Telehealth companies are attempting to influence the Drug Enforcement Agency on remote prescribing of controlled substances.
In May, the DEA extended flexibilities that allow telehealth companies to remotely prescribe certain controlled substances without an in-person visit until this November. The DEA's original proposed rule in February would have allowed Schedule III-V substances like codeine, Xanax and Ambien to be prescribed over telehealth for only for an initial 30-day dose. After the 30 days, patients would need to see a doctor once to get a refill. Schedule II substances like Vicodin, OxyContin, Adderall and Ritalin would have gone back to fully requiring an in-person visit before getting prescribed virtually.
Until Nov. 11, there will be a compete continuation of the prior rules, meaning new or established relationships are allowed for the prescribed use of certain controlled substances. After that date, new relationships for remote prescribing of controlled substances cannot be established unless the DEA publishes revised guidance. Relationships established prior to Nov. 11 can continue operating under the prior rules until the following year.
By pushing back the deadline, the DEA has given itself time to rethink the future of remote prescribing of controlled substances. But telehealth companies are not waiting for the DEA's next guidance to act. One company has hired a former DEA official while others have contracted with lobbyists to push the agency for permanent flexibilities around remote prescribing.
“You think of DEA as just one mind,” said Eric Triana, chief compliance officer at Talkiatry, a company that prescribes certain Schedule III and Schedule IV controlled substances via telehealth. “[Inside DEA], there are a lot of competing opinions about what the regulation should be.”
The company's CEO previously told Modern Healthcare approximately 18%, or about 10,000, of Talkiatry’s total patients are prescribed medication that would require an in-person visit. Triana spent more than 20 years at the DEA in various roles. Talkiatry hired him to help get ahead of potential regulatory changes.
"For me, coming to Talkiatry was a fit, because in general, I just believe in providing those mental health services," Triana said.
The DEA did respond to a request for comment on the remote prescribing rules and Triana's employment at the agency.
Bicycle Health, a virtual care startup providing opioid use disorder treatments, was founded in 2017 with a single clinic in Redwood City, California. After the pandemic began, the company went exclusively virtual.
In advance of the DEA's new guidance, Bicycle hired government relations firm Tiber Creek Group to help influence the agency’s rulemaking process, said founder and CEO Ankit Gupta.
“We're working with a government relations firm and trying to basically help the government find the right solution that both improves access and has the right guard rails to get high quality care to patients,” Gupta said.
Tiber Creek Group did not respond to a request for comment.
The American Telemedicine Association, a trade group that represents telehealth companies, is encouraging members who engage in remote perscribing of controlled substances to communicate with the DEA.
“This has been a huge priority for us,” said Kyle Zebley, executive director of ATA Action, a lobbying arm of the American Telemedicine Association. “At the end of the day, if you are currently receiving, or a patient that may need to receive controlled substances in the future, according to those draft rules, you're going to have to go and see a licensed medical professional in-person for a diagnosis.”
Zebley said the ideal outcome is the creation of a credentialing process by the DEA that would allow for virtual providers to continue offering care without in-person restrictions.
“The DEA would use its authority to create a special registration process that would allow for a process that is workable enough, that can still be achieved by a sufficient number of providers to deliver the necessary care,” Zebly said.
As they wait for the DEA, telehealth companies are preparing for a host of potential changes. Zack Gray, co-founder and CEO of virtual opioid use disorder company Ophelia Health, said the company has tentative plans in place if DEA were to require in-person examinations.
“We've done as much as we think is necessary without forming a distraction for Ophelia,” Gray said.
According to an Ophelia spokesperson, the company did not pay an outside government relations firm to lobby the government but is an active member in the American Telemedicine Association.
Despite any lobbying efforts, Zebley said companies should prepare for the worst.
“Be ready for the status quo to be over and get ready for the most extreme and restrictive route that the DEA might choose to go down,” Zebley said. “It is better to hope for the best and prepare for the worst.”
