Accounting for unobservable exposure time bias when using Medicare prescription drug data.

OBJECTIVE To describe the prevalence and correlates of unobservable medication exposure time, and to recommend approaches for minimizing bias, in studies using Medicare Part D data.. SAMPLE 179,065 Medicare patients hospitalized for an AMI in 2007 or 2008. METHODS We compared two methods for creating medication exposure observation periods using acute care discharge vs. post-acute care discharge dates. We examined options for increasing cohort sizes by requiring different thresholds for observable days, or by using as a covariate, in the observation period. We calculated the extent and health status correlates of unobserved Medicare Part D exposure time and examined its association with receipt of beta-blockers. RESULTS 39% of patients had unobservable time during the 30 day exposure assessment period following acute care; they were significantly older, had more comorbidity and longer acute care stays, had worse 1-year survival, and were significantly less likely to be classified as beta-blocker users. Using the alternative exposure assessment window, only 29% of the sample had unobservable time, and differences between groups were less pronounced. Significant gains in sample size can be obtained by restricting or controlling for the number of observable days required in the exposure assessment period. CONCLUSIONS Unobservable exposure time is common among Medicare Part D beneficiaries, and they are often in worse health. To retain patients with unobservable exposure time, we recommend stratifying patients on receipt of post-acute facility-based care, calculating and using observable days as a covariate and, when appropriate, using the discharge date from contiguous post-acute facility care for beginning the exposure assessment period.