by Rachel Simon, MD and Aaron D. Fox, MD MS
It was a Friday afternoon and the patient – a young woman with severe opioid use disorder – came into the office crying. Her prescribed buprenorphine wasn’t reducing her cravings, she was achy and nauseous from opioid withdrawal, and she had just been turned away by the methadone clinic up the street. The patient wanted to start methadone treatment, but the clinic only saw new patients on weekday mornings, so she would need to wait until Monday morning. For the clinic, those are the rules; for her, another weekend of suffering. Why couldn’t we, addiction medicine specialists working in community health centers, simply change her medication from buprenorphine to methadone, like we would with an ineffective antibiotic or oral hypoglycemic that had lost its effect?
Overdoses are rising at an alarming rate across the country. One reason is the lack of access to treatment: only one out of ten individuals with opioid use disorder (OUD) receive first-line treatment with opioid agonist therapy, namely, methadone or buprenorphine.1 Methadone is particularly challenging for patients to access, and one major reason is the onerous federal regulations that govern the prescribing and dispensing of methadone. Notwithstanding significant advancements in the field of addiction medicine, and growing evidence that supports alternate treatment modalities, these federal rules have largely gone unchanged for over half a century. Amending the outdated regulations, and making it easier for patients to start methadone or buprenorphine treatment, will be necessary to engage people with OUD and address the overdose crisis.
Under federal regulations, methadone, when used to treat OUD, must be prescribed and dispensed at a federally licensed opioid treatment program (OTP). With only two thousand OTPs in the country, patients — especially those in rural areas — face long commutes and high transportation costs to reach these facilities, which poses a significant barrier to treatment.2 The rationale behind these regulations is confounding, particularly considering that when it is used for pain, methadone can be prescribed by any licensed practitioner and dispensed at any community pharmacy. If patients with diabetes were required to attend an endocrinology clinic to receive insulin, access would similarly be limited, and like with other chronic health conditions, OUD can safely and effectively be managed in primary care.3
Federal OTP regulations also impose limitations on take-home doses, which creates another barrier to treatment. For the first three months of methadone treatment in an OTP, a patient must travel to the facility every day for observed dosing. To receive a month’s supply of methadone, a patient must at a minimum attend an OTP for two years. Most patients find these restrictions infantilizing, curtailing their autonomy and self-efficacy, and antithetical to important recovery goals, such as resuming work, caring for their loved ones or traveling.4 Other treatment barriers imposed by OTPs include counseling requirements, which are not set by the federal government but instead mandated by many OTPs themselves. Long medication lines in public spaces, law enforcement surveillance, and observed urine toxicologies are other realities of attending OTPs that add fear and shame to accessing OUD treatment.
Black and Latinx people with OUD are disproportionately harmed by these oppressive methadone regulations, in part because OTPs are more likely to be found in predominantly Black and Latinx neighborhoods, and Black and Latinx individuals are less likely to have access to and to be offered buprenorphine.5, 6
The Substance Abuse and Mental Health Administration (SAMHSA) temporarily loosened OTP restrictions on take-home methadone doses in the wake of the COVID-19 pandemic. Stable patients meeting relatively broad criteria were able to receive twenty-eight days of methadone and less stable patients could receive fourteen days. Preliminary data show that patients benefitted from these changes, citing increased self-efficacy without apparent increases in methadone overdoses or diversion.7, 8 Furthermore, a recent study from Canada found that receiving more take-home doses decreased OUD treatment disruption and discontinuation.9 In response to positive findings, SAMSHA extended these flexibilities. In May 2023, they released an updated take home extension guidance allowing for additional flexibility. Under this guidance, a patient that meets certain criteria is now able to receive seven take home doses in the first two weeks and up to fourteen in the first month.10 Troublingly, many OTPs have not kept apace. Nearly half of surveyed OTPs did not adopt the federal flexibilities during the early pandemic period and continued to impose restrictions on treatment.11 More must be done to promote equitable access to methadone for patients with OUD.
The Modernizing Opioid Treatment Access Act – An Opportunity for Reform
The Modernizing Opioid Treatment Access Act (HR 1359) was introduced by Representative Donald Norcross (D-NJ) and Don Bacon (R-NE) in March 2023. A similar bill (S 644) has been introduced in the Senate by Senator Edward Markey (D-MA). The proposed legislation presents an opportunity for Congress to usher in much-needed reforms to methadone treatment. If passed, these bills would allow physicians licensed in addiction medicine or addiction psychiatry to prescribe methadone in an office-based setting and would allow patients to pick up their methadone in a community pharmacy. This would be life-changing for patients — particularly Black and Latinx patients and patients in rural settings — who would no longer have to commute to an OTP every morning and wait on long lines to receive their treatment. This approach to OUD treatment is the standard in Canada, UK and Australia, so the proposed changes are neither radical or extreme.12 The increased access to methadone would, in turn, help patients remain on treatment, prevent overdoses, and encourage those not yet on treatment to start it. We, as individuals, and the New York Society of Addiction Medicine strongly support the bill for these reasons.
To be sure, the MOTAA falls short. With fewer than 4,000 addiction physicians across the country, the bill’s limits on methadone prescribing will keep access restricted. Rural areas will continue to be the hardest hit. In the state of Wyoming, for example, there are no OTPs and only two addiction physicians. The bill puts forth only modest adjustments to OTP regulations. Restrictions on take-home methadone doses are not evidenced-based or patient-centered, and they are inconsistent with approaches to treating other chronic medical conditions. As has been done safely in Canada, the UK and Australia, we need to grant all physicians and advanced practice providers the ability to prescribe this medication.
Regardless, these bills represent an incredible opportunity to increase access to a first-line medication for opioid use disorder. The American Society of Addiction Medicine already has policy that supports office-based methadone prescribing with pharmacy dispensing, and the organization has publicly endorsed the Modernizing Opioid Treatment Access Act. The New York Society of Addiction Medicine is also strongly in support of these bills and encourages all members to get involved with advocating for its passage.
The next meeting for NYSAM public policy and advocacy committee will be Wednesday July 19th at 7:00 pm. Please contact Aaron Fox for more information about the monthly remote meetings.
- Wakeman SE, Larochelle MR, Ameli O, et al. Comparative Effectiveness of Different Treatment Pathways for Opioid Use Disorder. JAMA Netw Open. 2020;3(2).
- Joudrey PJ, Edelman EJ, Wang EA. Drive Times to Opioid Treatment Programs in Urban and Rural Counties in 5 US States. JAMA. 2019;322(13):1310–1312.
- Fiellin DA, O’Connor PG, Chawarski M, Pakes JP, Pantalon MV, Schottenfeld RS. Methadone maintenance in primary care: a randomized controlled trial. JAMA. 2001 Oct 10;286(14):1724-31.
- Caty Simon, Louise Vincent, Abby Coulter, et al. The Methadone Manifesto: Treatment Experiences and Policy Recommendations From Methadone Patient Activists. AJPH. 2022; 112: S117-S122.
- Hansen HB, Siegel CE, Case BG, et al. Variation in use of buprenorphine and methadone treatment by racial, ethnic, and income characteristics of residential social areas in New York City. J Behav Health Serv Res. 2013;40(3):367-377.
- Lagisetty PA, Ross R, Bohnert A, et al. Buprenorphine Treatment Divide by Race/Ethnicity and Payment. JAMA Psychiatry. 2019;76(9):979–981.
- Levander XA, Hoffman KA, McIlveen, JW et al. Rural opioid treatment program patient perspectives on take-home methadone policy changes during COVID-19: a qualitative thematic analysis. Addict Sci Clin Pract . 2021; (16)72.
- Joseph G, Torres-Lockhart K, Stein MR et al. Reimagining patient-centered care in opioid treatment programs: Lessons from the Bronx during COVID-19. J Subst Abuse Treat. 2021.
- Gomes T, Campbell TJ, Kitchen SA, et al. Association Between Increased Dispensing of Opioid Agonist Therapy Take-Home Doses and Opioid Overdose and Treatment Interruption and Discontinuation. JAMA. 2022;327(9):846–855.
- SAMHSA Take Home Extension Guidance. May 1, 2023. https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines/methadone-guidance
- Krawczyk N, Maniates H, Hulsey E, et al. Shifting Medication Treatment Practices in the COVID-19 Pandemic: A Statewide Survey of Pennsylvania Opioid Treatment Programs. J Addict Med. 2022 Feb 14.
- How Can Patients Access Methadone in Other Countries? The Pew Charitable Trusts. May 17, 2023. https://www.pewtrusts.org/en/research-and-analysis/articles/2023/05/17/how-can-patients-access-methadone-in-other-countries