Some people being treated for opioid use disorders can soon take home doses of their methadone medications or schedule telehealth appointments in ways they haven’t always been able to do before.
For the first time in more than two decades, the US Department of Health and Human Services is making significant updates to regulations governing Opioid Treatment Programs or OTP, certified and accredited programs that provide medications such as methadone or buprenorphine for people diagnosed with an opioid use disorder. These are the only certified programs through which people can access methadone treatment, a medication approved to treat opioid use disorder by reducing cravings and withdrawal and blunting or blocking the effects of opioids.
A final rule, scheduled to publish Friday, will update the OTP regulations. The updates include expanding eligibility for patients to take home doses of their methadone treatment, allowing them to start treatment via telehealth and allowing nurse practitioners and physician assistants to order medications.
These updates are intended to “meet people where they are,” HHS Secretary Xavier Becerra said, and to make treatments more accessible.
“If you are trying to take care of your family, get a new job, maybe go back to school and stay in recovery, being able to access treatment via telemedicine, that’s just a basic thing that makes a difference in somebody’s life to help them stay well,” said Rachel Pryor, counselor to the secretary.
“Being able to take home doses of methadone so that you don’t have to go back and forth to a methadone clinic every single day, that helps you keep your job and get your life back,” she said. “We’re just trying to help people keep their lives together.”
Becerra has heard firsthand how quickly a life can spin out of control. On Wednesday, he met with four young people, through the drug abuse prevention organization CADCA, who have been affected by the nation’s ongoing substance use crisis.
LaDarrick Smith, a student at Morehouse College in Atlanta, told Becerra about a friend who started vaping at a young age and then started using drugs and is now in prison. They still stay in touch, Smith said, and his friend never intended for his life to spiral that way.
“We have to do more to catch folks before they get out of control, and out of control could be, in this case, prison for his friend, or it could be overdose and maybe dying,” Becerra said. “To do that, we have to know how to better reach people.”
‘A historic modernization’
During the Covid-19 pandemic, regulations were relaxed around using telemedicine for the treatment of opioid use disorders, Pryor said, and the latest updates to the OTP regulations make these telemedicine options permanent.
“This final rule represents a historic modernization of OTP regulations to help connect more Americans with effective treatment for opioid use disorders,” said Dr. Miriam Delphin-Rittmon, HHS assistant secretary for mental health and substance use and leader of the Substance Abuse and Mental Health Services Administration or SAMHSA, in a written statement.
“While this rule change will help anyone needing treatment, it will be particularly impactful for those in rural areas or with low income for whom reliable transportation can be a challenge, if not impossible,” she said. “In short, this update will help those most in need.”
Access to medications for opioid use disorder has been an ongoing issue for people in the United States, said Dr. Noa Krawczyk, an assistant professor in the Department of Population Health at the NYU Grossman School of Medicine and a member of the Center for Opioid Epidemiology and Policy, who is not involved with HHS.
The latest efforts by officials to expand access to treatment are “great,” Krawczyk said, but there is still more work to be done to ensure that both harm reduction tools and medications are accessible for those who need them the most. For instance, not all US counties have an Opioid Treatment Program, she said, and these geographic disparities affect access.
“Historically, how medications for opioid use disorder have been regulated has made them very difficult to proliferate. For example, methadone, which is the most evidence-based treatment that we’ve had since the ’70s, is very restricted. In the US, you can only get it through an Opioid Treatment Program right now, a special clinic that has very distinct licensing and which is not available in most counties,” Krawczyk said.
“There’s a lot of stigma against these medications,” she said. “People have a negative notion around methadone. They think that if you’re on one of these medications, you’re replacing one drug for another, which is a very big myth, since they’re extremely effective and help people achieve a lot of different goals, including staying alive.”
More testing for ‘very scary’ drug
The final rule that updates the OTP regulations is the latest in a string of actions that the Biden-Harris administration has taken recently to battle the nation’s ongoing overdose epidemic.
HHS also announced Thursday that certain federal grant funds now can be used to purchase test strips for xylazine, an animal sedative commonly known as tranq. This means grant recipients — such as local health departments, first responders or health systems — can use the funding to purchase xylazine test strips as tools to help prevent overdose and other drug-related harms.
“We want communities to be able to have resources to purchase these test strips so that individuals will know what’s going on in their drug supply,” said Capt. Christopher Jones, director of the Center for Substance Abuse Prevention at SAMHSA.
Test strips to detect whether fentanyl is present within recreational drugs are commonly used, and xylazine test strips are becoming more widely available. Fentanyl is a powerful synthetic opioid that is about 100 times more potent than morphine and 50 times more potent than heroin. Xylazine is not an opioid but rather a sedative that’s commonly used in veterinary medicine.
“In 2021, we made it clear that fentanyl test strips were an allowable use for these grantees. What we are making public is that xylazine test strips are also an allowable use for these grantees,” Pryor said. “Xylazine is a very scary thing that is out there today on the streets with fentanyl.”
When xylazine is added to fentanyl products or other drugs, it can increase the risk of an overdose.
“Xylazine, because it adds a sedative effect, it adds to what the opioids already do in terms of slowing down breathing and having a risk for an overdose. It can lengthen or strengthen that effect, so it is more dangerous,” Krawczyk said. “This is definitely an emerging issue that we need to learn and do much more about in terms of trying to get test strips out and educate people about how to address xylazine in the drug supply and medically.”
The White House has declared fentanyl laced with xylazine to be an emerging threat facing the United States. A report published last year by the US Centers for Disease Control and Prevention found that, among 21 jurisdictions, the monthly share of fentanyl overdose deaths where xylazine was detected climbed from about 3% of deaths in January 2019 to nearly 11% in June 2022 – representing almost a four-fold increase.
Overall, the number of overdose deaths associated with any drug continues to increase each month in the United States, though the pace appears to be slowing. Deaths reached a record high in May and have changed little in the following months, through August.
According to provisional data from the CDC’s National Center for Health Statistics, more than 112,000 people died from a drug overdose in the 12-month period ending in August.
“Drug overdoses reach every corner of our society, taking lives and causing immeasurable pain to families and communities. That’s exactly why President Biden made it a key priority of his Unity Agenda. We have made important progress, but there is still a lot of work to do,” Becerra said in a written statement.
“But we have the tools, evidence-based strategies, and shared commitment across our nation to take on the overdose epidemic,” he said. “HHS is focused on the full range of solutions needed to address substance use. We will continue to use every lever available to tackle this and save lives. That includes a focus on prevention, as well as expanding treatment and engagement with those struggling with substance use disorder.”
Earlier this week, HHS — through SAMHSA — released an updated toolkit on how to prevent and respond to overdoses. The latest version of the Overdose Prevention and Response Toolkit has appendices for specific audiences, including people who use drugs, people who take prescription opioids, first responders and health care practitioners.
The hope is for these latest HHS actions, including the final rule for Opioid Treatment Programs, to drive down overdose death rates, Jones said.
“When we’re looking at over 110,000 overdose deaths, we have to pull all the levers that we have to drive down overdoses, and medication treatment for opioid use disorder is one of the strongest evidence-based practices we have,” he said. “We know it can reduce risk for dying by 50%. And so this rule is modernizing how we provide medication treatment in Opioid Treatment Programs so that more people can get access.”
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