The Korea National Health Insurance (K-NHI) has covered medical devices with low cost-effectiveness evidence by what is known as the Selective Benefit (SB) since December of 2013 as a type of conditional coverage. Most medical devices in the SB category are new technology and have higher levels of clinical effectiveness and/or functions than those in the benefit category, but they are characterized as being expensive. We compare the K-NHI medical device coverage system to those in Japan and Taiwan so as to be more informed about how to cover and set prices for new medical devices.

We searched for materials related to medical device coverage or the reimbursement systems of three countries (Korea, Japan, and Taiwan). National health insurance laws, policy reports, and the websites of the Ministries of Health of the respective countries, for instance, were also reviewed.

The NHI systems of Korea, Japan, and Taiwan have several similarities with regard to their medical device benefit lists. They reimburse listed medical devices separately although they cover them basically by including procedures or a diagnosis-related group (DRG) fee. The K-NHI reimburses for medical devices with low cost-effectiveness using the actual market medical price, similar to other medical devices in the benefit category. However, there are no detailed rules regarding how to set prices for these devices. Every listed medical device is covered at the notified price in Japan, but the prices of new medical devices with improved functions can add 1 -100 percent of the price to the notified price. The prices of devices related to new medical procedures are determined by cost-accounting methods. The NHI service in Taiwan compensates for medical devices which are alternates but clinically improved types through a balance billing method.

The NHI systems in Japan and Taiwan set prices with regard to reimbursements for new medical devices separately, specifically for devices which are advanced clinically or functionally but expensive. The K-NHI must consider establishing a pricing or reimbursement system for new medical devices through the discussion with stakeholders for reasonable reimbursements and decreasing the financial burden on the K-NHI.