The Drug Enforcement Administration (“DEA”) recently issued its final rule authorizing the use of mobile narcotic treatment programs (“MNTPs”) to allow registered Narcotic Treatment Programs (“NTPs”) employing mobile units to dispense medication for maintenance or detoxification treatment remotely. Registration Requirements for Narcotic Treatment Programs with Mobile Components, 86 Fed. Reg. 33,861 (June 28, 2021). DEA had issued a notice of proposed rulemaking in February 2020 (see our post here). We note that the Centers for Disease Control and Prevention reported in December that over 81,000 drug overdose deaths occurred in the year ending May 2020, the highest number ever recorded during a twelve-month period. Overdose Deaths Accelerating During Covid-19 (Dec. 17, 2020). Kudos to the Drug Enforcement Administration (“DEA”) for recognizing the increased demand for treatment by patients with opioid use disorder in underserved and remote areas and, most important, for taking steps to improve access.
DEA authorizing NTPs to operate MNTPs as a coincident activity waives the requirement that NTPs obtain a separate registration for each mobile unit. DEA previously authorized MNTPs to dispense remotely on an ad hoc basis, and placed a moratorium on new authorizations in 2007. The agency opined that the final rule allows the use of MNTPs “to be expanded more extensively, more consistently, and with greater protections against theft and diversion than was possible before.”
While increasing access to treatment, the final rule imposes a number of requirements that minimize risk of controlled substance diversion, including that the MNTP’s must “come back” to the registered location each day.
An MNTP, as defined, is an “NTP operating from a motor vehicle…that serves as a mobile component (conveyance)…operating under the registration of the NTP, and engages in maintenance and/or detoxification treatment with narcotic drugs in schedules II–V, at a location or locations remote from, but within the same State as, its registered location.” MNTPs are motor vehicles propelled under their own motive power lawfully on public streets and roads; more than three wheels must be in contact with the ground. The final rule expressly excludes trailers from qualifying as MNTPs.
NTPs must notify the local DEA office in writing of their intent to operate an MNTP and must receive explicit written approval from DEA before operating an MNTP. NTPs must also provide local and state licensing and registration information to DEA investigators during inspections and prior to transporting controlled substances.
MNTPs can operate at any remote location or multiple locations, including correctional facilities, as long as it is consistent with applicable federal, state, tribal, and local laws and regulations, and the local DEA office does not direct otherwise.
Only the registered NTP can supply narcotic drugs to their MNTPs. MNTPs may only dispense approved medication for treatment. They cannot conduct any other controlled substance activities such as sharing, transferring or reverse distributing while away from their registered location. MNTPs cannot act as controlled substance collectors, function as hospitals, long-term care facilities, or emergency medical service vehicles. They cannot transport patients.
Also, an MNTP can only operate in the state where the registered NTP is located and registered. DEA registrations are based on state licenses so DEA registrations cannot authorize controlled substance activities outside that state.
For good reason, because MNTPs will transport and dispense methadone and other controlled substances, the mobile units are subject to enhanced security requirements. Authorized personnel must retain control over controlled substances during transfer between the registered location and the MNTP, transporting to and from remote dispensing sites, and at the dispensing sites. Narcotic drugs must be stored in an installed safe. MNTPs must also be protected by an alarm system that transmits signals directly to a central monitoring station or police agency.
The controlled substance storage area cannot be accessible from outside the vehicle. Patients must wait in an area physically separate from the storage and dispensing area. Patients must wait outside if the MNTP does not have seating or a reception area separate from the storage and dispensing area.
NTPs must also establish procedures in the event an MNTP becomes disabled. The procedures must require that the controlled substances be accounted for, removed from inoperable MNTPs, and secured at the registered location.
As noted above, while there are no mileage limits on the range that MNTPs can travel and dispense, the requirement that MNTPs return to the registered location upon completion of dispensing at the conclusion of each day dictates distance. Controlled substances must be removed and secured at the registered location after daily operations. DEA has concluded that requiring MNTPs to return to their registered location and securing the controlled substances reduces the risk that controlled substances will be diverted.
However, NTPs can apply to DEA for a waiver to the requirement that MNTPs return to the registered location at the end of each day. NTPs must submit with their waiver request a proposed alternate return period for the MNTP, enhanced security measures and other factors the agency should consider for waiving the requirement. DEA will evaluate each request on a case-by-case basis to determine whether the NTP has “demonstrated exceptional circumstances that warrant the exception.” DEA will also consider whether the MNTP’s security, recordkeeping and other relevant effective controls will be maintained if it grants the waiver. DEA promised to evaluate the final rule within in a year to determine whether to allow all MNTPs to be excepted from having to return at the end of the day without requiring NTPs to apply for a waiver.
MNTPs may park at their registered location or in any secure, fenced area after its controlled substances have been removed at the end of a day. The NTPs must notify the local DEA office where the MNTP will park.
MNTPs are subject to the same recordkeeping requirements as NTPs, including maintaining a dispensing log at the registered site. As an alternative to maintaining a paper dispensing log, the final rule allows MNTPs and NTPs to use an automated/computerized data processing system for storage and retrieval of the dispensing records, if:
- The automated system maintains all required information;
- The automated system is capable of producing a hard copy printout of the dispensing records;
- The MNTP or NTP prints a hard copy of each day’s dispensing log initialed by each person who dispensed medication;
- DEA approves the automated system;
- The MNTP/NTP maintain an off-site back-up of all computer-generated program information; and
- The MNTP/NTP can produce accurate summary reports for any time-frame DEA personnel select during an investigation; summary reports in hard copy must be in a maintained systematically organized file at the registered site of the NTP.
NTPs must retain required MNTP records for two years unless the state requires records be retained for a longer period.
The final rule takes effect on July 28, 2021, and not a moment too soon.