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Health Affairs, Vol. 27, No. 6. (2008), 1620-31.

An analysis of Medicare national coverage decisions (NCDs) from 1999 through 2007 reveals that the Centers for Medicare and Medicaid Services (CMS) considers the available evidence as no better than fair for most of the technologies considered. Still, the CMS issues favorable decisions in 60 percent of the cases it takes on, although almost always with conditions placed on coverage. Since enactment of the 2003 Medicare Modernization Act, which legislated maximum review times for NCDs, the CMS has eliminated "long duration" decisions (more than one year) and has issued several "coverage with evidence development" decisions, which promise flexibility but also carry implementation challenges.
PJ Neumann, MS Kamae, JA Palmer
 
Medical care, Vol. 48, No. 6 Suppl. (Jun 2010), pp. S137-44.

BACKGROUND: Evidence-based medicine is increasingly expected in health care decision-making. The Centers for Medicare and Medicaid have initiated efforts to understand the applicability of Bayesian techniques for synthesizing evidence. As a case study, a Bayesian analysis of clinical trials of implantable cardioverter defibrillators was undertaken using patient-level data not typically available for analysis. PURPOSE: Conduct Bayesian meta-analyses of the defibrillator trials using published results to demonstrate a Bayesian approach useful to policy makers. DATA SOURCES, STUDY SELECTION, DATA EXTRACTION: We reconsidered trials in a 2007 systematic review by Ezekowitz et al (Ann Intern Med. 2007;147:251-262) and extracted information from the original published articles. Employing a Bayesian hierarchical approach, we developed a base model and 2 variants, and modeled hazard ratios separately within each year of follow-up. We considered sequential meta-analyses over time and found the predictive distribution of the results of the next trial, given its sample size. DATA SYNTHESIS: For the most robust of 3 models, the probability that the mean defibrillator effect (in the population of trials) is beneficial is greater than 0.999. In that model, about 5% of trials in the population of trials would have a detrimental effect. Despite the moderate amount of heterogeneity across the trials, there was stability of conclusions after the first 3 of the 12 total trials had been conducted. This stability enabled reasonable predictions for the results of future trials. LIMITATIONS: Inability to assess treatment effects within subsets of patients. CONCLUSIONS: Bayesian meta-analyses based on literature surveys can effectively inform coverage decisions. Bayesian modeling for endpoints such as mortality can elucidate treatment effects over time. The Bayesian approach used in a sequential manner over time can predict results and help assess the utility of future clinical trials.
SM Berry, KJ Ishak, BR Luce, DA Berry
 
In Health Affairs, Vol. 27, No. 6. (2008), 1620-31.

An analysis of Medicare national coverage decisions (NCDs) from 1999 through 2007 reveals that the Centers for Medicare and Medicaid Services (CMS) considers the available evidence as no better than fair for most of the technologies considered. Still, the CMS issues favorable decisions in 60 percent of the cases it takes on, although almost always with conditions placed on coverage. Since enactment of the 2003 Medicare Modernization Act, which legislated maximum review times for NCDs, the CMS has eliminated "long duration" decisions (more than one year) and has issued several "coverage with evidence development" decisions, which promise flexibility but also carry implementation challenges.
PJ Neumann, MS Kamae, JA Palmer
 
In Medical Care, Vol. 45, No. 10. (2007), S9-S12 10.1097/MLR.0b013e318041385f.

Background: The 3 primary administrative data sets developed by the Centers for Medicare and Medicaid services (CMS) to support the Medicare Part D program implementation represent a valuable source of data for health services researchers. This paper describes the structure of the Medicare Part D program and the related databases, and discusses their utilization for research purposes. Results: The Medicare Part D administrative data include information on plan benefits (integrated into the Health Plan Management System), beneficiary enrollment files, and prescription drug event (PDE) claims-type data. The enrollment data may be of use in investigating the benefits and plan types that appeal to beneficiaries, but their application is limited by the fact that, although individual beneficiaries' enrollment choices are recorded, only summary enrollment data are currently publicly available. PDE data are likely to be of most interest to researchers as they are detailed (including beneficiary identifiers, contract identifiers pharmacy provider information on drugs provided, drug cost, and insurance status), beneficiary-specific (allowing them to be linked to beneficiary characteristics), and an unusual output for a program reimbursed under a capitation-based system. Because PDE data are highly sensitive, only summary data on the number of Part D prescriptions filled are publicly available. Conclusions: Although the data collected in relation to the Medicare Part D program could be applied to many questions of interest to health services researchers, their utility is limited by the sensitive natures of many of these data, making it difficult currently to obtain access for research purposes. (C) 2007 Lippincott Williams & Wilkins, Inc.
Leslie Greenwald
 
Dr. Barry Straube, the chief medical officer at the Centers for Medicare and Medicaid Services, offers his assessment of the nation's kidney dialysis program -- and what it could mean for the future of universal health care.

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