Zhongtai Securities has released a research report stating that the newly issued draft guidelines for laboratory test pricing primarily represent a standardization and restructuring of the price system, with limited short-term impact on the financial performance of the in-vitro diagnostics (IVD) industry. As pricing items are unified and charging rules become standardized, the possibility for medical institutions to exploit pricing differences between individual test items will gradually narrow, which is expected to enhance transparency in industry charges. Structurally, innovative testing items and the detection of biomarkers for emerging diseases stand to benefit more clearly. Notably, the guidelines include a specific listing for Alzheimer's disease (AD) blood biomarker testing, providing a policy foundation for the future inclusion of related testing products into the official pricing system.
The National Healthcare Security Administration has released the "Guidelines for Establishing Pricing Items for Medical Laboratory Services (Draft for Comment)," which proposes consolidating existing price items for laboratory services into 573 standardized items. These items will feature unified names, service descriptions, billing units, and coding systems. The main viewpoints from Zhongtai Securities are as follows:
The guidelines establish a foundational framework by defining 573 price items covering major testing areas, including biochemical tests, immunological tests, microbiological tests, nucleic acid tests, tumor marker tests, and routine laboratory tests. The guidelines standardize the description of service outputs for these items. Most items are defined as detecting target substances in samples using appropriate methods selected based on clinical needs and issuing a test report. The guidelines also set standardized parameters for price composition, billing units, potential surcharges, and extensible items. Historically, inconsistencies have existed where the same test had different names or the same name had different prices across regions, leading to significant charging disparities. By unifying codes and service definitions, the guidelines are expected to significantly enhance price standardization, laying the groundwork for future cross-regional healthcare insurance settlements.
Pricing authority is delegated to provincial and municipal healthcare security departments, which will implement a maximum price cap management mechanism. When setting prices, these departments must fully consider the cost levels of mainstream testing methodologies. The prices set are considered government-guided prices, managed under a maximum price cap system with no restrictions on downward adjustments. This mechanism provides a unified pricing framework while allowing local authorities flexibility to manage prices according to regional medical resources, cost structures, and payment capacities.
The guidelines continue the reform direction of separating technical service fees from consumable costs. The price for laboratory services is defined as comprising mainly human resource consumption and basic material resource consumption. Basic materials, including reagents, disinfectants, and syringes, are incorporated into the item price and are not charged separately. Other consumables beyond these basics are to be sold at a zero markup based on actual procurement cost. This design clarifies the boundaries of price composition and further standardizes the charging system, reducing opportunities for non-standard profit margins. To account for cost differences arising from various testing methodologies or application scenarios, the guidelines introduce "surcharge items." For instance, techniques like high-performance liquid chromatography, mass spectrometry, or ultracentrifugation can incur a surcharge on top of the base item price, with specific surcharge or discount standards determined by provincial/municipal authorities. If multiple surcharges apply to a single service, charges are based on the base price plus the applicable surcharges.
Items related to the detection of neurological markers for Alzheimer's Disease (AD) are centrally listed under items 185 to 195. These include key indicators such as beta-amyloid, Tau protein, phosphorylated Tau protein (pTau), and neurofilament light chain (NfL). Previously, the promotion of AD blood biomarker testing in domestic medical institutions was hindered by the lack of specific price items, making it difficult to apply for charges or include them in insurance payment systems. By clarifying the pricing framework for these tests, the guidelines provide a basis for subsequent provinces to set specific fee standards. This is expected to facilitate the transition of AD blood testing from being "technically feasible" to "clinically billable," thereby clarifying its industrialization path.
The guidelines stipulate that medical institutions must store and upload compliant test result data when providing laboratory services and must use nationally defined standard reference intervals. Failure to provide data or use standard intervals will result in a reduction in reimbursement. By integrating data provision and reference interval standardization into pricing rules, the policy aims to enhance the standardization and comparability of test results, providing a foundation for insurance oversight and clinical quality assessment. Furthermore, the guidelines uniformly include an "artificial intelligence assistance" extensible item within test descriptions, although no separate surcharge is currently applied for this feature.
Risks include potential delays in policy implementation, slower-than-expected research and development progress, challenges in product commercialization and scaling, and the risk of information used in the research report becoming outdated.