New CMS Guidance for Biotech Industry on Coverage with Evidence Development: It’s All About the Outcomes

BiotechBlog

Robert E. Wanerman, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored a guest post on BiotechBlog, titled “New CMS Guidance for Biotech Industry on Coverage with Evidence Development: It's All About the Outcomes.”

Following is an excerpt:

For many biotech manufacturers, obtaining Medicare coverage is a significant milestone in commercializing an item or service. Although Medicare coverage for specific items or services that use biotechnology methods for their production, design or delivery can vary in different parts of the United States, a small number of them are guaranteed nationwide coverage if the Centers for Medicare and Medicaid Services (“CMS”) has issued a National Coverage Determination (“NCD”). Obtaining a NCD is a difficult process for companies in the biotech industry, and depends on factors such as the quantity and quality of clinical data, including outcomes data, and a consensus of professional opinions or practice guidelines.