Blowouts in batches, stratification and classification have appeared, and the collection rules for high-value medical consumables continue to iterate

Medical Network, June 8th, June 4th, the National Medical Insurance Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance, the National Health Commission, the General Administration of Market Supervision, the State Food and Drug Administration, and the Central Military Commission’s Logistics Support Department.
The "Guiding Opinions on Carrying out the Centralized Procurement and Use of High-Value Medical Consumables by National Organizations" (Yibaofa [2021] No.
31, hereinafter referred to as "Circular 31"), from the overall requirements, coverage, procurement rules, safeguard measures, Six aspects of policy linkage, organization and implementation, etc.
, provide relevant guidance for the national organization of the centralized procurement and use of high-value medical consumables: clarify the overall idea of ​​national organization, alliance procurement, and platform operation, and the state will formulate basic policies and It is required to organize various regions to form alliances, with public medical institutions as the main executive body, carry out the national organization of centralized procurement of high-value medical consumables, explore and improve the centralized procurement policy; gradually expand the coverage, promote the return of high-value medical consumables to a reasonable level, and reduce Patient burden
.

 

Pilot first

 

The issuance of Circular 31 is a summary of the past two years of national, provincial, and municipal medical consumables procurement experience
.

 

In July 2019, the General Office of the State Council issued the "Notice on Issuing the Reform Plan for Governance of High-Value Medical Consumables" (Guobanfa [2019] No.
37), requiring "exploration in accordance with the principles of quantity procurement, linkage of quantity and price, and promotion of market competition.
High-value medical consumables are categorized and centralized procurement
.
All public medical institutions purchasing high-value medical consumables must be publicly traded on the procurement platform and purchased under sunshine
.
For large clinical use, high purchase amount, mature clinical use, and high production by many companies Value medical consumables, explore centralized procurement by category, encourage medical institutions to jointly carry out mass negotiation procurement, and actively explore cross-provincial alliance procurement
.
Directly implement high-value medical consumables that have passed medical insurance access, have clear medical insurance payment standards, and have relatively stable prices.
Online procurement
.
Strengthen the supervision of the actual procurement of high-value medical consumables by medical institutions
.
” After the release of the document, Jiangsu, Shandong, Anhui and other provinces took the lead in pilot projects to kick off the prelude to centralized procurement of medical consumables
.

 

According to statistics, there are currently nearly 400 centralized procurement projects for medical consumables currently being implemented across the country, from the centralized procurement method, evaluation method, group classification, selection method, medical insurance fund protection, the selection of distributors, and price linkage.
Procurement is rich and diverse, and all are different
.
Including 130 new projects launched from January 1, 2020 to April 30, 2021, of which, a total of 70 projects were launched in the pilot project of centralized procurement (accounting for 54% of the new projects in the current year)
.

 

(1) One national centralized procurement project, namely the National Organization for High-value Medical Consumables Joint Procurement Office issued the "National Organization for Centralized Procurement of Coronary Stents (GH-HD2020-1)" in October 2020, and the first consumable was launched The joint procurement of the country will be officially opened on November 5, 2021
.

 

(2) The inter-provincial alliance has carried out 14 centralized procurement projects and formed more than ten inter-provincial procurement alliances, such as Beijing-Tianjin-Hebei 3+N, Henan Ten-province Alliance, Shaanxi Alliance, Guangdong 16-province Alliance, Chongqing Alliance, Inner Mongolia The Alliance, 6+2 Alliance, etc.
, involve 30 provinces (cities, districts) and 1 Xinjiang Construction Corps, covering almost the whole country.
The joint purchase of varieties involves intraocular lenses, balloons, orthopedics and other consumables
.
Some alliances have also carried out the purchase of new crown reagents
.

 

(3) Provincial-level centralized procurement projects carried out 24 projects involving 13 provinces including Anhui, Jiangsu, Shanxi, Qinghai, Fujian, Hubei, Zhejiang, Shanghai, Henan, Shaanxi, Hunan, Shandong and Hebei
.
Species encompass coronary stents, coronary balloon, intraocular lens, orthopedic materials, staplers, guide wire, medical film, patch, a pacemaker, a catheter, infusion, new crown reagents
.

 

　　 (4) the amount of municipal alliance with centralized procurement project carried out 13 mainly concentrated in Shanxi, Henan and Shandong provinces, both with a volume of procurement, procurement catalog varieties mainly related to syringes, infusion sets, blood collection tube, blood collection needles and so on
.

 

　　 (5) 18 municipal-level centralized procurement projects were carried out, mainly in seven provinces including Heilongjiang, Guizhou, Shanxi, Jiangsu, Zhejiang, Fujian and Chongqing
.

 

　　Consumables with quantity procurement requirements are synchronized with medicines

 

　　Since 2019, the state has issued a series of reform documents, and centralized procurement has become a breakthrough point in the reform.
The centralized procurement of high-value medical consumables has been frequently mentioned
.

 

　　In January 2019, the "Notice on Printing and Distributing the Pilot Program for the Centralized Procurement and Use of Drugs Organized by the State" (Guobanfa [2019] No.
2), clarified that "in accordance with the overall idea of ​​national organization, alliance procurement, and platform operation, that is, the national plan Basic policies, scope and requirements, organize pilot areas to form alliances, use public medical institutions in the alliance areas as the main body of centralized procurement, and explore the centralized procurement ideas of cross-regional alliances centralized procurement; and propose to summarize and evaluate the pilot work on the basis of gradual Expand the coverage of centralized procurement and guide the society to form long-term and stable expectations
.
In November 2019, the "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 Fujian Province and Sanming City in Deepening the Reform of the Medical and Health System" (Guoyugaifa [2019] No.
2) pointed out that local areas should target larger clinical dosages , The high-value medical consumables produced by many enterprises with high purchase amount, more mature clinical use, and centralized procurement should be explored by category; pilot provinces for comprehensive medical reform should take the lead in exploring
.
In November 2019, the "Several Policies and Measures on Further Deepening the Reform of the Medical and Health System by Using the Centralized Procurement and Use of Medicines as a Breakthrough" (Guoyugaifa [2019] No.
2) stipulated that on the basis of doing a good job in centralized drug procurement, explore Gradually incorporate high-value medical consumables into the scope of centralized procurement by national organizations or local governments
.
In March 2020, 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, proposing that "will further promote the normalization of the centralized procurement of high-value medical consumables in various provinces and cities, and expand the high-value medical The coverage of consumables varieties will promote the return of the price of high-value medical consumables to a reasonable level, reduce the burden on patients, reduce corporate costs, purify the circulation environment, guide standardized use, and better ensure that the people have medical treatment
.
"

 

　　In January 2021, the "Opinions on Promoting the Normalized and Institutionalized Development of Drug Centralized and Volume Procurement" (Guobanfa [2021] No.
2) further clarified that "Improve the market-led drug price formation mechanism and give full play to the medical insurance fund strategy Promote the normalized and institutionalized development of centralized and volume procurement, and improve the working mechanism of government organizations, alliance procurement, and platform operations
.
”

 

　　The author believes that Circular 31 is the State Council ’s guiding document in the field of medical devices to promote the normalization and institutionalization of centralized procurement .
From the perspective of the guiding principles, specific content and requirements of the document, it is no different from Circular 2
.
It can be inferred that the centralized procurement of high-value medical consumables will advance simultaneously with medicines in the future
.

 

　　New regulations indicate a new direction

 

　　Prior to the issuance of Circular 31, the procurement of medical consumables was basically carried out in pilot projects in accordance with the requirements for centralized procurement of pharmaceuticals.
The publication of the document clarified the scope of the collection of high-value consumables, that is, the clinical use is larger and the purchase amount is relatively large.
Consumables that are high in quality, more mature in clinical use, more competitive in the market, and higher in homogeneity.
All public medical institutions are required to participate in centralized procurement to achieve concentration in terms of quality standards, production capacity, supply stability, and corporate credit.
Companies with volume procurement requirements can participate in centralized procurement
.

 

　　In addition to insisting on the same demand-oriented as the centralized procurement of drugs with volume, the document also combines the characteristics of medical consumables, including the principles of ensuring quality, integrating recruitment and procurement, linking volume and price, trading volume, ensuring use, unimpeded adoption and settlement, etc.
, Puts forward the unique principle of “one product, one policy” of centralized procurement with volume, that is: implement policies in accordance with their aptitude, taking into account the characteristics and functions of the clinical use of different high-value medical consumables, differences in technology, use, and production and supply capabilities, etc.
, to form specific procurement Plan; and "combine the purchase volume of similar high-value medical consumables with similar therapeutic purposes, clinical efficacy, and product quality, unified bidding, and fair competition; encourage merging and grouping, and promote competition
.
A variety of high-value medical consumables that need to be used in combination can be integrated into The system is regarded as a variety for procurement
.
According to the characteristics of clinical use of high-value medical consumables, the degree of standardization, the number of participating companies and other factors, policies can be implemented in accordance with their aptitude, and procurement can be carried out by means of bidding , competitive negotiation, and inquiry
.
Independent quotation, through quality and price competition to produce selected prices and selected companies
.
If multiple companies are selected, the price difference between different companies should be reasonably controlled
.
According to the principle of quantity-price linkage, the agreed purchase volume of each selected company shall be clarified, and the purchase agreement shall be reasonably determined Period"
.

 

　　The above new rules will accelerate the national joint procurement of high-value medical consumables organized by the state, and will play a unified and standardized role in the procurement of provinces, prefectures and cities' alliances and provincial medical consumables
.

 

　　The author believes that in the next two years, the mass procurement of Chinese medical consumables will blow out in batches, layers, and classifications.
The rules for centralized procurement will continue to be iterated and improved, and the tendering methods will be more colorful, and will reduce falsely high prices.
Play a huge role, and have a profound impact on medical institutions, production and distribution companies, registrants and record holders
.

　　Medical Network, June 8th, June 4th, the National Medical Insurance Administration, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance, the National Health Commission, the General Administration of Market Supervision, the State Food and Drug Administration, and the Central Military Commission’s Logistics Support Department.
The "Guiding Opinions on Carrying out the Centralized Procurement and Use of High-Value Medical Consumables by National Organizations" (Yibaofa [2021] No.
31, hereinafter referred to as "Circular 31"), from the overall requirements, coverage, procurement rules, safeguard measures, Six aspects of policy linkage, organization and implementation, etc.
, provide relevant guidance for the national organization of the centralized procurement and use of high-value medical consumables: clarify the overall idea of ​​national organization, alliance procurement, and platform operation, and the state will formulate basic policies and It is required to organize various regions to form alliances, with public medical institutions as the main executive body, carry out the national organization of centralized procurement of high-value medical consumables, explore and improve the centralized procurement policy; gradually expand the coverage, promote the return of high-value medical consumables to a reasonable level, and reduce Patient burden
.

 

　　Pilot first

 

　　The issuance of Circular 31 is a summary of the past two years of national, provincial, and municipal medical consumables procurement experience
.

 

　　In July 2019, the General Office of the State Council issued the "Notice on Issuing the Reform Plan for Governance of High-Value Medical Consumables" (Guobanfa [2019] No.
37), requiring "exploration in accordance with the principles of quantity procurement, linkage of quantity and price, and promotion of market competition.
High-value medical consumables are categorized and centralized procurement
.
All public medical institutions purchasing high-value medical consumables must be publicly traded on the procurement platform and purchased under sunshine
.
For large clinical use, high purchase amount, mature clinical use, and high production by many companies Value medical consumables, explore centralized procurement by category, encourage medical institutions to jointly carry out mass negotiation procurement, and actively explore cross-provincial alliance procurement
.
Directly implement high-value medical consumables that have passed medical insurance access, have clear medical insurance payment standards, and have relatively stable prices.
Online procurement
.
Strengthen the supervision of the actual procurement of high-value medical consumables by medical institutions
.
” After the release of the document, Jiangsu, Shandong, Anhui and other provinces took the lead in pilot projects to kick off the prelude to centralized procurement of medical consumables
.

 

　　According to statistics, there are currently nearly 400 centralized procurement projects for medical consumables currently being implemented across the country, from the centralized procurement method, evaluation method, group classification, selection method, medical insurance fund protection, the selection of distributors, and price linkage.
Procurement is rich and diverse, and all are different
.
Including 130 new projects launched from January 1, 2020 to April 30, 2021, of which, a total of 70 projects were launched in the pilot project of centralized procurement (accounting for 54% of the new projects in the current year)
.

 

　　 (1) One national centralized procurement project, namely the National Organization for High-value Medical Consumables Joint Procurement Office issued the "National Organization for Centralized Procurement of Coronary Stents (GH-HD2020-1)" in October 2020, and the first consumable was launched The joint procurement of the country will be officially opened on November 5, 2021
.

 

　　 (2) The inter-provincial alliance has carried out 14 centralized procurement projects and formed more than ten inter-provincial procurement alliances, such as Beijing-Tianjin-Hebei 3+N, Henan Ten-province Alliance, Shaanxi Alliance, Guangdong 16-province Alliance, Chongqing Alliance, Inner Mongolia The Alliance, 6+2 Alliance, etc.
, involve 30 provinces (cities, districts) and 1 Xinjiang Construction Corps, covering almost the whole country.
The joint purchase of varieties involves intraocular lenses, balloons, orthopedics and other consumables
.
Some alliances have also carried out the purchase of new crown reagents
.

 

　　 (3) Provincial-level centralized procurement projects carried out 24 projects involving 13 provinces including Anhui, Jiangsu, Shanxi, Qinghai, Fujian, Hubei, Zhejiang, Shanghai, Henan, Shaanxi, Hunan, Shandong and Hebei
.
Species encompass coronary stents, coronary balloon, intraocular lens, orthopedic materials, staplers, guide wire, medical film, patch, a pacemaker, a catheter, infusion, new crown reagents
.

 

　　 (4) the amount of municipal alliance with centralized procurement project carried out 13 mainly concentrated in Shanxi, Henan and Shandong provinces, both with a volume of procurement, procurement catalog varieties mainly related to syringes, infusion sets, blood collection tube, blood collection needles and so on
.

 

　　 (5) 18 municipal-level centralized procurement projects were carried out, mainly in seven provinces including Heilongjiang, Guizhou, Shanxi, Jiangsu, Zhejiang, Fujian and Chongqing
.

 

　　Consumables with quantity procurement requirements are synchronized with medicines

 

　　Since 2019, the state has issued a series of reform documents, and centralized procurement has become a breakthrough point in the reform.
The centralized procurement of high-value medical consumables has been frequently mentioned
.

 

　　In January 2019, the "Notice on Printing and Distributing the Pilot Program for the Centralized Procurement and Use of Drugs Organized by the State" (Guobanfa [2019] No.
2), clarified that "in accordance with the overall idea of ​​national organization, alliance procurement, and platform operation, that is, the national plan Basic policies, scope and requirements, organize pilot areas to form alliances, use public medical institutions in the alliance areas as the main body of centralized procurement, and explore the centralized procurement ideas of cross-regional alliances centralized procurement; and propose to summarize and evaluate the pilot work on the basis of gradual Expand the coverage of centralized procurement and guide the society to form long-term and stable expectations
.
In November 2019, the "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 Fujian Province and Sanming City in Deepening the Reform of the Medical and Health System" (Guoyugaifa [2019] No.
2) pointed out that local areas should target larger clinical dosages , The high-value medical consumables produced by many enterprises with high purchase amount, more mature clinical use, and centralized procurement should be explored by category; pilot provinces for comprehensive medical reform should take the lead in exploring
.
In November 2019, the "Several Policies and Measures on Further Deepening the Reform of the Medical and Health System by Using the Centralized Procurement and Use of Medicines as a Breakthrough" (Guoyugaifa [2019] No.
2) stipulated that on the basis of doing a good job in centralized drug procurement, explore Gradually incorporate high-value medical consumables into the scope of centralized procurement by national organizations or local governments
.
In March 2020, 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, proposing that "will further promote the normalization of the centralized procurement of high-value medical consumables in various provinces and cities, and expand the high-value medical The coverage of consumables varieties will promote the return of the price of high-value medical consumables to a reasonable level, reduce the burden on patients, reduce corporate costs, purify the circulation environment, guide standardized use, and better ensure that the people have medical treatment
.
"

 

　　In January 2021, the "Opinions on Promoting the Normalized and Institutionalized Development of Drug Centralized and Volume Procurement" (Guobanfa [2021] No.
2) further clarified that "Improve the market-led drug price formation mechanism and give full play to the medical insurance fund strategy Promote the normalized and institutionalized development of centralized and volume procurement, and improve the working mechanism of government organizations, alliance procurement, and platform operations
.
”

 

　　The author believes that Circular 31 is the State Council ’s guiding document in the field of medical devices to promote the normalization and institutionalization of centralized procurement .
From the perspective of the guiding principles, specific content and requirements of the document, it is no different from Circular 2
.
It can be inferred that the centralized procurement of high-value medical consumables will advance simultaneously with medicines in the future
.

 

　　New regulations indicate a new direction

 

　　Prior to the issuance of Circular 31, the procurement of medical consumables was basically carried out in pilot projects in accordance with the requirements for centralized procurement of pharmaceuticals.
The publication of the document clarified the scope of the collection of high-value consumables, that is, the clinical use is larger and the purchase amount is relatively large.
Consumables that are high in quality, more mature in clinical use, more competitive in the market, and higher in homogeneity.
All public medical institutions are required to participate in centralized procurement to achieve concentration in terms of quality standards, production capacity, supply stability, and corporate credit.
Companies with volume procurement requirements can participate in centralized procurement
.

 

　　In addition to insisting on the same demand-oriented as the centralized procurement of drugs with volume, the document also combines the characteristics of medical consumables, including the principles of ensuring quality, integrating recruitment and procurement, linking volume and price, trading volume, ensuring use, unimpeded adoption and settlement, etc.
, Puts forward the unique principle of “one product, one policy” of centralized procurement with volume, that is: implement policies in accordance with their aptitude, taking into account the characteristics and functions of the clinical use of different high-value medical consumables, differences in technology, use, and production and supply capabilities, etc.
, to form specific procurement Plan; and "combine the purchase volume of similar high-value medical consumables with similar therapeutic purposes, clinical efficacy, and product quality, unified bidding, and fair competition; encourage merging and grouping, and promote competition
.
A variety of high-value medical consumables that need to be used in combination can be integrated into The system is regarded as a variety for procurement
.
According to the characteristics of clinical use of high-value medical consumables, the degree of standardization, the number of participating companies and other factors, policies can be implemented in accordance with their aptitude, and procurement can be carried out by means of bidding , competitive negotiation, and inquiry
.
Independent quotation, through quality and price competition to produce selected prices and selected companies
.
If multiple companies are selected, the price difference between different companies should be reasonably controlled
.
According to the principle of quantity-price linkage, the agreed purchase volume of each selected company shall be clarified, and the purchase agreement shall be reasonably determined Period"
.

 

　　The above new rules will accelerate the national joint procurement of high-value medical consumables organized by the state, and will play a unified and standardized role in the procurement of provinces, prefectures and cities' alliances and provincial medical consumables
.

 

　　The author believes that in the next two years, the mass procurement of Chinese medical consumables will blow out in batches, layers, and classifications.
The rules for centralized procurement will continue to be iterated and improved, and the tendering methods will be more colorful, and will reduce falsely high prices.
Play a huge role, and have a profound impact on medical institutions, production and distribution companies, registrants and record holders
.