Breakthrough Reimbursement Proposals Percolate From FDA, Industry
This article was originally published in The Gray Sheet
Executive Summary
As industry continues to nudge CMS to follow FDA's lead in making reforms that streamline the path to market for innovative new devices, the agencies are themselves floating solutions. All sides are thinking up strategies to rely on FDA's determination that a device meets certain "breakthrough" standards to trigger a streamlined path to data-conditioned reimbursement. But some in industry are concerned about an overemphasis on national, rather than local, coverage, and, in particular, the Medicare coverage-with-evidence-development process.
You may also be interested in...
Despite Only Two Parallel Review Success Stories, CMS Touts Better Coordination
While only two devices have received approval and a national coverage determination through US FDA/CMS' parallel review program, a top CMS official says industry needs to look beyond just the numbers. Instead, she says the parallel review program is part of a sea-change that has allowed for better communication between CMS, FDA and sponsors.
Medicare Will Look To Informal Pathways For Faster Medtech Reimbursement
The US Centers for Medicare and Medicaid Services has withdrawn efforts on a proposed rule to offer faster Medicare reimbursement to novel devices, but the agency still plans to work on different approaches to provide "timely patient access" to device innovations, a spokeswoman said. AdvaMed says it is disappointed by CMS's decision to withdraw the rule after a 10-month review by the Office of Management and Budget.
FDA, CMS Heads Press For 'Single Front Door' For Real-World Evidence
US FDA, CMS and NIH continued push for more collaboration. Co-agency article outlining collaboration on real-world evidence suggests one path forward under a new administration.