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Investigational Device Submission Requirements

Effective for Category A and B IDE studies approved by the FDA on or after January 1, 2015, interested parties (i.e., study sponsors) that wish to seek Medicare coverage in Category A or B IDE studies must submit a request for review and approval via email to clinicalstudynotification@cms.hhs.gov or via hard copy to the following address:

Centers for Medicare and Medicaid Services (CMS)
Center for Clinical Standards and Quality
Director, Coverage and Analysis Group
Attention: Clinical Study Certification
Mail Stop: S3-02-01
7500 Security Boulevard
Baltimore, Maryland 21244

Providers participating in and seeking Medicare reimbursement for items and services in Category A or B IDE studies, prior to submitting claims, are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage.

Providers participating in and seeking Medicare reimbursement for items and services in Category A or B IDE studies, prior to submitting claims, are responsible for checking the CMS Coverage Website to identify whether CMS (or its designated entity) has approved the study for purposes of Medicare coverage.

IRB Renewal/Extensions – All IRB renewal/extension submissions for IDEs and PMAs approved by Cahaba prior to January 1, 2015, should be emailed to Cahaba GBA at CMD@cahabagba.com.  Please include the following:

Once the submission has been reviewed, an approval letter for the IRB renewal/extension will be emailed to the contact person provided.

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