State Drug Administration: Interim Measures for the Administration of Medical Supplies for Basic Medical Insurance

Guide: Deepen the reform of high-value medical supplies, improve the use of medical insurance funds, improve the level of medical supplies guarantee for basic medical insuranceOn June 8,, the State Administration of Medical Insurance issued the Interim Measures for the Administration of Medical Supplies for Basic Medical Insurance (draft for comments), which aims to standardize and strengthen the access and payment management of medical supplies to medical supplies, deepen the reform of high-value medical supplies, improve the efficiency of the use of medical insurance funds, improve the level of medical supplies for basic medical insurance, and safeguard the health rights and interests of the peopleThe scope of application is: refers to the approval of the drug supervision and administration department, can be charged separately, and has a unified code of medical medical supplies for medical care suppliesThese Measures shall apply to the medical insurance access, payment and corresponding management supervision of medical suppliesInterim Measures for the Management of Medical Supplies forBasic Medical Insurance(Draft for Comments)Chapter 1 General ProvisionsArticle 1 "Purpose" for regulating and strengthening medical supplies medical insurance access and payment management, deepening the reform of high-value medical supplies, improving the efficiency of the use of medical insurance funds, raising the level of medical supplies protection for basic medical insurance, and safeguarding the health rights and interests of the people These Measures are formulated in accordance with the spirit of the Social Insurance Law of the People's Republic of China, the Opinions of the State Council of the CPC Central Committee on Deepening the Reform of the Medical Security System (No5 of 2020), and the Notice of the General Office of the State Council on the Issue of the Reform Program for the Administration of High-Value Medical Supplies (No37 of 2019)Article 2 "Scope of Application" The medical supplies referred to in these Measures refer to medical supplies approved by the drug supervision and administration department, may be charged separately, and have a unified code of medical supplies for medical securityThese Measures shall apply to the medical insurance access, payment and corresponding management supervision of medical suppliesArticle 3 "Access Management" The administrative department of medical security under the State Council, taking into account the functional function, clinical value, cost level, medical insurance fund affordability and other factors, adopted the access law to formulate the "Basic Medical Insurance Medical Supplies Catalog" (hereinafter referred to as the "Basic Medical Insurance Supplies Catalog" and regularly updated, dynamic adjustmentMedical supplies in the "Basic Medical Supplies Catalog" are included in the scope of payment of medical insurance funds in accordance with the provisionsArticle 4 The medical insurance access management of medical supplies adheres to the principles of basic, reasonable satisfaction with clinical needs, scientific norms and dynamic adjustment Based on the full life cycle cost of medical supplies, highlighting clinical value, on the basis of strengthening safety, effectiveness and economic assessment, according to the functional positioning of basic medical insurance, gradually clarify the standard of medical insurance payment Article 5 "Classification and Coding" Basic medical supplies for basic medical insurance shall, in principle, be classified and coded in accordance with the principles and standards established by the administrative department of medical security under the State Council, and shall be appropriately adjusted according to the needs of the medical insurance access management Included in the "medical medical supplies classification and code" scope of medical supplies, on the basis of the three-level classification, according to the situation to distinguish materials, specifications article 6 of the "Catalog Structure" "Basic Medical Supplies Catalog" structure mainly includes the exception and the catalog two parts In all cases, the arrangement of the "Basic Medical Medical Supplies Catalog", name and coding specifications, payment scope, etc are explained and explained The catalog includes numbers, functional classifications, health insurance codes, payment ranges, units, payment standards, methods of determining payment criteria, notes, etc Article 7 (Division of Duties) The administrative department of medical security under the State Council shall be in charge of medical insurance access, payment, management, and classification and coding of medical insurance supplies Responsible for establishing and improving the medical insurance access management system for medical supplies, perfecting relevant policies, leading the formulation of basic medical insurance medical supplies catalog adjustment program and soliciting the opinions and suggestions of relevant departments of the State Council, issuing the national "basic medical insurance medical supplies catalog" and regularly adjusting, to strengthen the guidance, management and supervision of all areas Negotiate the standard of payment for health insurance for exclusive products, etc The State Medical Security Administration shall be entrusted by the administrative department to undertake the specific organization and implementation of the adjustment of the State's "Basic Medical Insurance Medical Supplies Directory" provincial medical security administrative departments are responsible for the administration of medical insurance payments for medical supplies within their administrative areas Specificinclud includes the development of medical supplies payment management measures in accordance with the requirements, according to procedures to determine the catalog of medical supplies medical insurance payment standards, strengthen the overall management of medical supplies guidance, management and supervision the regional medical security administrative department is responsible for strengthening the use, payment management and supervision of medical supplies, implementing relevant policy measures, and strengthening monitoring and evaluation The determination of the second chapter of the , "Basic Medical Supplies Catalog" Article 8, "Basic Conditions for Inclusion in the Catalog" into the scope of payment of basic medical insurance, medical supplies shall be registered or filed in the drug supervision department in accordance with the provisions, and at the same time have clinically necessary, safe, effective, economic and other basic conditions of medical supplies Article 9 "Cases not included in the catalogue" medical supplies that meet one of the following conditions, shall not be included in the catalogue , cannot charge separate fees; , dentures, dentures, prosthetic limbs, hearing aids and other non-therapeutic rehabilitation devices; third, family planning, public health and other aspects of the special (except as otherwise stipulated by the State); IV, clinical value is not high, may be completely replaced; V, other state provisions do not meet the scope of basic medical insurance Article 10 "Conditions for transferring out the scope of payment of basic medical insurance" meets the medical supplies in one of the following cases, and after expert evaluation, directly transfers out the scope of payment of basic medical insurance in principle The drug regulatory department shall disqualify the registration or filing; , consider ingest safety, clinical value, economy and other factors, the risk is assessed to be greater than the income; third, is included in the negative list by the relevant departments; Ivy, through fraud and other illegal means to enter the medical insurance directory; Five, in accordance with the provisions of the State, other directly transferred circumstances 11 (Definition of the List) The Administrative Department of Medical Security under the State Council organizes experts to evaluate and determine the scope of medical supplies to be paid for by basic medical insurance on the basis of the functional function and scope of use of medical supplies, and form a unified national "basic medical insurance medical supplies catalog" According to the development of clinical needs, basic medical insurance guarantee capacity and medical supplies industry, the administrative department of medical security under the State Council takes the lead and regularly evaluates and adjusts the "Basic Medical Insurance Medical Supplies Catalog" For medical supplies that meet the conditions for direct transfer, in principle, directly call out the "basic medical insurance medical supplies catalog." Article 13 "Access to newly listed medical supplies" newly listed medical supplies, first of all according to the medical supplies coding rules for coding Such as the medical supplies code and the catalog medical supplies code consistent, automatically belong to the scope of payment of medical insurance funds, payment policies and rules and the same code in the catalog of medical supplies consistent If the medical supplies code and the catalog medical supplies coding is inconsistent, by the State Council Medical Security Administration department timely organized expert review, determine whether to include in the "basic medical insurance supplies catalog." Chapter III, "Basic Medical Supplies Catalog" use Article 14 "Code renewal and use" The State Administration of Medical Security shall code medical supplies in accordance with the unified coding rules Strengthen the interface application of medical supplies medical insurance coding and unique identification of medical devices Establish a medical supplies code in the medical insurance catalog regular maintenance, audit, publicity, release mechanism The medical supplies coding database in the health insurance catalog is updated quarterly Medical insurance departments at all levels should use uniform medical supplies coding in accordance with the regulations Article 15 (Recruitment and Hanging Network) Medical supplies purchased by public medical institutions shall be purchased after the provincial centralized procurement platform is registered through the corresponding procedures for centralized procurement Negotiating access to medical supplies in the negotiation agreement period directly online procurement article 16 "Medical institutions equipped" fixed-point medical institutions shall give priority to the provision and use of "basic medical insurance medical supplies catalog" medical supplies and medical insurance departments organized by the centralized volume procurement of medical supplies Chapter IV Medical Insurance Payment Article 17 "Payment Conditions" Medical Supplies Directory of Basic Medical Insurance Supplies, medical supplies must meet the following conditions at the same time, the medical insurance fund to pay First, for the purpose of diagnosis and treatment of diseases; ii, conforms to the scope of application registered or filed in the drug supervision and administration department; iii, meets the scope of payment as defined in the Basic Medical Supplies Directory; Ivy, shall be issued by medical personnel with corresponding qualifications in designated medical institutions (first aid, rescue may be appropriately relaxed to non-fixed-point medical institutions); Five, other conditions prescribed by the State Article 18 The medical supplies in the catalogue of "The Fund Shall not Pay" shall not be paid by the medical insurance fund if one of the following circumstances is available , non-disease diagnosis and treatment projects used; , use of various scientific research, clinically verified medical and therapeutic projects; three, beyond the scope of reasonable use; IV, other non-compliance with the provisions of the basic medical insurance payment scope article 19 of the ,The funds and patients are not paid for the situation" catalogue of medical supplies, with one of the following circumstances, the medical insurance fund and patients will not pay , due to the use of consumables itself caused by unsuccessful use; two, more than the actual number of implanted implants cost Article 20 The standard of payment for medical supplies is the standard for payment by the health insurance fund Article 21 of the , "The determination and adjustment of the standard of payment for health insurance"
for exclusive products, in principle, to determine the first medical insurance payment standard If the negotiation is successful, the health insurance department shall pay according to the payment standards established by the negotiation agreement Unsuccessful negotiations, not included in the scope of health insurance payments, have been included in the list to be transferred out Negotiating rules for medical supplies will be developed separately for non-exclusive products, in principle, payment standards are determined and adjusted through centralized procurement The provincial medical security administrative departments shall, in accordance with the results of the purchase of the provinces, alliances and provinces (autonomous regions and municipalities directly under the Central Government), determine the standard of medical insurance payment for the province (autonomous regions and municipalities directly under the Central Government) at the lowest winning price for medical supplies with the same category and similar functions For medical supplies that are not included in the scope of the volume purchase, the payment standards shall be determined by the provinces (autonomous regions and municipalities directly under the Central Government) according to the calculation method of the payment standard in the catalogue The rules for determining the standard of payment for medical supplies medical insurance shall be formulated separately Article 22 The specific payment method and payment ratio of medical supplies shall be determined in principle by the provincial administrative department for medical security or the co-ordination area Support all parts of the catalog of medical supplies into the scope of packaging payment by disease, according to disease diagnosis related group payment Chapter V The management and supervision of medical supplies for basic medical insurance
Article 23 (Regulation of fixed-point medical institutions) implements the responsibility for the management of medical supplies of designated medical institutions Strengthen the self-management level of fixed-point medical institutions, urge fixed-point medical institutions to improve the in-hospital access mechanism, strengthen the monitoring and supervision of the use of medical supplies Strengthen the capacity-building of medical supplies management, refine policy measures, comprehensive use of agreements, administration, law and other means to strengthen the fixed-point medical equipment medical supplies medical insurance payment supervision and management Fixed-point medical institutions should establish and improve the basic medical supplies procurement, equipment, use, payment, settlement and other aspects of the management system to ensure safety, reasonable, standardized use, and in accordance with the requirements of publicizing the price of medical supplies, regularly to the medical insurance departments to report medical supplies into and out of storage and other data Article 24 "Strengthening supervision of medical personnel" designated medical institutions shall take the initiative to strengthen the management of medical service behavior, strengthen the management of medical insurance physicians, actively carry out training and guidance to medical personnel, improve the system, improve measures, and strive to improve the rationality and standardization of the use of medical supplies The medical insurance department should strengthen the audit of the reasonableness of the use of medical supplies and the compliance of the cost of medical insurance, and regularly supervise and inspect The medical personnel of the designated medical institutions should strengthen the policy publicity and patient communication The use of medical supplies at a price higher than the payment standard or medical supplies in the non-medical insurance catalogue should guarantee the right of informed consent of the insured Article 25 "Strengthening supervision of enterprises" establish and improve the supervision mechanism of medical supplies enterprises in the catalogue, linking the behavior of enterprises in data information transmission, promotion and use of medical supplies, and compliance with agreements, and the management of the Basic Medical Supplies Directory We will improve the credit commitment system of enterprises and punish enterprises that have failed to trust them Article 26 "Strengthening internal supervision of the medical insurance system" The management of medical supplies for basic medical insurance shall be subject to the supervision of the discipline inspection department and the community Strengthen the management of experts, improve the production of experts, experts responsible, interest avoidance, accountability and other mechanisms We will strengthen the construction of a clean government and improve the internal management system of complaint reporting, interest avoidance and confidentiality Chapter VI of the By-laws Article 27 "Responsibilities and Powers" In addition to special provisions, local medical insurance departments shall implement the National Directory of Basic Medical Insurance Medical Supplies, which may not be adjusted without authorization article 28 "Temporary Adjustment" In the event of a public health event or emergency that seriously endangers the health of the masses, the administrative department of medical security under the State Council may temporarily adjust or authorize the provincial medical security administrative department to temporarily adjust the scope of payment, payment limit and payment standard sizing of medical supplies for medical insurance article 29 The implementation of these Measures The interim measures shall be interpreted by the administrative department of medical security under the State Council and shall come into effect as of the date of publication