According to the Substance Abuse and Mental Health Services Administration (SAMHSA), over 6.1 million people over age 12 have opioid use disorder (OUD). Increasing access to OUD treatment would reduce the number of people who seek drugs in the dangerous black market and, in turn, reduce the risk and incidence of overdose deaths.
In the United States before 1972, primary care physicians would prescribe methadone to people with OUD. Since 1972, however, only government-approved opioid treatment programs (OTPs) have been allowed to dispense methadone to treat OUD. SAMHSA places regulations and restrictions on organizations that seek to operate OTPs. OTPs must obtain certification from the Drug Enforcement Administration (DEA) to operate a narcotics treatment program. States must also license OTPs, imposing additional regulations, costs, and restrictions.
The various layers of regulations hinder the proliferation of OTPs. These and other government obstacles explain why only about 400,000 individuals with OUD received methadone in 2019, while 1.6 million US residents reported developing OUD that year. Recognizing these barriers, Congress has attempted incremental reforms. For the past few sessions of Congress, the bipartisan Modernizing Opioid Treatment Access Act (MOTAA) has failed to pass. If enacted, MOTAA would expand access to methadone treatment by allowing board-certified addiction medicine physicians to prescribe methadone in their offices and clinics.
However, President Donald Trump’s February 19 executive order implementing his “Department of Government Efficiency” Deregulatory Initiative provides an opportunity to expand access to methadone treatment for people with opioid use disorder (OUD). Seizing on this deregulatory momentum, the American Society of Addiction Medicine (ASAM) has spearheaded a letter to Attorney General Pam Bondi and Acting DEA Administrator Derek Maltz, calling for a review of methadone treatment regulations. The letter argues that these regulations are “not based on the best reading” of the underlying law and “constitute a significant regulatory action that materially harms competition in health care delivery.” The American Society of Health-System Pharmacists, the National Commission on Correctional Health Care, the National Community Pharmacists Association, and the R Street Institute endorsed the letter.
Many policymakers have long believed that the current methadone treatment regime is mandated by federal statute. In reality, much of it was created by federal regulatory agencies— specifically the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS)—pursuant to authority delegated by Congress.
The direct legislative sources are the Narcotic Addict Treatment Act (NATA) of 1974 and 21 U.S.C. § 823(h). NATA authorized the use of narcotic drugs like methadone to treat addiction but required practitioners dispensing such drugs to be registered with the DEA and that SAMHSA and the DEA approve treatment programs. 21 U.S.C. § 823(h) states that the attorney general, through the DEA, “shall register an applicant to dispense narcotic drugs to individuals for maintenance treatment or detoxification treatment” in compliance with standards set and certified by the Secretary of HHS.
Congress didn’t specifically require the DEA to set up OTPs. It authorized the DEA to set up some sort of registration and regulatory system. The DEA decided to implement 21 USC Sec 823 (h) by requiring OTPs.
In its letter to Bondi and Maltz, ASAM argues that because 21 U.S.C. § 823(h) does not explicitly mandate the use of OTPs — but instead grants the Attorney General (through the DEA) the authority to register practitioners “in accordance with” HHS standards — the requirement that methadone be dispensed only through OTPs is a regulatory choice, not a statutory mandate.
Before discussing how the regulatory change can help, it’s worth clarifying a key distinction: addiction and dependency are not the same. Opioid addiction and opioid dependency are two distinct subsets of OUD. Dependency refers to the physiological adaptation to the drug such that abrupt cessation can cause a physical withdrawal reaction. Addiction is a behavioral disorder characterized by compulsive use despite negative consequences. People with addiction still feel compelled to use opioids even when they are no longer physically dependent.
Methadone and buprenorphine are time-tested, evidence-based medications used to treat OUD. Clinicians have been using methadone to treat OUD since the 1960s. They’ve been using buprenorphine since the 1990s. Some patients respond better to methadone; others do well with buprenorphine.
If the ASAM-inspired initiative is successful, the Trump administration will implement regulatory reforms that could remove obstacles preventing people with OUD from accessing methadone treatment. These reforms can go even further than MOTAA’s modest, incremental reform. The administration can permit all licensed clinicians who are interested in treating OUD to register with the DEA to provide methadone treatment. The administration could remove regulatory barriers to patients with OUD accessing methadone through primary care clinicians, including nurse practitioners, in their community offices and clinics. The DEA and SAMHSA have already implemented this policy for buprenorphine prescribing.
Critics of treating methadone prescribing like buprenorphine prescribing worry that patients might “divert” the methadone to the black market. But the evidence suggests otherwise.
In March 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA) temporarily loosened methadone take-home restrictions for opioid treatment programs (OTPs), permitting “stable” patients to receive up to a 28-day supply. The policy proved so effective that SAMHSA made it permanent. Researchers from the Centers for Disease Control and Prevention and the National Institute on Drug Abuse analyzed the effects of this change and reported in JAMA Psychiatry in July 2022 that “monthly methadone-involved overdose deaths remained stable after March 2020.” The National Institutes of Health reported that same month that “the percentage of overdose deaths involving methadone declined between January 2019 and August 2021.”
It often surprises people that the DEA allows any clinician with a standard narcotics license to prescribe methadone for pain yet prohibits them from prescribing it for addiction treatment. According to the National Institute on Drug Abuse, “Methadone diversion is primarily associated with methadone prescribed for the treatment of pain and not for the treatment of opioid use disorders. In one survey, giving methadone away was identified as the most common form of methadone diversion, which aligns with other findings that 80 percent of people who report diverting methadone did so to help others who misused substances.”
Of course, no reform is secure unless Congress codifies it. One drawback of relying on executive actions and regulatory reassessments is that they can change in subsequent administrations. While the Trump Administration can move quickly to improve access to methadone treatment, a subsequent administration could revert to the old approach. Ideally, Congress should codify any regulatory reforms in statute.
In a Cato Policy Brief, Sofia Hamilton and I point out that clinicians in Australia, Canada, and the UK have been prescribing methadone to patients with OUD in their offices and clinics for nearly 60 years. They coordinate with community pharmacists who are part of the treatment team. Regulators in those countries defer to clinicians to exercise their medical judgment in deciding the timing and amount of take-home methadone. We argue that clinicians and patients in the United States deserve the same freedom.
We call on lawmakers to enable patients with OUD to receive methadone treatment from sources other than government-approved OTPs. Providers should include office-based addiction specialists, primary care physicians, nurse practitioners, and physician assistants. These treatment options can coexist with more traditional inpatient or outpatient treatment programs.
Ideally, lawmakers should end drug prohibition. As a result of the failed war on drugs, federal bureaucrats, police, SAMHSA, and the DEA regulate how clinicians practice medicine. Prohibition lets lawmakers, policymakers, and law enforcement agents intrude into clinical decision-making and the patient-doctor relationship.