DEA’s Crackdown on Online Prescriptions Threatens Patients, Startups

DEA’s Crackdown on Online Prescriptions Threatens Patients, Startups

  • Thanks to the pandemic, doctors have been able to prescribe more kinds of drugs online.
  • One such drug is buprenorphine, a medication that treats opioid-use disorder. 
  • Proposed rules would put an end to that, making care for addiction harder to find.

For the past three years, doctors have been able to do something that’s normally illegal: prescribe potentially addictive medications, called controlled substances, to patients they see online.

Thanks to the public-health emergency, this temporary allowance — along with other loosened regulations — changed how providers deliver healthcare in the US. 

Startups pushed into the industry with renewed force, raising a record $59.3 billion from venture capitalists since 2020

Some startups went too far, harming patients. But many rose to prominence, at least in part, because of gaps in access to care. 

Addiction medicine is one such example. During the pandemic, patients with opioid-use disorders have been able to get prescriptions for buprenorphine, a controlled medication that curbs cravings, on devices with internet access. 

For some, telehealth advocates argue, it’s been an important lifeline given the fact that lethal overdoses are still outpacing care for addiction.

The COVID-related public-health emergency, and the loosened rules, are set to expire in May. How the government will account for what’s changed since 2020 will determine both how much mental-health care people can get online, and the fates of startups providing it.

Proposed rules would limit online addiction treatment

In February, the Drug Enforcement Administration, or DEA, published much-anticipated rules meant to set the record straight on online prescribing. The rules, if implemented, generally don’t allow providers to prescribe controlled medications online if they don’t see the patients in person.

For buprenorphine and other drugs, there’s an exception that would allow for initial 30-day prescriptions for online patients. But to continue, they would have to get in-person exams.

Those who started any controlled drugs online during the pandemic would have an extra 180 days to find an in-person provider. 

The rules are far more limiting than the industry anticipated. 

“We want to keep our patients happy, we want to keep our clinicians happy, we want to be compliant, and we want to be able to keep the business sustainable,” Zack Gray, a cofounder and the CEO of the addiction-treatment startup Ophelia Health, said. “But all of those things together can be very challenging, and it becomes even more challenging when the government introduces additional arbitrary requirements.”

Some patients are flights away from in-person care

For some patients, especially in rural areas, in-person appointments are hard to find.

Last year, Alabama passed a new law prohibiting providers from prescribing controlled drugs to patients they hadn’t seen in person within the past year. 

The change sent Bicycle Health scrambling. At the time, the startup was treating about 500 Alabama residents online with buprenorphine, Ankit Gupta, the founder and CEO of Bicycle Health, said. 

Bicycle flew in a few providers to take emergency appointments in Birmingham, Alabama. Gupta estimated that 300 patients were able to see Bicycle’s providers, 100 were able to switch to clinics, and 100 were left without care. 

Stopping buprenorphine treatment can lead to withdrawal symptoms and put people at risk of relapsing.

Ankit Gupta, the CEO of Bicycle Health.

Ankit Gupta, the CEO of Bicycle Health.

Bicycle Health

A tiny Alaskan fishing village just off the coast of Russia relies somewhat heavily on the startup Boulder Care for buprenorphine treatment, Stephanie Strong, the founder and CEO of Boulder Care, said. 

People there share WiFi to see Boulder’s providers, and the startup works with a mainland pharmacy to fly them medication.

If the proposed DEA rules take effect, these folks would have to take multiple flights to Anchorage, Alaska, to see the nearest addiction-treatment provider, Strong said.

Primary-care offices are backed up

It’s not easy to find providers who will treat opioid addiction. Until recently, prescribing buprenorphine required a special DEA credential. As of 2022, only about 9{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of licensed physicians had it. President Biden eliminated that credential in December.

But studies suggest primary-care providers are reluctant to treat addiction patients in part because of capacity, stigma, lack of experience, and costs. Past efforts to clear the way with regulations haven’t worked.

And for new patients, the average wait time to see a primary-care doctor is 26 days, suggesting patients with 30-day buprenorphine prescriptions could struggle to find appointments in time to refill them. 

More than 40{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of patients at Bicycle and most patients at Boulder and Ophelia, which collectively treat about 23,000 patients, don’t have primary-care physicians, their CEOs said.

The DEA’s proposals say that patients with online-buprenorphine prescriptions can get their in-person visits with providers who refer them back to their telehealth doctors.

Bicycle is talking to companies like Optum and CVS to set up easy-referral processes, but it’s unclear what will come of it, Gupta said. 

“Regardless of the network Bicycle creates, there will be a large population of patients who would not be able to comply,” he said, citing physical and financial barriers. 

Stephanie Strong, the CEO of Boulder Care.

Stephanie Strong, the CEO of Boulder Care.

Boulder Care

The risks of controlled drugs

Buprenorphine has two forms. Patients can take it by itself, or take it combined with naloxone. Both are “very effective” at treating opioid-use disorder, the DEA said. 

As a partial-opioid agonist, it only partially activates opioid receptors in the brain, reducing cravings and the possibility of overdosing.

Bottles of the generic form of the prescription-pain medication buprenorphine.

Bottles of the generic form of the prescription-pain medication buprenorphine.

Getty Images

But controlled substances come with risks of addiction. Buprenorphine can technically get people high, so there is a fear that some patients could misuse and sell it. 

“I think these proposals represent important guardrails on prescribing of controlled substances that are vital to protecting the public health,” Anna Lembke, a professor of psychiatry and addiction medicine at Stanford University, said of the DEA’s proposed rules. 

Still, the medication was involved in just 2.6{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of opioid-related overdose deaths from July 2019 to June 2021. The frequency of prescriptions for it have not shot up since the start of the pandemic.

Bicycle, Ophelia, and Boulder use urine testing to make sure that patients are taking their medication as prescribed. 

Before starting treatment with Ophelia, 81{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of surveyed patients were misusing drugs, including illegal buprenorphine, Gray said. Six months in, only 3.3{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc} of surveyed patients were.

Zack Gray, the CEO of Ophelia Health.

Zack Gray, the CEO of Ophelia Health.

Ophelia Health

Finding a path forward

There are a number of ways the government could proceed.  

Nate Lacktman, a healthcare lawyer, wants the DEA to adjust the rules, then tackle a special-registration process for telehealth that it’s been required to make for a long time.

The registration would permit providers to prescribe controlled substances online, while creating a central hub through which the providers can be monitored, he said.

Others, like the American Telehealth Association, have asked Congress to extend online-controlled-drug prescribing through the end of 2024, like it did for other forms of telehealth

Some advocates have appealed directly to President Joe Biden. He could declare the opioid crisis a public-health emergency, allowing online-buprenorphine prescribing to continue. Or he could make drug control a Cabinet-level position, allowing for more resources and teamwork. 

“We need coordination here,” Patrick Kennedy, a mental-health advocate and former lawmaker, said, adding: “The DEA has a role to play, but it needs to find its own lane.” 

The simplest solution could be to give patients more time to find in-person appointments.

The DEA’s deadline for the public to comment on the rules is March 31.