New medical devices, drugs, and biologicals
A medical device, drug, or biological not described in clause (i), (ii), or (iii) if—
(I)#
payment for the device, drug, or biological as an outpatient hospital service under this part was not being made as of December 31, 1996 ; and
(II)#
the cost of the drug or biological or the average cost of the category of devices is not insignificant in relation to the OPD fee schedule amount (as calculated under paragraph (3)(D)) payable for the service (or group of services) involved.