Md. Code Regs. 10.20.01.08

Current through Register Vol. 52, No. 1, January 10, 2025

Section 10.20.01.08 - Limitations

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.

Md. Code Regs. 10.20.01.08

Regulations .08 General Regulations (Kidney Disease Program), adopted as an emergency provision effective November 1, 1991 (18:23 Md. R. 2481); emergency status expired March 30, 1992
Regulations .08 adopted effective March 31, 1992 (19:3 Md. R. 304)
Regulation .08 amended effective April 4, 2011 (38:7 Md. R. 431)
Regulation .08A amended effective February 12, 2007 (34:3 Md. R. 299)