CMS Working On Coverage With Evidence Development Despite Scrutiny
Executive Summary
CMS "hopes to issue" a revised draft guidance document on coverage with evidence development (CED) in the spring or summer of 2006, according to Tamara Syrek Jensen, deputy director of CMS' coverage and analysis group
You may also be interested in...
CMS To Use Coverage With Evidence Development When Rx Benefit Is Likely
The Centers for Medicare & Medicaid Services will use coverage with evidence development only when an agent is highly likely to show benefit in a broader patient population than its labeled indication, CMS Senior Advisor Peter Bach said Dec. 5
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials