Quiero saber acerca de...

Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
khammond on DSKJM1Z7X2PROD with RULES

same State as, the NTPs registered location, for the purpose of maintenance or detoxification treatment. See NPRM, 85 FR 11008, 11009. DEA did not include guidance on ancillary requirements for NTP patients such as toxicology and serology, infectious disease screenings, and harm reduction interventions, because if and how such services are provided is outside the scope of DEAs authority. Although nothing in the rule prohibits a mobile NTP from providing such services, if they can be provided in a manner consistent with the rule and other laws, it is similarly outside the scope of DEAs authority to explicitly permit mobile NTPs to conduct the medical and psychosocial services required to induct and maintain MAT/MOUD, to utilize a QSOA with an entity or entities that can provide these services, and to provide counseling services electronically by qualified providers. Further, the registered NTP should decide whether its mobile component will offer these services based on the needs of the community they are servicing, staffing, financial impact to the NTP, etc. As long as the NTP follows all applicable, Federal, State, local, and tribal laws, DEA knows of no reason, at this time, why these activities would be prohibited.
The Mobile Component Servicing Correctional Facilities Comments: Approximately 20
commenters addressed the benefits of mobile components servicing incarcerated individuals with OUD. All of these commenters asserted that this rule would help in the treatment of incarcerated individuals. Commenters posited that the proposed revisions might allow NTPs to bring their mobile components to correctional facilities, as these facilities might have logistical difficulties arranging the transport of inmates to NTPs. One commenter recommended that DEA collaborate with NTPs and other Federal agencies to maximize opportunities to increase the use of mobile methadone to increase treatment access for these vulnerable populations. Several commenters similarly suggested that NTPs partner with law enforcement and State opioid treatment authorities to expand access to the services provided by the mobile component to correctional facilities. An organization representing individuals in medication-assisted recovery from OUD
declared that it would encourage its members to advocate for the use of mobile components in these facilities with their State opioid treatment authorities and local law enforcement agencies.

VerDate Sep<11>2014

15:59 Jun 25, 2021

Jkt 253001

Some commenters noted that existing mobile NTPs have proven to be helpful in providing treatment for incarcerated individuals; however, no specific examples were provided. Another commenter, a non-profit organization, gave an example where mobile NTPs in Atlantic County, New Jersey provide medication methadone, buprenorphine, and naltrexone and counseling to inmates onsite, and link those being released from correctional facilities to community-based NTPs. The non-profit also stated that one NTP that shared that its mobile NTP had treated more than 1,000 inmates in more than two years, and that these inmates subsequently had a lower recidivism rate compared to the general correctional facility population.
Other commenters cited studies that showed how access to MAT services would decrease the rates of recidivism and post-release mortality as patients successfully transition from the correctional environment into an outpatient treatment setting. Two commenters both referenced data from a study in Rhode Island; the commenters reported that the data showed that offering MAT during incarceration and upon release resulted in a 60 percent decrease in overdose mortality among people who were recently incarcerated.
One of the commenters described the study as recent, but neither provided a specific citation for the study.
Finally, a pharmaceutical manufacturer sought clarity for itself, and its treatment provider customers, on whether NTPs operating a mobile component as described in the proposed rule would be allowed to regularly use the mobile component to transport and provide NTP services, including methadone treatment, to inmates housed in correctional facilities. The manufacturer believed the plain language of the proposed rules legal authority, as well as the proposed changes to 21 CFR 1301.13e4, authorize a properly registered NTP
operating a mobile component to dispense narcotic drugs for addiction treatment to inmates at a correctional facility.
DEA Response: As stated before, the intent of this rule is to increase access to maintenance or detoxification treatment to those individuals who need it. As many of the commenters indicated, incarcerated individuals are a group who would greatly benefit from mobile NTPs servicing correctional facilities. The current use of mobile components by some NTPs in states such as New Jersey and Rhode Island, coupled with research presented by several commenters demonstrating lower recidivism rates as a result of
PO 00000

Frm 00021

Fmt 4700

Sfmt 4700

33873

treatment received while incarcerated, show that these mobile components are beneficial. Therefore, to avoid any possible confusion, in this final rule, DEA is adding an additional provision to 21 CFR 1301.13e4 to clarify that NTPs may operate mobile components at correctional facilities where otherwise permitted by law. DEA would like to remind NTP registrants that they must follow all applicable, Federal, State, local, and tribal laws when operating these mobile components at correctional facilities.
Promulgation of Telemedicine Special Registration Regulation and Related Issues Comments: Several commenters expressed concerns regarding the status of the telemedicine special registration that Congress mandated DEA implement by October 2019 in the Substance UseDisorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act SUPPORT Act, Public Law 115271, sec. 3232, 132 Stat. 3894, 3950 2018.
One commenter mentioned that while this proposed rule was a step in the right direction, it falls short of the special registration for telemedicine, which would help more people who struggle to find access to buprenorphine providers. One commenter similarly noted that the proposed rule was an important step in expanding access to care for those with OUDs; this commenter, along with the others, also urged DEA to promulgate regulations implementing the telemedicine special registration as quickly as possible.
DEA Response: Although these comments regarding telemedicine special registration are beyond the scope of this rule, DEA understands commenters frustration with the delay.
DEA intends to promulgate regulations for the telemedicine special registration in the near future.
Comment: One commenter suggested that the definition of mobile NTPs be expanded to include mobile internetbased health applications.
DEA Response: In this final rule, DEA
will not expand the definition of mobile NTPs to include mobile internet healthbased applications. The dispensing of controlled substances through internet applications raises risks and other issues quite different than those raised by dispensing through a mobile conveyance. Thus, such internet dispensing is beyond the scope of this rule, but will be considered in the context of the aforementioned special telemedicine registration rulemaking.

E:FRFM28JNR1.SGM

28JNR1