Have an Impact: U.S. Dialysis Center Standards Up for Revision

[Zach]

The Clinical Standards Group (CSG) in the CMS Center for Clinical Standards and Quality (CCSQ) is responsible for developing, updating and overseeing the CMS regulations on the Conditions for Coverage (CfCs) for ESRD facilities.  These particular regulations were last revised in 2008; therefore, CSG is asking the ESRD community to review the current Conditions for Coverage (CfCs) and provide suggestions for additions/changes/obsoletions that may be useful in a future update to the current regulations.
 
Please email ESRDCSG@cms.hhs.gov with your suggestions for future updates to the CMS regulations on the Conditions for Coverage (CfCs) for ESRD facilities.


More info from CMS (Medicare):
The ESRD Conditions for Coverage (CfCs) are the minimum health and safety rules that all Medicare and Medicaid participating dialysis facilities must meet.

The April 15, 2008 ESRD Conditions Final Rule modernizes Medicare's ESRD health and safety conditions for coverage and updates CMS standards for delivering safe, high-quality care to dialysis patients. The revised regulations are patient-centered; reflect improvements in clinical standards of care, the use of more advanced technology, and, most notably, a framework to incorporate performance measures viewed by the scientific and medical community to be related to the quality of care provided to dialysis patients.
http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/ESRD.html

From the U.S. National Kidney Foundation:
http://www.kidney.org/sites/default/files/docs/conditions_for_coverage_new.pdf

[iolaire]

http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/ESRD.html

This one is a good read the PDF is http://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/Downloads/ESRDfinalrule0415.pdf if you are thinking about comments or want to read other's comments.  Its full of comments and responses like:
Comment: One commenter suggested § 494.80(c), which addresses the frequency of dialysis adequacy monitoring, be modified to require facilities to ‘‘monitor fluid status.’’ The commenter cited a study that argued Kt/ V levels did not correlate with mortality or morbidity and that better methods of measuring intravascular volume and related blood pressure changes are needed.
Response: Proposed § 494.80(a)(2) would require the interdisciplinary team to evaluate fluid management needs. We have retained this provision in this final rule. We have also added, ‘‘manage the patient’s volume status’’ at § 494.90(a)(1), under the ‘‘Patient plan of care’’ condition.

Its a good view of both patient and center comments.  For example there is a section on heat in the unit where the commenters contrast the patients desire for a warm environment versus the center staff that might have more coverings on and want it cooler.  In that case they agreed and suggest a neural the unit must be comfortable rather than comfortable for patients.

[iolaire]

I also like responses such as this, which basically says if workers (such as social workers) have too big a caseload that's a center problem as they are required to have adequate staffing and are paid for that staffing...  So the centers can not use overworked employees as an excuse..

Comment: Although most comments recommended that social services be part of the plan of care, two commenters disagreed, stating that social workers have too big a caseload and are not capable of providing professional counseling services. One commenter stated that until there is consensus on outcomes, CMS should not include an outcomes-based social service requirement in the plan of care. Commenters supporting social services in the plan of care submitted a lengthy list of references that highlight the importance of social services as related to improved patient outcomes.
Response: In the previous conditions (§ 405.2162) as well as in this final rule (§ 494.180(b)), dialysis facilities are required to have adequate staff available to meet the care needs of their dialysis patients. This requirement applies to the provision of social services as well. Facilities may want to assess the caseloads of social workers to ensure there are adequate staff to provide the appropriate level of social services, including counseling. Social workers who meet the qualifications at § 494.140(d) are capable of providing counseling services to dialysis patients. Furthermore, Medicare payment for social worker counseling services is included in the dialysis facility composite rate.
We are setting forth some process requirements within the ‘‘Patient plan of care’’ condition because measurable outcomes in all areas are not yet available. When evidence-based or consensus outcome measures and standards become available, we may consider whether some process requirements may be removed from the conditions for coverage in the future.
Comment: We received a comment recommending that consistent language be used for all plan of care elements so that for all care plan areas the dialysis facility ‘‘must provide the necessary care and services to achieve and sustain an effective (treatment program).’’

[Rerun]

Thanks Guys!

                                   

[Zach]

NRAA Comments on CMS Conditions of Coverage

http://newsmanager.commpartners.com/nraarw/downloads/NRAA%20Conditions%20for%20Coverage%20Comment%20letter%20final.pdf

April 1, 2015

Mr. John Thomas
Director, Clinical Standards Group (CSG) Center for Clinical Standards and Quality Centers for Medicare & Medicaid Services Department of Health and Human Services 7500 Security Boulevard
Baltimore, MD 21244

Dear Mr. Thomas:
The National Renal Administrators Association (NRAA) is pleased to submit the following recommendations for changes to the CMS regulations governing the Conditions for Coverage for ESRD facilities. NRAA is a voluntary organization representing dialysis providers throughout the United States. Our membership is primarily community based small dialysis organizations (SDOs) and medium sized dialysis organizations (MDOs), both for-profit and non-profit providers serving patients in urban, rural and suburban areas in both free-standing and hospital-based facilities.

NRAA appreciates the opportunity to provide feedback to CMS as the agency considers updates to these regulations. We also appreciate the partnership our organization has with CMS, as well as the agency’s responsiveness on issues of importance to small and independent dialysis facilities. From the onset, CMS worked with the dialysis community to develop the Conditions for Coverage and, as such, the regulations stand as an example of how an effective collaboration between dialysis facilities and CMS can result in improvements in care for ESRD patients. We hope the comments below will further improve and clarify these regulations so that facilities can better serve their patients. We remain supportive of CMS’s efforts to ensure that dialysis patients receive the highest quality care and look forward to continuing our productive working relationship.

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. In addition to creating confusion in facilities, the discrepancy also creates confusion among the surveyors who evaluate the facilities. Further, the guidance contained in the Conditions for Coverage, as well as the measures in the QIP and Five Star Program should be developed and revised in accordance with expected patient outcomes. Too many times, facilities are asked to adhere to requirements that ultimately do not affect patient health or improve the quality of care patients receive. These requirements can be burdensome for facilities and do not advance CMS’s goals.

…/...

continues on the webpage above or on the attached PDF.

[Zach]

ESRD community submits comments on conditions for coverage

April 9, 2015

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."

Download full comments
http://www.nephrologynews.com/ext/resources/files/documents/CfC-2015-comments/AAKP-Conditions-for-Coverage-Comments.pdf


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 foiundation 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.

Download full comments
http://www.nephrologynews.com/ext/resources/files/documents/CfC-2015-comments/20150401-NKF-response-on-Conditions-for-Coverage.pdf
 

National Renal Administrators Association

The NRAA urged CMS to better align the varos 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."

Download full comments
http://www.nephrologynews.com/ext/resources/files/documents/CfC-2015-comments/NRAA-Conditions-for-Coverage-Comment-letter-final.pdf


Renal Physician's Association

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

"RPA recognizes that 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"

(Download full comments from the RPA on PDF from this IHD post)