In the late spring of 2020, during the height of the COVID-19 pandemic – before the rollout of the vaccines – the federal government, along with community, municipal, and state partners, made several important changes to rules around medication-assisted treatment for opioid use disorder (MAT for OUD). They changed rules around prescriptions and refills. They also changed rules around payments for MAT by Medicare and Medicaid.
Around the country, those changes increased access and reduced harm caused by the opioid addiction and overdose crisis at a critical time.
In May 2023, the public health crisis that allowed the federal government to implement nationwide changes in health policies will officially end. That means many of the restrictions placed on the initiation, prescription, and ongoing use of MOUD in MAT programs may return.
The question many treatment providers, treatment advocates, and people who use MOUD in MAT programs currently want answered is this:
Will the changes that increased access and reduced harm stay in place?
The big-picture answer to that question is good news:
Yes, most policies that increased access and reduced harm among people with OUD will stay in place.
That is very good news.
However, there’s one policy that may revert to pre-COVID rules. The requirement for an in-person visit with a physician within 30-days of initiation of treatment with buprenorphine, which is one of the three MOUDs – along with methadone and naltrexone – prescribed to people with OUD in MAT program might return. Treatment and harm-reduction advocates say reinstituting that rule could cause harm. Others say it will reduce the risk of buprenorphine diversion. Buprenorphine diversion means the use of buprenorphine for non-medical purposes.
This article will discuss that rule and the new law – the Mainstreaming Addiction Treatment Act – that’s ensures the best of the COVID-era policy changes regarding medications for opioid use disorder (MOUD) and medication-assisted treatment (MAT) will remain permanent moving forward. First, though, we’ll review exactly what we mean when we say MAT. We’ll also review the latest data on opioid addiction and overdose crisis.
First, the latest data.
The Opioid Crisis in the U.S.: The Latest Facts and Figures
Here’s the data on overall overdose and opioid related overdose for 2019-2021, as reported by the Centers for Disease Control (CDC):
- 2019:
- Total: 70,630
- Opioid-involved: 67,697
- 2020:
- Total: 91,799
- Opioid-involved: 78,056
- 2021:
- Total: 106,699
- Opioid-involved 73, 453
The latest complete 12-month time period we have verified data for is September 2021-September 2022, when 100,521 people died of overdose, with 75,862 attributed to opioids. That figure is not yet verified, but if that trend continues, we may see a small overall decline between 2021 and 2022 for the first since the decline between 2017 and 2018.
However, there’s something important to note in those provisional figures for 2022. While overall overdose fatalities declined, the number of fatal overdoses related to opioids increased. That makes the topic of this article – maintaining increased access to buprenorphine – more important now than ever. The increase in opioid fatalities is driven by fentanyl, an opioid that’s increasingly present in all illicit drugs sold on the black market in the U.S.
According to the Drug Enforcement Agency (DEA), the influx of fentanyl makes all illicit opioids more dangerous. Authorities estimate that over half of illicit drugs sold on the street now contain enough fentanyl to cause death: this is a frightening fact. However, misinformation and a lack of awareness around opioids means we risk associating dangerous drugs like fentanyl with FDA-approved medications for opioid use disorder and people on MAT.
Let’s make it clear: evidence shows medication-assisted treatment for opioid use disorder – including the disordered use of fentanyl-laced opioids – is a lifesaving, gold standard treatment.
What is MAT?
Here’s the official, most widely recognized definition of MAT, published by the Substance Abuse and Mental Health Services Administration (SAMHSA):
Medication-assisted treatment (MAT) is the use of medications, in combination with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance use disorders.
The Federal Drug Administration (FDA) has approved three medications for opioid use disorder (MOUD):
- Methadone: Decreases withdrawal symptoms, decreases cravings, prevents other opioids from acting on the brain
- Buprenorphine: Decreases withdrawal symptoms, decreases cravings, partially prevents other opioids from acting on the brain
- Naltrexone: Reduces cravings, prevents other opioids from acting on the brain, must be initiated after 7-10 days opioid abstinence
According to SAMHSA, people with OUD who engage in MAT programs show:
- Decreased rates of fatal opioid overdose
- Increased time in SUD treatment programs
- Reduced overall opioid use
- Reduced overall criminal activity
- Reduced infectious diseases transmission
- Improved ability to seek and gain employment
- Improved family and social function
- Decreased overall mortality
Those benefits – proven by decades of research – tell us in no uncertain terms: MAT is the gold-standard treatment for OUD, and we should do anything we can to increase access to MAT programs for people with OUD.
Why Keep The COVID-Era Changes to MAT?
In a data brief published in 2021, experts on addiction and medication-assisted treatment identified three reasons it’s important to maintain the new regulations around MAT as we move forward into a post-COVID era:
- Rates of opioid use disorder increased during COVID-19
- Opioid overdose rates increased during the pandemic
- Access to MOUD and MAT was reduced due to COVID-related issues
Data published since the pandemic shows that the changes instituted during COVID had a positive impact across the board, and did not result in any increases in MOUD related overdose death or the diversion of medications for opioid use disorder, including buprenorphine.
A study on the effect of the new regulations for buprenorphine showed the following:
- Between June 2019 and June 2021, buprenorphine was involved in:
- 2.2% of all overdose deaths
- 2.6% of opioid related deaths
- 92.7% of overdose deaths involving buprenorphine involved other opioids and other substances of misuse
Those figures make it clear that loosening restrictions on buprenorphine during the COVID-19 pandemic did not contribute to an increase in fatal opioid overdose. We’ll summarize the primary takeaway from this study with the words of Dr. Lauren Tanz of the CDC:
“These findings help us better understand the circumstances of overdose deaths involving buprenorphine, which is crucial in our ability to inform policy, ensure safety, and improve clinical outcomes for people with substance use disorders. It is important to note the presence of other drugs in overdose deaths involving buprenorphine. The complex nature of substance use disorders and polysubstance use requires specific strategies to address it.”
In addition, it’s critical to recognize the existence of the MAT treatment gap, which is the difference in the number of people who need MAT and the people who receive MAT. Here’s the latest data we have on that topic.
Medication-Assisted Treatment for OUD
- A total of 5.6 million people had OUD, including people with:
- Heroin use disorder
- Prescription opioid use disorder
- Other opioid-related SUDs
- 1.2 million people with OUD received treatment for OUD
- 533,000 people with OUD received MAT for OUD
- 1.1 million people received MAT for opioid use, with or without OUD diagnosis
- 887,000 who reported misusing opioids received MAT for OUD
We’ll translate that data into plain language: 90 percent of people diagnosed with OUD did not receive the gold-standard treatment for OUD, a.k.a. medication-assisted treatment (MAT). That’s another serious issue we can address by increasing our efforts around awareness, education, advocacy, and reducing barriers to care.
Let’s take a look at those changes – and the ones that will stay permanent as a result of the Mainstreaming Addiction Treatment (MAT) Act of 2022.
What Were the COVID-Era Changes to Buprenorphine in MAT?
Federal regulators changed rules in three areas: the initiation of buprenorphine treatment, the ability of physicians to write prescriptions for buprenorphine, and the ability of patients to get refills or take-take home doses of buprenorphine.
We’ll review those changes one by one, starting with treatment initiation.
Initiation of Buprenorphine Treatment
Before COVID, regulations required initiation to take place in a qualified provider’s office. In addition, an in-person exam by a medical provider was required for initiation of MAT.
During COIVD, regulations changed to allow initiation of MAT by a qualified provider’s office, but eliminated the requirement that initiation occur in-person in a qualified provider’s office.
MAT Act Changes
This is the one area where the MAT act draws criticism from providers and treatment advocates. Under the MAT Act, providers will be allowed to initiate buprenorphine treatment via telehealth – i.e. video or telephone – but new patients must be present for an in-person examination within 30 days of initiation.
Many advocates are certain this will reduce access and cause harm. To address these concerns, the new proposal – the rollback – is currently in a “30-day comment period, after which the DEA will consider public feedback before drafting final regulations.
Prescriptions for Buprenorphine
Before COVID, physicians or other qualifying practitioners were required to have a DEA waiver – called an “X waiver” – to prescribe buprenorphine.
During COVID, the federal government expedited the X waiver process and increased the number of patients a physician was permitted to prescribe buprenorphine.
MAT Act Changes
This is an area where advocates, providers, and the federal government agree: the X-waiver was an unnecessary burden that was a significant barrier to treatment. Under the MAT Act, the X-waiver is completely eliminated. This means that any physician – family doctors and addiction specialists alike – can prescribe buprenorphine for MAT. In addition, the MAT Act removed the limits on the number of patients a doctor can prescribe buprenorphine for MAT: now doctors can prescribe buprenorphine to all their patients who need it, with no restrictions on the total number of buprenorphine prescriptions allowed.
Refills for Buprenorphine
Before COVID, federal regulations limited patients to five refills without a new prescription and limited prescriptions and refills to a standard 30-day supply of the medication.
During COVID, federal regulations for buprenorphine refills did not change. However, some states allowed pharmacies to refill up to a 90-day supply of buprenorphine without authorization from the initial prescriber, or when COVID-19 prevented reauthorization.
MAT Act Changes
These rules will stay the same under the MAT Act. Some states will make the 90-day supply rule permanent, while others will not. For a state-by-state breakdown on current MAT prescriptions and prescription refill rules, please read “Overview of Opioid Treatment Program Regulations by State” published by the Pew Charitable Trusts.
How The MAT Act Helps People With OUD
We’ll be clear: some advocates think the MAT Act does not go far enough in easing MAT restrictions, some think it strikes a perfect balance, and others think it goes too far. Full disclosure: we can’t find anyone in the public record speaking out against the MAT Act. However, since the beginning of the harm reduction movement of which MAT is a part, there have been many critics of MAT and any rules making MAT more accessible.
A study published in 2017 describes how harm-reduction got a bad reputation in the U.S.:
“There has been fierce political resistance to implementation and scale-up of harm reduction in the USA. This resistance is rooted in historical demonization of particular psychoactive drugs that were associated with stigmatized racial/ethnic groups.”
Thankfully, with some notable exceptions that mischaracterize harm reduction strategies as “free crack pipes for all,” the political resistance to harm-reduction has faded in response to the staggering death toll associated with the opioid addiction and overdose crisis. Stigma still exists, though. But it has faded: both houses of Congress passed the MAT Act, and the President signed it into law.
With regards to concern about the diversion of buprenorphine increasing overdose risk, we’ll quote the authors of a recent study on the relationship of COVID-era changes on over 89,000 overdoses reported between July 2019 and June 2021:
“The findings of this cross-sectional study suggest that actions to facilitate access to buprenorphine-based treatment for opioid use disorder during the COVID-19 pandemic were not associated with an increased proportion of overdose deaths involving buprenorphine. Efforts are needed to expand more equitable and culturally competent access to and provision of buprenorphine-based treatment.”
We’re confident that when the dust settles and when experts finalize the new, post-COVID rules around MAT, policymakers will follow the evidence. We’re confident they won’t allow decades of stigma to guide their decision-making process. As of now, the evidence shows that MAT with buprenorphine saves lives. Evidence also shows the new rules created during the pandemic helped, rather than harmed, the individuals, families, and communities impacted by the opioid crisis.
Keeping the rules in place would reduce harm. We think they should stay in place. Why? Because reducing the harm caused by addiction is our primary goal, every day of the year.
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