Should the Medicare ESRD Program Pay for Daily Dialysis? An Ethical Analysis

Discussions for Patients, Family, and Friends HD For Patients
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There is an article online from the National Kidney Foundation in their journal “Advances in Chronic Kidney Disease” - the current issue (2007 07 [Vol. 14, Issue 3]) Should the Medicare ESRD Program Pay for Daily Dialysis? An Ethical Analysis by Anantharaman P and Moss AH.

The authors evaluate the ethics involved in deciding if Medicare (and by extension payers generally) should fund more frequent treatments. The authors suggest that Medicare should use “ethically appropriate criteria such as the likelihood of benefit, urgency of need, change in quality of life, duration of benefit, patient selection, the amount of resources required, and equitable distribution of those resources.” The authors then evaluate the data against each of their criteria. Their conclusion is that funding is not justified

For the authors it all comes down to we don’t have enough data to decide that SDH successfully meets three criteria: likelihood of benefit, urgency of need, duration of benefit. The biggest problem I have with this is that they are not acknowledging that the three times a week standard dose was never vetted through large scale clinical trials. Has the “dialysis weekend” ever been medically justified?

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Bill.

Does the article compare the costs? Is daily significantly more expensive than thrice weekly? My understanding is that the costs are realitively similar.

Do the authors evaluate the economic impact of what a dialy dialysis patient contributes compared to a thrice weekly patient? I am incredibly more productive on daily than I ever was on thrice weekly or PD.

Thanks for the post. Erich

3

The article is trying to convey that if the patient is not dying there’s no purpose of paying for additional medical services. If the patient can still live at 3x per week then let it be…

What I think about this? INMUMANE…perhaps, TORTURE?..this is ethical…

4

My monthly bills for daily are approximately $14,000 per month. This always seemed like a lot until I’ve read on other boards that 3x a week people are seeing their insurance pay upwards to $30,000 per month. What are the rest of you paying, if you know.

Cathy

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[quote=Cathy S;13949]My monthly bills for daily are approximately $14,000 per month. This always seemed like a lot until I’ve read on other boards that 3x a week people are seeing their insurance pay upwards to $30,000 per month. What are the rest of you paying, if you know.

Cathy[/quote]

On my early days of dialysis, under my Father’s private insurance plan they would charge up to $75,000

6

I don’t have the patience to read the entire article now (perhaps it’s my ADD), so I’m just going to shot from my hip.

It’s seems obvious that the real cost of ongoing treatments at home should be less tha in-center. Overhead would be less with the RNs and Techs necessary at in-center (sure, we have RN’s too), and less space is required for a home-only clinic than in-center. However, more machines would be required for home dialysis since they are not shared, but I believe that cost really isn’t that much and decreases as volume goes up (just like personal computers). I also believe industry companies like NxStage and FMC are in it for the “razor blade” side of the business; they want to manufacture and sell the consumables; witness the recent purchase of Medisystems by NxStage.

It really irritates me when incomplete analysis is done (okay, I’m being hypocritical; I didn’t read the complete article). Here’s a guy who did a previous article on palliative care of dialysis patients and I did read more of that article. He’s talking about the necessity of Nephrodocs gettiing more involved with the deaths of their pts. How can we expect him to also write on AN Ethical Analysis of whether Medicare should pay more for ESRD. Cc’mon, give me a break! it reminds me of the days when some talked about aged and sick people just put away. Is the data available to perform a complete analysis which the authors claim isn’t there? Perhaps so, or maybe not. But it doesn’t help that COngress won’t pass any new legislation that would in part colect the kind of data the authors say is necessary. So we’re kind of between a rock and a hard place.

The bureaucrats also refuse to look at costs in the aggregate. WHy not try combining Part A and B costs together to see a more complete picture of real costs affecting Medicare? And add in Part D as well, even though many of us aren’t pafrticipating in that portion of Medicare.

I could probably rant on now, but at this point I think I lost my train of thought. SO I’l just ring in later, But Bill, this did raise my dander!

7

Arghh!!! Now that I’ve finally found time (a broken ankle will slow you down enough to do that) to read the full-length article, I’m just as appalled as I feared I’d be. I took a medical ethics class in college taught by two national experts (one of whom I still run into periodically on airplanes), and just don’t believe that they would have come to the same conclusion based on the available evidence. So, let me object to this point by point:
• Likelihood of benefit - Let’s see, the number one cause of death on dialysis (as in the general public) is heart disease (generally left ventricular hypertrophy)–which is worsened by high blood pressure. The authors acknowledge that short daily HD (SHD) improves blood pressure and can help regress left ventricular mass. So, it directly impacts this vital problem. Yet, somehow, they managed to cite a positive article about SHD that reported AV fistula patency of 92% (#28, Woods JD et al) as claiming vascular access problems with SHD, an article from 1968 (#43–how relevant is that likely to be to today’s vascular access outcomes?), an article about benefits of nocturnal dialysis (#44), and two reports about home dialysis machines (#45, #46)–which are not even studies. Hmmm. If we can’t trust the references in one section to prove their point, how can we trust any of the others?

In this section, the authors state, “To date, the data on the net benefits of daily dialysis have only shown improved outcomes for some clinical endpoints like blood pressure control and quality of life, and these findings have only been in small clinical trials. There have not been any large-scale clinical trials attesting to the positive impact of daily dialysis on other clinical outcomes.” Um, yeah. So, they’ve found improvements in the clinical endpoints that point directly to morbidity and mortality, but without “large scale clinical trials.” I’d love to know where the “large scale clinical trials” of Kt/V urea as a measure of dialysis dose are, since so much of the “evidence-based medicine” in dialysis rests on this premise. And, as Bill so aptly pointed out, where are the large-scale clinical trials proving the benefit of conventional hemodialysis?. Oh yeah. There aren’t any.

Urgency of Need - How the authors can claim in one paragraph that the high mortality rate of U.S. dialysis patients (~21%/year) creates an urgency to do something–but then say in the next there isn’t “sufficient evidence yet to conclude that the ethical criterion of urgency of need argues for funding of daily dialysis,” frankly boggles the mind. Each year, more than 24 times as many Americans die on dialysis as were killed in the 911 attack in New York. We spent billions after 911 to support the families who had losses. What are people on dialysis worth? What constitutes “sufficent” evidence?

Change in Quality of Life - Yay–the authors believe this criterion is met. I wonder if they are aware that physical and mental functioning (aspects of health related quality of life measured by standard tools) predict morbidity and mortality?. So, heading back to the “Likelihood of Benefit” category, I would say that they need to revise that criterion to met as well.

Duration of Benefit - Interestingly, the authors fail to cite the (admittedly small) studies that have demonstrated survival benefits of SHD over CHD. Perhaps they weren’t aware of them? I believe that they are incorrect that this criterion has not been met.

Interestingly, under Patient Selection, the authors seem to think that because every patient is not a candidate for SHD, that no-one should have it funded. Good thing this wasn’t the decision for PD or transplant! And fascinating that CHD–with its documented poor outcomes–seems to be an acceptable “default” modality that anyone can do. (At least for a while…)

Frankly, I get the sense that the authors had some reason for wanting to maintain the status quo, though I can’t imagine what that would be.

8

[quote=Dori Schatell;13987]Arghh!!! Now that I’ve finally found time (a broken ankle will slow you down enough to do that) to read the full-length article, I’m just as appalled as I feared I’d be. I took a medical ethics class in college taught by two national experts (one of whom I still run into periodically on airplanes), and just don’t believe that they would have come to the same conclusion based on the available evidence. So, let me object to this point by point:
• Likelihood of benefit - Let’s see, the number one cause of death on dialysis (as in the general public) is heart disease (generally left ventricular hypertrophy)–which is worsened by high blood pressure. The authors acknowledge that short daily HD (SHD) improves blood pressure and can help regress left ventricular mass. So, it directly impacts this vital problem. Yet, somehow, they managed to cite a positive article about SHD that reported AV fistula patency of 92% (#28, Woods JD et al) as claiming vascular access problems with SHD, an article from 1968 (#43–how relevant is that likely to be to today’s vascular access outcomes?), an article about benefits of nocturnal dialysis (#44), and two reports about home dialysis machines (#45, #46)–which are not even studies. Hmmm. If we can’t trust the references in one section to prove their point, how can we trust any of the others?

In this section, the authors state, “To date, the data on the net benefits of daily dialysis have only shown improved outcomes for some clinical endpoints like blood pressure control and quality of life, and these findings have only been in small clinical trials. There have not been any large-scale clinical trials attesting to the positive impact of daily dialysis on other clinical outcomes.” Um, yeah. So, they’ve found improvements in the clinical endpoints that point directly to morbidity and mortality, but without “large scale clinical trials.” I’d love to know where the “large scale clinical trials” of Kt/V urea as a measure of dialysis dose are, since so much of the “evidence-based medicine” in dialysis rests on this premise. And, as Bill so aptly pointed out, where are the large-scale clinical trials proving the benefit of conventional hemodialysis?. Oh yeah. There aren’t any.

Urgency of Need - How the authors can claim in one paragraph that the high mortality rate of U.S. dialysis patients (~21%/year) creates an urgency to do something–but then say in the next there isn’t “sufficient evidence yet to conclude that the ethical criterion of urgency of need argues for funding of daily dialysis,” frankly boggles the mind. Each year, more than 24 times as many Americans die on dialysis as were killed in the 911 attack in New York. We spent billions after 911 to support the families who had losses. What are people on dialysis worth? What constitutes “sufficent” evidence?

Change in Quality of Life - Yay–the authors believe this criterion is met. I wonder if they are aware that physical and mental functioning (aspects of health related quality of life measured by standard tools) predict morbidity and mortality?. So, heading back to the “Likelihood of Benefit” category, I would say that they need to revise that criterion to met as well.

Duration of Benefit - Interestingly, the authors fail to cite the (admittedly small) studies that have demonstrated survival benefits of SHD over CHD. Perhaps they weren’t aware of them? I believe that they are incorrect that this criterion has not been met.

Interestingly, under Patient Selection, the authors seem to think that because every patient is not a candidate for SHD, that no-one should have it funded. Good thing this wasn’t the decision for PD or transplant! And fascinating that CHD–with its documented poor outcomes–seems to be an acceptable “default” modality that anyone can do. (At least for a while…)

Frankly, I get the sense that the authors had some reason for wanting to maintain the status quo, though I can’t imagine what that would be.[/quote]

Give 'em hell,Dori!

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[QUOTE=Dori Schatell;13987]Arghh!!!
Frankly, I get the sense that the authors had some reason for wanting to maintain the status quo, though I can’t imagine what that would be.[/QUOTE]

It’s an unfortunate fact, but when researchers decide to write on a particular subject, they often have a result in mind and by necessity only try to find data to support their objective.

Here’s the story on Alvin Moss, one of the authors. You tell me which direction he wants to go in.

Alvin H. Moss, MD, is the Director of the Center for Health Ethics and Law and a Professor of Medicine at the Robert C. Byrd Health Sciences Center of West Virginia University. He is a graduate of Harvard University and the University of Pennsylvania School of Medicine. He is a practicing internist, nephrologist, and palliative care specialist. His interest in medical ethics grew out of his involvement with renal dialysis and transplantation.

He was a participant in the National Leadership Training Program for Physicians in Clinical Medical Ethics at the University of Chicago supported by the Pew Charitable Trusts and the Henry J. Kaiser Family Foundation. Dr. Moss is the chairman of the Hospital Ethics Committee and medical director of the Palliative Care Consultation Service at West Virginia University Hospitals. He is the Executive Director of the West Virginia Center for End-of-Life Care and is certified by the American Medical Association’s Education Program for Physicians in End-of-Life Care (EPEC). He chaired the working group of the Renal Physicians Association and the American Society of Nephrology that developed the clinical practice guideline, “Shared Decision Making in the Appropriate Initiation of and Withdrawal from Dialysis.” He chaired the End-Stage Renal Disease Peer Work Group for the Robert Wood Johnson Foundation-funded national program, Promoting Excellence in End-of-Life Care, which published recommendations to the field on how to improve end-of-life care for dialysis patients.

His research interests include dialysis ethics, advance care planning, and improving care at the end of life.

I hate to say it, but does this guy really care about extending the life of CKD patients. Maybe his next study will be on the efficacy and cost savings of doing dialysis once per week! I’m sure he’d get alot more patients for his -end-of life studies. As for me, I’m going to continue with SIX treatments per week, and continue to press for more Medicare funding. ANd since I started SDD, I’ve got the energy to do it. Perhaps that’s just one of the positive outcomes of daily home dialysis???

10

I’ve had the same thought, Rich–you have to wonder whether in the effort to help people on dialysis have good deaths (a worthwhile goal), Dr. Moss is neglecting the responsibility to prolong life through better, more physiological treatment.

I also have to wonder whether an ethical analysis that was not based on the status quo would come out with the same result. What if, instead of assuming in-center hemo 3x/week, he repeated this analysis in a more neutral way? The results might be very different. IMHO, the presumption that standard, in-center hemo is the default treatment suitable for everyone is the biggest flaw in his argument–as Bill pointed out in his first post.

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Yes why not test Rich’s one day a week and also two, three, four … seven. With the worst outcomes in the world we should be challenging our premises.

12

Wait a minute, Bill! I’m not volunteering for the sliding scale study; I would just assume that Dr. Moss find others for that.

13

I’d do a one run a week schedule.

Just as long as the run was 168 hours long - wearable kidney?