July 7, 2009 - An era-changing letter, written by some of the best known and prestigious nephrologists in the US, states that the annualized mortality rate for dialysis patients could possibly be reduced by 50% — saving approximately 50,000 American lives per year — by making dialysis treatment schedule changes. They conclude the “data is convincing” that longer treatments, possibly with shorter intervals between treatments, will greatly reduce the occurrence and severity of hypertension-related cardiovascular diseases that are a leading cause of death for dialysis patients.

RenalWEB has obtained a copy (see WORD document or web page) of the June 5th letter that was sent to President Obama’s healthcare reform czar Nancy-Ann DeParle and Dr. Barry Straube of the Centers for Medicare and Medicaid Services (CMS). It was sent from the Steering Committee of the April 23-26, 2009 conference “ESRD: State of the Art and Charting the Challenges for the Future,” which was held in Boston and was sponsored by the Harvard Medical School Department of Continuing Education.

It is shocking in today's medical environment that such dramatic improvements in survival are possible WITHOUT any new pharmaceuticals or technology breakthroughs. Tens of thousand of lives can be saved immediately with back-to-basics changes in corporate and government policies.

Besides the improved mortality rate claim, the letter makes several points that are likely to shake up current models of care for the nearly 400,000 US dialysis patients:

• Only 14% of current morbidity and mortality can be accounted for by assessing the CMS mandated clinical performance measures that dialysis facilities report (albumin, Ca, P, Kt/V, PTH, hemoglobin, etc). It was concluded that the system must address those issues that make the greatest difference in outcomes, not continue outmoded measurements that do not reflect quality of care. (Editor's note: Yet, independent dialysis providers must devote enormous amounts of effort and money to implement CMS's CROWNWeb program.)
  
  
• Longer and more frequent treatments can result in “vastly improved patient rehabilitation,” which is currently below 20%. Accordingly, it is strongly urged that the bundling payment system which is due to be implemented in 2011 should emphasize patient rehabilitation.
  
  
• Hemodialysis catheter use is tied to an increasing number of infections, higher mortality, and must be greatly reduced.
  
  
• The current formulas (Kt/V, URR) for prescribing and measuring the delivery of dialysis are insufficient. “The original premises on which both the concept and the mathematics are based are incorrect.”
  
  
• Sodium modeling likely adds to cardiovascular disease.

The committee concludes:

“Substituting longer, daily or nocturnal dialysis, performed at home or in-center, with greater attention to cardiovascular disease, infection, and a-v access is the roadmap for major improvement in care. The current reimbursement-delivery of care model does not acknowledge this need sufficiently.”

Editor's comment: Turning ocean liners around

There are three ocean liners that need to turn completely around for patients to enter this new era: CMS, Fresenius Medical Care, and DaVita. There are a number of personal and professional conflicts for individuals in each of these entities.

Nancy-Ann DeParle is a former director of the Health Care Financing Administration, the predecessor to CMS. DeParle was on the DaVita Board of Directors from May 2001 to July 2008. She earned more than $2 million in compensation and stock sales, according to records at the Securities and Exchange Commission.

I am impressed that the chief medical officers of the two major dialysis providers signed this letter as committee members. It is now up to the captains/CEOs of these companies to decide if they can morally continue on their current course. If they do not act, or act too slowly, they should not be surprised by the outrage and anger of the tax-paying public — or their own patients.

Finally, this letter also raises serious professional ethical issues for the physicians and nurses that receive profit-sharing or other corporate compensation based on outdated — and deadly — models of care.

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For background information, see this RenalWEB report on the April 23-26, 2009 conference “ESRD: State of the Art and Charting the Challenges for the Future”.

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This message has been edited. Last edited by: Gary Peterson,

Dear Gary,

As usual, I enjoyed your recent comments on the Boston meeting and your comments on turning ocean liners around – although the problem is even greater, and more resembles turning a supertanker round in a very narrow estuary.

The group in Boston is to be commended for their important recommendations, although to at least some of us old-timers it is another case of déjà vu all over again.

We have known the problem of the mortality of U.S. dialysis patients for many years and in the past it was too often explained away as due to our different patient population. The paper dealing with mortality by Foley and Hakim in the current JASN is an excellent discussion of the issues of blood access, dosage and time, nutrition and practice patterns, staffing issues, and patient education – the issues detailed in the Boston recommendations. Not enough dialysis as a cause of patient mortality and morbidity began to be ignored 30 or more years ago and has only become more of a concern following the HEMO study and the recent renewal of interest in home and more frequent hemodialysis. Japanese patients routinely dialyze 4 hours thrice weekly; weigh about two thirds of what US patients weigh and rarely miss a dialysis; 7.9 percent of U.S. patients miss one or more treatments a month and almost 20 percent of their treatments are shortened by 10 minutes or more. Based on 2004 data for patients on three times a week hemodialysis, only 6 percent of Australian and 2 percent of New Zealand patients dialyzed less than 12 hours a week, compared with 67 percent of U.S. patients. At the other end of the spectrum, 31 percent of Australian and 39 percent of New Zealand patients dialyzed 15 or more hours a week while extremely few U.S. patients did so. Australia and New Zealand also lead the world in terms of the use of conventional home hemodialysis, alternate night hemodialysis, and five or six nights a week nocturnal hemodialysis. These facts have been known for years.

The Boston group notes that longer and more frequent treatments can result in “vastly improved patient rehabilitation.” We have known this since the mid-60s when the Seattle Artificial Kidney Center was treating most of its patients by three times a week nocturnal home hemodialysis for 6 to 8 hours. The Washington State Division of Vocational Rehabilitation bought machines and supplies, paid for training and the ongoing treatment for home hemodialysis patients because they had the best rate of rehabilitation of any of the Division’s programs. In 1972, Scribner and others told Congress that the costs of caring for ESRD patients would be partly offset because many of them would be transplanted or on home dialysis, rehabilitated, returned to work and pay taxes.

We all have known that fistulas are the best blood access for some thirty years and yet the use of grafts and catheters is only now beginning to decline.

A Kt/V of 1.0 was touted as “adequate” dialysis at the same time that Babb and Scribner’s work on middle molecules suggested the dialysis index as a measure of adequacy. Kt/V won the day, perhaps because it could so easily be calculated using the HP hand-held calculator. Now, finally its use is being questioned. Nearly 40 years ago, John DePalma defined adequacy as: “the amount of dialysis time per week that permits the patients to be rehabilitated, eat a reasonable diet (as far as protein and calories), make blood, maintain a near normal blood pressure and prevent the progression of peripheral neuropathy.” One has to believe that since then clinical judgment has been largely superseded by overreliance on numbers, a problem not unique to nephrology. In 1969, DePalma was also the first to report on the benefits of more frequent home hemodialysis in seven patients treated for four to five hours five times a week.

Overnight conventional three times a week hemodialysis at home or in a center was known to be better than thrice weekly short center dialysis 40 years ago; experience now shows that alternate nights is better; and more frequent hemodialysis at home, particularly overnight, clearly is the best treatment at present. The idea that it is normal for most patients to suffer hypotension and other problems during thrice weekly center hemodialysis and take hours to recover after treatment seems to have become accepted over the years.

Patients suitable for home hemodialysis need to be told that survival in center is worse than survival with breast or prostate cancer and that reports are beginning to appear that more frequent short daily or long nightly dialysis may provide survival similar to that with a deceased donor transplant. We must ensure that bundling and other changes from CMS do not discourage these treatments. Patients who have experienced more frequent dialysis almost all would never go back to three times a week dialysis, as their physicians can confirm. Some will say a randomized controlled trial is necessary to confirm the benefits, but according to a recent editorial in Nature Reviews Nephrology because of the cost, difficulties with recruitment and other reasons such a trial is most unlikely and observational studies and case control studies must be evaluated. There is no excuse for Congress or CMS to delay measures to improve access of suitable patients to the needed changes in treatment.

A couple of comments to think about:

I recently asked an Australian friend why Australia and New Zealand are so successful with home dialysis. His response was that they have no large for-profit providers, physicians are salaried, most dialysis, including peripheral units, is run out of university programs and large city hospitals, and the government actually has a reasonable relationship with nephrologists.

Scribner’s last comment before he died in 2003 was on what he saw would be the effects of more frequent dialysis: “The resulting healthy, well-nourished, normotensive hemodialysis patients will occur lesser additional health care costs than their sickly, malnourished, hypertensive counterparts on short three times weekly hemodialysis.”

We all need to thank the Boston group for pulling together the issues so well, and all of us, including the government, need take their suggestions to heart for the sake of the patients.

Christopher Blagg MD

Dear Dr. Blagg, thank you for your many dedicated years of service to people such as myself who suffer from severe CKD. I truthfully do not understand the opposition to knowledge known since the 1960's that longer duration and more frequent dialysis prolongs lives. The data is clear and evident.

It is my prayer that the American dialysis debacle will soon be overcome. Unfortunately, as you pointed out, the new bundle payment system is unclear on how it will affect the provision of home and daily dialysis.

Nevertheless, I appreciate the efforts that you continue to make on my behalf.

Peter Laird, MD

There is no patient accountability in our current system of care for dialysis patients. We must start here! Noncompliance is costing our healthcare system. Patients frequently shorten and/or miss treatments. Unfortunetly there is no immediate consequence to the patient for these actions. The cost to healthcare is great as these patients tend to not only miss dialysis treatments but other medical appointments as well. The ER becomes their PCP. Cost to the dialysis provider is increased due to staffing,scheduling, rescheduling,increased labs,and supply waste.Cost to the healthcare system is great in increased medical care, transportation, etc. The entire healthcare system is burdened due to the lack of follow thru of these patients. It is very frustrating when we (the healthcare providers) care more about the patients health than the patients themselves. The end result is these patients become sicker,require more hospitalizations, and the cycle continues. We can provide quality care for these patients if they take the responsibility and allow us to! Nurses continue to educate these patients but until there is consequences of action it doesn't seem to sink in for a large percentage of patients. The current system we work under encourages "disability" - we must change this and encourage rehab, return to work, and keep patients active and responsible.
Toni Huffman RN
Clinical Manager
Operations Manager

Toni, you can't expect people to "comply" with treatments they don't understand. Given that CKD is a chronic disease, our healthcare "system" (and I hate to even use that word, preferring "chaotic mess") is based on a Western medical, acute care model in which there is no room for the type of intensive and ongoing education that is needed to self-manage a complex chronic disease. Even the word "compliance" arises out of that model--it is a poor fit for chronic disease, where people are on their own far more of the week than they are under your care. They need to learn not just what you want them to do, but WHY it's in their own best interests to do it--and how much LESS they would need to do in terms of dietary and fluid limits, and medications to take, if they got longer and/or more frequent treatments and the dialysis did more of the work. It was only in the most recent changes to the Conditions for Coverage that education has even started to be required. You are blaming the victims!

Gary, I'm sure you noted that the CMOs of both Fresenius and DaVita signed that historical letter. I am tremendously proud of those committee co-chairs and the courageous public stance they have taken, and thrilled that they are keeping CMS's feet to the fire by releasing press releases about the lack of a CMS response. The fact that a blue ribbon panel of nephrologists would openly state that thrice weekly 3-4 hour treatments are insufficient is HUGE, and we need to help carry forward the momentum to turn their efforts into real change in dialysis.

I agree 100% with Dori. Education is absolutely imperative-starting NOW. Understanding helps breed responsibility and creates healthier patients. It is not enough to TELL patients what is expected of them. Rather, it is crucial that the dialysis experience be a true partnership between the health care provider and the patient and his family. We simply MUST break down the barriers between the professional on one side and the patient on the other. The current system, based on outdated attitudes, can encourage disability and "learned helplessness." It is in the interest of all parties to change the whole approach to dialysis care. Patients and professionals should not be adversaries. There should not be an unscalable wall between them.

Longer, more frequent dialysis coupled with interactive education is long overdue but not easy to accomplish in the present environment. Hopefully, that is changing.

It would be interesting if professionals had to live with dialysis (and all its demands and restrictions) for even a few months. Very few chronic diseases have such an immense impact on every single facet of life, from the kitchen table to the bedroom, and beyond.

By the way, I am a nurse, but my perspective on dialysis is highly personal. My late husband was a home hemodialysis patient for almost 25 years, but was educated about his disease and dialyzed much longer than the norm. He worked, volunteered, traveled and helped raise our son. All patients deserve such a high quality of life.

Denise Eilers, RN, BSN