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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
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components during emergency situations such as those described by the two commenters, as long as all applicable, Federal, State, local, and tribal laws are followed when operating these mobile components. As discussed in the NPRM, prior to this rule, DEA
only authorized mobile NTPs on an ad hoc basis and had placed a moratorium on new authorizations in 2007. See 85
FR 11008, 11009. This rule will allow the use of mobile NTPs to be expanded more extensively, more consistently, and with greater protections against theft and diversion than was possible before.
The Costs and Benefits Associated With Mobile Components Comments: Many commenters believed that this proposed rule would give providers a lower cost option for reaching patients where it may not be otherwise financially feasible to establish a new registered NTP location.
Several commenters stated that the proposed rule would reduce the costs for NTPs wanting to expand their geographic reach and increase the treatment they are able to provide.
Several commenters pointed to benefits that would result from the use of these mobile components that might not be quantifiable. Multiple commenters stated that the proposed rule would save many lives, as well as improve the health and well-being of patients receiving treatment, and allow these patients to live productive and satisfying lives. One commenter mentioned that the use of mobile NTPs could start saving thousands of lives and decrease illicit opioid use.
Other commenters mentioned the savings that would be realized by allowing the mobile components to register only once. One commenter estimated savings between $1,270,670
and $1,482,272 would be possible over five years simply because operating out of the mobile unit would allow more treatments to be dispensed and operating over multiple locations would bring in more revenue. However, the commenter did not explain the basis for this estimate.
Conversely, one State behavioral health agency expressed general concerns about the startup costs associated with operating a mobile component, and stated that some NTPs may find this expense to be a barrier to establishing a mobile component. The commenter further indicated that as a result, some NTPs may desire to partner with agencies who already own wellequipped mobile components. The commenter recommended that DEA
explicitly indicate whether it will allow
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a registered NTP to partner with an organization who owns a mobile NTP
e.g., hospital or health center.
As discussed in detail above, many commenters were opposed to requiring the mobile component to return to the NTPs registered location on a daily basis; the costs of the daily round trips were chief among the issues raised when voicing their concerns. These commenters generally believed that the costs associated with traveling to and from the communities served by mobile NTPs e.g., staff time, travel costs, wear and tear on vehicles, etc. could easily rival the cost of opening a new registered NTP location, especially when the communities are 100 to 200
miles away, as noted by some commenters. Two commenters gave an example of a mobile NTP with at least one nurse and one medical assistant traveling 100 miles round trip six times per week for a year and estimated the yearly cost, based on the proposed rules estimated per mile operating cost, would be close to $62,000. Similarly, another commenter remarked that in the summary and benefits section of the proposed rules preamble, the mileage used to estimate operating costs for a mobile NTP, no more than 5,000 miles per year 100 miles per week, was rather low, especially for rural areas in some States.
Three commenters also detailed other expenses that might result from operating the mobile component. One commenter stated that while the proposed rule provided potential safeguards addressing security, theft, and misuse, the rule did not discuss in its cost-benefit analysis the intangible costs associated with detecting any violation of either operating the mobile component as a treatment center or any of the rules other prohibitions.
However, the commenter did not detail any specific cost numbers for these intangible costs. One commenter expressed concerns that the costs associated with paying an entire team of healthcare professionals for their travel time would likely be expensive and possibly even cost prohibitive, particularly if mobile NTPs will provide the same interdisciplinary services offered at registered NTP locations. This commenter further stated that the proposed rule failed to address these costs. Another commenter also mentioned the small, extra expense of hiring security personnel to protect the mobile NTP, which the commenter recommended if the regulations would no longer require the mobile NTPs to return to the DEA-registered location at the end of each day.

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Finally, a commenter expressed great appreciation that the proposed rules economic analysis qualitatively described benefits and cost-savings that cannot be quantified, including reduced health care costs, criminal justice costs, and lost productivity costs that will be reduced as a result of increased access to treatment. However, the commenter stated that this analysis omitted other important unquantifiable benefits, such as improved quality of life and improved dignity for patients who can access treatment. The commenter stated that the major benefit of this proposed rule is its expected effect on the cost to treat each patient with OUD and the number of patients who have access to such treatment i.e., a decrease in costs and an increase in patients, noting that this will improve the quality of life and dignity for patients who can access this critical treatment. Therefore, the commenter suggested that DEA should revise its economic analysis and acknowledge these benefits in the final rule. In addition, this commenter stated that DEA should clarify in the final rule that the benefit-cost analysis framework applied in the proposed rule shows that a reduction in the marginal cost of treating patients for OUD could expand output, which would be a social benefit.
The commenter explained that the analysis conducted by DEA in the proposed rule assumes that NTPs are currently incurring costs to expand treatment access by opening additional registered NTP locations. However, the commenter further noted that if DEAs assumption is not true, and NTPs are not currently incurring costs to expand registered NTP locations, then under this rule, NTPs might actually incur more costs, the costs associated with operating a mobile NTP.
DEA Response: DEA appreciates the support from commenters agreeing with the agencys assessment that this rule will provide a less costly avenue for NTPs to expand operations and treat more patients compared with opening a new registered NTP location. As stated earlier, the intent of the proposed rule is to ensure that treatment is made more widely available to those who need it.
Although not readily quantifiable, saving lives, preventing overdoses, and ensuring patients receiving treatment are able to live productive lives help further the purpose in the proposed and final rule. Regarding one commenters view that DEA has not accounted for a potential increase in costs to the agency related to monitoring the security and recordkeeping of mobile components, DEA anticipates that its field offices will conduct any necessary security reviews
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