State Guidance and System Changes Related to COVID-19: Impact on Opioid Treatment Programs

Abstract

Introduction:

In the United States, methadone treatment may only be provided through opioid treatment programs (OTPs), which During the pandemic, federal regulators relaxed several operate under a complex system of federal and state regulations. longstanding restrictions for OTPs by permitting expanded eligibility for take-home medication and allowing counseling and medication management through telehealth. The purpose of this study was to assess the guidance provided by states regarding the revised guidelines and efforts to protect staff and patients in response to the pandemic.

Methods:

Between September and October of 2020, The National Association of State Alcohol and Drug Abuse Directors (NASADAD)and Friends Research Institute, fielded a web-based qualitative survey of state opioid treatment authorities (SOTAs) across the United States, the District of Columbia, and Puerto Rico. The study conducted the survey prior to the availability of the COVID vaccines. It queried 42 SOTAs concerning state guidance provided to OTPs on treatment operations and practices for existing patients and new admissions; actions to protect staff and patients; changes in treatment need and operational capacity; and administrative practices regarding treatment. This study examines the responses of 42 SOTAs (65%) who completed the survey.

Results:

Using content analysis, responses to the survey indicate that most states provided guidance to OTPs in response to the revised federal regulations and the need to protect staff and patients. All respondents reported that their states permitted increased number of take-homes doses for existing patients (100%) and most reported doing so for new admissions (69%; N=29). Ninety-eight percent (98%; N=41) reported permitting remote counseling for existing patients and 90% (N=38) permitting this for new admissions. SOTAs reported providing guidance on staff safety, operational procedures, oversight, and reforming billing practices to align with new models of service delivery.

Conclusions:

SOTAs generally reported that federal guidance increased patient access, engagement, and retention. Increased take-home flexibilities were viewed as important for expanding access and continuity of treatment, with the majority of SOTAs stating that the revised treatment practices (e.g., expansion of telehealth, flexible medication dispensing practices) were beneficial. These regulatory flexibilities, many believe, promoted the continuation of treatment and successful patient outcomes during the pandemic.

1.1. Introduction

1.1.1. Methadone Regulations in the U.S.

Methadone is an opioid agonist that is an effective treatment for opioid use disorder (OUD). Numerous studies have documented the effectiveness of methadone treatment in reducing opioid use and preventing overdose death (Volkow et al., 2014; National Academies of Sciences, Engineering, Health and Medicine, 2020; Substance Abuse and Mental Health Services Administration [SAMHSA], 2021; Ma et al., 2019; Sordo et al., 2017; Degenhardt et al., 2017). In the US, methadone treatment for OUD may only be used within federally certified and accredited OTPs. As of 2020, there were approximately 1,746 OTPs (Frontz, 2020), providing treatment to over 400,000 people (SAMHSA, 2020). These programs administer and dispense methadone (and to a lesser extent buprenorphine), provide drug testing, and counseling. OTPs are regulated by the federal Substance Abuse and Mental Health Services Administration (SAMHSA), the Drug Enforcement Administration (DEA), and state governments.

Federal and state regulations set parameters on the number of methadone doses that can be dispensed for take-home consumption, medical assessment requirements, counseling, and drug testing. Prior to COVID-19, federal regulations (42 CFR § 8.12(h)(4) stipulated in-person attendance 6 days per week for the first 90 days of treatment and outlined a schedule and criteria for earning additional ‘take-home’ doses of medication thereafter. Under the federal regulations, patients would be eligible for a maximum of 14 days of take-home medication after one year of treatment, and a maximum of 28 days after two years in treatment, if they met eight specific criteria (e.g., absence of recent drug and alcohol use; regular clinic attendance, etc.). In addition, patients were required to have an in-person physical examination at admission, receive in-person counseling, and have a minimum of eight drug tests per year. While methadone has ample evidence of effectiveness as a treatment for opioid use disorder, innovation in treatment delivery had long been constrained by stringent federal and state regulations.

In response to the COVID-19 public health emergency, SAMHSA issued guidance providing regulatory flexibilities for OTPs to reduce crowding and consequently COVID transmission at these busy programs. Under the initial federal emergency guidance disseminated on March 16, 2020, OTPs were permitted to dispense up to 28 days of take-home medication for ‘stable’ patients and 14 days of take-home medication for ‘less stable’ patients. The March 2020 guidance did not set minimum time in treatment requirements nor definitions of stability. Subsequently, in November 2021, SAMHSA issued additional guidance extending the flexibilities and provided eight criteria for stable and five criteria for less stable patients.

Under the November 2021 guidance, “less stable” patients were defined as individuals who completed a minimum of 30 days in treatment and whose medical record documented partial adherence with their treatment plan for at least 30 days, 30 days of negative toxicology tests, absence of recent medication diversion activity, assurance of safe medication storage, and evidence that the benefits of providing unsupervised doses outweigh the risks. Patients could receive up to 14 days of take-home doses after meeting the criteria for a “less stable” patients (vs. meeting the eight-point take-home criteria under the pre-emergency regulations, including at least one year in treatment).

Stable patients, on the other hand, were defined as individuals who have completed a minimum of 60 days in treatment and whose medical record documented complete adherence to treatment protocols, including 60 days of negative toxicology tests and all the criteria for less stable patients, plus stability of living arrangements and social relationships and absence of serious behavior problems and substance misuse-related behaviors. Patients could receive up to 28 days of take-home doses after meeting criteria for a “stable” patient (vs. meeting the eight-point take-home criteria under the pre-emergency regulations, including at least two years in treatment). Within these guidelines, the actual number of take-homes provided was left to the discretion of OTPs. Notably, SAMHSA recently revised the guidance further, allowing for take-home medication during the first 30 days of treatment (up to 7 days of take-home doses during the first 14 days of treatment, up to 30 days during the first 30 days of treatment, and up to 28 days thereafter). SAMHSA also stated that these flexibilities would continue for one year after the end of the COVID-19 emergency (per declaration of the DHHS Secretary) while the agency pursued more permanent regulatory changes (as reflected in the Notice of Proposed Rule Making issued in December 2022).

In conjunction with rule changes for take-home medications, other federal and state guidance sought to promote a safe clinic environment for staff and patients. Guidance included granting exemptions from the requirement to perform in-person physical examinations for new patients treated with buprenorphine (though not methadone) and allowing existing OTP patients to receive counseling remotely via telehealth. The emergency guidance permitted, but did not require, states to adopt these changes and, in turn, most states permitted but did not require OTPs to adopt these changes. In addition, many states established social distancing practices, mask and hygiene policies, work from home protocols, and additional medication distribution practices (e.g., drive-through dosing) to ensure the safe continuation of treatment.

Reports indicated that many OTPs embraced these changes, although there was some variability in how OTPs exercised the new discretion and opportunities to expand access to care (Levander et al., 2021). These regulatory flexibilities allowed OTPs to continue operations and meet the needs of patients while protecting public health. One large ‘secret shopper’ study with ~300 OTPs across 14 states found that about 85% of U.S. clinics contacted during May-June 2020 were accepting new patients, with a mean (median) wait time to first appointment of 3.5 (2) days for Medicaid and 4.1 (3) days for self-pay (Joudrey et al., 2021).

Numerous commentaries and think pieces by researchers and thought leaders have addressed the changes to the organization and delivery of OUD treatment stemming from the COVID-19 pandemic. Many of these publications called for regulatory reform in the wake of successful experiences with ensuring treatment access during the pandemic (Green et al., 2020; Hatch-Maillette et al., 2021; del Pozo & Rich, 2020; Frank, 2021; Greenblatt et al., 2020; Hughto et al., 2021; Krawczyk et al., 2020; Leppla & Gross, 2020; Livingston et al., 2021; Nunes et al., 2021; Pena & Ahmed, 2020; Peterkin et al., 2021; Stringer et al., 2021; Tracy et al., 2021). There is a growing consensus that there are many lessons to be learned from this experience, including ways to promote treatment access through increased take-home flexibility, telehealth and mobile technologies, and other ways to reduce patients’ burdens.

1.1.2. Purpose of the Present Study

SAMHSA regulations define a “State Authority” to oversee and support the treatment of opioid addiction and quality of care in OTPs in their respective states, territories, and the District of Columbia. The State Authority responsibility is generally assigned to a SOTA, who is responsible for the oversight of OTPs and serves as the primary interface between these programs and state and federal regulators. Although there is variation in how this responsibility is implemented, SOTAs communicate state and federal regulations and guidance to OTPs and monitor program operations. OTPs requesting exemptions from federal regulations, must obtain approval from their SOTA prior to submitting the request to SAMHSA. Thus, SOTAs have a unique perspective on methadone treatment policies and practices.

In September and October of 2020, just prior to the availability of two formulations of the COVID vaccine, NASADAD, in collaboration with Friends Research Institute, surveyed the SOTAs and received responses from 40 states, the District of Columbia, and Puerto Rico concerning guidance provided by the states on the implementation of revised treatment practices in response to the COVID-19 pandemic. The focus of the present study was to learn what guidance was provided by states to support the continuation of treatment in OTPs during the pandemic, what steps were taken to support the safety of staff and patients, what steps were taken to support the continued operation of OTPs, and lessons for the future organization and delivery of methadone treatment. It should be noted that because most patients in OTPs receive methadone rather than buprenorphine, the present study primarily explores adjustments in methadone treatment practices.

2.1. Methods

2.1.1. Researching Organization

NASADAD is a private, membership based, non-profit organization focused on supporting state-level leadership in alcohol and drug publicly funded prevention, treatment, and recovery systems throughout the U.S. NASADAD’s support includes providing technical assistance on topics of interest or professional need; updating membership on federal policy developments and activities impacting the provision of treatment, prevention, and recovery activities; promoting networking across states and territories; and conducting inquiries/surveys across to share information across membership and identify areas of technical need.

NASADAD’s organizational structure includes the Opioid Treatment Network, which is a component group comprised of SOTAs from across the nation. From time to time, NASADAD surveys the SOTAs for their views on topics of importance to the field. In collaboration with Friends Research Institute, NASADAD fielded a web-based qualitative survey of SOTAs between September and October 2020 focused on the impact of the COVID-19 pandemic on treatment services in OTPs their state. Forty-two of 65 invited SOTAs responded to the survey invitation, yielding an overall response rate of 65%. The survey was conducted prior to the availability of the COVID-19 vaccines.

2.1.2. Sampling Strategy

SOTAs were selected for surveying due to their role in providing oversight of OTPs and acting as the primary interface between OTP programs and state/federal regulators. This sample frame includes 49 states, the District of Columbia, Puerto Rico and the US Virgin Islands, spanning all jurisdictions with OTPs and designated SOTAs. Wyoming was excluded because it did not have an OTP. SOTAs were provided information about the survey and asked to participate. Participation was voluntary. During the survey period, reminders were sent to targeted respondents reminding them of the survey and encouraging their participation. While there was no unambiguous pattern to the states that did not respond to the survey, most of the non-responding states had relatively low population density. The responding SOTAs oversaw OTP systems that served a substantial majority of the US population treated with methadone for opioid use disorder.

2.1.3. Survey Instrument

The study team developed the survey questions which were designed to enhance understanding of changes in OTP policies and treatment practice as a result of the COVID-19 pandemic. In terms of its content, the survey queried SOTAs through three major sections containing closed-ended items about guidance provided by states about OTP treatment operations and practices for existing patients and new admissions; actions to ensure the safety of OTP staff and patients; changes in treatment need and OTP capacity to meet them; and administrative practices regarding programming, admissions, workforce, and resource allocation. In total there were 24 closed-ended questions concerning respondents’ knowledge of policy changes, understanding of changes in treatment practices, and the impact of COVID-19 on methadone treatment. In addition, several open-ended items were integrated into the survey allowing free text responses were included for adding additional context to responses concerning OTP operations, billing practices, benefits/challenges, and continued policy implications. For brevity, only three aspects of these open-ended questions (billing practices, continued operations, and primary implementation challenges) are presented in this article. Responses to questions were voluntary and SOTAs could skip any question they did not wish to answer.

NASADAD sent an announcement via email to all SOTAs providing a link to access the survey. The announcement provided background on the survey, its purpose, its voluntary nature, and contact information for questions. Respondents were given up to four weeks to complete the questions with additional reminders sent to promote survey response. The Western Institutional Review Board determined that the present study was exempt from IRB review as a secondary analysis of survey data.

The web-based Survey Monkey data collection platform was used to collect all response data. Surveys were reviewed for completeness in Survey Monkey, then transitioned into Excel for data cleaning. Data cleaning procedures included removing incomplete surveys (surveys that did not provide any information), duplicate surveys, and reconciling updated surveys. Closed-ended items were then exported to SPSS for descriptive analysis. Open-ended items remained in Excel for examination through content analysis.

2.1.4. Analysis

Responses to the closed ended portion of the survey were analyzed descriptively (frequencies, proportions) between November 2020 and March of 2021 in SPSS. Open-ended responses were subjected to qualitative content analysis in Excel (Hsieh & Shannon, 2005), a process whereby responses for each question were grouped by the “sameness” or “similarity” of the response. Four evaluators conducted reviews using a categorization scheme to review all open-ended responses. Content categories for open-ended questions were created based on expectations of appropriate responses with new categories added (as needed) based on actual findings. Each evaluator conducted a review of open-ended responses, coded responses based on the categorization scheme devised prior to analysis, then a “review of reviewers” session was conducted to validate the coding of all responses.

3.1. Results

3.1.1. Revised Treatment Practices

A summary of guidance reported by SOTAs for existing patients and new admissions is shown in Table 1. All 42 respondents reported permitting expansion of take-homes for existing patients and 69%(N=29) reported doing so for new admissions. Ninety-eight percent (N=41) of respondents reported permitting the use of remote counseling for existing patients through telehealth, with 90% (N=38) of respondents reporting this option in use with new admissions. In terms of counseling, 21% (N=9) and 12% (N=5) of respondents reported permitting the suspension of counseling requirements for existing and new patients, respectively, in their states. Regarding drug testing, 40% (N=17) of respondents reported permitting the temporary suspension of drug testing for existing patients, while 21% (N=9) reported this occurring with new admissions.

Table 1.

State Authority (N=42) guidance to OTPs in response to COVID-19 for existing and new patients in the early pandemic (through September/October 2020).

	For Existing Patients n(%)	For New Admissions n(%)
Permit more take-home methadone doses	42 (100%)	29 (69%)
Permit remote medical visits for methadone dose adjustment	35 (79%	N/A
Permit nurse practitioners or physician’s assistants to make methadone dose adjustments	25 (60%)	N/A
Permit remote counseling	41 (98%)	38 (90%)
Suspend counseling requirements	9 (21%)	5 (12%)
Suspend drug testing requirements	17 (40%)	9 (21%)

Notes:

⁽¹⁾At the time of the survey, SAMHSA take-home guidance was framed around stable vs. less stable patients and was silent about the distinction between existing patients and new admissions,

⁽²⁾Valid responses = 42 of 65 surveys sent (65%)

Regarding revisions to treatment practices for existing patients, 76% (N=32) of respondents reported allowing remote medical visits to adjust methadone doses. Another 60% (N=25) of respondents reported dose adjustments in their state were being conducted by nurse practitioners or physician assistants, which require a federal exemption from the regulations.

SOTAs were asked to respond to questions concerning how procedures were adjusted to meet the counseling, methadone dose adjustment, and alternative dose administration strategies for existing patients. The following responses reflect what was reported by SOTAs who reported adjusting treatment procedures/protocols.

Seventy-six percent (N=32) of 42 valid responses reported permitting the use of phone or video to review/adjust methadone dosage with existing patients in their state. Of those that reported permitting the use of phone or video to review/adjust methadone dosage with existing patients, 91% (N=29) of 32 valid responses reported the use of phone and video, and nine percent (N=3) reported the use of video only. Ninety-eight percent (N=40) of 41 valid responses also reported that the use of phone and video was the most common method for continuing counseling with existing patients. Of those that reported the use of phone and video to continue counseling with existing patients, 90% (N=37) reported using both phone and video to continue counseling with existing patients, eight percent (N=3) reported the use of video, and two percent (N=1) reported the use of phone only. Of the 42 valid responses reporting adjustments to methadone dispensing practices, 83% (N=35) reported the permitting the implementation of drive through pick-up methadone at their OTPs, 67% (N=28) reported the establishment of home delivery, while 21% (N=9) reported the institution of off-site mobile pick-up of take-home doses.

3.1.2. Social Distancing and Masking

All (N=42) respondents reported that their states have provided guidance to OTPs for keeping staff safe during the pandemic through the institution of social distancing, hygiene, and working remotely to provide treatment services. Nearly all respondents reported OTPs in their state instituted social distancing measures and staff masking mandates (95%/N=40 and 90%/N=38, respectively). Moreover, 74% (N=31) of respondents reported that OTPs allowed some staff to work from home.

3.1.3. Operational Review and Oversight

When asked in open-ended format about operational planning and review in their state during the pandemic, several mechanisms were noted for maintaining oversight of OTPs. Fifty-one percent of 41 respondents reported performing OTP reviews (e.g., virtual and live site visits) and 68% of 41 respondents mentioned ongoing communication with OTPs as part of their review process (e.g., scheduled calls, routine emails, scheduled reporting). In terms of OTP reviews, respondents cited continued review of Medicaid claims, remote inspections, review of practice modifications established during COVID-19, OTP certifications, and waivers.

3.1.4. Billing Practices

In response to open-ended questions about whether billing practices were revised in their states, 57% (N=21) of 37 respondents indicated that billing practices had changed during the pandemic, including payment for new services (10 SOTAs), new billing procedures for take-home medications (6 SOTAs), expansion of billing through Medicaid (5 SOTAs), new payment sources (2 SOTAs), and temporarily suspending billing (2 SOTAs). For example, of the respondents that reported including payment for new services, one state reported that an Executive Order was released requiring insurers to cover all medically necessary telehealth services at the same rate as in-person services. Some respondents reported that bundled rates were created in their state to ensure reimbursement for increased amounts of take-home medications as well as telehealth services.

3.1.5. Primary Benefits

When asked in open-ended questions about the primary benefits of the state policies associated with the pandemic, 100% of the 38 responding SOTAs reported that treatment service access, engagement, and retention were improved because of implementing pandemic-related policies. These SOTAs reported increased use of telehealth and reduced drop-out rates and missed treatment appointments. A few (8%/N=3) of 38 SOTAs also reported enhanced/revised regulations and coordination with official entities as a beneficial outcome. For these states, implementation of revisions to state regulations improved communication and coordination within the states for the delivery of treatment and utilization of resources. One state referenced disaster and pandemic planning as a benefit to the implementation of state policies associated with the pandemic and one state referenced enhanced visibility of OTP innovation and service creativity (“other”) as a beneficial outcome.

3.1.6. Primary Challenges

In response to an open-ended question concerning primary challenges with implementation of policies related to service delivery, over half (53%/N=20) of 38 responding SOTAs noted challenges with coordinating service delivery during the pandemic related to medication distribution and managing OTPs. When the pandemic occurred, respondents referenced OTPs not being prepared to deliver an increased number of take-home doses for significantly more patients, resulting in long lines and difficulty with scheduling remote appointments. Staff shortages also were cited as a reason for difficulties with medication distribution under revised protocols, including, drive-through pickup and home delivery. Respondents reported staff resignations, staff illness, and staff loss to other healthcare entities (e.g., private treatment organizations) as key reasons many OTP were short-staffed. In relation to managing OTPs, some states noted a lack of adequate space for social distancing.

4.1. Discussion

The COVID-19 pandemic was met with rapid federal and state response to relax a number of OTP regulations and practices in order to reduce the exposure to patients in OTPs to COVID. Emergency exemptions offered states new discretion in determining OTP patient stability and allowed them to substantially increase the number of take-home doses provided, deliver services remotely through telehealth, and suspend certain practices, such as drug testing. The current study examined changes in federal and state guidance and OTP practices in response to the COVID pandemic, from the perspectives of SOTAs responsible for OTP oversight. At the time of the survey, nearly all SOTAs reported their state permitted expanded take-home eligibility for existing patients. Most SOTAs also reported permitting remote counseling and methadone dose adjustment via telehealth.

SOTAs generally reported that federal guidance increased patient access, engagement, and retention. Increased take-home flexibilities were viewed as important for expanding access and continuity of treatment during the pandemic, with the majority of SOTAs stating that the revised treatment practices (e.g., expansion of telehealth, flexible medication dispensing practices) were beneficial. These regulatory flexibilities, many believe, promoted the continuation of treatment and successful patient outcomes during the pandemic.

Our findings reflect the practices of 42 responding states and jurisdictions, which are echoed in research on the perspectives of OTP staff on extending flexibilities for OTPs beyond the pandemic. Treitler and colleagues (2022) found that providers viewed the increased flexibilities as a tool to allow for more adaptable, patient-centered care (Treitler et al., 2022). A study by Hunter and colleagues (2021) with OTP providers and leadership found perceived benefits of these flexibilities, but also some apprehension due to changes in monitoring practices and reduced psychosocial services that could create potential detriment to quality of care and patient outcomes (Hunter et al., 2021).

There is limited research on the clinical impact of OTP practice changes during the pandemic, but the available data suggests that many patients do well under relaxed attendance requirements. One study at an OTP found that the pandemic saw a doubling of the number of methadone take-homes dispensed and similar rates of positive drug test results before and after the exemptions were initiated (Amram et al., 2021a). A report from a large OTP in Bronx, New York documented temporary suspension of drug testing and a dramatic increase in take-homes, reducing the number of patients with daily or near-daily dosing from 47.2% to 9.4% (Amram et al., 2021b). These authors described the experience as positive for patients and suggested decreasing reliance on toxicology testing in favor of more patient-centered metrics of engagement (Joseph et al., 2021). On the other hand, a study at an OTP in Minnesota found that the proportion of positive drug tests for opioids, benzodiazepines, and methamphetamine increased in July 2020 compared to July 2019, while methadone-negative tests increased (indicative of non-adherence to medication orders and possible medication diversion), suggesting that some patients may have fared worse under increased unsupervised dosing (Bart et al., 2021). However, the broader societal disruption of the pandemic and associated stressors are confounds that inherently limit before and after comparisons.

Findings from the present study shed light on SOTAs’ perspectives on changes in OTP practices during the pandemic, and also have implications for the future of methadone treatment in the US. While the pandemic was an unprecedented emergency, crises that can disrupt treatment delivery can come in many forms. Although there was some variation, in general states showed great flexibility in responding to the COVID-19 crisis. As described by McIlveen and colleagues (2022), some SOTAs moved very quickly to support OTPs in expanding access to take-home medication at the start of pandemic. Relaxing the federal regulations enabled states and OTPs to provide services in a manner that was more consistent with services provided for other health conditions. Importantly, the pandemic served as a catalyst for reconsidering some of the longstanding federal regulations governing methadone treatment. In November of 2021, SAMHSA announced that pandemic-era flexibilities would be continued for one year after the end of the public health emergency (as determined by the Secretary of Health and Human Services). More recently in December 2022, SAMHSA issued a Notice of Proposed Rule Making (NPRM) to permanently update the 42 CFR Part 8 regulations. Thus, the experience during the pandemic set the stage for broader regulatory reforms. A study using the CDC’s national mortality database showed a reduction in the percentage of methadone-involved overdose deaths relative to all drug overdose deaths from January 2019 to August 2021, providing some evidence that the expansion of methadone take home doses during the pandemic was not associated with a proportional increase in methadone overdose deaths (Jones et al., 2022).

The loosening of the prescriptive federal regulations leaves OTPs with much more discretion in delivering treatment services and determining patients’ take-home schedules. In a number of cases, SOTAs described how states instituted additional adjustments to state regulations and rules in order to improve treatment access and system efficiency (e.g., changes to Medicaid rules; mandating support for telehealth). However, in some cases misalignment between federal and state regulations can still serve as barriers to mounting a coordinated national response to rapidly evolving public health crises. Moreover, regulatory reform at the federal level will not supersede state regulations, which can potentially place additional constraints on OTPs, providers, and patients.

4.1.1. Study Limitations

Our study has some important limitations that should be mentioned. First, the survey was a one-time, baseline, web-based survey. Although the response rate was high, some SOTAs did not answer all questions, a common limitation with survey research. However, responding SOTAs represented over 90% of the nation’s OTPs and nine of the 10 largest cities in the United States. While many SOTAs responded to the optional open-ended items, there were some missing data on the questions. Secondly, although the survey questions were straightforward and had good face validity, as with any survey study it is possible that queries were misinterpreted or interpreted in different ways by different respondents. Finally given the many potential state characteristics, we did not conduct an analysis by state-level characteristics.

Despite these limitations, the study offers insights into practices utilized in OTPs in the early months of the COVID-19 pandemic from the perspective of SOTAs. It will serve as a baseline for future surveys on the impact of regulatory reforms.

Highlights:

• Methadone is an opioid agonist that is an effective treatment for opioid use disorder (OUD).

• During the pandemic, federal regulators relaxed several longstanding restrictions for opioid treatment programs (OTPs) and their patients.

• These regulatory flexibilities allowed OTPs to continue operations and meet the needs of patients while protecting public health.

• Changes permitted expanded eligibility for take-home medication and allowed counseling and medication management through telehealth.

• Increased take-home flexibilities were viewed as important for expanding access and continuity of treatment.

Abbreviations:

OTP

Opioid Treatment Program

SOTA

State Opioid Treatment Authority