What DEA's special registrations mean for telehealth prescribing

A look into the special registrations framework

In a proposed rule made available on the Federal Register in January, the DEA outlined three types of registrations that would allow healthcare practitioners to prescribe controlled substances via telehealth.

The first, the telemedicine prescribing registration, would authorize qualified clinician practitioners to prescribe Schedule III-V controlled substances via telehealth. The second, the advanced telemedicine prescribing registration, would allow specialized clinician practitioners, such as psychiatrists and hospice care physicians, to prescribe Schedule II-V controlled substances via telehealth. And the third, the telemedicine platform registration, would authorize covered online telehealth platforms to dispense Schedule II-V controlled substances.

They were worried that anything that they had on the shelf was just going to get permanently kept on the shelf, and it would never see a light of day.

In addition, the proposed rule requires registrants to maintain a state telemedicine registration for every state where a patient is treated.

The framework comes more than a decade after lawmakers first mandated that the DEA create special registrations that would exempt certain healthcare practitioners from having to conduct in-person examinations prior to prescribing controlled substances virtually.

The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 established the in-person exam requirement but created seven categories for telehealth providers who would not be bound by it, including those holding a special registration from the DEA. Though industry groups have asked for clarity regarding the special registrations and even submitted recommendations, this is the first time the DEA has proposed a plan.

According to Marika Miller, an associate at Foley and Lardner and member of the firm's national Telemedicine & Digital Health Industry Team, the change in administration likely prompted the agency to release the proposal.

"They were worried that anything that they had on the shelf was just going to get permanently kept on the shelf, and it would never see a light of day," she said. "And so they wanted to push out as much as they could….They really wanted to get the conversation started on the special registration process.I think they knew it wasn't perfect."

The urgency is further heightened by the fact that a pandemic-era flexibility that allows telehealth prescribing of controlled substances without a prior in-person exam is set to expire at the end of 2025.

Gina Bertolini, a healthcare partner at K&L Gates, stated that the new framework appears to be the DEA's attempt to balance the expanded access to needed medications that telehealth prescribing provides with the guardrails required to curb fraud, waste and abuse.

"[The framework] is a recognition of 'let's allow some additional flexibility in particular as it relates to pre-COVID, but let's put in place some mechanisms that might minimize the types of nefarious activity,'" she said.

How it adds to telehealth providers' administrative burdens

The special registrations framework would increase telehealth providers' administrative burdens in numerous ways. While the added burdens could help prevent fraud and abuse, it could also curb access to needed medications.

The new framework requires both individual providers and online telehealth platforms to complete special registrations. Miller noted that this requirement would help the DEA keep track of telehealth prescribers and the platforms through which prescribing occurs, but it does create administrative burdens and additional costs.

Further, the new framework requires the prescriber to maintain a registration in every state where they prescribe or dispense. This would make operations especially challenging for multistate providers -- which many telehealth-only companies are – because they would have to navigate complex licensure and state laws to provide prescriptions, Bertolini said.

But the most controversial of the new rule's requirements concerns the prescribing of Schedule II medications, which include popular drugs for attention-deficit/hyperactivity disorder (ADHD) like Adderall and Ritalin.  These medications have a high potential for abuse, and there are already examples of telehealth prescribers taking advantage of their demand. Over the past few years, telemental health companies Cerebral and Done Health came under federal scrutiny over their ADHD medication prescribing practices, with the leaders of Done Health being indicted last June.

The new rule includes additional requirements for telehealth prescriptions of Schedule II medications, including that the clinician must be physically located in the same state as the patient and the average number of telehealth-based Schedule II prescriptions must be less than 50% of the total number of Schedule II prescriptions issued by the clinician.

Miller and Bertolini agree that these requirements spell trouble for virtual-only prescribers.

You've got to have a measured approach with recognizing the importance of facilitating this care and expanding access to care in particular to underserved populations but being reasonable about what kinds of measures can be put in place to minimize the risk of diversion.

Miller called the requirements "completely unworkable" for fully remote prescribers and platforms. At the same time, Bertolini said they appear to be "somewhat of an arbitrary approach or an arbitrary guardrail if you will. Like, why 50%? And why impose or further discriminate against practitioners who can prescribe [these medications]? Because [the rule] would effectively rule out folks whose practice is 100% telemedicine."

In a Feb. 14 letter to the DEA's Acting Administrator Derek Maltz, ATA Action stated that Schedule II prescribing requirements would limit access to needed medications, particularly in states facing significant clinician shortages.

Still, there are some aspects of the rule that, while adding to the virtual prescriber's workload, could help mitigate drug diversion and misuse.

The new rule requires special registrants to conduct a nationwide prescription drug monitoring program (PDMP) check before prescribing virtually; however, this requirement will not go into effect for another three years.

Until then, registrants must conduct a PDMP check of the state/territory where the patient is located, the state/territory where the registrant is located and any state/territory with a PDMP reciprocity agreement with the states where the patient and registrant are located.

Though ATA Action has pointed out that technical and operational barriers may make the nationwide PDMP check a challenge, the group expressed gratitude for the three-year delay.

Additionally, Miller highlighted that the DEA has included a caveat wherein the nationwide check requirement will not be enacted without an established nationwide database.

"If there's no nationwide database in place, [providers] wouldn't have to do a nationwide check," she said. "So there is some fairness here."

Current outlook for the proposed rule

Miller and Bertolini emphasized that the proposed rule will likely see several changes before it is finalized.

The DEA is accepting comments on the rule through March 18, 2025. Bertolini believes there will be a significant number of comments, especially given that the last DEA-proposed rule on virtual prescribing received 38,000.

"I think the comments will be valuable because it is important for people who are boots on the ground providing this care or working in the community where diversion is happening to provide and share their experiences and their perspectives," said Bertolini.

In addition to the administrative burdens outlined above, Bertolini noted that arguments against the proposed rule could center on how the rule treats providers who are prescribing controlled substances differently than their peers, which could, in turn, stigmatize the patients who need these medications. Still, providers must accept that telehealth does open the door to drug diversion and potential misuse, making guardrails to telehealth prescribing a necessity. 

"You've got to have a measured approach with recognizing the importance of facilitating this care and expanding access to care in particular to underserved populations but being reasonable about what kinds of measures can be put in place to minimize the risk of diversion," Bertolini said.

This measured approach will likely include guardrails like the PDMP nationwide check and other requirements related to record keeping and patient ID verification, Miller said.

However, the next steps and timeline remain in question. Miller underscored that the current administration has numerous other pressing priorities. So, there is a chance that the DEA will take the time to revise the rule to include industry suggestions.

Not to mention that the DEA has its other telehealth prescribing regulation deadline coming up at the end of this year. After a protracted back-and-forth between the agency and telehealth proponents, the DEA extended a pandemic-era flexibility that allows healthcare practitioners to provide virtual prescriptions for controlled substances without conducting an in-person medical evaluation of the patient through Dec. 31, 2025.

It is not beyond the realm of possibility that the flexibility will be extended further to give the DEA more time to work on the special registrations process -- provided the Trump administration doesn't decide to let the flexibility expire. With a new administration at the helm, the future of telehealth prescribing is unclear. But one thing is apparent: the telehealth industry is primed to continue to press the DEA for broader telehealth prescribing allowances.

"It's just such a question mark of what the outlook of this registration process will look like because there's potential that this just never happens again, that we saw this here, and then it just remains on hold for years -- somebody has to push it forward," Miller said.

Anuja Vaidya has covered the healthcare industry since 2012. She currently covers the virtual healthcare landscape, including telehealth, remote patient monitoring and digital therapeutics.