[Congressional Record Volume 141, Number 36 (Monday, February 27, 1995)]
[Extensions of Remarks]
[Pages E446-E447]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


              SAVING LIVES--SETTING STANDARDS FOR DIALYSIS

                                 ______


                        HON. FORTNEY PETE STARK

                             of california

                    in the house of representatives

                        Monday, February 27, 1995
  Mr. STARK. Mr. Speaker, there are approximately 200,000 Medicare 
beneficiaries in the Endstage Renal Disease [ESRD] Program, initially 
established by the Social Security Act Sec. 1881. This debilitating 
disease costs approximately $10 billion per year translating to a cost 
of $51,000 per patient.\1\ Dialysis treatment for the ESRD patient is 
in essence an artificial kidney, and while there have been multitudes 
of research papers and numerous conferences addressing the issue of 
standards for dialysis treatment, the development of these standards 
has been a slow process. There is presently a need for quality 
assessment and continuous quality improvement (QA & CQI) within 
dialysis facilities, reformation of reimbursement schedules, improved 
data collection, and the introduction of industry-wide treatment 
standards for the benefit of the patient as well as the providers.
     Footnotes at end of article.
  In recent years, numerous studies have shown relatively unexplained 
and dramatic differences in survival rates between kidney dialysis 
facilities. While it is often explained that facilities with higher 
mortality rates also treat sicker patients, this only explains part of 
the story. Mortality rates between facilities range from 0 to 43 deaths 
per 100 dialysis years, which means that there are other causes of 
death attributable to the treatment centers that cannot be explained by 
how sick their patients are.\2\ To be blunt, some facilities are 
allowing their patients to die prematurely and needlessly. I believe 
that there is now a relative consensus among kidney disease experts 
that if certain quality standards are met during the course of dialysis 
treatment, a patient has an improved chance of prolonged survival.
  Mortality rates for dialysis patients remain consistently greater 
than 20 percent.\3\,\4\ Similarly, renal failure has a significant 
impact on the life expectancies of its victims. According to a recent 
NIH Consensus Panel, at 49 years of age, the average life expectancy of 
a patient with ESRD is 7 years, compared with 30 years for an age-
matched person without ESRD.\5\
  The mortality rates for patients with ESRD are increased for men, 
whites, elderly, diabetics, and patients with impaired functional 
status and malnutrition.2,3,6-8 Survival is further complicated by 
the changes within the ESRD patient population and the growing list of 
comorbidities that contribute to their worsened state of health. 
Although differences between patient subgroups can result in variable 
risk factors for death, it seems that dialysis treatment times 
consistently effect the mortality rates of renal failure patients.
  Dialysis functions as an artificial kidney by removing waste products 
from the blood, and the standard for dialysis should be expressed in 
terms of the formula KT/V. This formula has been offered as the most 
effective measurement in determining the adequacy of hemodialysis 
treatment. Most authors agree that the KT/V must be at least 1.0 or 
greater to achieve an adequate dose of dialysis, and many have 
concluded that levels as high as 1.2-1.4 are necessary to reduce 
mortality.
  Therefore, I am introducing a bill today to require the Secretary of 
HHS to deny payment to a facility after January 1, 1997, if a majority 
of its patients do not receive a dialysis treatment which sufficiently 
cleans the blood. Hemodialysis must be supplied to achieve a delivered 
KT/V of 1.2. This bill will also establish contingencies whereby 
dialysis facilities could calculate treatment effectiveness using the 
urea reduction ratio [URR] instead of the KT/V. In simple terms, the 
URR measures the percentage of waste products cleansed from the blood 
over the course of a single dialysis treatment. The standards would be 
set to achieve a delivered URR of  65 percent. Although the 
URR does not have the accuracy 
[[Page E447]]  of the KT/V, it requires only simple mathematics without 
the need for computer software and can provide a useful verification of 
treatment effectiveness. It is understood that there are other factors 
affecting the outcome of patients on dialysis; however, dialysis has 
become quantifiable and, therefore, should be utilized to effectively 
realize treatment goals.
  Putting this in layman's terms, it is possible to measure the amount 
of dialysis a patient will receive by knowing the duration of 
treatment, the amount of waste products in the blood, and the quantity 
of blood that the dialysis filter will clear of those waste products 
during treatment. In essence, the longer a patient remains on a 
dialysis machine, the more likely they are to achieve the 1.2 figure.
  It is appalling to think that some facilities would cut the amount of 
time on the dialysis machine in order to save money. Quality dialysis 
facilities have shown us that they can make money and still provide 
adequate time on the machine. Furthermore, statistical studies have 
demonstrated that increased time translates into less death. I believe 
there is enough medical consensus on this point that it would be 
improper for Medicare to continue to pay for facilities that do not 
provide adequate levels of dialysis as measured by the KT/V value. That 
is what my bill seeks to do: Force those facilities which are not 
providing sufficient dialysis to improve their level of care in 
accordance with a set of industry-wide standards, and ultimately stop 
the premature death of their patients.
  Many studies have shown the correlation between increased treatment 
time and decreased mortality rates. 7,9-14 However, it has been 
argued that the combination of falling real-dollar reimbursement rates 
and increases in the required bundle of services have caused not only a 
decline in the amount of dialysis being delivered but also a reduction 
in the ability of dialysis centers to provide adjunct resources such as 
dietary counseling, social work management, mental health information, 
and vocational rehabilitation. As Congress considers this legislation, 
it also needs to examine and address this whole range of issues 
impacting on the lives of dialysis patients.
  Medical science is continually evolving, of course, and future 
information may provide us with a better measure of dialysis or show us 
that 1.2 is not the right number to strive for. Therefore, my bill 
authorizes the Secretary to adjust the KT/V value or substitute a 
different formula if a report is sent to Congress explaining the wisdom 
of such a change. My bill also addresses the issue of monitoring 
dialysis facilities in order to assess their compliance with the above 
standards.
  Once the progression to chronic renal failure has occurred, the main 
goals of the medical community should be to maintain and improve, if 
possible, the quality of life of the end-stage renal disease patient. 
Treatment plans should focus on prescription and delivery of adequate 
dialysis, attention to the social and psychological factors that 
influence survival and functional outcome of hemodialysis patients, 
provision of dietary counseling and management, assessment and 
reduction of malnutrition, control of hypertension, strict management 
of diabetes, maintaining vascular access, and provision of vocational 
rehabilitation.
  In closing, Mr. Speaker, I urge the renal community to evaluate the 
need for reform within the dialysis industry to reduce the untimely 
deaths of so many patients with kidney failure.
                               references

     \1\VanValkenburgh D and Snyder S. Challenges and barriers to 
     managing quality in an end-stage renal disease facility. 
     ``American Journal of Kidney Diseases'' 1994;24(2):337-345.
     \2\McClellan W and Soucie M. Facility mortality rates for new 
     end-stage renal disease patients: Implications for quality 
     improvement. ``American Journal of Kidney Diseases'' 
     1994;24(2):280-289.
     \3\Levinsky N and Mesler D. Measuring, managing, and 
     improving the quality of end-stage renal disease care. 
     ``American Journal of Kidney Diseases'' 1994;24(2):235-246.
     \4\Lowrie E. Chronic dialysis treatment: Clinical outcome and 
     related process of care. ``American Journal of Kidney 
     Diseases'' 1994;24(2):255-266.
     \5\Consensus Development Conference Panel. Morbidity and 
     mortality of renal dialysis: An NIH Consensus Conference 
     statement. ``Annals of Internal Medicine'' 1994;121(1):62-70.
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     \7\Lowrie EG and Lew NL. Death risk in hemodialysis patients: 
     The predictive value of commonly measured variables and an 
     evaluation of death rate differences between facilities. 
     ``American Journal of Kidney Diseases'' 1990;15:458-482.
     \8\Owen WF, et al. The urea reduction ratio and serum ablumin 
     concentration as predictors of mortality in patients 
     undergoing hemodialysis. ``NEJM'' 1993;329:1001-1006.
     \9\Collins AJ, et al. Urea index and other predictors of 
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     Diseases'' 1994;23:272-282.
     \10\Held PJ, Levin NW, Bovbjerg JD, Pauly MV, and Diamond LH. 
     Mortality and duration of hemodialysis treatment. ``JAMA'' 
     1992;265(7):871-875.
     \11\Hakim RM, et al. Adequacy of hemodialysis. ``American 
     Journal of Kidney Diseases'' 1992;20:107-124.
     \12\Blagg C. The US Renal Data System and the Case-mix 
     Severity Study. ``American Journal of Kidney Diseases'' 
     1993;21(1):106-108.
     \13\Hakim RM, Breyer J, Ismail N, Schulman G. Effects of dose 
     of dialysis on morbidity and mortality. ``American Journal of 
     Kidney Diseases'' 1994;23(5):661-669.
     \14\Parker T, Husni L, Huang W. Survival of hemodialysis 
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     1994;23(5):670-680.
     

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