The Morning Call (Sunday)

Feds rework rules to limit drug access via telehealth

Proposal could affect how millions obtain some prescripti­ons

- By Amanda Seitz and Lindsay Whitehurst

WASHINGTON — The Biden administra­tion moved to require patients to see a doctor in person before getting attention-deficit/ hyperactiv­ity 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.

The Drug Enforcemen­t Administra­tion said late Friday it plans to reinstate once long-standing 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 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 such as 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.

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 which Americans have accessed certain medication­s during the pandemic has helped many get needed treatment, but concerns have also mounted that some companies may 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 any time you remove those barriers, it’s also an opportunit­y for profit seekers to exploit the lax rules.”

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 drugmakers, 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 data from the Centers for Disease Control and Prevention.

Fentanyl is increasing­ly appearing on the illicit market, pressed into fake prescripti­on pills or mixed into other drugs.

The proposed rules threaten a major blow to a booming telehealth industry, with tech startups launching in recent years to treat and prescribe medication­s for mental health disorders. The industry has largely benefited 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 such as opioids or ADHD 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 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 inperson visits with their doctors now, said Bostonbase­d 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.

 ?? JENNY KANE/AP ?? The Biden administra­tion is moving to require an in-person doctor visit before gaining access to certain drugs, such as the ADHD medication Adderall, shown here.
JENNY KANE/AP The Biden administra­tion is moving to require an in-person doctor visit before gaining access to certain drugs, such as the ADHD medication Adderall, shown here.

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