Looming Regulatory Changes Could Remake MAT Access

The federal government is signaling big moves around deregulating medication-assisted treatment (MAT).

Key federal stakeholders have indicated reforms are a top priority going forward. Already, the House of Representatives passed the Restoring Hope for Mental Health and Well-Being Act, potentially clearing the way for easier prescribing of methadone and buprenorphine.

If realized, the changes to MAT regulation would remake the addiction treatment space. This could include widening access to naloxone and buprenorphine. It could also see methadone being available in primary care and retail clinics.

Advocates for deregulation say it removes barriers to much-needed care. Critics say wide deregulation, especially of methadone, puts patients’ safety at risk.

What’s happening now?

On Nov. 16, National Institute on Drug Abuse Director Nora Volkow said “there’s absolutely no reason” why primary care providers shouldn’t prescribe methadone. Volkow is the top addiction subject matter expert in the federal government. 

Methadone, a controlled substance and synthetic opioid, is underutilized, she said. Volkow added that Methadone should be dispensed in retail pharmacies like in other countries.

“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,” Volkow said at the STAT Summit.  

The long-running overdose death crisis in the U.S. has worsened since the pandemic. Deaths have increased by 42% following the pandemic’s onset.

Today, only opioid treatment programs (OTPs) may prescribe and dispense methadone. Patients in the early stages of recovery must take it onsite. Thus, patients must make daily trips to OTPs to get MAT. OTPs may give patients they deem stable take-home doses. The number of doses the federal government allows has temporarily been increased in reaction to the pandemic.

Also on Nov. 16, the Food and Drug Administration said auto-injector and nasal sprays of the opioid overdose reversal drug naloxone could be safely dispensed without a prescription. This is an early-step determination for the FDA to clear the way for over-the-counter naloxone. 

Congress’ final effort before the new year might include Restoring Hope for Mental Health and Well-Being Act. The bill encapsulates several behavioral health reforms introduced by several lawmakers. This bill, in part, would eliminate the X waiver. The X waiver requires physicians to receive additional certification to prescribe buprenorphine. It also limits the number of patients physicians may treat with buprenorphine.

The big picture

About 6.5% of people who report having a substance use disorder (SUD) receive treatment for it. About 11% of people with an opioid use disorder (OUD) received MAT, according to the latest National Survey on Drug Use and Health.

Volkow said regulations on providers and patients limit MAT in spite of its efficacy. Some studies show methadone sees over four times higher retention rates and better long-term outcomes independent of the frequency of counseling in treatment.

At the federal level, intermingling crises have led to a greater focus on behavioral health. Most notable, these include the coronavirus pandemic, the mass murder at Robb Elementary in Uvalde, Texas, and the overdose death crisis.

The American Rescue Plan Act, passed into law in March 2021, added $900 million in new funding to two major behavioral health workforce aid programs. In June, the Bipartisan Safer Communities Act appropriated $2.16 billion for mental health initiatives and expanded Medicaid-backed behavioral health clinics.

All of this is in line with Pres. Joe Biden’s unity agenda, a health care-heavy agenda he laid out during his state of the union address.

What’s next for MAT?

Before the election, Congress packaged several behavioral health and other health care bills into the Restoring Hope for Mental Health and Well-Being Act (H.R. 7666). It cleared the house on a bipartisan vote of 402-20.

The National Defense Authorization Act or government funding bill may provide a vehicle for H.R. 7666 to pass. Both are must-pass bills and could have space for large reforms with their already large funding numbers and wide purview. The former authorizes defense spending while the latter keeps the federal government open.

And all the while, advocates will push legislators to see things their way.

“You have a number of policy officials that are very disconnected from the clinical realities of treating the patient,” Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD), told Behavioral Health Business.

AATOD opposes the deregulation of methadone and the elimination of the X waiver. AATOD is an OTP and opioid treatment provider advocacy group.

The realities Parrino mentions include the rise of fentanyl as the main driver of overdose deaths and those seeking treatment at OTPs. Fentanyl, which is much more powerful than other opioids, requires higher doses of methadone to stabilize patients. His worry is that the system of primary care providers and retail pharmacies won’t provide adequate oversight, leading to more overdose deaths.

For buprenorphine, the worry is that it won’t be paired with other therapies, raising the question of what kind of treatment people with SUD will receive in primary care settings.

“That’s highly problematic because we’re in an age of treating very complex opioid use disorder driven by fentanyl,” Parrino said.

Several other groups have expressed their desire to see the X waiver go.

Pamela Greenberg, CEO and president of the Association for Behavioral Health and Wellness, an insurance industry group, told BHB that there is support for nixing the X waiver. Her organization would like to see it go.

The X waiver flexibilities and other telehealth prescribing flexibilities could end with the federal public health emergency declaration. This could bludgeon a burgeoning virtual MAT segment that has landed millions of investment dollars and grown quickly during the pandemic.

“It’s the only treatment that currently requires this additional waiver to be able to prescribe,” Doug Nemecek, chief medical officer for behavioral health at Cigna’s health service arm Evernorth, told BHB. “We recognized concerns about pill mills for opioids. … However, the bigger picture is that people need access to this evidence-based treatment that don’t have it today, … and treatment models exist that allow this to be done in a safe and effective way.”