Editor’s note: The Kidney Care Quality Alliance, formed in 2008 by Kidney Care Partners, announced recently that it would begin developing a new set of quality measures for the renal community. A top priority, the group says, is a measure for fluid management. We asked Edward R. Jones, MD, and Allen R. Nissenson, MD, co-chairs of the KCQA, how the measures would be developed and the importance of fluid management. KCP is a broad-based coalition of patient advocates, clinicians, care professionals, dialysis providers, researchers and manufacturers working together to improve quality of care for individuals with chronic kidney disease (CKD) and end-stage renal disease.

NN&I: Why does the Alliance feel the need to develop a set of measures beyond what the Centers for Medicare & Medicaid Services has already developed for the Quality Incentive Program?

Jones/Nissenson: Kidney Care Partners launched the Kidney Care Quality Alliance (KCQA), prior to the passage of the ESRD Quality Incentive Program (QIP) in 2008. KCP first engaged in measure development to support the implementation of a value-based purchasing (VBP) program in the Medicare ESRD program. While KCP has always been supportive of VBP, for it to succeed, the measures that are used to evaluate facility performance must be related to the services provided by the facilities and meaningful to patients in terms of care outcomes.

We believed then, as we do now, that measurement and transparency are core elements of any successful quality program. KCP also felt strongly that quality measures must be consensus-based and grounded in clinical evidence. KCP established an independent structure and process to allow the community to engage in the development of valid, consensus-based measures that will help drive positive patient outcomes. The Kidney Care Quality Alliance (KCQA), which has included other stakeholders including nondialysis entities, such as health insurers and consumer groups, provides that structure and process.

As the QIP was taking shape, CMS began rolling out various quality measurement programs. Pay-for-reporting programs were being proposed in other sectors of health care; websites comparing performance at the facility level and star ratings programs also were being launched. As we looked at the changing landscape, it became clear that the community needed to play a leadership role in measure development. CMS is moving quickly to develop numerous measures to use in its various quality programs, including but not limited to the QIP. Most of these measures are not tailored to address the unique nature of dialysis patients. While we understand that to some extent CMS is engaging in a series of quality measurement experiments, we also are acutely aware that these programs can and do have a significant impact on patients. For that reason alone, we feel we have a responsibility to engage proactively and at a higher level than in the past. We can no longer simply react to CMS proposals. We need to be in a position to offer more effective and supportable approaches to quality measurement.

Recognizing that quality programs like the QIP evolved over time and that we have an obligation to help shape that evolution, we launched the KCQA initiative. We believe the KCQA can become a measure development powerhouse. We have access to some of the best minds in kidney care. We have professionals with a wealth of experience involved in our research and deliberations. We have the benefit of participation of numerous patient organizations. And CMS sits at the table as well.

The bottom line: Through the KCQA, we believe we can develop meaningful evidence-based measures that will lead to positive patient outcomes, better provider performance, and lower health care costs – all within a consensus-based framework.

NN&I: How did fluid management become a high priority?

Jones/Nissenson: KCP convened KCQA in February 2014 for the purpose of developing patient-centric, facility-level performance measures addressingESRD care. We anticipate that measures developed by KCQA will be presented to the National Quality Forum (NQF) for endorsement consideration.

KCQA began its process with an environmental scan to identify the universe of current ESRD measures—what had been reviewed by NQF before, what was found in publicly available sources (e.g., DOPPS, National Quality Measures Clearinghouse), what was being used for internal quality improvement purposes, and where gaps in the measure set existed when mapped against the domains and subdomains of KCP’s report, A Strategic Blueprint for Advancing Kidney Care Quality. The environmental scan provided a common baseline of the ESRD measure landscape that informed KCQA members during their identification of top priorities.

Following this review, KCQA members participated in a process to prioritize the measure development areas that could be most influential in improving patient outcomes and potentially, through care improvement, reducing costs.

Specifically, KCQA prioritized 35 of the Blueprint’s(sub)domains for kidney care quality through two rounds of a modified Delphi process, conference call/webinars to discuss results, and a final ratification. KCQA members identified the top five measurement areas, in priority ranked order as:

1. Fluid management

2. Re-hospitalization

3. Vascular access

4. Nutrition

5. Health-associated infections

During the modified Delphi process, KCQA members were asked to prioritize the candidate measurement areas against the following five criteria:

  • Clinical impact: Viewed as important by patients, health care professionals, and health care providers; measures developed in this area are likely to improve survival, reduce hospitalizations, and/or improve patients’ health-related quality of life and experience with care.
  • External impact: Viewed as important by stakeholders, such as CMS and Congress, and is thus important for public reporting and payment.
  • Collaboration/engagement: Will promote progression towards care coordination and more holistic care delivery; provides increased opportunity for partnership between patients, health care professionals, dialysis facilities, hospitals, other care providers, and CMS; and/or have the potential to address resource utilization.
  • Feasibility: Necessary data are readily available, can be captured without undue burden to patients or health care providers, and could be effectively implemented for use in quality improvement and incentive programs.
  • Usability/actionability: Will provide comprehensible and meaningful information to patients, health care professionals, health care providers, and policymakers.

Following this comprehensive process, KCQA approved fluid management as its measure development area for 2014. The group made this a priority because this is the number one reason that dialysis patients are hospitalized. Tracking this measure would be extremely meaningful to patients. KCQA further prioritized topics within fluid managementto the following four areas:

  • Extracellular fluid (ECF) volume management
  • Ultrafiltration rate (UFR)
  • Dialysis frequency/duration
  • Sodium management (dietary and dialysate)

KCQA also conducted a “Call for Measure Concepts,” that invited all KCQA members to submit candidate concepts for fluid management measures.

To undertake the technical work involved in measure constructions, KCQA conducted a “Call for Nominations” for appointment to the KCQA Measure Feasibility/Testing Workgroup. Based on these nominations, the KCQA Steering Committee(see list)appointed a Workgroup to identify the top 4-5 measure concepts, and then measure specifications (numerator, denominator, exclusions), from which KCQA can select the 1-2 related measures for testing.

The Workgroup convened numerous times––in public session––to develop their recommendations. During this process, Workgroup members operated by consensus, first winnowing the 63 concepts in the four fluid management areas to several measure concepts before in-depth discussions of the feasibility and evidentiary base. Ultimately, seven candidate measures were specified at the numerator, denominator, and exclusions levels—further reduced to two measures, one in extracellular fluid volume management and one in ultrafiltration rate.

We already know about the connection between fluid management and morbidity. A 2010 study published in the Clinical Journal of the American Society of Nephrology among 25,291 dialysis patients tracked 41,699 care episodes that resulted in inpatient hospitalization, observations,or ER visits due to complications primarily from fluidoverload––at a cost to the Medicare system of $6,372 per patient ($266 milliontotal).

Additionally, fluid management was identified as the top priority area according to physicians, nurses, patients, and dialysis facilities. Next to removal of catheters, it is the most important area to improve patient survival; to result in fewer hospital admissions, readmissions, and less ERuse; to improve patient quality of life; and to reduce health care spending by lessening the burden on the Medicare program and the American taxpayer.

NN&I: Is it the Alliance’s goal to have these measures adopted by CMS as part of the Quality Incentive Program?

Jones/Nissenson:We believe that the renal community––and KCQA specifically––is in the best position to create measures that are not only relevant, practical, and proven to drive better outcomes, but also measures where data are available, evidence is appropriate, and collection, aggregation, and analysis are possible.

Those who have been tracking quality measure development activities might recall that KCP launched a similar effort in 2005 that led to the development of quality measures eventually endorsed by NQF.

CMS has always expressed a desire to work with community stakeholders in the agency’s own measure development, and we commend them for that.We share the agency’s desire to continue to raise the quality bar, and we look forward to working collaboratively with agency officials on new measure development through the KCQA. We believe that having a CMS representative serve on the KCQA Steering Committee and participate in our deliberations helps create that collaborative framework that is vitally important in measure development.

NN&I: What are the next steps to getting the process rolling?

Jones/Nissenson: 5KCQA has begun the testing process, which will rely on volunteering KCQA member dialysis organizations. Our goal is to complete testing in time to meet NQF’s deadline for submission of measures for its current Renal Project on February 26, 2015.

Visit KCP’s website (www.kidneycarepartners.com) for more information on the Alliance and progress on the fluid management quality measure.