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OBJECTIVE@#Discuss the working ideas of the dynamic adjustment mechanism of medical device classification in the United States, and provide reference for the construction of medical device related mechanisms in China.@*METHODS@#Collect and interpret the documents of regulatory background, procedures and orders of the dynamic adjustment mechanism of the medical device classification in the United States, and summarize the overall situation and specific cases of the medical device classification adjustment under this mechanism in recent years.@*RESULTS@#The US work idea of the medical device classification dynamic adjustment mechanism is based on the latest valid scientific evidence, conducting risk analysis and identification, and determining the corresponding measures.@*CONCLUSIONS@#During the adjustment process, industry stakeholders have repeatedly discussed and achieved final agreement. Its procedures and working ideas can be used as a reference for China's work.
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China , Estados Unidos , United States Food and Drug AdministrationRESUMO
Objective To provide reference for the adjustment of provincial health insurance directory by comparing the differences between 2017 and 2009 edition of National Health Insurance Directory(NHID) and exploring the characteristics of NHID adjustment. Methods The Excel 2016 was used to carry out a comparative analysis of the drugs included in the two editions of NHID from the 4 aspects such as classification,drug name,dosage form and payment range. Results The adjustments of NHID in 2017 include drug variety,payment range,drug classification and coding.A total of 339 drugs were added, of which 133 were chemical drugs with a growth rate of 11.4%,and 206 were Traditional Chinese Medicine with a growth rate of 20.0%.In addition,dosage form was added in 149 drug varieties.The adjustment mainly focuses on chronic diseases such as hypertension and diabetes,serious diseases such as cancer,innovative drugs,and pediatric drugs. Conclusion The adjustment of 2017 edition of NHID embodied the policy thinking of "filling,selecting,supporting innovation and encouraging competition". Moreover,the drug classification,name and coding are more scientific and reasonable.
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It discussed the methods,coverage,data resources,implementation process,result analysis and practical significance of the full cost accounting for medical service items,so as to provide references for improving the delicacy management in hospitals and constructing the price dynamitic adjustment mechanism based on item cost structure.
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It discussed the methods,coverage,data resources,implementation process,result analysis and practical significance of the full cost accounting for medical service items,so as to provide references for improving the delicacy management in hospitals and constructing the price dynamitic adjustment mechanism based on item cost structure.
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Objective: By constructing the cash flow model, it proposed the premium adjustment mechanism of critical illness insurance(CII). Methods: Based on the practical data of critical illness insurance in China, it established some actuarial assumptions and cash flow model to simulate and analyze premium adjustment mechanism of CII. Results: ( 1) Because of the deterioration of critical illness incidence rate and the change of market interest rates , CII guaranteed premium usually resents pricing risk, which showed that the cash flow is negative, sometimes accumulated cash is negative; (2) based on the criteria of insurance cost adjustment, it is suggested that when the loss rate reached more than 70%, which could permit the insurance company adjust the premium, if the loss rate reached more than 80%, it needs to compulsory the insurance companies to adjust premium. Conclusion: The study proposes the mechanism of CII premium adjustment, provides guidance for practice.