More than 300 organizations sent letters to the White House and Congress on Tuesday asking them to extend telehealth controlled substance prescribing rules for an additional two years.
They say the Drug Enforcement Administration (DEA), which is working on a long-term solution, does not have enough time left in the year to finalize a rule before the pandemic-era prescribing flexibilities expire.
But the route to an extension may be complicated by hesitancy to continue to allow Schedule 2 substances, like Adderall for attention-deficit/hyperactivity disorder, to be prescribed via telehealth.
There are opportunities for DEA and the Department of Health and Human Services (HHS) or Congress to extend the prescribing flexibilities. Each route has its obstacles.
Congress
Telehealth stakeholders are pushing Congress to do a two-year extension of pandemic-era telehealth prescribing flexibilities.
They argue that distinguishing between classes of drugs is superfluous when faced with a ticking expiration date.
“As we go to Congress and ask for intervention to extend the DEA flexibilities, questions arise about which Scheduled drugs should be accessible during the extension,” Krista Drobac, founder of the Alliance for Connected Care, said in a statement. “Trying to decide which patients of those with ADHD, narcolepsy, cancer, pain, addiction, depression or anxiety should have to go to the office vs use telehealth is the crux of the issue. This is why we need a two-year extension. Threading the needle on access vs. prevention of diversion hasn’t been done yet. As a health care person, I want all people to have access, but law enforcement feels differently. We need to find the balance.”
Drobac argues that there isn’t enough time left on the congressional calendar to parse between whether some substances should be permitted to be prescribed online and others shouldn’t.
Another lobbyist said House Republicans are not keen to continue Schedule 2 telehealth prescribing and will not fight for it to be included in a healthcare package this year.
Rep. Brett Guthrie, R-Kentucky, chair of the House Energy and Commerce subcommittee on Health, told Fierce Healthcare there could be reason for concern about Adderall and other Schedule 2 substances being prescribed via telehealth and that Congress is "still trying to figure that out."
Guthrie said he is generally supportive of extending telehealth flexibilities and referenced the two-year extension of other Medicare telehealth flexibilities, which does not include the prescribing extension.
One of the House Republican Doctors Caucus co-chairs, Michael Burgess, M.D., R-Texas, and Doctors Caucus member Larry Bucshon, M.D., R-Indiana, told Fierce Healthcare they currently do not have an opinion on telehealth prescribing of Schedule 2 substances. Bucshon said he is generally supportive of telehealth.
A healthcare lawyer familiar with the issue said Congress could do a short-term extension, between 30 days and 90 days, to punt the issue to the next Congress. Congress could also do a two-year extension consistent with the other expiring flexibilities, they said.
Drug Enforcement Administration
According to two lobbyists close to the issue, the new telehealth prescribing rule sitting at the White House Office of Management and Budget (OMB) is bound by gridlock. OMB has tried several times to release the rule, but HHS has blocked it, a lobbyist said.
This gridlock isn’t likely to be solved without a shove from above.
“This rule is going to sit at OMB until somebody flinches,” a lobbyist said.
Fierce Healthcare reported that the new proposed rule excludes Schedule 2 controlled substances, makes providers prescribe 50% of controlled substance prescriptions in person and requires prescribers to check every state’s prescription drug monitoring programs before prescribing a controlled substance.
The DEA has not disputed any of the reported claims about its pending telemedicine prescribing rule despite extensive media attention.
Stakeholders want to find a way around these restrictions.
DEA and the secretary of HHS could precipitate an extension of the pandemic-era prescribing flexibilities if “the [Attorney General] and Secretary determine the prescribing via telehealth is ‘consistent with effective controls against diversion and otherwise consistent with the public health and safety,’” a lawyer told Fierce Healthcare, quoting the Controlled Substances Act.
This is the route the administration took to keep the flexibilities from expiring when the public health emergency ended.
Now, the DEA does not want to do an extension of the current pandemic-era flexibilities, several sources said.
The DEA wrote in its March 2023 proposed rulemaking, “Telehealth prescribing of controlled substances when the practitioner and patient have not had an in-person visit” that Congress has not authorized the prescription of schedule II substances via telehealth.
“Excluding schedule II controlled substances and all narcotic controlled substances is consistent with the limitations Congress placed on the use of telemedicine,” the March 2023 proposed rule says. “Congress directed DEA and HHS to authorize the use of telemedicine only when doing so is 'consistent with effective controls against diversion and otherwise consistent with the public health and safety,' but permitted DEA and HHS to determine the precise circumstances that were most appropriate. Given the ongoing opioid epidemic at the time of publishing, DEA believes that allowing for the prescription of any schedule II substances or the general prescription of narcotic controlled substances as a result of telemedicine encounters would pose too great a risk to the public health and safety."
Several sources said Attorney General Merrick Garland could step in and force DEA to do an extension.
Tension is already high between the DEA and the Department of Justice (DOJ), though, over the rescheduling of marijuana. According to two lobbyists, the DEA did not want to reschedule the drug, but the DOJ forced its hand, the lobbyists said.
The DEA may be in a similar situation with Schedule 2 drugs.
Garland did not respond to a request for comment by the time of publication.