This study examined the views of OTP staff from six programs located on the east and west coasts of the USA and their SOTAs, on the impact of the COVID-19 pandemic and its associated federal and state COVID-19 Public Health Emergency (PHE) regulatory exemptions. These regulatory exemptions went into effect in March 2020, at the start of the parent study which examined the effectiveness of an implementation facilitation intervention to prompt the use of IM (methadone treatment without counseling) and other approaches to address admission delays. Under the COVID-19 PHE, SAMHSA allowed states to request a blanket exemption from the prior OTP take home regulations to permit the use of clinical judgment, rather than adherence to eight specific criteria and tenure in treatment requirements. When implemented, the PHE policies allowed OTPs to provide stable patients up to 28 take-home doses and to provide “less stable” patients (who were deemed able to responsibly handle their medication) with up to 14 take home doses (SAMHSA, [32]). The pandemic, with SAMHSA’s support, also permitted the use of remote telehealth counseling via video or telephone [11].

Although states were not required to implement the expansion of take-home doses, all of the SOTAs in the present study quickly did so. McIlveen and colleagues noted that 45 states (of the 49 with OTPs) requested the blanket exemption [24]. Prior to the PHE, 10 states prohibited take-home doses in the first 30 days of treatment and seven prohibited take-home doses during the first 90 days of treatment [34]. Going forward, states are reviewing their policies based on their experiences during the pandemic to ensure clinically appropriate and accessible care.

Participants reported that the response to the COVID-19 pandemic provided more benefit to established patients than program applicants. Established patients were able to obtain a greater number of take-home doses more quickly than prior to the pandemic to increase physical distancing at the programs. Several reports have noted the benefits of these regulatory flexibilities including enhanced patient-centered care, improved patient-provider rapport, increased patient autonomy and engagement [1, 13, 21, 33]. A mixed methods study found that take-home dose flexibliity among stable patients was associated with receiving more take homes, higher rates of treatment retention, and lower rates of opioid positive drug tests [13]. Patients in that study reported that the increased number of take homes supported their recovery because they felt trusted by the staff, spent less time traveling to the program, which permitted increased time spent on work and recreation, and were less exposed to drug-using patients at the program.

Several studies indicate that prior concerns about the impact of increases in take-homes resulting in methadone diversion-related problems and methadone overdose death do not appear to have been realized [3, 6, 10, 20, 35, 37, 38]. While OTPs were able to provide patients with the new maximum number of take-home doses, several studies found that OTP staff used their discretion in determining who should get additional take home doses [11, 18]. Going forward, the impact of expanded take-home availability should be monitored [20].

Hatch-Maillette and colleagues [12] raised a caution that the greater flexibility in granting take-home doses under the PHE could potentially negatively impact patient equity given the lack of specificity in the definitions of what constituted a “stable” or “less stable” patient. SAMHSA issued proposed permanent regulatory revisions in December 2022 [9] and updated temporary regulatory guidance in April 2023 to extend take-home flexibility for 1 year while the final regulatory revisions go in effect.

Both the guidance and the proposed final regulations have only six (rather than eight in the pre-pandemic regulations) specific take-home criteria. These criteria are more specific than those of “stable” and “less stable” under the original PHE declaration but are much less prescriptive than those prior to the PHE. This middle ground should mitigate any concern of potential bias in approving take-homes. The guidance and proposed regulations also considerably reduce the tenure in treatment requirement, eliminate the reliance on complete abstinence of any drug, and leave take-home eligibility up to the clinical judgment of the provider [9]. These specific criteria should be helpful to both providers and patients to safely expand access to care.

Participants reported that the expansion of take-home dose availability required adjustments to the clinic workflow. Although nurses were administering methadone to fewer patients each day, each patient took longer because of the need to prepare and dispense a greater number of take-home doses. The newly-proposed SAMHSA revisions to the OTP regulations may help address this issue because they expand the definition of qualified practitioner who can administer or dispense methadone [9]. SAMHSA noted that this proposed change will permit greater staff flexibility within states that permit a wider variety of disciplines to administer and/or dispense methadone.

Established patients also benefited from the expanded use of remote telehealth counseling. This too was quickly approved by the participating SOTAs. OTP staff participants reported that attendance at counseling had dropped precipitously at the start of the pandemic prior to the use of telehealth. OTPs adjusted their treatment approach to permit patients to attend individual counseling sessions remotely (typically by telephone), although challenges remained for patients with limited resources. Such sessions were often limited to telephone voice counseling rather than by video because patients lacked access to smartphones with data plans or computers with cameras, microphones and internet connections.

Participants’ reports of attendance at individual counseling attendance during the pandemic once remote services were offered did not extend to group counseling, which was largely put on hold during the present study. Greater problems in implementing group counseling during the pandemic was found by other OTPs [11]. Since group counseling in OTPs prior to the pandemic was predominant, the shift to individual telehealth counseling was notable, though its impact on outcomes is not known. The drop in group counseling attendance was consistent with findings from a nine-state patient survey [27]. Another survey of 100 addiction treatment providers in California found that they believed remote individual counseling was as effective as in-person individual counseling, but they were less sure about the relative effectiveness of telehealth-delivered group counseling [23].

The impact of the switch from group to individual counseling is not known because of limited effectiveness data in OTPs on in-person group vs. individual counseling and limited effectiveness data on remote counseling [22]. We are aware of only one randomized trial of remote vs. in-person individual counseling in an OTP which found that both conditions had similar attendance and rates of positive drug tests [17]. Similarly, a small, randomized trial from the same group comparing remote vs. in person group counseling found no significant difference in attendance or in achieving two consecutive weeks of drug abstinence [17].

It should be noted that a randomized trial that compared interim methadone treatment without counseling to methadone treatment with counseling found no significant differences in treatment retention or illicit opioid use during the first 4 months of treatment [29]. More research is needed on the effectiveness of remote counseling and comparing individual to group counseling. Programs should weigh the benefits of increasing patient access to telehealth to support patient autonomy and equity and to remove the burden of commuting to the program while juggling responsibilities of work, childcare, and criminal justice supervision [12]. As noted in the present study and by others [23] this would be particularly beneficial to patients with care giving responsibilities.

In the present study, staff reported that program applicants did not benefit as much as established patients from the COVID-19 PHE flexibility because the increases in take-home doses and remote counseling were not relevant to the admission process. SAMHSA did permit medical assessments for OTP admission for buprenorphine treatment to be conducted remotely, however this was not permitted for methadone treatment. Thus, permitting other remote intake activities, including eligibility screening and psychosocial assessments, did not help program applicants gain admission more rapidly. Participants identified that medical staff shortages as a bottleneck to admissions prior to COVID were exacerbated during the pandemic because medical providers had to quarantine when they or someone in their household had been exposed to COVID. The medical staff shortage coupled with the in-person requirement for physical exams created strain on the OTPs in our study.

During the first year of the COVID pandemic, given the known association between retention in methadone treatment and the reduced risk of opioid overdose death [19, 30], implementing clinically appropriate options that aid access to services was critical. Post pandemic, the proposed SAMHSA revisions to the OTP regulations would permanently permit admission medical assessments for new patients via video (not voice only), or as an alternative, to permit the use of a physical exam conducted within seven 7 days of admission by a non-OTP. These flexibilities should help to facilitate new admissions. They would also permit the current temporary take-home flexibilities and expansion of qualified providers to remain in effect permanently.

This study has several limitations. First, it was conducted as part of an implementation facilitation study of interim methadone treatment and involved OTPs with treatment entry delays that preceded COVID-19. Thus, it may not generalize to clinics that were not experiencing treatment delays prior to COVID. Second, only six clinics in four states on the east and west coasts and their respective SOTAs participated in the study. Therefore, findings may not generalize to OTPs in other states. Third, the focus of the parent study was not on COVID regulatory flexibilities at the outset, so findings emerged in response to other questions about clinic processes related to the parent study. A study that focused specifically on COVID-related changes may have uncovered additional areas that were not mentioned due to the lack of topical overlap. Finally, the first wave of interviews referred to treatment activities occurring prior to the broad availability of COVID vaccinations in the US and may not reflect OTP treatment occurring today.