Press Releases



In conjunction with National Kidney Month, and with close collaboration with key stakeholders in the kidney disease community, the Centers for Medicare & Medicaid Services (CMS) today announced the launch of Fistula First, to get “breakthrough” improvements in the use of safe vascular access.  This is the first in a series of collaborative Breakthrough Initiatives targeting critical areas of opportunity for rapid health care improvement, leading to significantly better health for millions of Medicare beneficiaries and lower costs for the Medicare program.


Fistula First addresses the urgent need for patients who suffer from kidney failure (end stage renal disease or ESRD) to have safer, higher-quality access to hemodialysis through a fistula -- 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 for safe and easy access for dialysis.


“This Breakthrough Initiative reflects a clear, immediate opportunity to substantially improve the health of Americans who need kidney dialysis or transplantation,” said CMS Administrator Mark B. McClellan, M.D., PhD. "It illustrates how CMS can collaborate with health professionals, patients, and other partners to have significant impact on the quality of medical treatment.”


Patients who receive dialysis with an access other than a fistula have a 20 to 70 percent greater chance of death in the first year after their placement but currently, only a third of American patients are dialyzed with a fistula, compared with two thirds to nearly 90 percent in other countries. This difference in practice patterns is one of the primary reasons why the unadjusted mortality rate for ESRD patients is much higher in the U.S. (about 21 percent) than in Europe (about 16 percent) and is associated with over 5,000 unnecessary deaths each year.


Additionally, fistulas costs less to place and maintain than other forms of access and are associated with less rework and complications requiring hospitalization (i.e. “the Cost of Poor Quality”). About 25 to 50 percent of all hemodialysis patient admissions and hospital days are attributable to vascular access placement and related complications, contributing over $1 billion to total Medicare inpatient costs annually.


The goal of this initiative is to double the percentage of patients with fistulas as their access – moving from 33 percent to 66 percent over the next 5 years.   More than 300,000 Medicare beneficiaries currently receive dialysis treatment, a number that is expected to double by 2010. 


"Fistulas are the ‘gold standard’ for establishing access to a patient’s circulatory system in order to provide life-sustaining dialysis, with good reason," said McClellan.  “Now we’re going to work together to make them the standard of care for Medicare beneficiaries."


The most critical component to make the Fistula First breakthrough initiative a success is partner involvement.  By marshalling the knowledge and leadership of organizations and experts throughout the renal community, CMS has identified and put into place key practices to jumpstart the rate of fistula adoption.


In identifying the topics for its coming series of Breakthrough Initiatives, CMS worked with partner organizations throughout the medical community to single out the most vital areas that have the potential for dramatically decreasing the failure to deliver clinical quality care.  For Fistula First, a renal coalition was formed with professional and trade organizations and other stakeholders that have significant impact in helping make the clinical decision as the only choice. 


“We are taking the approach to health care quality improvement across many settings that incremental gains in quality improvement are not acceptable,” said McClellan.  ”We can not save lives or fix the problems in today’s healthcare without making a commitment to rapid transformational change.”


Key elements of the CMS’s Quality Improvement Program supporting the Fistuala First Initiative include:


  • CMS Dialysis Facility Compare on – the site contains dialysis facility service and quality information on all Medicare approved dialysis facilities in the United States .


  • ESRD Conditions of Coverage - Provides new, patient-centered federal regulations, which must be met by all dialysis facilities participating in Medicare (the first comprehensive revision in 28 years).


  • ESRD Clinical Performance Measures - A project that collects data annually to identify and track opportunities for improvement in areas that include adequacy of hemodialysis and peritoneal dialysis, anemia management, and vascular access management.


  • Quality Improvement Program – CMS’s 16 ESRD networks and 53 independent quality improvement organizations, under contract, provide the infrastructure to drive transformational quality improvement in numerous settings nationally and provide the infrastructure to reach the Fistuala First breakthrough goal.


CMS will announce other Breakthrough Initiatives soon, as a key part of the agency’s quality improvement strategy. Each initiative involves strong partnerships information sharing for promoting ongoing progress, and harnessing all available financial incentives to overcome barriers and make substantial and rapid culture and clinical change in medical practice.