JAPANESE REIMBURSEMENT The Central Social Insurance Medical Council is responsible for establishing and monitoring reimbursement. All providers are reimbursed under an official fee schedule, which allocates a certain amount of points for each diagnosis and procedure. Providers are reimbursed 10 yen for each point. 3 Classes of Japanese Reimbursement CLASS A A class A device is one whose cost is included the technical fee. A1 devices are usually supplies used in procedures and A2 often involves capital equipment with a disposable component such as those used for diagnosis. CLASS B Includes implantable devices that already have an insurance category, such as heart valves and stents. CLASS C New technologies, without an insurance category Class C is broken down into C1 which includes devices that are based on existing technology and C2 devices are ones for which there is no preexisting technology to use as a basis. Devices for which there is similar technology could get approved for reimbursement in one of the following ways: *Highly advanced medical technology (requires high level of physician skill) *Specially insured medical materials (reviewed 4 times a year) *Included in establishment of new technical fee Every two years medical device reimbursment is reviewed and can be reduced. The overall device reimbursement reductions vary from around 1% to as much as 7% or more. The reference price of equivalent medical devices in foreign markets seems to be a critical factor in reimbursement reduction decisions. Copyright © 2004 Kirk Zeller, All rights reserved