Recently, the National Healthcare Security Administration issued the Reply Letter on Proposal No. 02870 (Social Management Category No. 217) of the First Session of the 14th National Committee of the Chinese People’s Political Consultative Conference, which clearly stated that new technologies, new drugs, and new medical devices will be encouraged to be included within the coverage scope, so as to stimulate innovation and R&D momentum among pharmaceutical and medical device enterprises.
In fact, this is not the first time the National Healthcare Security Administration has made such a statement. As early as March 4, 2024, in the Reply to Recommendation No. 3298 of the Fifth Session of the 13th National People’s Congress, the National Healthcare Security Administration had already pointed out the need to further support exemptions from DRG payment for innovative medical devices.
At the local level, medical insurance authorities across regions are also actively exploring policies to support innovative medical devices. For example, Beijing has incorporated certain eligible drugs, medical devices, and diagnostic and treatment items into CHS-DRG out-of-payment management.
In July 2023, the Beijing Municipal Medical Insurance Bureau issued the Notice on Issuing the Measures for Out-of-Payment Management of New Drugs and New Technologies under CHS-DRG Payment (Trial), which for the first time proposed a DRG out-of-payment mechanism. The measures clearly stipulate that innovative drugs, innovative medical devices, and innovative medical service items may be paid based on actual incurred costs instead of DRG-based payment.
Meanwhile, many regions nationwide have successively introduced relevant policies to promote hospital adoption of “National Innovation” medical devices. For instance, regions such as Foshan and Xuzhou have implemented exemption payment for extremely high-cost cases and special medical service items; Sanming City has adopted an exclusion list system for certain medical consumables; Zhejiang Province has implemented a discounted compensation mechanism for da Vinci robotic surgeries, among others. These policies provide greater possibilities for the market promotion and application of innovative medical devices such as those developed by Asclepius Meditec.
At present, products approved through the “National Innovation” medical device pathway must demonstrate world-leading, domestically first-of-its-kind characteristics and possess significant clinical application value. Since the national regulatory authorities established the fast-track approval pathway for innovative medical devices in 2014, as of May 2023, among approximately 200,000 approved medical devices nationwide, only 202 innovative medical devices have successfully obtained market approval, with Asclepius Meditec’s hydrogen-oxygen generator ranking as the 92nd approved item.
However, unlike most “National Innovation” medical devices, the Asclepius Meditec hydrogen-oxygen nebulization device is not only the first of its kind in China, but is also the first of its kind globally. In addition, it represents an extremely rare broad-spectrum medical approach, with precedents for hydrogen-oxygen inhalation as an adjunctive therapy explored across almost all clinical departments. It is also expected to become a universally applicable medical device across departments following the full implementation of DRG/DIP policies in the future.
With the implementation of this policy by the National Healthcare Security Administration, it not only signals the market prospects of Asclepius Meditec hydrogen-oxygen generators within medical institutions, but also further drives the expansion of home-based clinical application scenarios.
