55 Pa. Code § 1121.53
(b) CMS establishes a FUL and the Department establishes a State MAC which set a limit on the drug cost component of the payment formula for selected multisource drugs. The FUL and the State MAC do not apply if the following exist:
(1) The licensed prescriber certifies that a specific brand is medically necessary by doing all of the following:
The provisions of this § 1121.53 amended under sections 201, 403, 403.1 and 443.4 of the Human Services Code (62 P.S. § § 201, 403, 403.1 and 443.4); § 1121.53(c) abrogated in part under section 2(4) of the act of October 28, 2022 (P.L. 1632, No. 98).
The provisions of this § 1121.53 amended January 16, 1987, effective March 1, 1987, 17 Pa.B. 261; amended December 14, 1990, effective January 11, 1991, 20 Pa.B. 6167; amended August 2, 1991, effective immediately and apply retroactively to July 1, 1989, 21 Pa.B. 3420; amended December 11, 1992, effective January 1, 1993, 22 Pa.B. 5995; amended September 22, 1995, effective October 1, 1995, 25 Pa.B. 3978; amended August 5, 2005, effective August 10, 2005, 35 Pa.B. 4309; amended April 13, 2012, effective April 14, 2012, 42 Pa.B. 2015; § 1121.53(c) abrogated in part October 28, 2022 (P.L. 1632, No. 98); amended January 2, 2026, effective January 3, 2026, 56 Pa.B. 16. Immediately preceding text appears at serial pages (422712) to (422715).
(Editor’s Note: This regulation was promulgated under section 6(b) of the Regulatory Review Act (71 P.S. § 745.6(b)).)
This section cited in 55 Pa. Code § 1121.11 (relating to types of services covered); 55 Pa. Code § 1121.51 (relating to general payment policy); 55 Pa. Code § 1121.52 (relating to payment conditions for various services); 55 Pa. Code § 1121.54 (relating to noncompensable services and items); and 55 Pa. Code § 1121.56a (relating to drug cost determination).