Research Updates in Kidney and Urologic Health

NIDDK and CMS Hold Workshop on Daily Hemodialysis

Most hemodialysis patients in the United States go to a clinic three times a week for dialysis sessions that last for four or five hours. The Medicare program, which has covered treatments for end-stage renal disease (ESRD) since 1972, pays at a rate based on this standard schedule. In recent years, however, a few clinics have reported favorable results with alternative weekly schedules that range from five or six shorter daytime treatments to seven longer, slower treatments performed overnight at home. The term "daily hemodialysis" has been applied to all of these alternative schedules.

In April 2001, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the Centers for Medicare & Medicaid Services (CMS)—formerly the Health Care Financing Administration—convened a workshop to

• review current knowledge of daily hemodialysis
  
  
• consider the requirements for a clinical trial to obtain more systematic data
  
  
• discuss the practical and economic aspects of implementing daily hemodialysis on a wider scale

Scientific Basis

A panel of experts discussed the scientific rationale for increasing hemodialysis frequency. They reviewed current formulas for measuring dialysis dose based on kinetic modeling and the urea reduction ratio. Panel members discussed different techniques that may be needed to measure the efficiency of high-frequency hemodialysis. Urea itself is not the most harmful toxin that accumulates in kidney failure, but it serves as an indicator because it is the most easily measured. Daily hemodialysis may be more efficient at removing more harmful toxins that are not measured by conventional means. The panel also discussed the need to observe differences in outcomes that may be related to patient size.

Current Results

A second panel looked at what is known from the few studies of daily hemodialysis that have taken place around the world. Preliminary studies indicate that daily hemodialysis may be associated with lower morbidity from complications such as hypertension, malnutrition, and anemia. One speaker asserted that the main benefit is a higher quality of life, free from the chronic complications of kidney failure and hemodialysis. All participants agreed that well-designed clinical trials are needed to determine who could benefit from daily hemodialysis.

Trial Design

In the third session, participants discussed the practical issues that must be addressed in designing a clinical trial of daily hemodialysis. Topics included patient recruitment, blinding and randomization, subject characteristics, outcomes, sample size, and timing. A CMS official provided an overview of the Medicare demonstration waiver authority, including a discussion of how CMS Medicare demonstrations contribute to the development of Medicare policy and the strengths and limitations of experimenting with innovative benefit models and payment policies.

Industry Perspective

A panel of industry representatives discussed operational problems that should be anticipated if daily hemodialysis is instituted. These problems include setting up and organizing in-center daily hemodialysis, training for nocturnal hemodialysis, addressing the impact of the ongoing nursing shortage, making training facilities available, installing and monitoring water treatment systems, monitoring home hemodialysis safety, and determining proper reimbursement.

Economic Issues

CMS representatives participated on a panel that discussed the economic implications of daily hemodialysis. On the surface, increasing dialysis frequency would appear to raise costs, and CMS is not allowed to pay for more than three hemodialysis treatments a week. A full cost analysis, however, may reveal that increased work productivity and savings in other indirect costs make daily hemodialysis cost-efficient. CMS will need detailed cost data from facilities participating in a proposed clinical trial, but perhaps a bundle payment system could be developed that would ease facilities' participation.

Recommendations

Four breakout groups offered a number of recommendations in the areas of trial design for short daily sessions and long nocturnal sessions, for economic issues, and for epidemiological monitoring. The groups recommended that clinical trials focus on the effect of daily hemodialysis on patient mortality and morbidity, including hospitalizations for cardiovascular events, myocardial infarction, and cerebrovascular accidents. Economic measures of cost-effectiveness should include quality, as well as length, of life as a measure of treatment effectiveness.

A centrally located data collection system should be implemented. It could begin as a joint U.S.-Canada registry that would then expand to additional countries. At the conclusion of this meeting, those physicians currently involved in daily hemodialysis met and discussed the creation of a North American registry.

[Top]