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Medicare: National Coverage Determinations Are Generally Timely, but Improvements Are Needed

GAO-25-107623 Published: Sep 09, 2025. Publicly Released: Sep 09, 2025.
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Fast Facts

When Medicare beneficiaries need medical devices or health care services, they can choose from among the items and services that Medicare has decided to cover. 

Medicare sets time frames for determining coverage and meets its goals more than 80% of the time. However, the agency doesn't systematically identify the reasons why some decisions are delayed, which may make it harder to improve timeliness.

There are also concerns that Medicare isn't transparent about how it prioritizes reviews of new coverage requests. Making this information available could improve the quality of requests.

Our recommendations address these issues.

A doctor is showing a pacemaker to a senior patient, sitting on a sofa in a home-like health care office.

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Highlights

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.

Example of a Cardiac Pacemaker

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.

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.

Recommendations for Executive Action

Agency Affected Recommendation Status
Centers for Medicare & Medicaid Services The Administrator of CMS should identify the causes of any delays in national coverage determinations and take actions, as appropriate, to better ensure that analyses are finalized within the specified time frames. (Recommendation 1)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.
Centers for Medicare & Medicaid Services The Administrator of CMS should make available to the public the criteria it uses to prioritize its analyses of national coverage determination requests. (Recommendation 2)
Open
When we confirm what actions the agency has taken in response to this recommendation, we will provide updated information.

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