Creation/Revision Date: December 10, 2009
December 11, 2009
Barry Straube, M.D., Director and Chief Medical Officer
Office of Clinical Standards and Quality
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building
7500 Security Boulevard
Baltimore, MD 21244-1850
Re: Assessment of the End Stage Renal Disease Network Program
Dear Dr. Straube,
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with renal disease. We are writing to provide comments on selected portions of the CMS OCSQ Assessment of the End Stage Renal Disease Network (ESRD) Program.
Overall RPA is supportive of the concepts set forth in the document, and in particular for the need to ensure that the activities specified in the Network Scope of Work accurately reflect the complexity of the ESRD Network Program and the overall goals of the Network Program in improving care for ESRD patients.
RPA strongly supports the concept of maintaining the ESRD Network’s status as independent organizations that are focused on the best care for patients with ESRD and kidney transplants. We believe that subsuming these organizations under the auspices of the Quality Improvement Organizations (QIOs) or other organizations as a matter of policy is not in our patients’ best interest.
The Overarching Goals of the Network Program
RPA encourages the concept that the primary focus of the ESRD Networks is to provide quality oversight of the ESRD program and serve as an advocate for Medicare beneficiaries with ESRD. Under the Social Security Act, the ESRD Networks are intended to provide support to both ESRD patients and facilities. While the Networks need to provide technical support to facilities with regard to issues related to improving quality of care, the Networks’ role should not be to advocate for the facilities, but rather to advocate for patient needs to facilitate improved care.
Funding of the Network Program
RPA strongly believes that there should be increased funding for Network activities. The current funding for Network activities, unchanged on a per-treatment basis since the program’s inception (at $0.50 per treatment), represents a major obstacle to achieving effective quality improvement. Although the absolute dollar amount has increased as the number of patients with ESRD has increased, the quality requirements have grown to an even greater extent, and as a result the funding level has proportionately fallen in inflation-adjusted dollars. In addition, neither the accounting nor the financial support for the $0.50 per treatment has been transparent—this is an obvious shortcoming in the execution of fiduciary responsibility in this area that should be addressed. RPA would recommend that CMS consider that creation of a separate fund earmarked for Network activity would be the most appropriate and effective process for addressing these issues.
Prioritization of Network Activities
RPA encourages CMS to prioritize Network activities. It will not be possible for the Networks to accomplish an unlimited number of tasks, particularly if funding levels are not increased. Prioritization would provide direction to the Networks and assist them in ensuring that the most top-level tasks and objectives are achieved. To this end, RPA believes that the most important priorities should include:
a. Support for QI at the facility and physician levels – networks must produce products that demonstrably improve performance and process;
b. Support for insuring patient accessibility to dialysis and transplant care
c. Support for meaningful patient grievance processes that are patient centered but objective, accurate, and fair to all parties.
Focus of Quality Improvement Activities
RPA is disappointed that the redesign document continues to propose that Network Quality Improvement activities remain focused on the traditional outcomes of “adequacy” of dialysis based on urea kinetics, anemia management and vascular access. While these parameters are important and are easily quantified, RPA encourages movement toward intermediate outcomes that are associated with improvement in the quality of lives on dialysis. These should include attention to infections and inflammation (including but not exclusively vascular access infections), management of fluid overload, and management of co-morbid conditions including diabetes and heart disease. Quality measures in these domains need to be based on robust disease-specific data, cognizant in the often paradoxical relationships between traditional risk factors and outcomes in ESRD populations.
The care of patients with ESRD should be patient-centered rather than taking a one-size-fits-all approach. Performance measures need to reflect this need for patient-centered care and recognize differences in goals of therapy among different populations of patients.
a. Young, healthy patients usually seek care that gives them the longest and healthiest lives. Such patients may trade rigors of the treatment and diet for the hope of longer, healthier lives. Performance measures for these patients may include for example high goals for standardized weekly Kt/V, low goals for inflammatory markers, and perhaps incentives for more frequent or intense dialysis with lower total body fluid.
b. Elderly, debilitated multi-system disease patients often seek care that will give a measure of comfort, reduce suffering and maximize their quality of life, in exchange for striving for longer life. Performance measures for these patients may need to exclude standardized weekly Kt/V and measures of inflammation, but rather focus on patient-selected QoL measures. Several ways to allow patients to individually select such measures have been published.
c. Other patients may elect a path somewhere between these two, and RPA believes that the system should allow for this. All such “pods of care” or decisions may be reviewed and revisited by patients, their families and caring physicians.
Relationship of the ESRD Networks to the Requirements for Physical Environment of Care
Like all members of the dialysis care community, RPA believes that the need to maintain patient comfort and dignity during care is an important aspect of quality care. The Network redesign document repeatedly stresses that the most common complaint from ESRD patients relates to the ambient temperature in ESRD facilities, with patients complaining that it was too cold. We would disagree that oversight of the physical environment is a responsibility of the ESRD Networks, and would encourage that this issue be a focus of the state survey agencies in ensuring compliance with the ESRD Facility Conditions for Coverage.
Patient grievances are an important concern and RPA supports efforts to improve the mechanisms by which the Networks handle grievances. We therefore support the standardization of the definitions of grievances, and the use of standard processes for addressing these grievances. There is a need to recognize, however, that in addition to the responsibility of facilities to ensure the rights of patients, ESRD patients also have responsibilities to not be disruptive. Any grievance process needs to address the complex psychosocial factors, including high rates of co-morbid conditions, substance abuse and psychiatric disorders that often accompany ESRD.
While the need for attribution of improvements in care to Network interventions is recognized, RPA is concerned regarding the approach proposed in the redesign document. The use of comparison groups for the purpose of attribution needs to be clarified. In particular, the statement that the Office of Human Research protection (OHRP) “…has ruled that these types of quality improvement projects are permitted without Institutional Review Board (IRB) approval” may not be consistent with OHRP’s interpretation of the necessity of IRB approval, nor with prior determinations in this regard. As such, we would urge CMS to seek clarity on this issue prospectively to avoid future unintended consequences resulting from CMS interpretation of necessity of IRB approval.
As always, we welcome the opportunity to work collaboratively with CMS in its efforts to improve the quality of care provided to the nation’s ESRD patients, and we stand ready as a resource to CMS in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at firstname.lastname@example.org.
Edward R. Jones, M.D.