美國新法案旨在加快聯邦醫療保險的承保決策速度
New U.S. legislation aims to speed up Medicare coverage decisions
Updated at: June 5, 2026 at 01:00 AM
2026 年初，美國衛生機構與立法者發起了一項重大計畫，旨在減少聯邦醫療保險(Medicare)的給付延遲。
In early 2026, U.S. health agencies and lawmakers launched a major effort to reduce delays in Medicare coverage.
過去，病患在 FDA 批准後，往往需要漫長等待才能取得新款醫療器材的給付。
Historically, patients often faced a long wait for new medical devices to be covered after FDA approval.
為了縮短這段落差，聯邦醫療保險與醫療補助服務中心(CMS)與 FDA 推出了「RAPID」捷徑機制。
To bridge this gap, the Centers for Medicare & Medicaid Services and the FDA introduced the RAPID pathway.
透過在臨床開發期間統一證據要求，RAPID 的目標是將突破性器材的給付時程縮短至 60 到 90 天。
By aligning evidence requirements during clinical development, RAPID aims to shorten the coverage timeline for breakthrough devices to just 60 to 90 days.
除了行政變革，國會也正透過新法案解決系統性的瓶頸。
Beyond administrative changes, Congress is tackling systemic bottlenecks through new legislation.
2026 年的《聯邦醫療保險優勢改善法》(Medicare Advantage Improvement Act of 2026) 尋求將事先授權(prior authorization)的時間縮短至最快 24 小時，並限制使用自動化的拒絕演算法。
The Medicare Advantage Improvement Act of 2026 seeks to shorten prior authorization times to as little as 24 hours for expedited requests and limits the use of automated denial algorithms.
儘管產業界大多歡迎這些變革，認為這能讓病患更快取得救命技術，但也有專家呼籲審慎。
While the industry largely welcomes these changes as a way to provide faster patient access to life-saving technology, some experts urge caution.
批評者警告，加速這些流程絕不能犧牲嚴謹且以實證為基礎的安全標準，並強調速度與優質照護之間必須取得平衡。
Critics warn that accelerating these processes must not compromise rigorous, evidence-based safety standards, emphasizing the need for a balance between speed and quality care.
