The manufacturers of disposable medical device for treatment of disease or mitigating symptom shall apply for the reimbursement price at HIRA (Health Insurance Review & Assessment service). HIRA will inform the result to applier, and announce it in their website, approximately 5~6 month after application
The careful approach is necessary because the decision of HIRA will affect directly on the sales and benefit of the manufacturer and/or distributor.
The decision is classified to 3 cases.
When HIRA classified the device being with indisputable effect and cost-effective, they announce the result of their classification and limit of reimbursable price for each product. HIRA will be reimburse the cost of used device, in addition to treatment fee, within pre-designated limit of reimbursable price.
Being classified to be reimbursed is advantageous for expanding your total sales, but it may not be good for your net profit because HIRA evaluate the price of the device very tightly.
2. Allowed Payable Device (Not be reimbursed)
When HIRA estimate that the device has good treatment effect but is not cost-effective than other alternative products or treatment method, it can be classified as allowed payable device. In this case, doctor can used the device for the treatment of the designated disease on the burden of patient. It has similar effect of approval that doctor can sell the device to patient directly without any limit.
3. Inchargable (Not applicable)
This classification means that the price of the device can not be charged to customer nor HIRA. It happens in following two cases.
The first case is that the device is not proper for use on the burden of user, like the device under clinical investigation, the device without proper clinical effect, etc.
The second is the case when the cost related the device is already reflected as a part of treatment fee. The representative case is blood circuit including blood filter for the kidney dialysis.
* There is no exact expression for the each classification in English, so the aforementioned expression may include misapprehensive description. For more clarification, please ask us.