WHY U.S. PATIENTS DO NOT HAVE ACCESS TO THE DIALYSIS TREATMENT THAT PROVIDES THE BEST QUALITY OF LIFE
BACKGROUND ON THE MEDICARE ESRD PROGRAM
· There are now more than 380,000 patients with end stage renal disease (ESRD) in the United States. This number is increasing by 6 to 7% each year and will double in ten years time.
· Medicare pays for maintenance hemodialysis treatment at about $130 per treatment for up to three treatments per week.
PROBLEMS WITH THREE TIMES A WEEK TREATMENT
· More than 95% of U.S. dialysis patients are treated only three times a week. This is in contrast to normal kidneys that function continuously.
· The intermittent nature of thrice-weekly hemodialysis results in:
□ Large swings in electrolytes and acid-base balance and rapid removal
of fluid cause nausea, vomiting, headaches, cramps and low blood
pressure during and after dialysis.
□ Increased risk of high blood pressure, chronic fluid overload and congestive heart
□ Inadequate control of calcium and phosphorous causing bone disease damage to
□ An interval of almost three days each week during which patients do not receive
dialysis. The death rate after this interval is twice that seen following the two-day
intervals between dialyses.
● Survival of U.S. dialysis patients is significantly poorer than that of patients
in Japan and elsewhere in the Western world. Despite efforts to improve dialysis
over recent years, survival has not improved
● Patient quality of life is significantly poorer than that of the general population.
ADVANTAGES OF DAILY HEMODIALYSIS THERAPY
· Extensive clinical evidence from more than 300 papers shows more frequent dialysis (5 or more times a week) results in striking improvements in patient outcomes, particularly quality of life, and decreases total costs of care. Benefits include:
♦ Improved symptoms during and between treatments (less cramps, headaches,
nausea, vomiting and post dialysis fatigue).
♦ Improved patient quality of life, sexual function and well being
♦ Improved opportunity for rehabilitation and return to work or school
♦ Improved blood pressure control
♦ Better control of calcium and phosphorous with nightly hemodialysis
♦ Improved sleep patterns with nightly hemodialysis
♦ Fewer hospitalizations and fewer hospital days. (Potential 20-60% savings to
Medicare Part A)
♦ Reductions in the dose of intravenous drugs. (EPO and Vitamin D). (Potential
25-50% savings to Medicare Part B)
♦ Reduction in the need for blood pressure drugs. (50% to 75% reduction with
consequent financial benefit to patients).
CMS ADMINISTRATIVE OPTIONS
· CMS enjoys broad discretion to establish payment policies for ESRD services that promote the general goals of the program and serve the overall needs of beneficiaries.
· Daily dialysis improves clinical outcomes and patient quality of life and helps minimize morbidity, so resulting in savings for the Medicare ESRD Program.
· Reimbursement for daily dialysis advances program objectives by making improved treatment available to patients on a cost-effective basis.
· CMS should develop reimbursement strategies that best serve the health needs of beneficiaries and that encourage more efficient delivery of dialysis services.
· The proposed CMS strategy of bundling more services into the present composite rate based on three treatments per week may result in savings to the ESRD Program and improve the stock value of vertically integrated dialysis companies, but there is no evidence to show that it will improve the quality of care and wellbeing of dialysis patients.
THE PROPOSED NIH STUDIES
· A meeting in April 2001 discussed possible large multicenter trials of daily and nightly dialysis sponsored by NIH and CMS. Because of financial constraints and the difficulties inherent in recruiting patients for such studies, NIH now proposes two limited trials over the next four years to follow several hundred patients on six times a week dialysis for six months. These studies suffer from inadequate funding as CMS will only reimburse for four dialyses weekly. The results are already known from the reports of many small studies and the main new finding will be whether patients will agree to be randomized into such a study. NIH may then undertake a larger and longer study.
· The Renal Physicians Association “supports enactment of legislation requiring CMS to immediately provide reimbursement for more frequent dialysis sessions while waiting the results of clinical trials and/or demonstration projects in this area.
· Waiting for the results of these trials will delay any reimbursement changes for at least five years. This is unacceptable when the half-life of U.S. dialysis patients is six years.
WHAT IS HAPPENING ELSEWHERE
● In Ontario, Canada, the Ministry of Health is considering paying for daily dialysis.
Studies there have shown the patient benefits described and global savings of 18%.
● In the Netherlands, some insurance companies are paying for daily dialysis and
the Dutch government is considering payment.
MEDICARE REIMBURSEMENT POLICY LIMITS ADOPTION OF THIS NEW MODALITY OF TREATMENT
· Current composite rate reimbursement limits hemodialysis generally to three times a week. This precludes patients from enjoying the great benefits of more frequent dialysis.
· Current reimbursement creates a financial disincentive for facilities to adopt daily dialysis, even though its benefits are well established.
· Although direct reimbursement to dialysis facilities must be increased to allow greater access to more frequent dialysis, overall costs to Medicare would be reduced because of fewer hospitalizations and reductions in the use of intravenous drugs.
· On March 25th, the chief actuary noted that in the last year Medicare spending on hospitalization was up 10%. More frequent dialysis is one way that this can be reduced for ESRD patients.
· The Kidney Patient Daily Dialysis Quality Act of 2003: Congressman Jim McDermott (Dem., Washington) and Congresswoman Jennifer Dunn (Rep., Washington) introduced H.R. 1004 on February 27, 2003.
· Key Elements of HR1004:
q Establishment of a payment rate for the new modality of daily hemodialysis (and equivalent treatments requiring blood access), independent of location and that takes into account the cost of more frequent dialysis, benefits to patient well-being, and the reduced total medical costs. Rates will be defined for:
¨ Ongoing daily dialysis at home or in-center
¨ Training of patients for hemodialysis at home
q Identical reimbursement rates for Method I and Method II billing.
q Empowerment of the Secretary of CMS to define standards of care for the new modality in consultation with the nephrology community.
q Clinical judgment of the physician working with the individual patient to decide who is a “qualified individual”
q More frequent hemodialysis is defined as hemodialysis sessions or equivalent therapy requiring blood access performed at least 5 times per week.
HR 1004 is supported by the National Kidney Foundation and the American Nephrology Nurses Association. The Renal Physicians Association “supports enactment of legislation requiring CMS to immediately provide reimbursement for more frequent dialysis sessions while waiting the results of clinical trials and/or demonstration projects in this area.” The American Association of Kidney Patients in its statement concerning daily hemodialysis options encourages “the development of new treatment methods which will result in improved quality of care and clinical outcomes for kidney patients.”
All studies have shown that both short daily and long nightly dialysis are significantly better for patients than conventional three times weekly dialysis.
The best argument for daily dialysis is the growing number of glowing patient testimonials concerning the benefits they have found with this treatment.
This should now be made an option available to all suitable ESRD patients.