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集采反内卷!医保新周期,医疗器械企业该如何应对?
思宇MedTech· 2025-07-25 04:47
Core Viewpoint - The article discusses the recent developments in China's healthcare reform, particularly focusing on the medical device industry, highlighting the shift towards quality-driven procurement, credit evaluation systems, and the integration of innovative technologies into the healthcare payment system. Group 1: Procurement and Quality Control - The 11th batch of national drug procurement has been officially launched, emphasizing four principles: stabilizing clinical use, ensuring quality, preventing collusion, and countering internal competition [2] - New rules require that production lines must not have GMP violations within two years, and all selected companies must undergo comprehensive inspections [3] - The trend of "de-emphasizing low prices" is accelerating in high-value consumables procurement, with new mechanisms like clinical recommendations and quality reviews being introduced [3] Group 2: Credit Evaluation System - A dual-dimensional credit evaluation system has been established to address issues of market manipulation and excessive pricing by some companies [4] - By the end of 2024, 735 companies have been identified as untrustworthy, leading to restrictions on their procurement qualifications [4] - The new market entry logic emphasizes compliance and quality-driven operations, marking a shift from previous practices [4] Group 3: Pricing and Payment Reforms - The National Healthcare Security Administration (NHSA) is actively managing price risks, having completed eight rounds of price checks involving 566 companies and 726 product specifications [5] - The payment model has shifted from a "post-payment" to a "pre-payment" system, with total healthcare expenditure expected to reach 2.98 trillion yuan in 2024, reducing patient out-of-pocket expenses by approximately 5% [9] - The integration of innovative technologies into the payment system is accelerating, particularly for companies involved in AI imaging and interventional consumables [10] Group 4: Immediate Settlement and Direct Payment - The immediate settlement mechanism has been implemented in 91% of the national healthcare areas, reducing the settlement cycle from 30 to 20 working days [11] - The direct payment mechanism for selected companies is being promoted, which could significantly benefit cash-sensitive small and medium-sized medical device companies [11] Group 5: Regulatory Oversight and Compliance - The NHSA is enhancing its regulatory oversight, with a focus on compliance and transparency in the supply chain [12] - The establishment of big data models for monitoring healthcare practices is underway, with a focus on identifying and addressing fraudulent activities [14] - Future regulations will emphasize the tracking of medical devices and the ability to close data loops, which will directly impact market performance [17] Group 6: Innovations in Medical Services - The NHSA is accelerating reforms in medical service pricing, with over 100 projects focusing on cutting-edge technology and urgent clinical needs [18] - This creates a pathway for the integration of innovative medical devices into clinical use, payment, and service pricing [19] Group 7: Strategic Directions for Medical Device Companies - The article outlines five key areas for medical device companies to focus on in light of the ongoing healthcare reforms, emphasizing the need for quality, compliance, and value recognition [20][23]