Both payment method reform and quantity based procurement are actively leaving a buffer zone for innovative medical devices,and now this"zone"has the possibility of expansion.
01.Regarding the"exemption"of innovative medical devices,the National Medical Insurance Administration has made a statement
Recently,the National Medical Insurance Administration released the"Reply to Proposal No.3298 of the Fifth Session of the 13th National People's Congress"(hereinafter referred to as the"Reply"),which responded to the payment methods for new technologies,special drugs,devices,high-value consumables,etc.,releasing a new signal for the reform of medical insurance payment methods.
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In its response,the National Medical Insurance Administration pointed out that in order to standardize DRG work,it has formulated and issued the"Technical Specification for Grouping and Payment of CHS-DRG"for National Medical Security Disease Diagnosis Related Groups.For new technology projects that have been registered in the medical insurance agency,the technical specifications specify that payment for each project can be temporarily executed for one year,and then the payment standards for the disease grouping can be revised based on data calculation.For difficult and severe cases,technical specifications can clearly increase the weight value of the difficult and severe DRG group,and reduce the weight value of the mild DRG group
The traditional project-based medical insurance payment method is fundamentally different from DRG/DIP.Payment by project is based on the usage of drugs,medical service items,medical consumables,etc.during the diagnosis and treatment process,and is borne by patients and medical insurance funds according to their respective actual expenses.
Paying per project can to some extent loosen the constraints on new technologies.In this mode,hospitals do not need to worry about the potential losses caused by the use of new drugs,technologies,and devices under the DRG/DIP mode,and innovative technologies and products also have room for development.
In addition,the National Medical Insurance Administration also named and supported Beijing's innovative mechanisms related to special drugs,devices,high-value consumables,and new technologies in the CHS-DRG payment policy.
The"Reply"states:"For drugs,medical devices,and diagnostic and treatment items that meet certain conditions,Beijing will be included in the CHS-DRG payment exclusion management;Handan,Hebei has clarified that disease groups with abnormally high and abnormally low payment values can be paid according to the project,and the list of special treatments,special medications,and high-value consumables can be determined,but can not be included in the DRG group to ensure full coverage."
The reform of medical insurance payment methods has opened the door,and new technologies,drugs,and devices will also have room for survival.
02.Not giving the green light to all innovations
The DRG/DIP reform has reached a critical stage.According to the three-year action plan for DRG/DIP payment method reform,from 2022 to 2024,we will comprehensively complete the task of DRG/DIP payment method reform and promote high-quality development of medical insurance.According to the schedule,the three-year plan is about to enter the middle stage.
This major change in payment methods is fundamentally reshaping the operational mechanisms of medical institutions.In the new operating mechanism,drugs,consumables,and inspection costs have lost their profit status and are instead pushed towards cost centers.Medical institutions are eager to cut off redundant costs,and the"slimming movement"is spreading throughout the industry.
However,in order to continuously improve medical standards,the spark of innovation cannot be extinguished.In the storm of change,buffer zones have been created for the development of new technologies and products.
In July last year,the National Medical Insurance Administration clarified in its response to Proposal No.8013 of the Fifth Session of the 13th National People's Congress that it is studying and improving relevant policies,guiding various regions to timely include eligible innovative medical consumables in the medical insurance payment scope according to procedures.At the same time,we will promote the reform of medical insurance payment methods,determine payment standards for CHS-DRG and DIP,and support innovative medical consumables in accordance with relevant regulations and procedures.
In addition,space is also reserved for innovative equipment in volume based procurement.In its response to Proposal No.4955 of the Fifth Session of the 13th National People's Congress,the National Medical Insurance Administration pointed out that due to the immature clinical use of innovative medical devices and the difficulty in estimating their usage,it is still difficult to implement a quantity based approach.Setting aside a certain market beyond centralized volume procurement to provide space for innovative product development.
However,an undeniable fact is that there is a clear correlation between the use of new technologies and products and the growth of medical expenses.In the wave of healthcare payment reform,controlling excessive healthcare is a necessary step.This also means that in the new policy environment,the healthcare market will definitely screen out"valuable innovations"more quickly,rather than just accepting all innovations.
In July last year,the Beijing Medical Insurance Bureau issued a notice(trial)on the issuance of the CHS-DRG payment for new drugs and technologies,injecting a shot of adrenaline into the innovative medical device market.According to this d0cument,eligible new drugs and devices will be granted CHS-DRG payment exemption in Beijing.
To enter the CHS-DRG payment exclusion category,six conditions must be met simultaneously.It is explicitly required that clinical efficacy should be significantly improved compared to traditional drugs/medical devices.
It can be seen that the innovative research and development of medical devices must prioritize clinical needs as the primary priority.Among them,the best solution is to be able to solve practical problems with higher cost-effectiveness.
03."A timed reform buffer zone"
For medical device companies,in addition to having true innovation and research and development advantages,it is also crucial to grasp the time window.
According to the above notice,drugs and medical devices that meet the conditions,It should refer to"new generic name drugs/medical devices approved for marketing by the drug regulatory department within three years(including the application year and the previous two natural years,the same below);drugs with significant changes in their main functions or indications within three years;drugs newly included in the national medical insurance drug catalog within three years;and medical devices that can be charged separately due to price adjustments within three years.".
This means that the preferential policies for innovative medical devices have a deadline.
A senior medical researcher told CyberBlue Instruments that,from a national perspective,there are currently no other cities that have followed Beijing's policies.In addition,there is currently no data summary on the progress of policy implementation in the Beijing region.Based on this,the impact of CHS-DRG's payment exemption on the clinical development of new drugs and innovative medical devices still needs further observation.
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Figure 16 Ranking of innovative medical device registration provinces in China(blue:number of products,red:number of enterprises)
Image source:National Medical Products Administration
"DRG reform is a market choice.In the long run,it is not realistic for innovative drugs and medical devices to always avoid this policy."
Innovative medical devices cannot stay in the"green zone"for too long.Quickly acquiring the market and shortening the maturity cycle have become a major challenge for innovative medical devices.
The above individuals believe that in order for innovative medical devices to develop,they fundamentally need"collaboration",that is,exploring the innovative collaborative path of"medicine,industry,academia,research,and application",in order to promote their high-quality development.Vertically,domestic medical devices have made significant progress,but horizontally,there is still an objective gap between them and foreign first-class enterprises.
The core of innovative medical device development lies in"basic technology",and this foundation is not solid.No matter how many favorable policies can play a limited role in promoting it.In addition,innovation is a cost competition,and confidence and capital are the chips to persevere.Policies and market environment should give innovative enterprises the motivation and sense of security for long-term development,rather than letting them leave just to make quick money.
From 2014 to 2022,the National Medical Products Administration approved a total of 189 innovative medical devices.Among them,a total of 55 innovative medical device products were approved for market launch in 2022,an increase of 57.1%compared to 2021.Overall,the medical device market is developing rapidly,but the high-end medical device field has not yet achieved revolutionary breakthroughs,and many cutting-edge tracks are dominated by multinational enterprises.
The moment of qualitative change has not yet arrived,and before that,the journey of breaking through domestic medical devices is still ongoing.
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