National Medical Insurance Administration: Trial implementation of pre-project approval system for medical service price projects to promote the rapid implementation of high-level medical innovation

The National Medical Insurance Administration issued a notice today (15th) to pilot a pre-project establishment system for medical service price projects for high-level medical new technologies and products. When new medical technologies and products are still in the clinical research stage, the medical insurance department will conduct price policy evaluations in advance, striving to achieve a seamless connection between officially approved clinical applications and price establishment, so that high-quality medical innovations can benefit the people faster.

In the past, new medical technologies and devices had to wait until they were approved by the health, drug regulatory and other departments before starting the price establishment process. It often took a long time to be included in the charging catalog, so patients could not use them in time. The price pre-project establishment system launched this time is to move the relevant work forward.

Wang Xiaoning, Director of the Department of Pharmaceutical Pricing and Bidding and Procurement of the National Medical Insurance Administration: Specifically, it is to move the time point for the intervention of price support policies from "after approved application" to the "clinical research stage." For example, if a new biomedical technology is accepted by the health department and a new product is accepted by the drug regulatory department and enters the special review process for innovative medical devices, you can apply for price pre-approval. This changes the relationship between price establishment and application approval from a "series" relationship to a "parallel" relationship.

According to regulations, when new technologies enter clinical research and new products are included in the special review process for innovative medical devices, but have not yet been formally approved for clinical application, the provincial medical insurance department can accept the application and conduct pre-project evaluation in advance. Once the technology and product are officially approved, the price project can be quickly completed and the approved application and price project can be seamlessly connected. This measure will help stabilize the expectations of medical institutions and enterprises, allowing the public to enjoy better and more efficient diagnostic and treatment services faster.

The pre-project establishment system for medical service prices focuses on supporting three types of high-level innovations.

Dong Zhaohui, Deputy Director of the Department of Pharmaceutical Pricing and Bidding and Procurement of the National Medical Insurance Administration: First, new technologies with great clinical value and breakthroughs in diagnosis and treatment methods; second, new equipment that meets major clinical needs, effectively solves diagnosis and treatment problems in key areas, and improves the efficiency and accuracy of diagnosis and treatment; and third, new consumables that fill gaps in diagnosis and treatment, focus on patient benefit, and change surgical plans.

Price pre-establishment is not “lowering the threshold”

The relevant person in charge of the National Medical Insurance Administration said that price pre-establishment is not a "shortcut" to "open the floodgates" or "lower the threshold". Provincial medical insurance departments must focus on high-level new technologies and new products, steadily promote price pre-establishment work, and at the same time strictly grasp the access standards and select qualified projects on the basis of merit.

Jiang Bingzhen, Director of the Pharmaceutical Pricing Department of the Pharmaceutical Pricing and Bidding and Procurement Department of the National Medical Insurance Administration: During the implementation of this system, we will definitely adhere to high standards and strict requirements, and focus our policy resources on supporting major innovative projects that can solve urgent clinical needs and mainly benefit patients.

The National Medical Insurance Administration has made it clear that in order to ensure that resources are accurately invested in high-level innovation, products and conventional reagents that are only iterative upgrades based on existing medical consumables and equipment are not within the scope of pre-project support.

Wang Xiaoning, Director of the Department of Pharmaceutical Pricing and Bidding and Procurement of the National Medical Insurance Administration: For provincial medical insurance departments that relax quality standards and have pre-project approval conclusions that are repeatedly inconsistent with macro policy orientations and reform governance directions, the National Medical Insurance Administration will take measures such as suspending price pre-project acceptance qualifications as appropriate. If the provincial medical insurance departments discover during their work that the quality of medical institutions' declarations is not high and they abuse the pre-project declaration channels, they may take measures such as suspending the price pre-project declaration qualifications according to the circumstances.

The New Deal also sets constraints on the prices of related consumables. Provincial medical insurance departments are required to simultaneously check the price levels of supporting medical consumables when carrying out pre-project approval. If the depreciation of medical equipment or the cost of medical consumables accounts for more than 60% of the price of a new project, or the price of a single piece of medical consumables is higher than 5,000 yuan, the provincial medical insurance department should urge medical institutions and enterprises to explain the rationality and economics of the price, truthfully report the ex-factory price and price composition details, guide the pricing to match the clinical value, fully take into account the affordability of the people, and prevent the prices of innovative products from being artificially high.

Adopt the "one province applies for national reference" model

Many clinicians are looking forward to the pre-establishment system for medical service prices. It is believed that this policy, through early intervention and process optimization, will open up the key blocking points in medical technology innovation from the laboratory to the ward, promote more high-level medical new technologies and new products to be implemented in the clinic, and allow the people to enjoy better and more efficient diagnosis and treatment services.

The pre-establishment of medical service price projects adopts the "one province application, national reference" model: after the same technology or product completes the first application, other medical institutions do not need to submit repeated applications, and provincial medical insurance departments will no longer accept repeated applications. This will speed up the promotion and application of new technologies across the country.

He Zhiying, Director of the Institute of Regenerative Medicine, Dongfang Hospital Affiliated to Tongji University: During the clinical research stage of our new biomedical technology, we can apply to the National Medical Insurance Bureau, which greatly advances the time. In addition, I think there is another key point. Many patients with rare diseases can truly achieve price accessibility through the intervention of medical insurance. One of our coagulopathy products was originally priced at more than 2 million yuan. With the intervention of medical insurance costs, the price has now become 1.4 million yuan.

Many clinicians said that the pre-project approval system provides "reassurance" to scientific researchers, clinicians and patients, and clarifies the expectations for the transformation of results, which helps dispel concerns and encourages hospitals to actively carry out clinical research and enterprises to increase investment in R&D.

Chen Hui, Director of the Department of Burns and Plastic Surgery at Beijing Jishuitan Hospital Affiliated to Capital Medical University: Pre-approval of a project during the clinical research phase may actually have an expectation of its potential transformation, which is beneficial to our clinicians or investing companies, who are willing to develop new technologies and new projects faster. In terms of burn plastic surgery and wound repair, stem cells and some 3D printed skins can be directly applied to large-area wounds, which will shorten the treatment cycle and increase the patient's survival rate.