Chapter 5122-40 | Opioids

Rule 5122-40-01 | Definitions and applicability.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) In addition to the definitions in rule 5122-24-01 of the Administrative Code, the following definitions apply to Chapter 5122-40 of the Administrative Code:

(1) "Certified nurse practitioner" means an advanced practice registered nurse who holds a current, valid license issued under Chapter 4723. of the Revised Code and is designated as a certified nurse practitioner in accordance with section 4723.42 of the Revised Code and rules adopted by the board of nursing.

(2) "Correctional facility" means any of the following:

(a) A "state correctional facility," as defined in section 2967.01 of the Revised Code;

(b) A "local correctional facility," as defined in section 2903.13 of the Revised Code;

(c) A correctional facility that is privately operated and managed pursuant to section 9.06 of the Revised Code.

(d) A facility operated directly or at the direction of the department of youth services.

(3) "Department" mean the Ohio department of mental health and addiction services.

(4) "Dispense" has the same meaning as in rule 4729:1-1-01 of the Administrative Code.

(5) "Interim treatment" means that a patient, on a temporary basis, may receive some services from an opioid treatment program while waiting to access more comprehensive treatment services. The duration of interim treatment is limited to one hundred eighty days.

(6) "Licensed practical nurse" means an individual who holds a current, valid license issued under Chapter 4723. of the Revised Code that authorizes the practice of nursing as a licensed practical nurse.

(7) "Medication-assisted treatment" has the same meaning as in section 340.01 of the Revised Code."

(8) "Medical director" is a physician who assumes the responsibility for the delivery of all medical services performed by an opioid treatment program, either by performing them directly or by delegating specific responsibility to authorized program physicians and qualified healthcare professionals functioning under the medical director's direct supervision.

(9) "Medication unit" means any center for substance abuse treatment (CSAT) approved facility established as part of, but geographically separate from, an opioid treatment program from which mediation assisted treatment is administered or dispensed.

(10) "Medication maintenance" means the administering or dispensing of medication assisted treatment at stable dosage levels for a period in excess of twenty-one days in the treatment of a patient for opioid addiction.

(11) "Mobile medication unit" means a vehicle that is associated with an opioid treatment program. Mobile medication units can dispense narcotic drugs in schedules II-V at remote locations for the purpose of maintenance or withdrawal management.

(12) "Non-mobile medication unit" means a stationary brick-and-mortar medication unit.

(13) "Opioid treatment program" (OTP) or "program" has the same meaning as in rule 4729:5-21-01 of the Administrative Code.

(14) "Partial opioid agonist" means buprenorphine products or combination products approved by the federal food and drug administration for maintenance or detoxification withdrawal management of opioid dependence, or any other partial agonists federally approved, controlled substances used for the purpose of opioid replacement treatment. These medications are used as an alternative to opioid agonists in the treatment of opioid addiction. At certain dosages, a partial agonist can both activate and block the effects of opioid medications or receptors, thereby assisting in control of opioid addiction. Partial agonists bind to the receptors and activate them, but not to the same degree as full agonists.

(15) "Permanent patient transfer" means the transfer of a patient from one opioid treatment program to another opioid treatment program.

(16) "Personally furnish" or "personally furnishing" has the same meaning as in rule 4729:5-21-01 of the Administrative Code.

(17) "Physician" means an individual authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.

(18) "Physician assistant" means an individual who is licensed to practice as a physician assistant under Chapter 4730. of the Revised Code.

(19) "Prescriber" has the same meaning as in rule 4729:5-21-01 of the Administrative Code.

(20) "Principal" means a person who has controlling authority or is in a leading position, e.g., executive director, chief financial officer, chief clinical officer, chief operating officer.

(21) "Program director" means a person who is identified in the central registry described in rule 5122-40-08 of the Administrative Code and is responsible for the day-to-day operation of the opioid treatment program in a manner consistent with the laws and regulations of the United States department of health and human services, United States drug enforcement administration, and the laws and rules of the state of Ohio.

(22) "Program prescriber" means a prescriber who is employed by or under contract to work for an opioid treatment program.

(23) "Program sponsor" is a person or representative of the program, who is responsible for the operation of the opioid treatment program and who assumes responsibility for all of its employees, including any practitioners, agents, or other persons providing medical, rehabilitative, or counseling services at the program.

(24) "Registered nurse" means an individual who holds a current, valid licensed issued under Chapter 4723. of the Revised Code that authorizes the practice of nursing as a registered nurse.

(25) "SAMHSA" means the federal substance abuse and mental health services administration.

(26) "State authority" or "state opioid treatment authority" (SOTA) means the agency or individual designated by the Ohio department of mental health and addiction services to exercise the responsibility and authority of the state for governing the treatment of opiate addiction by an opioid treatment program. The state authority shall act as the state's coordinator for the development and monitoring of opioid treatment programs and shall serve as a liaison with the appropriate federal, state, and local agencies.

(27) "State oversight agency" means the agency or office of state government identified by the governor to provide regulatory oversight of opioid treatment programs on behalf of the state of Ohio. The designated state oversight agency is responsible for licensing, monitoring, and investigating complaints or grievances regarding opioid treatment programs. The Ohio department of mental health and addiction services is the agency designated by the governor to provide regulatory oversight on behalf of the state of Ohio.

(28) "Telemedicine" or "telemedical," as used in this chapter, have the same meaning as "telehealth" as defined in agency 5122 of the Administrative Code pertaining to telehealth.

(29) "Withdrawal management" means the administering or dispensing of medications used in medication-assisted treatment in decreasing doses to an individual to alleviate adverse physiological or psychological effects of withdrawal from the continuous use of an opioid and as a method of bringing the individual to an opiate drug-free state.

(B) This chapter is applicable to any community mental health services provider or community addiction services provider subject to licensure as an opioid treatment program in accordance with section 5119.37 of the Revised Code, which includes any opioid treatment program requiring certification as certification is defined in 42 C.F.R. 8.2.

(C) An opioid treatment program directly operated by the department of veterans affairs, the Indian health service, or any other department or agency of the United States is not required to obtain a state license.

Last updated January 31, 2025 at 7:39 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 6/10/2022

Rule 5122-40-02 | State opioid treatment authority.

• Effective: January 1, 2019
• Promulgated Under: 119.03

The department shall designate an individual within the department to serve as the state authority to provide technical assistance to opioid treatment programs and the state oversight authority. The powers and duties of the state authority include, but are not limited to, the following:

(A) Assist in the development and implementation of rules, regulations, standards and best practice guidelines to assure the quality of services delivered by opioid treatment programs.

(B) Act as a liaison between relevant state and federal agencies.

(C) Review opioid treatment guidelines, rules, regulations and recovery models for individualized treatment plans of care developed by the federal government and other nationally recognized authorities approved by the department.

(D) Coordinate initial licensure between the department and other licensing, accrediting, and certifying entities as required in this paragraph.

(E) Assure delivery of technical assistance and informational materials to opioid treatment programs as needed.

(F) Perform both scheduled and unscheduled site visits to opioid treatment programs in cooperation with the identified state oversight office when necessary and appropriate.

(G) Consult with the federal government regarding approval or disapproval of requests for exceptions to federal regulations, where appropriate.

(H) Receive and refer patient appeals and grievances to the designated state oversight agency when appropriate.

(I) Review program monitoring activities pursuant to rule 5122-40-08 of the Administrative Code.

(J) Review diversion control plan pursuant to rule 5122-40-10 of the Administrative Code

(K) Review opioid treatment programs' disaster planning efforts pursuant to rule 5122-40-12 of the Administrative Code.

(L) Review opioid treatment programs' evaluation activities efforts pursuant to rule 5122-40-13 of the Administrative Code.

(M) Work cooperatively with other relevant state agencies to determine the services needed and the location of a proposed opioid treatment program.

(N) Notify the substance abuse and mental health services administration, the United States drug enforcement administration, the Ohio board of pharmacy, and the Ohio medical board of any official action taken against an opioid treatment program.

(O) The state authority shall approve medication exception requests for opioid treatment programs operated by the department of veterans affairs, the Indian health service or any other department or agency of the United States.

Last updated November 5, 2024 at 9:05 AM

Supplemental Information

Authorized By: 5119.391
Amplifies: 5119.391
Five Year Review Date: 10/31/2029
Prior Effective Dates: 7/1/2001, 6/1/2017

Rule 5122-40-03 | Issuance of licenses.

• Effective: June 10, 2022
• Promulgated Under: 119.03

(A) The department may issue a license for the program only if it has been determined to the department's satisfaction that the program is adequately staffed and equipped to maintain an opioid treatment program by demonstrating compliance with the licensure requirements set forth in section 5119.37 of the Revised Code and Chapter 5122-40 of the Administrative Code.

The department shall not issue a license if program cannot affirmatively demonstrate that it will maintain strict compliance with all laws relating to drug abuse or this chapter.

(B) The state authority shall coordinate the licensure process among the licensing authorities including the department, SAMHSA, the United States drug enforcement administration, and the state board of pharmacy.

(C) A license to operate an opioid treatment program is for a two-year time period, unless the department stipulates the opioid treatment program license period will be one year as described in paragraph (D) of this rule.

(D) The department may stipulate an annual renewal of an opioid treatment program license for a program that the department has concerns regarding either compliance with Chapter 5122-40 of the Administrative Code or active investigations by other state or federal regulating entities. Any decision the department makes pursuant to this chapter is final and not subject to appeal, or further review under Chapter 119. of the Revised Code.

(1) Each program with which the department has concerns will be given a three-month period in which to make corrections based on the department's written findings of non-compliance. The three-month period will begin on the date which the department sends the findings to the opioid treatment program.

(2) If the department determines that corrections have not been made at the end of the three-month period, the department may change the opioid treatment program license to a one-year license period beginning on a date determined by the department.

(3) The opioid treatment program will return to a two-year license period upon the completion of two annual licensure periods with no significant findings.

(E) A license is not transferable to any other site or property.

(F) A license is valid only for the licensed provider named in the application, and is not transferable to or assumable by any other person, corporation, or entity, including any person or entity which purchases the licensed program or the licensed program's corporate or managing entity, or enters into any similar purchase agreement.

(G) The license must be posted in an area visible to residents and visitors at the program facility at all times and made available for inspection to any person who requests it.

(H) The department may conduct surveys or inspections of licensed programs, as it deems necessary and appropriate, to determine initial or continued compliance with requirements or to determine whether deficiencies have been corrected, or upon complaint or allegation of licensure violations. Inspections or surveys may be unscheduled and unannounced. The department shall conduct inspections of all licensed opioid treatment programs at least once every twenty-four months.

(I) The department shall have access to all records, accounts, and other documents relating to the operation of the program, as well as access to all areas in the program facility and to the staff, and all patients, as the department deems necessary and appropriate.

(J) The program shall be responsible for notifying the department of any changes or proposed changes concerning the information submitted and attested to in the application, or in the operation of the program, or the continued compliance of the facility with the requirements for licensure.

(K) The department may permit the opioid treatment program to develop a plan of correction to address any noted violations or deficiencies.

(L) The department may grant a waiver or variance to the provisions of this chapter. However, requests for waivers and variances that would adversely affect the quality of services or the health and safety of patients will not be granted.

(1) A provider shall submit a written request to the department for a waiver or variance. The written request shall state clearly the rationale and need for the requested waiver or variance.

(2) The waiver shall be for a period of time determined by the department, not to exceed the expiration date of the current license.

(M) The department may deny or revoke a license of an opioid treatment program for one or more of the following reasons:

(1) The program does not meet the requirements of division (C) of section 5119.37 of the Revised Code and rule 5122-40-04 of the Administrative Code;

(2) The program fails to achieve or retain certification in accordance with Chapter 5122-25 of the Administrative Code;

(3) The program is not in compliance with the requirements for licensure as set forth by the rules in this chapter;

(4) The program has been cited for a pattern of serious noncompliance or repeated violations of statutes or rules during the period of current or previous licenses;

(5) The program presents or submits false or misleading information as part of a license application, renewal, or investigation;

(6) The program permits an employee to falsify information on patient records;

(7) The program is aware of an employee who has abused or neglected a patient and has failed to take appropriate disciplinary action to correct the situation;

(8) The program fails to provide timely access to its records as requested by the department;

(9) The program is in violation of any provision of any state or federal law or rule relating to drug abuse;

(10) The program, provider, owner, sponsor, medical director, administrator, or principal of the provider is not in good standing in any other jurisdiction in which the opioid treatment program currently provides services, or was not in good standing at all times within the past three years in any other jurisdiction in which the program previously provided substance use treatment services, that are comparable to the opioid treatment program services authorized under section 5119.37 of the Revised Code; or,

(11) The applicant, operator, owner, sponsor, medical director, administrator, or principal is or has been a principal with a opioid treatment program that has had a previous license to operate in Ohio revoked or denied renewal for any reason other than nonpayment of the license fee unless:

(a) A minimum period of three years has passed from the date of the director's order denying the issuance of an initial license or a minimum period of three years has passed from the date of the director's order revoking a license or denying the renewal of a license; and,

(b) The licensure revocation or non-renewal was not due to any act or omission that is a violation of any provision of any state or federal law or rule relating to drug abuse.

(12) The program fails to timely notify the department of any adverse action or proposed adverse action as required by rule 5122-40-04 of the Administrative Code.

(13) The program loses licensure or certification as an opioid treatment program from SAMHSA, the United States drug enforcement administration, or the state board of pharmacy.

(N) The denial or revocation of a license shall be subject to proceedings governed by Chapter 119. of the Revised Code.

(O) The revocation of a license pursuant to paragraph (M) of this rule shall be subject to proceedings governed by division (L) of section 5119.37 of the Revised Code.

(P) Termination of licenses

(1) A license shall be considered terminated and invalid in the following circumstances:

(a) The program has voluntarily discontinued operations; or,

(b) An application for renewal has not been received by the department ninety days prior to the expiration of the license.

(2) The termination of a license, as specified in paragraph (P)(1) of this rule, shall not be considered a denial or revocation of a license and shall not be subject to proceedings governed by Chapter 119. of the Revised Code. If the department determines that circumstances exist as specified in paragraph (P)(1) of this rule, it shall issue a letter to the operator specifying the date of termination of the license.

(Q) An opioid treatment program directly operated by the department of veterans affairs, the Indian health service or any other department or agency of the United States is not required to obtain a state license.

(R) Regardless of whether the department takes action to deny, withdraw, revoke a license for the reasons listed in paragraph (M) of this rule, it may refer matters to local, state or federal officials as appropriate.

Last updated November 5, 2024 at 9:05 AM

Supplemental Information

Authorized By: 5119.37
Amplifies: 5119.37
Five Year Review Date: 10/31/2029
Prior Effective Dates: 6/1/2017, 1/1/2019

Rule 5122-40-04 | General licensure requirements.

• Effective: June 11, 2021
• Promulgated Under: 119.03

(A) An alcohol and drug addiction program desiring to obtain an initial license or renew a license as an opioid treatment program shall:

(1) Be certified as a provider pursuant to Chapter 5122-25 of the Administrative Code at a minimum for the following services:

(a) General services in accordance with rule 5122-29-03 of the Administrative Code;

(b) SUD case management services in accordance with rule 5122-29-13 of the Administrative Code; and,

(c) Crisis intervention in accordance with rule 5122-29-10 of the Administrative Code.

(2) Submit with the application for initial license or license renewal a licensure fee as set by paragraph (B)(2) of rule 5122-40-08 of the Administrative Code;

(3) Submit a renewal application at least ninety days prior to the expiration of the current license.

(4) When applying for renewal licensure, be accredited as an opioid treatment program by an accreditation body that has been approved by SAMHSA;

(5) Be certified by SAMHSA pursuant to "certification of opioid treatment programs," 42 C.F.R. Part 8.11;

(6) Have a category III terminal distributor of dangerous drugs license from the state board of pharmacy pursuant to Chapter 4729. of the Revised Code;

(7) Have a security and alarm system that is approved by the United States drug enforcement administration;

(8) Meet the security requirements for the distribution and storage of controlled substances as required by 21 C.F.R. 1301.72 to 21 C.F.R. 1301.76;

(9) Operate the program in accordance with 21 C.F.R. 291.505, conditions for the use of narcotic drugs; appropriate methods of professional practice for medical treatment of the narcotic addiction of various classes of narcotic addicts under section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970, Pub. L. No. 91-513, 84 Stat. 1236 (Oct. 27, 1970);

(10) Have a program sponsor who has signed and submitted SAMHSA form SMA-162, application for certification to use opioid drugs in a treatment program under 42 CFR 8.11;

(11) Be in good standing with the state board of pharmacy, centers for medicare and medicaid services, Ohio department of medicaid, , and the United States drug enforcement administration;

(12) Be in good standing as defined by division (C)(1) of section 5119.37 of the Revised Code;

(13) Demonstrate the ability to meet the standards of medical care for opioid treatment services established by the American society of addiction medicine (ASAM) criteria, third edition (2013), or other nationally recognized standards organization selected by the director;

(B) Geographic restrictions:

(1) A program applying for an initial license shall not be issued a license if the provider is requesting an initial license for a particular location that is located on a parcel of real estate that is within a radius of five hundred linear feet of the boundaries of a parcel of real estate having situated on it a public or private school, child day-care center licensed under Chapter 5104. of the Revised Code, or child-serving agency regulated by the department under Chapter 5119. of the Revised Code.

(2) The five-hundred foot restriction may be waived if the program obtains a letter of support from each public or private school, licensed child day-care center, or other child-serving agency within the five hundred linear foot radius of the location where the opioid treatment program is to operate.

(3) Programs will perform their due diligence to evaluate this criterion before submitting the application for licensure.

(4) If a determination was not applied for and made by the program prior to submitting a license application pursuant to section 5119.371 of the Revised Code, the department, upon receiving a license application, shall proceed to make the determination if there is such a public or private school, licensed child day-care center, or other child-serving agency regulated by the department under Chapter 5119. of the Revised Code within the five-hundred foot radius of the location listed on the application and issue a declaration of its findings in accordance with section 5119.371 of the Revised Code.

(5) For license renewals, the geographic restrictions of this paragraph shall not apply pursuant to division (K) of section 5119.37 of the Revised Code, so long as the program remains continuously licensed.

(C) An opioid treatment provider shall inform the department of any adverse action or proposed adverse action that is issued to the provider or owner, or is issued to any other program, corporation, entity or partnership with which the opiate treatment program's sponsor, medical director, administrator or a principal is associated. Adverse action is defined as a notice issued by a state, province federal or similar licensing or regulatory authority to deny, revoke, suspend, place on probation or take similar action against a provider's license, certificate or other approval to operate an opioid treatment program. Notice provided to the department shall consist of a copy of the notice of adverse action or proposed adverse action, and all of that opioid treatment program's compliance or monitoring reports issued for the prior three-year period. The opioid treatment provider shall provide this information to the department at the following times:

(1) At the time of initial or renewal application; and,

(2) Within seven days of receipt of notice.

(D) Upon receipt of an application, the department shall review the materials to determine if they are complete. If an application is incomplete, the department shall notify the applicant of corrections or additions needed, and may return the materials to the applicant. Incomplete materials shall not be considered an application for licensure, and return of the materials or failure to issue a license shall not constitute a denial of an application for licensure.

Last updated November 5, 2024 at 9:05 AM

Supplemental Information

Authorized By: 5119.37
Amplifies: 5119.37
Five Year Review Date: 10/31/2029
Prior Effective Dates: 6/1/2017

Rule 5122-40-05 | Personnel.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Each opioid treatment program will have a program sponsor. .

(1) The program sponsor is responsible for the general establishment, certification, licensure, and operation of, as well as the employees of, the opioid treatment program.

(2) The program sponsor is to agree, on behalf of the opioid treatment program, to adhere to all requirements set forth in federal or state statutes, rules, or regulations regarding the use of medications used in medication-assisted treatment.

(3) The program sponsor need not be a licensed physician. If the program sponsor is not a licensed physician, the opioid treatment program will employ a physician for the position of medical director as specified in paragraph (B) of this rule.

(B) Each opioid treatment program will have a designated medical director.

(1) The medical director is to be available for consultation by program prescribers during all hours of the opioid treatment program's operation.

(2) The medical director is responsible for ensuring that the opioid treatment program is in compliance with all applicable federal, state, and local statutes, rules, and regulations.

(3) The medical director is responsible for maintaining authority over the medical aspects of treatment offered by the opioid treatment program, which includes all of the following:

(a) All medication treatment decisions;

(b) Administration and supervision of all medical services;

(c) Medication storage and review of safe handling of medications;

(d) Ensuring that evidence of current physiologic dependence on an opioid, length of opioid dependence, and exceptions to admission criteria are documented in the patient's clinical record before the patient receives the initial dose of medication used in medication-assisted treatment;

(e) Ensuring that a medical history and a physical examination have been done before a patient receives the initial dose of medication used in medication-assisted treatment;

(f) Ensuring that appropriate laboratory studies have been performed and reviewed. The initial dose of medication may be administered before the results of the laboratory tests are reviewed;

(g) Ensuring all medical orders are signed as mandated by federal, state, or local statutes, rules, and regulations;

(h) Developing or approving policy and procedures for take-home doses of medications used in medication-assisted treatment;

(i) Ensuring that justification for take-home doses is recorded in the patient's clinical record;

(j) Ensuring individuals are appropriately admitted to the opioid treatment program;

(k) Ensuring all medical services are appropriately performed by the opioid treatment program;

(l) Obtaining and maintaining their own continuing medical education in the field of addiction on a documented and ongoing basis;

(m) Determining the ability of program prescribers, other than physicians, to work independently within the applicable scope of practice.

(4) The medical director is to be a physician.

(5) The medical director will have a current U.S. drug enforcement administration (DEA) registration for prescribing, administering, or dispensing controlled substances.

(C) Each opioid treatment program will have a program director.

(1) The program director is responsible for the day-to-day operation of the opioid treatment program in a manner consistent with the laws and regulations of the United States department of health and human services, United States drug enforcement administration, and the laws and rules of the state of Ohio.

(2) The program director is to be available for consultation by program staff during all hours of the OTP's operation.

(3) The program director is to ensure documentation of a root cause analysis or intenstive review of systems is completed for all of the following reportable incidents:

(a) A medication error resulting in hospitalization of an active patient or permanent harm to an active patient.

(b) A death of an active patient occurring as a result of an overdose or a death of a former patient occurring within five days of that patient's discharge or termination of services.

(c) An overdose of an active patient, or the allegation of such an overdose, that was reported to the OTP.

(d) A call made by OTP staff for emergency medical services to be dispatched to the OTP site, including a parking lot used by the OTP's patients.

(4) The program director is to ensure documentation of individual case reviews is completed for both of the following:

(a) An individual who voluntarily discontinues OTP medical services; and

(b) An individual who declines or refuses non-medication services.

(5) The program director is to ensure a review of information in the drug database established and maintained by the state of Ohio board of pharmacy under section 4729.75 of the Revised Code, as described in paragraph (A) of rule 5122-40-08 of the Administrative Code, is completed, if this task is delegated to the program director by a physician.

(6) The program director is to ensure the opioid treatment program has a policy assigning all of the following responsibilities to specific staff of the opioid treatment program:

(a) Development and enforcement of policies and procedures for operation of the opioid treatment program;

(b) Maintenance and security of the opioid treatment program;

(c) Employment, credentialing, evaluation, scheduling, training, and management of opiod treatment program staff;

(d) Protection of patient rights;

(e) Conformity of the opioid treatment program with federal confidentiality regulations, namely 42 C.F.R. part 2; and

(f) Management of the opioid treatment program's budget.

(D) An opioid treatment program may employ and use health care professionals who are working within their scope of practice and appropriately licensed by an Ohio professional licensing board to perform their assigned functions within the OTP.

(1) All program prescribers will be actively licensed in Ohio and will have:

(a) A minimum of one year's experience in an addiction treatment settings; or

(b) Completion within six months of initial hire date a plan of education for obtaining competence in addiction treatment methods. The plan of education will be developed in consultation with and approved by the medical director. The medical director will certify the individual's completion of the plan of education when, in the discretion of the medical director, it is satisfactorily accomplished.

(2) During all hours of operation, every opioid treatment program will have a physician on call and available for consultation with other staff members at any time.

(3) During all hours of operation when medication is being administered, every opioid treatment program will have present and on duty at the facility at least one of the following:

(a) A physician assistant;

(b) A registered nurse acting in accordance with division (B) of section 4723.01 of the Revised Code;

(c) A licensed practical nurse acting in accordance with division (F) of section 4723.01 of the Revised Code;

(d) A pharmacist who is authorized to manage drug therapy pursuant section 4729.39 of the Revised Code but only if specifically authorized by a consult agreement and to the extent specified in the agreement;

(e) A certified nurse practitioner; or

(f) A physician.

(4) Each opioid treatment program will have adequate medical staff, and they will ensure proper implementation of the medical plan of care. A program prescriber will be available for consultation either in person or by telephone during all hours of operation.

(5) In the event of medical director absence for a limited-time period (more than six weeks) alternative coverage arrangements may be acceptable with departmental notice.

(6) The medical director or a program prescriber at the opioid treatment program will meet with each patient within two weeks of the admission. The medical director or a program prescriber will see patients at least once every six months thereafter during treatment. Each meeting will be documented in the patient's record. .

(E) If an opioid treatment program employs a program prescriber pursuant to paragraph (D) of this rule who is not a physician, the following requirements are to be met: :

(1) There is to be a written plan for ongoing supervision and case discussion of the program prescriber who is not a physician, to include such program prescriber's participation in:

(a) Regularly scheduled supervisory sessions with the medical director or prescribing physician. Sessions will be at least one hour of supervision every two weeks;

(b) Team meetings where cases are reviewed with the medical director or prescribing physician present.

In addition, if the program prescriber is a certified nurse practitioner, that certified nurse practitioner is to have a standard care arrangement with the opioid treatment program's medical director pursuant to section 4723.431 of the Revised Code unless the medical director has five existing certified nurse practitioners with a standard of care arrangement. In that latter circumtance, the certified nurse practitioner is to have a standard care arrangement with a program physician.

(2) The opioid treatment program is to maintain a ratio of no more than five program prescribers who are not physicians per medical director or prescribing physician

(3) A program prescriber who is not a physician must complete all federal training requirements.

(4) At initial hire, a program prescriber who is not a physician must submit a training and supervision plan to the SOTA.

(5) A supervision and training log must be maintained for each program prescriber who is not a physician documenting compliance with paragraphs (E)(1) and (E)(3) of this rule.

(F) Counselors with less than one year of full time equivalent experience in the field of addiction treatment will develop with their supervisor a plan to achieve competency prior to providing counseling services without their supervisor present during or constantly observing counseling sessions. The plan will specify the frequency of face-to-face clinical supervision meetings between the counselor and supervisor, and the time-frame for achieving competency which will be no more than one year.

(G) Each program will conduct a criminal records check of each staff who will have access to any form of medication. All criminal records checks conducted in accordance with this rule will consist of both a bureau of criminal identification and investigation to conduct (BCI&I) criminal records check and a federal bureau of investigations records check.

(1) The criminal records check will be based on electronic fingerprint impressions that are submitted directly to BCI&I from a "webcheck" provider agency located in Ohio. The employer may accept the results of a criminal records check based on ink impressions from a "webcheck" provider agency only in the event that readable electronic fingerprint impressions cannot be obtained.

(2) A program will not employ in a position which allows access to any form of medication to any person who has been convicted of a felony relating to controlled substances.

Last updated January 31, 2025 at 7:39 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 6/11/2021

Rule 5122-40-06 | Medication administration.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Medication administration is to consist of face-to-face interactions with patients; methadone medication is only to be administered or dispensed in oral, liquid doses.

(B) Medication administration is to be provided in a manner to ensure privacy.

(C) Opioid treatment programs are permitted to establish medication units following the guidelines of 42 C.F.R. 8.11(h).

(D) Medication is to be administered only by the following individuals:

(1) A physician;

(2) A pharmacist who is authorized to manage drug therapy pursuant section 4729.39 of the Revised Code but only if specifically authorized by a consult agreement and to the extent specified in the agreement;

(3) A registered nurse;

(4) A licensed practical nurse; or

(5) A physician assistant.

A provider of medication administration is to be supervised in their medication administration if such supervision is required by statute or rules adopted by the Ohio licensing board that issued such provider's license or certification.

(E) Dispensing medication is only to be performed by pharmacists in accordance with Chapter 4729. of the Revised Code. Personally furnishing medication is to be performed in accordance with rules adopted by the state of Ohio board of pharmacy and may only be done by the following individuals:

(1) A physician;

(2) A pharmacist pursuant to section 4729.39 of the Revised Code;

(3) A certified nurse practitioner:

(4) A physician assistant; or

(5) An individual to whom a program prescriber has delegated the act of personally furnishing as authorized by the state of Ohio board of pharmacy in accordance with Chapter 4729:5-21 of the Administrative Code.

(F) A written, signed, and dated order from a program prescriber is required for all medication admininistered, personally furnished, or dispensed. A copy of each order is to be maintained in the patient's record.

(G) Labels for dispensing or personally furnishing medication are to be prepared in accordance with 21 C.F.R. 1306.14 and section 3719.08 of the Revised Code and in accordance with Chapter 4729:5-21 of the Administrative Code.

(H) Medication orders are to be written by a program prescriber who is appropriately licensed and registered with the United States drug enforcement administration to order medications for opioid use disorder. The following procedures are to be followed in writing prescriber orders for these medications.

(1) A prescriber's order for medication is valid for a maximum time period of ninety days.

(2) A prescriber's order for medication is to be reviewed at least every ninety days and adjusted, reordered, or a notation made that the medication is to be discontinued.

(I) Opioid treatment programs are to be open and administer medication at least six days per week every week, except that programs may close on federal holidays indicated in paragraph (L) of this rule. Upon approval of an exception request from the state authority and SAMHSA, opioid treatment programs may close for one business day twice per year for administrative planning purposes. Closure dates are not to be within the same sixth month period.

(J) An opioid treatment program will enter into agreements with one or more alternate programs under which the opioid treatment program arranges for such programs to administer medication used in medication-assisted treatment in the event the opioid treatment program is closed due to emergency and unable to administer medication as required by paragraph (I) of this rule. Such agreements will cover any costs associated with the patient receiving the medication at the alternate site and are not to lead to any additional costs incurred by the patient.

(K) The take-home supply of medications for medication-assisted treatment for patients enrolled in an opioid treatment program receiving partial opioid agonist is limited to a one month supply. The take-home supply of such medication for patients enrolled in an opioid treatment program receiving methadone is limited to a one month supply and is to be in accordance with federal regulations.

(L) If the opioid treatment program is closed for any of the federal holidays set forth in 5 U.S.C. 6103 including, but not limited to, the following holidays, all patients receiving methadone may be given a one-day take-home dose at the discretion of the medical director.

(1) Thanksgiving day.

(2) Christmas day.

(3) New year's day.

(4) Martin Luther King day.

(5) President's day

(6) Memorial day

(7) Juneteenth national independence day

(8) Fourth of July

(9) Labor day

(10) Columbus day

(11) Veteran's day

(M) The opioid treatment program is to have written procedures for take-home medication doses that include:

(1) A statement that the opioid treatment program decisions on dispensing take-home doses of medication are to be determined by the medical director or other authorized program prescriber;

(2) A statement that the dispensing of medication for home administration is permitted only when such dispensing is found to be safe, outweighs potential risks, and is beneficial for the patient. Such dispensing is not a right and is not automatic. Rather, it is subject to medical-legal considerations on an individual case by case basis.

(3) A requirement that take-home doses of medication are to be given only to:

(a) A patient, who, in the opinion of the medical director or other authorized prescriber, is responsible in handling medication; or

(b) A trusted third party in accordance with federal drug enforcement administration regulations, when the pickup is approved in advance by the SOTA.

(4) A statement that prescriber orders for take-home doses of medication expire every ninety days;

(5) A requirement that education on the proper safe storage and disposal of take-home dose of medication be provided to patients prior to the first take-home dose.

(6) A requirement that child-resistant packaging or caps be used for take-home doses of medications; and

(a) If a take-home bottle or other form of packaging is returned by a patient for refills, the opioid treatment program is to accept the bottle or other form of packaging and dispose of it.

(b) If a take-home bottle or other form of packaging is utilized for take home doses, the medication bottles -are only to be used once.

(c) Under no circumstance is medication to be placed in a container provided by a patient (including previous take-home bottle).

(7) A requirement that each take-home bottle or other form of medication packaging used have a label that complies with section 3719.08 of the Revised Code and rule 4729:5-21-02 of the Administrative Code.

(8) A requirement that any take-home policies and procedures be individualized to each patient's treatment needs.

(N) An individual is to be a patient of an opioid treatment program licensed by the department to receive medication under the provisions of this rule except under the circumstances in paragraph (O) of this rule.

(O) A patient may attend a different opioid treatment program if prior approval is obtained from the patient's medical director or program prescriber to receive services on a temporary basis from another opioid treatment program licensed under this chapter or by SAMHSA. The approval is to be noted in the patient's record and include the following documentation:

(1) The patient's signed and dated consent for disclosing identifying information to the program which will provide services on a temporary basis;

(2) A medication change order by the referring medical director or prescriber permitting the patient to receive services on a temporary basis from the other program for a length of time not to exceed thirty days; and

(3) Evidence that the medical director or prescriber for the program contacted to provide services on a temporary basis has accepted responsibility to treat the visiting patient, concurs with his or her dosage schedule, and supervises the administration of the medication.

(P) A patient may receive medication from an opioid treatment program while the patient is at or admitted to any of the following: a correctional facility or a community mental health services or addiction services provider certified for residential and withdrawal management substance use disorder services as defined in rule 5122-29-09 of the Administrative Code, a long-term care provider, a skilled nursing facility, or any other inpatient or residential facility. A temporary medication request will be submitted through the SAMHSA extranet and approved by the state authority. Medication approval will be noted in the patient's record and will include the following documentation:

(1) The patient's signed and dated consent for disclosing identifying information to the program which will provide services on a temporary basis; and

(2) A chain of custody document showing that any medication used for medication-assisted treatment is transferred from medical staff of the opioid treatment program to medical staff of the partnering provider or appropriate law enforcement staff.

(Q) An opioid treatment program may admit patients for interim treatment in accordance with 21 C.F.R. 8.12(j)..

(1) All of the requirements for comprehensive maintenance treatment apply to interim maintenance treatment with the following exceptions for patients receiving methadone: no take-home doses are permitted except on Sundays and federal holidays if the program is closed on those days; a primary counselor is not required; and the rehabilitative and other services described in 42 C.F.R. 8.12(f)(4), (f)(5)(i), and (f)(5)(iii) are not required.

(2) Interim maintenance cannot be provided to an individual for more than one hundred and eighty days in any twelve month period.

(3) To receive interim maintenance, a patient is to be fully eligible for admission to comprehensive maintenance.

(4) Interim maintenance treatment is for those patients who cannot be enrolled in comprehensive maintenance treatment in a reasonable geographic area within fourteen days of application for admission.

(5) During interim maintenance, the initial toxicology and at least two additional toxicology screening tests should be obtained.

(6) Programs offering interim maintenance are to develop clear policies and procedures governing the admission to interim maintenance and transfer of patients to comprehensive maintenance.

(R) Each opioid treatment program is to have written procedures for pregnant patients that include at least the following:

(1) A requirement that each pregnant patient admitted to the opioid treatment program be informed of the possible risks to themselves or to their unborn child from the use of medications used in medication-assisted treatment, and be informed that abrupt withdrawal from these medications may adversely affect the unborn child;

(2) A statement that a pregnant patient, regardless of age, who has a documented opioid use disorder and who may be in direct jeopardy of resuming illicit opioid use with all of its attendant dangers during pregnancy may be placed on a regimen of medications used in medication-assisted treatment.

A statement that for such pregnant patient, evidence of current physiological dependence on opioid drugs is not needed if the medical director or other authorized prescriber certifies the pregnancy, determines and documents that the person may resort to the use of opioid drugs, and determines that the use of medications used in medication-assisted treatment is justified in their clinical opinion;

(3) A requirement that the admission of each pregnant patient to an opioid treatment program be approved by the medical director or other authorized prescriber prior to admitting the person to the program;

(4) A requirement that opioid treatment programs develop a form for release of information between themselves and the healthcare provider providing obstetrical care. This voluntary form should be offered for coordination of medical care;

(5) A requirement that each pregnant patient be given education on recognizing the symptoms of neonatal abstinence syndrome near the time of delivery;

(6) Procedures for prenatal care that include:

(a) Provisions for providing prenatal care by the program or by referral to an appropriate health care provider. If appropriate prenatal care is neither available on-site or by referral, or if the pregnant patient cannot afford care or refuses prenatal care services on-site or by referral, an opioid treatment program, at a minimum, should offer basic prenatal instruction on maternal, physical, and dietary care as part of its counseling services. If a pregnant patient refuses the offered on-site or referred prenatal services, the medical director or treating prescriber is to use informed consent procedures to have the person formally acknowledge, in writing, refusal of these services;

(b) A requirement that if a person is referred to prenatal care outside the agency, the name, address, and telephone number of the health care provider is to be recorded in the woman's clinical record;

(c) If prenatal care is provided by the opioid treatment program, the clinical record is to include documentation to reflect services provided;

(d) A requirement that if a person is referred outside of the agency for prenatal services, the provider to whom they have been referred is to be notified that the person is taking medication for an opioid use disorder; however, such notice is only to be given after the patient has signed a release of information;

(e) A requirement that any changes in medication be communicated to the appropriate healthcare provider if the person has prenatal care outside the agency and if the person allows communication among providers;

(f) A requirement that the program monitor the medication dose carefully throughout the pregnancy, moving rapidly to supply increased or split dose if it becomes necessary;

(g) A recommendation that blood serum levels of methadone be monitored once a trimester prior to delivery. Post-partum, the patient's withdrawal symptoms and clinical status should be re-evaluated every three days for two weeks to determine the appropriate dose of medications used in medication-assisted treatment by the appropriate healthcare professional. The medical director or other authorized prescriber is to request and review serum levels to determine whether any changes to treatment are indicated; and

(h) A requirement that the program offer on-site parenting education and training to all patients who are parents or refer interested patients to appropriate alternative services for the training.

(7) A statement that if a person refuses prenatal service by the opioid treatment program and by an outside provider:

(a) The medical director or other authorized prescriber is to note this in the clinical record; and

(b) The patient will be asked to sign a statement that says "I have been offered the opportunity for prenatal care by the opioid treatment program or by a referral to a prenatal clinic or by a referral to the physician of my choice. I refuse prenatal counseling by the opioid treatment program. I refuse to permit the opioid treatment program to refer me to a physician or prenatal clinic for prenatal services." If the patient refuses to sign the statement, the medical director or other authorized prescriber is to indicate in the signature block that "patient refused to sign" and affix their signature and the date on the statement.

(S) If a patient desires to be permanently transferred, medication administration is to continue until the patient completes the admission process at the admitting program.

Last updated January 31, 2025 at 7:40 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 1/1/2019, 6/10/2022

Rule 5122-40-07 | Program policies and patient records.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Each opioid treatment program will have written policies or procedures that include, but are not limited to, the following:

(1) Admission criteria for adolescents and adults for medication maintenance and withdrawal management that are in accordance with 42 C.F.R. 8.12(e).

(2) Procedures for providing counseling on preventing exposure to and the transmission of tuberculosis, hepatitis type B and C, and human immunodeficiency virus (HIV) disease for each patient admitted or readmitted to maintenance or withdrawal management;

(3) Policies and procedures for the frequency of testing someone with new or increased risk factors for tuberculosis, sexually transmitted diseases, hepatitis type B and C, and HIV disease.

(4) A policy or procedure that establishes primary counselors for patients that are in accordance with the requirements for counselors in rule 5122-40-09 of the Administrative Code.

(5) Policies and procedures that treatment will meet the standards of medical care for opioid treatment services established by the American society of addiction medicine, 2015 edition, or other nationally recognized standards organization selected by the director.

(6) Procedures for the ordering, delivery, receipt, and storage of any medication used for medication assisted treatment;

(7) A policy or procedure for the security alarm system that includes, but is not limited to, the following:

(a) Provisions for testing the alarm system; and

(b) Provisions for documenting the testing of the alarm system.

(8) A policy or procedure that specifies which staff will have access to the program's supply of medications used in medication-assisted treatment;

(9) Procedures for administering medications used in medication-assisted treatment in accordance with the requirements of rule 5122-40-06 of the Administrative Code;

(10) Procedures for dispensing medications used in medication-assisted treatment, including days and hours, in accordance with the requirements of rule 5122-40-06 of the Administrative Code;

(11) A policy or procedure for days and hours for non-medication dispensing program services;

(12) Policies and procedures for the involuntary termination of patients in accordance with the requirements of rule 5122-40-14 of the Administrative Code;

(13) Procedures for referring or providing prenatal services to pregnant patients in accordance with the requirements of rule 5122-40-06 of the Administrative Code;

(14) Policies and procedures for take-home doses of medications used in medication-assisted treatment in accordance with the requirements of rule 5122-40-06 of the Administrative Code;

(15) Policy or procedure for urinalysis for patients in accordance with the requirements of rule 5122-40-11 of the Administrative Code;

(16) Policies and procedures for urinalysis for employees of the opioid treatment program;

(17) Procedure for cleaning the medication areas;

(18) Policies and procedures for missed medication administration appointments;

(19) Policies and procedures stating that medications used in medication-assisted treatment will not be provided to a patient who is known to be currently receiving such medications from another opioid treatment program with the exception of guest dosing patients whose need for medication maintenance has been verified by the medical director or other authorized program physician of both the opioid treatment program where the patient is currently enrolled and at the program where the patient is requesting to receive services;

(20) Policies and procedures related to disaster planning, pursuant to rule 5122-40-12 of the Administrative Code;

(21) Policies and procedures relating to a diversion control plan, pursuant to rule 5122-40-10 of the Administrative Code;

(22) Policies and procedures for accessing the state's drug database pursuant to rule 5122-40-08 of the Administrative Code;

(23) Policies and procedures relating to permanent patient transfer, pursuant to rule 5122-40-08 of the Administrative Code; and

(24) A policy or procedure for asking for patient consent to disclose opioid treatment program information to the state's drug database upon admission and, if consent is not given at admission, every twelve months thereafter while the patient is in treatment.

(B) An individual client record will be maintained for each client and contain the following:

(1) The date of each visit that the patient makes to the program;

(2) The date, time, and amount of medication administered or dispensed along with the printed name and original signature of the service provider;

(3) Medical history;

(4) Documentation of physical examination and results;

(5) Results for serological tests for hepatitis type B and C performed by the program or a copy of results when performed by another entity. The program may accept results from tests performed within the past six months;

(6) Result of a serological test for HIV performed by the program or a copy of results when performed by another entity within the past six months. The program may accept results from tests performed within the past six months;

(7) Results of a serological test for syphilis performed by the program or a copy of results when performed by another entity within the past six months. The program may accept results from tests performed within the past six months;

(8) Results of tubercular skin test or interferon gamma release assay (IGRA) blood test performed by the program or a copy of results when performed by another entity within the past six months. The program may accept results from tests performed within the past six months;

(9) Results of a urinalysis for drug determination at the time of admission and the results of each subsequent urinalysis;

(10) An assessment in accordance with Chapter 5122-29 of the Administrative Code;

(11) An individualized treatment plan in accordance with Chapter 5122-27 of the Administrative Code;

(12) Progress notes in accordance with Chapter 5122-27 of the Administrative Code;

(13) Documentation of counseling on preventing exposure to tuberculosis, hepatitis type B and C, and the transmission of human immunodeficiency virus (HIV) disease;

(14) Documentation of provision of the following when the individual has been assessed as in need of these services, either directly or through referral to adequate and reasonably accessible community resources:

(a) Vocational rehabilitation services;

(b) Employment services; and

(c) Education services.

(15) Documentation to reflect that the program has attempted to determine whether or not the patient is enrolled in any other opioid treatment program. This documentation may be stored in either the client record or the central registry system;

(16) Documentation to reflect verification by the medical director or other authorized program physician of the need for medication assisted treatment for guest dosing patients;

(17) Information required by Chapter 5122-27 of the Administrative Code; and

(18) Documentation of any check of the prescription drug monitoring program data pursuant to rule 5122-40-08 of the Administrative Code.

(C) Patient records will be maintained for at least seven years from the last date of administering or dispensing a controlled substance.

(D) Opioid treatment programs may substitute in-office and staff supervised cheek swabs for toxicology testing for oral fluid testing, urine screens, urine drug screens, or urinalysis wherever required by rule in this chapter.

Last updated January 31, 2025 at 7:40 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 6/11/2021

Rule 5122-40-08 | Monitoring program.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Each opioid treatment program is to review the drug database established and maintained by the state of Ohio board of pharmacy under section 4729.75 of the Revised Code (Ohio's prescription drug monitoring program).

(1) Program physicians, or their designees as allowed by the state of Ohio board of pharmacy, are to review a patient's information in the database:

(a) At the patient's intake;

(b) At the initiation of treatment;

(c) After the initial thirty days of treatment;

(d) When the number of take home doses is increased;

(e) Every ninety days;

(f) When a patient refuses to participate in a drug screen; and

(g) After any positive drug test indicating any drug screen inconsistent with the patient's treatment plan.

(2) The physician, or the physician's designee as allowed by the state of Ohio board of pharmacy, is to review information in the drug database to ensure that the patient is not seeking prescription medication from multiple sources. The results obtained from the database are to be maintained with the patient records in accordance with section 4729.86 of the Revised Code.

(B) All opioid treatment programs are to participate in the central registry for dual enrollment, guest dosing, disaster planning, and administrative efforts.

(1) The central registry will be administered by the state authority.

(2) The central registry will be paid for by the opioid treatment programs through an annual licensing fee that is to be no more than the cost of the central registry. The amount of the fee will be set by the department on a state fiscal year basis and will be announced on or before July first of each year.

(3) To facilitate timely access to information in the central registry for dual enrollment verification purposes, opioid treatment programs will ensure that contact information for program staff is available to the extent necessary to reasonably facilitate direct communication between providers.

(4) Within twenty-four hours of patient admission or discharge, the program is to report to the central registry patient admission data which is to include:

(a) Provider identification, including program name, county, and address;

(b) Patient identification, including:

(i) Patient name or initials;

(ii) Sex;

(iii) Month, day, and year of birth; and,

(iv) Race,

(c) The month, day, and year of admission;

(d) The month, day, and year of discharge, if applicable;

(e) The type of admission (e.g. initial admission, transfer from another program, change in treatment service, etc.);

(f) The type of treatment provided (e.g. withdrawal management or maintenance);

(g) The type of medication prescribed;

(h) The dose of medication;

(i) Medicaid identification, if available; and

(j) Patient home address.

(5) A patient's medication and dosage is to be updated within the central registry system at least once a week for disaster planning efforts.

(C) Opioid treatment programs are to check the central registry at least once a day during normal business hours. Opioid treatment programs are to verify that new patients are not enrolled in another program through use of the central registry and by directly checking with other opioid treatment programs located within a radius of one hundred statute miles who do not participate in the central registry.

(1) Before a program admits a patient for treatment, the program is to:

(a) Notify the patient that it cannot provide medication assisted treatment to a patient who is simultaneously receiving medication assisted treatment from another program;

(b) Require the patient to sign a written statement documenting whether they are currently receiving medication assisted treatment from another program and retain the statement in the patient record. If the patient refuses to sign this statement, the program shall not admit the patient for treatment;

(c) Require the patient to provide the following information:

(i) Full name and any aliases;

(ii) Month, day, and year of birth;

(iii) Mother's maiden name;

(iv) Sex;

(v) Race;

(vi) Height;

(vii) Weight;

(viii) Color of hair;

(ix) Color of eyes; and

(x) Distinguishing markings, such as scars or tattoos.

(d) Obtain a current patient photo.

(e) Request the patient to voluntarily provide their social security number;

(f) Require the patient to sign an authorization for disclosure of confidential information, pursuant to 42 C.F.R. 2.34, for the limited purpose of authorizing the program to contact each opioid treatment program within a central registry system and within a radius of one hundred statute miles to determine if the patient is simultaneously receiving opioid agonist or partial opioid agonist therapy from another program; and

(g) Document in the patient record all information provided and authorizations of release of information signed pursuant to this rule.

(2) If the program receives the consent in paragraph (C)(1)(e) of this rule, it is to disclose to the central registry or any requesting opioid treatment program within two hundred miles of the program the information provided by the patient in paragraph (C)(1)(c) of this rule upon:

(a) Accepting the patient for treatment;

(b) Changing the dosage being administered or dispensed to the patient; or

(c) When the treatment is interrupted for a duration of greater than one week, resumed, or terminated.

(3) If the patient states that they are currently receiving medication assisted treatment from another program and the patient is not approved to receive services on a temporary basis before admitting the patient for treatment, the program is to:

(a) Require the patient to sign an authorization of disclosure of confidential information, pursuant to 42 C.F.R. 2.34, for the limited purpose of authorizing the program to contact the previous program to notify it that the patient has applied for admission for medication assisted treatment;

(b) Provide patient education materials about the transfer process, including but not limited to, the length of time associated with the transfer process, responsibilities of the patient, responsibilities of each agency, and client rights to be re-admitted to the transferring agency if space if available;

(c) Contact the previous program by telephone and notify the program that the individual has applied for admission for medication assisted treatment;

(d) Request information to be transferred from the previous program to the admitting program within seventy-two hours that includes medication type; medication dosage; length of time in treatment; current take home regimen or phase level; and most recent urine drug screen results;

(e) Request the program to cease providing medication assisted treatment if it has not already done so, and only if the admitting program has documentation to verify medication type and dosage;

(f) Request the previous program to provide the new program with written documentation (letter or discharge summary) that it has discharged the patient; and the previous program shall provide such information within seventy-two hours of receiving the request. If the previous program states that it has already discharged the patient, the new program may admit the patient for treatment; and

(g) Document the following information in writing in the patient's record:

(i) The name of the program contacted;

(ii) The date and time of the contact;

(iii) The name of the program staff member contacted; and,

(iv) The results of the contact.

(4) If the patient states that they are a visiting patient approved to receive services on a temporary basis, before providing medication assisted treatment to the patient the program is to:

(a) Contact the other program to determine that it has not already provided the patient with medication assisted treatment therapy for the same time period and that it will not do so; and

(b) Document the following information in writing in the patient's medication orders:

(i) The name of the program contacted;

(ii) The date and time of the contact;

(iii) The name of the program staff member contacted; and

(iv) The results of the contact.

(5) If the patient states that they are not currently receiving medication assisted therapy from another program, the program is to proceed with patient admission procedures.

(6) When a program determines that it is providing medication assisted treatment to a patient who is simultaneously receiving this therapy from one or more other programs, all of the involved programs are to immediately:

(a) Confer to determine which program will accept sole responsibility for the patient;

(b) Revoke the patient's take-home medication privileges; and

(c) Notify the state authority by telephone within seventy-two hours of such determination.

(7) The program which agrees to accept sole responsibility for a patient with multiple enrollments shall continue to provide medication assisted treatment. Each of the other programs involved are to:

(a) Immediately discharge the patient from the program;

(b) Document in the patient's record why the patient was discharged from the program;

(c) Provide to the new program, within seventy-two hours of the discharge, written documentation (letter or discharge summary) that it has discharged the patient; and

(d) Send written notification of the discharge to the state authority within seventy-two hours of the discharge.

(8) If the state authority determines that there is patient who is enrolled in multiple programs, and none of the programs has accepted sole responsibility for the patient, the state authority is to:

(a) Designate one program which is to accept sole responsibility for the patient; and

(b) Order the remaining programs to proceed in accordance with paragraph (C)(7) of this rule.

(D) An opioid treatment program that has followed the requirements of paragraph (C) of this rule has complied with the requirement to check for patient dual enrollment, regardless of whether or not the patient is actually dually enrolled in another program.

Last updated January 31, 2025 at 7:40 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 7/1/2001

Rule 5122-40-09 | Non-medication services.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Opioid treatment programs are to provide, at a minimum, the following services:

(1) General services, SUD case management services, and crisis intervention services pursuant to Chapter 5122-29 of the Administrative Code.

(2) Adequate medical, counseling, vocational, educational, employment, and other screening, assessment, and treatment services to meet patient needs.

(B) Opioid treatment programs will ensure that the services specified in paragraph (A) of this rule are made available in a combination and frequency that is tailored to each individual patient based on an individualized assessment and the patient care plan that was created after shared decision making between the patient and the patient's medical team. The program sponsor will document this availability in each patient's record.

All services are to be provided on-site at the opioid treatment program except that vocational services, educational services, and employment services may be provided off-site. A program sponsor may enter into a written agreement with any of the following to provide a service specified in paragraph (A)(1) of this rule to patients of the OTP:

(1) A class one residential facility, hospital, correctional facility, or nursing facility, when that facility or hospital is certified to provide the particular service under section 5119.36 of the Revsied Code or the staff member of that facility or hospital providing the particular service is an individual described in division (B) of section 5119.35 of the Revised Code.

(2) A community addiction services provider or community mental health services provider certified to provide that particular service under section 5119.36 of the Revised Code.

(3) An individual described in division (B) of section 5119.35 of the Revised Code.

(C) Services are allowed to be provided through telehealth pursuant to agency 5122 of the Administrative Code pertaining to telehealth, and these services are to be documented in accordance with rules. Telehealth services including induction of any form of medication assisted treatment will only be allowed in accordance with federal and state standards.

(D) Services provided through medication units are subject to rule 5122-40-15 of the Administrative Code.

(E) Upon admission, each patient shall receive the following information both written and verbally:

(1) Signs and symptoms of overdose; when, where, and how to seek emergency assistance; and education on the use of overdose reversal drugs;

(2) An explanation of the medication, including:

(a) Medication administration;

(b) Potential drug interactions;

(c) Medical issues related to withdrawal management from opioid treatment medications;

(d) Characteristics of the medications administered or prescribed by the program;

(e) Drug safety issues;

(f) Dispensing procedures and dosage restrictions; and,

(g) Side effects of medications administered or prescribed by the program.

(3) An explanation of alternative methods that are available for treatment of opioid addiction, whether offered by the program or not, and the potential benefits, risks and costs of each treatment; and

(4) A formal agreement of informed consent to be signed by the patient and a copy retained by him or her.

(F) Every person admitted to a opioid treatment program is to receive program orientation within two weeks of admission. The orientation is to be made verbally at the earliest opportunity at which the patient is stable and capable of understanding and retaining the information presented. Orientation is to include the following:

(1) An explanation of the patient's rights and right to file a grievance and applicable appeal procedures, in accordance with rule 5122-26-18 of the Administrative Code;

(2) An explanation of the services and activities provided by the opioid treatment program, including:

(a) Expectations and rules;

(b) Hours of operation;

(c) Access to crisis services;

(d) Confidentiality policy;

(e) Toxicological screening and random testing policies;

(f) Administrative withdrawal criteria, pursuant to rule 5122-40-14 of the Administrative Code;

(g) Interventions; and

(h) Various discharge criteria.

(3) An explanation about obtaining reports from the prescription drug monitoring program database, how the reports are used to treat and monitor the patient, and the requirement that the reports be maintained in the patient files;

(4) An explanation of any and all financial obligations of the patient; all fees charged by the opioid treatment program; and any financial arrangements for services provided by the opioid treatment program;

(5) Familiarization with the opioid treatment program's facility and premises;

(6) Provision of a an overdose reversal medication kit approved by the United States food and drug administration, including the nasal atomizer or other device furnished by the opioid treatment program or a prescription for such kit.

(a) The opioid treatment program is to provide instruction on the kits use including, but not limited to, recognizing the signs and symptoms of overdose and calling 911 in overdose situations.

(b) The opioid treatment program is to provide a new kit or prescription upon expiration or use of the old kit.

(c) The opioid treatment program is to be exempt from this requirement for one year if the client refuses the kit or already has a kit.

(G) Documentation that the patient has completed the orientation training and received the written information required in paragraphs (E) and (F) of this rule is to be completed and signed by the program and the patient and maintained in the patient's chart.

(H) Each opioid treatment program is to make available substance use disorder counseling, individual or group, to every patient as is clinically necessary.

(1) All patients will be assigned a primary counselor. The primary counselor will be individually determined by the specific needs of the patient and allow patients access to their primary counselor if more frequent contact is merited by need or is requested by the patient.

(2) The primary counselor is to:

(a) Allow the program to provide adequate psychosocial assessments, treatment planning, and individualized counseling; and

(b) Allow for regularly scheduled, documented individual counseling sessions.

(3) Counseling sessions are to be offered according to generally accepted best practices and, except as provided in paragraph (H)(4) of this rule, be available to the patient:

(a) At least weekly during the first ninety days of treatment, for at least fifty minutes in duration.

(b) Thereafter, counseling duration and frequency should be established by the counselor in collaboration with the patient and documented in the treatment plan, with consideration given to the ability of the patient to participate, recovery status, treatment engagement, and laboratory results.

(4) Exceptions to frequency of counselor to patient contact are to be clinically justified and documented in the client record. Justification will be based on the patient's choice for quantity, frequency, and the reason patient is unable to participate in counseling sessions as described in paragraph (H)(3) of this rule.

(5) Medication is not to be interrupted or made dependent upon completion of counseling as outlined in paragraph (H)(3) of this rule.

Last updated January 31, 2025 at 7:40 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 6/1/2017, 4/10/2020 (Emer.), 8/8/2020 (Emer.)

Rule 5122-40-10 | Diversion.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Each opioid treatment program will, as part of its quality improvement plan, have a diversion control plan that contains specific measures to reduce the possibility of diversion of controlled substances from legitimate treatment use and that assigns specific responsibility for implementing the plan to the medical and administrative staff of the program.

(1) The diversion control plan is to be reviewed and approved by the state authority.

(2) Diversion control plans are to minimize the diversion of medications used for medication assisted treatment to illicit use. Each plan will include:

(a) Clinical and administrative continuous monitoring of the potential for and actual diversion of controlled substances, including an investigation, tracking, and monitoring system of incidents of diversion; and

(b) Proactive planning and procedures for problem identification, correction, and prevention.

(B) Each opioid treatment program will have written pharmacy procedures that include:

(1) A requirement that accurate records for medications used for medication-assisted treatment administered and dispensed be traceable to specific patients and show the date, quantity, and batch or lot number of the medication bottle used for preparing individual doses of medication. These records are to be maintained for at least seven years from the last date of administering or dispensing the medication;

(2) A requirement that the opioid treatment program meet the security standards for the distribution and storage of controlled substances established the United States drug enforcement administration in 21 C.F.R. 1301.72 to 1301.76 and as specified in rule 4729:5-21 -03 of the Administrative Code;

(3) A requirement that the acceptance of delivery of medications used for medication assisted treatment is only to be made by a physician, pharmacist, registered nurse, or licensed practical nurse who has proof of completion of a course in medication administration approved by the Ohio board of nursing and does so under the direction of a physician;

(a) The person accepting delivery of medications used in medication-assisted treatment is to be an employee of the opioid treatment program.

(b) The opioid treatment program is to maintain a current list of those employees who are authorized to receive delivery of medications used in medication-assisted treatment. The list is to indicate the name and license number of each person and be signed and dated by the medical director of the opioid treatment program. For purposes of this paragraph, a signature may be handwritten or in any of the following forms:

(i) A code consisting of a combination of letters, numbers, characters, or symbols that is adopted or executed by an individual as that individual's electronic signature;

(ii) A computer-generated signature code created for an individual; or

(iii) An electronic image of an individual's handwritten signature created by using a pen computer.

(4) A requirement that the program is not to employ a physician or other employee who has access to controlled substances, including medications used in medication-assisted treatment, who has had an application for registration with the United States drug enforcement administration (DEA) denied or has had their registration revoked at any time;

(5) A requirement that the program notifies the field division of the United States drug enforcement administration for its geographical area of, upon discovery of any theft or significant loss of any controlled substance, including medications used in medication-assisted treatment upon the discovery of the loss or theft, the program is to do all of the following:

(a) Notify the field division of the United States drug enforcement administration for its geographical area by completing and submitting DEA form 106.

(b) Notify the state of Ohio board of pharmacy in accordance with rule 4729:5-3-02 of the Administrative Code.

(c) Notify the department of mental health and addiction services.

(d) Notify local law enforcement authorities in accordance with section 2921.22 of the Revised Code.

(6) A statement that adequate precautions are to be taken to store medications under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security;

(7) A requirement that patients be mandated to wait in an area physically separated from the area used for storage of medications used in medication-assisted treatment and dispensing; and

(8) A requirement that the area used for storage and dispensing of medications used in medication-assisted treatment will:

(a) Be located where personnel will not be unduly interrupted when handling drugs;

(b) Be maintained in a clean and orderly manner; and

(c) Not be cleaned by a current patient of the program.

Last updated January 31, 2025 at 7:40 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 7/1/2001, 10/1/2003

Rule 5122-40-11 | Toxicology.

• Effective: January 31, 2025
• Promulgated Under: 119.03

Each opioid treatment program will have written procedures for toxicology screening that include, at a minimum:

(A) Requirement that an initial toxicology screening be performed for each prospective patient as part of the documented physical evaluation completed by a physician prior to admission. The results of all tests are to be received within fourteen days following admission.

(B) Requirement that a toxicology screening be performed pursuant to 42 C.F.R. 8.12(f)(6).

(C) Requirement that programs have a standing physician's order for patient toxicology screening.

(D) Requirement that any urine screen sent in for confirmation be performed by a laboratory that is in compliance with all "Clinical Laboratory Improvement Amendments" under 42 C.F.R. 493.

(E) Requirement that toxicology screening be conducted in a manner to minimize falsification and that sample collection procedures include the following:

(1) Each specimen collection will be monitored.

(2) Each sample will be labeled to reflect the identification of the person from whom it was obtained and reflect the date the sample was obtained.

(F) Requirements that each toxicology screening include, at a minimum, analysis for the following:

(1) Opiates, including prescription opioid analgesics as defined in section 3719.01 of the Revised Code, heroin, and fentanyl;

(2) Methadone;

(3) Amphetamines;

(4) Cocaine;

(5) Barbiturates;

(6) Marijuana;

(7) Benzodiazepines, as defined in section 3719.01 of the Revised Code; and

(8) Buprenorphine.

(G) Results of toxicology screening will be reviewed by the program staff with the patient with documentation of such and a copy of the results placed in the patient's file, in accordance with the requirements of rule 5122-27-04 of the Administrative Code.

(H) Provisions for ensuring that presumptive laboratory results are distinguished from confirmatory laboratory results.

Last updated January 31, 2025 at 7:41 AM

Supplemental Information

Authorized By: R.C. 5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 7/1/2001

Rule 5122-40-12 | Disaster plan.

• Effective: June 11, 2021
• Promulgated Under: 119.03

(A) Each opioid treatment program shall maintain an up-to-date disaster plan that addresses emergency situations including fire emergencies, tornadoes, earth quakes, flooding, winter storms, and involuntary temporary or permanent facility closure.

(B) Opioid treatment programs shall establish a health and safety committee that initiates planning actions for disaster scenarios. This committee shall:

(1) Identify internal resources and areas of need that shall include at minimum:

(a) Personnel training;

(b) Equipment needs;

(c) Evacuation plans;

(d) Backup systems for payroll, billing records, and patient records; and,

(e) Communications;

(2) Identify external resources and areas of need that shall include at minimum:

(a) Suppliers of medication used for treatment of substance use disorder;

(b) Other opioid treatment programs; and,

(c) Alternative dosing locations;

(3) Develop a communication plan for the disaster scenario to inform patients, the state authority, SAMHSA, the United States drug enforcement administration, and any other parties deemed necessary; and,

(4) Develop disaster documentation procedures for guest patients that shall include at minimum:

(a) Temporary chart and client identification number;

(b) Identity verification; and,

(c) Medication verification.

(C) Each opioid treatment program shall provide the state authority with the emergency contact information for at least one member of the organization.

(D) Each opioid treatment program shall keep at least a ten-day supply based on average caseload of methadone and buprenorphine on site to prepare to receive clients from other facilities in disaster scenarios.

Last updated November 5, 2024 at 9:05 AM

Supplemental Information

Authorized By: 5119.37
Amplifies: 5119.37
Five Year Review Date: 10/31/2029
Prior Effective Dates: 6/1/2017, 4/10/2020 (Emer.), 8/8/2020 (Emer.)

Rule 5122-40-13 | Evaluation activities.

• Effective: January 1, 2019
• Promulgated Under: 119.03

(A) The department shall collect from the central registry system described in rule 5122-40-08 of the Administrative Code, on a regular basis the information listed in paragraph (B) of this rule for continuous quality improvement purposes.

(B) The central registry system shall collect and make available to the department the following data:

(1) The total number of patients;

(2) The type of medication assisted treatment used for each patient;

(3) The patient's admission date;

(4) The state residency of each patient;

(5) The housing status of the patient at admission;

(6) The employment status of the patient at admission;

(7) The pregnancy status of the patient;

(8) The patient's discharge date;

(9) The date on which the patient is no longer actively receiving treatment, if different than the discharge date;

(10) The patient's discharge reason:

(11) The number and type of administrative and medical withdrawals from the opioid treatment program;

(12) The number of overdose episodes experienced while in treatment;

(13) The patient's referral source; and,

(14) The patient's tobacco use.

(C) Programs shall enter data for paragraph (B) of this rule directly into the central registry system by the sixth working day of each month.

(D) Data collected from the central registry system and used for publicly available reports and publications will be presented in aggregate form, so that no individual patient or opioid treatment program may be identified.

Last updated November 5, 2024 at 9:05 AM

Supplemental Information

Authorized By: 5119.391
Amplifies: 5119.391
Five Year Review Date: 10/31/2029
Prior Effective Dates: 6/1/2017

Rule 5122-40-14 | Program withdrawal.

• Effective: January 1, 2019
• Promulgated Under: 119.03

(A) Administrative withdrawal is an involuntary withdrawal or administrative discharge from a opioid treatment program. The schedule of withdrawal may be brief, less than thirty days if necessary.

(1) Administrative withdrawal may result from any of the following:

(a) Disruptive conduct or behavior considered to have an adverse effect on the program, staff or patient population of such gravity as to justify the involuntary withdrawal and discharge of a patient. Such behaviors may include violence, threat of violence, dealing drugs, diversion of pharmacological agents, repeated loitering, or flagrant noncompliance resulting in an observable, negative impact on the program, staff and other patients;

(b) Incarceration or other confinement;

(c) Absence from scheduled treatment appointments; or,

(d) Urine drug screens inconsistent with the patient's treatment plan.

(2) The opioid treatment program shall document in the patient 's individualized treatment plan of care and chart all efforts regarding referral or transfer of the patient to a suitable, alternative treatment program.

(3) Opioid treatment programs wishing to use administrative withdrawal procedures with a pregnant patient must notify and consult the department's medical director and state authority for case review before initiating administrative withdrawal procedures.

(B) Medical withdrawal occurs as a voluntary and therapeutic withdrawal agreed upon by staff and patient in accordance with approved national guidelines. In some cases, the withdrawal may be against the advice of clinical staff (against medical advice).

(1) The opioid treatment program shall supply a schedule of dose reduction well tolerated by the patient.

(2) The program shall offer supportive treatment, including increased counseling sessions and referral to a self-help group or other counseling provider as appropriate.

(3) If the patient is readmitted, the program shall document attempting to assist the patient in any issues which may have triggered his or her abrupt departure.

(4) The opioid treatment program shall make provisions for continuing care for each patient following the last dose of medication and for re-entry to maintenance treatment if relapse occurs or if the patient should reconsider withdrawal.

(5) Female patients of child bearing age shall have a negative pregnancy screen prior to the onset of medically-supervised withdrawal.

(C) For either withdrawal scenario, the program shall have in place a detailed relapse prevention plan developed by the counselor in in accordance with best practices and in conjunction with the patient. The prevention plan shall be given to the patient in writing prior to the administration of the final dose.

Last updated November 5, 2024 at 9:06 AM

Supplemental Information

Authorized By: 5119.391
Amplifies: 5119.391
Five Year Review Date: 10/31/2029
Prior Effective Dates: 10/1/2003

Rule 5122-40-15 | Medication units.

• Effective: January 31, 2025
• Promulgated Under: 119.03

(A) Opioid treatment programs may voluntarily establish medication units with the appropriate licensure from the Ohio department of mental health and addiction services, the United States drug enforcement agency, the substance abuse and mental health services agency, and the state of Ohio board of pharmacy. Medication units will be associated with a single primary opioid treatment program or hub that will oversee their operations. . Any medication unit, regardless of whether it is non-mobile or mobile, will be licensed in accordance with section 5119.37 of the Revised Code and located in accordance with any state and local zoning restrictions that apply to the primary opioid treatment programs with which the medication unit is associated. All required services that are unable to be performed at the medication unit will be performed by the primary opioid treatment program.

(B) Mobile medication units may only be located in areas that are greater than five miles from the nearest opioid treatment program.

(C) Medication units will provide the following services:

(1) Administering and dispensing medications for opioid use disorder treatment;

(2) Collecting samples for drug testing or analysis; and

(3) Dispensing or personally furnishing of take-home medications.

(D) Medication units may provide the following services if they provide appropriate privacy and adequate space:

(1) Intake/initial psychosocial and appropriate medical assessments with a full physical examination to be completed or provided within fourteen days of admission; and

(2) Initiation of methadone, buprenorphine, or naltrexone after an appropriate medical assessment has been performed. Initiation of methadone will be performed by a qualified healthcare professional and monitored following appropriate medical practices.

(E) Medication units may also provide telecounseling services if they provide appropriate privacy and adequate space with appropriately credentialed staff in accordance with all federal and state regulation. Telecounseling services may include individual or group sessions. Medication units that choose to provide telecounseling will:

(1) Provide telecounseling services with appropriate application of clinical judgment to best meet patient treatment needs;

(2) Be in compliance with paragraphs (H)(3) and (H)(4) of rule 5122-40-09 of the Administrative Code; and

(3) Ensure that every patient has a designated program counselor, as described in 42 C.F.R. 8.12(f)(5)(i), who is the primary contact for behavioral health treatment and care coordination. While the patient may utilize other counselors for emergencies, all counseling, including telecounseling, will be handled by the program counselor. Opioid treatment programs will maintain clear and accurate caseload records for auditing purposes.

(F) The primary opioid treatment program is responsible for keeping all of the documentation on each patient, which may be readily accessed through electronic means by medication units. Original paper records generated by the medication unit will be transferred to the primary treatment program after they are generated.

(G) The medical director will maintain authority over the medical aspects of treatment offered by mobile and non-mobile medication units.

(H) Each mobile and non-mobile medication unit is to have a program director who, with respect to operation of the medication unit, is to exercise the same responsibilities that individual has under paragraph (C) of rule 5122-40-05 of the Administrative Code.

(I) Non-mobile medication units will obtain their supply of approved controlled substances directly from the manufacturer or wholesalers and maintain their inventory in accordance with applicable state and federal regulations.

(J) All medication units will participate in the central registry system to prevent clients from dosing at multiple opioid treatment programs and to ensure medication unit compliance with rule 5122-40-08 of the Administrative Code. Central registry verification can be performed either at the primary opioid treatment program or the medication unit but need not be done more than once per patient enrollment.

(K) If an opioid treatment program voluntarily decides to close the operation of a medication unit, it will notify the Ohio department of mental health and addiction services, the United States drug enforcement agency, the substance abuse and mental health services agency, and the Ohio board of pharmacy at least ninety days before the planned closure of the program. The opioid treatment program will present a plan to transfer existing patients to similar opioid treatment programs or other suitable treatment programs at the time of the notification.

Last updated January 31, 2025 at 7:41 AM

Supplemental Information

Authorized By: R.C.5119.37
Amplifies: R.C. 5119.37
Five Year Review Date: 1/31/2030
Prior Effective Dates: 6/11/2021