New U.S. legislation aims to speed up Medicare coverage decisions
美國新法案旨在加快聯邦醫療保險的承保決策速度
更新於: 2026年6月5日 上午01:00
In early 2026, U.S. health agencies and lawmakers launched a major effort to reduce delays in Medicare coverage.
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。
Historically, patients often faced a long wait for new medical devices to be covered after FDA approval.
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。
To bridge this gap, the Centers for Medicare & Medicaid Services and the FDA introduced the RAPID pathway.
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。
By aligning evidence requirements during clinical development, RAPID aims to shorten the coverage timeline for breakthrough devices to just 60 to 90 days.
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。
Beyond administrative changes, Congress is tackling systemic bottlenecks through new legislation.
除了行政變革，國會也正透過新法案解決系統性的瓶頸。
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.
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。
Meanwhile, the Timely Access to Coverage Decisions Act addresses regional variations by setting strict deadlines for Local Coverage Determinations.
同時，《及時保險給付決定法》(Timely Access to Coverage Decisions Act) 則透過為在地給付裁定(Local Coverage Determinations)設定嚴格期限，來解決地區差異問題。
While the industry largely welcomes these changes as a way to provide faster patient access to life-saving technology, some experts urge caution.
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。
