Ind. Code ch. 12-23-18

Ind. Code ch. 12-23-18
in effect

Ind. Code § 12-23-18-0.5 Opioid treatment program; requirements for operation

Sec. 0.5. (a) An opioid treatment program shall not operate in Indiana unless the opioid treatment program meets the following conditions: (1) Is specifically approved and the opioid treatment facility is certified by the division. (2) Is in compliance with state and federal law. (3) Provides treatment for opioid addiction using a drug approved by the federal Food and Drug Administration for the treatment of opioid addiction, including: (A) opioid maintenance; (B) detoxification; (C) overdose reversal; (D) relapse prevention; and (E) long acting, nonaddictive medication assisted treatment medications. (4) Beginning July 1, 2017, is: (A) enrolled: (i) as a Medicaid provider under IC 12-15; and (ii) as a healthy Indiana plan provider under IC 12-15-44.2; or (B) enrolled as an ordering, prescribing, or referring provider in accordance with Section 6401 of the federal Patient Protection and Affordable Care Act (P.L. 111-148), as amended by the federal Health Care and Education Reconciliation Act of 2010 (P.L. 111-152) and maintains a memorandum of understanding with a community mental health center for the purpose of ordering, prescribing, or referring treatments covered by Medicaid and the healthy Indiana plan. (b) Separate specific approval and certification under this chapter is required for each location at which an opioid treatment program is operated. If an opioid treatment program moves the opioid treatment program's facility to another location, the opioid treatment program's certification does not apply to the new location and certification for the new location under this chapter is required. (c) Each opioid treatment program that is enrolled as an ordering, prescribing, or referring provider shall report to the office on an annual basis the services provided to Indiana Medicaid patients. The report must include the following: (1) The number of Medicaid patients seen by the ordering, prescribing, or referring provider. (2) The services received by the provider's Medicaid patients, including any drugs prescribed. (3) The number of Medicaid patients referred to other providers. (4) Any other provider types to which the Medicaid patients were referred. As added by P.L.116-2008, SEC.2. Amended by P.L.1-2009, SEC.108; P.L.8-2016, SEC.2.

Ind. Code § 12-23-18-1 Rules

Sec. 1. (a) Subject to federal law and consistent with standard medical practice in opioid treatment of drug abuse, the division shall adopt rules under IC 4-22-2 to establish and administer an opioid treatment diversion control and oversight program to identify individuals who divert opioid treatment medications from legitimate treatment use and to terminate the opioid treatment of those individuals. (b) Rules adopted under subsection (a) must include provisions relating to the following matters concerning opioid treatment programs and patients who receive opioid treatment: (1) Regular clinic attendance by the patient. (2) Specific counseling requirements for the opioid treatment program. (3) Serious behavior problems of the patient. (4) Stable home environment of the patient. (5) Safe storage capacity of opioid treatment medications within the patient's home. (6) Medically recognized testing protocols to determine legitimate opioid treatment medication use. (7) The opioid treatment program's medical director and administrative staff responsibilities for preparing and implementing a diversion control plan. As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.3.

Ind. Code § 12-23-18-2 Diversion control

Sec. 2. (a) Not later than February 28 of each year, each opioid treatment program must submit to the division a diversion control plan that: (1) meets the requirements of section 1 of this chapter; and (2) includes in the opioid treatment program's diversion control plan the program's drug testing procedure for testing a patient during the patient's treatment by the program as required by section 2.5 of this chapter. (b) Not later than May 1 of each year, the division shall review and approve a plan submitted under subsection (a). (c) If the division denies a plan submitted under subsection (a), the opioid treatment program must submit another plan not later than sixty (60) days after the denial of the plan. As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.4.

Ind. Code § 12-23-18-2.5 Drug testing

Sec. 2.5. (a) An opioid treatment program must periodically and randomly test, including before receiving treatment, a patient for the following during the patient's treatment by the program: (1) Methadone. (2) Cocaine. (3) Opiates. (4) Amphetamines. (5) Barbiturates. (6) Tetrahydrocannabinol. (7) Benzodiazepines. (8) Any other suspected or known drug that may have been abused by the patient. (b) If a patient tests positive under a test described in subsection (a) for: (1) a controlled substance other than a drug for which the patient has a prescription or that is part of the patient's treatment plan at the opioid treatment program; or (2) an illegal drug other than the drug that is part of the patient's treatment plan at the opioid treatment program; the opioid treatment program and the patient must comply with the requirements under subsection (c). (c) If a patient tests positive under a test for a controlled substance or illegal drug that is not allowed under subsection (a), the following conditions must be met: (1) The opioid treatment program must refer the patient to: (A) the onsite physician; or (B) another health care provider authorized to conduct the clinical evaluation under section 5(g) of this chapter; for a clinical evaluation that must be conducted not more than ten (10) days after the date of the patient's positive test. The physician or health care provider shall consult with medical and behavioral staff to conduct the evaluation. The clinical evaluation must recommend a remedial action for the patient that may include discharge from the opioid treatment program or amending the treatment plan to require a higher level of supervision. (2) The opioid treatment program may not, unless otherwise authorized by the division, allow the patient to take any opioid treatment medications from the treatment facility until the patient has completed a clinical assessment under subdivision (1) and has passed a random test. The patient must report to the treatment facility daily, except when the facility is closed, until the onsite physician or other authorized health care provider who conducts the clinical evaluation under subdivision (1), after consultation with the medical and behavioral staff, determines that daily treatment is no longer necessary. (3) The patient must take a monthly random test until the patient passes a test under subsection (a). (d) An opioid treatment program must conduct all tests required under this section in an observed manner to assure that a false sample is not provided by the patient. As added by P.L.116-2008, SEC.5. Amended by P.L.131-2014, SEC.2; P.L.143-2025, SEC.2.

Ind. Code § 12-23-18-3 Opioid treatment program fees

Sec. 3. (a) By May 15 of each year, each opioid treatment program shall submit to the division a fee that is: (1) an amount established by the division by rule under IC 4-22-2; (2) not more than necessary to recover the costs of administering this chapter; and (3) not more than seventy-five dollars ($75) for each opioid treatment program patient who was treated by the opioid treatment program during the preceding calendar year. (b) The fee collected under subsection (a) shall be deposited in the fund. As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.6.

Ind. Code § 12-23-18-4 Opioid treatment program fund

Sec. 4. (a) As used in this section, "fund" means the opioid treatment program fund established under subsection (b). (b) The opioid treatment program fund is established to implement this chapter. The fund shall be administered by the division. (c) The expenses of administering the fund shall be paid from money in the fund. (d) The treasurer of state shall invest money in the fund in the same manner as other public money may be invested. (e) Money in the fund at the end of the state fiscal year does not revert to the state general fund. As added by P.L.11-2003, SEC.2. Amended by P.L.116-2008, SEC.7.

Ind. Code § 12-23-18-5 Standards for operation; report; initial patient assessment; prohibitions

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). (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. 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.

Ind. Code § 12-23-18-5.3 Rules concerning opioid treatment

Sec. 5.3. Subject to federal law and consistent with standard medical practices in opioid treatment for substance abuse, the division shall adopt rules under IC 4-22-2 concerning opioid treatment by an opioid treatment provider, including the following: (1) A requirement that the opioid treatment provider periodically review with the patient the patient's treatment plan. In the review, the opioid treatment provider shall consider changes to the plan with the goal of requiring the minimal clinically necessary medication dose, including, when appropriate, the goal of opioid abstinence. (2) Treatment protocols containing best practice guidelines for the treatment of opiate dependent patients, including the following: (A) Appropriate clinical use of all drugs approved by the federal Food and Drug Administration for the treatment of opioid addiction, including the following when available: (i) Opioid maintenance. (ii) Detoxification. (iii) Overdose reversal. (iv) Relapse prevention. (v) Long acting, nonaddictive medication assisted treatment medications. (B) Requirement of initial and periodic behavioral health assessments for each patient. (C) Appropriate use of providing overdose reversal, relapse prevention, counseling, and ancillary services. (D) Transitioning off agonist and partial agonist therapies with the goal, when appropriate, of opioid abstinence. (E) Training and experience requirements for providers who treat and manage opiate dependent patients. (F) Requirement that a provider who prescribes opioid medication for a patient periodically review INSPECT (as defined in IC 25-26-24-7) concerning controlled substance information for the patient. As added by P.L.8-2016, SEC.4. Amended by P.L.51-2019, SEC.1.

Ind. Code § 12-23-18-5.5 Opioid treatment programs; limitations; report to General Assembly; rules

Sec. 5.5. (a) The division may not grant specific approval to be a new opioid treatment program. This section does not apply to applications for new opioid treatment programs: (1) pending prior to March 1, 2007; or (2) that are operated by a hospital licensed under IC 16-21, an institution licensed under IC 12-25, or a certified community mental health center: (A) within the licensed hospital, institution, or center; or (B) in a separate office that meets federal opioid treatment program requirements; and that meets the requirements of this section. (b) A hospital licensed under IC 16-21, an institution licensed under IC 12-25, or a certified community mental health center may apply to the division to operate an opioid treatment program. Upon approval, the hospital, institution, or community mental health center may operate an opioid treatment program in compliance with this chapter and federal law. (c) Before June 30, 2018, the division may approve the operation of not more than five (5) additional opioid treatment programs described in subsection (a)(2) only if the division determines as described in subsection (f) that there is a need for a new opioid treatment program in the proposed location and the requirements of this chapter are met. (d) Beginning July 1, 2018, the division may approve the operation of not more than nine (9) additional opioid treatment programs described in subsection (a)(2) only if the division determines as described in subsection (f) that there is a need for a new opioid treatment program in the proposed location and the requirements of this chapter are met. (e) Not later than June 30, 2018, the division shall report to the general assembly in an electronic format under IC 5-14-6 concerning whether any new opioid treatment programs have been approved under subsection (c). The report must include the following: (1) The impact on access to opioid treatment programs. (2) The number of individuals served in the opioid treatment programs approved under subsection (c). (3) Treatment outcomes for individuals receiving services in the opioid treatment programs approved under subsection (c). (4) Any recommendations the division has concerning future treatment programs. (f) The division shall adopt rules under IC 4-22-2 setting forth the manner in which the division will determine whether there is a need for a new opioid treatment program in a proposed program location's geographic area. As added by P.L.210-2007, SEC.1. Amended by P.L.116-2008, SEC.9; P.L.209-2015, SEC.14; P.L.195-2018, SEC.7.

Ind. Code § 12-23-18-5.6 Central registry

Sec. 5.6. (a) The division shall establish a central registry to maintain information concerning each patient served by an opioid treatment program. (b) An opioid treatment program shall, at least monthly, provide to the division information required by the division concerning patients currently served by the opioid treatment program. (c) Information that could be used to identify an opioid treatment program patient and that is: (1) contained in; or (2) provided to the division and related to; the central registry is confidential. As added by P.L.116-2008, SEC.10.

Ind. Code § 12-23-18-5.8 Violations; penalties

Sec. 5.8. (a) The state opioid treatment authority may take any of the following actions based on any grounds described in subsection (b): (1) Issue a letter of correction. (2) Reinspect an opioid treatment program facility. (3) Deny renewal of, or revoke, any of the following: (A) Specific approval to operate as an opioid treatment program. (B) Certification of an opioid treatment facility. (4) Impose a civil penalty in an amount not to exceed ten thousand dollars ($10,000) per violation. (b) The state opioid treatment authority may take action under subsection (a) based on any of the following grounds: (1) Violation of this chapter or rules adopted under this chapter. (2) Permitting, aiding, or abetting the commission of any illegal act in an opioid treatment program facility. (3) Conduct or practice found by the state opioid treatment authority to be detrimental to the welfare of an opioid treatment program patient. (c) IC 4-21.5 applies to an action under this section. As added by P.L.116-2008, SEC.12. Amended by P.L.181-2021, SEC.2.

Ind. Code § 12-23-18-7 Adoption of rules establishing standards and protocols; use of alternative medication for treatment; explanation of side effects

Sec. 7. (a) The division shall adopt rules under IC 4-22-2 to establish standards and protocols for opioid treatment programs to do the following: (1) Assess new opioid treatment program patients to determine the most effective opioid treatment medications to start the patient's opioid treatment. (2) Ensure that each patient voluntarily chooses maintenance treatment and that relevant facts concerning the use of opioid treatment medications are clearly and adequately explained to the patient. (3) Have appropriate opioid treatment program patients who are receiving methadone for opioid treatment move to receiving other approved opioid treatment medications. (b) An opioid treatment program shall follow the standards and protocols adopted under subsection (a) for each opioid treatment program patient. (c) Subject to subsection (a), an opioid treatment program may use any of the following medications as an alternative for methadone for opioid treatment: (1) Buprenorphine. (2) Buprenorphine combination products containing naloxone. (3) Naltrexone injectable and extended release. (4) A federal Food and Drug Administration approved long acting, nonaddictive medication for the treatment of opioid or alcohol dependence. (5) Any other medication that has been approved by: (A) the federal Food and Drug Administration for use in the treatment of opioid addiction; and (B) the division under subsection (e). (d) Before starting a patient on a new opioid treatment medication, the opioid treatment program shall explain to the patient the potential side effects of the new medication. (e) The division may adopt rules under IC 4-22-2 to provide for other medications, including a federal Food and Drug Administration approved long acting, nonaddictive medication for the treatment of opioid or alcohol dependence, as alternatives to methadone that may be used under subsection (a). As added by P.L.131-2014, SEC.4. Amended by P.L.187-2015, SEC.21; P.L.209-2015, SEC.15.

Ind. Code § 12-23-18-7.5 Office based opioid treatment providers; treatment protocol; clinical practice guidelines

Sec. 7.5. (a) This section applies to an office based opioid treatment provider who: (1) has obtained a waiver from the federal Substance Abuse and Mental Health Services Administration (SAMHSA) and meets the qualifying standards required to treat opioid addicted patients in an office based setting; and (2) has a valid federal Drug Enforcement Administration registration number and identification number that specifically authorizes treatment in an office based setting. (b) The office of the secretary and the division shall develop a treatment protocol containing best practice guidelines for the treatment of opiate dependent patients. The treatment protocol must require the minimal clinically necessary medication dose, including, when appropriate, the goal of opioid abstinence, and including the following: (1) Appropriate clinical use of any drug approved by the federal Food and Drug Administration for the treatment of opioid addiction, including the following: (A) Opioid maintenance. (B) Opioid detoxification. (C) Overdose reversal. (D) Relapse prevention. (E) Long acting, nonaddictive medication assisted treatment medications. (2) A requirement for initial and periodic behavioral health assessments for each patient. (3) Appropriate use of providing overdose reversal, relapse prevention, counseling, and ancillary services. (4) Transitioning off agonist and partial agonist therapies, when appropriate, with the goal of opioid abstinence. (5) Training and experience requirements for prescribers of drugs described in subdivision (1) in the treatment and management of opiate dependent patients. (6) A requirement that prescribers obtain informed consent from a patient concerning all available opioid treatment options, including each option's potential benefits and risks, before prescribing a drug described in subdivision (1). (c) Before December 31, 2016, the office of the secretary shall recommend the clinical practice guidelines required under subsection (b) to: (1) the Indiana professional licensing agency established under IC 25-1-5; (2) the office of Medicaid policy and planning established under IC 12-8-6.5; and (3) a managed care organization that has contracted with the office of Medicaid policy and planning. As added by P.L.8-2016, SEC.5.

Ind. Code § 12-23-18-8 "Dispense"; provision of information to division; annual report

Sec. 8. (a) As used in this section, "dispense" means to deliver a controlled substance to an ultimate user. (b) Subject to the federal patient confidentiality requirements under 42 CFR Part 2, when an opioid treatment program dispenses a controlled substance designated by the Indiana board of pharmacy under IC 35-48-2-5 through IC 35-48-2-10, the opioid treatment program shall provide the following information upon request from the division: (1) The medications dispensed by the program. (2) The medication delivery process, which includes whether the medication was in liquid, film, or another form. (3) The number of doses dispensed of each medication. (4) The dosage quantities for each medication. (5) The number of patients receiving take home medications. (6) The number of days of supply dispensed. (7) Patient demographic information for each medication, including gender, age, and time in treatment. (8) The dispenser's United States Drug Enforcement Agency registration number. (9) The average number of patients served by: (A) the opioid treatment program annually; and (B) each employed or contracted prescriber of the opioid treatment program. (10) The annual ratio of employed or contracted prescribers to patients served at each opioid treatment program. (11) The number of patients and the average length of treatment for each medication dispensed by the opioid treatment program. (12) The number of patients completing an opiate treatment program treatment service having transitioned to opioid abstinence, including the use of long acting, nonaddictive medication for relapse prevention. (13) The number of patients demonstrating improvement in functioning, as defined by the division, while in treatment at an opiate treatment program. (14) An annual submission of each opiate treatment program's policy concerning: (A) the use of INSPECT (as defined in IC 25-26-24-7); (B) the protocol for addressing patients who are found, using INSPECT data, to have prescriptions for a controlled substance, including benzodiazepines or other opiate medications; and (C) the protocol for addressing patients who have illicit urine drug screens indicating the use of a controlled substance, including benzodiazepines or other opiates, whether prescribed or not. (15) The number of patients denied access to services due to inability to pay, including the demographic information of the patient concerning race. (16) The number of patients who are receiving behavioral health services in addition to medication. (17) The average mileage a patient is traveling to receive treatment. (18) The patient relapse rate or the average time an individual is receiving treatment from the opioid treatment program. (19) The number of admissions and discharges of patients at the opioid treatment program. (20) The number of pregnant women being treated. (21) Whether an individual is employed at the time of admission and whether the patient obtains employment during treatment. (22) The number of patients who are eligible for the Medicaid program. (23) A description of programs offered by the opioid treatment program. (24) A description of any community outreach or education to the public offered by the opioid treatment program. (25) The number of patients who have eliminated the use of an illegal substance after the first year of treatment at the opioid treatment program. (c) An opioid treatment program shall provide the information required under this section to the division in a manner prescribed by the division. (d) The division shall annually report the information collected under this section to the legislative council in an electronic format under IC 5-14-6 not later than October 1. As added by P.L.131-2014, SEC.5. Amended by P.L.8-2016, SEC.6; P.L.165-2017, SEC.1; P.L.51-2019, SEC.2.
Source: Open US Law by Vaquill AI (CC BY 4.0)URL: https://iga.in.gov/laws/2026/ic/titles/12Fetched: 10/17/2026

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