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
failure.
> Inadequate control of
calcium and phosphorous causing bone disease damage to
blood
vessels.
> 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.
LEGISLATIVE SOLUTION
• 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:
> 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
> Identical reimbursement rates for Method I and
Method II billing.
> Empowerment of the Secretary of CMS to define
standards of care for the new modality in consultation with the nephrology
community.
> Clinical judgment of the physician working with
the individual patient to decide who is a “qualified individual”
> More frequent hemodialysis is defined as hemodialysis
sessions or equivalent therapy requiring blood access performed at least
5 times per week.
ENDORSEMENTS
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.