Submission Requirements for Investigational Device Exemption Claims
Effective for Category A and B IDE studies approved by the FDA on or after 1/1/2015, interested parties (i.e. study sponsors) seeking Medicare coverage must submit a request for review and approval to CMS. Revised Chapter 14 of the Medicare Benefit Policy Manual contains detailed instructions on seeking CMS approval of Category A and B IDE studies for purposes of Medicare coverage. Additional information regarding submission of Category A and B IDE study review requests, along with the list of CMS-approved studies is available on the CMS Medicare Coverage Related to Investigational Device Exemption (IDE) Studies web page.
To avoid any delays in claims processing for IDE studies, approved by CMS, please provide the following information to National Government Services:
- IDE Number
- Copy of CMS Approval Letter
- Name and UPIN of facility where services will be provided
- Principal Investigator information
Please submit all information to NGS by one of the following methods:
- Email: NGSIDEREQUESTS@anthem.com
- Fax: 315-442-4257
For proper claim submission and to avoid claim denials, please review the following Centers for Medicare & Medicaid Services Internet-Only Manuals (IOMs)
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual, Chapter 16, Section 10 (General Exclusions from Coverage)
- CMS IOM Publication 100-04, Medicare Claims Processing Manual, Chapter 32, Section 68 (Investigational Device Exemption (IDE) Studies) & 69 (Qualifying Clinical Trials)
Additional Resources
Posted 5/19/2020