Federal audit finds Medicare coverage process efficient but opaque

Medicare’s process for deciding whether to cover new drugs, devices, and diagnostics largely meets its own deadlines. But a new federal audit warns that the Centers for Medicare & Medicaid Services (CMS) still leaves patients and providers in the dark about why some decisions drag on — and how the agency decides which requests move first. 

The Government Accountability Office (GAO) report, released September 9, 2025, found that CMS finalized 83 percent of its national coverage determinations (NCDs) within required nine- or twelve-month time frames between October 2012 and February 2025. Yet nine reviews stretched months, even years, past those deadlines. In one case, a cancer cell therapy decision took nearly a year longer than the law allows. 

GAO concluded that CMS has not systematically identified the causes of delays or shared the criteria it uses to prioritize reviews. Without such transparency, the watchdog warned, beneficiaries with life-threatening conditions may face needless waits for treatments already deemed safe and effective by the Food and Drug Administration. 

“The GAO report makes clear that CMS must do more to provide transparency and accountability in its coverage decisions,” said House Energy and Commerce Chair Brett Guthrie (R-Ky.) and Ways and Means Chair Jason Smith (R-Mo.) in a joint statement responding to the report. “Seniors should never be left waiting without clear answers about whether Medicare will cover the treatments and services their doctors recommend.” 

A trillion-dollar program under scrutiny

Medicare spent nearly $1 trillion in 2024, about 15 percent of all federal spending. With finances under strain and Congress facing pressure to contain costs, any inefficiency in CMS’s decision-making attracts attention. 

NCDs set nationwide rules for whether Medicare will pay for items ranging from cardiac pacemakers to Alzheimer’s drugs. A positive decision can instantly open access for millions of beneficiaries; a negative or delayed decision can stall uptake of new therapies for years. 

The GAO reviewed CMS’s handling of 53 coverage analyses over the past decade. While most met deadlines, the nine delayed cases raised red flags. CMS officials blamed the COVID-19 public health emergency, a 2018–2019 government shutdown, and the arrival of new clinical evidence during reviews. But GAO noted the agency does not document delays or analyze root causes. 

Staffing and workload squeeze

Behind the process problems lies a deeper resource crunch. CMS has faced a 22 percent staff reduction since December 2024, including key medical officers who conduct evidence reviews. A hiring freeze dating to July 2023 has compounded the shortage, and more retirements are expected in coming years. 

With fewer staff, CMS has turned to contractors for evidence assessments, particularly under its new Transitional Coverage for Emerging Technologies (TCET) pathway. But stakeholders told GAO that navigating the process remains expensive and unpredictable. 

Even for groups that successfully win coverage, the path can be bumpy. While many stakeholders praised the thoroughness of CMS’s analyses, they also said communication was inconsistent, with requesters sometimes receiving little feedback at critical junctures. 

Transparency gap 

Perhaps the sharpest criticism concerns CMS’s lack of clarity on how it prioritizes requests. The agency says it considers the magnitude of impact on beneficiaries and staff resources, but those criteria are not public. GAO found that four of 13 stakeholders interviewed could not understand why some requests advanced quickly while others languished on a wait list. 

In 2023, CMS began publishing a quarterly dashboard of accepted but not-yet-initiated requests. Still, GAO urged the agency to go further by releasing its full prioritization criteria. Doing so, auditors argued, could improve stakeholder trust, sharpen request quality, and streamline reviews. 

The Department of Health and Human Services agreed with GAO’s two recommendations: identify causes of delays and make prioritization rules public. CMS has said it is developing a new internal database that would notify requesters automatically of milestones such as public comment deadlines. But there is no timeline for when that tool will become available. 

Political pressure mounts

Congressional Republicans seized on CMS’s 2022 decision to restrict coverage for an entire class of anti-amyloid Alzheimer’s treatments despite FDA approval as evidence of unchecked discretion. The agency issued a blanket NCD that severely limited Medicare coverage for drugs like Aduhelm, citing insufficient evidence of clinical benefit for the Medicare population. Republicans argued this left patients who might benefit from these treatments without access, even when their doctors deemed them medically necessary. 

The Alzheimer’s controversy exemplifies broader tensions over CMS’s coverage process. While the agency must balance innovation access with evidence-based medicine, critics argue its opaque decision-making creates uncertainty for patients, providers, and manufacturers. 

Democrats have been more measured in their criticism, often pointing to the need for balance between speed and safety. Recent caucus statements emphasized that Medicare should not become a bottleneck for transformative therapies, but must guard against premature adoption of costly technologies without strong evidence. 

The bipartisan undertone: Medicare’s processes, designed decades ago, are straining under today’s scientific and political pressures. With cancer immunotherapies, gene therapies, and AI-driven diagnostics all pressing for coverage, lawmakers see urgency in reform. 

The bigger picture

The GAO’s conclusions echo a broader theme in U.S. health policy: as biomedical innovation accelerates, regulatory and reimbursement structures lag. For Medicare’s 68 million beneficiaries, that gap can mean delayed access to promising treatments. For innovators, it creates financial uncertainty that may deter investment. 

CMS has taken steps — from publishing dashboards to experimenting with TCET — to modernize. The agency also works with FDA through parallel review processes and has created alternative pathways like Category B Investigational Device Exemption to expedite certain coverage decisions. 

As medical innovation continues to advance rapidly, the pressure for Medicare to keep pace will only intensify.