Medicare: National Coverage Determinations Are Generally Timely, but Improvements Are Needed
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.
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) |
HHS concurred with this recommendation, and in June 2026, updated the Center for Medicare and Medicaid Services' (CMS) Coverage and Analysis Group Standard Operating Procedure (SOP) to ensure delays in national coverage determination (NCDs) are documented and the causes are addressed. Specifically, the SOP directs CMS staff to record in its internal and public tracking systems a brief description of the cause of a delayed NCD, that is, an NCD for which CMS published a proposed decision more than 6 months after the tracking sheet or published a final decision memo more than 90 days after it published a proposed decision. Additionally, the SOP directs CMS staff to analyze the cause of the delay through discussions with staff and management and take actions based on the nature of the delay. Specifically, staff will develop and implement actions to prevent future delays if the determined cause was within CMS's control. Further, CMS staff will conduct a more indepth analysis if the corrective actions fail to prevent similar future delays. Consistent with its documentation procedures, in October 2025, CMS published on its public Medicare Coverage Database the cause of two NCD delays that were due to a lapse in appropriations and told us that it had also documented the delays in its internal NCD database. By documenting and analyzing the causes of delayed NCDs, CMS will be better positioned to monitor its performance and make changes as appropriate to improve NCD timeliness, which may, in some cases, facilitate access to new or enhanced evidence-based services.
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| 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) |
As of January 2026, CMS continues to work on this recommendation.
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