By Peter Laird, MD
The survival differences between Japan and the United States are well documented and extensively researched with the preponderance of the evidence focusing on dialysis practice difference. I have written on this issue several times in the past three years. (here, here and here) Many have wrongly in my opinion put forth the low incidence of renal transplant in Japan and alleged exclusion criteria coupled with lower co-morbid conditions that have not withstood the light of day as the explanation of these differences. Dr. A.K. Singh entered this debate a few days ago on his Kidney Doctor Blog:
There are a number of differences in dialysis practice that alone or together could explain the difference in mortality. While the very low transplantation rate in Japan, i.e. selection bias, might be a part of the explanation, it does not explain the two-fold higher mortality rate in the US. In Japan, like the US, there is a highly prevalent diabetic population on dialysis with an average age in the 60s that similarly dialyzes 3 times a week in center. It's either better dialysis or some other factor, but not just differences in transplant rates, nor is it because the Japanese are very selective in who they treat on dialysis.
The underlying untold story line to the great Japanese dialysis survival debate is the allegation that we could never take a group of patients in America and duplicate the Japanese survival outcomes with only a change in dialysis practice due to alleged higher co-morbidities, alleged lower incidence of diabetes, and alleged selection bias. I would urge all to consider that we actually have these answers already starting first of all historically when home dialysis patients and in-center dialysis patients had outcomes as equal or better than the current Japanese survival data. Dr. Lowrie boasted of a mortality rate as low as 7% in 1972:
Over an eight-year period 172 patients received an allograft from a living, related donor, 112 receivedcadaveric transplants, and 125 were placed on home dialysis. In a period of three years, 287 patients passed through our center dialysis program. Analysis of survival curves shows that patient survival was significantly better in recipients of transplants from living, related donors and in dialysis patients than in those receiving a cadaver graft. One-year patient survival rates for recipients of parental, sibling and cadaver allografts were 84.2, 89.5 and 68.7 per cent respectively. Survival rates at one and two years for home-dialysis patients were 88.5 and 77.8 per cent, and similar values for center patients were 92.9 and 86.1 per cent. These probabilities should be considered in the choice of which form of therapy to employ in a given patient, and illustrate the need for continued investigation into the prevention of allograft rejection and cadaver-recipient selection, (N Engl J Med 288:863–867, 1973)
Presented in part at the Fifth International Congress of Nephrology, Mexico City, Mexico, October 8–13, 1972.
The first three years of the demonstration (2006 through 2008) were evaluated and the case-mix adjusted results indicate the following for Fresenius Medical Care (FMC) patients enrolled in the demonstration:
- A significantly larger percentage of patients in the FMC program survived to the one year and two year time points.
- Patient survival at the one year time point for FMC was 90.7% vs 85.4% for the comparison group. Patient survival at the two year time point for FMC was 80.1% vs 73.9% for the comparison group. This equates to mortality improvement for FMC versus the comparison group of 36.3% at the one year time point (9.3% vs 14.6%) and 23.8% at the two year time point (19.9% vs 26.1%).
- A significantly lower percentage of patients in the FMC program were hospitalized for the first time by one year and two years.
- Improvement for FMC versus the comparison group in first hospitalizations for “all causes” at one year of 13.6% (51.1% vs 59.1%) and at two years 20.5% (60.5% vs 76.1%).
- A significantly lower percentage of patients in the FMC program were hospitalized for cardiovascular disease for the first time by one year and two years.
- Improvement for FMC versus the comparison group in first hospitalizations for “cardiovascular disease” at one year of 14.1% (50.0% vs 58.2%) and at two years 20.7% (59.7% vs 75.2%).
This project utilizing the Medicare Advantage allocation which has no wall between Part A and Part B in a capitated system allowing Fresenius to eliminate the extra profit centers in fee for service practice at the hospital and other points of care that standard Medicare cannot eliminate. This study has not received broad attention especially given that this was with standard 3.5 hours thrice weekly dialysis in-center. What is also not published nor recognized widely is that Fresenius accomplished similar outcomes in their joint Kaiser/FMC ventures in Southern California which I was able to observe firsthand for two years as a patient. Changing practices by first of all aligning cost incentives to prevent hospitalization and outside medical utilization results in cost containment and improved survival. The principle investigator for Fresenius offered detailed analysis of why they were able to achieve these results in an interview with Medscape:
Mr. Farrell: We really think this is right in the sweet spot of where CMS wants to take health reform. One point about our demonstration program was that this was individual enrollment of patients, so at any given dialysis clinic you might have a handful of patients who choose to enroll in this program. This presents an opportunity when you move to a broader accountable care structure. What we have proposed with CMS is the concept of the integrated care health home, with the nephrologist as the principal care physician for these patients and the dialysis clinic provider and our integrated care program providing the data systems and care program infrastructure of the medical home. We'd like to see CMS give us an opportunity to deploy this kind of a model on a full clinic basis rather than individual patient enrollment. This would give us the opportunity to operationalize this model in a more integrated and efficient manner with our clinics and nephrologists in support of our patients. We're very encouraged by the results we were able to achieve in this demonstration project, even in this individual enrollment environment, but see a huge opportunity for ESRD patients if we are able to deploy this model on a larger scale.
If this model sounds familiar, it is because it is the integrated medical care system that Kaiser pioneered over fifty years ago which allows the provider to capitalize on economies of scale and to capture the health care savings by preventing illness and undo utilization of resources. In addition, I have reported on the benefits of nutritional supplementation in the dialysis unit nearly three years ago on DSEN:
In the vacuum left by Medicare, some nephrologists have taken matters into their own hands. One exceptional example is Dr. Phillip Tuso, a nephrologist with Kaiser Permanente who created FIRN in response to the high number of his own patients with food insecurity that were dying at an alarming rate from malnutrition. Dr. Tuso started this non profit organization dedicated to relieving food insecurity within his dialysis population which has succeeded greatly in reducing mortality among his dialysis patients. Hospitalizations are likewise over 50% lower than before he began this intervention in 2004 saving Kaiser Permanente millions of dollars from one dialysis unit alone.
One nephrologist who was motivated by the knowledge of a simple and cost effective intervention with nutritional supplements serves as a outstanding model for how America could once again regain the threshold of humane care of those at risk of food insecurity in our dialysis population. It is time for America to save both lives and money with a simple intervention with oral nutritional supplements. The best medicine is once again the cheapest medicine.
I believe the Japanese survival debate is a false debate clouded by a lack of evaluation of known data and by ignoring extensive studies revealing that the cause of our different outcomes is our different dialysis practices. The American dialysis patient is not the cause of our terrible outcomes as many academic American nephrologists would like all of us to believe. In addition, Japan also has a different payment system where nephrologists are paid per hour of dialysis not per session of dialysis. I have spoken to many leaders in the dialysis industry in the last three years and many place the blame of our outcomes squarely on our perverse payment system that does not reward dialysis providers for keeping patients out of the hospital and avoiding complications.
I believe it is time to go beyond vacuous debates that fail to examine all of the evidence and instead to move forward with concrete practice changes already demonstrated in Europe, Japan, Australia and even right here in America that I have witnessed firsthand. Practice patterns will change when CMS creates incentives for outcomes instead of processes or biochemical profiles. Practice patterns differences are the reason for the excellent Japanese survival on dialysis and I believe that we can not only duplicate but surpass their survival rates by combining the practice changes that Fresenius utilized in an integrated care system with standard thrice weekly in-center dialysis and nutrition and holistic support and then surpassing that model by incorporating daily dialysis. That is the experiment and the direction that we need to take and stop endless and useless debates long since settled by the preponderance of the evidence.