As drug deaths surged above 112,000 a year in the U.S., driven by the spread of the synthetic opioid fentanyl, addiction experts have pointed to a troubling paradox. Proven medications, including methadone, have been shown to save lives, cutting the risk of relapses and fatal overdoses by nearly 60%. Yet they are rarely prescribed.
Despite the growing risk of death, only one-in-five people experiencing opioid addiction gain access to medications. Clinicians and treatment advocates say that's due in part to the fact that methadone is heavily regulated.
Now for the first time in more than 20 years, the Biden administration is publishing new federal rules for methadone treatment aimed at widening access for more patients.
"The easier we make it for people to access the treatments they need, the more lives we can save," said HHS Deputy Secretary Andrea Palm, in a statement.
"With these announcements, we are dramatically expanding access to life-saving medications."
Under the revised rules, methadone will still only be available through a limited number of roughly 2,000 federally-approved opioid treatment programs (OTPs) nationwide.
But patients accessing those clinics will now be able to receive more take-home doses of the medication; they'll be able to receive care more frequently after a telehealth consultation; and nurse practitioners and physicians assistants working at OTPs will be able to order the medication.
The new rule also eliminates a long-standing restriction that required patients to experience opioid addiction for at least a year before receiving methadone. The new actions will take affect within six months, the government says.
In a statement, White House drug czar Dr. Rahul Gupta said the new rules "can mean the difference between life or death" for people addicted to fentanyl and other opioids.
The changes, which take effect this summer, drew praise from addiction policy experts, but some critics said they don't go far enough.
In a statement to NPR, the head of the American Society of Addiction Medicine said it should be easier for qualified doctors not employed by OTPs to dispense opioid treatment medications, including methadone.
"Now it is time for Congress to act," said Dr. Brian Hurley. "[A]llow addiction specialist physicians to prescribe methadone...that can be dispensed from a local pharmacy."
Sen. Edward Markey, a Democrat from Massachusetts, also supported the Biden administration reforms, but criticized the regulatory bottleneck requiring opioid treatment programs to distribute methadone.
"Ultimately, tethering methadone exclusively to opioid treatment programs is less about access, or health and safety, but about control, and for many investors in those programs, it is about profit," Markey said in a statement.
"The longer we leave this antiquated system in place, the more lives we lose."
The American Medical Association also supported the new rules, in part because they will liberalize access to buprenorphine, another proven opioid treatment medication.
"Prescribing buprenorphine through telehealth visits provides the opportunity to reach remote and underserved communities and patients who may be unable to travel daily to in-person appointments," said the AMA's Dr. Bobby Mukkamala in a statement.
These new rules are part of a wider strategy by the Biden administration over the last two years aimed at curbing unprecedented overdose death rates.
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