This text of Indiana § 12-15-35-46 (Review of proposed formulary) is published on Counsel Stack Legal Research, covering Indiana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.
(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 informatio
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(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.