The final session of the workshop aimed to review the presentations and discussions regarding potential legal and regulatory changes, as well as to seek reflections from people with a broad range of perspectives on the workshop discussions within a broader context of reforming drug policy and treatment for opioid use disorder (OUD).
LEGAL AND REGULATORY REFORMS
“For far too long, policy discourse on addiction has largely been directed to mediating conflict rather than developing and effectuating a consensus,” said Richard Bonnie, the Harrison Foundation professor of medicine and law and director of the Institute of Law, Psychiatry, and Public Policy at the University of Virginia. However, he said, presentations and discussions over the course of this workshop reflect a common understanding of the nature of addiction and the therapeutic benefits of methadone and reflect “support of a less restrictive and more patient-oriented approach to the treatment of opioid use disorder and the use of medications for opioid use disorder.” Moreover, he said, several workshop participants with legal expertise participating in the workshop noted “that the relevant federal agencies already currently have ample legal authority” to take the actions that are most urgently needed to facilitate a more effective and patient--
centered approach to the use of medication for OUD in general, and to methadone in particular.
Bonnie summarized six points discussed by several workshop participants with legal expertise (Bridget Dooling, Corey Davis, Matthew Lawrence, and Shelly Weizman, associate director of the Addiction and Public Policy Initiative at the O’Neill Institute for National and Global Health Law, Georgetown University Law Center), which were subsequently published after the meeting (Bonnie et al., 2022).1
Extending “take-home” flexibilities. In response to the COVID-19 public health emergency, the Substance Abuse and Mental Health Services Administration (SAMHSA) agreed to extend methadone take-home flexibilities for 1 year after the COVID-19 public health emergency expires while working on a permanent solution, said Bonnie. However, he noted that rulemaking is a time-consuming process that can become delayed or derailed during administrative transitions. “Our legal experts were of one mind in urging SAMHSA to couple its planned rulemaking with expeditious action to reauthorize current take-home flexibilities under the existing ‘opioid crisis’ public health emergency,” he said, assuming that a permanent solution will be much more flexible in allowing take-home access.
Using authority over public programs to check coverage barriers imposed by insurers. As was discussed by several participants during this workshop, insurer policies may interfere with patient–doctor relationships in employer-sponsored insurance, Medicaid managed care, and Medicare Advantage. Congress is currently considering parity reform legislation, which would give the Department of Labor more authority in relation to employer-sponsored insurance, said Bonnie, adding the Centers for Medicare & Medicaid Services (CMS) could do much to address insurance barriers in public programs. In particular, Bonnie said, “CMS should consider OTP [opioid treatment program] coverage in assessing Medicare Advantage network adequacy; should reevaluate and strengthen its risk adjustment model’s application to substance use disorders; and should collect and scrutinize data on barriers in Medicaid managed care. CMS has the authority to do all these things,” he said (Bonnie et al., 2022); CMS can also offer states a specific Medicaid demonstration opportunity to expand access to methadone under its section 1115 waiver authority. Such an initiative should prioritize access, quality, and integration into a state’s existing continuum of health and social services, said Bonnie.
Using existing federal authorities to incentivize states to enable expanded methadone access. One problem that was discussed in some detail is state policies relating to methadone access that are more restrictive than the federal policy, said Bonnie. This is a serious problem, he said; however, the federal government has tremendous leveraging tools at its disposal in
1 They are not meant to be viewed as formal recommendations of the National Academies.
situations of this kind. Specifically, it can tether certain incentives to block grants and other grant programs when state policies are more restrictive than the federal policy or when federal agencies want to incentivize states to undertake innovations. Bonnie suggested that this leveraging authority should be used more aggressively to “incentivize states to implement new models designed to expand methadone access, including in different populations (e.g., pregnant and parenting) and settings (e.g., prisons, jails, long-term care facilities, and inpatient substance use disorder treatment facilities).” He added that “federal agencies can also offer targeted technical assistance to states and providers to: 1) operationalize changes in the federal methadone regulatory framework, 2) implement federal parity rules, 3) adjust Medicaid reimbursement structures to align with best practices for care, and 4) rapidly translate new research into policy and practice” (Bonnie et al., 2022).
Using existing rulemaking authority to provide greater flexibility in the current regulations governing prescribing, dispensing, and treatment by OTPs. SAMHSA and the Drug Enforcement Administration (DEA) have the authority to mend most, if not all, of the regulations restricting methadone dispensing and prescribing by OTPs that critics of the existing regulations have proposed, said Bonnie. Examples include relaxing take-home limitations, dosing requirements on methadone, and toxicology screening requirements.
Using existing rulemaking authority to allow greater room for clinical discretion. The regulatory presumption should favor informed clinical judgment and respect the traditional orientation of the patient–clinician relationship, said Bonnie. Provisions that he suggested merit reconsideration include:
- Eliminating daily dose requirements.
- Expanding authority for otherwise authorized and registered prescribers to outside of OTPs. This can include expanding the types of facilities and programs that can provide treatment using methadone, including primary care, Federally Qualified Health Centers (FQHCs), certified community behavioral health clinics, mobile units, and harm reduction facilities.
- Eliminating mandatory eight-times-a-year toxicology screens.
- Updating criteria for take-home doses to meet patient needs and defer to the treating clinician.
- Allowing patients to access methadone at a pharmacy.
- Developing a specific regulatory framework for methadone in carceral settings with the goal of facilitating access.
Providing enforcement guidance on obligations imposed by the Americans with Disabilities Act (ADA) with particular attention to facilitating access to methadone in prisons and jails. Bonnie and colleagues added that
methadone patients’ civil rights should be a top enforcement priority among relevant federal agencies, including the Department of Justice’s Office of Civil Rights, U.S. Attorneys’ Offices, and the Department of Health and Human Services’ (HHS’s) Office of Civil Rights. Enforcement guidance is needed to explain the full extent of protections under the ADA2 and other applicable laws. Bonnie added that prisons, providers, or other entities found to be in violation of these laws should be investigated immediately.
EXPLORING OPPORTUNITIES TO REFORM METHADONE TREATMENT
Reform has to start with a bold, clear, and long-term strategic vision, said Weizman—perhaps a “methadone moonshot,” such as that suggested by Lawrence. Improving the system as it is now should be pursued in parallel with working toward long-term reform with intentional goals and sustained investment, she said, noting that this vision is in line with President Biden’s goal of universal access to medications for OUD by 2025, which he embraced in his State of the Union address.
A critical reform, according to Weizman, is a reconceptualization of OTPs. Even with incremental improvements, she said, an insufficient number of OTPs exist to meet the needs of patients. Different models and new paradigms for delivery of methadone are needed, which could include a range of solutions discussed at this workshop: a hub-and-spoke model, with OTPs, FQHCs, and/or community behavioral health centers serving as hubs; and pharmacies, hospitals, primary care providers, correctional facilities, or other providers serving as spokes where patients can receive care and treatment.
Alternatively, said Weizman, the buprenorphine model of prescribing and delivering medication could be adopted for methadone. “Whatever model is selected, it has to be part of a cohesive vision not only for methadone, but also for how we address addiction generally.”
Any new paradigm must be incentivized and supported by states and providers, using the many tools provided by the federal government, said Weizman. She suggested that Medicaid could facilitate reform by offering state Medicaid demonstration opportunities, waiver services, and alternative reimbursement structures. States and providers will need guidance on how to maximize these opportunities, she added; the entire system will need a deep commitment to technical assistance and financial support. Weizman also advocated tethering access to federal funds to a requirement that states
2 Following this workshop, the U.S. Department of Justice issued guidance on protections under the American with Disabilities Act. To learn more, go to https://www.ada.gov/opioid_guidance.pdf (accessed June 12, 2022).
cannot use methadone as grounds for removal of children, termination of parental rights, or engagement of child protective services.
Underscoring the importance of regulatory reform for methadone in correctional facilities, Brendan Saloner, Bloomberg Associate Professor of American health and addiction and overdose at Johns Hopkins School of Public Health, noted that the Medicaid Reentry Act would provide funding to provide treatment for people in prisons as well as a bridge back to the community, but as part of President Biden’s Build Back Better framework, faces an uncertain future in Congress.
To get started on these reforms, Weizman urged (1) retaining COVID-19 flexibilities; (2) moving from a legal framework guided by rigid regulations to a clinical approach (e.g., starting with daily dose and counseling requirements); and (3) expanding the authority for otherwise authorized and registered prescribers to dispense at remote locations. She advocated prioritizing high-risk populations, such as people in corrections and pregnant and postpartum women.
Weizman added that a bridge is needed to nimbly connect research to policy, which again will require technical assistance. For example, she noted that there has been substantial research on the consequences of the COVID-19 regulatory flexibilities, targeted research on the best way to approach illicitly manufactured fentanyl, and research on population-specific best practices.
REFORMING METHADONE TREATMENT WITHIN THE BROADER CONTEXT FOR IMPROVING ACCESS TO MEDICATIONS FOR OPIOID USE DISORDER
Individual workshop participants discussed several concrete next steps that could improve access to methadone, but would not require regulatory changes or new legislation. Weizman emphasized that implementation will require using a combination of different policy and legal tools. Some states and local governments are ready, but others will need to be pushed, she said. It is not done simply through the stroke of a pen, she said. “I think it’s a matter of the right combination of carrots and sticks and incentives and mandates that is going to get it done.”
Incorporating All Voices at Every Stage of the Reform Process
Any reforms under consideration should incorporate at every step of the way the perspective of people with OUD and those receiving methadone, including people with long histories in the system, activists, and even people who use drugs but are not in treatment, said Weizman. Joy Rucker, co-founder and former executive director of the Texas Harm Reduction
Alliance, agreed, saying she supported having people from the Urban Survivor’s Union,3 a grassroots organization of people who use drugs, participate in decision making about how methadone should be distributed. She referred to the organization’s Methadone Manifesto that was co-authored by people with lived experience. “The best way to create a system and make a policy change is to have the people that are most impacted and affected by these policies relate to you exactly what the impact of the policies [is] on their day-to-day lives,” said Rucker.
Redefining Success in Methadone Treatment
As a person who has been on methadone maintenance for nearly 20 years, David Frank, medical sociologist at the New York University School of Global Public Health, has a unique perspective on the disconnect between the way methadone is administered and how it is actually used. Methadone enabled Frank to get a bank account, maintain a job, and eventually to earn a Ph.D., yet while he appears to be one of methadone’s great success stories, he said he is not pursuing abstinence-based recovery and has never been compliant with the rules of his clinic. He suggested that success in methadone treatment needs to be redefined, and policies reconsidered to enable non-abstinence-based recovery.
Frank said he started using methadone as a way to continue using opioids, but avoid the difficulties and risks associated with criminalized opioid use. He said he continues to use drugs, including heroin, although less often and in a safer way than before he started methadone maintenance. But to do this, he said, “I have had to lie to counselors and doctors, restrict where I live to places that have access to clinics that aren’t testing for particular substances, and occasionally even fake drug tests.” Had he not employed these tactics, he said, he would have been forced out of treatment; he would have never been able to get his Ph.D. or begun working in the field if he was required to go to a clinic every single morning.
Frank noted that many people benefit tremendously from methadone, but are not interested in becoming abstinent. In a recent study, he found that while some people want to achieve abstinence, many people were more interested in stability and getting out of a chaotic lifestyle than in abstinence. Some wanted to continue using heroin or other drugs, but wanted to make sure they were never in withdrawal (Frank and Walters, 2021). He mentioned one person he spoke to as part of his dissertation who had completely stopped using heroin, but was required to come to the clinic every day because he continued to smoke marijuana and use alcohol. Frustrated
3 For more information on the Urban Survivor’s Union, go to https://ncurbansurvivorunion.org/national-usu (accessed May 4, 2022).
with this requirement and unhappy with the treatment he received at the clinic, he quit and died of a fentanyl overdose shortly thereafter.
Frank advocated moving away from the punitive focus on abstinence and embrace policies that enable people who continue to use drugs to stay in methadone and receive take-home doses, as they often are allowed with buprenorphine. John Brooklyn, clinical associate professor of family medicine and psychiatry at the University of Vermont (UVM) Larner College of Medicine and a physician expert in the UVM Center on Rural Addiction, added that as someone who treats thousands of people with methadone, his first question as a doctor is “what is your goal?” For some it is relief from pain, he said, while others wish to reduce their use or achieve abstinence. The goal may change over time, he said, but the policy of the program may not align with the patient’s wishes. If a program works with the patient, meets them where they are, and takes their goals as well as safety into consideration, Brooklyn believes people can be very successful.
Rucker echoed Frank’s and Brooklyn’s comments, adding, “We need to let people define what their recovery looks like.” Rucker also has lived experience with methadone as well as with suboxone and abstinence. The stigma associated with methadone use can be crippling and could be addressed by allowing people to pick up their medication in pharmacies rather than standing in line at a methadone clinic, she said. She recalled traveling long distances to a methadone clinic far from her home or work simply so she could have some anonymity. Rucker also opposed mandatory counseling and advocated delivery of opioid treatment to incarcerated people as well as continuation of that treatment upon release.
“Methadone has been used as a social control mechanism throughout the years and that is why we have all these barriers to access,” she said. “That is what needs to change.” Frank agreed, adding that the criminalization of methadone maintenance should be viewed in the context of the war on drugs and prohibition.
Providing Methadone through a Hub-and-Spoke Model
Vermont has established opioid treatment programs using a hub-and-spoke model, said Brooklyn. The hubs are centers of excellence located throughout the state that provide high-intensity, medication-assisted treatment connected to spokes in the community, which provide maintenance medication assisted treatment and other services, said Brooklyn. He said the hubs also have robust transfers back and forth from inpatient, residential situations, obstetricians, and the criminal justice system.
One of the challenges in Vermont and elsewhere in the United States is providing methadone to rural communities, said Brooklyn. He initiated a project where patients were given a secure medication dispenser and a
video app that enabled them to record themselves taking their medication, with the videos time and date stamped. This video-direct observed therapy approach has been used successfully for patients with tuberculosis, he said.
The project enrolled 58 patients, 41 of them on methadone and 17 on buprenorphine. Brooklyn said at the start of the project, 83 percent of the people in the study did not meet take-home criteria. Of the 15,581 videos received, only one showed evidence of diversion, he said. After 1 year, 98 percent of the participants were still in treatment, prosocial activities had increased from 79 percent to 93 percent, and patients reported weekly travel time savings of 5.5 hours and weekly travel cost savings of $72.00.
The Vermont program addresses both providers’ fears about diversion, drug use, and induction safety, while also addressing patients’ fears about missing work, clinic, or school, their lack of transportation, and concerns about stigma, said Brooklyn. He suggested that this model could be extended to rural communities throughout the United States. However, several workshop participants with lived experience expressed deep concerns about the use of video-direct observed therapy.
Integrating Opioid Treatment Fully into the Medical System
In other fields of medicine, providers and researchers work collaboratively and there is constant peer review, said Brooklyn. OTPs, in contrast, operate as fiefdoms and there is little peer oversight, he said. Perhaps, said Brooklyn, opioid treatment should be integrated fully into the medical system so that there is collaboration across disciplines, rather than living in a siloed world where the treatment received depends on the clinic administering the treatment. With national standards, such as those that exist for the treatment of diabetes or cancer, peer review could help mitigate poor treatment, he said. “Methadone programs should provide a full range of services; and if they can’t, they should be integrated into other areas that can help people become healthy humans and not just be patients on methadone,” said Brooklyn.
A Comprehensive Statewide Approach
The state of New York, which has more than 96 OTPs serving 40,000 patients, has already begun efforts to extend COVID-19 flexibilities, said Chinazo Cunningham, commissioner of the New York State Office of Addiction Services and Supports. Funding for 35 mobile methadone units linked to brick-and-mortar OTPs is planned, she said. They are also encouraging the use of telehealth and expanding a methadone delivery program started during the pandemic. To further improve access, they have added bundled payment rates to existing ambulatory patient group rates that
they hope will reduce the number of visits required for medication administration by paying programs for their services by the week regardless of whether a patient comes in for medication administration.
To reach one of the highest risk populations—people who are incarcerated in correctional facilities—New York Governor Hochul signed a law mandating that all jails and prisons across the state offer all three approved medications for opioid use disorder. Implementing the law will be challenging and will require funding from the state or opioid settlement money or other sources to enable implementation, said Cunningham. She added that they are also hoping to change the ability of skilled nursing facilities, residential treatment programs, and long-term care facilities to store and administer methadone.
Cunningham said her agency is also starting a harm reduction division to look at how treatment is implemented. “We need to focus on keeping people alive,” she said.
Modernizing the Data Collection Process
Alongside regulatory changes needed across the methadone treatment landscape, Saloner also emphasized the need to modernize the data collection process. “There are huge holes in our understanding of access and quality of care for methadone patients,” he said, as well as a lack of answers to fundamental questions such as how many people want access but cannot get it, how many new patients begin methadone treatment each year, and what the rates of retention are.
Saloner listed four elements of a modernized data strategy:
- Improving the National Survey of Drug Use and Health, which although it now collects data on use of methadone, misses critical populations as it does not reach into correctional facilities or interview people experiencing homelessness.
- Collecting methadone treatment use data as part of the national Treatment Episode Data Set (TEDS).4
- Undertaking a national longitudinal cohort study of methadone patients to better understand factors related to recovery outcomes and retention in treatment.
- Planning for data collection outside of OTPs, for example, at mobile units, long-term care facilities, office-based settings, pharmacies, and, as mentioned above, correctional facilities.
4 To learn more about TEDS, go to https://www.samhsa.gov/data/data-we-collect/teds-treatment-episode-data-set#teds_a (accessed May 4, 2022).
Understanding the Real-World Impact of Policy Interventions
While many studies have shown that methadone is effective, there is less known about how a changing policy environment would affect real-world populations, said Saloner. “We need to have a subtle and nuanced understanding of how specific policy interventions are saving lives and having an impact on other kinds of socially important metrics.”
“We have got the momentum going for policy change,” said Bonnie. From the bottom up, this will mean formulating not only policy experiments, but also the research that goes along with that. The discussions of this workshop provide a good starting point from which people can be brought together to devise a sensible research strategy. The top-down part, he said, relates to what the Office of National Drug Control Policy (ONDCP) and the White House will do next and how they will leverage their authority to move forward. Alan Leshner concurred, calling this a “landmark moment.” “It is the first time we have had ONDCP, SAMHSA, other parts of HHS, and [the] DEA all saying we need to expand access and address disparities.”
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