US CMS Coverage Office Reorganizes In Effort To Improve Efficiency
Executive Summary
The office that oversees Medicare coverage decisions and policies has restructured in an effort to improve predictability and efficiency in evaluating new technologies. Medtech industry leaders say more reforms are needed.
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US FDA's Sean Boyd gave an inside look at how the agency plans to organize its Office of Product Evaluation and Quality (OPEQ) – the so-called "super office" that will consolidate a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities. Plus: Five expected benefits for device-makers (and five for FDA) under the OPEQ reorganization are highlighted.
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The US Centers for Medicare and Medicaid Services has withdrawn efforts on a proposed rule to offer faster Medicare reimbursement to novel devices, but the agency still plans to work on different approaches to provide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.
21st Century Cures: Device Provisions
Dozens of reforms impacting the medtech sector were signed into law Dec. 13 as part of the 21st Century Cures Act. Here's a breakdown of the provisions most important to device- and diagnostic-makers.