Telepsychiatry experts are urging providers to create contingency plans following the announcement of the end of the COVID-19 public health emergency on May 11.
If a governing body doesn’t extend the suspension of the Ryan Haight Act, which requires at least one in-person medical exam, providers fear Americans with certain medical conditions may be left in a dire situation.
The Drug Enforcement Administration (DEA) was mandated to create a special registration process for remote prescribing in 2008, something it has yet to do. The recent Omnibus Bill requested once again that the DEA finalize the changes to the Controlled Substances Act. January was expected to bring word about the agency’s response, yet the month came and went without news. Without a top-down plan, providers are remaining hopeful while preparing for the worst.
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“I think the disruption to patient care will be quite massive,” Bicycle Health's CEO and founder Ankit Gupta told Fierce Healthcare. “We have patients who have told us they've had to drive 100 miles one way to find treatment and are quite appreciative of telemedicine treatment being available. I don't think the capacity to provide treatment in every city, every county has increased significantly during COVID.”
Bicycle Health is an online medication-assisted treatment provider for opioid dependence.
Telepsychiatry providers prepare to take drastic measures to offer care
Last July, when Alabama passed a bill requiring providers to perform one in-person visit a year to prescribe a controlled substance, Bicycle Health stepped in. Social workers helped patients find in-person providers but were only able to help one-fifth of patients, Gupta said. For the remaining 80%, Bicycle Health flew providers into the state.
If a plan isn’t offered, the ones who will be left out in the cold “are vulnerable, underserved Americans. There are few sets of patients more vulnerable. It's a life or death situation if their continuity of care is severed." — Kyle Zebley, the senior vice president for public policy at the American Telemedicine Association
Bicycle Health prescribes suboxone, a combination of buprenorphine and naloxone used to treat opioid use disorder (OUD). It is estimated that 3 million Americans suffer from OUD and are only one pocket of patients who were able to seek remote medication treatment during the PHE.
Gupta says the company is prepared to take drastic efforts again if regulators don’t step in, but it would be no easy feat.
“What we did in Alabama was a last-ditch effort,” Gupta said. “It's not sustainable by any means. If it comes to that, we're obviously prepared to do that, but it's also going to significantly limit our ability to provide high quality, confidential, convenient treatment for patients with opioid use disorder.”
If the DEA doesn’t step in, there are other paths to decrease barriers to care. Gupta looks to the Mainstreaming Addiction Treatment (MAT) Act which passed with the Omnibus Bill as proof that the cogs of government can move quickly when properly lubricated.
The MAT Act removed the federal requirement for providers to procure a DATA-waiver (aka X-waiver) registration to prescribe buprenorphine for the treatment of opioid use disorder. “We need to replicate that speed with the special registration process,” Gupta said.
Remote prescribing waivers could also move from the COVID PHE to the opioid addiction public health emergency, declared in 2017. Although, such a move would not support patients remotely being prescribed controlled substances like testosterone for gender-affirming care or Adderall for attention-deficit/hyperactivity disorder, experts say.
What policymakers, regulators can do to prevent a crisis
Kyle Zebley, the senior vice president for public policy at the American Telemedicine Association (ATA), is recommending that ATA member organizations create contingency plans.
“It's a perfectly predictable and preventable public health crisis,” Zebley told Fierce Healthcare. “The healthcare system is already under strain. We already have too little access to mental health treatment and other treatments through the healthcare system. I just don't understand how the Biden administration would allow for that to happen.”
Some have pointed to healthcare companies taking the tech maxim of “move fast and break things” too far, think Cerebral or Done, as a reason for a return to increased oversight. But with Department of Justice investigations underway, Zebley said, “the allegations that have come to light have come out through the normal oversight and law enforcement process.”
The American Hospital Association released a letter alongside the ATA asking for an outlined plan from the DEA. If a special registration process cannot be outlined in the next three months, an interim plan needs to be offered, the AHA wrote.
“I think it may ultimately take Congress and it might come after the end of the PHE, frankly, but it might take Congress not just giving DEA rules that it can follow but mandating certain changes in the Controlled Substances Act in order to provide for appropriate internet prescribing.” — Jacob Harper, partner at Morgan, Lewis & Bockius LLP
“We might quibble with the plan but at least that’s something,” Zebley said. In the ATA’s opinion, access to care should not be sacrificed for increased oversight when sufficient control already exists.
If a plan isn’t offered, the ones who will be left out in the cold “are vulnerable, underserved Americans. There are few sets of patients more vulnerable,” Zebley said. "It's a life or death situation if their continuity of care is severed."
Roughly two-thirds of U.S. counties either have no or low patient capacity to provide medications for OUD, according to the Department of Health and Human Services (PDF). Out of these counties, 77% are in rural areas.
Jacob Harper is a lawyer working in healthcare regulatory matters and isn’t surprised that the DEA seems to be existing on a different timeline than healthcare providers.
“They don't have the same priorities,” Harper told Fierce Healthcare. “Their priorities are not to ensure that patients get adequate, necessary care. Their job is to make sure that drugs that could be abused do not get into the hands of people who would abuse them.”
The Ryan Haight Act was born from the same sentiment. The act was in response to internet pharmacies that functioned as pill mills ultimately leading to the overdose and deaths of patients like Ryan Haight. With other modalities on the table like telephonic treatment, Harper thinks it’s expected that the DEA would be cautious.
However, recent research published in JAMA Network Open has shown that fears of OUD telehealth waivers leading to increased addiction have been unfounded. Researchers from the Centers for Disease Control and Prevention and the National Institutes of Health found that of the roughly 74,000 opioid-involved overdose deaths between July 2019 and June 2021, buprenorphine was involved in only 2.6% and did not increase over time.
“I think it may ultimately take Congress and it might come after the end of the PHE, frankly, but it might take Congress not just giving DEA rules that it can follow but mandating certain changes in the Controlled Substances Act in order to provide for appropriate internet prescribing,” Harper said.