The Clinical Standards Group in the CMS Center for Clinical Standards and Quality asked the ESRD community to provide suggestions for changes to the Conditions for Coverage, which was last revised in 2008.

Below are excerpts from comments submitted by renal groups. This list is not exhaustive, and the full comments are available for download.

Common concerns included dialysis patients not being properly informed of treatment choices, patients’ rights, and a lack of alignment between other quality programs related to ESRD facilities.

American Association of Kidney Patients

The AAKP suggested that each dialysis facility survey should provide evidence that patients have been fully informed on all options available to them for their treatment.

“An AAKP survey published in the March 2011 issue of the Clinical Journal of the American Society of Nephrology showed the majority of patients with ESRD would like to receive more comprehensive information about the various treatment alternatives available. Nearly 1,000 ESRD patients and their caregivers responded to the survey, which asked for their perspectives on dialysis education and therapy. More than 30 percent of the patients felt that the different options for treatment—in-center hemodialysis, peritoneal dialysis, home hemodialysis, and kidney transplantation—were not ‘equally or fairly presented to them.’ Only about a third of end-stage renal disease patients indicated that they were given sufficient information about home hemodialysis—a therapy option that offers some key advantages over in-center dialysis. AAKP believes the facility survey should provide evidence that patients have been fully informed on all options available to them for their treatment. This should be signed and witnessed before each individual patient.”

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National Kidney Foundation

NKF has concerns that despite the comprehensive statements surrounding patients’ rights there remains evidence that the majority of patients continue to be unaware of these rights. The foundation urged CMS to incorporate the following recommendation from a 2013 report from the Office of Inspector General.

(1) define “grievance” for facilities, (2) require that facilities report grievances regularly to their respective networks, (3) provide guidance to facilities on what constitutes a robust process for anonymous grievances, (4) work with the Agency for Healthcare Research and Quality to add a question to the standardized satisfaction survey to assess ESRD beneficiaries’ fear of reprisal, and (5) provide networks with better technical support for their grievance database.

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National Renal Administrators Association

The NRAA urged CMS to better align the various quality programs related to dialysis facilities.

“As CMS considers updates to the Conditions for Coverage, we urge the agency to create more alignment among its quality programs. The goals of the Conditions for Coverage, as well as the ESRD Quality Incentive Program (QIP) and the Five Star Program, are to ensure the best possible outcomes for ESRD patients. When various quality programs across CMS do not align, it can create confusion for dialysis facilities and impede their progress toward that overall goal, especially since dialysis facilities are operating within different quality programs and regulations simultaneously. For example, the calcium measurement in the Conditions for Coverage differs from the one used in the QIP. In the Conditions for Coverage, facilities are advised to follow the standards established in the Measures Assessment Tool (MAT). The MAT uses corrected calcium levels of greater than 10.2 while the QIP requires use of uncorrected calcium levels. As a result, facilities are trying to adhere to the QIP measure and not to the Core Survey process.”

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Renal Physicians Association

The RPA noted that the lack of uniformity in the training and education of the surveyors from state to state created variability in the program’s effectiveness.

“RPA recognizes that the Clinical Standards Group seeks input on the ESRD Conditions for Coverage and not on the dialysis facility survey process per se, however, given that the Conditions form the foundation for performing the surveys, we would be remiss to not note that  the current system for surveying dialysis facilities often results in the quality of the surveys being compromised.  While the dialysis facility certification process in some states is a positive and educational exercise that fosters the development of effective processes of patient care at the institution, in other states facility surveys can be arbitrary and punitive, and contrary to the needs of the local kidney patient population.  Lack of uniformity in the training and education of the surveyors causes significant variability in the caliber of inspections from state to state.  Some dialysis facility medical directors have noted that surveyors unfamiliar with renal care processes will often focus on issues peripheral or even unrelated to the delivery of safe dialysis while ignoring the more critical elements of ESRD services, or will cite the facility for ‘violations’ that do not reflect deviation from the Conditions or from state regulations governing ESRD facilities.”

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