A synopsis of how vascular access data will be managed within CMS’ CROWNWeb system.
The Centers for Medicare & Medicaid Services (CMS) is evaluating clinical data entered into its CROWNWeb system by participating Phase 2 facilities against that provided by dialysis facilities nationwide.
This evaluation is allowing CMS to determine if the data entered into the CROWNWeb system are comparable to that previously provided in other ways, and to establish if the data entries are in line with benchmarks currently set for the end-stage renal disease (ESRD) Clinical Performance Measures (CPMs) and Fistula First Breakthrough Initiative (FFBI).
During this review process, CMS evaluates a subset of data entered into CROWNWeb, which includes non-clinical files such as patients’ demographics and treatment information as well as clinical components used for CPM and FFBI calculations. These clinical components include elements such as dialysis adequacy, anemia management, mineral metabolism, and vascular access data.
The CROWNWeb system, which was launched in February 2009 in support of the updated Conditions for Coverage (CfCs) for dialysis facilities, is allowing CMS to quickly review these vital pieces of data by granting facilities the ability to submit their data electronically.
CROWNWeb is a Web-based data-collection system that allows authorized users to securely submit and access patient-based data (both clinical and non-clinical) from virtually anywhere at any time. It is the tool designed by CMS to enable facilities to meet §494.180(h) of the updated CfCs, published on April 15, 2008.
This section outlines the electronic submission of administrative and clinical data by all Medicare-certified dialysis facilities in the UnitedStates—a move away from the current paper-based data-collection methods. CMS is leveraging this tool to streamline how the renal community will both report and access facility and patient data.
The system is being released to the renal community in phases to allow CMS to conduct user analyses while providing future users an opportunity to complete the required account activation process (via the “QIPS Account Form”). Now in the second stage of its phase-in implementation process, CROWNWeb is now allowing CMS to review data for more than 280,587 dialysis patients, which represents more than 74% of the total ESRD population in the United States.
The majority of the clinical data calculated via CROWNWeb mirrors that collected during the previous ESRD CPM projects. Modifications were made to some of the calculations to expand facilities’ ability to gauge their patient care efforts, as well as to recognize recent changes required by the FDA related to labeling and use of medications.
These modifications have resulted in several changes to the CPM definitions in CROWNWeb, most notably, to the mean hemoglobin collection range. Historically, the percentage of patients with mean hemoglobins in the 11.0-12.0 g/dL range were reported in the anemia management CPM I. Now, to address recent FDA changes, this CPM is defined in CROWNWeb to include patients with mean hemoglobin levels in the 10.0-12.0 g/dL range.
Additionally, the system will feature two new vascular access CPMs: VA CPM IIIa (Monitoring and Surveillance of AVF and AV Grafts [AVG] for Access Dysfunction through Physical Examination) and VA CPM IIIb (Monitoring and Surveillance of AVF and AVG for Access Dysfunction through Pre-pump Arterial Pressure). To assist with the calculation of these new vascular access CPMs, CMS altered the vascular access choices that are available in CROWNWeb. These selections do not mimic the access options defined in the Fistula First data collection.
The vascular access type selected for each patient in CROWNWeb will reflect the vascular access that the patient is currently using for dialysis instead of any other vascular accesses that may be present. CROWNWeb will collect information on other vascular accesses that patients may have via additional questions, which will appear after the user indicates the vascular access that is actually in use.