Provisional Translation
| OTO No. | 532 | Classification | MHW-232 |
|---|---|---|---|
| Date of Acceptance | March 31, 1995 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | Health Insurance Law |
| Complainant | French Embassy (proxy complaint) | Exporting Countries | France |
| Subject | Review of materials price standards for heart pacemakers and clarification of decision-making process | ||
| Details of Measures | To ensure appropriate administration of the health care system, a two-tier system of costs for medical procedures and for materials is used for reimbursing medical institutions. Where pacemakers are concerned, based on an agreement between the Ministry of Health and Welfare and the Pacemaker Committee of the Japan Federation of Medical Device Associations (JFMDA), since April 1992 prices have been set by approval number. For pacemakers approved under the Pharmaceutical Affairs Law, after obtaining approval, the firm applies to request that the product be covered by health insurance, the reimbursement price is determined based on the product's features, and the product is included in the "Materials Price Standards" which is the notice from the minister for Health and Welfare. 1. Regarding review of the purchase price, the final reimbursement price was indicated and since the application's approval was obtained, the Materials Price Standards were amended to have health insurance cover this product from June this year. 2. Based on an agreement between the Ministry of Health and Welfare and the Pacemaker Committee of the Japan Federation of Medical Devices Associations, pacemaker prices are set by comparing the prices of models for which prices have already been set with that of the model for which pricing is being requested. Pricing for the new product is determined according to a relative evaluation system, by assigning a numerical score based on the degree of improvement of the product. As a rule, the new product is compared to other products made by the same company, but when no comparative product is available from the same company, products with similar features made by other companies may be used. Under this evaluation system, if a product of a different price with the same features is selected as the comparative product, the new price set will differ even if the evaluation score is the same. In order to avoid problems caused by the relative evaluation system such as that was raised in this complaint, the system of setting prices by approval number will be eliminated at the next review of fees for medical treatment (scheduled for April 1996). The ministry is currently coordinating with the pacemaker industry to set up an evaluation system based on function classification, under which pacemakers are grouped according to their respective functions. 3. The complainant was advised that the reimbursement price is determined by Ministry of Health and Welfare officials after a hearing, after application by the maker (importer), and based on the opinions of doctors who are experts in the field of pacemakers. |
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| Classification of Processing | 1. A 2. A 3. D |
Directions | 1. I-b 2. I-a |
| Remarks | 1. Improvement measures were taken in June 1995. | ||