Limited period of payment
(i) Drugs and biologicals
(i)Drugs and biologicals#
Subject to subparagraph (G), the payment under this paragraph with respect to a drug or biological shall only apply during a period of at least 2 years, but not more than 3 years, that begins—
(I) on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or
(II) in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service.
(i)(I)#
on the first date this subsection is implemented in the case of a drug or biological described in clause (i), (ii), or (iii) of subparagraph (A) and in the case of a drug or biological described in subparagraph (A)(iv) and for which payment under this part is made as an outpatient hospital service before such first date; or
(i)(II)#
in the case of a drug or biological described in subparagraph (A)(iv) not described in subclause (I), on the first date on which payment is made under this part for the drug or biological as an outpatient hospital service.
(ii)Medical devices#
Payment shall be made under this paragraph with respect to a medical device only if such device—
(I) is described by a category of medical devices established and in effect under subparagraph (B); and
(II) is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph.
(ii)(I)#
is described by a category of medical devices established and in effect under subparagraph (B); and
(ii)(II)#
is provided as part of a service (or group of services) paid for under this subsection and provided during the period for which such category is in effect under such subparagraph.