WASHINGTON -- The Biden administration moved Friday to require patients see a doctor in person before getting attention deficit disorder medication or addictive painkillers, toughening access to the drugs against the backdrop of a deepening opioid crisis.
The proposal could overhaul the way millions of Americans get some prescriptions after three years of relying on telehealth for doctor's appointments by computer or phone during the pandemic.
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The Drug Enforcement Administration said late Friday it plans to reinstate once longstanding federal requirements for powerful drugs that were waived once COVID-19 hit, enabling doctors to write millions of prescriptions for drugs such as OxyContin or Adderall without ever meeting patients in person.
Patients will need to see a doctor in person at least once to get an initial prescription for drugs that the federal government says have the the most potential to be abused - Vicodin, OxyContin, Adderall and Ritalin, for example. Refills could be prescribed over telehealth appointments.
The agency will also clamp down on how doctors can prescribe other, less addictive drugs to patients they've never physically met. Substances like codeine, taken to alleviate pain or coughing, Xanax, used to treat anxiety, Ambien, a sleep aid, and buprenorphine, a narcotic used to treat opioid addiction, can be prescribed over telehealth for an initial 30-day dose. Patients would need to see a doctor at least once in person to get a refill.
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Patients will still be able to get common prescriptions like antibiotics, skin creams, birth control and insulin prescribed through telehealth visits.
The new rule seeks to keep expanded access to telehealth that's important for patients like those in rural areas while also balancing safety, an approach DEA Administrator Anne Milgram referred to as "expansion of telemedicine with guardrails."
The ease with each Americans have accessed certain medications during the pandemic has helped many get needed treatment, but concerns have also mounted that some companies may take advantage of the lax rules and be overprescribing medications to people who don't need them, said David Herzberg, a historian of drugs at the University of Buffalo.
"Both sides of this tension have really good points," said Herzberg. "You don't want barriers in the way of getting people prescriptions they need. But anytime you remove those barriers it's also an opportunity for profit seekers to exploit the lax rules and sell the medicines to people who may not need them."
U.S. overdose deaths hit a record in 2021, about three-quarters of those from opioids during a crisis that was first spun into the making by drug makers, pharmacies and doctors that pushed the drugs to patients decades ago. But the grim toll from synthetic opioids like fentanyl far outstripped deaths related to prescription drugs that year, according to Centers for Disease Control Data. Fentanyl is increasingly appearing on the illicit market, pressed into fake prescription pills or mixed into other drugs.
The proposed rules deliver a major blow to a booming telehealth industry, with tech startups launching in recent years to treat and prescribe medications for mental health or attention deficit disorders. The industry has largely benefitted from the reprieve on in-person visits for drugs brought on by the pandemic, although some national retailers stopped filling drug orders generated by some telehealth apps over the last year.
The DEA has grown increasingly concerned over the last two years that some of those startup telehealth companies are improperly prescribing addictive substances like opioids or attention deficit disorder medication, putting patients in danger, a DEA official told The Associated Press on Friday.
The official said the agency plans to have the new rule in place before the COVID-19 public health emergency expires on May 11, which will effectively end the loosened rules. That could mean people who may seeking treatment from a doctor who is hundreds of miles away need to start developing plans for in-person visits with their doctors now, pointed out Boston-based attorney Jeremy Sherer, who represents telehealth companies. Patients will have six months to visit their doctor in person when the regulation is enacted.
"Providers and their patients need to know what that treatment is going to look like moving forward and whether, once the public health emergency ends in May, if they're going to need to figure out a way to have a visit in person before continuing treatment, and that can be a real challenge," he said.
Many states have already moved to restore limitations for telehealth care across state lines. By October, nearly 40 states and Washington, D.C., had ended emergency declarations that made it easier for doctors to see patients in other states.