0- What’s Wrong With the American Way of ESRD Treatment?

J. Michael Lazarus Harvard Medical School, Boston, Massachusetts

The question suggests that, indeed there is some- thing “wrong” with the American way of ESRD treatment. The inference is, that the approach to treatment in this country is different (worse?) than in other countries of the world. Recent reports of increased mortality in dialysis patients in this coun- try have ignited hot debate. It has been suggested that the reported increase in gross mortality over the past 10 years may be related to a decrease in dialysis treatment time (1) or an inadequate dialysis prescrip- tion (2). These two issues may possibly be related to the steady decrease in dialysis reimbursement (3). Analysis of gross mortality by Dr. Paul Eggars of HCFA suggests that, if corrected for age, there is no increase in mortality over time (4). Hull and Parker have suggested that, when compared to other coun- tries, patient survival in this country is decreased ( 5 ) . Are these differences in mortality related to differ- ences in case mix or do we provide inferior ESRD treatment?

There are other considerations in judging ESRD treatment. Differences in morbidity, as well as mor- tality should be considered in such comparisons. At present, there are little data on morbidity. One must consider the esthetic or non-essential amenities in comparing treatment as well as differences in avail- ability of options in various countries. In Japan, few patients are offered either cadaver or related donor transplants. Patients in Great Britain, for a number of reasons, are strongly encouraged towards CAPD/ CCPD or home hemodialysis. Finally, in considering the question, “What’s wrong with the American way of ESRD treatment?”, one must consider from whose viewpoint the question is answered. Clearly, the pa- tient will have one view, the physician another, and government or society yet a third.

I will address the question from a physician’s viewpoint, although this is and should be concordant with that of the patient. It is not clear that govern- ment or society will view this similarly, although in the long run, what is best for the patient is probably what is best for society. I am of the opinion that the American way of ESRD treatment is not inferior, and probably is superior to that in other industrial- ized countries. Undoubtedly, there are problems with our methods of ESRD treatment, but I am not

Address correspondence to: J. Michael Lazarus, MD, Ne- phrology Division, Brigham and Women’s Hospital, 75 Francis Street, Boston, MA 02115.

Seminars in Dialysis-Vol4, No 2 (Apr-June) 1991 pp 75- 77

sure the problems here outnumber those in other countries.

Of the many problems we face, I will focus on the one I consider most important - that is, the dete- riorating relationship between patient and physician. Most of us do not recall a time when government, i.e., Medicare (HCFA or one of it’s predecessors), was not in some way involved in the funding of health care. In the 1950’s and early 19603, prior to my medical training, I perceived of a special rela- tionship between physician and patient. The role of the physician in the community and the patient/ physician relationship was an important considera- tion in my selecting medicine as a career. Both of these roles have changed drastically over the last 25 years. In 1965, the Medicare/Medicaid Programs were established despite opposition of some who feared that federal financial participation in health care would lead to federal interference, altering the practice of medicine and undermining the patient/ physician relationship. However, physicians agreed to participate in Medicare, which was indeed the first in a series of steps leading to major changes in the practice of medicine. In 1972, nephrologists eagerly supported Public Law 92603, which assigned pa- tients with renal failure to the Medicare program. In so doing, we likewise, opted for a short-term gain of assured funding for the treatment of renal failure, not appreciating how that decision would so affect the practice of nephrology.

In my judgment, the mistake in this alliance was acceptance of the government’s plan for reimburse- ment. For reasons of simplicity and ease of payment, physicians agreed to accept reimbursement directly from the government, and by so doing, the real “customer” or beneficiary - the patient - was effec- tively culled out of the process. Initially, nephrolo- gists were reimbursed on a fee-for-service basis. Sub- sequently, reimbursement was tied to the dialysis treatment (the Initial Method or Alternative Reim- bursement Method) and evolved into the Monthly Capitation Method (MCP) in which physicians were reimbursed for a bundle of services (which has yet to be adequately defined). At each step, patients became less involved with decisions for their care; and the physician/patient relationship steadily changed. Similarly, methods of reimbursement to providers for the dialysis procedure excluded the patient from participation in decisions as to desired services. Many of us attempted to involve patients in the decision-making processes. Patients generally play the principal role in deciding the major type of

75

76 Lazarus

treatment, i.e., hemodialysis, peritoneal dialysis or transplant. However, even in the hands of the most conscientious physician, the patient played only a consultatory role in selecting other aspects of treat- ment and no role in financial considerations.

In a series of maneuvers over the past 20 years, HCFA or its predecessors have progressively reduced reimbursement to lower the total expenditures for ESRD treatment. Modifications in the mechanism of reimbursement were implemented to encourage physicians to change medical treatment to reduce the cost of the program, e.g., the development of the MCP to encourage home dialysis. Rarely, however, has government considered changes in methods of payment which would induce the patient to become a deciding player. In one abortive attempt at such a process, a program of competitive bidding in Colo- rado and California was initiated by HCFA several years ago. This was doomed from the start since the program did not foster a consideration of quality of treatment and did not encourage a joint patient/ physician relationship in the approach to a less ex- pensive treatment.

As we have continued down this ESRD/Medicare road, the patient, physician, and government (HCFA) have become adversaries. As physicians have attempted to respond to changes in the method and degree of reimbursement by altering treatment techniques and practice approaches, the patient has felt manipulated. This has often been perceived to be physician-induced - not a process in which the physician has responded to government regulatory changes. On the other hand, as physicians attempt to maintain the quality of care for patients, defending what is perceived to be appropriate treatment, the government (HCFA, Office of the Inspector General, and Congress) interpret this to be physicians looking after their own well-being.

We have now reached a point where government will not only determine reimbursement, but will “direct” quality assessment and quality assurance through recently introduced programs - “The Na- tional Medical Review Criteria Screens” and “Med- ical Case Review Procedures,” implemented by HCFA’s Health Standards and Quality Bureau. Quality assessment/quality assurance is an area that HCFA has long ignored. As reimbursement was steadily reduced, there has been no corresponding measure of adequacy to determine the effect of such reimbursement changes. HCFA now plans to be- come involved in evaluating such intricacies of treat- ment as the number of times patients are treated, the number of hours, the percent reduction of urea, the level of Kt/V, the level of other laboratory results, the indications for parenteral medications, the degree of interaction with paramedical personnel and the number and quality of visits by physicians.

Obviously, assessment and quality assurance are important. However, the government’s assessment and assurance of quality will possibly be significantly different from that of physicians and patients. There is great concern where HCFA will go with this pro- gram and how it will further impact on the relation-

ship between physician and patient. Physicians in individual dialysis units must take an active role in developing their own quality assessment/assurance program. We would do well to involve patients in this process. I would much prefer to have patients gauge the quality of their care than the government. In areas other than medicine, the American public has become a sophisticated consumer. Patients have been effectively removed from such a role in their ESRD care. They must become more involved, de- veloping knowledge about adequacy, appropriate treatment choices, particulars of treatment, and the cost of such treatment choices.

At present, most patients do not have sufficient background information or knowledge to be in- formed consumers. An example of the degree of the problem in this area is the observation that many patients who desire a shorter dialysis time view the decision of the nephrologist recommending longer treatment time as a punishment. However, in time, most patients could come to an understanding of important choices to be made. The average yearly cost of outpatient treatment is well known. If patients were given a “voucher” for the equivalent of that sum, they could then choose particulars of treatment. Patients would thus decide on the sacrifices they would be willing to make to obtain such a treatment plan. For example, to obtain a more biocompatible or potent dialyzer, a patient may be willing to partic- ipate in self care or re-use of the dialyzer. To be dialyzed at home with a nurse, he or she may be willing to select a less expensive dialyzer or a simpler delivery system. To avoid reuse, he or she could opt for less expensive, less biocompatible dialyzers. To be able to consume a more liberal diet, a patient may be willing to perform self dialysis for a longer period of time. Patients could elect to see physicians more or less often, depending upon their perceived need. The same could be arranged with regard to consul- tation with dieticians and social workers. In other words, the patient would “purchase” their medical care. Obviously, physicians and paramedical staff would act as counselors, aiding the patient in making informed choices.

At this point we are probably too far down the road to institute a system where patients receive funding directly from government to then purchase treatment. However, outpatient dialysis may lend itself to such a scheme. The cost of a year’s outpatient treatment would be assigned to the patient in the form of governmental insurance, a voucher, medical stamps (similar to food stamps), or any type of ledger system. If a system could be developed where pa- tients and government deal with one another with regard to payment for medical services, rather than have the physician function as an intermediary in this generally hostile environment, all parties would be served. Perhaps the cost of ESRD therapy is so enormous that such a system will never be manage- able. However, the situation has reached a point where there must be some effort to change.

From a physician’s viewpoint, I perceive this to be the major problem with our current way of ESRD

AMERICAN ESRD TREATMENT 77 rate differences between facilities. Am J Kidney Dis 15:458-482, 1990

2. Gotch FA, Yarian S, Keen M: A kinetic survey of US hemodialysis prescriptions. Am JKidnqvDis 15:511-515, 1990

dialysis treatment. Am JKidney Dis 15:441-450, 1990 4. Eggers PW: Mortality rates among dialysis patients in Medicare’s end-

stage renal disease program. Am JKidney Dis 15:414-421, 1990 5. Hull AR, Parker TF 111: Proceedings from the morbidity, mortality

and prescription of dialysis symposium, Dallas, TX, September 15 to 17, 1989. Am JKidney Dis 15:375-383, 1990

treatment and for one, would like to return to an

rectly with One another Concerning medical decisions and medical cost.

earlier time when patients and physicians dealt di- 3. Held PJ, Garcia JR, et al.: Price of dialysis. unit staffing, and length of

References 1. Lowrie EG, Lew NL: Death risk in hemodialysis patients: The predic-

tive value of commonly measured variables and an evaluation of death

A. Peter Lundin State University of New Vork, Health Science Center at Brooklyn, Brooklyn, New York

The question suggests that there is a peculiarly American way to treat patients with End Stage Renal Disease. I am not sure that the United States is markedly different in most aspects. As in most other countries where all forms of ESRD treatment are readily available, we have physicians and patients who will prescribe or prefer one form of treatment over another depending on individual needs or cir- cumstances. There are those who claim to detect bias in how various treatments are provided; that there is unfairness to women and minorities in transplanta- tion, and that life-saving dialysis may be withheld from those who are elderly or have other complicat- ing diseases (1-2). Similar biases seem to occur in other countries besides the U.S., however.

What is more difficult to explain away is the increasing evidence that the mortality rate for di- alysis patients is higher in the U.S. than in Europe or Japan. This increase is not solely due to the acceptance of older and sicker patients for dialysis. If the higher mortality rate in patients, matched for complications, is substantiated, then there may well be something wrong with the American way of di- alysis.

Held, et al. (3) compared the five year survival for new end stage renal disease (ESRD) patients started between 1982 and 1987 in the U.S., Europe and Japan. After correction for age and diabetes the survival of patients was best in Japan, followed by Europe with the U.S. showing the lowest survival rate. In smaller, more homogeneous populations such as those in Minnesota and Sweden, Kjellstrand, et al. (4) and Eggers (3, using Medicare data, found that higher acceptance rates for patients with com- plicating illnesses in the U.S. could account for much of the disparity.

Nevertheless, there are other data that should raise concern about the way dialysis is being done in the U.S. Gotch et al. (6) used kinetic analysis (Kt/V) to evaluate the dialysis prescription given at the home

Address correspondence to: A. Peter Lundin, MD, SUNV, Health Science Center at Brooklyn, 450 Clarkson Avenue, Box 52, Brooklyn, NY 11203-2098.

Seminars in Dialysis-Vol4, No 2 (Apr-June) 1991 pp 77- 79

units of 101 traveling patients. They found that an astounding 98% of the patients had treatments pre- scribed empirically, that is, without regard to any quantitative measure of dialysis delivered. Using the predialysis BUN alone, the most commonly used method of assessing dialysis adequacy, often leads to a vicious cycle of underdialysis.

When Sargent (7) studied the actual dialysis treat- ment delivered in 297 patients in 48 units, he found that at least half of the treatments in 44% of the units were not delivered adequately. Some of the speculated reasons were access problems, recircula- tion, and inefficient dialyzers. Non-delivery can be reduced to 10-20% when attempts are made to correct the problems; i.e., prospectively looking for and correcting access recirculation, and prescribing higher blood flows, more efficient dialyzers, and longer treatment times.

Reductions in Medicare reimbursement for di- alysis were found by Held, et al. (8) to result in fewer registered nurses being used and a shorter duration of dialysis treatments being prescribed in freestand- ing units. Shorter dialysis hours could be statistically correlated with higher mortality. Lowrie and Lew (9) in a sample of more than 12,000 dialysis patients found that thrice weekly treatments of 3.1 to 3.5 hours correlated with a probability of death almost twice that seen with treatments exceeding 4 hours.

The adequacy of shorter time dialysis was estab- lished using dialyzers of higher efficiency, higher blood flows, and ultrafiltration control machines that delivered dialysis fluid containing bicarbonate. These necessary conditions for shorter time dialysis have not been universally adhered to in the U.S.; many patients may have had their dialysis hours reduced without receiving the required compensa- tory changes, thus resulting in subadequate treat- ments.

I gained a bit of an unwanted reputation for myself some years ago by attempting to point out that the approval for unstandardized and unsupervised dialy- zer reuse would allow use of improper techniques and thereby bad dialysis. Shortening the dialysis time while using and reusing standard sized dialyzers mul- tiple times may be particularly devastating. I believe that evidence to support the reality of this concern will eventually emerge.