CMS Releases Regulation Modernizing Dialysis Centers

Main Category: Medicare / Medicaid / SCHIP
Article Date: 04 Apr 2008 - 14:00 PDT

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The Centers for Medicare & Medicaid Services (CMS) released a final rule that will modernize the Medicare conditions for coverage for the nation's dialysis centers and promote higher quality of care for patients receiving dialysis.

The final regulation will enhance the quality of care available to more than 336,000 Medicare beneficiaries with End-State Renal Disease (ESRD) who receive dialysis treatment from more than 4,700 Medicare-approved renal dialysis facilities across the U.S. The regulation reflects important clinical and scientific advances in dialysis technology and standards of care practices. The regulation also updates the current requirements that were first published in 1976.

"By bringing the standards of care for dialysis patients up to date, we are improving the health and quality of life for thousands of Medicare beneficiaries," said CMS Acting Administrator Kerry Weems. "With the new rules, people living with ESRD can be assured that they are getting the best care possible."

The final rule went on display at the Office of the Federal Register and will be published April 4, 2008.

These regulations will serve as minimum standards that dialysis facilities must meet in order to meet to be certified under the Medicare program. These conditions for coverage are part of the Medicare survey and certification process.

The rule focuses on the importance of patient rights, patient safety and the patient's participation in the development of his or her own plan of care. Each facility is required to develop a quality assessment and performance improvement (QAPI) program that would track the facility's performance in patient health outcomes. This regulation also reduces the detailed and burdensome requirements that dialysis facilities had to meet previously and provides flexibility for facilities to use their resources to meet the needs of individual patients and achieve better outcomes of care.

"This rule was designed with patient care in mind. We've added requirements for facilities to conduct a comprehensive assessment of the patient's health condition when starting dialysis treatment, as well as to work with an interdisciplinary team to develop an individualized care plan for every patient," said Barry M. Straube, M.D., CMS Chief Medical Officer and Director of CMS' Office of Clinical Standards & Quality.

"Facilities must work with patients to achieve and maintain the best possible outcomes of care," Straube said. "We've also added important protections to assure that all facilities develop a quality improvement system that helps them better assess patient outcomes and make positive changes that will improve health care delivery."

Beneficiaries will benefit by the following updates in the rule:

- Adopts updated Centers for Disease Prevention and Control (CDC) guidelines for hemodialysis facilities to increase patient infection control procedures.

- Adopts updated American Association for Medical Instrumentation (AAMI) water quality guidelines to promote safer water for dialysis use.

- Requires defibrillators in every dialysis facility, to allow facility staff to respond rapidly to individuals that may be having a heart attack.

- Incorporates sections of the 2000 Life Safety Code, which upgrades fire safety standards.

- Expands patient rights protections, including:

- A requirement to inform beneficiaries of their right to have advance directives,

- A facility-level grievance process that explains how a facility must respond to a patient's grievance, and

- A policy that provides a 30-day written notice to the patient before a facility can involuntarily discharge a patient.

- Requires a comprehensive patient assessment based on current medical practices and the patient's unique needs.

- Requires a personalized patient plan of care, based on current standards of care

- A facility-level quality assurance and performance improvement (QAPI) program to demonstrate how the facility will improve the quality of care it provides to patients.

- Minimum qualifications and training requirements for patient care technicians.

- Increases Medical Director involvement in the outcomes of the QAPI program and involuntary transfers or discharges.

The final rule meets CMS's overall goal of protecting patient safety, enhancing ongoing quality improvement, and improving patients' experience receiving dialysis services. CMS continues to work 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.

The final rule is displayed here.

Centers for Medicare & Medicaid Services