University of Pennsylvania ScholarlyCommons Issue Briefs Leonard Davis Institute of Health Economics 1-27-2022 Lowering the Barriers to Medication Treatment for People with Opioid Use Disorder: Evidence for a Low-Threshold Approach Shoshana V. Aronowitz University of Pennsylvania Czarina Navos Behrends Margaret Lowenstein University of Pennsylvania Bruce Schackman Janet Weiner University of Pennsylvania Follow this and additional works at: https://repository.upenn.edu/ldi_issuebriefs Part of the Health Law and Policy Commons, and the Health Services Research Commons Aronowitz, Shoshana V.; Behrends, Czarina Navos; Lowenstein, Margaret; Schackman, Bruce; and Weiner, Janet. Lowering the Barriers to Medication Treatment for People with Opioid Use Disorder: Evidence for a Low-Threshold Approach. LDI Issue Briefs. 2022; https://ldi.upenn.edu/our-work/research-updates/lowering-the-barriers-to-medication-treatment-for- people-with-opioid-use-disorder/ LDI briefs are produced by LDI's policy team. For more information please contact Penn LDI at pennldi- info@wharton.upenn.edu This paper is posted at ScholarlyCommons. https://repository.upenn.edu/ldi_issuebriefs/154 For more information, please contact repository@pobox.upenn.edu. Lowering the Barriers to Medication Treatment for People with Opioid Use Disorder: Evidence for a Low-Threshold Approach Abstract Overdose deaths have reached unprecedented levels in the U.S., despite effective medications to treat opioid use disorders (OUDs). Because the regulatory and administrative barriers to treatment are high, only about 11% of people with OUD receive effective medications, which include buprenorphine, methadone, and naltrexone. In response, clinicians and advocates have looked to a “low-threshold” approach that reduces the stigma surrounding effective medications and facilitates their use. This brief summarizes the barriers to treatment, the evidence on the low-threshold approach, and areas for future research. The evidence suggests that low-threshold approaches can increase access to treatment, with outcomes comparable to high-barrier, standard care. Policymakers, providers, and payers should lower the barriers to medication treatment through regulatory flexibility (including telehealth prescribing), and harm reduction strategies that de-emphasize abstinence and place a priority on initiating or re-initiating treatment whenever and wherever individuals are ready to do so. Keywords overdose, opioid, opioid epidemic, substance use Disciplines Health Law and Policy | Health Services Research Comments LDI briefs are produced by LDI's policy team. For more information please contact Penn LDI at pennldi- info@wharton.upenn.edu License This work is licensed under a Creative Commons Attribution-No Derivative Works 4.0 License. This brief is available at ScholarlyCommons: https://repository.upenn.edu/ldi_issuebriefs/154 January 2022 Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV ISSUE BRIEF Lowering the Barriers to Medication Treatment for People with Opioid Use Disorder Evidence for a Low-Threshold Approach Shoshana V. Aronowitz, PhD, MSHP, FNP-BC, Czarina Navos Behrends, PhD, MPH, Margaret Lowenstein, MD, MPhil, MSHP, Bruce R. Schackman, PhD, MBA, and Janet Weiner, PhD, MPH Overdose deaths have reached unprecedented levels in the U.S., despite effective medications to treat opioid use disorders (OUDs). Because the regulatory and administrative barriers to treatment are high, only about 11% of people with OUD receive effective medications, which include buprenorphine, methadone, and naltrexone. In response, clinicians and advocates have looked to a “low-threshold” approach that reduces the stigma surrounding effective medications and facilitates their use. This brief summarizes the barriers to treatment, the evidence on the low-threshold approach, and areas for future research. The evidence suggests that low- threshold approaches can increase access to treatment, with outcomes comparable to high-barrier, standard care. Policymakers, providers, and payers should lower the barriers to medication treatment through regulatory flexibility (including telehealth prescribing), and harm reduction strategies that de-emphasize abstinence and place a priority on initiating or re-initiating treatment whenever and wherever individuals are ready to do so. INTRODUCTION constraints. In response, clinicians and advocates have looked to a “low threshold” approach that reduces the stigma With overdose deaths in the U.S. reaching unprecedented surrounding effective medications and facilitates their use. levels in 2021, it becomes increasingly urgent to find new ways to deliver effective treatments for opioid use disorders Methadone and buprenorphine are both opioids, and their (OUDs). We have effective medications1 to treat OUD, use for OUD treatment is often portrayed in a stigmatizing including buprenorphine, methadone, and naltrexone, but light as “trading one addiction for another.” But this ignores in 2020, only about 11%2 of people with opioid use disorder the clear and convincing evidence that treatment with received one of them. In addition, there are significant racial methadone or buprenorphine substantially reduces the risk disparities3 with Black patients less likely than white patients of an opioid overdose. In a comparative effectiveness study, to receive medication treatment across multiple settings. Wakeman et al.4 (2020) estimated that these medications The barriers to treatment are high, and they include are associated with a 76% decrease in the risk of overdose philosophical, regulatory, administrative, and clinical at three months and a 59% decrease at 12 months. Leonard Davis Institute of Health Economics | Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV 1 ISSUE BRIEF Buprenorphine stands out as the front-line treatment most in-person visits are more effective than telemedicine visits amenable to a low-threshold approach. Methadone is a in improving treatment outcomes or minimizing diversion. highly regulated medication that, by law, must be dispensed In a recent study, Han et al.7 (2021) found that although by a certified treatment program with frequent, often daily, the use of buprenorphine increased in the U.S. between in-person dosing when used to treat OUD; in contrast, in 2015 and 2019, misuse and diversion decreased slightly. In contrast, buprenorphine can be prescribed by office-based fact, the opioids hydrocodone and oxycodone were much clinicians with a specialized federal waiver after an in-person more commonly misused than buprenorphine, and are not examination. They must obtain additional training in order to subject to the same kind of regulatory requirements. A obtain a federal waiver to treat more than 30 patients at a National Institute on Drug Abuse report8 notes that most time. Naltrexone is an opioid antagonist (meaning it blocks of the diverted use of buprenorphine and methadone is the effects of opioids) and can be administered as a monthly for the purpose of controlling withdrawal and cravings for injection by clinicians without special training or permission. other opioids and not to get high. As such, diversion may However, naltrexone requires that patients be opioid-free reflect the need to increase, rather than restrict, access to for 7-10 days, making it difficult for many patients to initiate prescribed buprenorphine. treatment. Because of problems in induction and retention in treatment, questions remain5 about the real-world effectiveness of long-acting injectable naltrexone. DEFINITION OF LOW-THRESHOLD APPROACH During the COVID-19 pandemic, federal agencies Jakubowski and Fox9 (2020) recently described four guiding relaxed certain restrictions surrounding methadone and principles of low-threshold approaches to OUD treatment. buprenorphine. For methadone, they allowed telemedicine Together they help define the parameters of a medication- appointments and additional take-home doses for first, low-barrier approach. The principles include: established patients; for buprenorphine, they allowed clinicians to prescribe buprenorphine with no specialized 1. Same-day treatment entry and medication training for up to 30 patients and allowed prescribers to access. Given the ongoing risk of overdose, any initiate buprenorphine over the phone. treatment delay, whether due to waiting lists, prior authorizations, or clinical protocols, can be deadly. In this brief, we discuss barriers to treatment, the low- threshold approach, the evidence of its effectiveness, and 2. Harm reduction approach. This principle areas for future research. acknowledges the primacy and urgency of the goal of reducing the harm from substance use, rather than achieving abstinence. BARRIERS TO MEDICATIONS FOR OUD 3. Flexibility. Rigid protocols for in-person TREATMENT appointments, psychosocial counseling, meeting In a recent review, Mackey et al.6 (2020) synthesized the attendance, or drug testing all serve to reduce the evidence on barriers and facilitators of medications for likelihood that a person can successfully initiate and OUD. They identified four types of barriers: stigma related maintain medication therapy. to OUD medications, treatment experiences and beliefs, 4. Wide availability in places where people with logistical issues (time and costs as well as insurance and opioid use disorder go. This includes non-traditional regulatory requirements), and knowledge of OUD and the settings, such as emergency departments, syringe role of medications. Stigma was the most common barrier services programs and mobile treatment sites. among patients, while logistical issues were the most common barrier among providers and administrators. In assessing the current research, we note that many of the THE EVIDENCE existing barriers and regulatory hurdles are themselves not A low-threshold approach holds great appeal for its evidence-based, and have historical roots in misperceptions potential to increase rates of medication initiation and and stigma around substance use. Because methadone and retention in treatment and to reach people underserved buprenorphine are opioids, does the potential for diversion by the standard, high-barrier care. Below we review the and misuse warrant regulatory restrictions and in-person, evidence around each of the principles guiding a low- observed induction? Currently no evidence exists that threshold approach. Leonard Davis Institute of Health Economics | Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV 2 ISSUE BRIEF 1. Same-day treatment initiation can overcome 3. Flexibility in the regulations and the requirements delays in initiating buprenorphine without any around prescribing medication for OUDs increased negative effect on treatment retention. One access during a global pandemic. As described concern is that initiating medication at the first visit by Aronowitz et al.15 (2021), this included expanded might worsen retention rates, because patients use of telehealth for buprenorphine prescribing, and would not have already successfully completed increasing leniency by methadone programs in their follow-up visits that engage them in care. But in a take-home dose scheduling. Anecdotally, Wang et al.16 recent retrospective study at an urban health center, (2021) report that telemedicine increased access to Jakubowski et al.10 (2020) found that 30-day retention buprenorphine during the pandemic and is eliminating in treatment was high (80%) with no difference many traditional barriers to treatment, particularly for observed for patients receiving prescriptions at their individuals leaving incarceration, and people who use initial encounter. Given the lack of evidence that syringe services programs. Harris et al.17 (2022) report delaying prescribing has benefits for the patient and an 80% retention rate in buprenorphine treatment for the overwhelming evidence for the benefits of MOUDs patients transitioned from a street medicine program overall, the authors suggest that same-day treatment to telemedicine in Baltimore during the pandemic. with medication should become the standard of care. Also in Baltimore, Nordeck et al.18 (2021) report that a buprenorphine program consisting of pop-up clinics 2. Harm reduction can reduce the negative and van service to vulnerable populations shifted consequences of drug use, including overdoses to telehealth during the pandemic and had 30-day and transmission of HIV, HCV, and other infectious retention rates of 63%, similar to its in-person rates. diseases. The salient feature of harm reduction is the elimination of abstinence requirements to start These findings are consistent with longer-term or continue treatment for OUD. There is no evidence studies of loosening the requirements around that abstinence requirements are effective in retaining medication prescribing. In a rural treatment setting, patients in medication treatment or in improving Weintraub et al.19 (2021) reported that, over 3.5 outcomes of care. A number of studies suggest that years, a program prescribing medication treatment people with OUD who continue to use a variety of by videoconferencing achieved retention rates substances, including cocaine,11 methamphetamines, and toxicology results comparable to face-to-face and benzodiazepines, can be successfully retained treatment. In New York City, a 7-year longitudinal in medication treatment12 for their OUD and achieve study20 of “low threshold” treatment in a public similar outcomes as people who do not use these hospital clinic (including unobserved home induction substances. of buprenorphine and no psychosocial counseling requirement) found the practice to be safe and In a qualitative study, Kapadia et al.13 (2021) described feasible, with retention rates comparable to other the attributes of a nurse-led, primary care model centers. for buprenorphine treatment that emphasizes a broad harm reduction approach. They identified Low-barrier approaches are justified based on mixed three important aspects of implementation: an evidence21 about the effectiveness of requiring organizational mission to provide equitable and counseling and other behavioral interventions, with low-stigma health care; providing low-threshold multiple high-quality studies showing no added buprenorphine and other clinical and social services; benefit of counseling compared to buprenorphine and creating and retaining health care workers in maintenance alone. These findings have led expert the harm reduction culture and mindset. In another groups like the National Academy of Sciences, study, Kapadia et al.14 (2021) identified some of Engineering and Medicine1 to recommend that “lack of the challenges that independent medical practices availability or utilization of behavioral interventions is might face in delivering low-threshold buprenorphine not a sufficient justification to withhold MOUDs.” treatment, including funding shortfalls and building relationships across treatment programs, community organizations, the legal system, and government agencies. Leonard Davis Institute of Health Economics | Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV 3 ISSUE BRIEF 4. Making medications widely available in non- reported offering on-site methadone or buprenorphine traditional settings can increase access for treatment. marginalized populations, such as homeless individuals and people who inject drugs. The idea c. M obile treatment sites. In June 2021, the Drug is to meet people where they are, both in terms of Enforcement Administration31 allowed certified opioid location and their receptivity to starting medication treatment programs (that dispense methadone) to add treatment. These settings include: a “mobile component” without separate registration for those services. The new policy is designed a. Emergency departments (EDs). There is strong to encourage expansion of these programs into evidence that initiating buprenorphine in EDs improves communities that lack access. Weintraub et al.32 (2021) engagement in treatment and is cost effective. In a described a mobile buprenorphine program in which randomized trial, D’Onofrio et al.22 (2015) found that staff traveled to rural areas in a modified recreational ED-initiated buprenorphine treatment, compared vehicle equipped with medical, videoconferencing, to a brief intervention and referral, significantly and data collection devices. Three-month treatment increased treatment engagement and reduced self- retention and opioid use outcomes were similar reported illicit opioid use at 30 days. Further, the to those achieved in office-based settings. Mobile intervention was cost-effective and high-value,23 outreach and buprenorphine treatment have also been with continued effectiveness at 2 months24 when successful in engaging hard to reach populations, buprenorphine was continued in primary care. Despite such as justice-involved individuals33 (with a mobile this strong evidence, a new national study25 indicates van parked outside of Baltimore City jail) and those that buprenorphine was prescribed after just 1 in experiencing homelessness34 (at local shelters and 12 ED visits for opioid overdose. In a recent study, homeless encampment sites). Lowenstein et al.26 (2021) implemented and evaluated a multicomponent strategy designed to increase ED buprenorphine prescribing in an urban, academic RESEARCH QUESTIONS health system. The strategy, which included provider training, electronic health record decision support, While existing research on low-threshold medication integration of peer recovery specialists into clinical treatments, including same-day treatment, generally teams, and the use of automated prompts, was shows that outcomes are not worse than traditional care, associated with sustained increases in ED initiation of most studies are small, short-term, and lack appropriate treatment. controls. More rigorous comparative effectiveness and cost effectiveness studies are needed to fully evaluate the b. Syringe services programs (SSPs). Now legal in 33 effects on a broad range of outcomes including retention states, SSPs are an important setting for reaching in treatment and overdose rates, as well as quality of life, people who inject drugs. A number of programs housing, employment, criminal justice involvement, and now initiate buprenorphine onsite. In one study, family considerations. Studies should avoid a sole focus on Bachhuber et al.27 (2018) found that retention abstinence outcomes, which is inconsistent with the harm rates for buprenorphine treatment in a Philadelphia reduction principle of low-threshold treatment, and may not SSP were comparable to rates achieved in more reflect patients’ own goals for their treatment. traditional settings. In Seattle, Hood et al.28 (2020) found that an SSP was an effective point of entry As Nunes et al.35 (2021) notes, the abrupt relaxation of for a co-located buprenorphine treatment program, regulations around medications for OUD represents a with sustained retention and reductions in opioid large natural experiment, one that could yield valuable use, despite patients who had housing instability information on the need for in-person visits, urine toxicology, and polysubstance use. Recently, Jakubowski and psychosocial counseling. Do initial and recurrent in- et al.29 (2021) described the implementation of person visits increase patient engagement, motivation, buprenorphine services in eight SSPs in New York and retention? When and for whom does psychosocial City, and recommended ways to facilitate treatment counseling serve to improve outcomes with medication through infrastructural support, training, and staffing. treatment, and when does it function as a barrier? These are Despite these successes, only 11% of SSPs30 in 2014 empirical questions that warrant further study. Moreover, Leonard Davis Institute of Health Economics | Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV 4 ISSUE BRIEF policy changes during the pandemic, such as allowing take-home doses of methadone, are designed to increase access to treatment. Understanding the actual effects of these changes on access, ABOUT LDI outcomes and costs, both intended and unintended, will be critical as policymakers debate making them permanent. Since 1967, the University of Pennsylvania’s Leonard Davis Institute of In addition, the impact on access to care for different populations Health Economics (Penn LDI) has been the needs to be considered. There are longstanding equity concerns in leading university institute dedicated to access to different treatments for racial and ethnic minorities; for data-driven, policy-focused research that example, white patients are far more likely to receive buprenorphine improves our nation’s health and health in office-based settings, while Black patients are more likely to care. Penn LDI’s priority areas include receive treatment in highly-regulated methadone clinics with long (1) health care access and coverage; waiting lists and burdensome demands on patients. Research is (2) health equity; (3) improving care for needed to analyze the effects of low-barrier care on addressing older adults; (4) opioid epidemic; and (5) these known disparities. population health. Penn LDI connects all twelve of Penn’s schools, the University In addition to further studies of treatment in EDs, SSPs, and mobile of Pennsylvania Health System, and the settings, there are many unanswered questions about the optimal Children’s Hospital of Philadelphia through use of telemedicine to make medication treatment of OUD more its more than 300 Senior Fellows. widely available. Providers need evidence to inform clinical protocols about how often to interact with patients, how best to monitor Learn more at ldi.upenn.edu. use and retention in care, and when to see patients in person. @PennLDI Insurers also need evidence to design and implement appropriate reimbursement. Are there characteristics or patient factors that can distinguish patients that would benefit from one approach or another? How and where do people who use drugs want to receive ABOUT CHERISH medication treatment, and what would encourage them to do so? The Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV (CHERISH) is POLICY AND PRACTICE IMPLICATIONS a multi-institutional Center of Excellence, funded by the National Institute on Out of necessity during the pandemic, policymakers lowered Drug Abuse. The Center’s mission is to barriers to medication treatment for OUD. With more than 100,000 develop and disseminate health economic people dying of an overdose in the past year, the urgent question research on healthcare utilization, health is whether to keep them lowered permanently, or even to further outcomes, and health-related behaviors relax regulations. The evidence suggests that expanding telehealth that informs substance use disorder options for buprenorphine and increasing flexibility for methadone treatment policy and HCV and HIV care of prescribing and dispensing have expanded access to medication people who use substances. To increase treatment, and warrant continuation. Given the effectiveness of the impact of this research, CHERISH medications and the depth and breadth of the treatment gap, supports research conducted at the federal and state policymakers should cast a critical eye on the rules individual, system, and community levels. and regulations that reduce access, and promote a low-threshold The Center is a collaboration among approach that could facilitate treatment for the vast majority of Weill Cornell Medicine, Boston Medical people at high risk for overdose or death. Center, Boston University School of Public While regulatory changes are consistent with some of the principles Health, the University of Pennsylvania, of low-threshold treatment, they are only a part of a broader and the University of Miami Miller School approach that seeks to directly address stigma as well as logistical of Medicine. barriers. Implementing low-threshold treatment more broadly will require providers and payers to embrace clinical paradigms that de- Learn more at cherishresearch.org. emphasize abstinence and place a priority on initiating or re-initiating @CHERISHresearch treatment whenever and wherever individuals are ready to do so. Leonard Davis Institute of Health Economics | Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV 5 ISSUE BRIEF REFERENCES 1.National Academies of Sciences, Engineering, and 14.Kapadia, S.N., Griffin, J.L., Waldman, J., Ziebarth, 25.Chua, K.P., Dahlem, C.H.Y., Nguyen, T.D., Brummett, Medicine. (2019). Medications for Opioid Use Disorder N.R., Schackman, B.R., & Behrends, C.N. (2021). C.M., Conti, R.M., Bohnert, A.S., Dora-Laskey, A.D., Save Lives. Washington, DC: The National Academies The experience of implementing a low-threshold Kocher, K.E. (2021). 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Journal of General Internal Medicine, 36(7), jsat.2020.108196 1898–1905. https://doi.org/10.1007/s11606-020- 06409-6 Leonard Davis Institute of Health Economics | Center for Health Economics of Treatment Interventions for Substance Use Disorder, HCV, and HIV 6