Medicare Benefit Policy Manual (Pub. 100-02), Ch. 14 § 30.1
Payment for Hospital IRB Approved Non-significant Risk Devices
30.1 – Payment for Hospital IRB Approved Non-significant Risk Devices
(Rev. 198, Issued: 11-06-14, Effective: 01-01-15, Implementation: 01-05-15)
Payment for an IRB approved device (provided to a non-hospital patient) and the related
services may not exceed what Medicare would have paid for a comparable approved
device and related services.