in-20260107-IR-440250797FNA: The Division of Mental Health and Addiction (division) is soliciting public comment on adding and amending rules at 440 IAC 10 concerning opioid treatment programs. The division seeks comment on the affected citations listed and any other provisions of Title 440 that may be affected by this rulemaking.

TITLE 440 DIVISION OF MENTAL HEALTH AND ADDICTION Notice of First Public Comment Period LSA Document #25-797 OPIOID TREATMENT PROGRAMS PURPOSE OF NOTICE The Division of Mental Health and Addiction (division) is soliciting public comment on adding and amending rules at 440 IAC 10 concerning opioid treatment programs. The division seeks comment on the affected citations listed and any other provisions of Title 440 that may be affected by this rulemaking. ADDITIONAL DOCUMENTS Regulatory Analysis: 20260107-IR-440250797RAA Notice of Public Hearing: 20260107-IR-440250797PHA CITATIONS AFFECTED: 440 IAC 10 AUTHORITY: IC 12-23-1-6; IC 12-23-18 OVERVIEW Basic Purpose and Background The proposed rule is adding and amending rules at 440 IAC 10 to clarify definitions; create medication units and mobile medication units; and incorporate recent legislative changes. For purposes of IC 4-22-2-28.1, small businesses affected by this rulemaking may contact the Small Business Regulatory Coordinator: For purposes of IC 4-22-2-28.1, the Small Business Ombudsman designated by IC 5-28-17-6 is: Resources available to regulated entities through the small business ombudsman include the ombudsman's duties stated in IC 5-28-17-6, specifically IC 5-28-17-6(9), investigating and attempting to resolve any matter regarding compliance by a small business with a law, rule, or policy administered by a state agency, either as a party to a proceeding or as a mediator. REQUEST FOR PUBLIC COMMENT The division is soliciting public comment on the proposed rule. Comments may be submitted in one of the following ways: COMMENT PERIOD DEADLINE All comments must be postmarked or time stamped not later than February 9, 2026. The rule, Regulatory Analysis, appendices referenced in the Regulatory Analysis, and materials incorporated by reference (if applicable) are on file at the Family and Social Services Administration, 402 West Washington Street, Room W451, Indianapolis, Indiana and are available for public inspection. Copies of the rule, Regulatory Analysis, and appendices referenced in the Regulatory Analysis are available at the Family and Social Services Administration office. If the division does not receive substantive comments during the public comment period or public hearing, the rule may be adopted with text that is the same as or does not substantially differ from the text of the proposed rule published in this notice. PROPOSED 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: (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: (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 under 42 CFR 8.12(i)(3) 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 within state lines and seventy-five (75) miles of the affiliated opioid treatment program. (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. (k) Medication unit staff will document current patient information in the affiliated opioid treatment program records. (l) Medication units are authorized to provide only the following services at their locations: (m) 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. (n) 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. (o) The medical director shall visit the medication unit at least: (p) The medication unit shall obtain its supply of approved controlled substances directly from the affiliated opioid treatment program and maintain the medication unit's inventory under applicable state and federal regulations. (q) The medication unit shall participate in the central registry system and prevent clients from dosing at the affiliated opioid treatment program or medication unit in compliance with section 33 of this rule. (r) 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. (s) For a patient to be eligible to receive medication or drug screening, or both, at the medication unit, the patient shall: (t) Patients in noncompliance with any of the affiliated opioid treatment program requirements, including counseling hours, will lose the privilege to receive services at the medication unit for at least one (1) month. OTP staff may then reevaluate and either: Staff shall clearly document the decision in the patient record. (u) Medication units: (v) 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 access to controlled substances maintained by the mobile medication unit. (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 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.