Thus, DEA has concluded that the various regulatory requirements and monitoring activities that DEA uses to combat unauthorized dispensing in general should be adequate to combat any unauthorized dispensing by mobile NTPs. Another commenter mentioned that DEA, SAMHSA, State regulators, and NTPs have taken steps to ensure continued access to treatment by changing dosing schedules to limit face-to-face contact, facilitating access to telehealth, and allowing home delivery of medications for OUD treatment to quarantined patients to prevent the spread of COVID-19. 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. DEA intends to promulgate regulations for the telemedicine special registration in the near future. The proposed new paragraph did not previously address this security condition. The majority of commenters proposed only requiring the mobile NTPs to return to the registered location once a week, while another commenter suggested a 72-hour turnaround time, and another commenter simply requested that the mobile NTP be allowed to remain in the field for multiple days. One of the commenters who suggested returning once a week, alternatively recommended the mobile NTPs not be required to return more frequently than every other day. 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. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. 11/07/2022, 16 In fact, some commenters contended that many of these communities were hundreds of miles, with some specifying 100 to 200 miles and some simply stating over one hundred miles, from the NTP's registered location. 24. 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. 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. Pursuant to this authority, DEA is hereby finalizing a regulation that would waive the requirement of a separate registration for narcotic treatment programs (NTPs) that utilize mobile components under certain conditions. 12866 and 13563. 2. SUSB data gives the number of firms for each NAICS code within a series of ranges of annual receipts. This CSA requirement of separate registrations for each principal place of business or professional practice where the practitioner dispenses controlled substances allows DEA to monitor the dispensing of controlled substances. Moreover, many OUD patients may be successfully treated with alternative medications such as buprenorphine or naltrexone. However, this commenter stated that it would seem practically impossible for DEA to fully exercise its discretion under 21 CFR 1301.73(l) and effectively set security standards for mobile components, given the changing locations of mobile components when contrasted with registered NTP locations. Some situations may require additional security measures for a mobile NTP to be able to adequately guard against loss through theft or other forms of diversion. 12866 directs agencies to Start Printed Page 33880assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). The commenter insisted that pending the development of better information regarding the risks of diversion, DEA should not specify when the mobile component must return to the NTP's registered location. DEA is finalizing the proposed rule with certain modifications to 21 CFR 1300.01, 1301.13, and 1301.72. It is important to note that DEA representatives and Diversion Program Managers have been incredibly cooperative in producing this document. "Integrated Service Delivery Models for Opioid Treatment Programs in an Era of Increasing Opioid Addiction . DEA appreciates that some registered NTP locations might not have enough room to park the mobile component overnight; therefore parking the mobile component in a secure fenced-in location would be permissible, as long as all DEA security requirements are met, the controlled substances are removed from the mobile component at the end of the day, and the local DEA office is notified of the location where the mobile component will be parked overnight. The many fixed capital and operating expenses associated with the startup and ongoing operation of a new facility discourage providers from doing this. https://store.samhsa.gov/SMA18-5063FULLDOC (last accessed: 9/2/2020). Reviews aren't verified, but Google checks for and removes fake content when it's identified. 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. Access to Treatment for Opioid Dependence in Rural America: Challenges and Future Directions. 6. The commenter stated that under the proposed revisions to 21 CFR 1304.24 there is a requirement that NTPs must maintain records of patient information including the dosage consumed, but no requirement that the records be maintained in real-time, potentially allowing such double-dipping to occur before an NTP could compare dispensing logs and discover it. The CBHSQ Report: Patients Who Are Privately Insured Receive Limited Follow-up Services After Opioid-Related Hospitalizations. Thus, as reflected in the rule, DEA has concluded that each mobile NTP component may only operate under the DEA registration of a single NTP locationand may only operate in the State in which that registered NTP is licensed. Regarding one commenter's 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 Start Printed Page 33872as a part of their routine NTP inspection workload, thus there will be no additional costs to DEA. Thus, to the degree commenters wish Start Printed Page 33875the government to clarify treatment standards specific to the mobile components of NTPs, they should contact the government entities that establish and enforce those standards. See NPRM, 85 FR 11008, 11010. The purpose of statutory and regulatory requirements is to ensure the safety and well-being of the NTP patient, the community and the public. This final rule builds on the existing experience and provides additional flexibility for NTPs in operating mobile components, subject to regulatory restrictions put into place to prevent the diversion of controlled substances. headings within the legal text of Federal Register documents. One of the commenters described the study as recent, but neither provided a specific citation for the study. DEA has no reason to conclude that the percentage of small NTP entities that begin operating mobile components in response to the rule will differ from the percentage of total NTPs (11 of 1,026, or 1.07 percent), especially since most NTP entities are small. If these summary reports are maintained in hard copy form, they must be kept in a systematically organized file located at the registered site of the NTP. DEA does not see any benefit to the public in explaining this fact further in the regulatory impact analysis. (at a 7 percent discount rate) to $3,953,059[27] The commenter thus indicated that this requirement would detract from the increased access to treatment and reduced costs of expanded access that this regulation aims to achieve. 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]. Topics include ordering medication, dispensing medication, recordkeeping, and security measures. 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. Personnel that are authorized to dispense controlled substances for narcotic treatment must ensure proper security measures and patient dosage. [4], Methadone is also a demonstrated diversion risk. DEA appreciates commenters' suggestions that the risk of theft or diversion of controlled substances left in a mobile NTP overnight could be mitigated by increasing the security requirements for mobile NTPs. The authority citation for part 1304 continues to read as follows: Authority: This term does not include a trailer. 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. The commenter further contended that it is not clear that moving the mobile component back to the registered location and removing the controlled substances daily decreases the risk of diversion. National Drug Intelligence Center. DEA already evaluates the security arrangements provided by a wide range of registrants under many different circumstances. Comparing the present value of the costs associated with operating a mobile NTP over a five-year period with the present value of the costs associated with opening an additional NTP location over a five-year period yields a net present value of cost savings between $319,069 (at a 7 percent discount rate) and $359,369 (at a 3 percent discount rate) for the operation of a mobile NTP. You will receive a link to create a new password. The Best Practices Guidelines do not include all potential options for prevention,. NTPs with mobile components are not allowed to modify their registrations to authorize their mobile components to act as collectors under 21 CFR 1301.51 and 1317.40. This final rule does not change the proposed new requirement in 1301.72(e), 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. [15] The application for such an exception must be submitted in accordance with 1307.03 of this chapter and must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. The final rule also contains additional requirements specified in the proposed rule to reduce the likelihood of diversion. DEA's analysis, summarized in the preceding section, finds that this final rule will result in a net cost-savings between $3,509,759 and $3,953,059, and is therefore below the $100 million threshold. In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. DEA also recognizes that this final rule is likely to result in benefits in the form of economic burden reductions (healthcare costs, criminal justice costs, and lost productivity costs) as access to treatment for underserved communities is expected to expand. Finally, one commenter suggested making requirements based on distance and population, and creating regulations built on collaboration. For the reasons outlined in the comparative analysis discussed above, DEA concludes that moving from the baseline regulatory environment to the regulatory environment of the final rule results in a cost reduction for NTP registrants that wish to expand their services to new geographic areas, and will spur an increase in the number of mobile NTPs. As further explained below, DEA has concluded that mobile NTPs must be required to return to their registered locations upon the completion of their operations each day and that such a requirement can be met while still increasing access to maintenance or detoxification treatment in rural and underserved areas. 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 treatment received while incarcerated, show that these mobile components are beneficial. 11/07/2022, 189 13. Additionally, a back-up of all computer generated records of dispensing by the NTP and its mobile component is required to be maintained off-site. 44 U.S.C. on Thus, the request to clarify the role of Hospital/Clinic in accordance with 21 CFR 1301.28 is beyond the scope of this final rule. Learn more here. Better Prevention, Treatment & Recovery Services, Better Availability of Overdose-Reversing Drugs, Federal Guidelines for Opioid Treatment Programs, Apply for Opioid Treatment Program (OTP) Certification, Submit an Opioid Treatment Exception Request, Training Materials and Provider Resources for Medication-Assisted Treatment (MAT), Medication-Assisted Treatment of Opioid Use Disorder: Pocket Guide, Mobile App for Practitioners Who Provide Medication-Assisted Treatment, All SAMHSA publications for Medication-Assisted Treatment, TIP 63: Medications for Opioid Use Disorders, Telemedicine and Prescribing Buprenorphine for the Treatment of Opioid Use Disorder, Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants, Narcotic Treatment Programs Best Practice Guideline, Implementing Medication-Assisted Treatment for Opioid Use Disorder in Rural Primary Care: Environmental Scan. DEA will closely monitor applications seeking an exception to that requirement. Certification is required to dispense medications for the treatment of substance use disorders. Rockville, MD: Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality. Thus, by requiring NTPs to secure their controlled substances within their registered NTP location after operation each day, DEA decreases the risk that those controlled substances will be stolenand thereby decreases the risk Start Printed Page 33867that the communities served by mobile NTPs will be harmed by diverted methadone. To the degree interested parties believe that the separate registration requirement should be waived in other circumstances, they may petition DEA to do so by regulation. DEA calculated this ratio to be 0.56, as listed in the table below. 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. DEA will evaluate each application on a case-by-case basis to determine whether the Start Printed Page 33877applicant has demonstrated exceptional circumstances that warrant a waiver of the daily return requirement. Therefore, DEA estimates that 1.85 percent (19 of 1,026) of total NTP entities in the United States are affected by this final rule. Similarly, proposed new 1301.74(j) and (l) referred to an NTP physician, whereas the revised text uses the more general term practitioner.. Document Drafting Handbook The registered NTP, not DEA, should decide which narcotic drugs should be dispensed to its patients, both at the registered location and on the mobile component, in accordance with each individual patient's medical needs as determined by a medical professional authorized to make such a determination. [23] documents in the last year, 878 The storage area for controlled substances in a mobile component of an NTP must not be accessible from outside the vehicle. New Documents 03-31-2020: 01-29-2020: Controlled Substance Prescriptions: Q&A: No: Questions and Answers for Providers of Electronic Prescription Applications, Pharmacy Applications, and . Topics include ordering medication, dispensing medication, recordkeeping, and security measures. Learn more about how federal nondiscrimination laws apply to opioid use disorder treatment and recovery services, including Medication Assisted Treatment. 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