2023 was a big year for opioid addiction treatment.
In January, the Consolidated Appropriations Act (CAA) passed. At first glance, the $1.7 trillion omnibus bill didn’t seem to have much to do with drugs. It funded the federal government for the following year and supported a range of domestic and international needs, including assistance for the war in Ukraine.
But the CAA did something else, too. In one small section of the lengthy bill – Section 162, better known as the “MAT Act” – the measure made a historic shift. It quietly removed, for the first time in twenty years, the federal requirement for the “x-waiver,” the specific license practitioners needed to prescribe buprenorphine for opioid use disorder (OUD). With the swipe of President Joe Biden’s pen, any physician, nurse practitioner or physician's assistant with a DEA license (which is to say, the majority of healthcare providers in the United States) could now prescribe buprenorphine just like any other controlled substance, with none of the old waiver’s additional training or licensure required.
And that’s not all. The MAT Act also quietly removed the additional requirements that once were placed on the drug. Since 2003, when buprenorphine first came on the market in the form of Reckitt Benckiser’s Suboxone and Subutex, the federal government placed several significant curbs on its use. These included patient caps (which rose from 30 to 275), counseling requirements, and discipline restrictions. In the first month of 2023, however, all those burdens – which critics complained unfairly targeted and stigmatized buprenorphine, since they weren’t placed on any other drug – disappeared. After two decades as an outlier, buprenorphine was finally in the medical mainstream.
2023 was a big year for methadone, too – thanks in part to changes originally wrought by the pandemic. For decades, since methadone’s national debut in the 1970s, critics complained that its system in America seemed frozen, unable (or unwilling) to change. For over fifty years, on every day but Sunday patients were forced to line up early outside their specialized clinics – few of which existed nationwide – to have a nurse watch them take their dose, and then submit to burdensome levels of drug testing and counseling. For many, being tied to both clinic and medication made methadone more “liquid handcuffs” than treatment.
When Covid swept the country, however, the need for social distancing outweighed the need for observed dosing, and in March 2020 SAMHSA released an exemption that allowed both “stable” and “less-stable” patients to receive between fourteen and twenty-eight take-home doses right away, to keep people from the clinic and “protect public health.” This was an enormous shift. Previously, SAMHSA’s federal standards stipulated that patients had to show two years of stable clinic attendance to receive a month’s worth of take-homes. But because of Covid, decades of stringent regulations were overturned and, with the medical director’s approval, patients could receive that amount almost immediately.
Even the DEA, never a fan of methadone, expanded access to the drug during the pandemic. In June 2021, the agency released new rules that allowed clinics to operate mobile vans to distribute methadone in underserved areas – no small feat since the agency itself had a moratorium on these units since 2007. Within a year, clinics in Rhode Island, New Jersey and New York reported utilizing these useful, but extremely expensive, vehicles.
By 2023, the effects of all this expansion were clear – and they were great. A Columbia University study of over 1,200 methadone patients found those with increased take-homes were no more likely to overdose or drop out of their programs than those who attended clinics every day, and states are expanding mobile services as more funding becomes available. As for buprenorphine, the federal Department of Health and Human Services found that increasing the potential number of prescribers did not result in an increase in diversion or misuse.
Now SAMHSA wants to make these changes permanent. Dr. Yngvild Olsen, director of SAMHSA’s Center for Substance Abuse Treatment (CSAT) and the medical director of a methadone clinic in Baltimore, spent 2023 taking public comment on rewriting the rules to make immediate access to high levels of take-home doses an official part of the federal guidelines, and the fate of the shift seems promising. Because of the popularity of expanded take-homes, the change, which SAMHSA argues promotes “clinical and person-centered decision making,” is expected to pass in spring 2024. It marks the first significant alteration of federal methadone guidelines in years.
Like I said, 2023 was a big year for opioid addiction treatment. After twenty years as an outlier, the CAA’s passage in January made buprenorphine the prescription equivalent of Adderall or Xanax, and after fifty years as one of the most burdensome forms of medical treatment in America, SAMHSA spent the past year formalizing rules that finally loosened methadone’s “liquid handcuffs” a bit. Thanks to last year’s changes at the federal level, the two drugs many call the “gold standard” of addiction treatment are more available now than ever before.
But if access to medications rose in 2023, so did something else: overdose deaths.
Official numbers are still coming in (and are always an estimate at best), but preliminary reports found that over 110,000 people died of overdose between April 2022 and April 2023. That’s over three hundred overdose deaths a day. And over 75,000 of those deaths were directly attributable to opioids like fentanyl, which dominates America’s illicit market, alongside new additions like xylazine and nitazenes. The opioid overdose crisis, simmering since the late 1990s, has reached a multi-year boil. Despite the increased availability of methadone and buprenorphine, illicit opioid use in America is now so dangerous and deadly – and, unfortunately, so extremely popular – that the country has experienced over 100,000 overdose deaths every year since 2021.
How could this be? And, more importantly, how could this be made better?
There are several competing ideas. With the equivalent deaths of a Boeing 747 crashing every day, the opioid epidemic is hard to ignore, and everyone from activists to congressmen are demanding solutions, which run the gamut of political and social thought. Some argue that legalization is the only way out, like in Oregon, where, to better address addiction as a public health issue, voters decriminalized nearly all drug possession in 2021. Others argue for more law enforcement – also like in Oregon, where voters are now reassessing their new law in the wake of high levels of open-air drug use and rising crime. Federally, the Biden administration has thrown its support behind harm reduction, perhaps in penance for Biden’s own legislative past.
For a country that supposedly defines addiction as a disease, however, all of these responses miss the point.
The most cogent reaction to the overdose epidemic came in December 2023 from the New York Times, in an editorial by Jeneen Interlandi. Its title – “We Already Know How to Treat Addiction” – tells its story. The country’s staggering number of overdose deaths could be prevented, Interlandi argued, if Americans simply treated addiction like the disease we say it is: with effective medications, proper funding, and scientific support.
Over the past fifty years, the medical treatment of opioid addiction has coalesced around a series of recognized, evidence-based, peer-evaluated medical protocols, which have transformed addiction from a moral failing into a functionally livable chronic disease. There are three drugs available to treat OUD – methadone, buprenorphine, and naltrexone – alongside a “growing roster of treatments (medications, behavioral therapies, counseling and other supports),” Interlandi wrote, which “have proved just as effective at managing addiction as statins are at managing cholesterol or aspirin is at preventing heart attacks.”
This makes the solution to the overdose epidemic easy. If we want to contain America’s leading cause of accidental death, Interlandi argues, we simply have to make treatment, especially with medications, more accessible and more appealing than the illicit opioid supply. “Evidence suggests that many more people would make use of these treatments if only they were easier to access,” she writes.
But increasing access to treatment isn’t so easy – as the reality of those changes made in 2023 attests.
MAT: Theory versus Practice
In theory, last year’s changes made medication-assisted treatment, or MAT, more available than ever, as federal access to methadone and buprenorphine increased. In practice, however, very little actually changed – as evidenced by the country’s rising overdose rates – because very little actually shifted on the ground. This is because federal regulations aren’t the only things standing in the way of getting people the treatment they need.
There are currently about 2,000 methadone clinics (or opioid treatment programs, OTPs) currently operating in America, treating about 600,000 people a year. This is by far the largest number of clinics and patients in the country’s history. But SAMHSA and the DEA aren’t the only groups regulating this treatment. Over the past fifty years, since the Nixon administration first created a nationalized methadone clinic system and the Reagan administration subsequently privatized it, a number of different entities – including states, municipalities, insurance companies, benefits programs, and accreditation agencies – have all laid claim on influencing methadone policy. And because methadone remains one of the most unpopular and stigmatized forms of treatment in America, many of these additional rules have made methadone harder, not easier, to access. This has had unfortunate ramifications for SAMHSA’s increased take-homes.
Despite the horrors of Covid, it quickly became clear that not every state wanted to be a part of the methadone revolution. A recent study found that several states, including Montana and Hawaii, never adopted the relaxed federal standards, while four others (Ohio, Indiana, Florida and Mississippi) rescinded the policy shortly after the pandemic peaked. This is compounded by the fact that some states, like Wyoming, don’t have any OTPs, and West Virginia, a state with one of the country’s highest overdose rates, has had an unofficial moratorium on opening new clinics for years. SAMHSA might be trying to make methadone easier and more accessible for the drug’s over-half-million current patients, but those efforts don’t make much of a difference when they’re not implemented on the ground. With methadone also under the thumb of State Opioid Treatment Authorities (SOTAs), local officials, and insurance reimbursement rates – all of which often have very different ideas about how the drug should, or shouldn’t, be made available – finding universal agreement to change national policy is as slow and difficult as “turning around an aircraft carrier,” said Mark Parrino, president of AATOD, the country’s largest methadone advocacy group, “not a PT boat.”
If traditional methadone clinics won’t change, then Interlandi and others suggest a workaround: get methadone out of its specialized clinics and into the medical mainstream. This could be done by allowing private physicians to use methadone to treat OUD the same way they can now prescribe buprenorphine, and in 2023, demands to “liberate methadone” emerged everywhere from the pages of the New York Times to conferences hosted by New York University. The idea has particular resonance on Capitol Hill. In March of last year, Rep. Donald Norcross, Democrat of New Jersey, introduced the Modernizing Opioid Treatment Access Act (MOTAA), which would allow board-certified addiction specialists to prescribe methadone for OUD and pharmacies to dispense it. “Improving access to treatment saves lives, period,” Norcross said. He blamed the “cartel of for-profit clinics” for holding a “monopoly on this life-saving medicine.”
In theory, Norcross’s idea is a good one. MOTAA would allow trained doctors to prescribe methadone – a medication successfully used to treat OUD for over six decades – at a moment when the overdose epidemic is at its peak. But if cries to liberate methadone are humane, Norcross’s legislation ignores two unfortunate realities.
The first is that MOTAA won’t make much of a difference. Addiction medicine only became a board-certified specialty in 2016 (previously, medical schools rarely taught addiction treatment), and there are only around 5,500 physicians nationwide who fulfill Norcross’s criteria. If estimates of 7.6 million Americans suffering from OUD are correct, each of these doctors would have to treat over 1,200 patients apiece to make up the difference. That situation seems unlikely.
So why not “liberate methadone” further and expand prescribing ability to all DEA-certified physicians, just like we did with buprenorphine last year? Because that risks ignoring the second unfortunate reality: most doctors don’t want to treat addiction. Twenty years of buprenorphine’s stunted prescriptions attest to this fact.
In the beginning, Suboxone was primarily limited to profiteering private practitioners, who ran lucrative “pill mill”-style clinics that charged exorbitant prices for prescriptions. Many blamed this situation on the drug’s expensive cost, lack of insurance coverage, and the “x-waiver” that kept benevolent doctors from participating. Over the past decade, however, as Obamacare expanded Medicaid coverage for addiction and cheaper generics were introduced, buprenorphine access has been democratized. Last summer I visited a mobile treatment van parked outside the Baltimore City detention center that offers immediate access to buprenorphine for “just-released people and other community members,” so they can “easily get the treatment they need.” Over the past twenty years, buprenorphine has trickled down from the mostly white patient population of the 2000s to inner-city treatment programs today.
But that’s not due to an increase in the private treatment of addiction. Despite spiraling rates of overdose deaths, prescriptions for buprenorphine didn’t spike when the x-waiver was removed and they haven’t substantially risen since. Instead, most doctors continue to avoid the task. This is in large part due to stigma – as Dr. Nel Trasybule, a University of Maryland primary care physician, told the New York Times, “I definitely wouldn’t want [buprenorphine prescriptions] to be the main reason patients are coming to see me.”
But it’s also due to the fact that, with the increased privatization of medical care, physicians are already burned out from their demanding schedules and are leaving the medical field in droves. Asking America’s already-stressed private doctors to treat the country’s worst-ever addiction crisis is idealistic at best and naive at worst, because it ignores the realities of our overburdened system. Treating addiction is “just one more thing at a time when we’ve been doing a lot of one-more-things,” said Megan Wojtko, director of community clinics in rural Maryland – and unlikely to happen when clinics are already overwhelmed by the country’s myriad other ills.
It’s also due to the fact that, in the era of fentanyl, treating OUD is more difficult than ever. Previously, a heroin user could be maintained on 12 to 24 milligrams of buprenorphine a day, or between 80 and 120 milligrams of methadone. But with fentanyl, which is fifty times stronger than heroin, the treatment situation is changing. Patients report that buprenorphine, a significantly less potent drug than methadone, simply can’t hold off withdrawal symptoms, and they need up to 180 milligrams of methadone a day to feel stable – a daunting prescription for the average family physician when as little as 30 milligrams can kill an opioid-naive person. Methadone is also a lot of work. Patients require four to six weeks of close observation as they’re slowly stabilized on the drug, something many doctors won’t have time to do. As practices get gobbled up by private equity firms and doctors have as little as fifteen minutes with each patient, it’s unwise to expect large numbers of private practitioners to take on the complex and intimidating process of methadone management, which is precisely what the “liberate methadone” movement seeks to do.
Alternative Options
All this leaves us in a pickle. On one hand, 2023 was a big year for opioid addiction treatment because well-intentioned and humane policy shifts at the federal level made methadone and buprenorphine more accessible than ever. On the other hand, however, 2023 was a terrible year for addiction treatment. Because of disinterested doctors and intransigent states, real access to methadone and buprenorphine was still blocked, and the country experienced its largest-ever number of overdose deaths – evidence that those federal expansions, no matter how well-intentioned, were insufficient to the problem at hand.
So what should we do instead? It’s clear that our current efforts aren’t enough. To truly decrease overdoses in 2024 and beyond, we can’t just rewrite guidelines that states don’t have to follow, or get rid of “x-waivers” that weren’t making a difference anyway, or put more methadone vans on the street. Ultimately, 2023 was an important year for addiction treatment because it provided the clearest image yet of just how inadequate and dysfunctional our response has been – and how deadly are the failures of not responding forcefully enough when fentanyl is killing over 75,000 people a year.
It’s time to explore something else, an alternative which I’ll outline in February in Part II of this essay. But I should also note that it shouldn’t be this hard. As Interlandi argued in the New York Times, it’s not like treating opioid addiction is impossible. We have three effective medications and over six decades of scientific research that show us precisely what to do. And it’s not as though other countries haven’t figured it out. Switzerland and Portugal have already used this research – our research, since methadone and buprenorphine treatment were developed by American doctors – to develop effective, functional systems of their own, which have lowered overdose deaths and rendered OUD a livable disease. The numbers make this clear. In contrast with America’s 100,000-plus deaths, Switzerland experienced just 160 overdoses in 2022.
We simply have to do what our research calls for – something I’ll outline in Part II. If we do, we’ll finally start to lower the country’s terrifying annual tally of overdose deaths, and finish a project we started a half-century ago.