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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
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MAT in combination with psychosocial services. An additional 6 percent received MAT without psychosocial services, and 43 percent received psychosocial services only.15 As of 2016, over 90 percent of NTPs were located in urban areas, forcing rural patients to travel great distances to receive their doses of medication.16
According to research published in 2014, some rural patients reported that the burden of traveling daily to receive their medication effectively prevents them from working,17 further increasing the risk that they will discontinue treatment.18
Without this rule permitting registered NTPs to operate mobile components as coincident activity, an NTP wishing to provide MAT services to patient populations with little or no access to an NTP would be required to register and open another NTP location in the underserved geographic area. The many fixed capital and operating expenses associated with the startup and ongoing operation of a new facility discourage providers from doing this.
For example, registrants would be required to obtain another NTP
registration at $296 per year and incur the cost of renting additional office space, and ensuring that the new location meets DEA requirements, that it is appropriately licensed by the State, and that it is accredited by an accrediting organization approved by SAMHSA. Additionally, opening a new location would entail additional staffing and facilities costs. Under the final rules regulatory provisions, registrants are able to operate a mobile component as a coincident activity of their existing registered location, foregoing the expenses of opening and operating a new registered location, in favor of the comparatively lower cost of operating a mobile component.
15 Ali, M. M., Mutter, R. 2016. The CBHSQ
Report: Patients Who Are Privately Insured Receive Limited Follow-up Services After Opioid-Related Hospitalizations. Rockville, MD: Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality.
Retrieved by ONDCP on August 18, 2017 at http
www.samhsa.gov/data/sites/default/files/report_
2117/ShortReport-2117.pdf.
16 Leonardson J, Gale JA. Distribution of Substance Abuse Treatment Facilities Across the RuralUrban Continuum. 2016. https
muskie.usm.maine.edu/Publications/rural/
pb35bSubstAbuseTreatmentFacilities.pdf.
17 Sigmon SC. Access to Treatment for Opioid Dependence in Rural America: Challenges and Future Directions. JAMA Psychiatry. 2014;
714:359360. doi:10.1001/
jamapsychiatry.2013.4450.
18 Leonardson J, Gale JA. Distribution of Substance Abuse Treatment Facilities Across the RuralUrban Continuum. 2016. https
muskie.usm.maine.edu/Publications/rural/
pb35bSubstAbuseTreatmentFacilities.pdf.

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DEA believes it is reasonable to assume that in any given geographic region, the fixed capital expenses of opening a new registered location most significantly office rent will always exceed the capital expenses of operating a mobile component most significantly the purchase price of a conveyance to be converted to a mobile NTP. These major capital expenses are discussed and compared in detail in the following paragraph; however, it is important to first set boundaries for this analysis by discussing what costs will not be included and why. DEA assumes that two significant expenses are the same for both activities, and therefore, are excluded from the analysis: The labor required to dispense narcotic drugs in schedules IIV, and the cost to outfit an NTP office or mobile conveyance with sufficient medical and office equipment.
Labor costs are considered to be equal for both activities as the final rule does not change the requirements for the personnel that are authorized to dispense controlled substances.
Whether an NTP expands via a new registered location or a mobile component, DEA assumes that the registrant would need to expand the quantity and type of labor required to dispense narcotic drugs in schedules II
V, at the same rate for both. However, it is likely that registered locations would be required to employ a medical administrative assistant to handle records management, billing, and reception; functions that a mobile component of an existing NTP would outsource to the labor provided by the associated registered NTP. DEA assumes that a new registered NTP location requires one medical assistant, and calculates the total annual compensation for this medical assistant to be $48,994.19
DEA also recognizes that there are startup costs that will be the same for both activities. This includes the purchase of medical equipment and basic office supplies, and the installation of an alarm system compliant with 21 CFR 1301.72aiii.
Such startup costs are accordingly also omitted from this analysis. Whether 19 The total annual cost of compensation is based on the median annual wage for Occupation Code 319092 Medical Assistants $33,610. May 2018
National Occupational Employment and Wage Estimates, United States, Bureau of Labor Statistics, https www.bls.gov/oes/current/oes_nat.htm319092 last visited November 11, 2019. Average benefits for employees in private industry is 31.4%
of total compensation. Employer Costs for Employee CompensationJune, 2019, Bureau of Labor Statistics, https www.bls.gov/news.release/
pdf/ecec.pdf last visited November 11, 2019. The 31.4% of total compensation equates to 45.8%
31.4%/68.6% load on wages and salaries. $33,610
1 + 0.4577 = $48,994.17.

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MAT services are being rendered via a mobile NTP or the traditional office environment, the same type and quantity of labor, medical equipment, and security equipment is assumed necessary to deliver the same amount of treatment while adhering to DEA
regulations.
According to the National Association of Realtors, the average annual price per square foot for office space throughout the United States was $46 in the first quarter of 2017 the most recent year in which this figure was updated.20 Based on DEAs knowledge of registrant operations, NTPs require a minimum of 1,000 square feet of office space, which equates to a conservative estimate of yearly rent for NTPs of $46,000.
Assuming the NTP agrees to a five-year lease, the present value of the cost of five years of office rent is $188,609.08
at a 7 percent discount rate and $210,666.53 at a 3 percent discount rate.
In comparison, commercial vehicles suitable for service as a mobile NTP
range in price from $30,000 to $40,000.21 Furthermore, the final rule does not require an NTP to obtain a separate registration for the mobile component at a cost of $296 per year, which is a cost that a new registered NTP location would incur. The present value of registration costs per registrant over a five-year period is $1,213.66 at a 7 percent discount rate and $1,355.59 at a 3 percent discount rate.
There are also several operating expenses that are unique to a mobile component that should be factored into this analysis. The first is the cost of the narcotic safe and associated installation costs. DEA recognizes that while both a mobile component and a traditional NTP office require a safe, the confined space of a mobile component likely requires some amount of customization in the installation process in order to meet the requirements of 21 CFR
1301.72a1. To account for this unique installation cost, DEA doubled the highest quoted price of the safe 22
and attributed that full amount to the 20 2017 Q1 Commercial Real Estate Market Survey. www.nar.realtor, 2017, www.nar.realtor/
research-and-statistics/research-reports/
commercial-real-estate-market-survey/2017-q1commercial-real-estate-market-survey.
21 Price range gathered by searching commercialtrucktrader.com for class 1, 2, and 3
light duty box trucks and class 4, 5, and 6 medium duty box trucks. These vehicle classes were used based on DEAs knowledge of the types of vehicles currently used by NTP registrants for mobile components.
22 Quotes for safes meeting DEAs regulatory specifications were sourced online from three leading manufacturers: Healthcare Logistics, Medicus Health and Harloff. The highest price quoted was $899.00. Doubling the price to account for installation yields a total cost of $1,798.00.

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