2023 Indiana Code › Title 12. Human Services › Article 23. Addiction Services › Chapter 18. Methadone Diversion Control and Oversight Program › 12-23-18-5. Standards for Operation; Diversion Control Plans; Annual Compliance Assessment; Report

Sec. 5. (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).
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.