“NIH More Frequent Dialysis Studies in a Nutshell.”

Discussions for Patients, Family, and Friends HD For Patients
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The Home Dialysis Central Topic of the Month is “NIH More Frequent Dialysis Studies in a Nutshell.” In my judgment these studies represent a temporizing, “Let’s study the problem” response to the overwhelming evidence of the pronounced benefits of more frequent vs. thrice-weekly dialysis. I suspect their real purpose is to provide an excuse for CMS to delay reimbursement for more frequent dialysis for many years. As I understand it, the first four years of the NIH program will be spent determining if patients can, in fact, be successfully randomized between the two groups. If so, then the subsequent five years will be devoted to the comparative study.

The first result will be to confirm a decade from now what we already know – that patients on more frequent dialysis live much longer and lead much higher quality lives than those on thrice-weekly dialysis. The second result will be that most of the patients now on thrice-weekly dialysis will be dead by the time the report is published and CMS has finally exhausted excuses not to cover this superior mode of treatment for ESRD patients.

The policy choice to pursue these studies rather than immediately cover more frequent dialysis and thus save countless lives seems unconscionable. I have written to the Inspector General of the Department of Health and Human Services requesting that the Secretary commission an independent ethics review of this policy choice by CMS and NIH. At the heart of the issue is the conflict between the optimum economic model for dialysis and the optimum clinical model for dialysis. My letter is much too long to publish here, but I would be happy to send anyone who is interested in this subject a copy if you will email me at mhodge@aol.com.

Mel

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Mel the one thing I disagree with is the idea that you could have written a letter too long to post here.

CMS could decide tomorrow to authorize a forth payment for anyone who dialyzes five or more times in a week. As it now stands one can get a forth payment authorized with medical justification so I think CMS should rule that dialyzing five or more times in a week implies medical justification. Simple and it could be done tomorrow. I think it is clear to any thoughtful observer that if someone voluntarily decides to dialyze five or more times in a week there must be a reason, it must make one feel better.

I’m with Mel this frustrates me to no end.

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Hi y’all,

Mel, I do share your frustration with this study–its premise is essentially that despite the multitude of small studies all showing benefit (for an improvement in treatment that is really common-sense anyway), they’re not random. This means that there are still folks out there (and I know some) who say that the sole reason for the improved outcomes is that “better” patients are self-selecting for these treatments, and these patients would do better no matter which treatments they chose.

I disagree. But the next 5 or 8 or 10 years will go by anyway, with or without the “definitive” study. Where will we be at the end of that time period if we haven’t collected the only data that CMS appears to be willing to accept in order to pay for that 4th treatment? Nowhere.

So, we’ve pledged our support to do what we can to make the study a success–while also doing anything in our power to advocate for better reimbursement for dialysis in general and home/more frequent dialysis in particular. Hedging our bets, you might say…

p.s. - I deleted the duplicate post, since you did sign your name at the end of your starting post, Mel, and because I thought it would be confusing for people to have two threads with the same name.

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When I read the above rationale I ask myself what is that suppose to mean? Are the deniers saying that we more frequent dialyzers are deluded? Are the deniers really saying that I would be as healthy, that I would have the same outcomes, if I dialyzed in center; that I am just wasting my time? Are the deniers saying that I can’t judge my own well-being?

If I had the opportunity to talk with a denier I would ask what is the downside of offering every American the opportunity to dialyze more frequently? Money? Are the Nephrologist who deny the benefit of more frequent dialysis choosing to speak on behalf of tax payors over people on dialysis? I would also ask where are the randomized, double blind studies showing that the preferred dialysis regime should be three treatments a week for 3 to 4 hours?

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Hi y’all,

Bill wrote:

Are the deniers really saying that I would be as healthy, that I would have the same outcomes, if I dialyzed in center; that I am just wasting my time? Are the deniers saying that can’t judge my own well-being?

Um, yes, unfortunately that is pretty much what they’re saying–that no matter which treatment you chose, you’d still do fine. And, in fact, in your particular case, they’d say you already beat the odds by surviving as long as you did on three times a week in-center–traveling and all…

Of course, what they don’t know is how you feel day-to-day–how your energy and appetite are, how able you are to do the things that make life worth living for you. There tends to be very little respect for patients’ “subjective” experience, and, as you well know, the Clinical Practice Guidelines are set up to support the status quo, because they’re based on literature that studies…the status quo. I think a better approach might be to study the folks who did switch from three times a week and use them as their own controls. But the numbers aren’t large enough to get the statistical power you’d need to draw conclusions that you could generalize to the larger population of patients.

I would also ask where are the randomized, double blind studies showing that the preferred dialysis regime should be three treatments a week for 3 to 4 hours?

Nope, there aren’t. That’s partly why this is so terribly frustrating…

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Any idea what ‘n’ would have the statistical power assuming the results scale? Meaning the results stay the same as n increases. As n has increased have outcomes narrowed?

What is the worst case scenario in the deniers view? What would happen if the policy was changed tomorrow? More …? What - hospitalizations? Infections?

Sure I had some success dialyzing incenter but one dialyzes for both today and tomorrow. I know, what I know based on my own experience. Thank you for this web site Dori. Reading posts here I know I’m not imagining anything.

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REDICULOUS!!!

when I arrived for home training my health was bad, bad, bad,bad…the in-center results…

Couple months later, I am a brand new person…the data and proof is there…they see it so if they’re delaying this it has to be for some odd reason that does not benefit the patient at all…but saves them money???..wouldn’t they prefer that patients die sooner and not live long? Isn’t that their worry?? :roll:

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If we had a highly efficient, well thought out health system except that it would only provide dialysis 3x a week then I might think there was a morbid calculus at work. But I think in this case it is inertia and conservatism. An entire industry has grown around 3x a week dialysis and 3xs a week is the path of least resistance.

I agree with Mel - we should raise the price of inertia. An independent body should review the situation and have an open discussion.

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Bill, I tried to follow up on your suggestion to post my letter here, despite its length. Unfortunately, the tables in my letter were garbled when I attempted to paste the Word file here. Unless someone knows how to get around this I’ll have to find time to redo the tables.

Dori, I repectfully disagree that we should “go along” with this decade-long delay in funding frequent dialysis. As I discussed in my letter there are a number of options – for example, last spring CMS developed a policy which they call “Coverage with Evidence Development” which is intended for new treatments that show substantial promise, but for which they would like to develop additional data. This seems to fit frequent dialysis perfectly.

Bill, I don’t believe the problem is inertia. I’m convinced the barrier is money. Frequent dialysis would nearly double the cost for CMS and wreak havoc with the business model of the for-profit dialysis firms even though the evidence shows that CMS would more than recover this cost in savings and surely a new business model could be created (probably based on home dialysis). The national kidney organizations that supposedly are patient advocates have failed to provide leadership which might be ascribed to inertia or more darkly, to acute sensitivity to where their funding comes from. Mostly miserably sick thrice-weekly dialysis patients are thus left with almost nobody working to give them a proven treatment that would materially better the quality and length of their lives – Gus’s testimony illustrates what so many are being denied. I estimate in my letter that the near-decade long delay in coverage pending completeion of the research studies will result in more than a quarter million avoidable deaths.

If this were HIV/AIDS and the government tried to withhold for a decade a treatment that was similar in magnitude of benefit and proof to frequent dialysis for ESRD patients I am certain there would be blood in the streets of Washington. I thinks it’s time for leaders in the dialysis community, particularly those who claim to be patient advocates, to rise up – and to quote an old movie – declare, “I’m mad as hell and I’m not going to take it anymore!”

Mel

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Hi y’all,

Mel said,

Dori, I repectfully disagree that we should “go along” with this decade-long delay in funding frequent dialysis.

Hey, I never said we should just go along with it–I said we would be cooperating fully with the study, while also doing what we can to advocate in the meantime for better funding options.

I’m convinced the barrier is money. Frequent dialysis would nearly double the cost for CMS and wreak havoc with the business model of the for-profit dialysis firms even though the evidence shows that CMS would more than recover this cost in savings and surely a new business model could be created (probably based on home dialysis).

I agree that the barrier is money–but I think it’s fundamentally about the “wall” between Medicare Part A (hospitalization) and Part B (dialysis) such that the Congressional Budget Office refuses to count hospitalization savings as something that ultimately reduces the higher up-front costs of more frequent dialysis.

Help me out, here, though. As a non-business person, how would home dialysis “wreak havoc” with the business model of dialysis providers?

I thinks it’s time for leaders in the dialysis community, particularly those who claim to be patient advocates, to rise up – and to quote an old movie – declare, “I’m mad as hell and I’m not going to take it anymore!”

I agree. I think a number of other disease or disability groups have done a much better job of advocating for their needs than people with ESRD have. The industry–through KCP as well as some of the organizations–has been trying to get patients to take part, but if they’re too successful, they can run into problems because it appears to be coercive, and if they’re not successful…well, you’ve seen how well that’s worked.

Any idea for how to get patients motivated to speak up for themselves? One of the huge barriers I see is that most of them don’t realize there are any treatment alternatives that would make them feel better (and give them the energy to advocate).

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:roll:

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Hi y’all,

Gus wrote:

Most of them are weak, no energy no life! The only way that in-center patients know of these options is that by [b]LAW that clinic social workers are required to explain of these options and also refer them where they can get it if the clinic does not have it…awhile back I mentioned about that…sad but true, in-center patients are not being given this information at all…or they’re denied of their right to choose

Actually, it’s a myth that centers are required to tell patients about all treatment options. In the ESRD Conditions for Coverage (the policy that governs dialysis care in the U.S.), it says that clinics must inform patients of the treatments that THEY OFFER. And nowhere does it say that they must tell patients where to get treatments a clinic doesn’t offer. Only 1/3 of all U.S. clinics offer PD, and only 1/10 offer home hemo of any type.

The Medical Education Institute put together extensive comments on the new draft Conditions for Coverage during the public comment period–and shared them with many other groups–requesting that they be changed so that patients WOULD have a right to be informed of all treatments and where to get them, especially since we’ve made it so easy, on Home Dialysis Central, for any clinic to find this information and share it with patients. CMS has 3 years to incorporate community comments into the Conditions for Coverage and release the final version. If they miss this deadline, the whole public comment process starts over. It’s been 29 years since those regulations were updated, so I hope they make the deadline.

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:stuck_out_tongue:

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Remember the question do you have trust in health care. Well here it is, in your face. No. Because all patients aren’t priviledge to all the resources available in having good health care. And as Gus mentioned patients don’t even have to be informed. The study is a scam. If they took a good look at the Lynchburg Patients and Rubin Patients they would find patients were not cherry picked. They would also find ALL patients improved. Not to mention, what’s wrong with looking at the Canadian Studies. The answers for more frequent dialysis are out there, they just don’t want to know. I also doubt in 5 or 10 years they will want to know either. Every one rightly so makes an issue of patients who die each year waiting for transplants. Where is the outcry for patients waiting to dialyze at home and no program being available. Talk nothing about getting extra treatment most patients can’t even get home. This issue isn’t at all about the patients. If I were to place a bet I’d say it’s all about the money.

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There is a bill in Congress – HR 3096 – that would provide Medicare payment for additional treatments. As of today there are 36 co-sponsors – 29 Democrats, 6 Republicans, and 1 Independent. This bill needs more support before it will ever get before Congress for a vote…and more bi-partisan support. Also, there is no companion bill in the Senate. Having bills in both the House and Senate with lots of co-sponsors usually improves the chances of passage.

To get bills introduced and passed, big corporations can hire lobbyists, contribute money to campaigns, and hold fundraisers for legislators. All we have to get HR 3096 passed are thousands of home dialysis patients. There are around 1300 home hemo patients in the U.S. If each one wrote and called his/her 2 senators and 1 representative we just might get legislative support for this bill and a companion bill introduced in the Senate. We’ve made it fairly easy to write letters. We have a sample letter in the Legislative Action Center on this website. If you put in your zip code, you can send what we drafted or write your own email to go to your elected officials.

Tell other patients who aren’t on this message board about this legislation. Ask clinics to post a notice in the home training area about this legislation and the Home Dialysis Central Legislative Action Center. The patients from WA have done a terrific job of getting WA legislators to co-sponsor this legislation. Now it’s up to the rest of us to do our part.

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I read this thread w/ great interest as I just went through the search for a dialysis clinic for my husband, after having done many weeks of online research which appeared to indicate that home hemodialysis is the best for him. After phone conversations w/ 4 clinics and visits to 2, I was extremely frustrated and very disgusted. :x :roll: :evil: :shock: Thanks to encouragement on this board, I didn’t give up and found a clinic 2 hours away which will train my husband on the NxStage w/ only one week notice that we are coming for training! :smiley:

I will never forget the feelings I had when I got the responses to my questions about home hemodialysis, especially the one dialysis nurse leading the orientation class, who was obviously irritated that I had even asked. Her response was curt and translated to something like, “hemodialysis at home is too difficult for most people to handle” and she changed the subject. :shock: When I asked about stats comparing the different kinds of dialysis, and comparing dialysis in and out of centers, she told me to ask my husband’s nephrologist and changed the subject again. :shock: :evil: :roll:

IOW, I got the impression that no one at 3 of the clinics wants any patient to have dialysis done at home. Are they ignorant, or do they think they are protecting their job, or what? :?

If I made up a generic flyer to be placed in the nephrologist’s office and the dialysis center, which advised patients that PD and hemodialysis are possible at home, and in many cases have better results, and in many cases have longer survival rates, would anyone post it? I doubt it. Based on my experience of just a few months, I (like Gus, who has a lifetime of experience) believe unless there is a law which requires that every patient be told and have to sign a paper which details the options, it will not be done in most nephrology offices, nor in most dialysis clinics. Since getting such a law passed may take years, and thousands will die unnecessarily in the meantime, what can we do to expedite it, and what can we do now?

I have already personally passed the word to relatives and friends of four dialysis patients. I gave them all my phone number, and I will be following up to make sure they know they do have options and they should make INFORMED choices. (I am sending them all to this board too. :smiley: ) I have printed out a few pages of information from the NKF site, a PKD site, and a couple of medical sites, which I will be mailing (some anonymously) to the nephrologist’s office, the dialysis clinics, and to the first surgeon my husband consulted. I can’t educate the whole world, but I can educate those here, who I have found to be ignorant of current information. I’m a firm believer in “Brighten the corner where you are.”.

BTW, one of my clients is a senior staffer in my Senators office and she will be getting a larger packet of info – gathered in part thanks to posts here and some other boards :slight_smile: I’ll post if I get a response from the Senator himself.

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Sorry – :oops: forgot to put my name on previous post

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Hi y’all,

Lorell wrote:

I will never forget the feelings I had when I got the responses to my questions about home hemodialysis, especially the one dialysis nurse leading the orientation class, who was obviously irritated that I had even asked. Her response was curt and translated to something like, “hemodialysis at home is too difficult for most people to handle” and she changed the subject. When I asked about stats comparing the different kinds of dialysis, and comparing dialysis in and out of centers, she told me to ask my husband’s nephrologist and changed the subject again.

Arghh!! I’m so sorry that you and your husband ran into this attitude, and wish I could say that it was rare. If this nurse was younger, she may never have seen a patient doing home hemo, and might not have realized that patients were capable of doing something that she thinks only professionals can handle.

One of the things we’ve succeeded in doing with this Home Dialysis Central website is becoming #1 on Google sponsored links for the search terms “dialysis,” “home dialysis,” “home hemodialysis,” and even “peritoneal dialysis.” So if anyone looks on the web, they will know that home options are possible.

We’ve also made free, full-color postcards available, which you can order right off of the site http://www.homedialysis.org/v1/contact/postcardsForm.shtml and give to other patients, family members, and professionals. We’ll mail them right to you–free. We’d like them to be at every patient meeting, every clinic, anywhere where patients and their families are. Keep in mind that the largest dialysis providers in the U.S. (Fresenius, DaVita, Renal Care Group, Dialysis Clinics Inc.) are sponsors of this site–so they should be willing to have those postcards given out to their patients.

Just since we launched this board, we’ve seen an increase in the numbers of clinics that offer home treatments–and some of that is no doubt due to more people asking for these treatments and actively seeking them out. So, it is possible to make a change in this industry. Let’s keep trying!

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Hehe, don’t break your head on that… :stuck_out_tongue:

Thanks for posting your experience that you had in that situation, I know that there are more patients who have had similiar experiences as yours and must stress that this kinda treatment and even worser is happening all over the nation.

This is one of the reasons that trying ask or request to go home to do dialysis is something that quite alot of clinics oppose leaving the patient empty handed. For example, the clinic where I was at in-center just didn’t wanna hear it, the staff and most cases some of the Doctors were against it. There was one patient that asked me that he wanted to follow my steps to home dialysis…but later was told that his Dr. was anti-home dialysis…a bitter man that walked the floor and just gave me the look…why? Because I was an advocator right on that floor and it didn’t workout…all resulting of leaving patients behind that wanted home dialysis…but just maybe some of them will walk out of there like I did…

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Dori,

To answer your question, “Help me out, here, though. As a non-business person, how would home dialysis “wreak havoc” with the business model of dialysis providers?” – I said frequent dialysis – not home dialysis – would wreck havoc with the business model of dialysis providers which is almost entirely in-center. Here’s why. The dialysis business has many attractive characteristics, but one of its characteristics which is problematic is that it is a high fixed, low variable cost business with a low profit margin (like the airline business). It doesn’t matter if a chair (or airline seat) is filled or not the costs are still there – staff, machine rental or depreciation, machine maintenance, facility costs, utilities, etc. The variable costs which are saved which are supplies are minor in comparison (like the saving in peanuts when the airline seat is empty).

The secret to running this kind of business profitably is to continually achieve a high level of capacity utilization – my guess is that the breakeven point in dialysis may be as high as 90%. Below that you lose money fast, but above breakeven you make a lot of money. The failure of CMS to keep up with inflation has the effect of moving the break even point up which you must constantly offset by finding more and more cost savings.

The thrice-weekly model fits this requirement nicely as you have your M-W-F and Tu-Th-Sa patients for each time slot to fill your chairs. By establishing a list of patients waiting for sevice from your center you can fill chairs almost at once when patients die or leave (the same tactic as having lines at checkout counters in stores).

Now suppose CMS tomorrrow agrees to cover whatever treatments nephrologists order with the same payment per treatment as now exists. If they all switched everyone from three to six per week all you would have to do is tell half your patients to find another center and the remaining half would keep your chairs filled. But that’s not the way it would work. Some patients would stay with three, others would go to four, five or six and others would likely experiment to find where they feel good and their lab values look good.

The effect on scheduling will be devastating – capacity utilization would drop perhaps 15-20% throwing centers into huge losses. In the airline business this situation already exists because passengers can elect to fly whenever they want – the result is that seat utilization above 70% is extremely difficult to achieve and an airline’s business model must take that into account.

The only solution for the dialysis industry if frequent dialysis is ever covered by CMS is to demand and get much higher payments per treatment to offset the fact that they can’t now achieve utilization higher than, say, 75%. This would be justified if CMS looked at Part A and Part D savings from frequent dialysis, but I suspect there is not a single dialysis company executive who would bet that this would happen. Is it any wonder that the dialysis companies (and hence the foundations they support) have shown little interest in frequent dialysis (e.g. - HR 3096 or its predecessors), and I would not be suprised if, in fact, they quietly oppose it.

As I suggested in my earlier post if frequent dialysis was covered without increasing substantially per-treatment coverage resulting in destruction of the current business model, short of exiting the busines the only new model which occurs to me is to switch everyone to home dialysis which does not have the same high fixed cost characteristic as in-center and since so many costs are shifted to the patient could be very profitable even at the present per-treatment coverage level. I would not be surprised if every dialysis company that fears that there is even a remote chance of frequent dialysis being covered is doing just such a study to see if a profitable home business could be established, if necessary.

Mel