Voglio sapere a riguardo di…

khammond on DSKJM1Z7X2PROD with RULES

33870

Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
DEA must pre-approve any electronic recordkeeping system used in lieu of a paper dispensing log. Prior to granting a registration to an NTP and its mobile component, under 1301.13e4 of this rule, the local DEA field office must evaluate all of the mobile components procedures and processes to determine if they provide effective controls against diversion. If the electronic recordkeeping system meets all of the recordkeeping and security requirements under the CSA, DEA will approve the system; this will be done on a case-by-case basis. If a registered NTP
has an electronic recordkeeping system that is approved by DEA, this does not necessarily mean the same system will be as useful on the mobile component;
this is why the electronic recordkeeping system on the mobile component must be evaluated separately.
Comment: One commenter expressed concern that under the proposed rule, it appeared that patients could engage in double-dipping by receiving treatment at a mobile NTP in the morning, and then at a registered NTP
location later in the day, for example.
The commenter stated that under the proposed revisions to 21 CFR 1304.24
there is a requirement that NTPs must maintain records of patient information including the dosage consumed, but no requirement that the records be maintained in real-time, potentially allowing such double-dipping to occur before an NTP could compare dispensing logs and discover it.
Therefore, to decrease the likelihood of patient overdoses, the commenter recommended that the final rule require all mobile NTPs to record doses in real time.
DEA Response: NTPs have protocols in place to ensure that their patients cannot engage in double-dipping by receiving treatment at a mobile component in the morning, and then at a registered NTP location later in the day; the use of paper or electronic logs should not have a major impact on these protocols. Moreover, regardless of whether NTPs have such a protocol in place, ordinary diligence by NTPs, including periodic comparisons between the dispensing logs of a mobile NTP and its registered NTP, should readily reveal any individuals who are engaged in such double-dipping and enable NTPs to take steps to prevent them from doing so in the future.
Although the use of real-time electronic dispensing logs might allow an NTP to uncover such doubledipping more quickly, DEA has concluded that requiring the use of technology could be burdensome and is not necessary to prevent double-

VerDate Sep<11>2014

15:59 Jun 25, 2021

Jkt 253001

dipping from becoming a significant source of diversion or significant risk of overdose among patients. Thus, DEA
has concluded that NTPs should generally be capable of guarding against double-dipping without further regulation. Every NTP has protocols in place to ensure that their patients receive the correct dose, and to ensure that the records containing this information are correct and up-to-date.
As stated earlier, DEA has concluded that the use of technology could be burdensome, which goes against the purpose of this rulemaking. For these reasons, DEA will not require all mobile components to record doses in real time;
however, if a mobile NTP chooses to do so, that would be permitted.
Advantages of Serving Multiple Locations Comments: One commenter stated that the proposed rule was ambiguous on whether the mobile component could park at a location, dispense medication, and then move to another location or locations for further dispensing. The commenter suggested that DEA revise the proposed rule to explicitly allow mobile treatment components to serve multiple locations in a single day, because this would enable opioid treatment providers to help patients residing in skilled nursing/long term nursing facilities to receive their medication for opioid use disorder. The commenter did not provide any specific information on how this would help.
DEA Response: DEA will leave the decision of whether a mobile component serves multiple locations in a single day to the NTP. For a mobile component in a more urban area, multiple stops might be more feasible, in comparison to a mobile component that would be serving a more remote area. As long as these mobile components follow all applicable Federal, State, local, and tribal laws, DEA will permit the mobile component to serve multiple locations. Although the proposed rule was not intended to limit mobile NTPs to serving a single location, DEA recognizes that references in the proposed regulatory text to mobile NTPs serving a location or a dispensing location in proposed 21
CFR 1300.01b and 1301.72e may have been confusing. Thus, in this final rule, DEA has revised these sections to clarify that a mobile NTP may serve multiple remote locations.
The Use of Past/Current Mobile Components Comments: Several commenters noted that mobile components have not only
PO 00000

Frm 00018

Fmt 4700

Sfmt 4700

been used in the past, but some States are currently using them, and they have had a positive impact on the communities they operate in. One commenter stated that Minnesota benefited from a mobile methadone unit that operated approximately 15 years ago, because it increased compliance with dosing and provided services to geographically remote patients, allowing for better supervision, and faster stabilization of both dose and behavior.
Another commenter said many NTPs already operate mobile components and these revisions will allow more flexibility, allowing even more NTPs to provide treatment via mobile components. A commenter who worked at a treatment program mentioned that their organization operated a mobile Suboxone program, and stated that it benefitted the community because the number of overdoses had been greatly reduced, and larger numbers of people were able to initiate treatment who would not otherwise have been able to without such access.
Finally, two commenters mentioned the use of mobile components in emergency situations, such as during Hurricanes Katrina and Sandy. One of these commenters mentioned how mobile methadone components are an important part of the broad continuum of care for individuals with OUD, and stated these mobile components provided essential treatment services during Hurricane Katrina. However, the other commenter noted that mobile components had been largely unavailable to providers responding to emergency situations. That commenter mentioned that during Hurricane Sandy in 2012, affected NTPs employed strategies such as alternative transportation, take-home dosing, and guest dosing at nearby programs i.e., temporary dosing at another NTP to ensure continued access to treatment, and stated that these actions had varying degrees of execution and success. The commenter went on to say that mobile NTPs were considered as an option for reaching patients when facilities were destroyed, but one unit was being repaired at the time and the other was not able to operate because there was not a functioning registered NTP location to store the methadone.
DEA Response: DEA appreciates the information provided by the commenters. As stated previously, the intent of this rule is to ensure that there is greater access to treatment for those who are suffering from OUD, and are unable to access treatment because of rural or geographic limitations, mobility issues, etc. The revised regulations will allow NTPs the option to use mobile
E:FRFM28JNR1.SGM

28JNR1