According to the People's Daily Beijing December 7, recently, "700,000 one-shot sky-high drug into medical insurance" has been on the hot search, becoming a hot spot of concern from all walks of life. In order to enable everyone to have a more comprehensive and objective understanding of the adjustment of the medical insurance drug list, the relevant person in charge of the Department of Pharmaceutical Administration of the State Medical Insurance Bureau was interviewed and deeply interpreted the work arrangements and relevant considerations of the 2021 National Medical Insurance Drug Catalogue Access Negotiation (hereinafter referred to as the "Drug Negotiation").
On-site negotiations are only one part of the catalog adjustment process
According to the relevant person in charge of the Department of Pharmaceutical Management of the National Medical Insurance Bureau, the adjustment of the national medical insurance drug list is a systematic work. The adjustment of the national medical insurance drug list in 2021 began in May and ended at the end of November, which took more than half a year. On-site negotiations are only one part of the catalog adjustment process. Before the "soul bargaining", the medical insurance party and the enterprise must carry out a lot of preparatory work, repeatedly arguing, reviewing, calculating, and communicating to ensure that the negotiation work is scientific, standardized, fair and just, and the whole process leaves traces.
"Drug negotiation is a consultation between the medical insurance department and the pharmaceutical enterprise on the payment standard of the drug (the payment standard of the exclusive drug is generally equivalent to its price), and the result of the consultation directly determines whether the drug is included in the national medical insurance drug list and at what price." According to Article 12 of the Interim Measures for the Administration of Drugs in Basic Medical Insurance promulgated by the State Medical Insurance Bureau, exclusive drugs determine the payment standard through access negotiations. The person in charge said.
The person in charge said that the main purpose of drug negotiations is to give full play to the role of strategic purchase by the medical insurance department, and to negotiate with enterprises on drugs included in the scope of negotiations, to achieve the goal of improving the efficiency of fund use and reducing the burden on patients, and to use limited medical insurance funds to maximize the guarantee effect. At the same time, through the value purchase and strategic purchase of medical insurance funds, the pharmaceutical industry is guided to take the road of innovative development.
The ultimate success of the negotiation depends on whether there is an intersection between the bottom line of the health care provider and the corporate side
How did the negotiated reserve price come about? According to the person in charge, the negotiated reserve price is calculated by experts organized by the medical insurance department. On the one hand, for drugs that have obtained negotiation qualifications, the medical insurance department organizes relevant enterprises to submit calculation materials according to a unified template, mainly including: basic information of drugs, relevant safety, effectiveness, economy and other information, intentional prices, and corresponding evidentiary materials. On the other hand, the medical insurance department organizes experts in pharmacoeconomics and medical insurance management to carry out scientific calculations from the perspectives of drug cost effect, budget impact, and medical insurance fund burden, etc., forming the highest price that the medical insurance fund can bear, that is, the negotiated reserve price, as the basis and bottom line for negotiators to carry out negotiations.
The negotiation site does not allow the enterprise to quote, and the expert directly shows the reserve price to see if the enterprise can accept it. In this regard, the person in charge said that according to the current negotiation rules, the on-site negotiation is jointly participated by the enterprise side and the medical insurance party, and the enterprise side is led by the authorized negotiator and the medical insurance party is presided over by the leader of the negotiation team, and the negotiation result is determined on the spot. First quoted by the enterprise side, the enterprise side has two opportunities to quote and confirm. If the price after the second confirmation of the enterprise is higher than 115% (exclusive) of the negotiated reserve price of the medical insurance party, the negotiation fails and is automatically terminated. For example, the price after the second confirmation of the enterprise is not higher than 115% of the negotiated reserve price of the medical insurance party, and it enters the negotiation link between the two sides. The price finally agreed upon by the two parties must not be higher than the negotiated reserve price of the health care provider. During the negotiation process, the authorized representative of the enterprise can ask for instructions by telephone or other means, but should give a clear opinion on the spot. After the negotiation, regardless of whether an agreement is reached, the two sides sign the confirmation of the result on the spot.
"The ultimate success of the negotiation depends on whether there is an intersection between the bottom line of the health insurance side and the corporate side." From a practical point of view, the responsibility of the negotiator of the medical insurance party is to use the negotiation mechanism to guide the enterprise to quote the lowest price it can accept. That is to say, negotiators strive to obtain more favorable prices for the people within the scope that the fund can afford and the enterprise can accept, which is the charm and value of 'soul bargaining'. The person in charge said.
Encourage enterprises to carry out real-world research on drugs
How to grasp the effectiveness of the drugs to be included in the list in the adjustment process? The person in charge said that according to the current rules, in order to ensure the effectiveness of drugs, it is mainly from the following aspects:
First, the drug must pass the review of the drug regulatory department and be approved for listing. Article 7 of the Interim Measures for the Administration of Drugs in Basic Medical Insurance stipulates that the drugs included in the national Drug Catalogue shall be chemical drugs, biological products, and proprietary Chinese medicines (ethnic medicines) that have been approved by the national drug regulatory authorities and obtained drug registration certificates. In recent years, the national medical insurance drug list has been adjusted, mainly for drugs newly approved for listing in recent years.
Second, enterprises must submit information that can prove the effectiveness of drugs. In the stages of declaration, review, negotiation, etc., relevant enterprises are organized to submit data and corresponding evidence on validity and other aspects as required. In order to ensure the authenticity of the information, the information submitted by the enterprise is publicized in the declaration process and subject to the supervision of the whole society. Please ask the drug supervision, health and other departments to provide drug support materials to provide support for the review.
Third, drugs can pass expert review. According to the adjustment rules, drugs that meet the declaration conditions and declare success need to accept multiple rounds of arguments from experts in pharmacy, clinical medicine, pharmacoeconomics, medical insurance management and other aspects. In the 2021 review, the study formulated the review index system, and the experts reviewed Western medicine and proprietary Chinese medicine from the aspects of safety, effectiveness, economy, innovation (inheritance and innovation), and fairness.
For example, the person in charge said that Ganlutna capsules were included in the scope of support for the "Major New Drug Creation National Science and Technology Major Project". In 2020 and 2021, they were successfully declared and successfully passed the expert review. The failure of the 2020 negotiations was not included in the catalogue. In this year's adjustment, after 32 expert reviews, an average score of 70.47 was obtained, and the drug was given the negotiation qualification according to the rules. Through negotiations, 66.92% of the price reduction was included in the catalogue. Through negotiated price cuts and Medicare reimbursement, the burden of medication on patients will be significantly reduced.
"It should be pointed out that since most of the drugs currently included in the scope of adjustment are newly approved and listed drugs, many are even drugs listed in the same year, and the expert review relies on the data collected in the clinical trial stage of the drug." In the future work, enterprises will be encouraged to carry out real-world research on drugs, and more real-world research data will be relied on in the adjustment of the catalog. The person in charge stressed.
The right to choose and decide on medication is truly returned to the clinician
In 2004, the former Ministry of Labor issued the Catalogue of Drugs for National Basic Medical Insurance and Work-related Injury Insurance, which began to limit the scope of payment for medical insurance drugs, and has been used ever since. Objectively speaking, limiting the scope of payment for medical insurance drugs has played a certain role in maintaining the safety of the fund and preventing drug abuse under specific historical conditions. However, at the same time, the fairness and rationality of limiting the scope of payment have also been repeatedly questioned.
In this regard, the person in charge said that since the establishment of the National Medical Insurance Bureau, actively carry out the state organization of centralized drug procurement, drug catalog access negotiations, fully promote the reform of DRG, DIP and other payment methods, strengthen the supervision of medical insurance funds, focus on improving the level of medical insurance informatization, intelligent management, the whole chain of the whole system, the use of drugs supervision and management capabilities and levels significantly improved, in addition to the instructions to limit the scope of drug payment the need has been greatly reduced. At the same time, more and more medical staff and patients have reported that the limiting of medical insurance drug payment scope has gradually become an important factor affecting the rational use of clinical drugs and even causing doctor-patient disputes. Therefore, from the perspective of maintaining the fairness of patient medication, improving the relationship between doctors and patients, and facilitating rational clinical treatment, it is necessary to gradually restore the scope of drug payment in the catalogue to the scope of the drug instructions approved by the drug regulatory department, and truly return the right to choose drugs and make decisions to clinicians.
"For the 94 drugs that have been successfully negotiated in this year's adjustment, the scope of payment has all been consistent with the instructions." The person in charge said.
The person in charge further introduced that other drugs with original payment limits in the catalog, in view of the complexity and sensitivity of the adjustment of payment limits, involving fund safety, patient benefits and corporate interests, in order to be safe and orderly, fair and just, after research, it was decided to carry out a pilot of medical insurance payment standards. In the pilot process, according to the voluntary application of the enterprise, the payment scope of the drugs included in the pilot scope will be restored to the drug instructions at the same time. In the early stage, experts were organized to repeatedly study and demonstrate the pilot work, and solicited the opinions and suggestions of the finance, health, drug supervision and other departments and local medical insurance departments, and reached an agreement. At the same time, the opinions and suggestions of relevant enterprises were also solicited. Some chemical drugs and proprietary Chinese medicines, such as glycine diazole sodium for injection, areecoxib tablets, Arbidol hydrochloride tablets, Danhong injection and other 30 kinds of drugs have been included in the pilot scope, and the medical insurance payment standards have been re-determined in accordance with the rules, and the payment scope has been restored to the drug instructions. During the pilot period, it is planned to include all pilot drugs in the scope of key monitoring, strengthen supervision, ensure the rationality of drug use, and safeguard the interests of patients and the safety of funds.
Finally, the person in charge said that in the next step, according to the progress of the pilot, under the premise of ensuring the safety of the fund and the fairness of patient medication, in accordance with the principle of reducing the increment and digesting the stock, the payment scope of more drugs in the catalog will be gradually restored to the drug instructions.
Edited by Yanting Chen
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