Specified covered outpatient drug defined
(i) In general
(i)In general#
In this paragraph, the term “specified covered outpatient drug” means, subject to clause (ii), a covered outpatient drug (as defined in section 1396r–8(k)(2) of this title ) for which a separate ambulatory payment classification group (APC) has been established and that is—
(I) a radiopharmaceutical; or
(II) a drug or biological for which payment was made under paragraph (6) (relating to pass-through payments) on or before December 31, 2002 .
(i)(I)#
a radiopharmaceutical; or
(i)(II)#
a drug or biological for which payment was made under paragraph (6) (relating to pass-through payments) on or before December 31, 2002 .
(ii)Exception#
Such term does not include—
(I) a drug or biological for which payment is first made on or after January 1, 2003 , under paragraph (6);
(II) a drug or biological for which a temporary HCPCS code has not been assigned; or
(III) during 2004 and 2005, an orphan drug (as designated by the Secretary).
(ii)(I)#
a drug or biological for which payment is first made on or after January 1, 2003 , under paragraph (6);
(ii)(II)#
a drug or biological for which a temporary HCPCS code has not been assigned; or
(ii)(III)#
during 2004 and 2005, an orphan drug (as designated by the Secretary).