This chapter establishes licensing standards for medication units in North Dakota, which are geographically separate facilities operated as extensions of a licensed opioid treatment program (OTP) where practitioners or pharmacists dispense opioid agonist/antagonist medications or collect biological specimens for drug testing. Operators must obtain division approval, meet state and federal certification requirements (including DEA registration and SAMHSA certification), and comply with ongoing licensing review cycles. Licensed medication units must maintain policies on physical operations, patient eligibility criteria, continuity of care with the home-base OTP, staff qualifications, health and safety procedures, and patient confidentiality.
View official sourceCHAPTER 75-09.1-12 LICENSING STANDARDS FOR MEDICATION UNITS Section 75-09.1-12-01 Definitions 75-09.1-12-02 Requirements for Medication Unit License - Application 75-09.1-12-03 Issuing License to Medication Unit 75-09.1-12-04 Denial of Application for Medication Unit 75-09.1-12-05 Licensing Review Requirements 75-09.1-12-06 Suspension and Revocation of License for Medication Unit - Appeal 75-09.1-12-07 Medication Unit Requirements 75-09.1-12-08 Health and Safety 75-09.1-12-09 Medication Unit Closures 75-09.1-12-01. Definitions. In this chapter, unless the context or subject matter otherwise requires: 1. "Condition" means a violation of the requirements of any applicable law or regulation has occurred. 2. "Corrective action plan" means a plan developed by the medication unit and submitted to the division identifying how the medication unit will correct a condition. 3. "Department" means the North Dakota department of human services. 4. "Division" means the behavioral health division of the department. 5. "Home-base opioid treatment program" means the opioid treatment program licensed according to chapter 75-09.1-10 to operate the medication unit. 6. "Interim license" means the proposed medication unit has met state requirements to move forward with federal requirements. A medication unit may not perform the duties of a medication unit under an interim license. 7. "Medication unit" means a facility established as part of, but geographically separate from, an opioid treatment program from which licensed private medical practitioners or pharmacists dispense or administer an opioid agonist or antagonist treatment medication or collect biological specimen samples for drug testing or analysis. Medication units are not required to be free-standing entities and may be located within other facilities, including a hospital, homeless shelter, correctional program, or public health location. 8. "Medication unit license" means a medication unit has met all state and federal requirements to operate the medication unit. 9. "Patient" means an individual who undergoes treatment in an opioid treatment program who may receive partial services at the medication unit. 10. "Recommendation" means a suggestion offered by the licensure team to strengthen and enhance the medication unit and services offered by the medication unit. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 1 75-09.1-12-02. Requirements for medication unit license - Application. 1. A medication unit application for licensure to operate a medication unit shall hold a current license in good standing as an opioid treatment program under chapter 75-09.1-01. 2. Before applying for a license, the home -based opioid treatment program shall submit an assessment of need for the proposed location of a medication unit and obtain written approval by the division. The assessment of need must include an assessment of the following criteria: a. A description of other existing services and medication units of the type proposed to meet the needs of the population proposed to be served in that location; b. Justification for the need of a medication unit in the location; c. Description of prospective operations for patient care at the medication unit; and d. Community relations plan developed in consultation with the county, city, or tribal authority, or designees. 3. Following written approval from the division to pursue licensure, the prospective medication unit shall submit a medication unit application, including required documentation and the application fee of one hundred fifty dollars to the department. Upon approval of the application requirements, the prospective medication unit may receive an interim license. 4. Within ninety days of receiving the interim license, a prospective medication unit shall submit to the division the following items for review: a. Documentation of the updated certification by the United States department of health and human services substance abuse and mental health services administration, including the application and required materials sent for certification; and b. Registration from the United States department of justice, drug enforcement administration. 5. To renew a medication unit license, the following must occur: a. A licensing renewal conducted by the division; b. Submission of application with required documentation to the division; and c. Application fee paid to the department. History: Effective April 1, 2020. General Authority: NDCC 50-31-03.1, 50-31-09 Law Implemented: NDCC 50-31-03.1, 50-31-09 75-09.1-12-03. Issuing license to medication unit. The division shall issue a license following: 1. A review and approval of application materials for up to one year and subsequent licenses for three years; 2. A licensing review with no conditions issued; or 3. A review and approval of implementation of any corrective action plan required as a result of a licensing review or investigation. History: Effective April 1, 2020. 2 General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 75-09.1-12-04. Denial of application for medication unit. The division shall deny an applicant's license: 1. When the applicant fails to meet the requirements of this chapter; or 2. The home-base opioid treatment program's license is not in good standing or has been suspended or revoked. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 75-09.1-12-05. Licensing review requirements. 1. The division shall conduct a licensing review within one year of the initial license and at least every three years thereafter to determine continued compliance with the standards contained in this chapter. 2. The division may conduct scheduled or unscheduled visits at times other than routine licensing reviews. 3. Within thirty days of the licensing review, the division shall send a licensure review report to the medication unit. 4. A licensure review report must contain a description of: a. The medication unit reviewed; b. Any conditions issued; and c. Any recommendations. 5. A medication unit receiving a condition shall submit to the division a corrective action plan within thirty days from receipt identifying how the medication unit will become compliant with the standards contained in this article. 6. The medication unit has sixty days after the corrective action plan is submitted to implement the actions to become compliant with the standards contained in this chapter. 7. The division shall require documentation or conduct an onsite review or both to ensure the medication unit has implemented its corrective action plan. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 75-09.1-12-06. Suspension and revocation of license for medication unit - Appeal. 1. The division may suspend or revoke a license for one or more of the following reasons: a. The home-based opioid treatment program's license has been suspended or revoked; b. The medication unit has violated any rules of the department; or 3 c. If the medication unit fails to correct conditions or fails to provide a sufficient explanation for its failure to take action, the division may suspend or revoke the medication unit's license or require other corrective measures from the medication unit. 2. An applicant for or a holder of a license may appeal a decision to deny, suspend, or revoke a license as set forth in section 75-09.1-01-27. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 75-09.1-12-07. Medication unit requirements. All licensed medication units shall: 1. Provide medication dosing and may provide urine screen collection and shall adhere to all state and federal regulations for those services. Any other services provided at the medication unit must have prior approval by the division; 2. Develop and implement a policy on the physical operations of a medication unit in conjunction with services at the home-based opioid treatment program; 3. Develop and implement a policy identifying the criteria a patient must meet to receive services offered at the medication unit; 4. Identify in a patient's treatment plan the services received at a medication unit; 5. Provide orientation to each patient regarding the services offered through the medication unit; 6. Develop treatment plans that reflect the utilization of a medication unit; 7. Develop and implement a process for a patient's continuity of care between services conducted at the medication unit and the home-based opioid treatment program; 8. Ensure all employee requirements required in chapter 75 -09.1-10 occur for employees of the medication unit; 9. Ensure the facility is clean and well-maintained; and 10. Provide protection of patient confidentiality, in accordance with federal and state confidentiality requirements. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 75-09.1-12-08. Health and safety. A medication unit shall: 1. Maintain health and safety policies and procedures; 2. Develop and implement a written emergency plan that addresses provisions for dealing with bomb threats, active shooter and other violent actions, fires, medical emergencies, natural disasters, and power failures; 3. Have staff certified in basic first aid and basic cardiac life support, and trained to respond to a suspected overdose; 4 4. Have overdose reversal medication readily available; 5. Make readily available first-aid equipment and supplies; and 6. Implement a written policy that addresses the use of nicotine products. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 75-09.1-12-09. Medication unit closures. If a medication unit closes involuntarily or voluntarily, the home-based opioid treatment program shall: 1. Provide the division with a plan detailing the procedures to ensure continuity of care for patients; and 2. Notify the division of the anticipated closure at least ninety days prior to the closure and identify the rationale for closure and the efforts to establish continuity of care for patients. History: Effective April 1, 2020. General Authority: NDCC 50-31-09 Law Implemented: NDCC 50-31-09 5