The Drug Enforcement Administration is reaching the final steps of its proposed rulemaking process for the prescription of controlled substances via telehealth, but its plans have been leaked.
The agency’s rule, which is under review at the White House, is a far cry from the unfettered access telehealth advocates were hoping for, a former DEA official told them, according to an anonymous source who spoke to Fierce Healthcare.
The telehealth prescribing flexibility has been used since 2020 to prescribe medications for conditions like substance use disorder and attention deficit disorder. The DEA proposed two rules for telehealth controlled substance prescribing early last year but pulled them back after receiving 38,000 public comments.
The new proposed rule was expected to be out in September, according to the administration's schedule of regulatory actions. The rule would set a post-pandemic norm for patients receiving medications through telehealth.
Though the proposed rule has not been approved by the White House’s Office of Management and Budget, advocates are already scrambling to change course.
The Department of Health and Human Services is also concerned with the rule as drafted. Lobbyists said HHS lodged hundreds of complaints against the DEA's draft rule.
According to the former DEA official, per Fierce Healthcare's source, the draft telemedicine prescribing rule that the DEA has been working on since it scrapped its last attempt proposes that when a patient and provider have not had an initial in-person visit, the types of medications they can prescribe should also be limited.
The unpublished rule reportedly restricts schedule II substances, like Adderall, from being prescribed at all unless an in-person visit has occurred. Schedule III-V substances can be prescribed based solely on a telehealth visit.
But, the draft rule reportedly only allows providers to do 50% of prescribing online, in an effort to prevent misuse and diversion. The other 50% of prescribing must be done in person.
The draft rule would also require prescribers to check all 50 states’ prescription drug monitoring programs before prescribing a controlled substance to a patient who they have not seen before in person.
However, there is not a national prescription drug registry where prescribers could easily check if the patient had obtained the medication in another state. In social media posts since the DEA's leaked draft rule, many providers have attested to the fact that there is not a single state that can check against all other states' prescription drug monitoring registries.
Providers also said that DEA would need to make a type of national PDMP registry available to them in order to carry out the stipulations of the draft rule.
In response to the leaked information, major telehealth advocacy groups are gathering signatures for letters they will send to Congressional leaders and the White House asking for a two-year extension of current flexibilities. Lobbyists have also taken to the Hill to work on solutions.
The letters, reviewed by Fierce Healthcare, ask Congress and the White House to step in to help the DEA promulgate the special telehealth registration system to track which telehealth providers can prescribe controlled substances. Hundreds of organizations have signed on so far.
The letters stress that the DEA is out of time to promulgate a rule for the telehealth prescribing of controlled substances before the waiver expires at the end of the year.
Because the DEA has effectively run out of time to hold a public comment period, review the comments and put forward a final rule, the letter to Congress encourages leadership to add the extension to the expected end-of-the-year legislative package. The letter to the White House Domestic Policy Council asks it to work with DEA on a two-year extension.
A telehealth lobbyist told Fierce Healthcare that the Biden administration has the authority to extend the pandemic flexibilities without action from Congress. The administration used this authority in May 2023 to extend the flexibilities until the end of 2024.
An extension from the administration would likely be easier than passing an extension through Congress, the lobbyist said. However, given that other telehealth extenders are likely to make a year-end legislative package, the lobbyist said there should be room to include an extension of the DEA rules as well.
Republicans and Democrats in both chambers have supported opening up telehealth prescriptions of controlled substances.
Senator Mark Warner, D-Virginia, released a statement after media reports of the restrictions in the forthcoming rule. Warner advocates that the DEA lift some of the reported restrictions on telemedicine prescribing without the patient and provider being required to meet in person.
“As currently reported, the DEA’s proposal provides an even worse solution than the one put forth under the first proposed rule," Warner said in a statement. "This arcane approach would represent a significant step back for patients who rely on telemedicine for critical medications, and yet another failure by the DEA to establish a meaningful special registration, which Congress has repeatedly directed it to do for over a decade."