Title: “Understanding CMS Authority to Limit Coverage of FDA-Approved Products: Legal and Policy Considerations”
Summary:
The article explores the legal framework and policy considerations surrounding the Centers for Medicare & Medicaid Services (CMS) authority to shape coverage of FDA-approved products under Medicare Part B. The CMS, tasked with determining whether therapies are “reasonable and necessary” for coverage among Medicare beneficiaries, faces controversy in exercising this authority. The authors review legal precedents and recent CMS decisions, emphasizing the challenges posed by limited clinical evidence for new drugs and devices. The article discusses the use of conditional coverage, such as Coverage with Evidence Development (CED), and the implications for Medicare’s ability to provide effective and efficient coverage. The authors suggest potential amendments to clarify CMS’s coverage discretion and address the evolving landscape of FDA approvals.