Kayla was referred to our addiction clinic after a visit to the emergency department for a skin infection, common in people who use drugs intravenously. Recognizing her fentanyl use was escalating out of her control, she made an appointment to discuss starting buprenorphine, a mainstay of treatment for opioid use disorder (OUD). While our initial office visit with Kayla was straightforward and optimistic, during subsequent visits she continued to experience symptoms of withdrawal and uncontrolled cravings to use fentanyl. Despite our adjustments, her frustration grew, and she began to lose hope that this would be successful. We needed another strategy.
Methadone would be a natural alternative treatment for a patient like Kayla but strict federal and state regulations severely restrict patients’ ability to access it. Passing the Modernizing Opioid Treatment Access Act (MOTAA) would allow addiction specialists to prescribe methadone for OUD directly to community pharmacies, expanding access to a lifesaving and overregulated medication.
Establishing care with a patient OUD can save a life. As physicians pursuing additional fellowship training in addiction medicine, we know that starting patients on medications for opioid use disorder–buprenorphine or methadone–decreases their risk of death by half. These medications work by engaging opioid receptors in the brain, interfering with the reward pathways that are hijacked in patients with addiction. Beyond the mortality benefit, medications for opioid use disorder (MOUD) free patients from the perpetual cycle of agonizing withdrawal and neurobiologically driven preoccupation to use, allowing them to return to life on their own terms. No other outpatient medication is as life-changing.
But these benefits are tempered by a dilemma that we face far too often. Only buprenorphine can be prescribed to a community pharmacy. Unfortunately, the proliferation of highly potent synthetic opioids like fentanyl has pushed many patients’, like Kayla’s, tolerance for opioids so high that buprenorphine may not adequately suppress their cravings. Higher rates of precipitated withdrawal—a phenomenon more common in the fentanyl era in which buprenorphine idiosyncratically worsens, rather than treats, opioid withdrawal—may dissuade patients from ever attempting buprenorphine initiation. For some patients with OUD, methadone is the preferred treatment. However, strict federal and state regulations uniquely restrict methadone for the treatment of OUD to specialized clinics called opioid treatment programs, commonly known as methadone clinics. Given the urgency of the opioid epidemic, ensuring access to all treatment options is essential.
Kayla was well aware of methadone. Family members on methadone had told her about their daily trips to the program, arriving at dawn to wait in line for a dose of medication that must be swallowed under observation. To comply with the programs’ early morning hours, she feared she would lose her overnight job. When she asked if she could get methadone from our clinic, we said no–all we could offer was a referral to an opioid treatment program. It was a sad, frustrating conversation. Unfortunately, it was also our last with her, as she hasn’t returned to our clinic.
In recent years, increased attention has been paid to the limited access to methadone. During the COVID-19 pandemic, social distancing requirements and a surge in overdose deaths prompted the easing of methadone restrictions out of necessity. In February 2024, the Department of Health and Human Services codified these changes into 42 CFR Part 8, better known as the “Final Rule.” This was the first time regulations guiding methadone clinics were updated in more than two decades. Under these new guidelines, which went into effect in October 2024, nearly all patients should now have access to 14 or 28 “take-home” methadone doses, greatly reducing the burden of daily visits. Other barriers to treatment were also removed, such as requiring patients to suffer addiction for at least a year before starting treatment or withholding medication if patients did not comply with counseling sessions.
Despite this progress, the Final Rule does not alter the fundamental segregation of methadone from all other medications. Inexplicably, this restriction applies only to methadone prescribed for the treatment of opioid use disorder. Any provider with a DEA registration can prescribe methadone for pain to a normal community pharmacy.
MOTAA would change this paradigm. If passed, MOTAA would allow methadone prescribed by addiction specialists for the indication of OUD to be filled at community pharmacies, as it is in other countries. The carceral system of observed doses and frequent visits would end. Addiction specialists would be able to continue caring for patients who need an alternative to buprenorphine, no longer fragmenting care by requiring referral to a new facility, which in some states may be an hours-drive away or not exist at all.
The main opponents to this legislation are opioid treatment programs fearing lost revenue. They argue that patients benefit from the structured environment of the program and that community prescribing will result in the diversion of methadone and increased risk of overdose. However, data from the pandemic refute this, and the issuing of the Final Rule represents a recognition that those restrictions are not necessary for the effective treatment of OUD.
Patients like Kayla navigating a lethal drug supply deserve every option for a tailored and effective treatment; doctors who have chosen to devote their careers to combating the overdose epidemic need every tool available. For too long, the restrictions on methadone have stigmatized an evidence-based, effective medication for a deadly disease. Thanks to the Final Rule, the regulations around methadone have eased for the first time in decades, but it’s not enough. MOTAA would undo the restrictions that uniquely curtail methadone and normalize it as a medication like any other.
Michelle Breda and Marco Barber Grossi are internal medicine physicians.
