ARTICLE SUMMARY:
The need to factor in reimbursement and not just regulatory needs during early-stage data planning has become a fact of life for device firms. But how does a company know what payors are looking for to support coverage of new technology? In our latest spotlight from Pathways’ Document Depot: CMS signals a future of more clinical guidance from Medicare.
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidances, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
FDA guidance documents are a routine part of the medtech development cycle. If the agency has published a guideline laying out data and/or submission expectations related to your company’s product, that document is going to be an important driver of your development planning. But a CMS guidance document? Not so much.
There is an ever-growing push for companies to plan evidence needs to support reimbursement and market access as early as possible, in conjunction with FDA study preparation. But definitive guidance about what data CMS (and other payors) will need is lacking.
