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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations
Other Comments 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 COVID19 public health emergency. The commenter stated that both the lack of treatment facilities and staffing shortages would negatively impact an agencys ability to admit clients into treatment, and that this will become more apparent due to the predicted increase in admissions following the public health emergency.
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 faceto-face contact, facilitating access to telehealth, and allowing home delivery of medications for OUD treatment to quarantined patients to prevent the spread of COVID19. Finally, one commenter stated that due to the ongoing public health crisis, DEA
should follow a tiered approach and immediately begin approving mobile components while devoting resources to finalizing this rule. The commenter further stated that DEA used its authority granted by 21 U.S.C. 822d to approve mobile components on an ad hoc basis prior to 2007, and thus there is no legal constraint on DEA to finalize this rule before beginning to approve mobile components on an ad hoc basis.
Several commenters expressed concern that SAMHSAs current requirement of daily dosing at the initiation of methadone treatment would limit the reach of newly operationalized mobile components to just one region/one community, given that a mobile component would have to repeatedly return to the same locations each day to provide daily methadone doses to newly initiated patients. To expand access to treatment, the commenters urged DEA to work with SAMHSA to revise regulations restricting take-home medications. Four commenters also suggested that DEA
should work with SAMHSA to allow NTP providers to prescribe medications to be filled at community pharmacies and to allow non-NTP providers to prescribe methadone.
DEA Response: DEA has worked closely with SAMHSA during the COVID19 public health emergency to provide guidance and support to NTPs to ensure that any individual who relies on MAT is able to continue treatment without disruption. It is DEAs intent that mobile NTP components will be able to help agencies facing lack of
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treatment facilities and staffing shortages resulting from COVID19 or any other public health or environmental emergency that impacts NTP access. DEA will continue to work with SAMHSA and its other partners after this public health emergency has ended to ensure that those suffering from OUD face fewer barriers to treatment.
DEA is using its discretion to approve mobile components under the authority granted to it by the CSA. 21 U.S.C.
822d. Any NTP that wishes to use a mobile component for maintenance or detoxification treatment will be able to start the approval process once the final rule has been published to ensure that all interested NTPs would be subject to the same requirements.
Comments: Two commenters noted that the proposed rule does not reference mobile NTPs need to adhere to Health Insurance Portability and Accountability Act HIPAA/privacy requirements. These commenters assumed that these same requirements applied to mobile NTPs but advised DEA to clarify this matter in the final rule to prevent misinterpretation. One of these commenters advised DEA to include a reference to best practice standards as defined by SAMHSA in TIP 63: Medications for Opioid Use Disorder.11 The commenter also recommended that DEA work closely with SAMHSA to develop a companion document to accompany the new requirements related to the administration of an NTP.
DEA Response: Regarding the commenters seeking clarity regarding HIPAA/privacy requirements for the mobile NTPs, DEA proposed requiring the records of the mobile components to be stored at the registered location of the NTP in a manner that meets all applicable security and confidentiality requirements. See NPRM, 85 FR 11008, 1101012 proposed 21 CFR 1304.24b.
These same requirements will apply in the final rule. NTPs already have protocols in place to protect patient information to ensure that they are in compliance with all Federal, State, local, or tribal requirements; the final rule is supplementary to these existing protocols. NTPs also have protocols and procedures in place to ensure that they are in compliance with all Federal, State, local, and tribal laws dealing with patient care, and best practices;
therefore, DEA will not include a 11 Substance Abuse and Mental Health Services Administration. 2020. Treatment Improvement Protocol TIP 63: Medications for Opioid Use Disorder HHS Publication No. PEP200201006.
https store.samhsa.gov/SMA18-5063FULLDOC
last accessed: 9/2/2020.

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reference to best practice standards as defined by SAMHSA in TIP 63:
Medications for Opioid Use Disorder. In sum, DEA does not anticipate any significant differences in how NTPs protect the privacy of patients served by registered NTPs and those served by their mobile components.
Comment: One commenter noted that it is also important to be clear that adding new mobile components does not imply that treatment standards would be different or less stringent than those of registered NTPs. The commenter suggested that in order to ensure high quality treatment, the rule provide additional information about clinical requirements and the States role in that area, leaving less room for problems as new mobile NTPs become operational. 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.
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.
One commenter recommended that the rule acknowledges that States may have additional requirements for NTPs beyond the Federal regulations. The commenter also inquired if all requirements that apply to a registered NTP location apply to a mobile component. The commenter expressed concern that without explicit guidance, it could lead to a misinterpretation of NTP requirements. The commenter also recommended adding language to the proposed regulation to clarify the expectation that a mobile NTP will provide services beyond the administration of the medication, such as counseling.
DEA Response: Under the rule, mobile NTPs are part of their DEAregistered NTP locations: Their dispensing of controlled substances through their mobile components is now a coincident activity allowed under their NTPs DEA registration. Thus, except where otherwise provided for by this rule or other laws or regulations, mobile NTPs are subject to the same standards as the NTPs of which they are a part.
DEAs NTP regulations seek to minimize diversion or abuse of the controlled substances dispensed by NTPs, but DEA does not establish broader treatment standards for NTPs.
Thus, to the degree commenters wish
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