A new federal rule enhances narcotic treatment programs' (NTPs) ability to dispense controlled substances—including methadone—from mobile units to help improve access to evidence-based treatment for opioid-use disorder (OUD) in rural areas and underserved urban areas or for those who are without stable housing.

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When the U.S. Drug Enforcement Administration (DEA) proposed waiving the requirement for NTPs to obtain separate registration for mobile components last year, the AMA heartily endorsed the idea.

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"Operation of mobile components by registered NTPs could significantly alleviate the disparities in access to OUD treatment in rural communities," AMA Executive Vice President and CEO James L. Madara, MD, wrote in a letter last year to Uttam Dhillon, who was then serving as the DEA's acting administrator.

"NTP mobile components could also help improve access for underserved communities in urban areas, including among the homeless population, as well as for individuals for whom transportation and child-care needs present barriers to accessing OUD treatment," the letter adds. "The AMA will strongly encourage our state medical society partners to help in supporting implementation of mobile components consistent with this rule, including state legislative and regulatory advocacy."

The letter cites several benefits of easing regulations to facilitate the use of NTP mobile units, including:

  • Potentially improving treatment access for pregnant and postpartum women, thus helping to address a factor in maternal mortality.
  • Improving NTPs' ability to provide patients with additional counseling and treatment resources.
  • Helping reduce stigma for evidence-based methadone-maintenance therapy as improved access leads to more patients initiating therapy, staying in treatment and demonstrating positive treatment outcomes.

The evolving overdose epidemic, which is now being fueled largely by illicitly manufactured and adulterated fentanyl and fentanyl analogs and exacerbated by the COVID-19 pandemic, is believed to have taken the lives of a record-high 93,331 people in the U.S. in 2020, compared with 72,151 in the year before.

Regina LaBelle, acting director of National Drug Control Policy, said in a news release that the new rule is a significant step forward in supporting the nation's drug-policy priorities "including expanding access to evidence-based treatment and advancing racial equity in our approach to drug policy."

In its final rule, which is already in effect, the DEA estimated that individual NTPs could save between $320,000 and $360,000 over five years by using mobile units rather than opening an additional brick-and-mortar location. The rule still requires that mobile components—used "for the purpose of maintenance or detoxification treatment"—operate within the same state that the NTP is registered.

The DEA also clarified several areas that will help increase access to care, including provisions authorizing a mobile component to serve multiple locations in a single day and specifically stating that "NTPs may operate mobile components at correctional facilities where otherwise permitted by law."

In its explanation of why the waiver is needed, the DEA cites a 2014 JAMA Psychiatry commentary, "Access to Treatment for Opioid Dependence in Rural America," as it notes that "some rural patients reported that the burden of traveling daily to receive their medication effectively prevents them from working, further increasing the risk that they will discontinue treatment."

More recently, researchers from Yale University and other U.S. and Canadian institutions wrote about growing problems in treatment access in a JAMA Network Open study "Methadone Access for Opioid-Use Disorder During the COVID-19 Pandemic Within the United States and Canada."

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In the District of Columbia and the 13 states and three Canadian provinces with the highest rates of opioid-related overdose deaths, more than one in 10 methadone clinics were not accepting new patients with one-third of those citing COVID-19 related factors as the reason, the researchers found.

"These results suggest that the methadone access shortage was exacerbated by COVID-19 and that changes to the U.S. opioid treatment program model are needed to improve the timeliness of access," the researchers say.

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