and where to get them. Is this happening? I doubt it. I've talked to folks who started treatment recently and did not find out about home options of any type until they called our office. Maybe folks are being "educated" during the last hour of in-center treatment when they're unlikely to remember anything. Perhaps that's on purpose, and perhaps not. And, it's easy to scare folks away from better home therapies. "There are no professionals at home to take care of you!..."

I'm not averse to a bit of headline grabbing if it brings more attention to the issues of "adequate" (NOT) dialysis. Adults learn from analogies, and this one may resonate, even though it's not an exact parallel in several ways (intent, in particular, as you've pointed out). Yes, we need solutions. But we also need CMS to pay attention to the fact that the way standard in-center HD is done today is sentencing far too many people to unnecessarily shortened lifespans and diminished quality of life.

Anna Bennett

Peter, you just suck me back in, just like Somerville... It is a weakness.

Thanks for reminding me of that post. I loved that post. And I loved calling Glen Chertow out on what he was doing two years ago. Fingers crossed, as you wrote recently, he is giving the key note at ASN. I wonder has he changed his mind now, two years later?

In 2008, back when I wrote that post,I wanted to write to effect the bundle and guess what, CMS is paying for Home Hemo! Training too! I was so happy to read that in the final rule this Summer (2010).

If I must say so myself, that post is an example of calling someone out, offering rebuttal, and showing that there is a better way. How did you do that in the Tuskegee post?

Also, I took it that when you spoke of the government, you were referring to CMS. (It must have been those CMS references that boggled me). Yes, NIH = Government, but NIH does not equal CMS as to the over-site of dialysis payments CMS solicits everyone when they are writing their rules (at least in comments). But then again, Army/Navy same thing, right? It's all military. NIH/CMS it's all medical.... Maybe NOT.

I applaud your Nephrologist for doing his job for the pay that was offered. I wish they all would do that. Bad, bad government for not offering them more financial incentive to do what is RIGHT and AVAILABLE.

Dori, thanks for the numbers, and also for showing that slowly there is growth in the right direction. I wish it were faster. We wrote to CMS to change the bundle.

My suggestion would be to focus and then rally the troops again for whatever issue is pending (and there are plenty to choose from). I knew how the NIH study would affect the bundle two years ago, and I wrote to deflate its impact. What are you taking aim at now Peter?

Is it policing the units to make sure everyone knows what is available? Is it educating the very few who are on-line and hoping that they pick up momentum? If I had my way, I would make www.KidneySchool.org mandatory for every person with CKD4, maybe then fewer will transition.

Focus and target and change things. Did Peter achieve his goal of inflaming people - well, in my case he did. Wish he hadn't. I was already focused and targeted, now I can add disappointed and annoyed to the mix.

Peter Laird, MD

The truth of the matter is that action has been slow and studies many. The point of my post is to combine a call to action with a call for further studies right now. We already have much information on how to imprvove dialysis care with absolutely no need for further study in many areas. The title of my post is a question that I did not answer in my post. For some, the answer may well be no, it is not like the Tuskegee study at all and I respect that opinion. Once again, Bill has the courage to not delete comments that he does not agree with including my own from time to time that he respects but does not agree with.

For others that recognize the impact that the holy grail of randomized and controlled trials has already had in negatively impacting dialysis care in America and the thousands if not millions of people who died earlier than they should have, that answer for them might be an emphatic yes. I will leave it for all readers to answer that question for themselves.

Anna Bennett

Oh Peter, I still can't believe that you are comparing deliberate withholding of treatment in minority underprivileged men in the south with a bunch of doctors in California measuring forearms in dialysis units.

The behavioral modification treatment for Sarcopenia (age related muscle wasting)is Exercise. What would the control group be? People who exercise vs. people who don't exercise? Would the study withhold gym membership and amino acids? Yeah, that is akin to withholding penicillin - in what world?

Zach over at IHD has been running his own anti sarcopenia study for a while, he advocates exercise daily for a better and longer life on dialysis.

My point is, there are battles to be fought, but comparing Tuskegee to today and citing a random (heh) RCT is simply inflammatory editorial - I still don't get the point.


Conducting truly random, controlled studies of the effect of intensive home hemodialysis and then precisely quantifying its benefits so these can be compared with the costs in the patient's burden of self-care, Medicare's contribution to start-up expenses, and the demand on national medical resources is not only important but also quite difficult. From a purely scientific point of view, not the benefits but the net cost-benefits of intensive home hemodialysis are still disputed. (P. Anantharman and A. Moss, "Should the Medicare ESRD Program Pay for Daily Dialysis?" Advances in Chronic Kidney Disease, vol. 14, no. 3, p. 290 (2007))

The government ultimately has to accept the blame for the inadequacy of the present dialysis program in the United States, since it could always pass regulatory legislation which would require the necessary improvements in dialysis treatment to be introduced, yet it does not. Instead, on the contrary, it follows a deliberately lax inspection routine for dialysis centers so they can maximize their profits while cutting patient services without being caught.

I doubt that enlisting nephrologists as the engine of reform to promote daily dialysis will work, since so many of them have now become owners of their own for-profit dialysis clinics, or are otherwise benefited by their alliance with capitalist interests invested in the currently predominant but inadequate modes of treatment.

Since 44% of dialysis patients offered daily dialysis refuse that option even after its health benefits are explained to them, I suspect that more intensive efforts to ensure their informed consent to their treatment modality would not have much impact on the number electing daily dialysis. (S Halpern,"Willingness of Patients to Switch from Conventional to Daily Hemodialysis," American Journal of Medicine, vol. 116, no. 9, p. 606 (2004)) Patients may quite rationally judge the burden of self-care with home daily hemodialysis to make the net value of their lives worse, rather than better, than thrice-weekly hemodialysis when they balance the gain in health and life expectancy against the massive burdens of the treatment.

A thought-experiment to clarify this issue would be to imagine how dialysis patients would respond to clinical studies showing that dialysis performed all day, all night, everyday and forever would yield vast improvements in patient health and life expectancy, as might in fact be the case. Would anyone elect this option even with this evidence of clinical benefit, or would patients rationally prefer a worse state of health and an earlier death to living a life of perpetual dialysis? Since it would seem insane to prefer perpetual dialysis for any gains in health and life expectancy, the rationality of trading away some gains in health and life expectancy to escape the excessive burdens of treatment is clear.

Anna Bennett

"since it could always pass regulatory legislation which would require the necessary improvements in dialysis treatment to be introduced, yet it does not."

Ok, now we are getting closer....

What regulatory Legislation do you want passed?

Do you want to nationalize the units?

Peter Laird, MD

Dear Somerville, the fact remains that we know many ways today already on how to improve care in American dialysis unit that has not yet been translated into actual care practices at the point of service. You are correct that no one would want or advocate or even consider 24/7 dialysis EXCEPT as an implantable device. So your thought experiment is not valid since you excluded the consideration of an implantable device which many believe, not just as a thought experiment, that the implantable device will do exactly as you state in your thought experiment, except without all of the complications of usual care dialysis as we know it today.

The actions I listed above are the point of the post. Anna, I understand you take exception to the analogy with Tuskegee and it was never my intention to be anymore than provocative, not inflammatory as you stated earlier. If it was over the top for you or anyone else, I do apologize. My intentions were simply a call to action instead of inaction and many issues that we already know that are not yet implemted, but instead we call for more studies.

FIrst: "It is time to implement and not simply study effective measures now as many patients do not have the time to wait for a randomized and controlled trial to confirm what we already know."

Second: "I would hope that the American academic nephrology community would not only call for more studies, but better yet, call their nephrology colleagues to action. Lives are lost daily because we have yet to act upon that which we already know."

Anna Bennett

Peter, I hope that you see what I find maddening/inflamatory. It is perfectly exemplified in your last comment:

First: "It is time to implement and not simply study effective measures... "

Second: "...not only call for more studies, but better yet, call their nephrology colleagues to action... "

You have to admit, they are slightly contradictory in meaning. But I get that.

Now for the nuts and bolts: WHAT DO YOU WANT THEM TO CALL FOR??? Offer more access to HDHD?

But now that the fire was lit in these comments - hey, I took that bait. What specially do you want to ask?

CMS is paying for HDHD, so why aren't you offering it?

Are you trying to say that CMS isn't paying for HDHD? If so, shhh don't tell DaVita or they'll start pulling machines.

My point is, we can't just rail on with this type of editorial, if we aren't prepared to offer some constructive insight into the problem. Blaming the government is all too easy, and I am so sick of hearing the blame game from all sides, that I can't imagine in this political climate that any substantive change can be made when all people do is try to out blame one another.

David W. Moskowitz MD, MA(Oxon.), FACP

Glad to see somebody else use the Tuskegee analogy. It was the topic of my article about dialysis a year ago: http://tinyurl.com/healthcrime. My reason was different than Dr Laird's.

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