Notice from five departments including the Shandong Provincial Medical Security Bureau on strengthening the management of the entire process of centralized bulk procurement of drugs and medical consumables

Weihai Medical Security Bureau Weihai Industry and Information Technology Bureau Weihai Health Commission Weihai Market Supervision Administration

Forwarding the relevant documents of Shandong Provincial Medical Security Bureau and other five departments on strengthening the management of the whole process of centralized bulk purchase of drugs and medical consumables

Weihai Medical Security Bureau [2023] No. 16

Medical Security Bureau, Industry and Information Technology Bureau, Health and Health Bureau, Market Supervision Administration of each district and city, Science and Technology Innovation Bureau, Economic Development Bureau (Industry and Information Technology Bureau), Market Supervision Administration of national development zones, Party Group and Human Resources Department, Science and Technology Finance Bureau, Social Work Department, Comprehensive Supervision and Law Enforcement Bureau of Nanhai New Area, National Development Zone Management Office of Municipal Health Commission, and relevant medical institutions:

The Provincial Medical Security Bureau, Provincial Department of Industry and Information Technology, Provincial Health Commission, Provincial Drug Administration, and Provincial Public Resources Trading Center "Notice on Strengthening the Management of the Whole Process of Centralized Bulk Purchase of Drugs and Medical Consumables" (Lu Medical Security [2023] No. 14) is now forwarded to you. Please follow the requirements and earnestly implement it.

Attachment: Notice of five departments including Shandong Provincial Medical Security Bureau on strengthening the management of the whole process of centralized bulk purchase of drugs and medical consumables

Weihai Municipal Medical Security Bureau

Weihai Municipal Industry and Information Technology Bureau

Weihai Municipal Health Commission

Weihai Municipal Market Supervision Administration

March 27, 2023

(This document is disclosed voluntarily)

Notice on strengthening the management of the whole process of centralized bulk purchase of drugs and medical consumables

Lu Yibaofa [2023] No. 14

To implement the CPC Central Committee and the State Council's announcement on deepening the centralized bulk purchase of drugs and medical consumables The decision-making and deployment of the reform will further strengthen the management of the entire process of centralized bulk procurement of drugs and medical consumables, and continue to consolidate and enhance the results of the centralized bulk procurement reform with information-based and refined management, and promote the coordinated development and governance of medical insurance, medical care, and medicine. The following matters are hereby notified on strengthening the management of the entire process of centralized bulk procurement of drugs and medical consumables:

I. Work objectives

Adhere to the people-centered approach, adhere to problem-oriented, demand-oriented, goal-oriented, and effect-oriented, implement the monitoring and response of the supply guarantee of centralized bulk procurement of drugs and medical consumables throughout the process, and form a working mechanism of real-time monitoring, hierarchical response, and linkage between provinces, cities, and counties. Relying on the procurement subsystem of drugs and medical consumables of the national medical insurance information platform, strengthen the information support for monitoring the supply guarantee of centralized bulk procurement of drugs and medical consumables, and improve the ability to detect problems early. Strengthen departmental collaboration, form a collaborative and efficient working force, further consolidate the supply guarantee responsibilities of selected enterprises, standardize the reporting of demand, signing of agreements, and procurement execution of medical institutions, guide medical institutions to use and give priority to the selected products, and ensure that the people continue to enjoy the results of the centralized procurement reform.

II. Main measures

(I) Standardize the reporting of quantities and strengthen the review of reported quantity data. Medical institutions should establish a multi-party linkage mechanism among pharmacy, medical affairs, medical insurance, and clinical departments, and report the purchase demand scientifically and reasonably in combination with the actual clinical needs and drug usage trends. In principle, it should not be less than the actual purchase volume of the previous year. For medical institutions whose reported volume is more than 20% less than the actual purchase volume of the previous year, the municipal and county medical insurance departments should supervise the medical institutions to make explanations and focus on monitoring during the procurement implementation process. For those whose reported data is obviously unreasonable or the basis for explanation is insufficient, they should be returned to the medical institutions for re-reporting.

(II) Strengthen organizational implementation and sign purchase and sales agreements in a timely manner. Medical institutions and pharmaceutical companies should sign purchase and sales agreements through the provincial centralized procurement platform for drugs and equipment within the specified time, earnestly fulfill the obligations agreed in the agreement, and embody the spirit of the contract. The Provincial Public Resources Trading Center will timely summarize the signing of purchase and sales agreements, urge pharmaceutical companies and guide municipal and county medical insurance departments to urge medical institutions to complete the signing of purchase and sales agreements on time.

(III) Implement usage docking and promote accurate product supply. The selected enterprises can grasp the details of the agreed purchase volume and the progress of supply and distribution of medical institutions through the supply monitoring module of the drug and medical consumables procurement subsystem (hereinafter referred to as the "supply monitoring module"). The selected enterprises should meet the clinical needs of medical institutions in a timely and sufficient manner as agreed in the agreement, including the agreed purchase volume and the part exceeding the agreed purchase volume, and ensure that the supply and distribution rate of the selected products for each medical institution with an agreed purchase volume reaches more than 80%.

(IV) Promote the docking of demands and smooth the feedback channels for problems. Relying on the supply monitoring module, establish a docking mechanism for demands between medical institutions and selected enterprises. In response to problems such as untimely product supply, medical institutions will feedback the relevant problems to the selected enterprises, and the selected enterprises should respond within 2 working days and promise a time limit for problem resolution, which shall not exceed 5 working days. For the selected enterprises that fail to respond on time and fail to resolve relevant problems within the promised time, the municipal and county medical insurance departments shall promptly supervise and resolve them according to the feedback from medical institutions.

(V) Strengthen supply monitoring and implement hierarchical linkage disposal. Give full play to the role of the supply monitoring module. Municipal and county medical insurance departments should grasp the supply of selected products in medical institutions within their jurisdiction in real time. For low distribution rates, unbalanced supply of medical institutions of different levels, and problems reported by medical institutions, they should promptly check and deal with them through interviews and supervision, and focus on monitoring and handling the supply guarantee of selected products in primary medical institutions. If the problem is prominent or not solved in place, it should be reported to the Provincial Medical Insurance Bureau in a timely manner.

(VI) Strengthen procurement monitoring and strengthen the assessment of medical institutions. Municipal and county medical insurance departments, together with health and health departments, strengthen real-time monitoring and grasp the procurement situation of various medical institutions within their jurisdiction, focusing on monitoring the progress of procurement of selected products, the proportion of procurement quantity of selected products, the procurement of non-selected products and replaceable (completely replaceable, mostly replaceable) drugs, and spot-checking and monitoring of illegal offline procurement, extraordinary orders, and untimely confirmation of receipt. Medical institutions should use the supply monitoring module to grasp the progress of the agreed procurement volume, the proportion of procurement quantity of selected products, the procurement of non-selected products and replaceable drugs in real time. If problems are found, they should promptly conduct self-inspection and self-correction, strictly review and comment on prescriptions, and promote scientific and rational use of drugs.

(VII) Make good use of monitoring data and improve the punishment and restraint mechanism. Explore setting different levels of indicators according to the distribution rate below 80%, 60%, and 30%, the proportion of medical institutions with agreed quantities that have more complaints and are resolved in a timely manner below 80%, 60%, and 30%, and the failure to timely supervise and rectify, resolve, and cooperate with relevant departments at all levels. In the follow-up procurement and provincial centralized procurement, relevant enterprises will be given risk warnings for reporting quantities, reduce the agreed procurement volume, and refuse to participate in centralized procurement. In accordance with regulations, the procurement credit evaluation system will be implemented for the selected enterprises and distribution enterprises. For medical institutions that do not report quantities but still purchase a large number of selected products, and the actual procurement volume of selected products exceeds 4 times the agreed procurement volume, the medical insurance department will supervise the medical institutions to make explanations based on the historical procurement data of the medical institutions. For medical institutions whose procurement progress is lower than the scheduled progress, whose procurement quantity of selected products is significantly lower, especially the procurement quantity of non-selected products exceeds the procurement quantity of selected products, the procurement quantity of alternative drugs exceeds the procurement quantity of the previous year, or even purchases a large number of non-selected products or alternative drugs without reporting the quantity, as well as those that violate the regulations of offline procurement, place orders beyond the norm, and fail to confirm the receipt of goods in time, in principle, at least once a quarter, notification reminders should be issued, and those with prominent problems should be notified in time, and those who fail to rectify the problems in time should be interviewed and supervised, and handled in conjunction with the discipline inspection and supervision departments, and connected with the special assessment of the retention of surplus from centralized volume procurement, medical insurance agreement management and other work.

3. Improve the level of system informatization and standardization

(I) Improve the information security level of the procurement subsystem. Continue to strengthen the construction of intelligent early warning capabilities for network security, monitor the operation of the system in real time, improve the ability to collect and judge security threat information, strengthen the sharing of network and data security protection information and notification and early warning, gradually promote the application of CA digital certificates and electronic signatures, strengthen identity authentication and authorization management, and build a solid network and data security defense line. Relying on the procurement subsystem, data sharing with industrial information technology, health care, drug supervision, and public resource trading departments shall be strengthened. All relevant departments at all levels shall attach great importance to data security, prevent data leakage, and effectively prevent and resolve network and data security risks.

(II) Comprehensively deepen the application of the procurement subsystem. Strengthen the implementation of the medical security information business coding standard in the procurement business field, promote the full business process of basic information such as medical institutions, production enterprises, and product information, and carry out the coding standard "vertical full penetration and horizontal full coverage" to further improve the standardization level of procurement business informatization. Deepen the application of the procurement subsystem, gradually carry out the verification and analysis of data such as the medical insurance settlement list and the medical expense detailed list, promote the connection with the distribution enterprise ERP system and the medical institution procurement system, realize the synchronization and sharing of supply and procurement information, realize accurate connection and rapid response, and give full play to the platform support and leading role.

(III) Steadily improve the effectiveness of data governance. Based on national data standards, strictly implement various data standards and specifications, conduct data quality self-inspection on a regular basis, strengthen the monitoring and early warning of the quantity and quality of procurement data, and improve data governance capabilities and levels. Strengthen the mining and analysis of big data for procurement, and provide big data support for macro decision-making analysis of medical insurance, supervision of medical insurance funds, and handling of medical insurance business. On the basis of the gradual online supply monitoring module for centralized volume-based procurement of drugs and medical consumables, accelerate the monitoring of procurement and supply of non-centralized volume-based procurement varieties.

IV. Organizational guarantee

(I) Strengthen departmental coordination. The medical insurance department takes the lead in organizing and implementing centralized volume-based procurement, establishing and improving work mechanisms, coordinating the implementation of reform policies, and promoting centralized volume-based procurement and direct settlement between medical insurance funds and pharmaceutical companies on a regular basis, and continuously expanding the range of varieties. The industrial and information technology department urges enterprises to fulfill the first person in charge of production and supply, supports enterprises in carrying out production technology transformation, and improves the supply guarantee capacity of selected varieties. The health and health department strengthens the performance assessment of public medical institutions, guides and supervises the use of selected products by medical institutions, strengthens the pharmacy management of medical institutions and promotes rational use of drugs. The drug supervision and administration department conducts supervision and inspection and random inspection of the manufacturers of selected varieties in the province, urges the selected enterprises to fulfill their main responsibility for quality, and investigates and punishes violations involving quality and safety in accordance with the law. The Provincial Public Resource Trading Center shall do a good job in statistics, aggregation and analysis of monitoring data, coordinate with the medical insurance department to strengthen the interviews, notifications and supervision of the procurement and supply of pharmaceutical companies and medical institutions, and implement the credit evaluation system for procurement in accordance with regulations.

(II) Carefully organize and implement. All relevant departments at all levels shall establish an information sharing mechanism to strengthen the connection and cooperation between departments. A communication meeting mechanism shall be established at least once a year to study and solve major problems in the advancement of work. All relevant departments, medical institutions and selected enterprises in all regions shall earnestly apply the system functions, give full play to the important role of the supply monitoring module in strengthening supervision, promoting implementation and ensuring supply, further consolidate the supply guarantee responsibility of selected enterprises, standardize the reporting of demand, signing of agreements and procurement execution of medical institutions, prevent medical institutions and medical personnel from illegally using high-priced non-centrally purchased or non-selected products in centralized procurement to replace selected products, strengthen the management of the whole process of centralized volume procurement of drugs and consumables, and continuously consolidate and expand the results of reform.

(III) Do a good job in publicity and guidance. All relevant departments in all regions shall strengthen the interpretation and positive publicity of the centralized volume procurement policy, and reasonably guide public opinion and public expectations. We should carry out in-depth policy interpretation and training for medical personnel, give full play to their important role in clinical treatment, and do a good job in guiding the use of selected products and explaining to patients. We should strengthen public opinion monitoring and response, actively respond to social concerns, and create a good reform atmosphere.

This notice will take effect on April 10, 2023 and will be valid until April 9, 2026.

Shandong Provincial Medical Security Bureau

Shandong Provincial Department of Industry and Information Technology

Shandong Provincial Health Commission

Shandong Provincial Drug Administration

Shandong Provincial Public Resources Trading Center

March 9, 2023