To Save Lives From Opioid Overdose Deaths, Bring Methadone Into Mainstream Medicine


Eliza was in her mid-twenties and living on the street with an opioid use disorder (OUD) when she became pregnant. She enrolled in a methadone program and was doing well despite requirements to attend a clinic every day for her methadone. But after Eliza gave birth, she moved into a family shelter that was far from the methadone clinic. In the midst of a pandemic, caring for a newborn and breastfeeding, Eliza had to take two crowded trains—with an unvaccinated baby—to reach the clinic almost daily because there were no methadone clinics near the shelter. Eliza was forced to risk the health of herself and her baby to access a medication treating her chronic medical condition. As many patients before her have described, methadone treatment’s strict visit requirements became a form of “liquid handcuffs.” The current inflexible model of methadone delivery can inhibit autonomy, stifle treatment capacity, and perpetuate stigma among an already marginalized population. In the wake of the COVID-19 pandemic, US lawmakers are considering reforming methadone treatment. In this post, we call for expanding methadone to office-based settings as a critical step towards overdose prevention and improving the lives of patients with OUD. These changes could start a new chapter in the treatment of OUD.

Methadone Regulations Remain Inflexible To Patient Needs

Methadone is the oldest medication for the treatment of OUD with decades of science supporting its effectiveness in improving the health of people with OUD, including during the current fentanyl crisis. Yet the federal regulation of methadone treatment has remained largely unchanged for the past fifty years. The structure of methadone treatment, which must be delivered at licensed opioid treatment programs (OTPs), starkly contrasts with the outpatient treatment of other chronic medical conditions in the US. Patients receiving methadone at an OTP must report a minimum of six days per week for medication administration during the first 90 days of treatment, which frequently interferes with employment, childcare, and other daily priorities. Allowance of take-home medication slowly increases thereafter only if certain requirements are met. Patients may additionally need to wait on long public lines, complete routine urine screening that is often observed by clinic staff, and participate in mandated counseling on which medication receipt is often contingent, regardless of life circumstances or personal preference.

There has been little room for flexibility in the structure of methadone treatment. The regulations require that patients “earn take-home privileges,” waiting up to up to one year before receiving a 14-day supply of medication. If a patient becomes sick or plans any travel, it becomes a logistical nightmare to ensure an OTP clinician “grants” them take-home doses. Patients make tremendous sacrifices to obtain a lifesaving medication that should be viewed just like any other. Some patients prefer buprenorphine (another type of medication to treat OUD) to methadone, as buprenorphine can be prescribed more flexibly in office-based settings. However, not all patients respond to buprenorphine or have access to it. Clinicians and patients need access to effective alternatives. 

Methadone Regulations Hurt Marginalized Communities

Established in 1972 during the Nixon Administration, the OTP model for methadone treatment was largely motivated by fears that patients would sell their methadone (the 1974 methadone legislation was initially named the Diversion Control Act). Influenced by racist views of the heroin epidemic of the 1970s and journal articles that solidified the relationship between methadone and crime reduction among young, Black men, federal regulations prioritized social control of deviance rather than the promotion of health. This history–which harms mostly minoritized communities–continues to limit the acceptability and quality of methadone treatment.

Methadone’s inflexible treatment structure–daily dosing, routine urine screens, often mandated counseling–creates an additional system of punitive treatment and control of poor and Black and Latinx communities who have been inordinately impacted by the war on drugs. Furthermore, due to a legacy of strong community stigma and resistance against the opening of new clinics, OTPs have been further siloed and disproportionately located in Black and Latinx communities, who have historically had less power to resist. Whiter and wealthier communities, on the other hand, are more likely to have access to office-based buprenorphine, which is less stigmatized and not as strictly controlled.

The current regulations also reduce access to methadone within suburban and rural communities. There are fewer than 1,700 OTPs within the US, and many rural and suburban areas lack methadone treatment services. There is no OTP in the entire state of Wyoming, and there are just three OTPs in North Dakota and only one in South Dakota. Community opposition, financial barriers, staffing, and overlapping federal, state, and local regulations prevent OTP expansion despite rising treatment need. The average estimated drive time for people living in rural areas to their nearest OTP is six times greater than those living in urban areas. Many racial minorities and rural patients access care at federally qualified health centers (FQHCs), yet according to a 2018 survey, only sixteen percent of FQHCs dispense methadone for OUD.

COVID-19 Changes To Methadone Regulations

Patients, providers, researchers, and government officials have advocated for more flexible methadone treatment for decades. A 1983 Reagan administration review to reduce burdensome regulations concluded that OTP regulations “have not kept pace with the state of the art and are too inflexible to allow adequate treatment.” Only a global pandemic has managed to provoke the most significant regulatory change surrounding methadone in the US since 1974. 

On March 16, 2020, to prevent the spread of COVID-19, the Substance Abuse and Mental Health Services Agency (SAMHSA)—one of the three federal agencies charged with methadone regulation—exercised its regulatory discretion and released a waiver allowing patients, based on deemed “stability,” to receive up to 14 or 28-days of take-home medication much faster than they would have otherwise been eligible for such take-homes under existing regulations. Emerging research has demonstrated support for these flexibilities among patients and providers, while evidence of increased methadone overdose or diversion during COVID-19 has not emerged.

In response to early positive reactions regarding the take-home flexibilities, SAMHSA released a statement in November 2021 stating the take-home medication waiver would be extended for an additional year “while working towards a permanent solution.” Yet many individual OTPs have chosen to not implement SAMHSA’s waiver at all or have already returned to daily dosing (partially due to financial incentives that benefit in-person dosing). Even though research has demonstrated that patients prefer increases in take-homes, and data on longer take-homes points to improved retention in care, changes in take-home medication regimens have not been widely adopted.

Improving Methadone Treatment Long-Term: What SAMHSA Should Do

The federal laws and regulations governing methadone have long been viewed as inflexible. However, recent scholarship following the swift changes made to methadone regulation during COVID-19 are challenging this view. An April 2021 George Washington University Regulatory Studies Center report reveals that SAMHSA has the legal authority to “extend the flexibility granted during the COVID-19 public health emergency without additional authorization from Congress.” Statutes within laws approved by Congress often leave key decisions to the regulatory agencies charged with enacting the law. In other words, SAMHSA could take action without Congressional approval.

First, given the urgency of addressing the ongoing overdose epidemic, SAMHSA should fully utilize its discretion to make increased availability of take-home methadone permanent and encourage individual OTPs to follow suit. SAMHSA could also issue a guidance document clarifying that methadone treatment does not always need to be paired with urine drug screening and behavioral counseling. Rather, these tools can instead be offered when deemed beneficial to the patient. Second, SAMHSA, in collaboration with the Drug Enforcement Administration (DEA), should explore issuing a waiver that would allow health care providers to prescribe methadone outside of the OTP setting, similar to the x-waiver for buprenorphine.

Improving Methadone Treatment Long-Term: What Congress Should Do

Although permanent increases in take-home methadone would be a step in the right direction, the time is ripe for policymakers and health systems to rethink how methadone regulations can be further improved. In December 2021, US Congressman Donald Norcross (D-NJ) introduced H.R.6279, also known as the Opioid Treatment Access Act of 2022. The Opioid Treatment Access Act has bipartisan support and would give statutory authority to:

  1. Allow pharmacy-based dispensing and office-based prescribing of methadone outside of OTPs to physicians board-certified in addiction psychiatry or addiction medicine.
  2. End registration requirements for mobile methadone vans connected to OTPs.
  3. Modestly increase flexibility surrounding take-home methadone requirements.

The move toward a pharmacy and office-based model would allow methadone treatment to be integrated into the rest of the healthcare system. This would be life-changing for patients, many of whom would no longer have to drive far distances or use public transportation to travel to an OTP on a daily basis. Pharmacy dispensing of methadone would also benefit patient privacy and reduce community resistance to methadone as it would not require the opening of new facilities. Black and Latinx communities would also have a local alternative to the inflexible OTP model.  A pharmacy or office-based model would make it easier for patients to initiate employment, which has been shown to correlate with treatment adherence, take care of their families, and attend medical appointments. The bill would also modestly reduce the wait times to receiving take-home doses, meaning patients would have to wait 45 days before receiving their first take-home dose instead of 90 days.

While moving towards a pharmacy-dispensing system of methadone delivery represents progress, the bill falls short of addressing many of the current barriers to methadone in two ways:

First, the bill limits methadone prescribing to subspecialty board-certified physicians in addiction medicine or addiction psychiatry, prohibiting methadone prescribing for OUD among primary care physicians or advanced practice providers. According to the American Board of Medical Specialties, there are only 1,883 addiction medicine and 1,288 addiction psychiatry physicians nationwide. In the state of Wyoming, where more than one hundred people died from overdose in the last year, there are only two addiction medicine physicians. If methadone prescribing is limited to addiction specialists, methadone will remain inaccessible to large swaths of the country, as rural counties have far fewer addiction specialists and OTPs than urban areas. The current bill would also still require patients to travel to an OTP to start the medication in communities with no office-based addiction specialists. Timely medication initiation is critical as delays in access are associated with increased mortality.

Expanding prescribing privileges beyond addiction care providers, including primary care providers, providers from other specialties (such as psychiatry or OB-GYN), nurse practitioners, and physician assistants, could significantly broaden the reach of methadone to populations that need it most. For over a decade, Canada, Australia, and the United Kingdom have safely allowed office-based methadone prescribed by primary care clinicians to expand access. For patients for whom buprenorphine does not work, low-barrier access to methadone treatment that is integrated into our larger healthcare system is urgently needed to prevent rising overdose deaths from fentanyl and fentanyl analogues.

Second, the bill continues to rely on inflexible take-home methadone dosing schedules not rooted in evidence. While the bill would halve the number of days—from one year to six months and from two years to one year—patients must wait to receive their first 14- or 28-day take-home supply, this approach remains inflexible and not patient-centered. These numbers represent arbitrary cut-offs that reinforce the paternalistic stance towards patients that has long characterized the OTP system. Rather, patients and clinicians should be allowed to work together to create a treatment structure that is most supportive of success just as we do for any other chronic medical condition. Novel research is needed to better inform the process of identifying patients who may benefit from more structured treatment. More flexible regulations would also allow researchers to study this question with fewer obstacles.

The Health Subcommittee of Congress conducted a markup of the Opioid Treatment Access Act on May 11, 2022. Early signs suggest the provisions related to office-based methadone prescribing and pharmacy-based dispensing may not move forward. If this remains true, it suggests an ongoing need to better inform congress and the public about the opportunity meaningful methadone reform represents as we attempt to confront the opioid overdose epidemic.

Summary And Steps Forward

We can and must do more for the patients whose lives are disrupted and placed at risk by the current OTP system. Under our current policies for the treatment of OUD, estimates project 1.2 million Americans will die of an overdose by 2029. In summary, we suggest three next steps to urgently expand methadone treatment:

  1. We call on SAMHSA to exercise their regulatory discretion to relax rules surrounding take-home methadone and consider issuing a waiver in collaboration with the DEA that allows providers to prescribe methadone outside of the OTP setting.
  2. We call on Congress to amend H.R.6279 or introduce an alternative bill to expand methadone prescribing beyond addiction care providers. Take-home methadone dosing should be decided by science, clinicians, and patients.
  3. We call on all leaders to ensure harm reduction strategies, including overdose prevention centers, and the decriminalization of substance use, are part of a multi-pronged approach to address our country’s overdose epidemic, in addition to increasing access to treatment.

If methadone were available like any other medication, Eliza could receive a prescription of methadone from her primary care physician and pick it up at a local pharmacy. Rather than commute to the clinic every day, she could be protected from overdose while being empowered to focus on the health and wellness of herself and her family. The current system actively disincentivizes access to a highly effective treatment for OUD for patients like Eliza. Without an office-based methadone option for OUD, patients are denied the opportunity to choose what works best for them. Now is the time to build an equitable methadone treatment system. Otherwise, patients will continue to die prematurely from preventable overdose deaths.

Authors’ Note

In addition to the authors listed above, the following individuals contributed to this piece (in alphabetical order): Susan Calcaterra, Abby Coulter, Corey Davis, Aaron Ferguson, David Frank, Simeon Kimmel, Marilena Marchetti, Helen Redmond, Louise Vincent, and Zoe Weinstein.

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