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6月4日，The National Medical Insurance Bureau jointly with the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance, the National Health and Health Commission, the General Administration of Market Regulation, the State Food and Drug Administration, and the Logistics Support Department of the Central Military Commission issued the Guiding Opinions on carrying out the national Organization of high-value medical consumables centralized Procurement and use (medical insurance development (2021) No. 31，Hereinafter referred to as "Document 31")，From the overall requirements, coverage, procurement rules, safeguard measures, policy cohesion, organization and implementation of six aspects，In order to carry out the centralized procurement and use of high-value medical consumables by the State organization, relevant guidelines are put forward: the general idea of national organization, alliance procurement and platform operation is clarified，Basic policies and requirements are formulated by the State，Organize the regions into coalitions，Public medical institutions as the main body of implementation，Carry out the national organization of high-value medical consumables centralized procurement，Explore and improve the collection policy;Gradually expand coverage，We will promote the return of prices of high-value medical consumables to reasonable levels，Reduce patient burden。 The introduction of document 31 is a summary of the national and provincial and municipal medical consumables procurement experience in the past two years。 In July 2019, The General Office of the State Council issued the Notice on Printing and Distributing the Reform Plan of high-value Medical Consumables (GuOCofa [2019] No. 37), requiring "to explore the classified centralized procurement of high-value medical consumables in accordance with the principles of volume procurement, volume and price linkage, and promoting market competition.。All public medical institutions to purchase high-value medical consumables must be publicly traded on the procurement platform, sunshine procurement。For high-value medical consumables with large clinical dosage, high procurement amount, mature clinical use, and production by multiple enterprises, explore centralized procurement by category, encourage medical institutions to jointly carry out volume negotiation procurement, and actively explore cross-provincial alliance procurement。For the high-value medical consumables that have passed the medical insurance access and clear medical insurance payment standards, and the price is relatively stable, the direct network procurement is implemented。Strengthen the supervision of the actual purchase amount of high-value medical consumables in medical institutions"。After the introduction of the document, Jiangsu, Shandong, Anhui and other provinces took the lead in pilot, opening the prelude to centralized procurement of medical consumables。 According to statistics, there are nearly 400 medical consumables centralized procurement projects being implemented in the country, which are rich and diverse in terms of collection methods, evaluation methods, group classification, selection methods, medical insurance fund protection, distribution provider selection, price linkage and other aspects of the volume procurement。Including 130 new projects from January 1, 2020 to April 30, 2021, of which 70 pilot projects for centralized procurement were carried out (accounting for 54% of new projects in the year).。(1) One national centralized procurement project That is, in October 2020, the National Organization of high-value medical consumables Joint Procurement Office issued the "National Organization of Coronary Stent Centralized Volume Procurement Document (GH-HD2020-1)", which launched the first national joint procurement of consumables, and officially opened the bid on November 5, 2021。(2) The inter-provincial alliance carried out 14 centralized procurement projects More than ten cross-provincial purchasing alliances have been formed，Such as Beijing-Tianjin-Hebei 3+N, Henan ten province alliance, Shaanxi Alliance, Guangdong 16 province alliance, Chongqing Alliance, Inner Mongolia Alliance, 6+2 alliance，A total of 30 provinces (municipalities and districts) and 1 Xinjiang Construction Corps are involved，It covers almost the whole country，Combined with the procurement of varieties involving intraocular lenses, balloons, orthopedics and other consumables。Some alliances have also made bulk purchases of COVID-19 reagents。(3) 24 provincial-level centralized procurement projects were carried out It covers 13 provinces, including Anhui, Jiangsu, Shanxi, Qinghai, Fujian, Hubei, Zhejiang, Shanghai, Henan, Shaanxi, Hunan, Shandong and Hebei。The varieties include coronary stent, coronary balloon, intraocular lens, orthopedic material, stapler, guide wire, medical film, patch, pacemaker, indwelling needle, infusion set, novel coronavirus reagents, etc。(4) 13 centralized procurement projects of the municipal alliance have been carried out Mainly concentrated in Shanxi, Henan, Shandong three provinces, all with quantity procurement, procurement catalogue varieties mainly involve syringes, infusion sets, blood collection, blood collection needles and so on。(5) 18 municipal centralized procurement projects have been carried out Mainly concentrated in Heilongjiang, Guizhou, Shanxi, Jiangsu, Zhejiang, Fujian, Chongqing and other seven provinces。
The procurement requirements for consumables are synchronized with pharmaceuticals
Since 2019, the state has introduced a series of reform documents, and centralized procurement has become a breakthrough in reform, and the centralized procurement of high-value medical consumables is often mentioned。 2019年1月，Notice on the Issuance of the Pilot Program for Centralized Drug Procurement and Use by the State Organization (2019) No. 2)，It is clear that "according to the general idea of national organization, alliance procurement, and platform operation.，That is, the State formulates basic policies, scope and requirements，Organize pilot areas to form alliances，Public medical institutions in the alliance area are the main body of centralized procurement，Explore the idea of centralized procurement of cross-regional alliance with quantity ";And put forward in the summary evaluation pilot work on the basis of，Gradually expand the coverage of centralized procurement，We will guide society to form expectations for long-term stability。2019年11月，Notice of the Leading Group of The State Council on Deepening the Reform of the Medical and Health System on Further Promoting the experience of deepening the reform of the medical and health system in Fujian Province and Sanming City (National Medical Reform Development (2019) No. 2) pointed out that all places should target at high-value medical consumables with large clinical dosage, high procurement amount, mature clinical use and production by many enterprises，Explore centralized procurement by category;Comprehensive medical reform pilot provinces should take the lead in exploring。2019年11月，"Several Policy Measures to Further Deepen the reform of the medical and health system with centralized drug Procurement and use as a breakthrough" (National Medical Reform (2019) No. 2) stipulates that: On the basis of doing a good job of centralized drug procurement，Explore the gradual inclusion of high-value medical consumables in the scope of centralized procurement by national organizations or local governments。2020年3月，The Opinions of the Central Committee of the Communist Party of China and The State Council on Deepening the Reform of the Medical Security System (Zhongfa (2020) No. 5) was issued，It is proposed that "the normalization of centralized procurement of high-value medical consumables in provinces and cities will be further promoted.，Expand the coverage of high-value medical consumables，We will promote the return of prices of high-value medical consumables to reasonable levels，Reduce patient burden，Reduce business costs，Clean circulation environment，Guided normative use，Better guarantee that the people have access to medical care."。 2021年1月，"Opinions on Promoting the normalization and institutionalization of Centralized Drug Procurement" (State Office of the People's Republic of China (2021) No. 2) further clarified that "Improve the market-led drug price formation mechanism.，We will give full play to the strategic purchase role of medical insurance funds，We will promote regular and institutionalized implementation of centralized procurement，Improve the working mechanism of government organization, alliance procurement, and platform operation."。 The author believes that document 31 is the guiding document of The State Council to promote the normalization and institutionalization of centralized procurement in the field of medical devices, and from the guiding principles, specific content and requirements of the document, it is no different from document 2。It can be inferred that the centralized procurement of high-value medical consumables will advance simultaneously with drugs in the future。
The new rules point in a new direction
Before document 31 came out，The quantity procurement of medical consumables is basically carried out in accordance with the requirements of centralized quantity procurement of drugs，The introduction of the document has clarified the range of high-value consumables collection varieties，That is, consumables with large clinical dosage, high purchase amount, mature clinical use, full market competition and high homogenization level，And requires that all public medical institutions should participate in centralized procurement，Enterprises that meet the requirements of centralized procurement in terms of quality standards, production capacity, supply stability, and enterprise credit can participate in collective procurement。 In addition to adhering to the same principle of demand orientation, ensuring quality, integrating recruitment and procurement, linking quantity and price, exchanging quantity for price, ensuring use, smooth adoption and settlement, etc，Also combined with the characteristics of medical consumables，The unique principle of "one product, one policy" of centralized purchasing with quantity is put forward，That is: according to the material policy，Consider the clinical use characteristics, functions, techniques and use differences of different high-value medical consumables，And production and supply capacity and other factors，Forming specific procurement plans;And "combine the procurement volume of similar high-value medical consumables with similar therapeutic purposes, clinical efficacy and product quality.，Unified bidding，Fair competition;Encourage grouping，Promote competition。A variety of high-value medical consumables that need to be used jointly can be integrated into a system and purchased as one variety。According to the clinical use characteristics of high-value medical consumables, the degree of standardization, the number of participating enterprises and other factors, due to the material policy, bidding, competitive negotiation, inquiry and other ways can be adopted for procurement。Enterprises voluntarily participate, offer prices independently, and produce selected prices and selected enterprises through quality and price competition。If a number of enterprises are selected, the price difference between different enterprises should be reasonably controlled。In accordance with the principle of linking volume and price, clarify the agreed procurement quantity of each selected enterprise, and reasonably determine the procurement agreement period."。 The above new rules will accelerate the national joint mining of high-value medical consumables organized by the state, and play a unified role in the procurement of medical consumables by the alliance of provinces and cities and the provincial level。 The author thinks，In the next two years, the quantity procurement of medical consumables will burst out in batches, layers and classifications，The rules of collection will be constantly iterated and improved，The bidding method will be more colorful，It will play a huge role in reducing inflated prices，It will have a profound impact on medical institutions, production and circulation enterprises, registrants and record holders。 |
