§ 12-15-35-35 — Prior approval program for outpatient drugs; standards

Indiana § 12-15-35-35

• Jurisdiction: Indiana
• Art. 15: MEDICAID
• Ch. 35: Drug Utilization Review

Text

(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) 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:
(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) 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:
(A) A statement of the date, time, and place at which the board
meeting will be convened.
(B) A general description of the subject matter of the board
meeting.
(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) Ensure that:
(A) there is access to at least two (2) alternative drugs within
each therapeutic classification, if available, on the formulary;
and
(B) a process is in place through which a Medicaid recipient
has access to medically necessary drugs.
(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) 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) 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.
(b) The board shall advise the office on the implementation of any
program to restrict the use of brand name multisource drugs.
(c) 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 recommendations to the office.

Legislative History

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.