Investigational Device Exemption Requests - Medical Policy Article

Effective for dates of service on or after 2015-01-01, Medicare allows claims related to certain IDE clinical studies only when studies are approved by CMS (or its designated entity) and listed on the CMS Coverage Website: Category B IDEs (G-numbered, FDA-designated B1–B4) are claim-eligible, and Category A IDEs permit billing only for routine care items and services. Providers seeking Medicare coverage for Category A or B IDEs must submit a review/approval request to CMS (clinicalstudynotification@cms.hhs.gov) and follow the Medicare Claims Processing Manual (Pub.100-04, ch.32, secs.68–69); NGS processes renewals/modifications for providers in CT, IL, ME, MA, MN, NH, NY, RI, VT, and WI.

"Providers participating in an IDE clinical study may file Medicare claims for CMS Category B IDEs that are approved by CMS (or its designated entity) and listed on the CMS Coverage Website."