Two critical medications were made more easily available and saved lives, but old restrictions may return.
America’s opioid crisis spiked during the COVID-19 pandemic. Economic disruption, social isolation, and despair all helped drive fatal overdoses to one record number after another from 2020 to 2022.
However, one good thing happened during the pandemic in the battle against opioid deaths: Federal policymakers who regulate two Food and Drug Administration-approved medications used to treat opioid use disorder (OUD)—buprenorphine and methadone—came up with innovative ways of providing access to this evidence-based care. This proved critical in helping people obtain lifesaving treatment during a time of social distancing and other pandemic-related obstacles.
Access to these drugs has traditionally been tightly regulated. For example, doctors were required to have a Drug Enforcement Administration (DEA) waiver to prescribe buprenorphine to patients, who had to be seen in person (doctors were also limited in the number of patients they could see and were subject to random DEA audits), and methadone patients had to pick up their medication in person each day and be observed taking it.
But during the federal COVID-19 public health emergency declaration, doctors were permitted to prescribe buprenorphine via telehealth appointments for the first time, and Congress passed legislation eliminating the DEA waiver rule. Another flexibility installed during the pandemic allowed opioid treatment programs (OTPs)—facilities that provide OUD medications and the only ones allowed to dispense methadone—to provide up to 28 days of take-home medication for patients, instead of making people go to the facility every day to collect single doses.
Now that the health emergency has officially been declared over as of May 11, some of the pandemic innovations will remain in place—but there are efforts at both the state and federal levels to roll back others, which worries Dr. Brandee Izquierdo, the director of Pew’s behavioral health programs.
“These policies undoubtedly saved lives,” Izquierdo says. “We’ve made progress; now is not the time to go back.”
Izquierdo leads Pew’s substance use prevention and treatment initiative, which focuses on increasing access to evidence-based treatment for people with OUD. Pew’s initiative employs more than 20 staff members based in Washington, D.C., and provides research and technical assistance to regulators in efforts to address the opioid crisis.
“COVID exacerbated the opioid crisis exponentially,” Izquierdo says.
Izquierdo, herself a person in long-term recovery, points out that many people with OUD often have to remain on medication for life.
She grew up in a family with drug and alcohol issues, she says. Her first encounter with alcohol at age 11 “unleashed a beast.” Before she reached adulthood, she was addicted to multiple substances. At one point, she found herself in a jail cell.
“I was just lucky enough to have access to treatment,” Izquierdo says. She has been in recovery for over 12 years, during which time she has earned bachelor’s, master’s, and doctoral degrees from the University of Baltimore and forged a career focused on expanding access to behavioral health and recovery services.
Izquierdo knows the cruelty of addiction and the importance of clearing away obstacles to medical treatment when a person who uses drugs is experiencing withdrawal and trying to enter recovery. Opioid sickness is quick and painful, and “if people cannot get access to lifesaving medication, they are going to go to the street to find it or something else,” she says.
Illicit drugs have always been hazardous, but today they are more dangerous than ever before—often contaminated with illicit fentanyl, a synthetic opioid that can be deadly even in small doses. To make things worse, that drug is now often combined in the street market with xylazine, an animal tranquilizer, with disastrous results.
Preliminary data from the Centers for Disease Control and Prevention indicates that about 109,000 people died of drug overdoses in the United States in 2022, and opioids were far and away the No. 1 cause.
Overdose deaths have been increasing for many years, according to the CDC WONDER online database. Deaths rose from under 20,000 in 2000 to almost 71,000 in 2019, the last year before the pandemic. In 2020, as the pandemic hit, drug-involved overdose deaths increased dramatically to more than 106,000. While the number also went up in 2022, the rate of increase slowed down.
The effects of the pandemic hit hard in inner cities, where OTPs are a principal source of medications for people with OUD. Patients in treatment found that getting to their OTPs every day became more difficult because of disruptions in public transportation, reduced availability of child care, and the health effects of COVID-19 itself, as well as a fear of catching it.
Racial disparities also became more apparent. The CDC reports that Black Americans die from overdoses at a far higher rate than White or Hispanic Americans, and fewer Blacks than Whites have access to treatment—especially buprenorphine, which is most often prescribed in private doctor’s offices and obtained at pharmacies.
“Buprenorphine is widely used—I’ll just say it—in White communities,” says Philip Rutherford, chief operating officer at Faces & Voices of Recovery in Minnesota. “Buprenorphine does not have the same adoption rate in Black and Brown communities, and there is a lack of equity in prescribing buprenorphine.”
Which is why the pandemic-era flexibilities around buprenorphine—including telehealth access—were so important. Telehealth increased access to this medication across a broader pool of patients. Racial and ethnic minorities, veterans, people experiencing homelessness, individuals involved in the criminal justice system, and those living in rural areas were all found to have greater access to buprenorphine via telehealth.
Researchers found that remote visits rapidly increased for patients either beginning or continuing buprenorphine treatment. Patients also noted greater satisfaction with remote care, saying that with telehealth, geography or transportation issues no longer limited their ability to receive treatment, and that virtual visits felt less stigmatizing than in-person care. They also said that having a choice in how they received care was important.
In December, President Joe Biden signed an omnibus bill from Congress that included the Mainstreaming Addiction Treatment (MAT) Act, which permanently removed the requirement that doctors obtain a special waiver from the DEA to prescribe buprenorphine. And in January, the Substance Abuse and Mental Health Services Administration (SAMHSA) followed up with regulatory guidance on the medication, saying that any physician with a standard DEA registration number can now prescribe buprenorphine, making it more widely available.
The new law also seeks to reduce the stigma associated with addiction treatment by calling for a national campaign to encourage health care providers to incorporate medication treatment for addiction into their practices. Long-standing stigma around who is treated for OUD, sometimes even from medical professionals, can often prevent patients from getting help, and doctors from wanting to offer this lifesaving care.
In other changes to care access, as the pandemic hit full force in March 2020, SAMHSA loosened methadone restrictions to permit take-home supplies of either 14 days or 28 days for patients considered stable.
There were fears—still shared by some in the field of addiction prevention and treatment—that patients would overdose on take-home medication or sell it on the street.
But SAMHSA cites research showing relatively few incidents of misuse or diversion, meaning distributing the drug to another person. The agency also reports that take-home medication has led to greater patient engagement with treatment and higher patient satisfaction.
And a Pew study in collaboration with George Washington University and New York University found that take-home medication has eased burdens on patients, given them an improved sense of self-esteem and autonomy, and also helped them stay in recovery longer.
To Rutherford, this makes sense. “People are going to do what they need to do to not get ill from opioid withdrawal,” he says. “They are going to use their medication correctly because they don’t want to get sick.”
Tiffinee Scott, a peer recovery specialist who has lost family members to overdose, is an advocate and organizer who chairs the Maryland Peer Advisory Council. She says that allowing take-home medication has lessened—but hardly eliminated—the stigma of going to an OTP and being observed by a staff member taking medication. Such observed dosing, as well as requirements for urine screenings, are viewed by many in the recovery field as punitive rules that reflect a distrust of patients and add to the stigma of OUD.
“A person with diabetes requires their medication; what is the difference for a person who is sick with opioid use disorder?” Scott asks. “If I can get heart disease medication that lasts for 30 days, why shouldn’t I be able to get medication to prevent opioid sickness? I think it’s just stigma. We choose to label people instead of supporting people.”
The loosening of methadone rules started as a COVID-emergency measure, but the federal agency has now moved to make it permanent: In December, SAMHSA proposed rules to codify the changes.
Some states, however, are still convinced that letting patients get up to 28 days of methadone will lead to more overdoses and street sales, Izquierdo says. And because states can install their own layer of regulations on these medications, there is sometimes a disconnect between federal regulations and those at the state level.
Many states have rules governing OTPs that are not based in evidence and in turn limit access to care or worsen patient experience.
Nineteen states and the District of Columbia impose barriers on the opening of new OTPs. West Virginia is the most restrictive; no new OTPs are allowed there. And throughout the country, OTPs are not available in many communities, especially in rural areas, with not a single OTP in the state of Wyoming.
Twenty-three states impose regimented, one-size-fits-all counseling schedules for patients on methadone treatment, rather than allow individualized care. However, established research shows that medication alone can be effective without counseling.
Twenty-six states require methadone patients to undergo more frequent urine screenings for illicit drug use than what is required by federal regulation. Izquierdo believes that also is not necessary—and adds to the hurdles facing patients trying to stay in recovery.
Even some OTPs, Izquierdo says, are unsure about the benefit of loosening regulations.
“We have a lot of opioid treatment programs saying there are negative issues with providing methadone on a take-home basis,” she says. “They say, ‘We need to be able to see the patients to make sure they are taking their dosage correctly.’”
Pew sees the waiver removal, now made permanent through the MAT Act; broadening of the number of physicians eligible to prescribe buprenorphine and allowing access to the medication through telehealth appointments; and reform of methadone restrictions as victories for reducing addiction harm. But progress has been “two steps forward and one step back,” Izquierdo says.
In February, the DEA proposed a new rule that would reinstate many pre-pandemic requirements and disallow telehealth appointments for buprenorphine treatment. It was concerned that buprenorphine would be sold on the streets.
“The idea was, OK, we’re over the hurdle; the COVID emergency is lifting,” Izquierdo says. “The impulse was to go back to the nonemergency policies. But you can’t ignore evidence that some of these public health emergency measures worked.”
Recent research shows that the pandemic telehealth rules have helped patients initiate—and stay in—buprenorphine treatment, and that patients abstained from illicit opioids at rates comparable to those who received care in person. Notably, research has also shown that greater buprenorphine access has not led to more buprenorphine-related overdoses.
“Telehealth prescribing of buprenorphine has been critical to creating more equitable access to this medication across communities,” Izquierdo says. “It really solved a lot of issues, but we’re in a holding pattern right now on telehealth rules.”
Negative reaction to the DEA’s rollback plan from patients and health care advocates was strong and immediate: The agency received 38,000 comments, most imploring it not to return to tighter pre-COVID restrictions.
The DEA agreed to pause and give the issue greater consideration. On May 9, it extended the telehealth policy until Nov. 11 while it reviews what to do next.
What should be next, says Scott, the Maryland reform advocate, is that regulators and health care providers work even harder on practices that keep people alive.
“Access to health care should be universal,” Scott says. “I, as a person, should be able to get the resources I need, no matter where I live or what bus line I am on, or what doctors or clinics are in my community. It’s about justice.”
Tom Infield is a longtime Philadelphia journalist and frequent contributor to Trust.
Lead photo: Tiffinee Scott, a peer recovery specialist, descends stairs at Baltimore’s Light of Truth Center Inc., which provides housing and resources for women in recovery. While the COVID-19 pandemic has exacerbated the opioid crisis, it has also—out of necessity—helped loosen long-standing restrictions around medications used to treat opioid use disorder and allowed them to be prescribed via telehealth. But now that the public health emergency is officially over, efforts to roll back these flexibilities are underway.