HHS Expands Access to Methadone, Buprenorphine

As part of a broader overdose prevention strategy, the Biden administration announced changes to decades-old federal rules, which aim to simplify and expand access to addiction treatment in order to save more lives.

Specifically, the final rule, issued by HHS, makes permanent pandemic-era flexibilities that allow eligible patients with an opioid use disorder (OUD) to receive take-home methadone doses. Studies have suggested that take-home doses improve treatment adherence and reduce patients’ risk of illicit opioid use, according to a Substance Abuse and Mental Health Services Administration (SAMHSA) press release.

“At HHS, we believe there should be no wrong door for people who are seeking support and care to manage their behavioral health challenges, including when it comes to getting treatment for substance use disorder. The easier we make it for people to access the treatments they need, the more lives we can save,” said HHS Deputy Secretary Andrea Palm in the press release.

In addition, the administration announced that grant dollars can now be used to buy xylazine test strips, providing one more mechanism for preventing overdose deaths. Xylazine, a veterinary tranquilizer thought to be involved in a growing number of overdose deaths, is approved by the FDA for use in animals, but has not been approved for use in humans. HHS released a specific plan to address fentanyl-laced xylazine in July 2023.

The new final rule also includes the following additional provisions:

• Allows the use of telehealth to initiate treatment for an OUD and to reduce transportation barriers; for treatment with methadone, audio-visual telehealth is allowed, and for treatment using buprenorphine, audio-only technologies are permitted
• Allows nurse practitioners and physician assistants to order medications in opioid treatment programs, where state laws permit such a practice
• Eliminates “stringent admission criteria,” which previously restricted eligibility for treatment to those with at least a 1-year history of addiction
• Increases access to “interim treatment” by enabling patients to start medications while waiting for additional services to become available

“While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible,” said Miriam E. Delphin-Rittmon, PhD, the HHS Assistant Secretary for Mental Health and Substance Use, who leads SAMHSA, in the press release.

“In short, this update will help those most in need,” she added.

Delphin-Rittmon also highlighted SAMHSA’s updated “Overdose Prevention and Response Toolkit,” which was released earlier this week and provides guidance on the role of opioid overdose reversal medications, and how to respond to an overdose.

Importantly, in January 2023, the Biden administration also eliminated the X-waiver requirement for clinicians who use medications to treat patients with substance use problems.

The Biden administration aims to invest $83 billion in treatment, which is 42% more than under the Trump administration, according to a White House press release.

“Under President Biden’s leadership, we have invested more funding and broken more barriers to treatment than any previous administration,” noted Rahul Gupta, MD, MPH, director of the Office of National Drug Control Policy. “As a physician who has provided addiction treatment firsthand, I know these actions can mean the difference between life or death.”

Bobby Mukkamala, MD, chair of the American Medical Association’s Substance Use and Pain Care Task Force, hailed the final rule as a “step in the right direction in the fight against the worsening overdose epidemic.” The task force was especially pleased to see the administration’s focus on increasing equitable access to care and reducing the stigma around treatment, he said.

“Whether audio-only, video visits, or in-person appointments, physicians provide high-quality, evidence-based care for OUD, including prescribing medication that can save lives,” he noted. “Modernizing rules and regulations for prescribing these medications continues to be of paramount importance.”

The final rule takes effect April 2, with a compliance date of October 2.

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