A new regulation on Medicare coverage at outpatient dialysis centers aims to bring the requirements in line with new technology and scientific advances.
The final regulation, published in the Federal Register last month, also directs dialysis centers to focus more on patient needs. The final rule includes updated requirements for safety, patients' rights, quality reporting, and patient assessment.
The changes are so significant that the Centers for Medicare and Medicaid Services is granting centers 180 days to come into compliance with the new requirements instead of the standard 60 days.
“It's a cultural change in many ways as much as it is having to build new processes or implement new equipment,” Dr. Barry M. Straube, director of the CMS Office of Clinical Standards and Quality, said during a press briefing to announce the publication of the final rule.
The new requirements set a minimum standard that dialysis centers must comply with to be certified as Medicare providers. Under the final rule, centers must conduct a comprehensive assessment of the patient's health condition when they start dialysis and create a personalized care plan for each patient. That care plan should be developed by an interdisciplinary team made up of the treating physician, a registered nurse, a social worker, and a dietician.
The regulation also includes new patient rights protections. For example, patients must be informed of their right to have advance directives, and they must be given 30-day written notice before their dialysis services can be terminated involuntarily.
Centers will also be required to establish a center-level quality assessment and performance improvement program to show how the facility plans to improve quality of care.
The final rule also includes a requirement for dialysis centers to submit performance data through the Consolidated Renal Operations in a Web-enabled Network (CROWNWeb) system starting next year. Facilities will have until Feb. 1, 2009, to develop or enhance their systems to begin submitting end-stage renal disease clinical performance data electronically.
The final rule has been in the works for some time and officials at the CMS have sought significant input from the end-stage renal disease community since the proposed rule was issued in 2005. There are unlikely to be surprises in the regulation, he said.
CMS officials do not expect the regulation to be a major financial burden on dialysis facilities. Most costs associated with new requirements should be offset by the elimination of other resource-heavy requirements, Dr. Straube said.