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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Improving the understanding, detection, and management of kidney disease.

Quality Improvement/Evidence of Therapy

This section describes current quality improvement and evidence of therapy programs of the Federal government related to chronic kidney disease.

Agency for Healthcare Research and Quality (AHRQ)

AHRQ databases of interest to the kidney community include the Medical Expenditure Panel Survey, Healthcare Cost and Utilization Project, National Guideline Clearinghouse, National Quality Measures Clearinghouse, and the Department of Health and Human Services (HHS) Measure Inventory (a repository of measures currently in use across HHS for quality measurement, improvement, and reporting). AHRQ also produces annual reports such as the National Healthcare Quality and Disparities Reports which may be of interest.

AHRQ has established Evidence-Based Practice Centers (EPCs) that produce evidence-based reports and technology assessments on a variety of clinical, behavioral, and organization and financing topics. These evidence reports may be used to inform guidelines, research agendas and quality measures, and serve as the basis for educational materials for consumers, clinicians and policymakers. Additionally, AHRQ leads the Accelerating Change and Transformation in Organizations and Networks (ACTION II) program. This is a model of field-based research designed to promote innovation in healthcare delivery by accelerating the diffusion of research into practice. One of the current ACTION II projects aims to implement and evaluate the Comprehensive Unit-based Safety Program to reduce preventable vascular-access infections in end-stage renal disease facilities. The Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) Network consists of research centers that conduct studies on the outcomes, effectiveness, safety, and usefulness of medical treatments, devices and services. Recent activity includes the completion of two studies funded by the American Recovery and Reinvestment Act (ARRA). Researchers at Johns Hopkins University studied the comparative effectiveness of antihypertensive medications on preventing morbidity and mortality in dialysis patients, early versus conventional initiation of dialysis therapy on cardiovascular and other patient outcomes, and iron management strategies on anemia management and other clinical outcomes. Researchers at the University of North Carolina at Chapel Hill compared intravenous iron formulations in end-stage renal disease. Overall this research resulted in approximately sixteen manuscripts, several of which have been published in major medical journals.

AHRQ continues to award extramural research grants to study chronic kidney disease, in areas such as patient safety, disease management and assessment in patients with multiple chronic conditions.

Contact Information
Dina Moss, MPA
ACTIONII Program Officer
Email: dina.moss@ahrq.hhs.gov

Christine Chang, MD, MPH
EPC Program
Email: Christine.chang@ahrq.hhs.gov

Barbara Bartman, MD, MPH
DEcIDE Network
Email: Barbara.bartman@ahrq.hhs.gov

Elizabeth M. Bishop, PhD, MS
National Healthcare Quality and Disparities Reports, Chronic Kidney Disease/End Stage Renal Disease and Diabetes
HHS Measure Inventory
Email: Elizabeth.bishop@ahrq.hhs.gov

Last Updated: June 1, 2014

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Centers for Disease Control and Prevention (CDC)

CDC's CKD Health Evaluation Risk Information Sharing (CHERISH) is designed to test the feasibility of implementing a chronic kidney disease (CKD) screening and detection program in four states to assess the degree of kidney disease in a high-risk population, to determine the participant's subsequent access to care, and to address the likelihood of disease progression in those with evidence of CKD. This study is being conducted in collaboration with the National Kidney Foundation.

Contact Information
Desmond Williams, MD, PhD
CKD Initiative Team Lead
CDC Division of Diabetes Translation
Phone: 770–488–1158
Email: DEWilliams@cdc.gov
Web: http://www.cdc.gov/ckd

CDC is conducting bloodstream infection (BSI) surveillance and promoting BSI prevention among hemodialysis facilities. The CDC Dialysis BSI Prevention Collaborative is a partnership of freestanding and hospital-based outpatient dialysis facilities across the country aimed at preventing BSIs in hemodialysis patients. CDC provides evidence-based prevention guidelines and access to the National Healthcare Safety Network, a surveillance system that allows facilities to track infections. Also, CDC has developed for both patients and providers educational tools and materials to prevent dialysis-associated infections.

Contact Information
Priti Patel, MD, MPH
CDC Division of Healthcare Quality Promotion
Phone: 404-639-4273
Email: PPatel@cdc.gov
Web: http://www.cdc.gov/ckd
http://www.cdc.gov/dialysis

CDC, in collaboration with the Veterans Affairs - Puget Sound Health Care System, is using chronic kidney disease (CKD) progression models to evaluate the natural history of the disease by estimating the rate of progression through the stages of CKD and development of complications. These models are constantly updated and validated.

Contact Information
Meda Pavkov, MD, PhD
CDC Division of Diabetes Translation
Phone: 770–488–1160
Email: MPavkov@cdc.gov
Web: http://www.cdc.gov/ckd

CDC's Cost-Effectiveness Study is using a lifetime simulation model to assess the costs and benefits of various interventions to prevent, delay, and treat chronic kidney disease (CKD) and its complications. The goal is to develop a model that will not only help predict the progression of CKD, but will also test the long-term effectiveness of various public health interventions, and thus ultimately help achieve an efficient use of public health resources to prevent and control CKD.

CDC is also researching the cost of illness through its Cost-of-Illness Study to document the direct and indirect costs of CKD and other diseases or conditions.

Contact Information
Desmond Williams, MD, PhD
CKD Initiative Team Lead
CDC Division of Diabetes Translation
Phone: 770–488–1158
Email: DEWilliams@cdc.gov
Web: http://www.cdc.gov/ckd

Last Updated: June 1, 2014

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Centers for Medicare & Medicaid Services (CMS)

  1. ESRD Quality Incentive Program: The first program of its kind in Medicare, the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) promotes high-quality outpatient care for patients with ESRD by linking a portion of each facility’s reimbursement for dialysis treatment directly to its performance on measures selected by the Centers for Medicare & Medicaid Services (CMS). Changes in reimbursement systems (via the ESRD Prospective Payment System) and an increased emphasis on patient outcomes (as embodied by CMS’s Value-Based Purchasing efforts) may result in unintended consequences for Medicare beneficiaries; for example, facilities may undertreat patients in order to maximize profits and minimize costs. The ESRD QIP helps guard against that possibility by evaluating the quality of care that dialysis facilities provide. The ESRD QIP reduces payments (by up to two percent) to facilities that do not meet or exceed certain performance standards, and the program communicates the results to the facilities themselves and the public at large.

    The ESRD QIP includes clinical measures (which evaluate the quality of care provided by facilities) and reporting measures (which evaluate whether facilities collect and/or report data to CMS). These performance measures change from year to year. Currently, ESRD QIP measures address:

    • Anemia Management
    • Dialysis Adequacy
    • Vascular Access
    • Mineral Metabolism
    • Infections
    • Patient Experience of Care

    In addition, CMS is committed to improving the quality of care delivered to beneficiaries, as well as ensuring that access to care is not impeded—especially to racial and ethnic minorities, as well as other medically underserved populations. CMS closely monitors practice patterns as well as patient outcomes; if it discovers issues with regard to access, cost, or quality of care, then the facility involved will be thoroughly investigated, followed by appropriate and timely corrective action.

    Contact Information
    Anita Segar
    Phone: 410-786-4614
    Email: anita.segar@cms.hhs.gov
    Web: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ESRDQIP/index.html

  2. ESRD Quality Measures Development Program: The Quality Measurement and Health Assessment Group at CMS is responsible for the development, maintenance, and implementation of quality measures for dialysis facilities certified by Medicare. The group supports other CMS components in implementing these measures for value-based purchasing through the QIP, quality reporting, and public reporting through the Dialysis Facility Compare website. Measures developed and currently maintained address quality of care provided to dialysis patients in the areas of dialysis adequacy, anemia management, mineral bone disease, vascular access, hospitalizations, rehospitalizations, and mortality. Ongoing work is expanding these measures to assess quality as defined in the CMS Quality Strategy.

    Contact Information
    Joel Andress
    Phone: 410-786-5237
    Email: joel.andress@cms.hhs.gov

  3. Conditions for Coverage Program:The Center for Clinical Standards and Quality’s (CCSQ) clinical standards group develops and maintains the ESRD conditions for coverage, the minimum health and safety requirements that dialysis facilities must meet in order to participate in Medicare. These conditions (found at 42 CFR Part 494) set requirements for infection control, water and dialysate quality, reuse of hemodialyzers and bloodlines, physical environment, patient’s rights, patient assessment, patient plan of care, care at home, quality assessment and performance improvement, special purpose dialysis facilities (for example, summer camps), laboratory services, personnel qualifications, responsibilities of the medical director, medical records, and governance. The group collaborates with fellow CMS and HHS components, as well as with external stakeholders, to ensure that these standards are up to date and effectively interpreted and applied.

    Contact Information
    Lauren E. Oviatt
    Phone: 410-786-4683
    Email: Lauren.Oviatt@cms.hhs.gov

  4. Survey and Certification Program:The Survey and Certification Group of CMS is responsible for ensuring that all Medicare-certified ESRD facilities meet Federally-mandated standards, which are set to protect the health and safety of the ESRD patients. The standards include safety, clinical care, and infrastructure standards which are critical elements for the well-being of patients.

    • Safety standards include: infection control practices; water treatment and dialysate preparation elements; reprocessing activities; and equipment/structural maintenance.
    • Clinical standards include: review of the facility’s capacity to monitor, recognize, and address individual clinical care issues and the facility-wide quality assessment and performance improvement (QAPI) program. Patients’ rights are also reviewed.
    • Infrastructure standards include: personnel qualifications; medical recording structure; the and governance structure

    The survey process is conducted by specifically-trained health care professionals (based in State health departments) who conduct on-site facility reviews. These surveyors utilize national/facility data, national/community-based standards, patient/personnel interviews, observations of facility practices, and review of medical records to conduct their reviews. The surveyors follow-up on each survey by monitoring the appropriateness of corrective action plans and program improvements.

    Contact Information
    Judith Kari
    Phone: 410-786-6829
    Email: Judith.Kari@cms.hhs.gov
    web: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/index.html

  5. Dialysis Facility Compare: The Dialysis Facility Compare (DFC) contains information about Medicare certified dialysis facilities. Included is facility name and contact information, location, types of services provided, certification date, and quality measures for each facility. DFC allows patients, family members, healthcare providers, and stakeholders, to compare the quality of dialysis facilities across the country, and to access a variety of kidney disease and dialysis resources. DFC also includes demographic data, medical claims, payment, and entitlement data on patients with Medicare who have ESRD; and aggregate ESRD patient information.

    Contact Information
    Elena Balovlenkov
    Phone: 410-786-6718
    Email: elena.balovlenkov@cms.hhs.gov
    web: http://medicare.gov/DialysisFacilityCompare/

  6. Consolidated Renal Operations in a Web-Enabled Network (CROWNWeb): CMS utilizes CROWNWeb data as one of the primary data sources for the Quality Measures (QM) Project, enabling ESRD stakeholders to gauge patient care outcomes by offering comparisons of clinical performance results at the facility, ESRD Network, and national levels. The database can quickly calculate and produce QM reports, allowing facilities to more closely monitor patient clinical measures and rapidly evaluate treatment trends to ensure patients receive the appropriate treatment. CROWNWeb data reporting of attestations are used to calculate facility Total Performance Scores as part of the Quality Incentive Program (QIP). Facilities are evaluated and scored based on their compliance with CMS-mandated reporting measurements. Using CROWNWeb (and other) data sources, scores are calculated for each facility, and score certificates must be published in a visible area in each facility.

Last Updated: June 1, 2014

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Department of Defense (DoD)

The DoD and Veteran's Administration (VA) work collaboratively to develop evidence-based clinical practice guidelines. The VA/DoD Clinical Practice Guideline (CPG) for the Management of Chronic Kidney Disease was updated and published in 2008. The VA/DoD guideline development process follows a rigorous evidence review and grading process. Guideline champions—subject matter experts, specialists, consultants, and/or individuals doing research in the field—are selected in both VA and DoD. Guideline working group members are selected across the VA and DoD and are part of interdisciplinary teams caring for patients with chronic kidney disease. The guideline working group members develop researchable questions based on the PICO format (problem, intervention, comparison, and outcome) and review the evidence presented in some of the national and international guidelines. There is a contract with an Evidence-Based organization to do a systematic review of the literature and present evidence synthesis to the working group members to minimize bias. Guideline recommendations are developed based on the evidence and graded by the working group members using the same grading process spelled out by the US Preventive Services Task Force. Recommendations for care of patients with chronic kidney disease are outlined in the VA/DoD Clinical Practice Guideline (CPG) for the Management of Chronic Kidney Disease.

After the guideline is approved and published by the VA/DoD Evidence-Based Working Group, consisting of members from the VA, Army, Air Force and Navy, the VA and DoD collaborate to develop implementation tools, clinical documentation, and quality improvement procedures into the electronic medical information systems. VA and DoD are in the process of developing several CKD encounter form templates as well as referral forms for nephrology consultation, renal nutrition, and vascular access placement to better treat patients.

Contact Information
James Ellzy, CDR, US Navy
Director of Clinical Quality
Phone: 703-681-0064
Email: James.ellzy@amedd.army.mil
Web: www.tricare.mil

Last Updated: March 1, 2012

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Health Resources and Services Administration (HRSA)

Funded by HRSA, the Organ Procurement and Transplantation Network (OPTN) is the unified transplant network established by Congress under the National Organ Transplant Act (NOTA) of 1984. The OPTN is a unique public-private partnership that links Organ Procurement Organizations (OPOs), transplant programs, and histocompatibility laboratories together into a national transplant system. The primary goals of the OPTN are to maximize the benefits to patients through patient-centric organ allocation policies; increase the efficiency, effectiveness, and safety of the national organ allocation and distribution system; and increase the supply of donated organs (including kidneys) available for transplantation.

The OPTN monitors the outcomes of OPOs and transplant programs by using risk-adjusted data models and assists members in improving performance outcomes through a peer-mentoring process.

As of November 15, 2013, there were 120,624 candidates on the OPTN organ waitlist of which 98,701(81.8%) were waiting for a kidney transplant.

NOTA established the Scientific Registry of Transplant Recipients (SRTR), which provides analytic support to the OPTN in the development and evaluation of OPTN organ (including kidney) allocation and other policies. The SRTR conducts independent research to add to the body of knowledge about organ donation and transplantation. Transplant program and OPO performance reports and data are available on the SRTR website. The SRTR also makes solid organ transplantation data available to bonafide transplant researchers from the time of listing of the potential transplant recipient through graft failure or patient death.

Contact Information
Robert Walsh
Director, Division of Transplantation
Phone: 301–443–6839
Email: rwalsh@hrsa.gov
Web: www.organdonor.gov

Last Updated: June 1, 2014

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Indian Health Service (IHS)

The IHS Diabetes Program is building implementation tools, clinical documentation, and quality improvement procedures into the medical information system. For example, the program offers "Quick Guide Cards " for health professionals on various diabetes related topics, including CKD. Each set includes an overview, resources (e.g. algorithms), and several 'How To' short video tutorials.

Access IHS's 2012 Best Practice: Screening for Chronic Kidney Disease Document and Treatment Algorithms for Diabetes and CKD from the IHS CKD and Diabetes Hub .

Contact Information
Division of Diabetes Treatment and Prevention
About IHS:
Phone: 505-248-4182
Email: diabetesprogram@ihs.gov
Web: http://www.ihs.gov/MedicalPrograms/Diabetes/index.cfm?module=home
About CKD:
Andrew S. Narva, MD, FACP, FASN
Chief Clinical Consultant for Nephrology
Phone: 301-594-8864
Email: narvaa@niddk.nih.gov

Last Updated: June 1, 2014

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Veterans Affairs (VA)

The VA and Department of Defense (DoD) work collaboratively to develop evidence-based clinical practice guidelines (CPG). The VA/DoD Clinical Practice Guideline for the Management of Chronic Kidney Disease was last updated and published in 2008. VA/DoD is in the process of completing a subsequent round of updates with an expected completion date of end-fiscal year 2014. The VA/DoD guideline development process follows a rigorous evidence review and grading process. Guideline champions are selected in both VA and DoD who are subject matter experts, specialists and consultants or who are doing research in the field. Guideline working group members are selected across the VA and DoD and are part of interdisciplinary teams caring for patients with chronic kidney disease (CKD). The guideline working group members develop researchable questions based on the PICO format (problem, intervention, comparison, and outcome) and review the evidence presented in some of the national and international guidelines. There is a contract with an evidence-based organization to do a systematic review of the literature and present evidence synthesis to the working group members to minimize bias. Guideline recommendations are developed based on the evidence and graded by the working group members using the same grading process spelled out by the United States Preventive Services Task Force. Recommendations for care of patients with CKD are outlined in the VA/DoD Clinical Practice Guideline for the Management of Chronic Kidney Disease.

After the guideline is approved and published by the VA/DoD Evidence-Based Working Group, consisting of members from the VA, Army, Air Force and Navy, the VA, and DoD collaborate to develop implementation tools, clinical documentation, and quality improvement procedures into the electronic medical information systems.

VA also collaborates with the Centers for Medicare and Medicaid Services (CMS) in their quality improvement programs pertaining to dialysis care by reporting to Consolidated Renal Operations in a Web Enabled Network (CROWNWeb).

Contact Information
VHA National Kidney Program
Email: VHANationalKidneyProgramOffice@va.gov
Web: http://www.medicalsurgical.va.gov/kidney/program.asp

Last Updated: June 1, 2014

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This information was reviewed by KICC agency representatives. It may not reflect new or future agency activities. For more information, please contact the listed representatives.

Page Last Updated: June 4, 2014