Authority: IC 12-15-1-10; IC 12-15-21-2

Affected: IC 12-13-7-3; IC 12-15; IC 26-2-8-106

Sec. 8. (a) Prior authorization is required for a brand name drug that:

1. (1) is subject to generic substitution under Indiana law; and
2. (2) the prescriber has indicated is "brand medically necessary", either orally or in handwriting on the prescription or drug order, or typed in the comments of an electronic prescription.

(b) In order for prior authorization to be granted for a brand name drug, the prescriber must:

1. (1) indicate on the prescription or drug order, in the prescriber's own handwriting or electronically typed in the comments of an electronic prescription, the phrase "brand medically necessary"; and
2. (2) seek prior authorization by substantiating the brand name drug is medically necessary as opposed to the less costly generic equivalent.

The prior authorization number assigned to the approved request must be included on the prescription or drug order issued by the prescriber or relayed to the dispensing pharmacist by the prescriber if the prescription is orally transmitted. The office may exempt specific drugs or classes of drugs from the prior authorization requirement, based on cost or therapeutic considerations. Prior authorization will be determined in accordance with the provisions of 405 IAC 5-3 and 42 U.S.C. 1396r-8(d)(5).

(Office of the Secretary of Family and Social Services; 405 IAC 5-24-8; filed Jul 25, 1997, 4:00 p.m.: 20 IR 3346; filed Sep 27, 1999, 8:55 a.m.: 23 IR 319; readopted filed Jun 27, 2001, 9:40 a.m.: 24 IR 3822; readopted filed Sep 19, 2007, 12:16 p.m.: 20071010-IR-405070311RFA; readopted filed Oct 28, 2013, 3:18 p.m.: 20131127-IR-405130241RFA; errata filed Nov 1, 2016, 9:36 a.m.: 20161109-IR-405160493ACA; readopted filed Jul 28, 2022, 2:21 p.m.: 20220824-IR-405220205RFA; readopted filed May 30, 2023, 11:54 a.m.: 20230628-IR-405230292RFA; filed Oct 6, 2023, 2:09 p.m.: 20231101-IR-405230367FRA)