Under current law, a Narcotic Treatment Program (“NTP”) registered with the Drug Enforcement Administration (“DEA”) can only provide treatment at its registered location. With the current opioid epidemic, the need to ensure access to medication-assisted treatment is more acute than ever. To help address this public health crisis, DEA has published a proposed rule that would increase accessibility to medication-assisted treatment for patients with substance use disorders, including opioid use disorder. Registration Requirements for Narcotic Treatment Programs With Mobile Components, 85 Fed. Reg. 11,008 (Feb. 26, 2020). DEA proposes to waive the requirement that registered NTP operating mobile units that dispense narcotic drugs for maintenance or detoxification treatment at remote locations would need to obtain a separate DEA registration as a coincident NTP activity. The proposal would allow the NTPs to bring treatment via Mobile Narcotic Treatment Programs (“MNTPs”) to areas previously inaccessible and treat patients unable to travel. The proposal would make maintenance and detoxification treatment more available while requiring safeguards to minimize the risk of methadone and other controlled substance diversion.
DEA authorized MNTPs to operate ad hoc prior to 2007, but placed a moratorium on authorizing additional MNTPs since that time. Id. at 11,009. We were unable to determine how DEA authorized NTPs to use MNTPs, but it appears that the NTPs made special arrangements with local DEA offices. Id. at 11,015. Nineteen NTPs operated MNTPs over the past five years, and eight NTPs continue to operate MNTPs authorized by DEA. Id. at 11,009. DEA notes that the authorized MNTPs complied with the Controlled Substance Act and DEA’s regulations so the proposed rule “builds on the existing experience and provides additional flexibility” for NTPs to operate MNTPs “subject to the regulatory restrictions put into place to prevent the diversion of controlled substances.” Id.
DEA would define a “Mobile Narcotic Treatment Program” as “a motor vehicle . . . that serves as a mobile component (conveyance) that is operating under the registration of a narcotic treatment program, and engages in maintenance and/or detoxification treatment with narcotic drugs in schedules II-V, at a location remote from, but within the same State as, its registered location.” The agency would further define “Motor Vehicle” as “a vehicle propelled under its own motive power and lawfully used on public streets, roads, or highways with more than three wheels in contact with the ground. This term does not include a trailer.” Id. at 11,018.
NTPs would have to notify the local DEA office in writing of their intent to operate an MNTP, and must receive written approval from DEA before beginning operation. MNTPs, as controlled premises, are subject to DEA inspections. The MNTP can only operate in the state where the NTP is registered. NTPs must provide valid proper city/county and state licensing and registration information to DEA for the MNTP at the time of inspection, and prior to transporting controlled substances. MNTPs cannot reverse distribute, share, or transfer controlled substances to another MNTP while away from the registered NTP. NTPs will not be permitted to modify their registrations to authorize the MNTPs to act as collectors. Nor can the MNTPs function as hospitals, long-term care facilities, or emergency medical service vehicles, and they cannot transport patients.
Each MNTP must have a securely locked safe to store narcotic schedule II-V substances and an alarm system. The MNTP’s storage area cannot be accessible from outside. The person transporting controlled substances in the MNTP must retain control over them when transferring them between the NTP and the MNTP, from the MNTP to the dispensing location, and when dispensing at the dispensing location. The controlled substances must be properly secured in the safe at all other times. The MNTP must be immediately return to the registered NTP location at the end of the day, and all controlled substances removed and secured within the NTP.
NTPs with MNTPs will have to establish a standard operating procedure to ensure that the controlled substances are accounted for, removed from the MNTP, and secured at the NTP if the MNTP becomes inoperable.
Patients receiving medication at an MNTP must wait in an area physically separated from the storage and dispensing area by a door or entryway or outside if it lacks seating or a reception area separated. The MNTPs must comply with standards established by the Secretary of Health and Human Services regarding narcotic drug take-home quantities. DEA will exercise discretion regarding the security required for MNTPs based on factors such as the program location, the number of patients and the number of physicians, staff members and security guards. An MNTP may only be supplied with narcotic drugs by the registered NTP operating the MNTP.
DEA’s proposal to authorize registered NTPs to operate MNTPs to dispense and administer remotely without having to obtain a separate registration should help expand accessibility to needed treatment. DEA learned from authorizing MNTPs prior to 2007, and from the few MNTPs that continue to operate, that it is possible to dispense methadone remotely from non-registered locations without increasing the risk of diversion. This action complements prior action by DEA to expand the number of narcotic dependent patients that could be treated by qualified physicians.
We note that DEA’s proposal gives the local office the discretion to decide whether or not to allow the NTP to utilize an MNTP. It is unclear whether an NTP would be able to appeal an adverse decision to DEA headquarters on any adverse decision. Also, the requirement that the drugs be returned to the NTP each day will limit the geographic reach of an NTP to operate an MNTP.
Electronic comments on the proposed rule must be submitted, and written comments must be postmarked, on or before April 27, 2020.