As fentanyl proliferates the illicit drug market and opioid-related overdoses surge, access to the life-saving medication methadone is more critical than ever.

Efforts to increase access to take-home methadone have paid off, and the Substance Abuse and Mental Health Services Administration (SAMHSA) cemented COVID-era flexibilities earlier this year.

For substance use disorder (SUD) treatment providers involved with methadone prescribing, SAMHSA’s final rule simplified processes and extended significant benefits for patients. Still, pain points remain for this segment of the SUD industry.

The field of methadone prescribing is unusual from other types of medicine in that it is structured based on laws and regulations, Dr. Michael Giles, CEO of Sonara Health, told ATB.

“That’s not normally how medical practice is structured,” Giles said. “It’s normally structured around what the evidence says is the best thing to do, and that wasn’t possible until very recently in this space.”

Dallas, Texas-based Sonara partners with Opioid Treatment Programs (OTPs) to increase patients’ access to take-home methadone using secure, QR-code-labeled methadone bottles, which patients record themselves taking on a web-based application.

Patients using the Sonara system receive an average of twice the amount of take-home methadone compared to patients not using Sonara who have been in treatment for a similar amount of time, Giles told ATB.

Sonara raised $2.25 million in 2020 from “shark” investor Mark Cuban and other investors. In 2022, the company secured an additional $3 million from First Trust Capital Partners and Blue Cross Blue Shield of Kansas.

Methadone flexibilities have also been good for Sonara’s business. Before the changes in regulation, the company partnered with nine OTPs and has since added 30 additional partnerships, Giles told ATB.

Methadone can reduce opioid cravings and sustain recovery from opioid use disorder (OUD). Patients are required to receive the medication under a clinician’s supervision, but daily visits to OTPs can profoundly impact a patient’s life by making achieving employment difficult, for example. Older patients or those with limited mobility can also struggle to attend in-person visits.

SAMHSA’s final rule enabled OTPs to provide more personalized care, including the removal of length-of-treatment guidelines for take-home methadone.

“[SAMHSA’s final rule] simplifies complicated daily transportation issues, improves the productivity of employed patients and provides patients the flexibility to continue their treatment at home when determined to be safe and medically appropriate by our medical providers,” Dr. Joshua Hall, medical director for Crossroads Treatment Centers, told ATB in an email. “This also brings a welcome responsibility for medical providers to carefully evaluate the appropriateness of each patient on a personal level for treatment at home.”

Greenville, South Carolina-based Crossroads operates more than 100 outpatient SUD facilities in nine states, including Georgia, Kentucky, New Jersey, North Carolina, South Carolina, Pennsylvania, Tennessee, Texas and Virginia. Founded in 2005, Crossroads offers patients medications for SUDs, counseling, peer support and care coordination as part of an individualized, comprehensive treatment plan.

Private equity firms Revelstoke Capital Partners and Canada-based Caisse de dépôt et placement du Québec (CDPQ) recapitalized Crossroads in 2022. The company named ex-Landmark Health regional medical officer Dr. James Stephen its chief medical officer in 2023.

Regulations differ across state lines

While access to take-home methadone has improved on a federal level, some states maintain more restrictive regulations.

In January, SAMHSA released a map identifying which states concurred with post-COVID flexibilities. While most states concur with take-home MOUD flexibilities, seven states, including Indiana, Montana and Wisconsin did not.

Substance Abuse and Mental Health Services Administration Substance Abuse and Mental Health Services Administration

SAMHSA gave State Opioid Treatment Authorities (SOTAs) until October 2024 to decide whether to align with the final rule, Dr. Ben Nordstrom, chief medical officer at Behavioral Health Group, told ATB in an email.

“We are a multistate operation, so we are making sure our policies and procedures hew to whichever regulations, federal or state, are more restrictive,” Nordstrom said.

Dallas, Texas-based BHG operates more than 110 OTP facilities in 22 states. The provider applies a comprehensive approach to OUD treatment, including access to medication, counseling, family therapy and medical services, among other offerings.

BHG acquired Boise, Idaho-based Center for Behavioral Health in 2022 and has partnered with Sonara.

For Crossroads, the rule provided “clear guidance,” but the provider, like BHG, must still maintain compliance with states with more stringent stipulations.

Acceptance of the final rule “varies a lot,” Giles said. Some more conservative states have not yet commented on whether they will adopt the new SAMHSA rules.

“It makes it difficult for us to convince providers to utilize Sonata because they don’t feel confident that they’re not breaking any rules,” Giles said. “A big part of what we do is work directly with the state opioid treatment authorities to help create frameworks for how the SOTAs can think about the new SAMHSA rules.”

Despite state-by-state differences, providers agree that SAMHSA’s final rule, which still maintains the structure of OTPs, will help patients.

“SAMHSA picked a good time to rethink the regulatory structure around OTP operations,” Nordstrom said. “The drug landscape is very fluid right now, and programs need flexibility to deal with the new challenges. We always did, but it is more important now than ever.”

Other challenges and solutions

While lagging consensus on take-home methadone flexibilities remains an issue for multistate OTPs, other problems still plague the industry.

Nordstrom identifies affordability as among the greatest barriers to MOUD access, and the greatest opportunity to improve the status quo.

Patients with the ability to pay are much more likely to enter treatment that can cut the risk of death from an opioid overdose in half, he said.

“The federal government has stepped in and been the payer of last resort for other conditions,” Nordstrom said. “For example, Medicare will pay for anyone who needs hemodialysis if they have no other payer. I wish we could find the political resolve to make resources available for people to get medication for OUD in the same way.”

Medicaid re-determinations have also created additional barriers to care, Nordstrom said. Patients who were disenrolled from Medicaid resulted in many patients having to pay for treatment out of pocket. Patients who live in states that did not expand Medicaid were impacted to a greater degree, he said.

Other social barriers to methadone access include stigma, discrimination in health care settings and criminal justice system inequities, according to research.

The stigma surrounding methadone is top of mind for Hall. Research has shown that stigma can deter patients from seeking treatment and contributes to the underutilization of methadone.

“Another misconception around substance use treatment is that it’s not effective, which is simply not true, or that it has a “timeframe” and it should work in three months, six months, a year,” Hall said. “But what many people don’t realize is that substance use disorder is a chronic disease. … Any roadblocks or policies that keep people from getting primary healthcare and the substance use treatment they deserve is something we need to look at to improve health equity.”