Two associations, one representing NTPs and the other representing the interests of individuals in medication-assisted treatment (MAT), noted a potential funding source available through the U.S. Department of Agriculture (USDA). Thus, while these benefits are not quantified, DEA expects that this final rule will result in a net benefit to society. Comments: One commenter discussed how some State treatment agencies have already experienced staffing shortages or may in the future, and how it is also possible for an agency to suffer full closure due to the COVID-19 public health emergency. The process for applying for such an exception will be as set forth in 21 CFR 1307.03, which allows any person to apply for an exception to any provision of the DEA regulations. 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. Leonardson J, Gale JA. (1) For any conveyance operated as a mobile narcotic treatment program (NTP), a safe must be installed and used to store narcotic drugs in schedules II-V for the purpose of maintenance or detoxification treatment, when not located at the registrant's registered location. The comment period closed on April 27, 2020. Narcotic Treatment Programs: Best Practice Guideline U.S. Department of Justice, Drug Enforcement Administration, Office of Diversion Control , 2000 - Drug abuse - 64 pages 0 Reviews regulatory information on FederalRegister.gov with the objective of to the courts under 44 U.S.C. This requirement, along with the others specified in section 1304.24(b)(1), is based on recommendations in the Narcotic Treatment Programs Best Practice Guideline (April 2000). 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. daily Federal Register on FederalRegister.gov will remain an unofficial In 2012, the last year for which the SUSB has published the necessary receipts data,[31] This final rule ensures that these regulatory requirements can be enforced consistently over any current or future NTP wishing to operate a mobile NTP. DEA intends to promulgate regulations for the telemedicine special registration in the near future. DEA Response: DEA appreciates commenters' concerns over the proposed requirement that the mobile component and the controlled substances it carries return to the NTP's registered location daily. E.O. Thus, if an NTP wishes to treat patients with methadone at a remote correctional facility or similar rural location, that NTP could simply register a physical location in the area to which to return its mobile component and where to secure its controlled substances. Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities. The SBA size standards for each of the NAICS codes that best correspond to NTPs are listed below: Firms below this SBA size standard (based on annual receipts for these codes) are small firmsand thus small entities under the RFA. Other commenters mentioned that the use of these mobile components could have positive outcomes outside of treatment for OUD, stating they could help with human immunodeficiency virus prevention, overdoses, and relapses. Finally, one organization and an anonymous commenter supported the requirement that a mobile NTP only operate in the same State in which the NTP is registered with DEA. New Documents Office-based opioid treatment (OBOT). This commenter further stated that the proposed rule failed to address these costs. 21 CFR 1304.24(b) requires that an NTP maintain the records, required by 21 CFR 1304.24(a), in a dispensing log at the registered location. In addition, the revised 1301.72(e) specifically provides that the application must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. Narcotic treatment programs: best practice guideline [Unknown, .] Starting January 1, 2020, under the Calendar Year (CY) 2020 Physician Fee Schedule final rule, the Centers for Medicare & Medicaid Services (CMS) will pay Opioid Treatment Programs (OTPs) through bundled payments for opioid use disorder (OUD) treatment services in an episode of care provided to people with Medicare . Another commenter expressed concern that NTPs would choose to only operate within their own State if (1) State methadone authorities hesitated to license a mobile component with a registered location in another State, or (2) States placed more onerous licensing processes on mobile components from another State. TIP 63: Medications for Opioid Use Disorders DEA is also requiring that the safe be equipped with an alarm system that transmits a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve if there is an attempted unauthorized entry into the safe. Relatedly, in several places, references in the proposed rule to the remote location where the mobile NTP operates are replaced with references to the mobile NTP's location or locations to clarify that a mobile NTP can operate at more than one remote location under appropriate circumstances. documents in the last year, 941 Naltrexone is a non-controlled substance and, as such, may be dispensed without a DEA registration. 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. Five commenters cited studies that provided statistics on the number of NTP patients that traveled across state lines to access services, and calculated the mean driving distance to a methadone clinic in five rural states. It covers patient assessment, treatment planning, and recovery care. 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. DEA Response: DEA appreciates the concerns expressed regarding the security requirements for mobile NTPs. AMTA works in conjunction with the DEA and a number of other parties including SAMHSA, to develop the Narcotic Treatment Programs Best Practice Guidelines, which is released at AMTA's conference in San Francisco in April 2000. . The table below summarizes this calculation. Document page views are updated periodically throughout the day and are cumulative counts for this document. However, other than those security requirements, DEA will not specify what should be included in the NTP's standard operating procedures, or what plans NTPs should implement regarding dosing patients while the mobile component is out of service. The Drug Enforcement Administration (DEA), in conjunction with our Association, is in the final stages of developing theBest Practice Guidelinesfor addiction treatment providers throughout the country. DEA Response: DEA appreciates the support from commenters agreeing with the agency's assessment that this rule will provide a less costly avenue for NTP's to expand operations and treat more patients compared with opening a new registered NTP location. , which provided an opportunity for comment on the proposed rule. One commenter stated that DEA should extend the regulations to require mobile components to have minimum treatment standards and use a multifaceted approach (e.g., counseling, recovery network, mandatory number of treatment visits per month for each patient). However, if the State in which the NTP is located requires that records be retained longer than two years, the NTP should contact its State opioid treatment authority for information about State requirements. Narcotic Treatment Programs. 2014; 71(4):359-360. doi:10.1001/jamapsychiatry.2013.4450. 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. Based on DEA's 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. The need for such security applies equally in the mobile NTP context. For example, DEA is now requiring that persons enrolled in any NTP, including those who receive treatment at a mobile NTP, wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance such as a door or other entryway. documents in the last year, by the Energy Department The RFA requires agencies to analyze options for regulatory relief of small entities unless it can certify that the rule will not have a significant impact on a substantial number of small entities. This PDF is 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 II-V, and the cost to outfit an NTP office or mobile conveyance with sufficient medical and office equipment. The commenters included: Researchers, practitioners, universities, non-profit organizations, addiction treatment programs, State and city boards of behavioral health and human services, associations, manufacturers, a law enforcement office, and other individual or anonymous commenters. The commenter stated that if this final rule succeeds at expanding treatment for opioid use disorder to patients while simultaneously minimizing diversion risks, DEA should further expand the program. DEA evaluated the impact of this rule on small entities and discussions of its findings are below. Thus, because the appropriate safety measures for a mobile NTP will vary based on circumstances and legal requirements, DEA will not attempt to specify additional safety requirements for NTPs as part of this rule. All of these commenters asserted that this rule would help in the treatment of incarcerated individuals. DEA regulations have always required that all registrants maintain effective security to guard against theft and diversion of controlled substances. 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. documents in the last year, 23 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. The Drug Enforcement Administration (DEA) presents best practices for each aspect of narcotic treatment programs (NTPs) to assist in complying with existing laws and regulations. Most commenters believed that requiring the mobile components to return to the registered location less frequently would increase access to treatment while still maintaining appropriate safeguards against potential theft and diversion. 21 U.S.C. Absent this rule, however, treating patients in these remote areas would likely require opening not just one more registered location, but many. Similarly, another commenter remarked that in the summary and benefits section of the proposed rule's 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. Federal Register. This guide will help you learn about activities underway to address the opioid crisis in rural communities at the national, state, and local levels across the country. As stated before, the intent of the rule is to ensure that more individuals have access to treatment despite geographical limitations. An Analysis of the Operational Costs of Trucking: 2017 Update. (2) With regard to the requirement of paragraph (e)(1) of this section, that upon completion of the operation of the mobile NTP on a given day, the conveyance must be immediately returned to the registered location, and all controlled substances must be removed from the conveyance and secured within the registered location, an NTP may apply for an exception to this requirement as provided in this paragraph. The Guidelines represent a critical breakthrough in crafting a cooperative working relationship between the treatment community and the DEA. Moreover, this final rule already provides for certain measures designed to enhance DEA's ability to monitor the activities of mobile NTPs, such as the requirement that NTPs notify their local DEA office before using a mobile component to dispense controlled substances. Guidance for healthcare professionals and addiction treatment providers on appropriate prescribing practices for the treatment of OUD. Several commenters stated that the proposed rule would greatly improve health outcomes for people with substance use disorder living in both rural and urban areas. In making this determination, the Administrator will consider the applicant's security and recordkeeping as well as any other factors he deems relevant to determining whether effective controls against diversion will be maintained. 180 of 411 (43.78%) firms within code 622210 fell below the SBA size standard and thus were small firms. Some commenters sought clarification of certain provisions in the proposed rule or recommended additional changes. documents in the last year, 271 Open for Comment, Small Business Lending Company Moratorium Rescission and Removal of the Requirement for a Loan Authorization, Economic Sanctions & Foreign Assets Control, Endangered and Threatened Wildlife and Plants, California Department of Fish and Wildlife, Culturally Significant Objects Being Imported for Exhibition-Determinations, Energy Conservation Program: Test Procedure for Central Air Conditioners and Heat Pumps, Dried Prunes Produced in California; Increased Assessment Rate, Notice of Intent To Repatriate Cultural Items: Beloit College, Logan Museum of Anthropology, Beloit, WI, Taking Additional Steps To Address the National Emergency With Respect to the Situation in Nicaragua, Lowering Prescription Drug Costs for Americans. statements/100-opioid-abuse. SUSB annual or static data includes: Number of firms, number of establishments, employment, and annual payroll for most U.S. business establishments. Specifically, under this final rule, an NTP is permitted to dispense narcotic drugs in schedules II-V from a mobile component at location(s) remote from, but within the same State as, the NTP's registered location, for the purpose of maintenance or detoxification treatment. This manual provides guidelines for the operation of opioid treatment programs (OTPs). See NPRM, 85 FR 11008, 11010. 18. Prior to 2007, DEA authorized mobile NTPs on an ad hoc basis. Thus, DEA compared the costs of delivering MAT services in a baseline regulatory environment, in which no new mobile NTPs are authorized, to the costs of delivering an equivalent level of MAT services in the final rule's regulatory environment, in which a registered NTP may begin to operate a mobile component as a coincident activity, if authorized by DEA. The organization further noted that operating a mobile NTP across State lines would call into question which Start Printed Page 33864State has oversight and how the originating State could enforce their rules on a mobile NTP that is not located within their borders. Based on these revisions, NTP registrants that operate or wish to operate mobile components (in the State in which the registrant is registered) to dispense narcotic drugs in schedules II-V at remote location(s) for the purpose of maintenance or detoxification treatment do not need a separate registration for such mobile component. One commenter pointed out the known criminal activity risks associated with having controlled substances on site, such as theft, and noted that brick-and-mortar NTPs often protect their employees and patients through various security measures. Additionally, allowing mobile NTPs to remain in operation for multiple days without returning to their registered locations not only presents an elevated risk of diversion, there are alternative options that make it generally unnecessary. DEA does not, in the general course of business, collect or otherwise maintain information regarding associated or parent organizations holding multiple registrations. It is not an official legal edition of the Federal Comment: Finally, one commenter stated that DEA's security requirements in 21 CFR 1301.72 through 1301.76 are extremely outdated and currently put all registered NTPs, as well all DEA registrants, at high risk for diversion, and that this risk would extend to mobile NTPs. Preview this book . Therefore, the commenter recommended that DEA not finalize this proposed provision, or at the very minimum, that DEA provide clarity in the final rule preamble regarding the factors and additional security measures.Start Printed Page 33869. Another commenter noted that current regulations provide DEA discretion to prescribe security requirements to the NTP based on certain factors. Subscribe to our newsletter and stay up to date with the latest updates and documents! This final rule is not a major rule as defined by the Congressional Review Act (CRA), 5 U.S.C. Quotes for safes meeting DEA's regulatory specifications were sourced online from three leading manufacturers: Healthcare Logistics, Medicus Health and Harloff. Thus, DEA applied the calculated firm-to-establishment ratio of 0.56 to the 1,832 NTP registrations in DEA's database to estimate the number of NTP entities, resulting in an estimate of 1,026 NTP entities in the United States. Requiring an NTP's mobile component to return nightly better enables the NTP to monitor its mobile component's dispensing, and thus become more readily aware of any problemssuch as the double-dipping discussed below (under Recordkeeping Requirements for Mobile Components)or other discrepancies that may signal that the mobile NTP's controlled substances are being diverted or otherwise improperly dispensed. The highest price quoted was $899.00. 802, 821, 822, 829, 871(b), 951, 958(f). JAMA Psychiatry. Prior to parking the conveyance at a secure, fenced-in location, all controlled substances must be removed from the conveyance and returned to the registered location and, the local DEA office must be notified of the location of Start Printed Page 33876the secure, fenced-in area. These commenters urged DEA to allow NTPs located in one State to provide services to underserved areas in neighboring States. 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 final rule also contains additional requirements specified in the proposed rule to reduce the likelihood of diversion. See NPRM, 85 FR 11008, 11011. Two commenters also noted that the proposed rule focused exclusively on the operational aspects of administering a methadone clinic, but did not address any counseling activities that are required for NTPs. At all other times during transportation, all controlled substances must be properly secured in the safe. Accordingly, this rule has been reviewed by OIRA. See NPRM, 85 FR 11008, 11010-12 (proposed 21 CFR 1304.24(b)). In section 1300.01, DEA adds a definition for a mobile NTP. These tools are designed to help you understand the official document The definition is revised to clarify that it is the operation of the mobile NTP (i.e., administering maintenance and/or detoxification treatment from the mobile component) that is the coincident activity, not the vehicle itself. Some commenters noted that existing mobile NTPs have proven to be helpful in providing treatment for incarcerated individuals; however, no specific examples were provided. establishing the XML-based Federal Register as an ACFR-sanctioned The commenter also inquired if all requirements that apply to a registered NTP location apply to a mobile component. c. Redesignate paragraph (m) as paragraph (o); and. 8. The sort of broader changes to DEA security regulations suggested by the commenter are beyond the scope of this rule. Narcotic treatment programs: best practice guideline In this rulemaking, DEA has not considered whether waiving the separate registration requirement in any other circumstances would be consistent with the public health and safety, because such a determination was not necessary for this rulemaking. The commenter stated that there may be value in allowing each individual State to set and adjust the mileage limit that would be most appropriate for mobile NTPs operating in their State. DEA Response: The risk of a mobile NTP engaging in unauthorized out-of-State dispensing is not appreciably greater than any other practitioner engaging in such dispensing. These studies noted that many of these patients lived in areas that have been hit hardest by the opioid epidemic, and would benefit greatly from mobile medication delivery. 11/07/2022, 242 DEA has also summarized the remainder of the comments that did not fit into one of the thirteen main issues. on documents in the last year, 9 Thus, DEA will not mandate that armed or unarmed security personnel be utilized by these mobile components. 3. The commenter also requested that DEA consider clarifying in the final rule's preamble section the role of Hospital/Clinic as non-practitioner registrants to provide buprenorphine products for the treatment of [OUD] in accordance with 21 CFR 1301.28.. 11/07/2022, 16 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. DEA, however, cannot forego case-by-case determinations, even if they inevitably bring some risk of delay or enforcement discrepancies. 03-31-2020: 01-29-2020: Controlled Substance Prescriptions: Q&A: No: Questions and Answers for Providers of Electronic Prescription Applications, Pharmacy Applications, and . This final rule, therefore, does not change the requirement for separate registrations at each principal place of business or professional practice for any other registrants (including specialty doctors) that dispense controlled substances. DEA Response: DEA will not define an exact distance that the mobile component can travel from its registered location. If such requirements are necessary, other Federal, State, local, and tribal authorities can create them. Data for NAICS codes related to NTPs are based on the 2017 SUSB Annual Datasets by Establishment Industry, last revised on July 16, 2020. It covers patient assessment, treatment planning . 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