Tens of thousands of Americans die of an opioid-involved overdose each year, while almost 10 million grapple with an opioid use disorder (OUD). One of the most effective treatments available is methadone, which reduces overdose and illicit opioid use, encourages treatment retention, cuts engagement in criminal activity, and facilitates more stable employment. However, as of 2022, only about a quarter of people with an OUD were taking any approved medication. When it comes to methadone, the biggest barrier to uptake is the anti-competitive system of red tape that limits access and undermines quality of care.

Methadone overregulation happens at both state and federal levels, making the life-saving drug incredibly difficult to access even though it is the best option for many people. In the United States, healthcare providers cannot prescribe methadone for an OUD, and pharmacies cannot dispense it. Instead, it is only available through highly restricted and restrictive specialty clinics called opioid treatment programs (OTPs). These clinics often require near-daily in-person visits to take the medication under supervision, making it especially difficult for people who must travel long distances to the nearest OTP.

Supporters of this OTP-only system claim the clinics are the sole safe and effective way for people with an OUD to access methadone, saying they encourage people to stay in treatment and prevent medication misuse and diversion. Detractors suggest that the system creates a near-monopoly that perpetuates access disparities while reducing patient choice and hindering the competition that can improve care. Here, we discuss what does and does not work in the current OTP system and describe how policy could improve access and care quality.

The Benefits of OTPs

Supporters of an OTP-only system claim that its comprehensive nature and strict structure is the only way to ensure treatment engagement, improve treatment outcomes, and keep communities safe. While some evidence suggests that people taking methadone are more likely to stay in treatment than those taking buprenorphine, much of the research is mixed—suggesting considerable individual variation in medication and program needs. For example, some individuals with an OUD find supervised, on-site dosing helpful, and some cite insecure housing and other circumstances that make it difficult to store take-home doses safely or conveniently.

When it comes to preventing diversion, research suggests that when methadone and other medications for OUD (MOUD) are diverted, it is usually to help someone avoid withdrawal symptoms or self-medicate when they cannot access treatment. Furthermore, there was no increase in diversion when the government relaxed MOUD restrictions during the COVID-19 pandemic.

The Drawbacks of an OTP-Only System

Not only does the OTP-only system appear unnecessary for preserving community safety, the programs are not appropriate for every person who could benefit from taking methadone.

First, although proponents claim that comprehensive, integrated care is a cornerstone of OTPs, the reality can fall short of optimal care. While OTPs must offer counseling, their lack of consistent quality controls often results in excessive patient-to-provider ratios and sub-therapeutic sessions. Additionally, roughly half of states mandate set counseling schedules—a major deterrent to people in treatment, many of whom report a desire for tailored programming. Furthermore, most OTPs do not offer the wraparound services many individuals need to improve treatment retention (e.g., child care, transportation, housing).

Second, policies in many states interfere with the patient-provider relationship when it comes to medication-related decisions. For example, some states limit the maximum dose a person can receive, while others require a goal to eventually stop methadone or mandate treatment discontinuation for any illicit substance use. Not only do such regulations undermine healthcare provider expertise, they also go against evidence-based recommendations. Similarly, states often place tight restrictions on take-home eligibility, setting guidelines based on time in treatment rather than an individual’s stability and needs. The need to visit the clinic almost daily for supervised dosing has been shown to disrupt people’s attempts to engage with other important parts of their lives and recovery, such as holding a job or caring for a family.

Third, heavy regulation of OTPs themselves—including medication storage requirements, zoning restrictions, and on-site provider mandates—often prevents new clinics from opening and hinders established clinics from opening new branches or mobile units. The United States has only about 2,100 OTPs, meaning almost 80 million Americans live in a county (often rural) that lacks methadone access. Consequently, OTP clients currently travel an average of 45 minutes each way for their appointments despite the fact that increased travel time leads people to miss doses, which increases their likelihood of using illicit opioids, experiencing an overdose, or quitting treatment altogether. Furthermore, the current regulatory system disincentivizes active and ongoing competition between clinics, leading private equity firms to acquire many OTPs. This effectively concentrates the market around interests that may not align with those of patients or providers. In fact, OTP market consolidation not only fails to improve access, it also appears to undermine patients’ ability to exercise choice as a way of shaping care to optimize engagement and satisfaction.

Building a More Diverse, Patient-Centered System

Improving OUD treatment access and outcomes in the United States requires OTP system improvements as well as alternative options.

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