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New AdvaMed Report Finds Critical Need for Enhanced CMS Resources


AdvaMed, the Medtech Association, released a new report, done in collaboration with Health Management Associates, that highlights the need for new resources to support the work of the Coverage and Analysis Group (CAG) at the Centers for Medicare & Medicaid Services (CMS). The resources are necessary for the agency to fulfill its responsibilities for making coverage decisions for 65 million Medicare beneficiaries.   

The report, Medicare’s Coverage Processes: An Analysis of Procedural and Resource Concerns, found that this resource shortage comes as CMS is expecting to take on new responsibilities, including coverage decisions for FDA-approved breakthrough medical technology for beneficiaries. These new responsibilities are expected to come through a Notice issued on Transitional Coverage for Emerging Technologies (TCET), and it is expected to strain the agency’s existing workload. 

“FDA has done a good job over the years of working to ensure it has the resources and staff at appropriate levels to keep pace with the medtech industry’s efforts to meet patient needs, particularly in the wake of the most recent MDUFA. However, when it comes to getting these approved devices covered under Medicare, CMS lacks the necessary resources to keep up,” Scott Whitaker, AdvaMed President and CEO said. “The problem is that too many companies with promising, FDA-approved medical technologies and treatments for patients often have to wait years for a decision by CMS. This isn’t good for patients in need. We look forward to working with CMS on the recommendations in this report that will help make this critical process faster, more predictable, and more transparent.” 

The report found that the number of National Coverage Decision (NCD) requests completing CMS’ review process has declined annually over the past 20 years, but the length of time these requests spend under review has increased. In addition to this finding, the report also notes stakeholders’ concerns about a lack of predictability and transparency with regard to CMS’s timelines for coverage acceptance or denial and how reviews are prioritized. 

The report includes several recommendations to improve the CMS’ coverage process to address predictability and transparency concerns, such as adding administrative timelines for review of coverage requests and creating performance metrics to ensure that decisions about coverage are made on a timely basis.      

On the question of resources, the report offers several ideas for enhancing CMS/CAG staffing resources, which CMS admits in the TCET Notice are very much needed. These include providing new funding for CMS/CAG through the appropriations process and allowing CMS to draw physicians or other clinician experts from with the larger Department of Health and Human Resources. These resources are needed if CMS is to improve processes for providing Medicare beneficiaries access to the innovative new technologies that are transforming health care delivery in the country. 

Read the full report here.

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