产品获批又遇到支付问题？美国也很难

Core Viewpoint - The article highlights the significant delay in the coverage of innovative medical devices by Medicare and Medicaid in the U.S., which can take nearly six years after FDA approval, impacting patient access to potentially life-saving technologies [1][2][5]. Group 1: FDA Approval vs. CMS Payment - The commercialization path for medical devices in the U.S. is often described as having "two doors," with the first being FDA approval for safety and efficacy, and the second being CMS payment coverage [3][10]. - The average time from FDA approval to CMS coverage decision for innovative devices requiring new payment pathways is nearly six years [2][5]. - Without CMS coverage, even advanced products remain unaffordable for most patients, limiting their market reach [4][10]. Group 2: Challenges of Innovation - U.S. companies face a dilemma where FDA approval signifies potential but CMS payment decisions are crucial for clinical adoption [5][16]. - The lack of payment pathways leads to a situation where only a few financially capable patients can access new devices, while most remain excluded [4][10]. Group 3: Current Policy Attempts and Limitations - CMS has introduced programs like TCET (Transitional Coverage for Emerging Technologies) to provide temporary payment for new technologies while collecting clinical evidence [9][14]. - The MCIT (Medicare Coverage of Innovative Technology) framework aimed to automatically cover FDA-approved products but was controversial and ultimately discontinued [9][14]. Group 4: Impact on Companies and Investors - FDA approval does not guarantee commercial success, as many companies struggle with payment obstacles post-approval, leading to extended exit timelines for venture capital [16][17]. - The uncertainty in payment pathways has accelerated mergers and acquisitions in the industry, as smaller companies seek partnerships with larger firms to navigate these challenges [18][19]. Group 5: Broader Implications - The article emphasizes that the challenges faced by U.S. companies in securing payment for innovative products reflect a global issue in healthcare innovation, where technological advancements often outpace regulatory and reimbursement frameworks [21].