Members of Congress and advocates worry a proposed rule from the Biden administration will make it harder for people to access a medication commonly used to treat opioid use disorder.
The Drug Enforcement Administration is proposing limiting telehealth prescriptions for buprenorphine to an initial 30-day supply until the patient can be seen in person by a physician.
The proposal follows a three-year period during the public health emergency where the DEA allowed providers to prescribe buprenorphine through telehealth without requiring an in-person visit — part of an effort to maintain access to care during the pandemic.
Providers said the pandemic-era flexibility worked, allowing them to expand access to the life saving-drug and keep patients in treatment. It was particularly helpful for people who lacked transportation or lived in areas with shortages of doctors. They say the flexibility should continue after the public health emergency ends next month.
“This could mean the difference between continuing therapy and going back to their addiction,” said Brock Slabach, chief operations officer for the National Rural Health Association, which represents health care providers in rural communities.
Buprenorphine treatment usually lasts from six months to one year and has been shown to reduce overdose deaths by diminishing the effects of withdrawal symptoms, which can lead people back to using opioids.
There were nearly 81,000 overdose deaths involving opioids in 2021, according to the Centers for Disease Control and Prevention.
But with the public health emergency ending in May, the DEA, which has the authority to regulate buprenorphine because it is a controlled substance, says it needs to transition to an approach that balances the need for opioid use disorder treatment with the risk of diversion — or the use of buprenorphine for illicit purposes — by requiring new patients to see a provider in person if they want to continue buprenorphine for longer than 30 days.
Under the proposed rule, people who were prescribed buprenorphine through telehealth during the pandemic who had not been evaluated by a provider in person will have 180 days after the rule takes effect to do so.
“DEA is committed to the expansion of telemedicine with guardrails that prevent the online overprescribing of controlled medications that can cause harm,” said DEA Administrator Anne Milgram in a statement last month.
The proposal unleashed a wave of anger and frustration from advocates and lawmakers who have long been skeptical of the DEA’s approach to medication-assisted treatment.
“Having barriers around life-saving medication is extremely problematic and life-threatening,” said Brandee Izquierdo, director of behavioral health programs for The Pew Charitable Trusts. “It’s going to create huge barriers for individuals seeking or already receiving buprenorphine through telehealth. And there’s no evidence to back [the rule] up.”
The American Society of Addiction Medicine wrote in its comment letter that it is “extremely concerned” about the “disproportionate weight” the DEA is giving concerns about buprenorphine diversion “even when it may mean reducing appropriate access to [opioid use disorder] treatment that benefits public health and safety.”
The letter argues the decision to evaluate a patient in person should be left up to a clinician, not a regulator.
Haiden Huskamp, a professor of health care policy at Harvard Medical School, said data that came out during the pandemic hasn’t shown an increase in buprenorphine overdoses or diversion with the increased use of telehealth.
“The evidence doesn’t seem to be there, and I think in the rule that the DEA proposed, there wasn’t really strong evidence cited, either,” Huskamp said.
She and other colleagues are calling for extending the prescribing flexibilities through at least December 2024 to gather more data.
Delays in care
Critics of the proposed rule worry 30 days would not be enough time for a person to see a doctor in person, especially if they don’t already have a primary care physician.
“I am concerned that a 30-day deadline to see a provider in-person would cause a lapse in treatment for individuals who have received initial prescriptions and encounter a situation in which they cannot see a doctor within the one-month deadline,” Rep. Frank Pallone Jr., the top Democrat on the House Energy and Commerce Committee, wrote in a March letter to Milgram.
Fourteen other members, led by Rep. Ann McLane Kuster, D-N.H., wrote in a letter to Milgram that “a patient who starts their 30-day treatment via telemedicine has no guarantee they will be able to access an in-person visit within one month – especially in rural and medically underserved areas where [opioid use disorder]workforce shortages persist.”
“This gap in care could create needless risk and lead to relapses, overdoses and loss of lives,” the members wrote.
The American College of Emergency Physicians recommended that window be extended to at least 90 days, while Blue Cross Blue Shield recommended allowing for a six-month supply of buprenorphine.
Some groups like the National Health Law Program and the National Rural Health Association have urged the DEA to continue the flexibilities under the public health emergency that was declared for the opioid crisis in 2017.
Exacerbating the problem is a continuing shortage of providers willing or trained to treat opioid use disorder. About 40 percent of counties have no provider registered to prescribe buprenorphine, according to a 2020 study from the Health and Human Services Office of Inspector General.
The omnibus spending law removed those registration requirements, allowing essentially any physician to prescribe buprenorphine, but it’s not yet clear how much that will incentivize providers to do.
“I don’t know that providers are chomping at the bit,” to provide medication-assisted treatment, Slabach said. “For rural populations with already significant health professional shortage areas, the notion that there’s going to be enough people doing medication-assisted treatment and working with vulnerable populations with limitations on transportation — I don’t think that’s realistic.”
Federal law
The DEA argues it is required by law to require an in-person evaluation for telehealth prescribing of buprenorphine outside of a public health emergency.
But advocates note that the same law allows the DEA to create a process to exempt providers from that requirement through a special registration. The DEA has not created that process 14 years after being told by Congress to do so.
Congress reiterated that directive in 2018 in legislation addressing the opioid epidemic and in the fiscal 2021 appropriations package.
“Unfortunately, despite what Congress has been directing it to do since 2008, the rule proposed by the DEA once again neglects to set up a special registration allowing specially certified and trained prescribers to continue to safely prescribe controlled substances virtually without requiring an in-person visit,” Sen. Mark Warner, D-Va., said in a statement last month.
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