Neglecting CMS approval requirements for your IDE study may jeopardize timelines, costs and more. Use the following insights and actionable steps to mitigate the risk of enrollment delays, financial and reputation damage by aligning your FDA IDE application with CMS requirements for coverage.
Clinical trials of investigational medical devices operate on strict timelines that are critical to companies' commercialization goals. When developing these timelines, sponsors typically account for IDE approval, site qualification and selection, and start-up activities including contracting, budgeting, and IRB approvals. However, one crucial step is often overlooked: securing approval from the Centers for Medicare & Medicaid Services (CMS) for coverage of routine care costs associated with the study. Here, we will unpack hgow proper CMS-IDE alignment can prevent study selays and budget overruns
In studies expecting to receive insurance reimbursement for routine care costs, securing CMS approval can make-or-break study initiation. IDE approval and IRB approval are required prerequisites before submitting to CMS for a coverage determination, which may take a month or more for approval.
Here's the critical reality: many U.S. IDE trial sites will not initiate enrollment without CMS coverage approval, unless the sponsor pays for all costs in the trial (a scenario that is usually cost-prohibitive). Sites that start enrollment without approval may do so unknowingly and could face later rejection of claims for procedure fees, leaving either the site or the sponsor responsible for unexpected costs.
This scenario can quickly add five or six figure burdens to sponsors, compromising budgets or creating burdens the sites or the patients did not anticipate, tarnishing credibility and reputations.
On the bright side, although CMS approval is only applicable to patients under Medicare or Medicaid, private payors often align with CMS coverage decisions, further amplifying the importance of securing this approval early in your study timeline.
CMS coverage of items and services in FDA-approved IDE studies is described in 42 CFR § 405.211. IDE approvals fall into one of two categories:
It's important to note that IDE approval alone is insufficient to secure coverage. A separate approval from CMS is required prior to the submission of the first related claim in an IDE study.
Routine costs in IDE studies that may be covered in either the experimental or control arms include:
Notably, such coverage does not include items and services provided solely to satisfy data collection and analysis needs, or items and services customarily provided by the sponsor free of charge.
The CMS submission must address 10 criteria required for Medicare Coverage of IDE studies, as described in 42 CFR § 405.212. Some of these criteria should be considered during protocol development, prior to submitting your IDE to FDA. Two particularly important requirements include:
Omitting these details from the protocol could delay CMS approval of the study, creating downstream timeline impacts.
If you and your trial sites expect or depend upon CMS coverage of procedural fees, routine care costs, and potentially investigational device costs, timeline planning must account for the CMS approval process. The sequence matters: secure IDE and IRB approvals first (including protocol elements in which CMS will be interested), then submit for CMS coverage determination well before your planned enrollment start date. Most importantly, do the following:
There is considerable finesse needed when addressing the required items in the CMS submission package for an IDE trial in a way that is acceptable to CMS reviewers. If you're planning an IDE study or if you're unsure about CMS requirements, experienced guidance can help navigate this complex process successfully.
Related reading: Clinical Reality Check: Core Considerations for IDE Success by Tracy Case.
The Clinical Research Team at Veranex has this experience. We have successfully guided numerous medical device innovators through IDE applications with CMS approval. We can help at any point prior to your IDE application, CMS submission and beyond backed by the power of the industry’s first iCRO.
Marc Zimmermann is Senior Director of Clinical Affairs for CRO & Consulting Services.
As a strategic and operational leader for U.S. and international clinical study programs Marc possesses 16+ years of experience in medical device industry, at CRO and Sponsor companies He possesses extensive medical device clinical research experience ranging from First-In-Human/feasibility studies to pivotal trials in pursuit of medical device commercialization along with special expertise with U.S. IDE studies of Class II (510(k) and De Novo) and Class III (PMA) medical devices, ranging from surgery-enabling technologies to short-term and long-term implants.
Tracy Case : Sep 17, 2025 2:41:36 PM
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