Indiana Code
Chapter 35. Drug Utilization Review
12-15-35-46. Review of Proposed Formulary

Sec. 46. (a) This section applies to a managed care organization that enters into an initial contract with the office to be a managed care organization after May 13, 1999.
(b) Before a managed care organization described in subsection (a) implements a formulary, the managed care organization shall submit the formulary to the office at least thirty-five (35) days before the date that the managed care organization implements the formulary for Medicaid recipients.
(c) The office shall forward the formulary to the board for the board's review and recommendation.
(d) The office shall provide at least thirty (30) days notification to the public that the board will review a managed care organization's proposed formulary at a particular board meeting. The notification shall contain the following information:
(1) A statement of the date, time, and place at which the board meeting will be convened.
(2) A general description of the subject matter of the board meeting.
(3) An explanation of how a copy of the formulary to be discussed may be obtained.
The board shall meet to review the formulary at least thirty (30) days but not more than sixty (60) days after the notification.
(e) In reviewing the formulary, the board shall do the following:
(1) Make a determination, after considering evidence and credible information provided to the board by the office and the public, that the use of the formulary will not:
(A) impede the quality of patient care in the Medicaid program; or
(B) increase costs in other parts of the Medicaid program, including hospital costs and physician costs.
(2) Make a determination that:
(A) there is access to at least two (2) alternative drugs within each therapeutic classification, if available, on the formulary;
(B) a process is in place through which a Medicaid member has access to medically necessary drugs; and
(C) the managed care organization otherwise meets the requirements of IC 27-13-38.
(f) The board shall consider:
(1) health economic data;
(2) cost data; and
(3) the use of formularies in the non-Medicaid markets;
in developing its recommendation to the office.
(g) Within thirty (30) days after the board meeting, the board shall make a recommendation to the office regarding whether the proposed formulary should be approved, disapproved, or modified.
(h) The office shall rely significantly on the clinical expertise of the board. If the office does not agree with the recommendations of the board, the office shall, at a public meeting, discuss the disagreement with the board and present any additional information to the board for the board's consideration. The board's consideration of additional information must be conducted at a public meeting.
(i) Based on the final recommendations of the board, the office shall approve, disapprove, or require modifications to the managed care organization's proposed formulary. The office shall notify the managed care organization of the office's decision within fifteen (15) days of receiving the board's final recommendation.
(j) The managed care organization must comply with the office's decision within sixty (60) days after receiving notice of the office's decision.
(k) Notwithstanding the other provisions of this section, the office may temporarily approve a managed care organization's proposed formulary pending a final recommendation from the board.
As added by P.L.231-1999, SEC.8. Amended by P.L.152-2017, SEC.29.

Structure Indiana Code