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Frequently Asked Questions

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Are there any specific items, services, or treatments that are only covered under Coverage with Evidence Development (“CED”)?

Yes, the following are examples of treatments covered only under CED: (Please click on the hyperlinks below to obtain further specific information such as decision memo, NCT#, Medicare approved registry and clinical study approvals).

  • Transcatheter Mitral Valve Repair
  • Percutaneous Image-guided Lumbar Decompression for Lumbar Spinal Stenosis
  • Allogeneic Hematopoietic Stem Cell Transplant for MDS
  • FDG PET and Other Neuroimaging Devices for Dementia

For additional information, please visit the CMS Coverage with Evidence Development webpage under Qs & As - Mandatory Reporting of Clinical Trial Identifier Numbers on Claims.



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