In order to do a good job in the adjustment of the national medical insurance drug list in 2019, and to broaden the social consensus and ensure that the drug list adjustment work is open, fair and just, the Bureau has researched and drafted the "2019 National Health Insurance Drug Catalogue Adjustment Work Plan (Draft for Comment)". It is now open to the public for comments. The public can submit their opinions through the following channels and methods before March 26, 2019.

1. Email: gjypmltz2019@nhsa.gov.cn

2. Communication address: No. 2, Yuetan North Street, Xicheng District, Beijing, China, Department of Medical Service Management, National Medical Security Bureau, Zip Code: 100830

National Health Insurance Agency

March 13, 2019

annex:

2019 National Health Insurance Drug Catalogue Adjustment Work Plan

(draft for comment)

In order to implement the decision-making arrangements of the Party Central Committee and the State Council, further improve the level of drug use for insured persons, and regulate the management of medical insurance, according to the "Social Insurance Law of the People's Republic of China" and related documents, the National Basic Medical Insurance (including work injury insurance and birth) is now under 2019. Insurance) The drug list (hereinafter referred to as the drug list) adjustment work plan.

First, the target task

Guided by Xi Jinping's new era of socialism with Chinese characteristics, comprehensively implement the spirit of the 19th and 19th Central Committees of the Party and the Central Committee for Economic Work, adhere to the people-centered development thinking, and focus on building a sound and fairer The sustainable medical security system expands the scope of the catalogue according to the fund's ability to pay, and strives to achieve a more optimized drug structure, more standardized management, and higher efficiency in the use of medical insurance funds, further improving the level of basic medical insurance and ensuring that drugs are more difficult to use.

Second, the basic principles

(1) Adhere to the maintenance of the health of the insured as the fundamental starting point. On the basis of the fund's affordability, the clinical value will be highlighted, the short-term guarantees will be supplemented, the guarantee effect will be improved, the scope of the catalogue will be expanded appropriately, the basic clinical medication needs of the insured personnel will be better met, and the health rights of the insured persons will be effectively safeguarded.

(2) Adhere to the basic positioning of insurance. Based on China's economic and social development level, comprehensive consideration of the affordability of medical insurance funds, the burden of insured persons and the demand for clinical drugs, adhere to the basic medical insurance positioning, not only do their best, but also do their best, determine the scope and level of medication, and realize the scope of protection. The support capabilities are matched.

(3) Adhere to an open, fair and impartial expert review system. The drug catalogue is reviewed and determined by experts according to the scientific norms of procedures, and the administrative department does not interfere with the results of expert review. The adjustment plan widely listens to opinions and suggestions from various quarters. Standardize and publicize the review process, strictly discipline, and take the initiative to accept discipline inspection and supervision, social and other parties to ensure openness, fairness and justice.

(4) Adhere to overall planning and consideration. Give full play to the respective advantages of Western medicine and traditional Chinese medicine, and establish and improve targeted evaluation methods based on their respective basic theories, and make overall consideration of the quantitative structure and growth of Western medicines and proprietary Chinese medicines. Comprehensive consideration of the basic theory and basic norms of clinical medication, the basic laws and management requirements of medical insurance, as well as the policy provisions of the departments of drug supervision, health and wellness, and traditional Chinese medicine.

Third, adjust the content

The adjustment of the drug list involves three aspects of western medicine, Chinese patent medicine and Chinese medicine decoction, including two items: drug transfer and drug transfer. Based on the drug information approved by the State Food and Drug Administration for listing, enterprises are not accepted for reporting or recommendation, and no evaluation fees and other various fees are charged.

Western medicines and proprietary Chinese medicines to be transferred shall be medicines registered and listed by the State Drug Administration before December 31, 2018 (inclusive). Priority is given to the treatment of major diseases such as national essential drugs, cancer and rare diseases, chronic diseases, children's drugs, and emergency rescue drugs. According to the field of drug treatment, pharmacological effects, functional indications, etc., organize experts to review by category. Comparing drugs of the same type according to the principles of pharmacoeconomics, it is preferred to select varieties that are sufficiently clinically proven, safe, effective, and reasonably priced. The transfer is divided into two types: regular access and negotiation access. Under the premise of satisfying the validity and safety, the price (expense) is equivalent to or lower than the existing varieties in the drug list, and can be included in the catalogue by routine means. Patent exclusive drugs that have a higher price or have a greater impact on the health care fund should be negotiated.

The traditional Chinese medicine decoction pieces are managed by the admission method, and the national level adjustment targets are limited to the traditional Chinese medicine decoction pieces prepared according to the national drug standards.

The original drugs in the drug list, if they have been banned from production, sale and use by the State Drug Administration, shall be transferred; if there are other requirements and conditions that do not meet the medical insurance requirements, they may be transferred after the corresponding review procedures.

Synchronously adjust and improve the drug catalogue, use management methods, standardize the drug name dosage form, and appropriately adjust the category of the drug A and B, the catalogue classification structure and so on. In the process of adjusting the category A and B, priority is given to essential drugs.

Fourth, organizational form

(1) Establishing a working group

The drug list adjustment work is led by the National Health Insurance Bureau. It will work with the Ministry of Human Resources and Social Security, the Ministry of Finance, the National Health and Health Commission, the State Food and Drug Administration, and the State Administration of Traditional Chinese Medicine to study and formulate work plans, and study the principles, procedures, and coordination of catalogue adjustment. Policy issues. Establish a working group in the National Health Insurance Bureau to undertake daily work.

(2) Identifying experts

It is divided into consulting experts, selection experts, measurement experts, and negotiation experts. It is mainly composed of clinical medicine and pharmacy experts, including a certain number of medical insurance experts and pharmacoeconomic experts. They are responsible for specific evaluation work such as drug consultation and selection, and negotiating drugs. Measurement and so on. Consulting experts and selection experts do not cross each other.

Consultation experts: about 300 people. It is composed of experts and scholars who are recommended by relevant academic groups and industry associations, who are strong in business, strong in business, familiar with and enthusiastic about medical insurance, and voluntarily participating in catalogue review. It is divided into two groups: western medicine and traditional Chinese medicine, and there are separate groups and several professional groups. The main tasks are to provide consultation on drug classification and data analysis, to demonstrate the technical points of drug review, and to provide opinions on the scope of alternative drugs.

Selection of experts: about 20,000 people. The medical security departments of all provinces (autonomous regions and municipalities directly under the Central Government) organize local academic associations and industry associations to recommend them, including experts in different fields, different levels of medical institutions, different departments and professional clinical medicine, pharmacy and medical insurance management. A random number of experts were randomly selected to vote for the list of candidate drugs.

Measurement experts: about 30 people. It is composed of experts in medical insurance management and pharmacoeconomics recommended by the local medical insurance department and relevant academic groups. Experts are divided into fund measurement group and pharmacoeconomics group, which provide evaluation opinions for negotiating drugs from the impact analysis of medical insurance funds and drug economy.

Negotiating experts: It is composed of representatives of the National Medical Insurance Agency, local medical insurance departments and relevant experts, and is responsible for conducting on-site negotiations with the negotiating pharmaceutical companies.

(3) Establishing a negotiation group

A negotiating team is formed by the National Medical Insurance Agency, local medical insurance department representatives and relevant experts to conduct on-the-spot negotiations with the negotiating pharmaceutical companies. The drugs agreed upon in the negotiations are included in the drug catalogue, and the national unified medical insurance payment standards and management policies are determined.

(4) Establishing a supervision team

It is located in the Disciplinary Committee of the State Organs of the State Medical Insurance Bureau and is responsible for supervising the adjustment work and accepting reports of social complaints.

V. Working procedures

The drug list adjustment is divided into five stages: preparation, review, release of the regular access list, negotiation, and release of the negotiation access list:

(1) Preparation stage (January-March 2019)

1. Prepare a work plan and seek the opinions of the Ministry of Human Resources and Social Security, the Ministry of Finance, the National Health and Health Commission, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine and other relevant departments and the society.

2. Form a working organization, set up a review expert database, establish a basic database for review, and formulate confidentiality and confidentiality regulations.

(II) Review stage (April-May 2019)

1. Determine the list of candidates. Consult the experts to determine the technical points of the drug review, and review the points according to the main points, and determine the list of candidate drugs to be transferred (including negotiation) and recalled. For the medical insurance catalogues in the 2018 National Essential Drugs List, the experts are invited to give priority consideration.

2. Select an expert to vote. From the selection expert database, according to the region of the expert, the type and level of medical institutions, the professional department and the reported drug review classification group, the experts selected for the selection are randomly selected. The participating regions are no less than two-thirds of the country's provinces; no less than 30% of the experts participating in the selection are from the secondary and below medical institutions; and the selection experts for each drug group are not less than 50 in principle.

3. Determine the list of transferred drugs. The consulting experts determined the list of drugs to be transferred (including negotiation) according to the results of the selection of experts and the number of varieties to be included, and discussed some drugs that need to be strengthened, and proposed corresponding management measures.

4. Consult the relevant companies on the list of negotiated drugs and confirm the negotiation intention.

(III) Regular catalog release stage (June 2019)

1. Preparation of a notice on the issuance of a drug list and the publication of a list of negotiated drugs.

2. Consult the relevant department for the notice and inform the catalogue adjustment.

3. A new version of the drug list was issued and the list of drugs to be negotiated was announced.

(4) Negotiation stage (June-July 2019)

1. Organize enterprises to provide negotiation materials in the prescribed format and time limit.

2. Organizational measurement experts conduct assessments through medical insurance big data analysis and pharmacoeconomics, and provide assessment opinions.

3. The negotiating experts negotiated with the enterprise based on the assessment opinions and determined the unified national medical insurance payment standards and management policies.

(5) Release of the negotiation access list (August 2019)

The National Health Insurance Bureau issued a document to include successful drugs in the drug list, and clearly defined management and implementation requirements.

6. Supervision mechanism

(1) Proactively accept supervision by all parties. The Disciplinary Committee of the State Medical Insurance Bureau directly established a supervision team to arrange special personnel to participate in the catalogue adjustment work. The work plan and work procedures are widely consulted by relevant departments and the whole society.

(2) Improve the internal control mechanism. Clear job positions and personnel responsibilities, improve system confidentiality, interest avoidance, accountability and other institutional measures to ensure that the directory adjustment work is fair, safe and orderly.

(3) Strengthening expert supervision. Establish a system of expert responsibility, avoidance of interests, accountability, etc., and all the evaluation and selection work will be traced throughout the process to ensure that the experts independently and impartially submit comments.