How Proper CMS-IDE Alignment Prevents Study Delays and Budget Overruns

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 
 

Why CMS Approval for IDE Studies Matters More Than You Think 

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. 

Understanding What's Covered by CMS Under Federal Regulations for IDE Studies 

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: 

• Category A (Experimental) IDE Study: Allows coverage of routine care items and services furnished in the study, but not of the Category A device itself. 
  
• Category B (Nonexperimental/Investigational) IDE Study: Allows coverage of both the Category B device and the routine care items and services in the trial. 

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. 

What Constitutes Routine Costs? 

Routine costs in IDE studies that may be covered in either the experimental or control arms include: 

• Items or services that are typically provided absent a clinical trial (conventional care) 

• Items or services required solely for the provision of the investigational item or service, the clinically appropriate monitoring of effects, or the prevention of complications 
• Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service, particularly for the diagnosis or treatment of complications 

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. 

Protocol Considerations that Impact CMS Submissions Prior to IDE Application 

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: 

1. Results Release Protocol: The study protocol must describe the method and timing of release of results on all pre-specified outcomes, including release of negative outcomes. The release should be hastened if the study is terminated early. 
2. Medicare Population Generalizability: The study protocol must describe how Medicare beneficiaries may be affected by the device under investigation, and how study results are or are not expected to be generalizable to the Medicare beneficiary population. Generalizability to populations eligible for Medicare due to age, disability, or other eligibility status must be explicitly described. 
   

    
   Omitting these details from the protocol could delay CMS approval of the study, creating downstream timeline impacts. 

Carefully Consider Sequencing and Timelines Including CMS Approval for IDE Studies: Practical Actions to Take 

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: 

1. Ensure the CMS required elements are included in the study protocol prior to submitting the IDE to FDA,  
2. Project plan the study timeline to minimize delays to CMS approval, and  
3. Develop the CMS submission, with particular care in addressing the 10 CMS criteria, prior to anticipated IDE and IRB approval, to ensure no long lead times after these milestones are met.
   

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. 

About the Author: Marc Zimmerman

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.