Cardiology Billing Update: Novitas Clarifies Regulations on IDE, HUD, CAS Clinical Trial Requests

Novitas (Medicare Administrative Contractor) has sought to provide additional clarification for those providers seeking participation in clinical trials and applications for Investigational Device Exemption (IDE), Humanitarian Use Device (HUD) and/or Post-Approval and 510K Extension Studies for Carotid Artery Stenting (CAS). The Medicare A/B Reference Manual, Chapter 7 (available here: has been revised. While there are no substantive changes to the regulations surrounding clinical trial participation, Novitas has added a helpful Frequently Asked Question (FAQ) section to the website, and has also created a specific e-mail address for providers to use to seek a status update on their submitted applications ( Additional information to note: Novitas will no longer accept applications for IDE via fax or e-mail: all requests must be submitted in hardcopy to the Contractor Medical Director’s (CMD) office.
For more information and detailed information on Medicare coverage of clinical trials, the qualification process, the correct HCPCS modifiers and ICD9 codes to use for  cardiology billing purposes, and more… visit the Novitas website directly.