1. (a) Except as provided in IC 12-15-35.5-9 , before the board develops a program to place a single source drug on prior approval, restrict the drug in its use, or establish a drug monitoring process or program to measure or restrict utilization of single source drugs other than in the SURS program, the board must meet the following conditions:

   1. (1) Make a determination, after considering evidence and credible information provided to the board by the office and the public, that placing a single source drug on prior approval or restricting the drug's use will not:

      1. (A) impede the quality of patient care in the Medicaid program; or
      2. (B) increase costs in other parts of the Medicaid program, including hospital costs and physician costs.

   2. (2) Meet to review a formulary or a restriction on a single source drug after the office provides at least fifteen (15) days notification to the public that the board will review the formulary or restriction on a single source drug at a particular board meeting. The notification shall contain the following information:

      1. (A) A statement of the date, time, and place at which the board meeting will be convened.
      2. (B) A general description of the subject matter of the board meeting.

      3. (C) An explanation of how a copy of the formulary to be discussed at the meeting may be obtained.

         The board shall meet to review the formulary or the restriction on a single source drug at least fifteen (15) days but not more than sixty (60) days after the notification.

   3. (3) Ensure that:

      1. (A) there is access to at least two (2) alternative drugs within each therapeutic classification, if available, on the formulary; and
      2. (B) a process is in place through which a Medicaid recipient has access to medically necessary drugs.
   4. (4) Reconsider the drug's removal from its restricted status or from prior approval not later than six (6) months after the single source drug is placed on prior approval or restricted in its use.
   5. (5) Ensure that the program provides either telephone or FAX approval or denial Monday through Friday, twenty-four (24) hours a day. The office must provide the approval or denial within twenty-four (24) hours after receipt of a prior approval request. The program must provide for the dispensing of at least a seventy-two (72) hour supply of the drug in an emergency situation or on weekends.
   6. (6) Ensure that any prior approval program or restriction on the use of a single source drug is not applied to prevent acceptable medical use for appropriate off-label indications.
2. (b) The board shall advise the office on the implementation of any program to restrict the use of brand name multisource drugs.

3. (c) The board shall consider:

   1. (1) health economic data;
   2. (2) cost data; and

   3. (3) the use of formularies in the non-Medicaid markets;

      in developing its recommendations to the office.

As added by P.L.75-1992, SEC.19. Amended by P.L.76-1994, SEC.5; P.L.231-1999, SEC.6; P.L.6-2002, SEC.3; P.L.107-2002, SEC.20; P.L.1-2003, SEC.58; P.L.37-2016, SEC.1.