Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 20 - KIDNEY DISEASE PROGRAM
Chapter 10.20.01 - General Regulations
Section 10.20.01.08 - Limitations
Universal Citation: MD Code Reg 10.20.01.08
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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