Regulation .05-1 Expanded Limitations.
Regulation .05-1 Expanded Limitations.LinkCopy Citation
A.
A drug is not covered for State-only participants if:
(1)
The manufacturer has not provided the same rebate to the State for State-only participants’ purchases of drugs as is required under Section 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 State-Only participants.
B.
A manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation or under 42 U.S.C. §1396r-8(c) more than 3 years after the date the rebate was paid.