Fact Sheets
CONDITIONS FOR COVERAGE FOR END STAGE RENAL DISEASE FACILITIES ISSUED
CONDITIONS FOR COVERAGE FOR END STAGE RENAL DISEASE FACILITIES ISSUED
Overview
The Centers for Medicare & Medicaid Services (CMS) has issued a final rule that establishes new Conditions for Coverage (CfCs) that dialysis facilities must meet to be certified under the Medicare program. This final rule: (1) focuses on the patient and the quality of care provided to the patient, (2) establishes a performance monitoring program for facilities, (3) encourages patients to participate in their plan of care and treatment, and (4) eliminates many outdated procedural requirements from the previous conditions for coverage, yet preserves strong standards that promote meaningful patient safety, well-being, and continuous quality improvement. This final rule reflects the advances in dialysis technology and standard care practices since the requirements were first issued in 1976.
Background
ESRD is permanent failure of the kidney that is irreversible and requires a regular course of dialysis or kidney transplantation to maintain life. Dialysis is the process of cleaning the blood and removing excess fluid artificially with special equipment that takes the place of the kidney function.
The existing ESRD CfC rule was originally adopted in 1976. In these existing requirements for dialysis facilities, CMS emphasized the policies and procedures that must be in place to support quality patient care, and focused on a facility’s capacity to furnish quality care in 1976.
To determine if an ESRD facility is to be certified by Medicare, the State survey agency performs an on-site survey of the facility using the standards in the ESRD CfCs. The ESRD facility is considered Medicare certified and eligible for Medicare payment if the survey finds that a facility complies with the conditions for coverage and all other Federal requirements are met. Medicare payment for outpatient maintenance dialysis is limited to facilities meeting the ESRD CfCs.
On February 4, 2005, CMS published in the Federal Register a proposed rule titled “Conditions for Coverage for End Stage Renal Disease Facilities.” In that rule, CMS proposed a number of revisions to the existing requirements and proposed adding new requirements that ESRD dialysis facilities must meet in order to be certified under the Medicare program such as a new requirement for facilities to develop a quality assessment and performance improvement program.
CMS’s Commitment to Improved Quality Outcomes
Revising the ESRD requirements is part of our larger effort to modernize regulations and improve the availability of quality-of-care information; to promote transparency; and to move toward a patient outcomeâbased system that focuses on quality assessment and performance improvement. Revising the conditions for coverage will encourage improvement in outcomes of care for beneficiaries by requiring that all facilities report data on CMS’s existing clinical performance measures (CPMs). The collection and reporting of the ESRD CPMs is an effective tool to facilitate quality improvement. This requirement will allow CMS to track improvements in several outcomes for those individuals with end-stage renal disease that receive dialysis services.
Highlights of Provisions in the Final Rule Include
- Updated CDC guidelines for hemodialysis facilities
- Updated AAMI water quality guidelines
- Defibrillators in every dialysis unit
- Incorporates sections of the 2000 Life Safety Code for fire safety
- Option for patients to have an advance directive
- Facilities provide written notice 30 days before a patient is involuntary discharged
- Facilities perform clinical assessment within 30 days, or 13 hemodialysis treatments, of patient starting treatment
- Home dialysis water purity requirements based on updated AAMI standards
- Facility-level quality assurance and performance improvement program
- Minimum qualifications and training requirements for patient care technicians (PCTs)
- Responsibility of Medical Director for Quality Assessment and Performance Improvement (QAPI) and involuntary transfers or discharges
- Electronic data collection and reporting
The CMS link to the final rule: www.cms.hhs.gov/CFCsAndCoPs/downloads/ESRDdisplayfinalrule.pdf