Article 9. Mobile Medication-Assisted Treatment Services
12VAC35-105-1821. Application for operation of a mobile medication-assisted treatment program.
Each mobile medication-assisted treatment program shall operate as a component of a licensed MAT location and shall be listed on the provider's license addendum.
Statutory Authority
§§ 37.2-302 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.
12VAC35-105-1822. Physical security controls; mobile MAT programs; storage areas.
A. For any conveyance operated as a mobile MAT program, a safe must be installed and used to store narcotic drugs in Schedules II through V for the purpose of maintenance or detoxification treatment, when not located at the provider's U.S. Drug Enforcement Administration (DEA) registered location. The safe shall:
1. Have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;
2. If it weighs less than 750 pounds, be bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and
3. Be equipped with an alarm system that, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or state police agency that has a legal duty to respond or a 24-hour control station operated by the DEA registrant.
B. The controlled substance storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through controlled substance storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.
C. The storage area for controlled substances in a mobile MAT program shall not be accessible from outside of the vehicle.
D. Personnel transporting the controlled substances on behalf of the mobile MAT program are required to retain control over all controlled substances when transferring the controlled substances between the DEA registered location and the conveyance, while en route to and from the dispensing locations, and when dispensing at the dispensing location. At all other times during transportation, all controlled substances shall be properly secured in the safe.
E. Upon completion of the operation of the mobile MAT program on a given day, the conveyance shall be immediately returned to the DEA registered location, and all controlled substances shall be removed from the conveyance and secured within the DEA registered location. After the conveyance has returned to the DEA registered location and the controlled substances have been removed, the conveyance may be parked until its next use at the DEA registered location or in any secure, fenced-in area once the local DEA office has been notified of the location of the secure, fenced-in area.
F. All mobile MAT programs shall establish a standard written operating procedure to ensure, if the mobile MAT program becomes inoperable, that all controlled substances on the inoperable conveyance are accounted for, removed from the inoperable conveyance, and secured at the DEA registered location.
G. With regard to the requirement within subsection E of this section, a mobile MAT program may apply to the DEA for an exception to this requirement. The application for such an exception must be submitted to the DEA in accordance with 21 CFR 1307.03. If the DEA grants an exception, the provider shall be permitted to operate in accordance with that exception. The provider shall maintain a record of the exception at the DEA registered location and in the mobile MAT program conveyance.
Statutory Authority
§§ 37.2-302 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.
12VAC35-105-1824. Other security controls for mobile MATs.
A. Individuals enrolled in a mobile MAT program shall wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance, such as a door or other entryway. Individuals served must wait outside of a mobile MAT program component if that conveyance does not have seating or a reception area that is separated from the narcotic storage and dispensing area. This requirement shall be enforced by the provider and all provider employees.
B. All mobile MAT programs shall comply with standards established by the U.S. Secretary of Health and Human Services respecting the quantities of narcotic drugs that may be provided to persons enrolled in a mobile MAT program for unsupervised use.
C. Provider personnel who are authorized to dispense controlled substances for narcotic treatment shall ensure proper security measures and patient dosage. The mobile MAT program shall comply with U.S. Drug Enforcement Administration (DEA) security requirements.
D. Any controlled substances being transported for disposal from the dispensing location of a mobile MAT program shall be secured and disposed of in compliance with 21 CFR Part 1317 and all other applicable federal, state, tribal, and local laws and regulations.
E. A conveyance used as part of a mobile MAT program may only be supplied with narcotic drugs by the DEA registered MAT that operates the conveyance. No persons permitted to dispense controlled substances to a mobile MAT shall:
1. Receive controlled substances from other mobile MAT programs or any other entity;
2. Deliver controlled substances to other mobile MAT programs or any other entity; or
3. Conduct reverse distribution of controlled substances on a mobile MAT program.
Statutory Authority
§§ 37.2-302 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.
12VAC35-105-1826. Records for mobile MATs.
A. A provider of a mobile MAT program shall maintain records with the following information for each narcotic controlled substance:
1. Name of substance;
2. Strength of substance;
3. Dosage form;
4. Date dispensed;
5. Adequate identification of individuals served;
6. Amount consumed;
7. Amount and dosage form taken home by individuals served; and
8. Dispenser's initials.
B. The records required by subsection A of this section shall be maintained in a dispensing log at the U.S. Drug Enforcement Administration (DEA) registered site of the mobile MAT program and shall be maintained in compliance with 21 CFR 1304.22 without reference to 21 CFR 1304.03.
C. As an alternative to maintaining a paper dispensing log, a mobile MAT program may also use an automated or computerized data processing system for the storage and retrieval of program dispensing records if the following conditions are met:
1. The automated system maintains the information required in subsection A of this section;
2. The automated system has the capability of producing a hard copy printout of the program's dispensing records;
3. The mobile MAT program prints a hard copy of each day's dispensing log, which is then initialed appropriately by each person who dispensed medication to individuals served;
4. The automated system is approved by DEA;
5. The mobile MAT program maintains an offsite back-up of all computer-generated program information; and
6. The automated system is capable of producing accurate summary reports for both the DEA registered site of the mobile MAT program and any mobile MAT program for any timeframe selected by department personnel during an investigation. If these summary reports are maintained in hard copy form, they must be kept in a systematically organized file located at the DEA registered site of the mobile MAT program.
D. The provider shall retain all records for a minimum of six years following the last patient encounter in accordance with § 54.1-2910.4 of the Code of Virginia.
Statutory Authority
§§ 37.2-302 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.
12VAC35-105-1828. Physical plant exemption for mobile MATs.
Mobile MAT program locations are exempt from physical plant requirements located within 12VAC35-105-260 through 12VAC35-105-380.
Statutory Authority
§§ 37.2-302 and 37.2-400 of the Code of Virginia.
Historical Notes
Derived from Virginia Register Volume 41, Issue 5, eff. December 5, 2024; Errata, 41:6 VA.R. 756 November 4, 2024.