Voglio sapere a riguardo di…

khammond on DSKJM1Z7X2PROD with RULES

33864

Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
State has oversight and how the originating State could enforce their rules on a mobile NTP that is not located within their borders. The anonymous commenter also supported limiting the mobile NTP to the same State in which the NTP is registered, stating the restriction would prevent the mobile NTP from breaking the laws of the surrounding states it would be operating in, which might be different than the laws of the State in which the NTP is registered.
DEA Response: DEA appreciates the concerns raised by commenters that the proposed requirement that mobile NTPs only operate in the same State as their associated NTPs registered location may hinder the effectiveness of the rule in providing services to underserved communities. The intent of the rule is to increase access to these rural and underserved communities, while ensuring that certain recordkeeping and security requirements are met to prevent the diversion of controlled substances.
As stated in the preamble to the proposed rule, however, the CSA and DEA regulations have always required, with limited exceptions, practitioners to have separate registrations in each State in which they dispense controlled substances. See NPRM, 85 FR 11008, 11010. A practitioner, including an NTP, must maintain a DEA registration in each State in which it dispenses controlled substances because DEA
registrations are based on State licenses to dispense controlled substances. See, e.g., Clarification of Registration Requirements for Individual Practitioners, 71 FR 69478, 69478 Dec.
1, 2006. DEA relies on State licensing bodies to determine that NTPs are qualified to dispense controlled substances for detoxification and maintenance purposes. State authority to conduct these activities only confers rights and privileges within the issuing State; consequently, a DEA registration based on a State license cannot authorize controlled substance dispensing outside of the State. This aspect of the CSA and DEA regulations also helps to ensure that each State retains the primary authority to regulate the practice of medicine within its borders. Therefore, DEA can only authorize an NTP and, as a coincident activity, its mobile component, to dispense controlled substances in the same State in which its brick-andmortar NTP is registered with DEA to dispense controlled substances.
Restricting a mobile NTP to a 200-mile radius of the DEA-registered site would not address this requirement, as the State authority to operate an NTP is
VerDate Sep<11>2014

15:59 Jun 25, 2021

Jkt 253001

limited to the borders of the State, regardless of distance.
DEA also cannot authorize NTPs to avoid this requirement by allowing a single mobile NTP to partner with multiple NTPs with registered locations in different States. This rule authorizes a registered NTP to operate a mobile component away from its registered location as a coincident activity of its DEA registration, which, as stated above, is predicated on state authorization. Moreover, this arrangement is critical to ensuring that a registered NTP maintains effective security and recordkeeping oversight of its mobile NTP operations to safeguard against diversion of the mobile NTPs controlled substances. Allowing multiple registered NTPs to share the same mobile component would diminish any individual locations perceived authority and responsibility for the controlled substances contained on the mobile NTP. For example, it would complicate the NTPs task of reconciling the dispensing logs from both the mobile component and the NTPs registered location to ensure that only the NTPs enrolled patients are receiving controlled substances.
Furthermore, the task of recording and investigators task of tracing the movement of controlled substances received at the NTPs registered location and transferred to the mobile NTP
components would also be complicated.
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.
Comment: One commenter noted that although the proposed rule limited mobile components to the same State as the existing registration, it did not enumerate explicit measures for physically monitoring unauthorized out-of-State dispensations. The commenter stated that a lack of monitoring requirements in the proposed rule seemingly undermined effective DEA enforcement of its standards, thus enabling unauthorized medical practice to go undetected, and, accordingly, impeding States rights to authorize practitioners.
DEA Response: The risk of a mobile NTP engaging in unauthorized out-ofState dispensing is not appreciably greater than any other practitioner engaging in such dispensing. 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
PO 00000

Frm 00012

Fmt 4700

Sfmt 4700

unauthorized dispensing by mobile NTPs. Moreover, this final rule already provides for certain measures designed to enhance DEAs 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.
Mobile Components Facilitate Expanded Access in Rural Areas Comments: A majority of commenters voiced support for the proposed rule saying that it would expand access to treatment for those who needed it.
Multiple commenters stated that the proposed regulation was a step in the right direction because it reversed outdated regulations that have inhibited access to treatment. 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.
These commenters noted that rural or geographically remote areas that were lacking in opioid replacement medication services faced a treatment gap because of issues like poverty, lack of access to care, and premature deaths;
these mobile components could bridge these gaps, and allow more individuals to have access to treatment programs, which would help improve the odds of long-term recovery. 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. Other commenters also noted how the mobile components would allow many underrepresented groups like those suffering from mobility issues, mental health issues, incarceration, and homelessness to access treatment.
Several commenters also stated that these mobile components, while expanding access, would reduce costs because there would not be as great of a need to build more brick-and-mortar NTPs.
Two associations, one representing NTPs and the other representing the interests of individuals in medicationassisted treatment MAT, noted a potential funding source available through the U.S. Department of Agriculture USDA. Both associations mentioned that the funding is available to assist NTPs with the purchase of mobile vans, if the NTPs meet USDA
criteria in serving rural communities as defined by a population of 50,000 or less. Both associations also stated that they would advise NTPs to actively pursue this funding, working in
E:FRFM28JNR1.SGM

28JNR1