Medicare's national coverage determinations in diagnostic radiology: examining evidence and setting limits.

OBJECTIVE: To systematically review and summarize the Center for Medicare and Medicaid Services (CMS) national coverage determination (NCDs) pertaining diagnostic imaging technologies from 1999 through 2010. METHODS: All NCDs pertaining to diagnostic imaging were identified from the Tufts Medical Center NCD database. The variables under study included the quality of the clinical evidence and the final coverage determination. The types of restrictions were categorized. We also categorized the final decisions as "positive coverage" or "no positive/no change in coverage" and assessed the correlation between positive coverage and other variables using Fisher exact test. RESULTS: Twenty-two of 152 (15%) NCDs pertained to diagnostic imaging technologies. The supporting evidence was judge to be good, fair, and poor in 5, 6, and 11 cases, respectively. Eleven technologies (50%) were covered with conditions, four (18%) deferred the coverage decision to local level, and two (9%) were completely not covered. In five instances there was no change to the prior coverage status. Of the 11 decisions resulting in positive coverage, 8 (73%) restricted use to specific population subgroups, 5 (46%) applied restrictions related to treatment, 4 were covered with evidence development, and 2 were restricted to care in specific settings. A significantly higher rate of positive coverage decisions was achieved if the available evidence was good (100% 5/5) or fair (83% 5/6) compared to technologies with poor evidence (10% 1/10) (P < .01). CONCLUSION: CMS has demonstrated a propensity to limit the use of advanced diagnostic imaging to scenarios in which appropriateness is supported by adequate evidence of clinical utility and improved outcomes with the quality of evidence being a significant factor on final decisions. Understanding the need for high-quality evidence and the types of limitations placed on coverage allows for appropriate planning for the incorporation of diagnostic imaging technologies into clinical practice.

Regression analysis on the variation in efficiency frontiers for prevention stage of HIV/AIDS.

OBJECTIVES: To investigate how the cost effectiveness of preventing HIV/AIDS varies across possible efficiency frontiers (EFs) by taking into account potentially relevant external factors, such as prevention stage, and how the EFs can be characterized using regression analysis given uncertainty of the QALY-cost estimates. METHODS: We reviewed cost-effectiveness estimates for the prevention and treatment of HIV/AIDS published from 2002-2007 and catalogued in the Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. We constructed efficiency frontier (EF) curves by plotting QALYs against costs, using methods used by the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany. We stratified the QALY-cost ratios by prevention stage, country of study, and payer perspective, and estimated EF equations using log and square-root models. RESULTS: A total of 53 QALY-cost ratios were identified for HIV/AIDS in the Tufts CEA Registry. Plotted ratios stratified by prevention stage were visually grouped into a cluster consisting of primary/secondary prevention measures and a cluster consisting of tertiary measures. Correlation coefficients for each cluster were statistically significant. For each cluster, we derived two EF equations - one based on the log model, and one based on the square-root model. DISCUSSION: Our findings indicate that stratification of HIV/AIDS interventions by prevention stage can yield distinct EFs, and that the correlation and regression analyses are useful for parametrically characterizing EF equations. Our study has certain limitations, such as the small number of included articles and the potential for study populations to be non-representative of countries of interest. Nonetheless, our approach could help develop a deeper appreciation of cost effectiveness beyond the deterministic approach developed by IQWiG.

Cost-effectiveness analysis of oseltamivir for influenza treatment considering the virus emerging resistant to the drug in Japan.

AIM: The purpose of this study is to evaluate the cost-effectiveness of oseltamivir for influenza in Japan considering the complications and the emergence of oseltamivir-resistant virus. METHODS: Study design is a cost-effectiveness analysis in decision analytic modeling based on previously published evidence. Outcome measures included costs and quality-adjusted life year (QALY). RESULTS AND CONCLUSION: In the base-case analysis, the incremental cost-effectiveness ratio (ICER) of oseltamivir during influenza and complications was JPY398,571 ($3320) per QALY without productivity loss, which implied oseltamivir is evidently cost-effective. Furthermore, considering the productivity loss, the ICER for oseltamivir turned to be negative, which means simply dominant. When the prevalence was in the low range of 10% to 38%, oseltamivir became less cost-effective than conventional treatment. Regarding potential emergence of the drug-resistant virus, we found the dominance of oseltamivir will vanish if the emerging rate becomes larger than 27%. The two-way sensitivity analysis also suggested that if the resistant virus rate becomes less and the prevalence higher, then oseltamivir becomes more advantageous. The analysis for uncertainty, using cost-effectiveness acceptability curve by Monte Carlo simulation, resulted in the estimate of about 80% chance that oseltamivir could be cost-effective at the willingness-to-pay level of JPY6,000,000 ($50,000), which is commonly accepted as an affordable threshold.

Medicare's national coverage decisions for technologies, 1999-2007.

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.