The federal government is signaling major shifts in the regulation of medication-assisted treatment (MAT), a development that could fundamentally reshape addiction treatment in the United States. Key federal stakeholders have indicated that reforms around MAT deregulation are a top priority, and legislative momentum is already building. The House of Representatives recently passed the Restoring Hope for Mental Health and Well-Being Act, which, if enacted, could make it easier for clinicians to prescribe methadone and buprenorphine, potentially widening access to these lifesaving treatments.
MAT, which combines medications with counseling and behavioral therapies, is widely recognized as an evidence-based approach to treating opioid use disorder (OUD) and other substance use disorders (SUDs). Advocates for MAT deregulation argue that current policies create unnecessary barriers to care, while critics warn that reducing restrictions—particularly on methadone—could compromise patient safety.
What’s Happening Now: Voices From Federal Experts
On November 16, National Institute on Drug Abuse (NIDA) Director Nora Volkow emphasized that there is “absolutely no reason” why primary care providers shouldn’t be able to prescribe methadone. Volkow, widely regarded as the federal government’s top addiction subject matter expert, noted that methadone—a controlled synthetic opioid—is underutilized despite its proven efficacy. She suggested that methadone should be dispensed through retail pharmacies, following models used in countries like Canada and parts of Europe.
Volkow highlighted the strength of the U.S. health system and its capacity to expand access to treatment for people with SUDs. “We have a pretty powerful health structure in the United States, and we should optimize it in order to be able to maximize access to treatment for people with substance use disorders or other conditions—and that includes the use of methadone,” she said at the STAT Summit.
The timing of these remarks comes amid a worsening overdose crisis. Overdose deaths in the U.S. have increased by 42% since the onset of the COVID-19 pandemic, underscoring the urgent need for broader access to MAT.
Currently, only opioid treatment programs (OTPs) may prescribe and dispense methadone, and patients in early recovery must take doses onsite daily. OTPs may provide take-home doses to patients deemed stable, with the federal government temporarily increasing allowable doses during the pandemic to reduce exposure risk. Expanding methadone access to primary care and pharmacies is a key component of MAT deregulation, potentially removing logistical barriers for patients in rural or underserved areas.
In parallel, the Food and Drug Administration (FDA) recently announced that auto-injector and nasal spray forms of naloxone, the opioid overdose reversal drug, could be safely dispensed without a prescription. This preliminary determination is an early step toward over-the-counter access to naloxone, which aligns with the broader goal of MAT deregulation and harm-reduction strategies.
Legislative Momentum: The Restoring Hope Act
Congress’ legislative push for behavioral health reform is centered around the Restoring Hope for Mental Health and Well-Being Act (H.R. 7666), a bill that packages several behavioral health reforms from multiple lawmakers. This bipartisan legislation passed the House of Representatives with a 402–20 vote and could eliminate the X waiver—a requirement that physicians receive additional certification to prescribe buprenorphine. The waiver also limits the number of patients physicians may treat, creating a bottleneck in access to MAT.
The bill reflects broader federal priorities to expand behavioral health services. Recent initiatives include the American Rescue Plan Act, which added $900 million to behavioral health workforce programs, and the Bipartisan Safer Communities Act, which allocated $2.16 billion to mental health initiatives. These efforts align with President Joe Biden’s health care-focused agenda, emphasizing access, equity, and workforce investment. If enacted, these reforms would mark a significant step in advancing MAT deregulation, allowing more patients to access treatment in primary care and community settings.
The Current Landscape of MAT
Despite the clear evidence supporting MAT, access remains limited. Only about 6.5% of people reporting a substance use disorder receive treatment, and just 11% of people with opioid use disorder receive MAT. Methadone, in particular, has been shown to produce over four times higher retention rates and better long-term outcomes compared to other forms of treatment.
Federal restrictions on prescribing and dispensing—intended to prevent diversion and misuse—have limited MAT adoption. Expanding access through MAT deregulation could help address these gaps, particularly in rural communities and areas with limited OTPs. Meanwhile, overlapping crises such as the COVID-19 pandemic, mass shootings, and the ongoing overdose epidemic have intensified federal attention on behavioral health, reinforcing the need for policies that increase access to care.
Advocates vs. Critics: The Debate Over Deregulation
While many advocates support MAT deregulation, concerns about patient safety remain. Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), expressed worries that primary care providers and retail pharmacies may not have the specialized knowledge or infrastructure to safely manage methadone treatment, particularly for patients affected by fentanyl. Fentanyl—a synthetic opioid far more potent than heroin or prescription opioids—has become the main driver of overdose deaths, often requiring higher doses of methadone to stabilize patients.
Critics also caution that expanding access to buprenorphine without integrating counseling and behavioral therapies could result in incomplete care. While medication is essential, MAT’s effectiveness increases when combined with psychosocial support.
Conversely, organizations such as the Association for Behavioral Health and Wellness support eliminating the X waiver, arguing that current restrictions unnecessarily hinder access to life-saving treatment. The growing focus on telehealth and virtual MAT programs has also strengthened the case for MAT deregulation, providing patients with remote access to evidence-based care.
Implications for Virtual MAT
Telehealth and virtual MAT services have grown rapidly during the pandemic, fueled by federal flexibilities, including X waiver adjustments. Millions of dollars in private investment have supported the expansion of virtual treatment platforms, which allow patients to receive MAT remotely. However, these flexibilities could be threatened if the federal public health emergency declaration ends, potentially limiting virtual access. Advocates argue that sustaining these flexibilities is crucial to achieving the goals of MAT deregulation and reaching patients who otherwise lack access.
Looking Ahead: What the Future Holds
With the Restoring Hope Act passing the House, attention now turns to the Senate, where lawmakers could attach it to must-pass bills like the National Defense Authorization Act or the government funding bill. These legislative vehicles provide opportunities to advance large-scale reforms in behavioral health, including MAT deregulation.
As debates continue, stakeholders on all sides will push for their priorities. Advocates argue that deregulation is essential for increasing access, reducing overdose deaths, and modernizing the treatment system. Critics emphasize patient safety and the need for careful oversight, particularly in a fentanyl-driven epidemic. If enacted carefully, these reforms could make methadone, buprenorphine, and naloxone more accessible while maintaining safe treatment practices.
Conclusion
The U.S. stands at a pivotal moment in the fight against opioid addiction. MAT deregulation could expand access to effective treatment for millions of Americans, reduce overdose deaths, and modernize addiction care delivery. At the same time, implementing these changes safely requires robust provider education, integration of behavioral therapies, and careful monitoring.
Federal policy in the coming months will determine the trajectory of MAT in America, and with careful execution, MAT deregulation could mark a historic step toward a more accessible and effective system of care for people with opioid use disorder.
