There has always been a debate in the industry regarding the understanding and definition of "high value" in high-value medical consumables. Until July 2019, the General Office of the State Council issued the "Notice on the Reform Plan for Managing High Value Medical Consumables" (Guobanfa [2019] No. 37), which stipulated that "high-value medical consumables refer to medical consumables that directly affect the human body, have strict safety requirements, have a large clinical usage volume, relatively high prices, and heavy burden on the public." This also clarified that "high-value" refers to the high usage price, high therapeutic value, and high risk threshold of consumables. The "three highs" attributes of high-value consumables had a "harmony" relationship with each other before the centralized quantity based procurement policy; After the policy of centralized quantity based procurement, the relationship between each other has become 'or'.
In order to enhance the management capability and level of medical consumables medical insurance payment, in June 2021, the General Office of the State Council issued the "Opinions on Promoting the High quality Development of Public Hospitals" (Guobanfa [2021] No. 18), which regards the refined management of high-value medical consumables as an important part of "improving the new efficiency of high-quality development of public hospitals". In July 2022, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly developed the "Evaluation Indicators for High Quality Development of Public Hospitals (Trial)" and "Evaluation Indicators for High Quality Development of Public Traditional Chinese Medicine Hospitals (Trial)" (hereinafter referred to as the "Evaluation Indicators"), which assess the achievements of medical institutions in structural optimization, innovation and efficiency improvement through two quantitative indicators: "the proportion of medical service income (excluding drug, consumables, and inspection and testing income) to medical income" and "cost consumption index", reflecting the hospital's refined level of high-value medical consumables management. In May 2023, the National Healthcare Security Administration issued the "Notice on Doing a Good Job in the Management of Payment for Medical Consumables in Basic Medical Insurance (Draft for Comments)", which will force medical institutions to improve their internal refined management level from the aspects of promoting unified classification and coding of medical consumables, clarifying the scope of medical consumables medical insurance payment, gradually implementing medical insurance common name management, and strengthening medical consumables medical insurance payment access management in the future. Due to the wide variety of high-value medical consumables, similar functions but significant price differences, and the same clinical indications but individual differences in patient usage, the difficulty of fine management of medical consumables is enormous. Although from the perspective of institutional construction, in June 2021, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the "Notice on Issuing the Management Measures for Medical Consumables in Medical Institutions (Trial)" (Guoweiyifa [2019] No. 43), which provides clear and detailed management requirements for the internal management of consumables in medical institutions in terms of organizational structure, personnel allocation, management content (selection, procurement, acceptance, storage, application, distribution and clinical use), and management measures (monitoring, evaluation, information construction and supervision management). However, from the perspective of policy implementation, the management of high-value medical consumables has always been a key and difficult issue for medical institutions to enhance their connotation construction.
The four issues of refined management of high-value consumables discussed in this article mainly focus on clinical use. This requires the collaboration of medical (including quality control), medical insurance (including pricing), medical engineering (or material procurement) and other departments to analyze and handle specific problems. This article will also analyze and provide suggestions on the problems that are prone to occur in the management process of medical consumables from the perspective of fund supervision. 1、 Whether high-value medical consumables can be charged in compliance with regulations is directly related to the promotion and clinical use of new medical technologies, especially the innovative use of more precise/minimally invasive/safe diagnostic and treatment technologies due to the innovation of main materials (updates and iterations). The problem of charging for high-value consumables is directly related to the management of corresponding new medical technologies. Although management departments in various regions have gradually introduced the "Catalogue of Chargeable Medical Consumables", due to the limited scope of consumables covered by the catalogue and the endless use of new medical consumables caused by medical technology innovation, it is particularly important to guide clinical compliance fees for high-value medical consumables, which is also a high-frequency issue discovered during the supervision of medical insurance funds. The manifestation is: charging for consumables without any charging basis through "charging" or "swapping charges"; Consumables with charging basis will be subject to "incorrect charging", "missed charging", "duplicate charging", etc. due to execution errors.
Suggestions for refined management of medical institutions: 1. Move risks forward and strengthen source control. Before the selection of consumables for hospital price negotiations, the price management department should intervene early when relevant medical new technologies are approved. Based on the process of technology approval, the clinical department and relevant departments should be clearly informed whether they are chargeable consumables.
2. Adopt a dual approach to strengthen the management of non chargeable consumables. On the one hand, we need to do a good job in the pricing and fee declaration of new technology medical service projects, and use solid cost calculation data and in-hospital medical technology evaluation (Min HTA) results to promote the approval of chargeable medical consumables. On the one hand, it is necessary to manage the cost allocation of non chargeable consumables, propose a cost accounting plan based on the characteristics of the product, and form a consensus with the clinical use department and performance management department to avoid "incorrect charging, missed charging, and duplicate charging" due to inconsistent requirements and execution.
2、 According to the logistics/warehouse management approach, the discrepancy between the inventory and sales records is that within a certain period of time, the quantity of products received (purchase quantity) equals the quantity used (consumption quantity/billing quantity) plus the inventory quantity. After vigorously promoting UDI (Unique Identification of Consumables)+QR code billing, medical institutions can basically solve the problem of discrepancies between inventory and sales in high-value consumables management. However, with the continuous promotion of centralized procurement of consumables and the integration of national/provincial alliances/medical institution alliances, in the context of everything being able to be "integrated", high-value medical consumables are bound to decrease in price (generally reaching more than 50% of the proportion). For medical consumables that no longer have high prices, the issue of how to bear the cost of "one item, one code" and "coding" is extended. That is to say, from the perspective of cost management within the hospital, once the price drops to the point where it cannot cover the "coding" cost, such consumables should be charged and managed as regular consumables. However, from the perspective of clinical risk management, these materials are still "high-value consumables" and still require the management requirements of "one item, one code" in clinical use tracking and quality evaluation. For medical institutions with strong economic strength and operational capabilities, choosing "one item, one code+scan code billing" is still the optimal solution. This is also the main reason for the occurrence of "discrepancies between accounts and reality" in small and medium-sized medical institutions, as the "input-output ratio" needs to be considered from the perspective of hospital operation.
If neither the management nor the managed intentionally make a "mistake" subjectively, but the mistake still occurs, we should consider improvement and perfection from the perspective of institutional design. Suggestions: 1. Introduce the concept of tolerance rate in inventory management, similar to drug management, and set a range of allowable differences (such as amounts or values within 2 ‰). On the one hand, this is in line with the objective situation of natural wear and tear during clinical use, as well as the difference between inventory counting and billing time in clinical departments. After all, there are similarities and differences between the management of hospital consumables and market-oriented goods warehouses. Even though hospital consumables management is striving towards zero inventory with the help of third-party warehouse management, the clinical departments of hospitals cannot avoid storing a certain amount of consumables for emergency use. On the other hand, it also provides hospitals with room for improvement in self-management.
2. "Inconsistent inventory of consumables" is like the symptoms of a patient's illness rather than the cause. Only by identifying the underlying reasons for the discrepancy (whether it is caused by "charging for exchanging consumables", "sharing disposable consumables", or unclear financial settlement accounts...) can hospitals be targeted to solve problems and improve their level of refined management. According to Article 38 of the Regulations on the Supervision and Administration of the Use of Medical Security Funds, only in the case of "swapping consumables fees" is it within the regulatory scope of medical insurance fund recovery/punishment. For other reasons, it is recommended to transfer the clues to the "health" or "financial audit" departments for oral management, in order to truly play the role of medical insurance supervision and achieve twice the result with half the effort for medical institutions.
3、 The use of high-value medical consumables beyond the scope of the Medical Device Registration Certificate is currently the most complex and difficult issue in consumables management, as it relates to whether the scope of the Product Registration Certificate matches (is consistent with) the clinical indications. In August 2021, the State Administration for Market Regulation issued the "Management Measures for Registration and Filing of Medical Devices", which accelerated the approval process for new and clinically urgently needed medical consumables from the aspects of "innovative product registration procedures", "priority registration procedures", and "emergency registration procedures". However, in order to meet the demand for rapid market launch, the scope of the Product Registration Certificate for most Class III medical devices (medical consumables) is smaller than that of foreign registrations and also smaller than the gradually expanding indications in clinical practice. The author believes (suggestion): 1. Medical institutions should strengthen the approval process for the clinical use of new medical technologies (one patient, one review, one case, one batch), effectively play the role of the hospital's medical technology management committee and ethics committee, and clinical departments should strictly follow the indications to ensure medical safety. At the same time, medical institutions need to cooperate with enterprises and use objective data from clinical applications as support to encourage enterprises to expand the scope of product use on the Medical Device Registration Certificate as much as possible.
2. If such problems are discovered during the fund supervision process and it is confirmed that there is a problem of "swapping consumables fees/reimbursements", relevant management penalties should be imposed in accordance with the "Regulations on the Supervision and Administration of the Use of Medical Security Funds"; Otherwise, the clues should be handed over to the market supervision department to urge the enterprise to strengthen management and expand the scope of product use on the Medical Device Registration Certificate as soon as possible, fundamentally solving the problem. When there is a violation of patient rights, the clues should be handed over to the health management department or health supervision department to strengthen/improve the internal management of the hospital from the perspective of medical technology management.
4、 Promoting the rational use of high-value medical consumables in clinical practice, reducing patients' cost burden, and avoiding waste of medical insurance funds is an eternal issue in the refined management of consumables in medical institutions. Since the launch of the reform of medical insurance payment methods in 2019, the management method of bundled payment has forced medical institutions to strengthen internal cost control and quality evaluation and other internal management measures, neither over serving nor under serving. Therefore, the rational use of high-value medical consumables relies on the development and implementation of standardized clinical pathways; It also relies on the cost accounting and performance allocation baton under package payment; It also relies on monitoring consumables usage data and evaluating quality and effectiveness measures.
Only by strengthening information technology construction can Huashan achieve the goal of a three pronged approach. Here, it should be noted that although strengthening information technology construction has been promoted through various work such as medical insurance standardization and medical insurance list settlement, and consensus has been formed among hospital managers, there is still a lot of room for experts in medical, medical insurance, medical staff (material management), and information to work together to improve and perfect whether the data of various sub management systems in the hospital's HIS system are connected, whether the data of consumables management is related to clinical diagnosis and treatment data, and even affect the intelligent control of charging and reimbursement policies through the judgment of clinical indications.
On May 19, 2023, the Executive Meeting of the State Council approved the Implementation Opinions on Strengthening the Normalization Supervision of the Use of Medical Security Funds. When the wave of medical insurance fund supervision comes under the form of national flight inspections, medical institutions should first address the red line and bottom line issues related to fraud and insurance fraud, such as practicing in accordance with the law, charging in compliance with regulations, and managing financial receipts. As these regulations become more standardized, the issue of medical consumables closely related to medical technology management will gradually become prominent. Due to the complexity of medical consumables categories and the complexity of consumables management issues, it is destined to be a long and arduous journey to achieve refined management of medical consumables.