How GAO Did This Study
We reviewed CMS’s Medicare coverage process and other documentation. We also compiled coverage analyses data to report on CMS’s ability to meet specified time frames, among other things. We interviewed officials from CMS and other agencies, and requesters and public commenters, who have taken part in the process.
Why This Matters
The Centers for Medicare & Medicaid Services (CMS) makes national coverage determinations to grant, limit, or exclude coverage for medical items and services for 68 million Medicare beneficiaries. CMS follows an evidence-based process to determine whether items are reasonable and necessary for prevention, diagnosis, or treatment of an illness or other condition.
GAO Key Takeaways
Requests for national coverage determinations can be made by health providers, organizations, the public or internally by CMS. CMS reviews the requests and prioritizes the analyses to make coverage determinations. CMS met specified time frames of 9 or 12 months for 83 percent (44 of 53) of the analyses it made determinations for from October 2012 through February 2025. The remaining nine took an additional 6 to 351 days to finalize. We found the agency did not systematically identify the causes of delays when it did not meet specified time frames. Doing so would allow CMS to better monitor its performance and improve timely analyses, which, in some cases, could help Medicare beneficiaries access new or enhanced evidence-based items and services.
According to CMS officials, the agency works with contractors to help mitigate workload and staffing constraint challenges.
Additionally, stakeholders cited challenges related to varied frequencies of CMS’s communication about the status of their requests and a lack of transparency about the criteria the agency uses to prioritize requests. CMS officials said they are creating an internal database that would provide requesters with routine updates, but the agency has not made public the criteria used to prioritize requests, leading to stakeholder concerns about transparency.
Recommendations
We are making two recommendations to CMS: 1) identify the causes of national coverage determination delays to better ensure that analyses are finalized within specified time frames, and 2) make available to the public the criteria it uses to prioritize its coverage analyses. The Department of Health and Human Services concurred with our recommendations.
