Source｜National Medical Security Bureau

Recently, the National Medical Insurance Bureau, the National Development and Reform Commission, the Ministry of Industry and Information Technology and other 8 departments jointly issued the "Guiding Opinions on the Centralized State-owned Organization for the Centralized Procurement and Use of High-Value Medical Consumables", which clearly requires **public medical institutions (including the military) Medical institutions) should participate in the centralized procurement of high-value medical consumables in accordance with regulations. Medical insurance designated social medical institutions can voluntarily participate in centralized procurement in accordance with the relevant regulations of their province (autonomous region, municipality).

It also focuses on including some high-value medical consumables with large clinical usage, high purchase amount, mature clinical use, sufficient market competition, and high level of homogeneity into the procurement scope, and purchases in accordance with national organizations, alliances, and platforms. The overall idea of ​​the operation is to link the volume and price to deal with the problem of inflated prices.

Attached documents:

National Health Insurance Bureau, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Finance, National Health Commission, General Administration of Market Supervision, National Food and Drug Administration

Guiding Opinions of the Logistics Support Department of the Central Military Commission on the Procurement and Use of High-value Medical Consumables in National Organizations

Medical Insurance Issue (2021) No. 31

The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government, Xinjiang Production and Construction Corps, and all relevant units of the military:

In order to implement 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", improve the price formation mechanism for high-value medical consumables, tackle the problem of inflated prices, and further significantly reduce the burden on patients with medicines, with the consent of the State Council, we are now launching a national organization The following guidelines are proposed for the centralized procurement and use of high-value medical consumables.

1. General requirements

(1) Guiding ideology. Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 19th National Congress of the Communist Party of China and the 2nd, 3rd, 4th and 5th Plenary Sessions of the 19th National Congress of the Communist Party of China. , The overall idea of ​​platform operation, the state will formulate basic policies and requirements, organize various regions to form alliances, take public medical institutions as the executive body, carry out the centralized procurement of high-value medical consumables organized by the state, and explore and improve the centralized procurement policy , Gradually expand the coverage, promote the return of high-value medical consumables prices to a reasonable level, reduce the burden on patients, reduce business transaction costs, purify the circulation environment, guide medical institutions to standardize use, and better ensure that the people have medical treatment.

(2) Basic principles. The first is demand-oriented and quality assurance. According to clinical needs, following the law of medical technology development, reasonably determine the range of high-value medical consumables purchased in a centralized manner to ensure quality and supply, and meet the basic medical needs of the people. The second is the integration of recruitment and procurement, and the linkage of volume and price. Clarify the purchase quantity, exchange the quantity for the price, ensure the use, smooth the links of purchase, use, and settlement, reform the unreasonable factors in the purchase and use of high-value medical consumables, and solve the problem of inflated prices. The third is to implement policies in accordance with their aptitude and compete fairly. Considering the characteristics of the clinical use of different high-value medical consumables, the differences in functions, technologies, use, and production and supply capabilities, etc., a specific procurement plan is formed to guide fair competition. The fourth is departmental coordination and interaction between top and bottom. Strengthen the departmental cooperation mechanism, strengthen the supervision and monitoring of the production, supply, procurement, and use of selected products, improve the incentive and restraint mechanism, and coordinately promote the centralized procurement of high-value medical consumables at the national, domestic and local levels.

2. Coverage

(3) Variety range. The focus is to include some high-value medical consumables with large clinical usage, high purchase amount, mature clinical use, sufficient market competition, and high level of homogeneity into the procurement scope, and according to market sales, clinical use needs and medical technology Factors such as progress determine the shortlisting criteria.

(4) The scope of the enterprise. Medical device registrants (filers) who have obtained the legal qualifications of products within the scope of centralized procurement, and those who meet the requirements of centralized procurement in terms of quality standards, production capacity, supply stability, and corporate credit, can participate. The overseas medical device registrant (filer) shall ** the domestic corporate legal person in my country to assist it in fulfilling the corresponding legal obligations.

(5) Scope of medical institutions. **Public medical institutions (including military medical institutions, the same below) should participate in the centralized procurement of high-value medical consumables in accordance with regulations. Medical insurance designated social medical institutions can voluntarily participate in the concentration in accordance with the relevant regulations of the province (autonomous region, municipality directly under the Central Government). Purchase with quantity.

Three, procurement rules

(6) Agreed purchase quantity. The procurement base is determined based on the demand reported by medical institutions, combined with the previous year's use, clinical use status, and medical technology progress. The agreed procurement ratio is reasonably determined according to the market competition pattern and the number of selected companies. The agreed purchase amount is determined according to the purchase amount base and the agreed purchase ratio, and is disclosed in the purchase document. Encourage public medical institutions to purchase the selected products with priority for the parts whose actual demand exceeds the agreed purchase amount, and they can also purchase other online products with suitable prices through the provincial centralized pharmaceutical procurement platform.

(7) Bidding and winning rules. Consolidate the procurement volume of similar high-value medical consumables with similar treatment purposes, clinical efficacy, and product quality, unified bidding, and fair competition; encourage mergers and groups to promote competition. A variety of high-value medical consumables that need to be used in combination can be integrated into a system and be purchased as one variety. According to the characteristics of the 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. Enterprises voluntarily participate and offer independent quotations, and the selected prices and selected enterprises are generated through quality and price competition. If multiple companies are selected, the price difference between different companies should be controlled reasonably. In accordance with the principle of quantity-price linkage, clarify the agreed purchase quantity of each selected company and reasonably determine the purchase agreement period.

Four, safeguard measures

(8) Ensure quality. Scientifically and rigorously formulate high-value medical consumables procurement short-listed quality technical standards. Strengthen the quality supervision of the entire chain of production, circulation, and use of selected products, improve the handling mechanism for quality problems of selected products, and urge enterprises to implement their main responsibilities. If adverse events and quality problems occur during the use of the selected products, the medical institution shall report in a timely manner according to the procedures.

(9) Ensure supply and distribution. The selected companies should do a good job of predicting and preventing market risks, strengthen production arrangements, report production capacity, inventory and supply as required, and ensure that the procurement needs of the selected products of medical institutions are met in a timely manner during the procurement cycle. The selected products shall be distributed by the selected company independently or by the distribution company, and the accompanying services shall be provided by the selected company or a third party, and the relevant expenses shall be borne by the selected company. The delivery of selected products and their accompanying service provision capabilities shall cover the agreed supply area, and the delivery party and accompanying service provider shall respond to the procurement and use needs of medical institutions in a timely manner. In the event of failure to supply in time, in addition to force majeure, the selected enterprise shall bear the corresponding responsibilities and the resulting ** expenses, otherwise it will be regarded as a breach of trust and breach of contract.

(10) Ensure priority use. Medical institutions should give priority to purchasing the selected products in centralized procurement, formulate in-hospital diagnosis and treatment routes for preferential use of the selected products, and complete the agreed procurement volume in accordance with the procurement contract. Medical staff should give priority to using the selected products under the principle of reasonable diagnosis and treatment. Medical institutions that do not purchase and use the selected products in accordance with the regulations shall be punished in the performance evaluation of public hospitals, the formulation of total medical insurance indicators, the management and evaluation of designated agreements, and the evaluation of the target responsibility of the person in charge of the medical institution.

(11) Ensure payment back. Settlement based on the total budget management of the medical insurance fund, and establish a centralized procurement prepayment mechanism. The medical insurance fund is prepaid at a ratio of not less than 30% of the agreed annual purchase amount, and medical expenses applied for disbursement from the medical institution according to the procurement progress of the medical institution Gradually offset the advance payment. The medical institution shall settle the payment with the enterprise in a timely manner in accordance with the purchase contract, and the settlement time shall not exceed the end of the next month after the delivery is qualified. Promote direct settlement between medical insurance funds and enterprises.

V. Policy convergence

(12) Explore the coordination of medical insurance payment standards. For the centralized procurement of high-value medical consumables within the scope of medical insurance payment, the medical insurance payment standard of the selected product is determined according to the selected price, and the medical insurance payment standard of the non-selected product is not higher than the highest high-quality selected product of the same category and similar function.

(13) Improve the incentive mechanism of medical institutions. During the procurement cycle, the total amount of medical insurance will not be reduced due to the decline in the price of the purchased products. For the medical insurance funds saved due to centralized procurement, medical institutions can be motivated in a certain way on the basis of assessment. For specific measures, refer to the relevant regulations of the country to organize the centralized procurement of drugs. Medical institutions should improve internal assessment methods, transmit incentive policies to medical staff, and encourage reasonable and prioritized use of selected products.

Six, organization and implementation

(14) Establish a working mechanism and strengthen departmental coordination. The National Health Insurance Bureau, the National Health Commission, the National Food and Drug Administration, the Ministry of Industry and Information Technology, and the General Administration of Market Supervision and other departments should strengthen communication, coordination and linkage, perform their duties, form a joint force, and strengthen local cooperation. Guide, constantly sum up experience, improve relevant policies, and continue to promote the centralized procurement of high-value medical consumables. As the lead unit, the medical insurance department must strengthen overall coordination and comprehensive services, implement policies related to the centralized procurement of high-value medical consumables, supervise the implementation of the results, and guide the provincial-level centralized pharmaceutical procurement platform to carry out centralized procurement transactions in accordance with laws and regulations. Accelerate the use of uniform codes for medical security and medical consumables, and link them with the medical device ** mark, do a good job in prepayment and settlement of medical insurance funds, adjustment of medical service prices, assessment of designated medical institutions, etc., implement a medical price and recruitment credit evaluation system, Intensify the handling of companies that violate regulations, and guide and promote local governments to carry out centralized procurement of high-value medical consumables. The health department is responsible for guiding and supervising the use of selected products in medical institutions, and standardizing and rational use. The drug regulatory department should accelerate the full-chain application of the medical device ** label in the production and operation of high-value medical consumables, strengthen the quality supervision of selected medical device products, carry out adverse event monitoring, and urge enterprises to implement the main responsibility of quality **. The industry and information technology departments are responsible for supervising and urging enterprises to implement production and supply responsibilities in accordance with the agreed purchase volume of selected products, supporting enterprises to carry out production technology transformation, and improving the supply guarantee capacity of selected products. The market supervision department must severely investigate and punish various price violations, and resolutely crack down on behaviors that disrupt fair market competition. Development and reform, finance, military logistics and other departments must actively cooperate with the procurement of high-value medical consumables in large quantities.

(15) Elaborate organization and implementation, and orderly progress. All provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps sent representatives to form a joint procurement office, and according to the arrangements of the joint procurement office, statistics and reports the historical procurement volume and procurement requirements of related products. The Joint Procurement Office formulates and publishes procurement announcements in accordance with the relevant requirements of this opinion and on the basis of extensively listening to the opinions of relevant experts, departments, enterprises, and industry organizations. The Joint Procurement Office carries out specific operations of centralized procurement on behalf of the alliance area, releases the results of the selection, and organizes and supervises the implementation of the centralized procurement results. After the results of centralized procurement are generated, each region is responsible for implementing the network, signing, purchasing, use, payment collection and payment of the selected products in the region. The Joint Procurement Office has an expert group and a supervision group. The expert group is responsible for providing technical consultation on relevant policies, clinical use, and procurement operations; the supervision group is responsible for supervising the centralized procurement work, and timely accepting and handling relevant reports and complaints. The Tianjin Pharmaceutical Purchasing Center is responsible for the daily work of the state-organized high-value medical consumables joint procurement office, and is responsible for the specific implementation.

(16) Do a good job in policy interpretation and publicity guidance. All regions and relevant departments should strengthen policy interpretation, strengthen positive publicity on the effectiveness of centralized procurement of high-value medical consumables, increase policy awareness, and rationally guide social expectations. It is necessary to strengthen the monitoring of public opinion, promptly and proactively respond to social concerns, and strive to create a good atmosphere for reform. It is necessary to carry out in-depth policy interpretation and training for medical staff, give full play to its important role in clinical treatment, and guide patients to rationally choose products from centralized procurement.

National Health Insurance Bureau, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Finance

State-owned Health Commission, General Administration of Market Supervision, State-owned Drug Administration, Central Military Commission, Logistics Support Department

April 30, 2021