Work programme for the adjustment of the national medical insurance drug catalogue in 2020.

August 18, 2020 - August 3-10, 2020, the State Administration of Medical Security on the "2020 National Health Insurance Drug Catalog Adjustment Work Programme (Draft for Comments)" to the public for comments.
17th, the Work Programme for the Adjustment of the National Health Insurance Drug Catalog 2020 and the Guidelines for the Adjustment and Declaration of the National Health Insurance Drug Catalog 2020 were officially announced.
Annex 1: 2020 National Medical Insurance Drug Catalog Adjustment Work Programme In order to implement the decision-making and deployment of the CPC Central Committee and the State Council, further improve the level of drug security for insured persons, and standardize the management of medical insurance drug use, the Interim Measures for the Administration of Basic Medical Insurance Drugs (hereinafter referred to as the Drug Catalog) are formulated in accordance with the Opinions of the Cpc Central Committee and the State Council on Deepening the Reform of the Medical Security System of the People's Republic of China.
1. The target task is guided by Xi Jinping's new era of socialism with Chinese characteristics, fully implementing the spirit of the Second, Third and Fourth Plenary Sessions of the 19th National Congress of the Communist Party of China and the 19th Central Committee, adhering to the people's health as the center, deepening the reform of the medical security system, establishing a dynamic adjustment mechanism for the drug catalogue, and dynamically adjusting according to the fund's ability to pay The scope of the drug catalogue provides support for the normalization of the prevention and control of the new crown epidemic, and strives to optimize the structure of the drug catalogue, manage it more scientifically and standardizedly, pay more efficiently, ensure more fair access, promote the modernization of the medical insurance drug management system and governance capacity, and help solve the worries of the people in seeking medical treatment.
2. The scope of adjustment shall take into account the functional orientation of basic medical insurance, the clinical needs of drugs and the affordability of funds, and the scope of adjustment of the drug catalogue in 2020 shall be as follows: (1) Western medicines and traditional Chinese medicines outside the catalogue shall comply with the provisions of Articles 7 and 8 of the Interim Measures for the Administration of Drug Use for Basic Medical Insurance, and drugs outside the drug catalogue with one of the following circumstances may be included in the scope of new drugs to be added to the drug catalogue in 2020.
1. Medication for respiratory diseases related to new coronary pneumonia.
2. Drugs included in the National Essential Medicines Directory (2018 edition).
3. Drugs that are included in the list of new drugs that are clinically in urgent need of overseas, that encourage generic drug catalogs, or that encourage research and development to declare children's medicines, and are approved for market by the State Drug Administration by August 17, 2020 (inclusive, the same below).
4. The second batch of state-organized medicines centralized procurement of selected drugs.
5. New generic drugs approved for market by the State Drug Administration between January 1, 2015 and August 17, 2020.
6. Between January 1, 2015 and August 17, 2020, additional applications and approvals were made to the State Drug Administration based on the results of clinical trials, and drugs with significant changes in adaptive disorders, functional treatment, etc.
7. By December 31, 2019, 5 or more of the latest provincial essential health insurance drug catalogs are included.
, the main active ingredients were included in the "first batch of national key monitoring of rational drug catalogues (chemical drugs and biological products)" except.
and traditional Chinese medicines outside the catalogue of eligible drugs shall be declared by enterprises in accordance with the procedures and shall be included in the proposed new scope after examination and approval.
for exclusive medicines, whichever is August 17, 2020.
(2) Drugs in the catalogue of western medicines and traditional Chinese medicines that meet the requirements of Articles 9 and 10 of the Interim Measures for the Administration of Medications for Basic Medical Insurance, and which have one of the following circumstances, may be included in the scope of adjustment of the drug catalogue in 2020.
1. Call up the range of drugs in the catalogue.
(1) drugs that have been revoked, revoked or cancelled by the State Drug Administration.
(2) comprehensive consideration of clinical value, adverse reactions, drug economy and other factors, the assessment that the risk is greater than the benefits of the drug.
2. Adjust the scope of payment standard medicines.
(1) is within the validity period of the agreement and that the payment criteria for negotiated medicines need to be rede determined in accordance with the agreement.
(2) according to the enterprise declaration or expert evaluation, it is necessary to adjust the scope of payment negotiation drugs.
(3) compared with other drugs in the same therapeutic field, the price/cost is significantly higher, and in recent years occupied a large amount of funds of drugs.
(iii) Other 1. The eligible Chinese medicine tablets shall be included in the scope of adjustment in accordance with the provisions.
2. Improve the drug catalogue, standardize the drug name dosage form, appropriately adjust the drug A and B category, catalog classification structure, notes and other content.
3. Work Procedures 2020 Drug Catalog Adjustment is divided into five stages: (i) preparation phase (July-August 2020) for preparation, declaration, expert review, negotiation and bidding, and publication of results.
. The State Health Insurance Administration, in cooperation with the Ministry of Industry and Information Technology, the Ministry of Finance, the National Health and Health Commission, the State Drug Administration and the State Administration of Traditional Chinese Medicine, will study and formulate a work programme to determine the principles and procedures for the adjustment of the catalogue.
the programme after consultation with the community.
2. Set up working institutions, establish working mechanisms, set up a pool of experts, formulate work rules and provisions on integrity and confidentiality, interest avoidance, etc.
(ii) the reporting phase (August-September 2020) to issue the reporting guidelines.
the scope of the 2020 drug catalog, the recipient of eligible declarations shall submit the necessary information to the National Health Insurance Administration's Medical Insurance Center as required.
information should be reviewed in a formal manner and medicines examined in the form of a formal examination should be made public.
(iii) expert review phase (September-October 2020) to establish a review drug database in conjunction with the enterprise's declaration.
demonstrate to determine the technical points of the review.
organization review experts to review, forming a new transfer, direct transfer out, can be transferred out, adjust the scope of payment and other 4 aspects of the recommended list of drugs.
(iv) the negotiation and bidding phase (October-November 2020)1. Soliciting the interest of the relevant enterprises regarding the drugs to be included in the negotiations and bidding.
organization to submit negotiation (bid) materials as required, in accordance with the intention of the enterprise.
2. Organization of measurement experts through fund measurement, pharmaceutical economics and other methods to carry out assessments, and put forward assessments.
3. Negotiators negotiate or bid with enterprises on the basis of their assessment opinions, determine a unified national standard for the payment of health insurance, and simultaneously clarify management policies.
(v) the results phase (November-December 2020) to publish the results of the drug catalog adjustment, the release of a new version of the drug catalog, synchronously clear management and implementation requirements.
, the composition and responsibilities of experts (i) the evaluation experts are divided into integrated groups and clinical groups.
The comprehensive group of evaluation experts by the style, strong business, familiar with and enthusiastic medical security business, voluntary participation in the catalog review of pharmacy, pharmaceutical economics, medical insurance management experts, mainly responsible for proving the identification of technical points of drug evaluation, all drugs included in the scope of the review to provide evaluation advice.
clinical group evaluation experts are recommended by relevant academic groups and industry (associations) and are mainly responsible for ingicing on drugs in their area of expertise.
(2) The measurement experts are composed of experts in medical insurance management, pharmaceutical economics and other fields recommended by the local medical insurance department and relevant academic groups.
is divided into fund measurement group and drug economics group, respectively, from the impact of health insurance fund and drug economics evaluation of the two aspects of the negotiation of drugs and competitive drugs to put forward assessments.
(iii) Negotiating and Bidding Experts are composed of representatives of the health insurance department and relevant experts, responsible for on-site negotiations and bidding with the negotiation and bidding pharmaceutical companies.
, the supervision mechanism (1) take the initiative to accept the supervision of all parties to accept the supervision of the public, the news media, pharmaceutical enterprises.
publicly publish the work programme and make public the list of drugs that meet the conditions for declaration.
strengthen communication with enterprises, through holding symposiums and other ways to improve the transparency of directory adjustment work.
set up a report phone and mailbox to receive complaints from all walks of life.
(2) Improve the internal control mechanism to clarify the responsibilities of jobs and personnel, improve the disciplinary norms of information confidentiality, interest avoidance and accountability, and ensure that the adjustment of the catalogue is fair, safe and orderly.
(3) Strengthen expert supervision and establish a system of expert responsibility, interest avoidance, accountability, etc., and all the evaluation and measurement work will leave traces throughout, so as to ensure that experts are independent and impartial in their opinions.
Annex: 2020 National Health Insurance Drug Catalog Adjusts the Scope of Declared Drugs I, Drugs outside the Catalog meet the conditions listed in Part II of this Program (I) Western medicine and traditional Chinese medicine.
, the list of drugs (1) is within the validity period of the agreement, and in accordance with the agreement needs to re-establish the payment criteria of the negotiated drugs.
(2) is within the validity period of the agreement, with the approval of the State Drug Administration, the major changes in the treatment of adaptive disorders or functions and the enterprise voluntarily declares the negotiated drugs that limit the scope of payment.
Annex 22020 National Health Insurance Drug Catalog Adjustment Reporting Guidelines In accordance with the relevant requirements of the 2020 National Health Insurance Drug Catalog Adjustment Work Programme, in order to do a good job in the 2020 National Health Insurance Drug Catalog Adjustment Declaration, the relevant matters are herely notified as follows: First, the scope of declaration (I) of Western medicine and traditional Chinese medicine outside the catalog.
medicines outside the catalogue of drugs that comply with the provisions of Articles 7 and 8 of the Interim Measures for the Administration of Drug Use for Basic Medical Insurance and have one of the following circumstances may be declared in accordance with the procedures.
1. Drugs incorporated into the New Coronavirus Pneumonia Treatment Programme (Trial Vii).
2. Drugs included in the National Essential Medicines Directory (2018 edition).
3. Included in the List of Clinically Urgently Needed New Drugs Abroad (First Batch), List of Clinically Urgently Needed New Drugs Abroad (Second Batch), First Batch Of Encouraged Imitation Drugs List, First Batch Of Encouraging research and Development of Declared Children's Medicines List, Second Batch Encouraging Research and Development of Declared Children's Medicines List, and approved by the State Drug Administration before August 17, 2020 (inclusive, the same below).
4. The second batch of state-organized medicines centralized procurement of selected drugs.
5. New generic drugs approved for market by the State Drug Administration between January 1, 2015 and August 17, 2020.
6. Between January 1, 2015 and August 17, 2020, additional applications and approvals were made to the State Drug Administration based on the results of clinical trials, and drugs with significant changes in adaptive disorders, functional treatment, etc.
7. By December 31, 2019, 5 or more of the latest provincial essential health insurance drug catalogs are included.
, the main active ingredients were included in the "first batch of national key monitoring of rational drug catalogues (chemical drugs and biological products)" except.
(ii) western medicine and traditional Chinese medicine in the catalogue.
medicines in the medical insurance catalogue that meet the requirements of Article 10 of the Interim Measures for the Administration of the Scope of Drug Use of Basic Medical Insurance and have one of the following circumstances may be declared in accordance with the procedures.
1. Negotiated medicines that are within the validity period of the agreement and in accordance with the agreement are subject to the re-determination of payment criteria, and 2. Negotiated drugs that are subject to the validity period of the agreement and have under the approval of the State Drug Administration for major changes in the treatment of adaptive disorders or function.
(3) Chinese medicine tablets do not need to be declared by the enterprise.
, the reporting entity conforms to the scope of this guide to declare the drug listing license holder or its authorized subject.
, the declaration method unified to adopt the online declaration method, synchronous submission of paper declaration materials.
no fees are charged for the filing.
Fourth, the contents of the declaration mainly include the declaration of basic information on drugs, cost information, supporting materials, etc., the specific content and related requirements of the "2020 National Health Insurance Drug Catalog Adjustment And Declaration System" content.
5th, the declaration process (1) to receive the declaration.
1. Online filing.
file the application online through the 2020 National Health Insurance Drug Catalog Adjustment Reporting System.
online filing period is from 9:00 on August 21 to 17:00 on August 30, 2020, and the reporting system will automatically shut down after expiration.
to register as required to obtain information such as the unique unit account number before filing the reporting entity.
the same reporting entity corresponds to only one account, and duplicate registration is prohibited.
multiple drugs declared by the same reporting entity shall be declared under the same account number.
2. Submit paper declaration materials.
After the online declaration is submitted, the contents of the online filing and the "Enterprise Commitment Letter" will be printed and stamped with the unit's seal, together with other uploaded materials in order to be stapled, mailed or expressed to the National Health Insurance Administration Health Insurance Center.
paper declarations are sent by August 30, 2020, which is based on the postmark.
(ii) formal review.
1. Review.
the enterprise declaration information, will be in accordance with the reporting rules for audit, the results of the audit are divided into "pass", "not pass" and "supplementary information" three.
the reporting entity can log on to the reporting system to query the audit results.
that the audit results are "supplementary information" but do not complete the supplement as required are considered "non-passable".
2. Publicity.
list of drugs approved by the U.S. government will be made available online for a week.
if there are drugs that do not meet the conditions for declaration, all sectors of society can make comments.
(iii) the list will be published.
, the list of drugs that have been formally reviewed will be officially published.
, consultation channels during the declaration period, open a consultation phone and e-mail to answer the declaration-related questions.
: 010-89061448, 89061449.
: ybzx@nhsa.gov.cn (contact, organization and contact number required for enquiries).
: August 21 to August 30, 2020, 9:00-17:00 daily.
, paper information mailing address of the National Health Insurance Administration medical insurance center drug catalog adjustment declaration working group.
address.