Shanghai: 12 departments issued documents, innovative medical devices welcome good news

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Shanghai optimizes the admission process of innovative devices

Accelerate clinical application

  Recently, twelve departments such as the Shanghai Municipal Health Commission issued the Implementation Plan on Implementing the spirit of the Third Plenary Session of the 20th CPC Central Committee and the Fifth Plenary Session of the 12th CPC Municipal Committee to deepen the reform of the City's medical and health System, which once again clarified the support for innovative medical devices.

  The document proposes to improve the mechanism to support the development of innovative drugs and medical devices. Promote the reform of the drug device review and approval system, improve the review capacity, efficiency and transparency, and strengthen the data protection of drug clinical trials. Focus on "new excellent medical equipment" products, build a communication platform between production and medicine, and establish an efficient docking mechanism between production and medicine. Support the development of innovative medical devices, improve the price formation mechanism of innovative medical devices, optimize the admission process, and accelerate clinical application.

  As the innovation engine city of the national biomedical industry, Shanghai has spared no effort in supporting the development of innovative medical devices in recent years, especially in the hospital admission, payment and other links to specify a series of encouragement measures.

  In terms of hospital admission, in July last year, Shanghai issued Several Measures for Shanghai to Further improve the multi-payment Mechanism to Support the development of innovative pharmaceutical devices, which proposed to accelerate the clinical application of innovative pharmaceutical devices. Adjust and optimize the assessment mechanism of medical institutions, and hospitals shall not restrict the admission of innovative medical devices for reasons such as the number of drug catalogs and the "ratio of drugs/consumption". For the products that obtain the national medical insurance consumables code and meet the city's provisions on the management of the consumables catalog that can be charged separately, enterprises can directly apply for network procurement, implement an acceptance, reduce the handling process, improve the audit efficiency, and accelerate clinical use.

  In terms of payment, Shanghai requires that the DRG/DIP payer should be tilted in the face of innovative pharmaceutical devices, improve the payment standard of new technology application cases, and set no control ratio for high-rate cases of new technology application, and the application of new technology can be independently grouped into groups. Steadily expand the city's medical service projects and medical consumables medical insurance payment scope, priority coverage of innovative pharmaceutical devices.

  In October last year, Shanghai added 60 categories of consumables to the medical insurance payment scope, including some innovative consumables such as "optical coherence tomography (OCT) catheter". In December last year, the Shanghai Medical Insurance Bureau and the Shanghai Health and Health Commission issued the Notice on Reaffirming Matters Related to Accelerating the Clinical Application of Innovative Medical Devices, further reaffirming the relevant policies and regulations on accelerating the clinical application of innovative medical devices.

  According to a recent report by Wen Wei Po, Shanghai's basic medical insurance has been increasing its support for innovative medical devices. Innovative medical devices have achieved rapid admission, and the use of innovative medical devices in medical institutions has increased significantly. Innovative technologies are becoming more prominent in healthcare payments. In the 2023 version of the DRG payment grouping scheme, 17 groups of new technologies and new projects are grouped separately, involving 45,000 cases, with a single payment amount of 500 million yuan.

  As of September, Shanghai has been approved 4 types of domestic class 1 innovative drugs and 9 types of Class III innovative medical devices, and the number of innovative drugs and innovative medical devices approved has been the same as the whole year of 2023.

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Innovative devices into the hospital, payment resistance is reduced

  For the development of innovative medical devices, the ice breaking resistance in the hospital, application and payment links is relatively large. The positive sign is that the window for innovative devices is opening. National and local levels have increased support, and some regions have put forward specific measures to encourage the development of innovative medical devices.

  Taking the DRG/DIP reform that the industry is most concerned about as an example, under the new payment method, the application of innovative technologies and innovative products may be restricted.

  In July this year, the National Medical Insurance Bureau issued the Notice of the Office of the National Medical Security Bureau on issuing the 2.0 version of the Group Payment Plan by disease Group and disease type and further promoting related work. It is clear that for cases that are not suitable for payment according to the DRG/DIP standard due to the use of new drugs and technologies, medical institutions can independently declare special cases, and the number of special cases is in principle 5% of the total DRG discharged cases or less than 5% of the total DIP discharged cases.

  In addition, it is also proposed to explore an exception mechanism to support qualified new drug consumption technologies by project payment or weight (point) plus in the initial application, and then include DRG/DIP payment after sufficient data is accumulated in the later period.

  The local level is also actively promoting initiatives such as DRG/DIP excluding payments and special cases to encourage the development of innovative devices. On October 12, Zhejiang Medical Insurance Bureau issued the Notice of Zhejiang Medical Security Bureau on issuing Incentive Management Measures for Innovative Medical Technology Medical Insurance Payment in Zhejiang Province (Trial), which made it clear that eligible innovative drugs and innovative medical service projects (including medical consumables) can be included in the scope of DRG points payment incentive after declaration and identification.

  In the medical device review and approval process, the registration and listing process of innovative medical devices is also expected to accelerate.

  From January to August this year, the State Drug Administration approved 31 innovative drugs and 46 innovative medical devices, an increase of 19.23% and 12.16% over the same period last year, respectively.

  At the "Promoting high-quality Development" series themed press conference held by the State New Office in September this year, it was pointed out that the drug regulatory authorities are planning to comprehensively deepen the package of policy measures for drug regulatory reform in accordance with the deployment of the plenary session, focusing on creating a globally competitive pharmaceutical innovation ecology, and accelerating the pace of listing innovative drugs and medical devices.

  At the meeting, it was discussed that for innovative drugs and medical devices supported by the State, service guidance should be strengthened in the aspects of review and approval, inspection and verification, etc., and enterprises should be guided to adhere to clinical value-oriented and patient-centered research and development strategies. Improve the accessibility of innovative drugs and medical devices, implement the decision and deployment of the Party Central Committee on deepening the coordinated development and governance of the "three medical", and actively support the introduction of innovative medical devices into hospitals and medical insurance.

  The golden age of domestic innovative devices has arrived.