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A recent report from the U.S. Government Accountability Office (GAO) indicates that the Centers for Medicare & Medicaid Services (CMS) generally meets its established timelines for making national coverage determinations, a crucial process that impacts what medical devices and services are covered for millions of Medicare beneficiaries. The agency successfully met the specified time frames for 83 percent of the analyses it completed between October 2012 and February 2025. These determinations are based on an evidence-based review to ascertain if items are reasonable and necessary for the prevention, diagnosis, or treatment of illnesses or other conditions.

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Despite meeting its goals a significant majority of the time, the GAO report highlights that CMS does not systematically identify the reasons for delays when coverage determinations exceed the designated 9 or 12-month periods. The nine analyses that did not meet these time frames experienced delays ranging from an additional 6 days to over a year. The absence of a systematic approach to analyzing these delays could hinder CMS’s ability to improve its performance and potentially slow down Medicare beneficiaries’ access to new or enhanced evidence-based medical items and services. CMS officials noted that they collaborate with contractors to manage workload and staffing challenges, which can influence processing times.

Furthermore, the report points to concerns raised by stakeholders regarding the transparency of CMS’s prioritization process for new coverage requests. While CMS is developing an internal system to provide requesters with routine status updates, the criteria used to prioritize these requests have not been made public. This lack of transparency has led to concerns among stakeholders, who believe that making these prioritization criteria available could improve the quality of the requests submitted for review.

In response to these findings, the GAO is making two recommendations to CMS. Firstly, the agency is advised to identify the causes of delays in national coverage determinations to ensure that analyses are completed within the established time frames. Secondly, CMS should make public the criteria it uses to prioritize its coverage analyses. The Department of Health and Human Services has concurred with both of these recommendations.

Article by Mel Anara, based upon information from the U.S. Government Accountability Office.


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