For the first time in 30 years, the conditions for Medicare coverage for end-stage renal disease (ESRD) facilities have been updated. Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule, was published in the April 15, 2008 Federal Register and became effective on October 14, 2008.

Compliance was required by February 9, 2009. This extensive update expands upon incremental regulations put in place over the past several years and focuses on outcome-based quality assessment and performance improvement.

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When it comes to demanding quality outcomes, nephrologists have been at the forefront of medicine. Since the 1980s, nephrologists have focused on such quality measures as anemia, phosphorus, and albumin levels, and adequacy of dialysis to improve patient survival. We have learned over the years, though, that isolated quality measures are not the entire story and that processes of care play a greater role in patient outcomes than previously thought.

Quality assessment

The quality assessment and performance improvement program (section 494.150 of the Final Rule) expands medical directors’ responsibilities to oversee staff education, training, and performance as well as policies and procedures, particularly those related to infection control and discharge and transfer protocols.

Two major goals of this program are to decrease infection rates and to reduce medical errors. Provisions related to the patient’s plan of care have been expanded to include measurable and expected outcomes and timetables to achieve those outcomes. Outcomes are detailed and include delivered dose of dialysis, anemia management, transplant status and plan, rehabilitation, vascular access, and bone and mineral metabolism.

Nephrology leadership

Nephrologists have been the “captain of the ship” for dialysis units for many years. In varying degrees, we have acted as the local role model, trendsetter, and leader in the delivery of nephrology services. With the implementation of bundling over the next three years and the continued linkages between CKD, ESRD, and vascular access needs, the role of medical director must be expanded.

Dialysis organizations are working with their medical directors to assist them with this expanded role. We should all embrace this culture of change, accept the leadership role, and drive improved patient safety, quality of care, and outcomes.

The robust ability to accumulate real-time data in dialysis facilities will allow us to swiftly measure the impact of the transformational conditions for coverage on ESRD facilities and our patients.

Dr. Provenzano is chief of the section of nephrology at St. John Hospital and Medical Center in Detroit and a member of the Renal & Urology News editorial advisory board.