Jiangxi: "4 + 7" expansion of varieties, drugs without evaluation will be purchased in quantity

According to yaozhi.com, on November 26, the people's Government of Jiangxi Province issued the implementation plan for the procurement and use of drugs with volume in Jiangxi Province The notice specifies the scope, organization scope, procurement method, quantity procurement method and procurement cycle of drugs purchased It is worth noting that the scope of drug procurement stipulates that: for generic drugs that have never passed the consistency evaluation of quality and efficacy, select some drugs with large clinical dosage, high procurement amount and full competition, and organize the implementation of volume procurement All procurement alliances are encouraged to select varieties other than national and provincial volume procurement, and explore volume procurement The State shall organize the centralized purchase and use of selected drugs in pilot projects in accordance with the relevant policies of the state It means that drugs that fail to pass the consistency evaluation will also be purchased in quantity At the same time, it is clear that at most two enterprises in the same bidding group win the bid The original text of the notice is as follows: implementation plan of drug volume purchase and use in Jiangxi Province In order to promote the procurement and use of drugs in the whole province, according to the notice of the general office of the State Council on printing and distributing the pilot program of centralized procurement and use of drugs organized by the state (GBF [2019] No.2), the notice of the general office of the State Council on printing and distributing the key tasks of deepening the reform of the medical and health system in 2019 (GBF [2019] No.28), the notice of the State Health Insurance Bureau on the state The plan is formulated in combination with the actual situation of our province according to the requirements of the opinions on the supporting measures for organizing the pilot drug centralized procurement and use of medical insurance (health insurance Fa [2019] No 18) and the opinions on the implementation of the pilot drug centralized procurement and use of national organization of expanding the regional scope (health insurance Fa [2019] No 56) issued by nine ministries and commissions including the state health insurance bureau 1、 General requirements (I) objectives and tasks Through carrying out the purchase and use of drugs with quantity, the drug price will be significantly reduced, and the burden of patients' drug cost will be reduced; the transaction cost of enterprises will be reduced, the circulation environment will be purified, and the industry ecology will be improved; the public medical institutions will be guided to regulate the use of drugs, and the reform of public hospitals will be supported; the medical staff will be dynamically adjusted and reflected in accordance with the principle of "total amount control, structural adjustment, rise and fall, and gradually put in place" We should explore and improve the mechanism of drug centralized purchase and the mechanism of drug price formation led by the market （2） Overall thinking Guided by Xi Jinping's new socialist ideology with Chinese characteristics, he thoroughly implemented the spirit of general secretary Xi Jinping's inspection of Jiangxi's important speech According to the general idea of government organization, alliance procurement and platform operation, the 12 public procurement agencies were established by public health institutions in the province as a unit (directly distributed by medical institutions in China) The main body of procurement is to explore the cross regional alliance for centralized procurement with volume On the basis of summary and evaluation, gradually increase the quantity of drugs purchased, and guide the society to form long-term stable expectations （3） Basic principles First, we should take the people as the center, ensure the demand of clinical medication, effectively reduce the burden of patients' drug costs, and ensure the quality and supply of drugs Second, adhere to the law and compliance, strictly implement the relevant policies and regulations, ensure that the work procedures of volume purchasing are standardized, open and transparent, and accept the supervision of all parties in the whole process Third, adhere to the combination of market mechanism and the role of the government, not only respect the market-oriented drug price formation mechanism, but also better play the role of the government in building a platform, promoting docking, ensuring supply and strengthening supervision Fourth, adhere to the principle of linking volume and price, integrating bidding and procurement, clearing the payment for goods, sharing interests and win-win situation, and fully mobilize all parties to further promote the procurement with volume Fifthly, adhere to smooth transition and proper connection, and properly handle the relationship between volume procurement and existing procurement policies 2、 Scope and method of procurement (I) scope of drugs From the generic drugs corresponding to generic drugs that have never passed the consistency evaluation of quality and efficacy, select some drugs with large clinical dosage, high purchase amount and sufficient competition, and organize the implementation of volume purchase All procurement alliances are encouraged to select varieties other than national and provincial volume procurement, and explore volume procurement The State shall organize the centralized purchase and use of selected drugs in pilot projects in accordance with the relevant policies of the state （2） Scope of organization This plan is applicable to the public medical institutions and military medical institutions participating in the drug volume purchase and use in our province, as well as the production enterprises (drug listing license holders, national general agents of imported drugs are deemed as production enterprises) and drug trading enterprises within the scope of centralized purchase approved by the drug regulatory authorities and listed in mainland China We will encourage designated social medical institutions and designated retail pharmacies of medical insurance to participate voluntarily （3） Procurement method The "two envelope" comprehensive scoring method is adopted for public bidding procurement The bidding group is divided according to the name and dosage form of the current national medical insurance drug catalog In the same bidding group, the economic and technical bid evaluation is shortlisted and meets the standard After the price of different dosage forms, specifications and packages is calculated by the price difference comparison rule, the lowest commercial bid price of the smallest preparation unit and the highest comprehensive evaluation score of one enterprise are selected （4） Purchase with quantity According to the actual purchase volume of the previous year, the public medical institutions of the whole province estimate, report and summarize the annual purchase volume of the whole province For one enterprise, 50% of the annual purchase amount is taken as the agreed total purchase amount Among the two enterprises, 75% is the total agreed procurement volume, of which 50% is the agreed procurement volume of the lowest price selected enterprises, 25% is the agreed procurement volume of the highest score selected enterprises, and non selected drugs compete for the rest of the market share （5） Procurement cycle For drugs selected by one enterprise in the same bidding group, the procurement cycle is 12 months; for drugs selected by two enterprises, the procurement cycle is 24 months If the agreed purchase quantity is completed in advance within the purchase cycle, the excess part shall be purchased according to the selected price until the expiration of the purchase cycle 3、 Transaction rules (1) signing agreement and contract After the announcement of the results of the selection, the drug purchasing agency shall sign a purchase and sale agreement with the selected enterprises and their designated operating enterprises to determine the rights and responsibilities of all parties Medical institutions or their representatives sign purchase and sale contracts with suppliers After the contract is signed, the medical institution and the supply enterprise shall not enter into any other agreement deviating from the substantive content of the contract or put forward any interest requirements other than the contract （2） Ensure the quality and supply of drugs The manufacturer is the first person responsible for ensuring the quality and supply of drugs If it meets the legal qualification, it can be directly distributed by itself as a supplier; it can also independently select the qualified drug handling enterprise as a supplier for distribution For the same selected drugs, in each procurement alliance area, the production enterprise shall independently select the management enterprise with distribution ability and good reputation for distribution, and establish the emergency reserve, inventory and shutdown report system of the production enterprise according to the purchase and sale contract In case of non-compliance with the contract, failure to guarantee the quality and supply, compensation, punishment, withdrawal, alternative and emergency measures shall be taken accordingly to ensure the quality and supply of drugs （3） The combination of bidding and mining ensures the use Public medical institutions can include the selected drugs into the drug purchase catalogue of the hospital without the approval of the pharmaceutical management and pharmacotherapy Committee of the hospital; when purchasing drugs under the same general name, they must give priority to the selected drugs; ensure that the purchase quantity specified in the contract is completed within the purchase cycle; prohibit any form of "second price negotiation" behavior, and eliminate off-line procurement and other irregular procurement Elephant All relevant departments and medical institutions shall not influence the reasonable use and supply guarantee of the selected drugs on the grounds of cost control, drug proportion, and requirements for drug varieties, specifications and quantities of medical institutions （4） Purchase receipt management Public medical institutions shall purchase drugs from the provincial pharmaceutical purchasing service platform according to regulations, and confirm the receipt within 10 days from the date when the supplier delivers the drugs If it is not confirmed within the time limit, the platform will confirm the receipt by default If it is confirmed that the goods have not been received, the public medical institutions may provide relevant supporting materials and appeal to the medical insurance agencies and drug purchasing agencies （5） Use of non selected drugs Public medical institutions can purchase and use non selected drugs with appropriate price through provincial pharmaceutical procurement service platform on the premise of giving priority to purchasing selected drugs and ensuring the dosage of selected drugs The quantity of non selected drugs purchased shall maintain a certain proportion relationship with the quantity of selected drugs purchased after conversion according to the proportion relationship: the proportion of the quantity of non selected drugs and selected drugs selected by one enterprise shall not be higher than 1:1; the proportion of the quantity of selected drugs by two enterprises shall not be higher than 1:3 If a medical institution purchases drugs of the same type that meet the above conditions but fail to be selected, it shall be deemed to meet the requirements of "one product, two regulations" 4、 Settlement payment (1) implement the coordination of medical insurance payment standard and purchase price For the drugs purchased in volume, if they are within the scope of the medical insurance catalog, the cooperation between the payment standard of medical insurance and the purchase price shall be implemented, and the payment standard of the same drugs of all levels and all kinds of designated medical institutions paid by the medical insurance fund in the region of the purchasing alliance shall be unified In principle, the selected price of one enterprise shall be used as the payment standard; for the selected drugs of two enterprises, the selected price shall be used as the payment standard; for the non selected drugs, the lowest selected price shall be used as the payment standard In principle, for the original research drugs, reference preparations and generic drugs passing the consistency evaluation under the same general name, the medical insurance fund shall be settled according to the same payment standard For the drugs whose price is higher than the payment standard, the part exceeding the payment standard shall be paid by the patients themselves, and the part within the payment standard shall be shared by the patients and the medical insurance in proportion For some drugs with large price difference from the payment standard, the payment standard shall be adjusted step by step according to the principle of "step by step, classification guidance", and the payment standard shall be adjusted in place within 2-3 years, and supporting policies and measures shall be formulated; for non selected drugs with price more than twice of the payment standard, the medical insurance payment standard shall be reduced by no less than 30% according to the original price; for non selected drugs with price twice of the payment standard Within (including 2 times), the payment standard shall be followed in principle; the actual price shall be taken as the payment standard for drugs used by patients whose price is lower than the payment standard For non selected generic drugs under the same generic name that fail to pass the consistency evaluation, no transition period shall be set, and the payment standard shall not be higher than the lowest selected price For the drugs that are not purchased on the provincial pharmaceutical purchasing service platform in violation of the regulations, the medical insurance will not pay for settlement On the basis of ensuring the quality and supply, we should actively guide public medical institutions and patients to form rational drug use habits （2） Direct settlement and prepayment for medical insurance shall be implemented In order to ensure the timely settlement of payment and reduce the transaction cost of the enterprise, the medical insurance department and the supply enterprise directly settle the payment for selected drugs in the whole province Taking the purchasing alliance as the unit, the medical insurance departments of each region calculate the amount of the drug purchase fee with quantity according to the purchase price of the selected drugs in the quantity purchase, the purchase varieties and purchase quantity agreed by the medical institutions and enterprises, list the special purchase budget of the drugs with quantity purchase in the medical insurance fund budget, and implement the payment advance and assessment allocation system According to 50% of the special purchase budget of the selected drugs, the medical insurance fund shall be prepaid to provincial or municipal medical insurance agencies in advance as working capital The payment for the selected drugs purchased by the public medical institutions shall be prepaid by the corresponding provincial or municipal medical insurance agencies to the supplier in advance on a monthly basis; after the review by the medical insurance agencies, the payment shall be settled directly with the supplier on a monthly basis （3） Medical insurance and medicine