Sec. 10.20.01.08. Limitations

Latest version.

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 manufacturers 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.

                    
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