For President Donald Trump’s national emergency on opioid abuse to get traction in Appalachia and the rural South, the treatment effort will have to overcome some stubborn logistical barriers — and an obscure legal hurdle complicated by the president’s own push to reduce regulatory burden.
A shortage of treatment options, transportation limitations and widespread poverty have made opioid abuse hard to stop and even tougher to treat in rural areas where the problem has hit hardest.
To help make anti-addiction medications more available in rural areas, Trump’s emergency declaration called for expanding “telemedicine” services that allow addiction specialists to treat rural patients remotely through video consultations rather than in-person visits.
The National Institutes of Health is even funding a $1.7 million study of a mobile phone and tablet app called “emocha” that could help doctors remotely monitor rural patients’ adherence to daily drug treatments that help fight opioid addiction.
The technology allows patients to use their phones to record themselves taking the anti-addiction drug, buprenorphine, and send the video to medical personnel for verification. Patients can also use emocha to report cravings, side effects or other symptoms of addiction without compromising their privacy.
“Folks who are addicted to opioids tend to often be very disenfranchised generally, not just geographically but in many other ways, and often have a difficult time managing their medications. The value of emocha is that it works as well in urban Baltimore as it does in rural West Virginia and elsewhere,” said Dr. Robert Bollinger, who first conceived emocha while working in Uganda as director of the Center for Clinical Global Health Education at Johns Hopkins University.
The university licensed the technology to Baltimore-based emocha Mobile Health in 2014. The app is also being used to monitor the treatment of patients with tuberculosis and Hepatitis C, said Sebastian Seiguer, CEO and founder of emocha Mobile Health.
Other emerging technology, such as online digital counseling apps, along with pharmaceutical innovations including longer-lasting doses of buprenorphine could help bridge the geographic and clinical gaps faced by opioid abusers in isolated areas.
Last week, an advisory committee of the Food and Drug Administration recommended the agency approve potential weekly and monthly injectable doses of buprenorphine that could lighten the drug regimen for patients now using the daily pill or oral film formulation, which is applied under the tongue.
But before these potential advances can be realized fully for rural opioid patients, the Department of Justice and the Drug Enforcement Administration must address a problem with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. And one of Trump’s executive orders — discouraging the creation of new rules — could be getting in the way.
The Ryan Haight law was designed to stop inappropriate prescribing by shady internet pharmacies, but critics say it goes too far, blocking doctors from prescribing controlled substances and anti-addiction medications without first having an in-person evaluation.
For nearly a decade, the American Telemedicine Association has been asking the DEA to waive that requirement so doctors can prescribe for far-flung patients based only on video consultations.
“This was one of those unexpected consequences from a law that was not very well written originally nine years ago,” said Peter Yellowlees, president of the American Telemedicine Association. “And every year since, we’ve been trying to get the waiver. It’s been a long process and the DEA, in my view, has been very slow with this.”
The DEA under President Obama “never delivered on its initial Unified Regulatory Agency intention to promulgate” waiver guidelines in October 2015, the ATA noted in a letter to the DEA.
Yellowlees said he knew of no special-interest groups that opposed the measure. The American Medical Association supports easing federal certification requirements for physicians to begin prescribing buprenorphine and says doctors who prescribe other drugs should be able to prescribe the drugs used to help opioid addicts.
“It’s very strange,” said Yellowlees, a psychiatry professor at the University of California, Davis. “I’ve had personal meetings with DEA staff. DEA people have come to our conferences at our request. And there is a very simple way of modifying this, but for whatever reason they’ve just never gone down that pathway. I don’t understand it.”
DEA spokesman Rusty Payne said the agency is working on the waiver guidelines, but it’s unclear when the waiver will be ready and what it will entail.
A senior DOJ official suggested the effort could be delayed by a Trump executive order that discourages creation of new rules by requiring agencies to eliminate two rules for every new one created.
But in a statement, a White House spokesperson said the executive order applies to regulatory actions and may not affect the proposed telemedicine waiver which "could potentially be a deregulatory action if it imposes no costs or results in cost savings."
Resolving the legal obstacles could prove critical for rural Southern towns that account for 22 of the 25 cities with the highest rates of opioid abuse and 17 of the top 25 cities ranked by misuse of opioid prescriptions, according to a study by Castlight Health, a medical benefits platform provider.
Alabama, Florida, North Carolina, Oklahoma and Texas have multiple cities in both rankings.
With more than 2.5 million Americans who abuse opioids, there simply aren’t enough clinics to provide the necessary treatment. And about half of those who take buprenorphine to beat their addiction drop out of treatment after eight weeks, Seiguer said.
“We're trying to see if emocha can change that,” he said. Watching someone take their meds is the only proven way to make sure they do, Seiguer added.
“People perform better when they’re observed,” Seiguer said. “And (with emocha) the patient now has somebody who is in touch with them and who is contacting them and somebody who actually cares. That social support angle is what keeps the patient in care longer."
Tony Pugh: 202-383-6013, @TonyPughDC