The National Health Insurance Administration issued a document: the cost of supervising drug price investigations.
Release time:
2019-12-09
The National Medical Insurance Administration issued the "Opinions on Doing a Good Job in Current Drug Price Management" (hereinafter referred to as the "Opinions"). The "Opinions" proposed to give full play to the guiding role of medical insurance on drug prices and promote drug prices to return to a reasonable level.
The National Medical Insurance Administration pointed out that in order to implement the decision and deployment of the Party Central Committee and the State Council on drug supply and price stabilization, in accordance with the the People's Republic of China Price Law and the the People's Republic of China Drug Administration Law, to further improve the drug price formation mechanism, it is now doing a good job in the current drug price management The following opinions are put forward.
According to Cyberlan's inquiry, the latest version of the the People's Republic of China Drug Administration Law, Chapter 8, drug prices and advertising regulations, the state improves the drug procurement management system, monitors drug prices, conducts cost price investigations, strengthens drug price supervision and inspection, and investigates and deals with price monopolies in accordance with the law., Price hikes and other drug price violations, maintain the order of drug prices.
Promote the return of drug prices to reasonable levels
(I) adhere to the overall direction of market regulation of drug prices. The scope of drugs for which the medical security department manages prices includes chemical drugs, Chinese patent medicines, biochemical drugs, Chinese herbal pieces, and preparations for medical institutions. Among them, narcotic drugs and the first category of psychotropic drugs are subject to government-guided prices, and other drugs are subject to market-adjusted prices. Drug operators should follow the principles of fairness, legality, honesty and credit, and consistency between quality and price, so that drug prices reflect changes in cost and market supply and demand, and maintain reasonable and stable prices.
Give (II) play to the role of medical insurance in guiding drug prices. Deepen the reform of the centralized drug procurement system, adhere to the direction of "volume procurement, volume price linkage, recruitment and procurement", and promote the return of drug prices to a reasonable level. Explore the implementation of the development of medical insurance drug payment standards and dynamic adjustment according to the generic name. Improve the open and transparent negotiation mechanism for access to the list of medical insurance drugs. Improve the agreement management of designated institutions, strengthen the price supervision and information disclosure of drugs paid by the medical insurance fund, and positively guide the market price order.
(III) promote the formation of a reasonable drug price difference relationship. If there are differences in the dosage form, specifications and packaging of the same drug, in accordance with the principle of equivalent treatment costs, comprehensive consideration of clinical effects, cost value, technical level and other factors, to maintain a reasonable price difference relationship, the specific rules by the National Medical Security Bureau separately formulated. During the transition period, in the pricing, procurement and payment work, if the conversion of drug price difference relationship is involved, the implemented rules can be referred.
Regulates drug prices, investigates costs
Relying on provincial drug bidding and procurement agencies, promote the construction of regional and national drug alliance procurement mechanisms, unify codes, standards and functional specifications, and promote information interconnection, resource sharing, and policy linkage.
(I) establish a monitoring and early warning mechanism for abnormal changes in price supply. The National Medical Security Administration relies on multiple channels to organize and carry out domestic and foreign price information monitoring work, and promptly warn of abnormal changes in drug prices and supply. Provincial-level medical security departments should rely on provincial-level drug bidding and procurement agencies to improve drug supply and procurement information sharing mechanisms, and regularly monitor drug prices and supply changes. In case of abnormal changes in price, purchase quantity, distribution rate, etc., it is necessary to investigate and understand the situation in a timely manner and deal with it properly. Monitoring and response to the situation to be regularly reported to the State Medical Security Bureau. The State Medical Security Administration centralized sorting and analysis to the relevant departments and local early warning of key regulatory varieties.
The (II) strengthens its daily management by means of letters, inquiries and interviews. For drugs with abnormal price increases or frequency, large price differences between regions or between online and offline, price increases in circulation obviously exceeding a reasonable level, and inadequate distribution, medical security departments at all levels can consult relevant operators by letter and require written explanation of the situation; if the circumstances are serious and the impact is bad, they can interview or jointly interview relevant operators across regions to explain the reasons for the change, provide information on production, operation, finance and product flow related to the composition of drug prices and costs, and properly handle them by classification. If the reason for the price increase is unreasonable and insufficient, if the operator voluntarily adjusts the price to a reasonable range, he shall submit a written commitment letter to the medical security department and adjust it within the promised time; if he refuses to adjust, he shall take reminders and warnings depending on the circumstances., Issue warning information, reduce credit evaluation, suspend the Internet and other measures.
(III) improve the working mechanism of drug price and cost investigation. The national and provincial medical security departments may implement or entrust price cost surveys according to work needs and management authority. The scope of the survey includes but is not limited to abnormal price changes, excessive price differences with the same variety, and price increases in circulation links that significantly exceed a reasonable level. As well as varieties with insufficient competition, focus on situations where they have been interviewed by letter but cannot explain justifiable reasons or refuse to make adjustments. The results of the cost survey can be used as a basis for determining whether the operator is selling the drug at an unfair price. The business operator shall, in accordance with the requirements of the medical security department, provide the cost, financial and other necessary information of its pharmaceutical production and operation in a timely manner.
Preventing malicious price increases
In accordance with the principle of "giving priority to ensuring the supply of drugs and giving priority to meeting clinical needs", the policy of encouraging the supply of drugs in shortage, preventing malicious price increases of drugs in shortage and "hitchhiking" of drugs in non-shortage is adopted, and participating in the work of ensuring the supply and price stability of drugs in shortage in accordance with their duties.
(I) implementation of the drug shortage related to the listing and procurement policy. Local medical security departments should strengthen the guidance on the centralized procurement and use of drugs in shortage, and earnestly implement the policy of direct online procurement of drugs in shortage. For the varieties listed in the shortage drug list of the national and provincial shortage drug supply guarantee work consultation linkage mechanism office, operators are allowed to quote independently and directly link the net, and medical institutions purchase according to the net price or further negotiate with the operators for purchase. The shortage of drugs that are not listed on the provincial centralized drug procurement platform or are not listed in the centralized procurement catalog of the province, and medical institutions are allowed to file and purchase independently according to regulations. The medical insurance fund shall pay the shortage of drugs belonging to the medical insurance catalogue in a timely manner. The medical security department no longer formulates and publishes a list of low-cost drugs according to the price or cost of drugs.
(II) improve the shortage of drugs and procurement work rules. Provincial medical security departments guide drug bidding and procurement agencies to improve the working rules of direct online procurement, not only to improve price monitoring and management, but also to avoid unreasonable administrative intervention. If the drug operator in shortage requests to adjust the online price, it shall provide the drug bidding and purchasing agency with the drug production capacity, reasons for shortage, cost information, tax-paid ex-factory price certificate and other information, and shall not engage in profiteering, price monopoly, price fraud, etc. When the drug bidding and purchasing agency accepts the new quotation, it may simultaneously disclose the necessary information that does not involve trade secrets. If a public medical institution purchases a shortage of drugs on its own record, it shall promptly report the actual procurement source, price and quantity to the centralized drug procurement agency.
Opinions on Doing a Good Job in Current Drug Price Management
In order to implement the decision-making and deployment of the Party Central Committee and the State Council on drug supply and price stabilization, and in accordance with the the People's Republic of China Price Law and the the People's Republic of China Drug Administration Law, to further improve the drug price formation mechanism, the following opinions are hereby put forward on the current drug price management.
1. linking up and improving the current drug price policy
Based on the current drug price policy, adhere to the decisive role of the market in the allocation of resources, give better play to the role of the government, and continue to improve the market-led drug price formation mechanism around the overall development direction of the medical security system in the new era.
(I) adhere to the overall direction of market regulation of drug prices. The scope of drugs for which the medical security department manages prices includes chemical drugs, Chinese patent medicines, biochemical drugs, Chinese herbal pieces, and preparations for medical institutions. Among them, narcotic drugs and the first category of psychotropic drugs are subject to government-guided prices, and other drugs are subject to market-adjusted prices. Drug operators (including marketing license holders, production enterprises, business enterprises, etc., the same below) should follow the principles of fairness, legality, honesty and credit, and consistency of quality and price, so that drug prices reflect changes in costs and market supply and demand, and maintain prices Reasonable and stable.
Give (II) play to the role of medical insurance in guiding drug prices. Deepen the reform of the centralized drug procurement system, adhere to the direction of "volume procurement, volume price linkage, recruitment and procurement", and promote the return of drug prices to a reasonable level. Explore the implementation of the development of medical insurance drug payment standards and dynamic adjustment according to the generic name. Improve the open and transparent negotiation mechanism for access to the list of medical insurance drugs. Improve the agreement management of designated institutions, strengthen the price supervision and information disclosure of drugs paid by the medical insurance fund, and positively guide the market price order.
(III) promote the formation of a reasonable drug price difference relationship. If there are differences in the dosage form, specifications and packaging of the same drug, in accordance with the principle of equivalent treatment costs, comprehensive consideration of clinical effects, cost value, technical level and other factors, to maintain a reasonable price difference relationship, the specific rules by the National Medical Security Bureau separately formulated. During the transition period, in the pricing, procurement and payment work, if the conversion of drug price difference relationship is involved, the implemented rules can be referred.
The (IV) shall regulate the prices of narcotic drugs and category I psychotropic drugs in accordance with the law. The prices of narcotic drugs and category I psychotropic drugs will continue to be managed by the highest ex-factory (port) prices and the highest retail prices in accordance with the law, and corresponding management methods and specific policies will be studied and formulated. Among them, for the National Development and Reform Commission that has formulated and announced government-guided prices for narcotic drugs and first-class psychotropic drugs, it is temporarily based on the established prices, comprehensively considering the pricing time, changes in relevant price indices, and narcotic drugs and first-class psychotropic drugs. Factors such as the prevailing commercial circulation pricing rules shall be uniformly adjusted and implemented as temporary prices.
2. the establishment of a sound regulatory mechanism for the normalization of drug prices
Relying on provincial drug bidding and procurement agencies, promote the construction of regional and national drug alliance procurement mechanisms, unify codes, standards and functional specifications, and promote information interconnection, resource sharing, and policy linkage. Deepen "decentralization, management and service", on the basis of respecting market laws and respecting operators' independent pricing power, comprehensively use monitoring and early warning, letter inquiries, reminders, cost investigations, credit evaluations, information disclosure and other means to establish and improve drug prices Normalized supervision mechanism promotes operators to strengthen price self-discipline.
(I) establish a monitoring and early warning mechanism for abnormal changes in price supply. The National Medical Security Administration relies on multiple channels to organize and carry out domestic and foreign price information monitoring work, and promptly warn of abnormal changes in drug prices and supply. Provincial-level medical security departments should rely on provincial-level drug bidding and procurement agencies to improve drug supply and procurement information sharing mechanisms, and regularly monitor drug prices and supply changes. In case of abnormal changes in price, purchase quantity, distribution rate, etc., it is necessary to investigate and understand the situation in a timely manner and deal with it properly. Monitoring and response to the situation to be regularly reported to the State Medical Security Bureau. The State Medical Security Administration centralized sorting and analysis to the relevant departments and local early warning of key regulatory varieties.
The (II) strengthens its daily management by means of letters, inquiries and interviews. For drugs with abnormal price increases or frequency, large price differences between regions or between online and offline, price increases in circulation obviously exceeding a reasonable level, and inadequate distribution, medical security departments at all levels can consult relevant operators by letter and require written explanation of the situation; if the circumstances are serious and the impact is bad, they can interview or jointly interview relevant operators across regions to explain the reasons for the change, provide information on production, operation, finance and product flow related to the composition of drug prices and costs, and properly handle them by classification. If the reason for the price increase is unreasonable and insufficient, if the operator voluntarily adjusts the price to a reasonable range, he shall submit a written commitment letter to the medical security department and adjust it within the promised time; if he refuses to adjust, he shall take reminders and warnings depending on the circumstances., Issue warning information, reduce credit evaluation, suspend the Internet and other measures.
(III) improve the working mechanism of drug price and cost investigation. The national and provincial medical security departments may implement or entrust price cost surveys according to work needs and management authority. The scope of the survey includes but is not limited to abnormal price changes, excessive price differences with the same variety, and price increases in circulation links that significantly exceed a reasonable level. As well as varieties with insufficient competition, focus on situations where they have been interviewed by letter but cannot explain justifiable reasons or refuse to make adjustments. The results of the cost survey can be used as a basis for determining whether the operator is selling the drug at an unfair price. The business operator shall, in accordance with the requirements of the medical security department, provide the cost, financial and other necessary information of its pharmaceutical production and operation in a timely manner.
(IV) explore the establishment of a mechanism for encouraging trustworthiness and punishing dishonesty. The national and provincial medical security departments are linked together, relying on the centralized procurement and use of drugs, taking drug operators as the object, focusing on the key indicators of quality, supply, price, distribution and other aspects, to study and promote the evaluation of quantifiable drug price integrity, and explore the establishment of quantitative scoring, dynamic adjustment, open and transparentMedicinePrice recruitment credit evaluation system. Set incentives or restrictions based on credit ratings. Under the same conditions, high credit evaluation will be given priority in winning the bid; for those with negative credit evaluation, various ways such as restricting participation in centralized procurement and being included in the key supervision scope of the medical insurance fund will be restricted; for serious breach of trust, disciplinary measures such as suspension of the network may be taken depending on the circumstances.
(V) use information disclosure and other means to strengthen social supervision. Local medical security departments timely release drug price monitoring and early warning information, disclose the results of letter inquiries and interviews, price cost investigation results, publicly expose all kinds of violations and dishonesty cases that seriously affect drug prices and supply order, encourage all parties in the society to participate in supervision, and guide the formation of reasonable expectations. Cooperate with the construction of the credit evaluation system for price recruitment, and disclose the credit information of drug operators in a timely manner.
3. do a good job in the shortage of drugs to ensure the supply of stable prices related to the price of the recruitment work.
In accordance with the principle of "giving priority to ensuring the supply of drugs and giving priority to meeting clinical needs", the policy of encouraging the supply of drugs in shortage, preventing malicious price increases of drugs in shortage and "hitchhiking price increases" of drugs in non-shortage is adopted, and participating in the shortage according to their duties.DrugsGuaranteed supply and price stabilization work.
(I) implementation of the drug shortage related to the listing and procurement policy. Local medical security departments should strengthen the guidance on the centralized procurement and use of drugs in shortage, and earnestly implement the policy of direct online procurement of drugs in shortage. For the varieties listed in the shortage drug list of the national and provincial shortage drug supply guarantee work consultation linkage mechanism office, operators are allowed to quote independently and directly link the net, and medical institutions purchase according to the net price or further negotiate with the operators for purchase. None on the provincial drug centralized procurement platformEnterpriseThe shortage of drugs that are listed on the Internet or not listed in the centralized procurement catalogue of the province is allowed to be purchased by medical institutions on the record according to the provisions. The medical insurance fund shall pay the shortage of drugs belonging to the medical insurance catalogue in a timely manner. The medical security department no longer formulates and publishes a list of low-cost drugs according to the price or cost of drugs.
(II) improve the shortage of drugs and procurement work rules. Provincial medical security department to guide drugsTenderProcurementTo improve the working rules of direct online procurement, institutions should not only improve price monitoring and management, but also avoid unreasonable administrative intervention. If the drug operator in shortage requests to adjust the online price, it shall provide the drug bidding and purchasing agency with the drug production capacity, reasons for shortage, cost information, tax-paid ex-factory price certificate and other information, and shall not engage in profiteering, price monopoly, price fraud, etc. When the drug bidding and purchasing agency accepts the new quotation, it may simultaneously disclose the necessary information that does not involve trade secrets. If a public medical institution purchases a shortage of drugs on its own record, it shall promptly report the actual procurement source, price and quantity to the centralized drug procurement agency.
(III) strengthen information sharing and interconnection. Local medical security departments should strengthen information sharing and interconnection, timely understand the situation and provide information support for the shortage of drugs found by monitoring or feedback from all parties, and assist in solving the regional and temporary shortage and price increase caused by factors such as asymmetric supply and demand information and inadequate supply and distribution.
4. strengthen organization and implementation
(I) do a good job of coordination. All localities should cooperate with relevant departments to revise and improve policies in a timely manner, do a good job in all work involving prices and recruitment of drugs in shortage to ensure supply and stabilize prices, properly deal with the abnormal rise of some drug prices, and promptly hand over clues to cases of suspected monopoly behavior or other price violations to relevant departments.
(II) lay a solid foundation for work. All localities should make full use of new technologies and new methods such as the Internet and big data to accelerate the informatization and intelligent construction of drug price and supply supervision, guide and urge centralized drug procurement agencies, and follow the National Medical Security Administration on the establishment of monitoring abnormal changes in drug prices and supply Various requirements of the mechanism, timely upload monitoring data to ensure data quality. Encourage local medical security departments to explore specific practices for the normalization of supervision of innovative drugs in the light of reality.
(III) do a good job of propaganda and explanation. Local medical security departments should seriously study the new characteristics and new trends of drug price situation and price problems in the region, respond to hot issues of social concern in a timely manner, interpret drug price policies to drug production and operation enterprises and medical institutions in a targeted manner, build social consensus, and create a good atmosphere for drug price management.
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