The renal community has until Friday, Aug. 30, to submit comments on the proposed rule detailing changes to the End-Stage Renal Disease Quality Incentive Program for 2014. Several comments already submitted to CMS on the ESRD QIP focus on how the agency is using reporting measures to track infection control in the clinic, as well as concern about the burden on the clinic staff to report patient data for the ESRD QIP.

Following are the submitted comments, among 270 received already on the proposed rule, which focus on the ESRD QIP.

“As a nephrology nurse I am concerned about the process used to establish (performance) measures. There is a very short comment period for measures and some of the measures do not have an impact on patient outcomes. I am discouraged when I review the individuals selected for the [technical expert panels] and few if any of the members represent for nursing. In most cases, nurses are the ones that implement, monitor and report the measures. They are aware of the unintended consequences that can occur when a measure is implemented in isolation. For example, the Hgb ceiling without the floor, we have seen an increase in transfusions because of decreased ESA use. CMS should consider using measures for the percentage of patients within the safe range for a specific outcome.

“Measures should have at least one year of reporting data available using consistent, well-defined data elements before being adopted as clinical measures. Measures without both attainment and improvement benchmarks should not be part of the QIP. CMS also should not rely upon CROWNWeb until the data collected are reliable and valid for patient-level measures in the QIP."


“I have concern about the bloodstream infection clinical measure. Does this apply to new patients entering the dialysis unit for the first time after a diagnosis of ESRD and discharge from the hospital? Does this apply to all blood stream infections regardless of source? As a hospital-based unit we tend to get more elderly, newly diagnosed dialysis patients with other chronic conditions, and often wounds. Will we be penalized for bloodstream infections not related to vascular access if these patients come to us from the hospital on antibiotics for treatment of a bloodstream infection not related to vascular access?

“Another concern is related to catheters in place > 90 days. Of our 70 Medicare patients in our outpatient dialysis unit, there are two who adamantly refuse any vascular access other than a catheter. We have coached these patients but they continue to refuse even evaluation for AVF. Should the dialysis unit be penalized for patient noncompliance? We have other patients who have had multiple failed AVFs and are now catheter dependent. Can the criteria be expanded to exclude patients with no other vascular alternative?”


“My comments on the 2014 QIP are the following:

The NHSN Blood Stream Infection clinical measure. We ask that CMS modify this proposed measure to focus on “access related” bloodstream infections. By focusing on positive blood cultures with the suspected source identified as the vascular access site, the measure will closely focus on the care provided by the dialysis facility. This focus will also align with dialysis goals of reducing catheters and increasing fistulas in ESRD patients. Since the ESRD facility is not responsible for every positive blood culture, the dialysis facility’s performance should not be measured against every bloodstream infection that their patients have regardless of cause or where acquired.

In addition, in last year’s final rule CMS recognized that bias existed because some facilities may be more likely to identify and report dialysis events than others. We ask that CMS provide an update on the systems that have been established to validate data before making NHSN reporting a clinical measure.

The co-morbidities reporting measure. We request that CMS not implement the co-morbidities reporting measure until the dialysis community can automatically pull the co-morbidity information from the clinical EMRs into CROWNWeb. It would be very difficult for facilities with large patient census to evaluate every patient for 24 co-morbidities on Dec 31, 2014, as stated in the technical specs, and enter this data into CROWNWeb by Jan 31, 2015! (We) request that CMS consider postponing this measure until systems and processes can be established to capture, maintain and update this information so it can be electronically submitted to CROWNWeb without putting an administrative burden on the dialysis facilities.

Informed consent. We request that CMS change this measure to a reporting measure and provide clear guidance on what is required to meet the intent. Currently the guidance is vague as to whether ESRD patients require informed consent or documented education in the patient’s record. In addition, the requirement to have a document signed every year provides no value. The ESA APPRISE program for Oncology patients has an Acknowledgement Form that is good for 10 years; please do the same with the dialysis community.

CROWNWeb as a data source. To date the QIP program has primarily relied on Medicare claims as the data source for clinical measures. From experience, we have a high confidence level that this claims information is accurate. The use of CROWNWeb has primarily been through attestation, not reports generated by CMS. The validity of the information that might be pulled from CROWNWeb is unknown since the dialysis facilities have not routinely been provided reports from CROWNWeb. We ask that CMS rely on Medicare claims information for clinical measures until the validity of reporting from CROWNWeb can be verified. If CROWNWeb must be the data source for a clinical measure, ask that CMS place zero weight on the measure for the first year so the dialysis community can review the validity of CROWNWeb-generated data before it potentially impacts revenues.

Administrative burden. We ask CMS to take a global look at the burden placed on dialysis facilities for all aspects of the QIP. Although one measure may not seem like a significant burden, the cumulative effect of CROWNWeb, NHSN, ICH CAHPS, and co-morbidity reporting is significant to the organizations that have limited administrative staff members. No one wants to pull clinical staff away from patient care to collect and report this information. A solid QIP program has been established by CMS; request that new QIP measures be restricted to only one per year so the impact on outcomes can be fully reviewed."