Despite generally reduced medical insurance in Japan for medical devices, the Japanese government may increase coverage of some medical device software products in 2022. The Japanese medical device industry has proposed to the reimbursement arm of the PMDA – Central Social Insurance Medical Council (Chuikyo) – a request for proper evaluation of medical device software in Japan’s medical insurance system. Although the evaluation of medical device software in medical insurance has already been realized, the industry is proposing to further clarify the evaluation criteria and to establish the evaluation criteria in consideration of social and economic effects.
For example, when interpreting an image obtained by a diagnostic imaging device, in addition to evaluating the improvement of tumor detection accuracy by using the diagnostic support program, the industry suggests that if the difference in diagnostic accuracy of an experienced doctor and inexperienced doctor is reduced, the benefits should also be evaluated in the form of increased insurance points. This is because it may lead to relaxation of the facility standards for making the diagnosis. The industry also proposes that if the time required for a doctor’s diagnosis can be shortened by using diagnostic support software, it should also be evaluated from a medical economics point of view too.
The device industry’s argument says that the effectiveness of software should be evaluated from multiple points of view. Recently, the government and the medical doctors society frequently talk about the “work-life balance of medical doctors”. If new advanced software is used at more hospitals, it should relax the work burden to Japanese doctors, and then improve work-life balance. The device industry will keep discussing software’s value. There is a positive discussion now to urge Chuikyo to evaluate software more appropriately.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.trade.gov/market-intelligence/japan-software-medical-device-samd