Md. Code Regs. 10.09.03.05-1

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.09.03.05-1 - Expanded Limitations

A. A drug is not covered for State-only recipients 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.

Md. Code Regs. 10.09.03.05-1

Regulation .05-1 adopted as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); adopted permanently effective December 1, 1992 (19:23 Md. R. 2040)
Regulation .05-1 amended effective November 28, 2011 (38:24 Md., R. 1502)
Regulation .05-1A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912)
Regulation .05-1A amended effective March 3, 2003 (30:4 Md. R. 316); amended effective 44:19 Md. R. 896, eff. 9/25/2017