Readmission trends are consistent with hospitals' responding to incentives to reduce readmissions, including the financial penalties for readmissions under the ACA. We did not find evidence that changes in observation-unit stays accounted for the decrease in readmissions.
Measuring the Incidence, Causes, and Repercussions of Protocol Amendments Drug development companies frequently amend finalized clinical trial protocols. Yet the incidence, causes, and impact of protocol amendments have never been quantified. Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study, in collaboration with 17 large and midsized pharmaceutical and biotechnology companies, examining more than 3,400 clinical trial protocols across development phases and therapeutic areas. Data on protocol characteristics, the number of amendments, the nature and incidence of changes per amendment, the causes of amendments, and the time and cost to implement amendments were among those analyzed. Tufts CSDD found that more than 40% of protocols were amended prior to the first subjedfirst visit, and one third of amendments were avoidable. Each amended protocol had an average of 2.3 amendments resulting in 4 months of incremental time to implement. Protocol amendments translate into significant unplanned expense and delays for research sponsors and unexpected burden for investigative sites. These findings underscore the substantial impact of protocol amendments on drug development efficiency and present an opportunity to realize substantial cycle time and cost savings.
Medicare beneficiaries receiving home health services who are dually enrolled, live in a low-income neighborhood, or are black have higher rates of adverse clinical outcomes. These populations may be an important target for quality improvement under Home Health Value-Based Purchasing.
Since the implementation of Medicare's Hospital Readmissions Reduction Program in 2012, concerns have been raised about the effect its payment penalties for excess readmissions may have on safety-net hospitals. A number of policy solutions have been proposed to ensure that the program does not unfairly penalize safety-net institutions, which treat a disproportionate number of patients with low socioeconomic status. We examined the extent to which the program's current risk-adjustment factors, measures of patient socioeconomic status, and hospital-level factors explain the observed differences in readmission rates between safety-net and other hospitals. Our analyses suggest that patient socioeconomic status can explain some of the difference in readmission rates but that unmeasured factors such as hospitals' performance may also play a role. We also found that safety-net hospitals have experienced only slightly higher readmission penalties under the program than other hospitals have. Together, these findings suggest the need for a careful evaluation of policy alternatives that factor socioeconomic status into penalty calculations for excess readmissions to determine whether such alternatives could have a significant impact on penalties while remaining consistent with overall objectives for delivery system transformation.
The Medicare hospice benefit is associated with reduced hospital care at the end of life and reduced Medicare expenditures for most enrollees. Policies that encourage timely initiation of hospice and discourage extremely short stays could increase these successes while maintaining program goals.
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