The clinical and economic implications of specimen provenance complications in diagnostic prostate biopsies.

PURPOSE: Inaccurate diagnoses of prostate cancer can result from transposition or contamination of patient biopsy specimens, which are known as specimen provenance complications. We assessed the clinical and economic burden of specimen provenance complications in prostate biopsies in the United States. MATERIALS AND METHODS: We performed a comprehensive, systematic review of the literature to approximate the effect of specimen provenance complications on direct medical costs, patient QALYs and medicolegal costs. Data were extracted from published studies on specimen provenance complications rates, prostate cancer treatment efficacy, treatment cost, litigation/settlement costs after false diagnoses of prostate biopsies and patient quality of life. Sensitivity analysis was done to identify factors that most influenced the outcomes and assess the robustness of the findings. RESULTS: Of the estimated 806,251 primary and secondary prostate biopsies performed annually in the United States 20,322 specimen provenance complications were projected to result in 4,570 clinically meaningful false diagnoses and an expected loss of 634 QALYs. The total burden of specimen provenance complications was projected to exceed $879.9 million or $3,776 per positive cancer diagnosis. This estimate was most sensitive to the indemnity cost per false-positive case and the rate of transpositions at independent reference laboratories. CONCLUSIONS: The societal burden of specimen provenance complications in patients who undergo prostate biopsy exceeds $880 million annually in the United States. This analysis framework may be useful as policy makers, health organizations and researchers seek to decrease false diagnoses of prostate cancer and the consequent effects of delayed or unnecessary treatment. Further study is warranted to quantify the economic burden among additional diseases.

Health Care Coverage Decision Making in Low- and Middle-Income Countries: Experiences from 25 Coverage Schemes.

Lessons learned by countries that have successfully implemented coverage schemes for health services may be valuable for other countries, especially low- and middle-income countries (LMICs), which likewise are seeking to provide/expand coverage. The research team surveyed experts in population health management from LMICs for information on characteristics of health care coverage schemes and factors that influenced decision-making processes. The level of coverage provided by the different schemes varied. Nearly all the health care coverage schemes involved various representatives and stakeholders in their decision-making processes. Maternal and child health, cardiovascular diseases, cancer, and HIV were among the highest priorities guiding coverage development decisions. Evidence used to inform coverage decisions included medical literature, regional and global epidemiology, and coverage policies of other coverage schemes. Funding was the most commonly reported reason for restricting coverage. This exploratory study provides an overview of health care coverage schemes from participating LMICs and contributes to the scarce evidence base on coverage decision making. Sharing knowledge and experiences among LMICs can support efforts to establish systems for accessible, affordable, and equitable health care.