in-20261028-IR-440250797FRA: Adds 440 IAC 10-1-7.5, 440 IAC 10-1-27.1, 440 IAC 10-1-27.6, and 440 IAC 10-1-35.5 to update definitions. Amends 440 IAC 10-3-7 concerning issuing a conditional status of certification. Amends 440 IAC 10-4-10 concerning opiod treatment program (OTP) days of operation. Amends 440 IAC 10-4-13 concerning OTP staff positions. Amends 440 IAC 10-4-15 and 440 IAC 10-4-18 concerning patient admission criteria and procedures. Amends 440 IAC 10-4-19 concerning initial opioid treatment medication. Amends 440 IAC 10-4-22 concerning drug testing. Amends 440 IAC 10-4-26 concerning self-administered medication. Amends 440 IAC 10-4-39 concerning the conditional status for specific approval of an OTP. Amends 440 IAC 10-4-42 concerning phase treatment. Adds 440 IAC 10-4-44 and 440 IAC 10-4-45 concerning medication units and mobile medication units.

TITLE 440 DIVISION OF MENTAL HEALTH AND ADDICTION Final Rule LSA Document #25-797 DIGEST OPIOID TREATMENT PROGRAMS Adds 440 IAC 10-1-7.5, 440 IAC 10-1-27.1, 440 IAC 10-1-27.6, and 440 IAC 10-1-35.5 to update definitions. Amends 440 IAC 10-3-7 concerning issuing a conditional status of certification. Amends 440 IAC 10-4-10 concerning opiod treatment program (OTP) days of operation. Amends 440 IAC 10-4-13 concerning OTP staff positions. Amends 440 IAC 10-4-15 and 440 IAC 10-4-18 concerning patient admission criteria and procedures. Amends 440 IAC 10-4-19 concerning initial opioid treatment medication. Amends 440 IAC 10-4-22 concerning drug testing. Amends 440 IAC 10-4-26 concerning self-administered medication. Amends 440 IAC 10-4-39 concerning the conditional status for specific approval of an OTP. Amends 440 IAC 10-4-42 concerning phase treatment. Adds 440 IAC 10-4-44 and 440 IAC 10-4-45 concerning medication units and mobile medication units. Effective 30 days after filing with the publisher. HISTORY Notice of First Public Comment Period: 20260107-IR-440250797FNA Regulatory Analysis submitted with Notice of First Public Comment Period: 20260107-IR-440250797RAA Date of First Hearing: February 9, 2026 Notice of Second Public Comment Period: 20260617-IR-440250797SNA Regulatory Analysis submitted with Notice of Second Public Comment Period: 20260617-IR-440250797RAA Date of Second Hearing: July 20, 2026 CITATIONS AFFECTED: 440 IAC 10 SUMMARY/RESPONSE TO COMMENTS The Division of Mental Health and Addiction (division) requested public comment from January 7, 2026, through February 9, 2026, and during the public hearing on February 9, 2026. The comments received and the division's responses to the comments are summarized as follows: Commentor: Erin LaCourt, Sara Dumpert and Regina Hendley, Indiana Association for the Treatment of Opioid Dependence (INTOD) Summary of Comments: INTOD suggested that the DMHA (1) change proposed 440 IAC 10-4-13(c)(3) amendments related to requirements for professionals that must be physically present onsite; (2) incorporate the provision of telehealth services language into proposed 440 IAC 10-4-13(c) amendments; (3) modify the location restrictions for medication units in proposed 440 IAC 10-4-44(c); (4) expand the services authorized at medication units under 440 IAC 10-4-44(l); (5) modify proposed 440 IAC 10-4-44(p) to better align with 21 CFR 1301.12(a); (6) modify proposed 440 IAC 10-4-44(q) to reflect medication until participation in the central registry system as a component of the affiliated opioid treatment program; (7) modify proposed 440 IAC 10-4-44(s) and delete proposed 440 IAC 10-4-44(t) to better align with federal guidelines; (8) add a new subsection to proposed 440 IAC 10-4-45 related to a mobile unit's supply of approved controlled substances for clarity; (9) modify proposed 440 IAC 10-4-45(h) to clarify who may have access to controlled substances maintained by the mobile medication unit; and (10) modify the distance a mobile medication must operate in relation to an OTP. Response to INTOD: Comment 1: The division appreciates the feedback of INTOD. The division feels that a physician needs to be physically present in the facility for at least ten (10) hours per week to provide adequate patient care. The division is agreeable to a physician, physician's assistant, or advance practice registered nurse being physically present in the facility during the remaining program-established operating hours during which medication is dispensed and available for consultation during all operating hours in which patients are present in the facility. The division has made changes to the proposed 440 IAC 10-4-13(c) with consideration to the feedback of INTOD. Comment 2: The division appreciates the feedback of INTOD. The division feels that it is unnecessary to add language regarding telehealth because providers can refer to existing Indiana Code regarding telehealth. Comment 3: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has made the requested change to proposed 440 IAC 10-4-44(c). Comment 4: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has made the requested change to proposed 440 IAC 10-4-44(l). Comment 5: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has made the requested change to proposed 440 IAC 10-4-44(p). Comment 6: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has made the requested change to proposed 440 IAC 10-4-44(q). Comment 7: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has made the requested change to proposed 440 IAC 10-4-44(s) and deleted proposed 440 IAC 10-4-44(t). Comment 8: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has added the additional subsection to 440 IAC 10-4-45, specifically 440 IAC 10-4-45(n). Comment 9: The division appreciates the feedback of INTOD. The division agrees with the request from INTOD and has made the requested change to proposed 440 IAC 10-4-45(h) but has also added clarifying language related to compliance expectations. Comment 10: The division appreciates the feedback of INTOD. The division feels that the one hundred fifty (150) mile distance allowance allows for better coverage throughout the state and allows for more consistent treatment. The division requested public comment again from June 17, 2026, through July 20, 2026, and during the second public hearing on July 20, 2026. The comments received and the division's response to the comments are summarized as follows: Commentor: Anonymous Summary of Comments: This comment suggested that 440 IAC 10-4-26(d) be updated to reference 440 IAC 10-4-42 instead of 42 CFR 8.12(i)(3) to cure conflicting language and eliminate potential confusion. Response: The division appreciates the feedback. The division agrees with the request and has made the requested change to proposed 440 IAC 10-4-26(d). Commentor: Erin LaCourt, Sara Dumpert and Regina Hendley, Indiana Association for the Treatment of Opioid Dependence (INTOD) Summary of Comments: INTOD suggested that, for 440 IAC 10-4-13(c)(3) the division (1) provide clarification on distinction between "program-established operating hours during which medication is dispensed" and "operating hours in which patients are present in the facility," asserting that these hours are one in the same for OTPs; (2) remove references to the 1,000 patient census and 40-hour per week language; (3) consider the varying sizes of OTP's in the state of Indiana in relation to the requirement for a physician to be physically present at the facility; (4) clarify prescriber oversight of the facility; and (5) address logistical issues faced by OTPs during physician staff turn-over. Response: Comment 1: The division appreciates the feedback of INTOD. The division feels that the distinguishing language is necessary because, while the hours are the same for many of the OTPs, they are not the same for all OTPs in Indiana. Comment 2: The division appreciates the feedback of INTOD. The division feels that the references are necessary to clarify the requirement regarding the listed authorized health care providers being physically present at the facility. Comment 3: The division appreciates the feedback of INTOD. The division feels that the 10-hour per week requirement for a physician to be physically present at a facility is necessary regardless of the size of the OTP. Comment 4: The division appreciates the feedback of INTOD. The division does not feel that the prescriber oversight of the facility needs any further clarification. Comment 5: The division appreciates the feedback of INTOD. The division does not feel that any change in the rule is necessary to address this potential issue. FINAL RULE Sec. 7.5. "Affiliated opioid treatment program" means the opioid treatment program responsible for the oversight, compliance, staffing, records, and operations of mobile and nonmobile medication units. Sec. 27.1. "Medication unit" means a stationary facility established as part of, but geographically separate from, an affiliated opioid treatment program from which licensed private practitioners dispense or administer medication, conduct drug screening, and provide call-back services. Sec. 27.6. "Mobile medication unit" means a vehicular component of an affiliated opioid treatment program designated to administer and dispense medications for opioid use disorder treatment and conduct drug screening. Sec. 35.5. "Opioid use disorder" has the meaning set forth in 42 CFR 8.2. Sec. 7. (a) The division shall may issue a conditional status under this article upon the division's investigation and determination of any of the following conditions: (b) The time period of a conditional status is determined by the division, but may not exceed twelve (12) months from the date the conditional status was effective. (c) The division shall notify the entity of the following: (d) The division shall may terminate the entity's certification if the entity fails to meet the requirements within the allotted time period. Sec. 10. (a) Unless excluded by subsection (b), an OTP shall offer opioid treatment services sufficient to meet the needs of patients seven (7) days per week. (b) Service provision on Sundays and on federal and state holidays shall, at a minimum, include opioid medication administration services for patients not eligible to receive unsupervised medication; provided, however, if all patients of an OTP are eligible to receive unsupervised medication, the OTP may be closed for business on that Sunday or federal or state holiday. (c) An OTP may provide services on Sundays and on federal and state holidays through a contract with a qualified service provider if the contract assures that all the provisions of this rule will be met. (b) An OTP may close on Sundays and a national legal holiday recognized by the federal government. Sec. 13. (a) Each An OTP shall employ qualified individuals to fill the staff functions in this section. (b) An OTP shall have a medical director who shall meet meets the following requirements: (c) An OTP shall have a program physician, who may also be the medical director. A program physician shall meet the following requirements: (d) An OTP shall have a program director who meets the following requirements: (e) An OTP shall have nurses that who meet the following requirements: (f) An OTP shall have counselors that who meet the following requirements: (g) An OTP shall have a clinical supervisor that who meets the following requirements: Sec. 15. (a) An individual applying for admission to an OTP shall: (b) If an applicant lacking a laboratory study confirmation of addiction to an opioid drug is admitted to an OTP, The reason for the admission shall be documented in the patient's record. (c) An OTP physician may waive the requirement of a one-year history of addiction for the following individuals: (d) (c) An individual under eighteen (18) years of age may be admitted to an OTP only under the following circumstances: (e) (d) The medical director may refuse the admission of an applicant if, in the medical director's reasonable clinical judgment, the applicant would not benefit from the treatment. The medical director shall record the reason or reasons for a decision to refuse admission in an admissions denied log kept for this purpose. (f) (e) An admitting OTP shall verify that an individual meeting admission criteria is not currently enrolled in another OTP as provided as follows: (g) (f) An OTP shall give written notice to an individual seeking treatment that, if the individual refuses or fails to give the written authorizations for the release of information required under subsection (f), (e), the OTP may refuse to admit the individual. (h) (g) The OTP shall document in the individual's record the giving of the notice in subsection (g). (f). Sec. 18. (a) An OTP shall maintain current written policies, procedures, and protocols designed to ensure that patients are admitted to opioid treatment by qualified personnel. (b) To admit a patient to an OTP, qualified OTP personnel shall make a determination, using accepted medical criteria, that the patient meets the following criteria: (c) The OTP shall record the following information in the patient's record: (d) Admission to an OTP shall involve involves the following three (3) steps: Sec. 19. (a) An OTP shall use only opioid treatment medications approved by the Food and Drug Administration (FDA) under Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for use in the treatment of opioid addiction. (b) An OTP may use any of the following medications as an alternative for methadone for opioid treatment: (c) An OTP shall maintain current procedures that are adequate to ensure that each treatment medication used by the program is administered in accordance with its approved product labeling. Dosing and administration decisions shall be made by a program physician familiar with the most up-to-date product labeling. These procedures shall ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record. the following dosage form and initial dosing requirements are met: (d) OTPs shall maintain current procedures adequate to ensure that each medication for opioid use disorder used by the program is administered and dispensed in accordance with its FDA approved product labeling. The program must ensure that any significant deviations from the approved labeling, including deviations with regard to dose, frequency, or the conditions of use described in the approved labeling, are specifically documented in the patient's record. (d) (e) Before the patient may receive the initial dose of medication, the program physician or authorized health care provider shall document the following in the patient's record: The program physician shall check INSPECT as frequently as clinically indicated. (e) For patients deemed clinically appropriate for admission, medication is titrated to a dose with the rate of increase indicated based on a clinical assessment of the following: (f) The rate of titration and dose achieved shall be determined on a case-by-case basis through the course of multiple clinical assessments. These assessments shall also monitor for the following: (g) The initial dose of the following medications shall be as follows: (h) (f) Precautions shall be taken in the induction of the opioid treatment medication to assure ensure that an individual can tolerate the dosage of medication prescribed. (i) (g) A patient's initial dose of opioid treatment medication shall be administered under the direction of a program physician. (j) A patient admitted to an OTP shall not be provided with doses of opioid treatment medication for self-administration until clinical staff has observed the patient after the administration of medication at clinic visits for a minimum of five (5) days. Sec. 22. (a) An OTP shall do the following: (b) The results of all drug tests shall be recorded in the patient's record. (c) An OTP shall periodically and randomly test a patient including before receiving treatment, for the following: as required by IC 12-23-18-2.5. (d) A patient shall have a drug test under this section at the following times: (e) The OTP and a patient shall comply with the requirements of subsection (f) if the patient tests positive for any of the following: (f) If a patient tests positive under a test for a controlled substance or an illegal drug that is not allowed under subsection (e), the following provisions in IC 12-23-18-2.5(c) shall be met. (g) The results of a single drug test shall not be the sole basis for making significant treatment decisions; provided, however, that this subsection shall does not exempt an OTP from complying with the requirements of this section. Sec. 26. (a) An OTP shall do the following: (b) Treatment program decisions regarding the administering of opioid treatment medications to patients for unsupervised use, beyond the requirement in subsection (d), shall be determined by the medical director. In determining which patients may be permitted unsupervised use, the medical director shall consider the take-home criteria in subsection (e). (c) The determinations made under subsection (b) and the basis for the determinations, consistent with the criteria under subsection (e), shall be documented in the patient's medical record. (d) An OTP may provide unsupervised opioid treatment medication based on the patient's time in treatment pursuant to 42 CFR 8.12(i)(3) under section 42 of this rule unless the patient does not qualify under, and subject to the provisions of, the following: (e) In determining whether a patient may be permitted the unsupervised use of opioid treatment medication, the medical director shall consider the following take-home criteria in determining whether a patient is responsible in handling opioid treatment medication for unsupervised use: (f) Before self-administration privileges are granted: (g) The OTP shall prepare bottles for the self-administration of medication with labels containing the following information: (h) The OTP shall have written policies addressing the responsibilities of patients who are granted privileges for the self-administration of opioid treatment medication, including the following: (i) Regardless of a patient's time in treatment, the medical director may deny or rescind, if clinically appropriate, a patient's privileges to receive opioid treatment medication for self-administration. (j) Exceptions for self-administered medication may be requested, consistent with the federal requirements in 42 CFR Part 8, and submitted to the following: (k) An OTP shall submit exception requests to the SOTA for all self-administered opioid treatment medication for more than seven (7) days. the limit set in IC 12-23-18-5. (l) Any An OTP request under subsection (j) or (k) for an exception to the federal regulations for self-administered medications shall must include the following: Sec. 39. The division shall may do the following: Sec. 42. (a) An OTP shall follow the maximum take home schedule as follows: (b) The OTP shall obtain prior authorization from the division before any patient is prescribed more than seven (7) take home doses of opioid treatment medications at one (1) time. in accordance with IC 12-23-18-5. The division may approve the authorization only under the following circumstances: Sec. 44. (a) A medication unit may only be opened and operated by an existing, current OTP and shall: (b) An approved OTP is limited to opening and operating not more than two (2) medication units. (c) A medication unit must be located: (d) Approved medication units may only be established and operate within an accredited and existing: (e) Locations must be approved and certified by the division before opening under 440 IAC 10-3. (f) Under 440 IAC 10-3-2, medication unit locations must adhere to the initial and ongoing requirements of any accreditation bodies with governance over the affiliated opioid treatment program, including DEA, SAMHSA, and the board. (g) Medication units shall be staffed by at least one (1) licensed registered nurse, licensed practical nurse, nurse practitioner, authorized health care professional, or physician employed by the affiliated opioid treatment program. As census increases, the medication unit shall follow the staff to patient ratio as an affiliated OTP and per section 13 of this rule. (h) Under section 2 of this rule, medication unit staff will adhere to all policies, practices, and governance of the affiliated opioid treatment program, including policies and procedures of diversion control, as if the medication unit were located inside the affiliated opioid treatment program. (i) Medication unit staff will receive the same orientation and trainings as provided in section 14 of this rule for an affiliated opioid treatment program. (j) Medication unit staff will document current patient information in the affiliated opioid treatment program records. (k) Medication units are authorized to provide any service available at the affiliated opioid treatment program, following all applicable state and federal laws for privacy and adequate space, with staff present onsite at the medication unit or via telehealth in accordance with IC 25-1-9.5. (l) The affiliated opioid treatment program is responsible for maintaining all documentation on each patient, which the medication unit may access through electronic or other means. Original paper records generated by the medication unit shall be transferred to the affiliated opioid treatment program after generation and maintained in the normal course of business for the OTP. (m) The medical director shall maintain authority over the medical aspects of treatment offered by the medication unit. The medical director shall attend and document weekly calls with staff from the medication unit that cover the clinical care of patients at the medication unit. The medical director is not required to be present at the medication unit in person. (n) The medical director shall visit the medication unit at least: (o) The medication unit shall obtain a separate DEA registration in accordance with 21 CFR 1301.12(a) and may obtain its supply of approved narcotic treatment medication from a pharmaceutical distributor and maintain the medication unit's inventory under applicable state and federal regulations. (p) The medication unit shall participate in the central registry system as a component of the affiliated opioid treatment program where medication unit records are included and prevent clients from dosing at the affiliated opioid treatment program or medication unit in compliance with section 33 of this rule. (q) If an affiliated opioid treatment program voluntarily decides to close the operation of a medication unit, the affiliated opioid treatment program shall notify the division, DEA, SAMHSA, and the board at least ninety (90) days before the planned closure of the medication unit. The affiliated opioid treatment program shall present a plan to transfer existing patients to similar OTPs or other suitable treatment programs at the time of the notification. (r) For a patient to be eligible to receive services at the medication unit, the patient shall: (s) Medication units: (t) Medication units are an extension of the affiliated opioid treatment program, and therefore, are held to the same regulations governing OTPs. Sec. 45. (a) A mobile medication unit may only be opened and operated by an existing, current OTP with the authorization, licensure, and certification from the division, United States Drug Enforcement Agency (DEA), Substance Abuse and Mental Health Services Agency (SAMHSA), and Indiana board of pharmacy (board), and shall comply with rules and regulations set forth in section 44 of this rule. (b) An OTP intending to operate a mobile medication unit shall notify the division, DEA, SAMHSA, and the board in writing of the OTP's intent to do so, and receive explicit written approval from the division, DEA, and SAMHSA before operating the mobile medication unit. The mobile medication unit may only operate in the state of Indiana. (c) OTPs shall possess on file at the location of the OTP certified by the division the valid vehicle identification number or license plate number for any vehicles used as mobile medication units. (d) Mobile medication units of OTPs may not function as hospitals, long term care facilities, or emergency medical service vehicles, nor transport patients. (e) A mobile medication unit shall maintain records with the following information for each controlled substance: (f) For a vehicle operated as a mobile medication unit, the following requirements must be met: (g) Authorized personnel transporting controlled substances on behalf of the OTP are required to retain control over the controlled substances when transferring the controlled substances between the affiliated opioid treatment program and mobile medication unit and administering or dispensing medication. At all other times during transportation, the controlled substances must be properly secured in the safe. (h) Only prescribers, pharmacists, and licensed nurses may have dispensing access to controlled substances maintained by the mobile medication unit. All access to controlled substances maintained by the mobile medication unit must be in accordance with state and federal regulations. (i) After finishing the operation of the mobile medication unit on a given day, the mobile medication unit shall immediately return to the affiliated opioid treatment program, and all controlled substances must be removed from the mobile medication unit and secured within the affiliated opioid treatment program in compliance with 21 CFR 1301.72(e). (j) Affiliated opioid treatment programs with a mobile medication unit are required to establish standard operating procedures to ensure that if the mobile medication unit becomes inoperable (e.g., mechanical failure, accidents, fire, etc.), the controlled substances on the inoperable mobile medication unit are accounted for, removed from the inoperable mobile medication unit, and secured at the affiliated opioid treatment program as soon as reasonably possible or practicable. (k) Persons receiving treatment at a mobile medication unit are required to wait in an area that is physically separated from the medication storage area and any areas used for administering or dispensing medication by a physical entrance, such as a door or other entryway. Patients will need to wait outside a mobile medication unit if the unit does not have seating or a reception area that is separated from the medication storage area and any areas used for administrating [sic, administering] or dispensing medication. This requirement shall be enforced by an individual designated by the affiliated opioid treatment program. (l) A vehicle used as part of a mobile medication unit may only be supplied with controlled substances by the affiliated opioid treatment program operating that vehicle. Persons permitted to administer or dispense controlled substances from the mobile medication unit shall not: (m) Mobile medication units shall operate within state lines and one hundred fifty (150) miles of the OTP. (n) The mobile medication until [sic, unit] shall obtain its supply of approved controlled substances directly from the affiliated opioid treatment program and maintain the mobile medication unit's inventory under applicable state and federal regulations. LSA Document #25-797 Notice of First Public Comment Period: January 7, 2026 Last Hearing Held: July 20, 2026 Approved by Attorney General: September 17, 2026 Approved by Governor: September 29, 2026 Filed with Publisher: October 1, 2026, 12:44 p.m. Documents Incorporated by Reference: None Received by Publisher