In general
The Secretary shall provide for an additional payment under this paragraph for any of the following that are provided as part of a covered OPD service (or group of services):
(i) Current orphan drugs
(i)Current orphan drugs#
A drug or biological that is used for a rare disease or condition with respect to which the drug or biological has been designated as an orphan drug under section 360bb of title 21 if payment for the drug or biological as an outpatient hospital service under this part was being made on the first date that the system under this subsection is implemented.
(ii)Current cancer therapy drugs and biologicals and brachytherapy#
A drug or biological that is used in cancer therapy, including (but not limited to) a chemotherapeutic agent, an antiemetic, a hematopoietic growth factor, a colony stimulating factor, a biological response modifier, a bisphosphonate, and a device of brachytherapy or temperature monitored cryoablation, if payment for such drug, biological, or device as an outpatient hospital service under this part was being made on such first date.
(iii)Current radiopharmaceutical drugs and biological products#
A radiopharmaceutical drug or biological product used in diagnostic, monitoring, and therapeutic nuclear medicine procedures if payment for the drug or biological as an outpatient hospital service under this part was being made on such first date.
(iv)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.
(iv)(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
(iv)(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.