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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
as a part of their routine NTP inspection workload, thus there will be no additional costs to DEA.
DEAs estimation of operating costs for a mobile NTP represents the average costs for an NTP choosing to operate a mobile component. As one commenter noted, in certain rural locations throughout the United States, these operating costs may be higher than the average costs presented in the regulatory analysis because NTPs may choose to travel further distances on a more frequent basis in order to reach patients in particularly remote areas. These operating costs may even surpass the costs associated with opening another registered location. Delivering treatment to patients in very remote locations will always carry higher transaction costs than delivering treatment to patients in readily accessible locations such as urban or suburban centers. Absent this rule, however, treating patients in these remote areas would likely require opening not just one more registered location, but many. DEA is confident that the operating costs of a single mobile NTP servicing a wide geographic area will always be less than those of multiple additional registered NTP
locations that would be required to treat the patients dispersed throughout the same area.
Additionally, DEA recognizes that some mobile components may indeed travel greater distances than the 100
miles per week estimated in the proposed rule. However, DEA considers this mileage estimate to be a reasonable average of the weekly distance any particular mobile component might travel to treat patients, especially when factoring in mobile components that will operate in more densely-packed urban and suburban settings. As another commenter noted, operating a mobile component may also result in higher cost savings than what is presented in the regulatory analysis due to the possible increased volume of patients treated by a mobile component. Again, DEAs analysis represents average cost savings when comparing the operation of a mobile NTP with a registered location, and therefore, this is factored into the agencys conclusions below.
Regarding one commenters challenge that the labor costs for the healthcare professionals needed to staff a mobile component would likely be prohibitive, DEA assumes that the labor required to provide MAT services are the same in a mobile component and a registered NTP setting. Therefore, any particular NTP would incur those labor costs when choosing to expand operations, whether via starting a mobile
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component or opening an additional registered NTP location.
DEA agrees with the commenter stating that this rule is likely to result in an increase in quality of life and personal dignity for previously untreated patients who are able to receive care from a mobile NTP. DEA
believes that these benefits are already discussed in the regulatory analysis below, and no further expansion is necessary.
DEA also agrees with the commenters summation that the framework for the analysis presented in the regulatory impact analysis of this rule is a marginal cost framework, i.e., a comparison of the incremental costs incurred by NTPs choosing to expand operations under the baseline regulatory environment vs.
under the rules regulatory environment.
DEA does not see any benefit to the public in explaining this fact further in the regulatory impact analysis.
The Ability of the Mobile Component To Operate as an Emergency Medical Services Vehicle or Hospital Comments: Several commenters noted that DEA did not address the specific services the mobile component could and could not provide to those individuals who utilize it. Many of these commenters also provided suggestions for the services they believed the mobile components should provide. One commenter suggested that DEA allow the mobile component to operate as an emergency medical services EMS vehicle or a hospital.
The commenter stated that by not allowing the vehicles to operate as an EMS vehicle e.g., to transport patients or a hospital, there was a risk to the communities being served by the mobile component, because many of the rural areas might not have local hospitals or only have access to hospitals that are overcrowded and underfunded. The commenter also noted that some community members utilizing the mobile component may mistakenly assume that the mobile component is able to treat overdose victims or try to seek emergency treatment at a mobile component instead of an EMS vehicle or a hospital.
One commenter suggested that DEA
revise the proposed amendment, 21 CFR
1301.134ii, to state explicitly that mobile NTPs are allowed to conduct the necessary medical and psychosocial services required to induct and maintain MAT/medications for opioid use disorder MOUD; to utilize a Qualified Service Organization Agreement QSOA with an entity or entities that can provide these services; and to provide counseling services
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electronically e.g., telehealth by qualified providers. The commenter also mentioned that allowing these services, which would have to be consistent with applicable State and Federal law, would decrease the risk of discontinuity of care, which could cause the patient to relapse and/overdose.
Another commenter noted that the proposed rule did not include guidance on ancillary requirements for NTP
patients such as toxicology and serology, and stated that the NTP
registrant should be required to indicate whether physical examinations, toxicology testing, and serology testing would be conducted in the mobile NTP
or at the registered NTP location. The commenter also asked if the mobile NTP
could conduct these services, and if not, recommended that the rule include clear guidance as to where these services could be provided or if these services could be conducted in coordination with a partner, like a hospital.
Finally, another commenter suggested that the final rule should expressly state that services such as infectious disease screenings and harm reduction interventions are available in mobile NTPs just as they are at the registered NTP locations. As these mobile NTP
components are to operate as coincident, or equivalent, to the registered NTP location, the commenter suggested, a mobile NTP should provide most or all of the same supplemental services that are logistically possible.
The commenter stated further that the exclusion of such language could be interpreted as prohibiting these critical public health interventions that are essential to addressing disparate rates of sexually transmitted and other infectious diseases among persons with substance use disorder, especially those who inject drugs.
DEA Response: DEA appreciates commenters concerns about those individuals in rural communities being served by the mobile component not having local hospitals or access to hospitals that are overcrowded or underfunded. However, as stated in the NPRM, the mobile components will not be configured in a way to allow them to serve as an EMS vehicle or hospital, and will not have the necessary equipment or supplies on board to function as such. See NPRM, 85 FR 11008, 11010.
In the preamble of the proposed rule, DEA stated it was proposing to waive the requirement of a separate registration for NTPs that utilize mobile components, and that specifically, an NTP would be permitted to dispense narcotic drugs in schedules IIV at locations remote from, but within the
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