Press release



The Centers for Medicare & Medicaid Services (CMS) announced today it is leading a national initiative to increase the use of fistulas in providing hemodialysis for Medicare beneficiaries with kidney failure, which is also known as end stage renal disease (ESRD).

"This new initiative aims to improve the quality of care and quality of life for Americans living with kidney failure," said Health and Human Services Tommy G. Thompson. "It is one of the many ways we’re working to help people receiving Medicare to get the best possible treatment."

A fistula is a "connection" surgically created by joining a vein and an artery in the forearm that allows blood from the artery to flow into the vein and provide access for dialysis.

"Fistulas are the ‘gold standard’ for establishing access to a patient’s circulatory system in order to provide life-sustaining dialysis," said CMS Administrator Mark B. McClellan, M.D., PhD. "They last longer, need less rework, and are associated with lower rates of infections, hospitalization and death for Medicare beneficiaries than other types of access."

The "Fistula First" initiative aims at having fistulas placed in at least half of new dialysis patients with a long-range goal of maintaining fistulas in 40 percent of eligible patients who remain on dialysis. Currently, only about 30 percent of Medicare beneficiaries dialyze with a fistula.

"Our health care system can do better," McClellan said. "There is no more striking example of where CMS should use its leadership position than to partner with the renal community and improve the lives of patients with kidney disease."

Hemodialysis is the most common treatment for ESRD. About 270,000 Medicare beneficiaries currently receive this treatment, and this number is expected to double by 2010. During a hemodialysis treatment, a machine pumps blood from the patient’s body, cleans it of waste products, and then returns it to the patient’s bloodstream. Flexible tubes are used to transport the blood, so an access to the bloodstream must be created.

The best access for hemodialysis patients is a vein in the forearm that is enlarged by creating a fistula. A fistula allows blood from the artery to flow into the vein. The higher blood pressure in the artery forces blood into the vein and safely enlarges the vein, creating a good site for the large gauge dialysis needles at the end of the flexible blood transport tubes.

Other access types include grafts (using a synthetic tube to connect the artery to a vein in the arm) and catheters (needles "permanently" inserted into a regular vein, but left protruding from the skin). Grafts and catheters usually require more maintenance, deliver less than optimal cleaning of the blood, lead to more infections and hospitalizations and cost more in the long run.

CMS is funding and overseeing the Fistula First initiative, which brings together a project team that is working with major stakeholders, including dialysis providers, primary care physicians, nephrologists, vascular access surgeons, interventional radiologists/nephrologists, professional societies and patient advocacy groups. The initiative is leading to a broad national partnership to ensure that many more hemodialysis patients have the opportunity to receive a fistula.

The goal of this initiative is to attain the rate of fistula use recommended in the National Kidney Foundation's Dialysis Outcomes Quality Initiative (K/DOQI), that is, placement of fistulas in 50 percent of new dialysis patients with a long-range goal of maintaining fistulas in 40 percent.

"The current rate of fistula use is about 30 percent shows a significant need for improvement in order to reach our national goals,’ said Brady Augustine, senior ESRD advisor to the CMS Administrator. "Overuse of grafts and catheters explains the current shortfall, and result in significant and expensive health risks for patients."

"The importance of having a healthy well functioning fistula can't be stressed enough" says Cathy Lewis, RN, chair of the Patient and Family Council of the National Kidney Foundation "A fistula is truly the best lifeline. We have a huge challenge ahead to engage patients, vascular surgeons, nephrologists, primary care physicians and all health care providers in changing practice to assure that AV fistulas are the first choice for every eligible patient."

CMS’ ESRD Network program will spearhead the implementation of the initiative.

"The CMS ESRD Networks have historically worked with dialysis facilities to identify and remedy lapses in appropriate care for our dialysis beneficiaries," says Steve Jencks, M.D., director of the Quality Improvement Group in CMS, "but in this case, we need to involve care givers outside of dialysis facilities, such as primary care physicians, nephrologists and vascular access surgeons, who play a major role in the timely placement of fistulas in eligible patients."

The Institute for Healthcare Improvement (IHI), a recognized leader in health care improvement, is under contract with CMS to assist the CMS project team, the ESRD Networks, and dialysis stakeholders to develop an approach to improving the coordination of care across providers, and to spreading best practices.

A team of clinical experts has provided guidance to the project, led by Clinical Chair Lawrence Spergel, M.D., FACS. Dr. Spergel is a vascular access surgeon with 30 years experience leading organizations to improved AV Fistula rates.

Work began on the early phase of the initiative in July 2003. A multi-disciplinary team from CMS, the ESRD Networks and major stakeholder groups was convened to develop a firm and broad understanding of the challenges and successes for fistula placement within the dialysis and surgical communities. Based on this early work, a set of improvement recommendations and tools was developed.

The recommendations are contained in a "change package" comprising 11 changes in practice across the ESRD treatment continuum that have shown results in practice and are supported by the published literature. The ESRD Networks are now working with the providers in their regions to implement these recommendations.

"The availability of recommendations and tools is typically not enough to bring about large scale changes in practice," said Kevin Nolan, an improvement advisor with IHI. "We also need to create social and professional expectations and norms that support behavioral change.

One way this can be fostered is by making visible the successes of early adopters. Early adopters are those practitioners and stakeholders who are first to follow the new recommendations and who generate clear improvement results. Sharing these early successes can provide other practitioners with encouragement and practical know-how for implementing the recommended changes."

"Measurement systems are in place to provide these results from the dialysis facility-level right up to the impact on the national numbers," said Dr. Spergel, Clinical Chair of the initiative, "but the willingness, motivation and participation of all partners in the 'Fistula First' initiative are equally important key elements to improving beneficiary care and outcomes across a vast and complex system will ultimately determine the level of improved patient care and outcomes."

More information about this initiative can be obtained by linking to the following URL