Validation of erythropoietin use data on Medicare's End-Stage Renal Disease Medical Evidence Report

Abstract

Abstract-Data from Medicare's End-Stage Renal DiseaseMedical Evidence Report (Form 2728) suggest that underuse of erythropoiesis-stimulating agents (ESAs) may be contributing to anemia in predialysis patients. However, the data quality of Form 2728 is not known. ESA prescription records were confirmed in Department of Veterans Affairs (VA) data sets and/or ESA claims in Medicare files and compared with data collected on Form 2728 among 8,033 veterans who initiated dialysis in 2000 and 2001 and were eligible for both VA and Medicare coverage in the 12 months preceding dialysis initiation. Among the cohort, predialysis ESA use was found in 4% (n = 323) more veterans by VA/Medicare data sets (n = 2,810) than by Form 2728 (n = 2,487). With the use of VA/Medicare data sets (gold standard), the accuracy of Form 2728 for predialysis ESA use was sensitivity 57.0%, specificity 83.1%, positive predictive value 64.5%, negative predictive value 78.2%, and kappa coefficient 0.41. Sensitivity for reported predialysis ESA use on Form 2728 was lowest among veterans who were female and nonwhite, of low socioeconomic status, and with anemia or other comorbid illnesses. The poor sensitivity and specificity of predialysis ESA use data on Form 2728 raise concerns about the validity of previous reports and study findings. Investigators should recognize these shortcomings and the introduction of possible bias in future research and reports.Key words: accuracy, elderly, end-stage renal disease, erythropoiesis, Medicare, predialysis, sensitivity, specificity, stimulating agent, validity, veteran.Abbreviations: CI = confidence interval, CKD = chronic kidney disease, CMS = Centers for Medicare and Medicaid Services, COPD = chronic obstructive pulmonary disease, ESA = erythropoiesis-stimulating agent, ESRD = end-stage renal disease, HSR&D = Health Services Research and Development Service, NPV = negative predictive value, PBM = Pharmacy Benefits Management, PPV = positive predictive value, PSSG = Planning Systems Support Group, RRT = renal replacement therapy, USRDS = United States Renal Data System, VA = Department of Veterans Affairs.

Form CMS-2728 Data Versus Erythropoietin Claims Data: Implications for Quality of Care Studies

“…In contrast to comorbidity data on Form CMS-2728, which has been validated with clinical data, 7 the validity of the Form CMS-2728 predialysis care measures has yet to be examined with the exception of one study investigating the validity of the predialysis ESA indicator in a Veterans Affairs population. 8 The accuracy of the predialysis ESA care indicator is especially important to scientific researchers, health care providers, and policy-makers in framing anemia management guidelines given recent findings suggesting that targeting higher hemoglobin levels with ESAs may confer no benefit or actually increase the risk of harm to CKD patients with anemia. [9][10][11][12][13] The purpose of this study was to compare predialysis ESA care reported on Form CMS-2728 with Medicare claims for ESA treatment submitted for patients 67 years and older at initiation of dialysis with Medicare as the primary payer.…”

Advancing veterans' healthcare using electronic data: Lessons learned from researchers in the field

“…Promoting high-quality care and providing the tools for independent living to veterans with spinal cord injury (SCI) [19], polytrauma [20], PTSD, substance-use disorder and other mental health conditions [21][22][23] and to others needing rehabilitative and assistive services [24][25] are high VA priorities. Investigating obesity and chronic kidney disease and its antecedents are important because these are among the most common chronic conditions afflicting veterans seeking care in the VA [26][27]. Understanding the healthcare needs and ensuring accessible care for women and other vulnerable populations [23,[28][29][30] are among the VA's top research priorities.…”

“…Data originating outside the VA are critical for learning about care received and costs of care for veterans obtaining services in the private sector and help to fill a gap in information for many studies. In addition to the National Patient Care Database [19][20][21]24,30], data sources evaluated include the Veterans Health Administration Corporate Data Warehouse [26], the VA's National Spinal Cord Dysfunction Registry [19], the Minimum Data Set (long-term care resident assessment) [24] [27], Medicaid and Medicare claims [29][30], and the Medicare Current Beneficiary Survey [31].…”

“…Second, data collected for purposes peripheral to direct patient care or billing seem to be particularly prone to inaccuracy [19][20]24,27,30]. Several studies examined data collection systems that require manual data entry by clinical staff, separate from routine medical record documentation [19,24,27].…”

“…Several studies examined data collection systems that require manual data entry by clinical staff, separate from routine medical record documentation [19,24,27]. Not surprisingly, accurate and complete data entry will receive lower priority when not essential for patient care.…”