Medicare Coverage Related to Investigational Device Exemption (IDE)

Requesting Coverage

Interested parties with Food and Drug Administration (FDA) approval letters dated January 1, 2015 or later for IDE Category A or Category B studies that are seeking Medicare coverage for Category A or B IDE studies must submit a request packet to CMS that includes the following information:

A. A request letter that describes the scope and nature of the IDE study. For your convenience we created a checklist and sample crosswalk to assist submitters in submitting a complete package. We encourage you to submit this crosswalk along with the request packet to facilitate CMS' review. The letter should focus on how the IDE study meets each of the regulatory Medicare coverage IDE study criteria, which are:

1. The principal purpose of the study is to test whether the device improves health outcomes of appropriately selected patients.
2. The rationale for the study is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
3. The study results are not anticipated to unjustifiably duplicate existing knowledge.
4. The study design is methodologically appropriate and the anticipated number of enrolled subjects is adequate to confidently answer the research question(s) being asked in the study.
5. The study is sponsored by an organization or individual capable of successfully completing the study.
6. The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CFR parts 50, 56, and 812, and 45 CFR part 46.
7. Where appropriate, the study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals.  Studies of all medical technologies measuring therapeutic outcomes as one of the objectives may be exempt from this criterion only if the disease or condition being studied is life threatening and the patient has no other viable treatment options.
8. The study is registered with the National Institutes of Health (NIH) National Library of Medicine’s (NLM)
9. The study protocol describes the method and timing of release of results on all pre-specified outcomes, including release of negative outcomes and that the release should be hastened if the study is terminated early.
10. The study protocol must describe how Medicare beneficiaries may be affected by the device under investigation, and how the 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.
B. FDA approval letter of the Category A or Category B IDE. (CMS will review a submission with a conditional FDA approval letter; however, please submit the final FDA approval letter to CMS at
C. IDE study protocol.
D. Institutional Review Board (IRB) approval letter (only submit one IRB approval letter per request).
E. National Clinical Trial (NCT) number (e.g., NCT00000123)
F. Supporting materials, as appropriate.

Claims Submission Related to IDE Studies

Medicare claims for routine care items and services related to Category A or B IDE studies and Category B IDE devices should be submitted to MACs that will identify routine costs for which Medicare payment is made for each related claim.

No comments:

Medical Billing Popular Articles