Regulation .08 Limitations.
Regulation .08 Limitations.LinkCopy Citation
A.
The Program does not cover a drug if:
(1)
The manufacturer has not provided the same rebate to the Kidney Disease Program as that provided for State-Only Pharmacy Assistance recipients’ purchases of drugs as is required under §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c));
(2)
The Program has provided notice to the manufacturer of the manufacturer’s failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and
(3)
The manufacturer has failed to demonstrate to the Secretary that the drug's availability is essential to Kidney Disease Program recipients.
B.
Effective April 4, 2012, a manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation more than 1 year after the date the rebate was paid.