Press Releases

PROPOSED MEDICARE RULE WOULD MODERNIZE END-STAGE RENAL DISEASE CONDITIONS FOR COVERAGE

PROPOSED MEDICARE RULE WOULD MODERNIZE END-STAGE RENAL DISEASE CONDITIONS FOR COVERAGE

The Centers for Medicare and Medicaid Services (CMS) today proposed a rule that would modernize the Medicare End-Stage Renal Disease (ESRD) conditions for coverage by promoting higher quality care amongst dialysis facilities that want to participate in the Medicare program.

The proposed regulation is applicable to over 4,700 Medicare-approved renal dialysis facilities and over 325,000 patients with chronic kidney disease.  In addition, the proposed regulation reflects important advances in dialysis technology and standard care practices because these requirements have not been revised in their entirety since 1976.

“This new rule brings our dialysis regulations up to date in a way that makes it easier for patients to be assured the best possible care,” said CMS Administrator Mark B. McClellan, M.D., Ph.D.

The proposed rule went on display today at the Office of the Federal Register and will be published on Feb. 4, 2005, followed by a 90-day public comment period.  

These regulations, when made final, will serve as the minimum quality standards applied during the Medicare survey and certification process. The proposed rule lessens prescriptive and burdensome requirements for dialysis facilities and provides flexibility for such facilities regarding the use of their resources to meet the needs of individual patients and achieve better outcomes of care.

This patient-centered rule also reflects current clinical and scientific advances in dialysis technology and standard care practices, including clinical practice guidelines developed by National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQI).

Proposed changes to the existing rule include:

Patient Safety:

• The incorporation of current Centers for Disease Control and Prevention infection control guidelines;
• The incorporation of current Association for the Advancement of Medical Instrumentation (AAMI) guidelines for water quality and hemodialyzer reuse;
• Additional patient safety protections such as defibrillators in the emergency equipment list and updated fire safety code provisions;
• Additional patient rights, such as advance directives, a 30-day notice prior to involuntary discharge, posting of external grievance mechanisms, and an internal patient grievance process;

Patient Clinical Care:

• A more comprehensive patient assessment, including a patient's suitability for a transplantation referral and criteria to identify unstable patients;
• Improvements to the existing patient plan of care, including a care-planning provision for transplantation status, a provision for regular patient-physician contact, and a requirement for transplantation referral tracking;
• A separate condition for coverage addressing the special needs of home dialysis patients, including a provision to ensure that services are at least equivalent to services provided in dialysis facilities;
• A Quality Assessment and Performance Improvement program designed by the facility and focused on improving patient outcomes of care, including provisions to identify medical injuries and medical errors, patient satisfaction, and grievances;

Administration:

• Minimum federal qualifications for patient care technicians (PCT) such as professionally-supervised on-the-job training and a written PCT training program with specified criteria, including patient sensitivity training;
• Electronic data reporting and collection of CMS Clinical Performance Measures Project data for improved facility-level quality of care accountability, and
• A proposal to develop national facility level clinical standards in accordance with the National Technology Transfer and Advancement Act of 1995.

The preamble to the proposed rule includes a detailed discussion regarding the possible use of minimum facility-wide standards with a request for public comment regarding whether to immediately adopt certain widely-accepted NKF-K/DOQI clinical practice guidelines as minimum facility-wide standards.

The preamble discussion also addresses the issue of how care and services should be provided to hemodialysis patients in nursing homes.  This discussion requests public comment regarding the best way to provide care and services to this vulnerable patient population.

The proposed rule serves CMS’ overall goal of protecting patient safety, stimulating ongoing quality improvement, and improving the patients’ experience receiving health care.  CMS is working to improve the quality of health care by measuring and improving outcomes of care, educating health care providers about quality improvement opportunities, and educating beneficiaries to make good health care choices.