Zhongtai: Draft Regulations for Approval of Inspection Projects Sent for Comments Released, Providing Additional Space for Innovative Testing and Establishing AD Biomarker Testing Items

Zhongtai released a research report stating that the new inspection project approval guidelines mainly focus on the standardization of pricing system restructuring, with limited short-term impact on the IVD industry's performance. With the unified pricing projects and standardized fee rules, the possibility for medical institutions to gain price space through project differences will gradually decrease, and industry fee transparency is expected to improve. Structurally, the benefits are more evident for innovative testing projects and emerging disease biomarker testing fields. Among them, AD blood biomarker testing is prominently featured in this guideline, providing a policy basis for the future incorporation of related testing products into the fee system. Event: The National Medical Insurance Administration released the "Examination Medical Service Price Project Approval Guidelines (Draft for Solicitation of Opinions)", intending to integrate the current examination medical service price projects into 573 items and unify project names, service content, pricing units, and coding systems. Zhongtai's main points include: Unified inspection project framework, covering mainstream testing fields with 573 price projects The guidelines establish a total of 573 inspection medical service price projects, covering major fields such as biochemical testing, immunological testing, microbiological testing, nucleic acid testing, tumor biomarker testing, and routine inspections. The guidelines standardize the service output descriptions of inspection projects, most of which are defined as detecting target substances in samples using suitable methods based on clinical needs and issuing inspection reports. The guidelines set standard pricing, pricing units, additional charges, and extension items for price composition. Historically, there have been inconsistencies in the names and prices of inspection projects, and significant differences in charges among regions. Through unified coding and service content, this initiative is expected to significantly improve the standardization of price projects, laying a foundation for future medical insurance cross-regional settlements. Price-setting authority devolves to local medical insurance departments, implementing a maximum price management mechanism The guidelines clarify that the prices of inspection medical service projects are to be set by provincial and municipal medical insurance departments, with due consideration given to the cost levels of mainstream testing methods. The prices set by each region are government-guided prices subject to maximum price management without a lower limit. This mechanism, while unifying the pricing project framework, allows local medical insurance departments room for price management based on regional medical resources, cost structures, and payment capabilities. Continuing the "Separation of Technical Fees" reform direction, innovative testing projects retain additional charge space The guidelines specify that the prices of inspection medical services mainly consist of human resource consumption and basic material resource consumption. Basic material resource consumption includes reagents, disinfection materials, syringes, and other laboratory basic consumables, which are included in project prices and no longer separately charged. Other consumables apart from basic material resources are sold at zero markup based on actual purchase prices. This design continues the core idea of "Separation of Technical Fees" in medical service price reform, clarifying the boundaries of price composition while further standardizing the inspection fee system and reducing non-standard profit space. To address cost differences brought about by different testing methods or applications, the guidelines set "additional charges" for price differentiation. For example, techniques such as high-performance liquid chromatography, mass spectrometry, ultra-speed centrifugation, etc., can be subject to additional charges on top of the base project price, with specific standards being set by provincial and municipal medical insurance departments. In actual charges, if multiple additional charges apply, the price is based on the project unit price with additional fees added based on the actual situation. AD-related neural biomarker testing projects are prominently listed, further clarifying the industrialization pathway In this guideline, multiple Alzheimer's disease (AD)-related neural biomarker testing items, including beta-amyloid protein, Tau protein, phosphorylated Tau protein (pTau), neurofilament light (NfL), and other key indicators, are listed in items 185 to 195. Previously, the promotion of AD blood biomarker testing in domestic medical institutions mainly faced the issue of lack of price projects, making it difficult for related tests to be declared for payment or included in the medical insurance payment system. This guideline explicitly outlines the price framework for related testing projects, providing a basis for provinces to follow in setting specific fee standards, thereby promoting the transition of AD blood testing from "technically viable" to "clinically chargeable" and further clarifying the industrialization pathway. Clearing the policy on inspection data storage and reduction, strengthening the standardization and comparability of inspection results The guidelines specify that medical institutions providing inspection services must store and upload inspection result data that meet requirements, and use the nationally specified standard reference ranges. Those who do not provide inspection data or do not use the standard reference ranges will face a certain degree of fee reduction policy. By incorporating inspection result data provision and the standard reference range standardization into price management rules, the policy helps enhance the standardization and comparability of inspection results, providing a basis for medical insurance supervision and clinical quality assessment. Additionally, the guidelines uniformly set up an "artificial intelligence-assisted" extension item in the inspection projects, incorporating it into the inspection process description, but without a separate charge at this time. Risk warning: Policy implementation falling short of expectations, R&D progress falling short of expectations, commercialization of products falling short of expectations, delayed information updates in research reports, etc.