CMS releases dialysis conditions for coverage

First revision of Medicare dialysis rules since 1976

WASHINGTON—On April 4, the Centers for Medicare & Medicaid Services published the final rule to modernize the Medicare conditions for coverage of dialysis centers in the United States.

The rules set the minimum requirements dialysis centers must meet in order to operate and be Medicare certified. This is the first time since 1976 that these rules have been updated. CMS said the new regulations reflect clinical and scientific advances that have been made in the last three decades.

“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.”

CMS said it focused the new rule on patient rights, patient safety and patient participation in developing a plan of care. Under the new rule, each facility is required to develop a quality assessment and performance improvement program (QAPI), which would track a facilities performance in a patient’s health outcomes.

“This regulation also reduces the detailed and burdensome requirements that dialysis facilities had to meet previously and provides flexibility fro facilities to use their resources to meet the needs of individual patients and achieve better outcomes of care,” CMS wrote in a news release.

Under the new rule, centers must adopt Centers for Disease Control and Prevention guidelines to increase patient infection control procedures. Clinics must also adopt updated guidelines from the American Association for Medical Instrumentation (AAMI) to ensure safer water in dialysis use.

The new rule requires defibrillators in every clinic so staff can better respond to patients that may have heart attacks. The regulation also upgrades clinics fire safety codes by using sections of the 2000 Life Safety Code.

In terms of patient rights, the new rule requires clinics to discuss advanced directives with patients. There must also be a facility-level grievance process, which must explain how a clinic responds to a patient’s issues. In addition, there now must be a policy under which a clinic has to provide a 30-day written notice before a clinic can involuntarily discharge a patient.

Facilities must have a comprehensive patient assessment procedure based on current medical practices and the patient’s unique needs. Furthermore, the rule says clinics must provide patients with a personalized plan of care.

In terms of renal staff, patient care technicians must now meet minimum qualification and training requirements. Medical directors will also have an increased role in the QAPI program as well as in involuntary transfers or discharges.

“This rule was designed with patient care in mind,” said Barry Straube, MD, CMS Chief Medical Officer. ‘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. Facilities must work with patients to achieve and maintain the best possible outcomes of care.”

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