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Document ID Nos. DEA-2023-0029-0001; DEA-2023-0028-0001
Public Interest Comment1 on the DEA Proposed Rules on (1) Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation and (2) Expansion of Induction of Buprenorphine via Telemedicine Encounter
Introduction & Background
In response to the COVID-19 pandemic, DEA made several significant changes to long-standing policy to accommodate social distancing while supporting patient care for treatment of opioid use disorder (OUD) with buprenorphine. Most relevant to these particular regulatory proceedings was DEA’s action to invoke the public health emergency (PHE) to waive the Ryan Haight Act requirement for an initial, in-person visit before a patient could begin treatment with buprenorphine. This cleared the way for patients and prescribers to meet via telehealth.3 DEA at first required audio-video connections and later provided additional flexibility to permit audio-only connections. These steps were important and undoubtedly saved lives.
In prior work, Laura E. Stanley and I found that DEA possessed sufficient legal authority to make its pandemic flexibilities permanent,4 so it is encouraging to see DEA moving forward to make telehealth a more realistic option for patients. While we worked on this legal question, public health researchers leapt into action and produced an impressive amount of research exploring the changes in the field. I am part of an interdisciplinary team at The George Washington University and New York University that produced two narrative reviews, one on pandemic flexibilities for methadone take-home supplies5 and another on buprenorphine initiation via telehealth.6 This comment shares the results of the buprenorphine initiation narrative review with DEA and offers recommendations to DEA based on its findings.
DEA should be commended for supporting patient treatment in the pandemic, despite what may have been some apprehension on DEA’s part about potential risks that their flexibility might exacerbate. We now have much more information about how those pandemic flexibilities worked in practice, and the evidence very strongly suggests that any risks of telehealth are outweighed by its tremendous benefits. With the end of the pandemic PHE expected in May 2023, DEA should also be commended for using lessons from the pandemic to make telehealth a permanent option for patients. While this progress is encouraging, DEA’s proposed rules impose an arbitrary limitation on telehealth that DEA should reconsider prior to finalizing.
In-Person Visit Requirements in 1306.31(c)(2) & 1306.34(b)(4)
In DEA’s proposed rule “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation,” DEA would restrict initial prescriptions via telehealth for non-narcotic controlled substances on Schedules IIIV.
This proposal retreats from some of DEA’s pandemic flexibility, which applied to narcotic and non-narcotic controlled substances on Schedules II-V. See proposed § 1306.31(c)(1)(i). The agency also proposes that prescribers may only prescribe a supply of medication beyond 30 days if the patient undergoes an in-person evaluation. See proposed § 1306.31(c)(2). In DEA’s proposed rule “Expansion of Induction of Buprenorphine via Telemedicine Encounter,” DEA proposes to extend this same approach to buprenorphine, which would otherwise be left out because it is classified as a narcotic. See proposed § 1306.34(b)(4).
Stated more simply, these proposed requirements allow a prescriber to use telehealth to give a new patient a prescription buprenorphine to treat opioid use disorder, but only for up to 30 days unless the patient has an in-person medical evaluation. This is a new kind of policy for DEA, and as such it deserves careful consideration before adoption. No matter how well-intentioned, the introduction of a new limit on access to healthcare services sparks the potential for significant, unintended consequences for patients, prescribers, pharmacies, payers, and more.
Unfortunately, DEA does not delve into potential consequences or explain its reasoning for this 30-day limit; instead it asserts that this limit is proposed “in order to balance benefits and risks to individual and public safety” without explaining how DEA would describe, assess, or weigh the relevant benefits and risks. See 88 Fed. Reg. 12,875, 12,882 (Mar. 1, 2023).
In rulemaking, DEA bears the burden of explaining that its actions are not arbitrary under 5 U.S.C. § 706(2). As the Supreme Court explained in Motor Vehicle Manufacturers Association v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983):
“Normally, an agency rule would be arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise. The reviewing court should not attempt itself to make up for such deficiencies; we may not supply a reasoned basis for the agency’s action that the agency itself has not given.” State Farm, 463 U.S. at 43.
DEA’s final rule, therefore, must do more to explain the agency’s basis for its novel telehealth limit in general, and for buprenorphine in particular. DEA could include this kind of explanation in the alternatives section of its regulatory impact analysis as required by EO 12,866. The results of our narrative review of 41 studies related to the pandemic flexibilities for telehealth and buprenorphine (see Appendix A) suggests, however, that DEA will find it challenging to argue that a limit based on any particular number of days is non-arbitrary. Our review found overwhelmingly positive results on the benefits of telehealth for buprenorphine initiation, and—despite worries and concerns—few to no materialized downsides. These results call into question—at a fundamental level—the need for DEA to impose an in-person visit requirement at all, especially one which is based on a number of days. While other commenters might suggest a “compromise” number of days, this comment calls upon DEA to consider its obligation to avoid arbitrary decision-making in the first instance. A “compromise” number of days that is no better explained or grounded in reason remains arbitrary.
Recommendation 1: In its final rules, DEA should abandon a time-based limitation on telehealth unless it can articulate a well-reasoned rationale.
Another concern about the telehealth limitation described above is that it appears to override flexibility provided by SAMHSA in its recent proposed rule relevant to opioid treatment programs.
In that proposal, SAMHSA did not place an in-person visit requirement on telehealth for buprenorphine initiation that takes place in opioid treatment programs. See 87 Fed. Reg. 77,330 (Dec. 16, 2022). DEA’s proposal appears to override the SAMHSA proposal by imposing a time-based limit on all prescribers—including those in opioid treatment programs—that SAMHSA did not. DEA and SAMHSA should resolve this policy conflict prior to finalizing these proposed rules so that both agencies can provide the public with a clear explanation of how the rules intersect.
Recommendation 2: DEA and SAMHSA should deconflict their rules and explain to the public how they intersect.
Leveraging Recent Research
Our narrative review on the pandemic flexibilities for buprenorphine initiative via telehealth is under review with a peer-reviewed journal. It summarizes 41 studies that help shed light on telehealth’s role in getting patients started on buprenorphine in the pandemic. Nothing we saw suggests that telehealth should always replace in-person care for every patient. Instead, the results show that telehealth has an important role to play, especially for those who might not otherwise be able to get it. The great risk of regulations that limit telehealth is that a set of patients will simply
not have access to life-saving treatment with buprenorphine.
As DEA finalizes its proposed rule, this comment encourages the agency to consider ways to bolster its analysis with the findings of the studies that we summarize in our review. To facilitate this review, this comment includes a preprint version of our narrative review, which contains citations to the relevant studies.
A Role for the Opioid PHE
With the end of the pandemic PHE coming up very soon, DEA should consider shifting the legal basis for its pandemic telehealth flexibilities for buprenorphine from the pandemic PHE to the opioid PHE. We discuss this option in an article published in 2021:
“DEA relied on the COVID-19 public health emergency as the basis for its action to permit telemedicine. As discussed above, under 21 U.S.C. § 802(54)(D), DEA has the authority to allow the ‘practice of telemedicine’ when it is being ‘conducted during a public health emergency declared by the Secretary under section 247d of title 42.’ Both the opioid crisis and the COVID-19 public health emergencies were declared under section 247d. Just as DEA used its authority to allow for the initial evaluation to be conducted via telemedicine during the COVID-19 public health
emergency, it has the discretion as a matter of law to use that authority to extend that policy under the opioid-specific public health emergency.”7
Relying on the opioid PHE would leave the highly net beneficial pandemic policies in place while giving DEA more time to complete its analysis of this important agency decision. DEA could use some extra time to consult with stakeholders on the implications of its novel telehealth policy proposal, assess the extent to which buprenorphine should be treated differently from other controlled substances in light of its unique safety profile, likelihood of diversion relative to other medications, etc., all while leaving the pandemic flexibilities in place and therefore helping to ensure continuity of care for patients.
Recommendation 4: DEA should consider using the opioid PHE to provide ongoing flexibility for buprenorphine prescribed via telehealth while working on a long-term solution.
Conclusion
In its proposed rules, DEA takes significant steps towards supporting the use of telehealth for patients receiving treatment for opioid use disorder with buprenorphine. In the four recommendations above, which are summarized below, this comment encourages DEA to reconsider its proposed in-person visit requirements, leverage recent research to bolster its rationale, and consider how the opioid public health emergency could help alleviate some of the time pressure to resolve these important issues.
Footnotes
1. This comment reflects the views of the author, and does not represent an official position of the GW Regulatory
Studies Center or the George Washington University. The Center’s policy on research integrity is available at
http://regulatorystudies.columbian.gwu.edu/policy-research-integrity.
2. Bridget C.E. Dooling is a Research Professor at the George Washington University Regulatory Studies Center.
