XIAO Dun-ming, ZHOU Shan-yan, CHEN Ying-yao
Objective To analyze the impact of tandem mass spectrometry （MS/MS） screening compared to the indanone-fluorescence method （hereinafter referred to as fluorescence analysis） on finance or health insurance in screening newborn genetic metabolic diseases in Shanghai, and provide policy recommendations for MS/MS reimbursement.Methods A budget impact analysis model was constructed using Microsoft Excel 2019, with a study period of 3 years （2025—2027）. Newborns of 2025 to 2027 were predicted based on the birth data of newborns in Shanghai and the average decrease of newborns in Shanghai. Clinical screening data and cost data were derived from relevant statistical websites, literature, and hospital survey data. Additionally, consultations with experts were conducted to understand national and Shanghai-specific screening and reimbursement policies. Among these, the fluorescence-based analysis method is primarily used for screening phenylketonuria, while MS/MS can be used for screening a variety of newborn genetic and metabolic disorders. So we separately calculated the impact of MS/MS screening compared to the fluorescence-based method on Shanghai’s fiscal budget and health insurance fund.Results The budget impact analysis on fiscal expenditures indicates that from 2025 to 2027, the fiscal expenditures for fluorescence analysis will be 1.58 million, 1.48 million and 1.39 million yuan, respectively. In contrast, MS/MS fiscal expenditures will be 22.75 million, 21.37 million, and 20.06 million yuan, respectively； compared with fluorescence analysis, the increased fiscal expenditures for MS/MS will be 21.18 million, 19.88 million, and 18.67 million yuan, respectively, showing a decreasing trend annually. The budget impact on health insurance funds shows that from 2025 to 2027, the expenditures for fluorescence analysis will be 1.11 million, 1.04 million and 0.97 million yuan, respectively； MS/MS health insurance fund expenditures will be 15.93 million, 14.96 million and 14.04 million yuan, respectively. Compared with fluorescence analysis, the additional health insurance fund expenditures for MS/MS will be 14.82 million, 13.92 million and 13.07 million yuan, respectively, also showing a decreasing trend annually. Policy-wise, the costs for tandem mass spectrometry screening are typically covered by fiscal payments or out-of-pocket by patients, with commercial insurance, charitable foundations, and other organizations serving as supplementary sources of funding.Conclusion The overall cost of expanding newborn screening for genetic metabolic diseases in Shanghai is controllable. To unify the payment standards and facilitate centralized management, it is recommended that the costs for tandem mass spectrometry screening in Shanghai be covered by government funding.
