Dialysis Outcomes Unchanged after ‘Bundling’ and ESA Label Changes

Five years after the shift to a “bundled” reimbursement system and revised drug labeling for erythrocyte-stimulating agents (ESAs), overall outcomes are no worse—and some outcomes have improved—for hemodialysis patients covered by fee-for-service Medicare, reports a study in JAMA Internal Medicine.

The retrospective analysis included data on nearly 70,000 incident hemodialysis patients, 66 years or older, who were enrolled in Medicare parts A, B, or D for at least 12 months before starting dialysis. One cohort initiated hemodialysis before the transition to a bundled comprehensive payment system and ESA labeling changes (2008–09); the other cohort started dialysis after these changes (2011–13). Differences in outcomes were compared between groups, including major adverse cardiovascular events (MACEs), hospitalization for congestive heart failure, venous thromboembolism, and red blood cell transfusions.

The two cohorts had similar baseline characteristics. There was no difference in the overall risk of MACEs, death, congestive heart failure hospitalizations, or venous thromboembolism. The postpolicy cohort had a significant reduction in stroke, hazard ratio (HR) 0.77.

Use of ESAs decreased after the policy and labeling changes, while the rate of blood transfusions increased: HR 1.09. Subgroup analyses showed significant reductions in MACEs and all-cause mortality for black patients: HR 0.82 for both outcomes.

The findings help to answer concerns that the change to bundled payments and the ESA drug labeling changes might adversely affect clinical outcomes for hemodialysis patients. The results show no overall change in MACEs after these changes, but a significant reduction in stroke.The changes are associated with a decrease in monthly ESA dose and a modest increase in blood transfusions. Black patients show significant reductions in MACEs and overall mortality [Wang C, et al. Association between changes in CMS reimbursement policy and drug labels for erythrocyte-stimulating agents with outcomes for older patients undergoing hemodialysis covered by fee-for-service Medicare. JAMA Intern Med Published online October 24, 2016. doi:10.1001/jamainternmed.2016.6520].

December 2016 (Vol 8, Issue 12)