Dialysis centers must meet new requirements to be certified under the Medicare program. On April 15, 2008, the Centers for Medicare & Medicaid Services (CMS) published its final rule establishing new Conditions for Coverage (CfCs) for End-Stage Renal Disease (ESRD) facilities. The rule updates existing CfCs, first published in 1976, to reflect major clinical advances in dialysis technology and standards of care. The rule is effective October 14, 2008, though facilities are given additional time to comply with particular infection control, life safety code and electronic data submission provisions.

The new rule explicitly focuses on improving patient care through rigorous data tracking. ESRD facilities must develop a “quality assessment and performance improvement” (QAPI) program to monitor the facility’s performance in the following patient health outcome measures:

• Adequacy of dialysis
• Mineral metabolism and renal bone disease
• Vascular access
• Medical injuries and medical errors identification
• Patient satisfaction and grievances
• Nutritional status
• Anemia management
• Infection control
• Hemodialyzer reuse program

To implement the “action-oriented and data-driven” QAPI program, every ESRD facility must comprehensively assess a patient’s health condition before beginning dialysis treatments. The facility must develop an individualized care plan for each patient through an interdisciplinary team that must include, at a minimum, the patient, a registered nurse, a physician, a qualified social worker and a registered dietician. The interdisciplinary team must be monitored by the facility’s medical director, who is ultimately accountable to the facility’s governing body for the quality of medical care provided to patients.

The new rule includes a number of additional provisions meant to improve patient care and facility accountability. Each facility must now have a defibrillator on hand. The medical director must approve any involuntary patient transfer or discharge, which now requires 30-days written notice. Patient care technicians must be state or nationally certified and must complete a written training program addressing patient care and the operation of dialysis equipment.

Further, CMS will now require facilities to meet updated requirements imposed by relevant public agencies. The rule incorporates the Centers for Disease Control and Prevention (CDC) guidelines for hemodialysis facilities, the Association for the Advancement of Medical Instrumentation (AAMI) water quality guidelines, and the 2000 Life Safety Code upgrades to fire safety standards.

Through these modernized guidelines and the data-driven QAPI program, CMS hopes dialysis patients will receive better and more cost-effective care. To download the final rule, please click here.

If you have any questions about compliance with the CMS final rule or about dialysis centers generally, please feel free to contact any of the following Arent Fox attorneys:

Michael S. Blass
blass.michael@arentfox.com
212.484.3902

Jill Steinberg
steinberg.jill@arentfox.com
212.492.3305

Lauren Tabak Fass
fass.lauren@arentfox.com
212.492.3288

Marianna F. Miyazaki*
miyazaki.marianna@arentfox.com
212.457.5477