Dear Dr. Olsen, Ms. Milgram, and Members of SAMHSA, DEA and Congress, 

This is a call to action for patient-centered methadone treatment.* 

The overdose crisis continues to ravage our families and communities, with over 107,000 lives lost over the past year alone. The COVID-19 pandemic has exacerbated this crisis, while also highlighting the deeply ingrained problems with opioid use disorder (OUD) treatment in the United States. Central to this problem is our outdated opioid treatment program (i.e. methadone clinic) system, which prioritizes control of patients and medications over health and saving lives. Decades of research as well as findings from the recent ONDCP-sponsored National Academies of Sciences, Engineering and Medicine Workshop on Methadone demonstrate that the burdensome opioid treatment program system too often stigmatizes and hurts rather than helps marginalized individuals with OUD. Importantly, research during the COVID pandemic shows medication ‘take home’ flexibilities and allowing for greater patient autonomy did not increase risk of methadone diversion or overdose. In fact, this flexibility improved patient agency and treatment experiences.

Methadone treatment saves lives and improves the health of people with OUD. These benefits extend to treated individuals’ families and our broader communities. However,  large numbers of people with OUD are unable to access methadone treatment because it is currently segregated from the rest of the healthcare system.  Burdensome regulatory requirements often make it impossible for OTPs to operate in most rural and suburban communities, leaving 80% of U.S. counties without access to this critical medication.

As people receiving methadone treatment, addiction clinicians, public health experts and community advocates, we urge SAMHSA and DEA to implement immediate regulatory reforms to create a more accessible, equitable and patient-centered methadone treatment system.    

Central to a vision for a more accessible and equitable methadone system are the principles that:  1) Methadone regulations should prioritize patient health over other concerns; 2) Methadone should be available in all treatment settings and communities; and 3) The structure of methadone treatment should be determined by the patient in consultation with their clinician, and by science - consistent with how we approach other chronic diseases. As such, we recommend the current methadone treatment system be expanded beyond OTP settings, as has been successfully implemented in other countries including the UK, Australia and Canada.  

Such a model would allow  patients and clinicians to work together to determine one of the following methadone treatment options that best fits patient needs and which can be adapted throughout their treatment experience:  

1. Methadone dispensing of observed and take-home doses at OTPs
2. Methadone prescribing at OTPs, with pick up of doses at local pharmacies
3. Methadone prescribing by primary care and other non-addiction specialist providers, with pick up of doses at local pharmacies

For all three scenarios, it is critical that federal regulations support flexible and individualized treatment plans in which A) Dose and frequency of take-homes/length of prescription is individualized to the needs of the patient as determined by patients in consultation with their clinician; and B) Ancillary services such as peer-support, individual and group counseling are made available but are optional to patients who choose to attend these services either at the OTP or other partnering organizations.

As has been outlined by attorneys and policy experts involved in the National Academies’ workshop, SAMHSA and DEA have the legal authority to act now to implement this vision through multiple regulation reforms without additional legislation. Congress should work in tandem to ensure these reforms are protected long-term. 

1. SAMHSA should immediately implement the following reforms: 

• Permit methadone for OUD treatment to be prescribed by any clinician authorized to prescribe controlled substances, or at a minimum on parity with buprenorphine
• Permit methadone for OUD treatment to be dispensed by any pharmacy authorized to dispense controlled substances
• Expand take-home flexibility, making take-homes the default rather than the exception
• Remove regulatory limits on dosing, permitting the dose to be set by the clinician as appropriate for the individual patient
• Remove requirements to provide ancillary services

2. DEA should immediately implement the following reforms: 

• Permit practitioners, including those in OTPs, to prescribe methadone for OUD treatment for pick up at local pharmacies
• Create and disseminate communication materials to DEA-licensed clinicians articulating support of the above regulatory changes, and commitment to prioritizing health for patients with OUD

3. Congress should pass legislation in the near future to protect these reforms long-term.

The Opioid Treatment Access Act (OTAA, HR 6279) of 2022 would have allowed addiction specialists working outside the OTP system to prescribe methadone for OUD and to allow for pharmacy-based dispensing. Despite its limitations -- including limiting prescribing to addiction specialists only and preventing individualized take home schedules -- this bill was a step in the right direction. Unfortunately, the OTAA has since been folded into the Restoring Hope for Mental Health and Well-Being Act (HR 7666) and many of the methadone-based reforms have been removed. Members of Congress should push to ensure a version of OTAA with suggested changes is brought forward in legislation. 

If SAMHSA and DEA act now with the support of the Office of National Drug Control Policy, these actions will expand OUD treatment access, reduce overdose, and support health and equity by:

• Making OUD treatment more patient-centered and increasing patient autonomy
• Increasing access to methadone for individuals who do not live in proximity to an OTP
• Reducing burden of engaging in methadone treatment by reducing travel times and frequency of encounters, and removing mandated ancillary services required by some OTPs
• Destigmatizing methadone by integrating it into the mainstream healthcare system like medications for other chronic diseases, including buprenorphine
• Placing methadone at parity with buprenorphine and extended-release naltrexone, giving patients in consultation with their clinician the option to decide which medication is more effective for them
• Decreasing community resistance and stigma for methadone treatment “Not in my backyard” (NIMBYism) by integrating methadone treatment into the rest of the healthcare system
• Expanding availability of methadone across settings that have high rates of OUD and limited access to evidence-based OUD treatment, including rural settings, the criminal legal system, hospitals, primary care practices, and harm reduction programs
• Reducing racial disparities in access to MOUD treatment by creating parity between methadone and buprenorphine treatment and the burden associated with their access

For these reforms to be successful, it is critical that federal agencies work in tandem with state governments and authorities, public and private insurance payors, and individual treatment program providers to ensure such changes align with local regulations and reimbursement structures. Local regulations and financing structures should prioritize individualized treatment plans and incorporate telehealth services that can serve as a critical mode of communication between providers and patients.

With fatal overdoses from illicitly manufactured fentanyl skyrocketing in our country, methadone is an invaluable medication to treat individuals with opioid use disorder and to prevent deaths. We must bring methadone back into our healthcare system so that those who need it can access this medication in a way that is accessible, equitable and informed by science. 

We thank you very much for your consideration and attention to this matter.

The National Coalition to Liberate Methadone
Board Members
Abby Coulter
Aaron Ferguson
David Frank, PhD
Paul Joudrey, MD MPH
Noa Krawczyk, PhD
Caty Simon
Leslie Suen, MD, MAS

* Visit this link for a bibliography of evidence supporting claims made above.