§ 12-23-18-5 — Standards for operation; report; initial patient assessment; prohibitions

(a) The division shall adopt rules under IC 4-22-2 to establish the following:
(1) Standards for operation of an opioid treatment program in
Indiana, including the following requirements:
(A) Except as otherwise prescribed by the division, an opioid
treatment program shall obtain prior authorization from the
division for any patient receiving more than fourteen (14) days
of opioid maintenance treatment medications at one (1) time
and the division may approve the authorization only under the
following circumstances:
(i) A physician licensed under IC 25-22.5 has issued an order
for the opioid treatment medication.
(ii) The patient has not tested positive under a drug test for a
drug for which the patient does not have a prescription for a
period of time set forth by the division.
(iii) The opioid treatment program has determined that the
benefit to the patient in receiving the take home opioid
treatment medication outweighs the potential risk of
diversion of the take home opioid treatment medication.
(B) Minimum requirements for a licensed physician's regular:
(i) physical presence in the opioid treatment facility; and
(ii) physical evaluation and progress evaluation of each
opioid treatment program patient.
(C) Minimum staffing requirements by licensed and unlicensed
personnel.
(D) Clinical standards for the appropriate tapering of a patient
on and off of an opioid treatment medication.
(2) A requirement that, not later than February 28 of each year, a
current diversion control plan that meets the requirements of 21
CFR Part 290 and 42 CFR Part 8 be submitted for each opioid
treatment facility.
(3) Fees to be paid by an opioid treatment program for deposit in
the fund for annual certification under this chapter as described
in section 3 of this chapter.
The fees established under this subsection must be sufficient to pay the
cost of implementing this chapter.
(b) The division shall conduct an annual onsite visit of each opioid
treatment program facility to assess compliance with this chapter.
(c) Not later than April 1 of each year, the division shall report to
the general assembly in electronic format under IC 5-14-6 the
following information:
(1) The number of prior authorizations that were approved under
subsection (a)(1)(A) in the previous year and the:
(A) time frame for each approval; and
(B) duration of each approved treatment.
(2) The number of authorizations under subdivision (1) that were,
in the previous year, revoked due to a patient's violation of an
applicable term or condition.
(3) The number of each of the actions taken under section 5.8(a)
of this chapter in the previous year.
(4) The number and type of violations assessed for each action
specified in section 5.8(a) of this chapter in the previous year.
(d) A facility shall report, in a manner prescribed by the division, all
information required by the division to complete the report described
in subsection (c).
(e) An opioid treatment program may close on Sundays and a
national legal holiday recognized by the federal government.
(f) The division may not require the medical director of an opioid
treatment program to obtain admitting privileges at a hospital.
(g) Any of the following health care providers may conduct an
initial assessment, examination, or evaluation of a patient, including
documenting the information in the patient's medical record, that is
within the health care provider's scope of practice and upon the
patient's admission to an opioid treatment program:
(1) A physician licensed under IC 25-22.5.
(2) An advanced practice registered nurse who:
(A) is licensed under and meets the requirements of IC 25-23;
and
(B) maintains a collaborative agreement under IC 25-23-1-19.4
with a physician who works onsite at the opioid treatment
program.
(3) A physician assistant who:
(A) is licensed under IC 25-27.5; and
(B) maintains a collaborative agreement with a physician who
works onsite at the opioid treatment program.
(h) The division may not establish rules or guidelines that are more
stringent than the regulations set forth in 42 CFR 8.12 concerning the
following:
(1) Criteria for patient admission to an opioid treatment program.
(2) Clinical standards concerning the administering or dispensing
of an initial dose of opioid treatment medication.

Legislative History

As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.8; P.L.131-2014, SEC.3; P.L.7-2015, SEC.38; P.L.8-2016, SEC.3; P.L.181-2021, SEC.1; P.L.143-2025, SEC.3.