Mental health advocates met with the White House’s Office of Management and Budget this month to urge the administration to include schedule IIN non-narcotic stimulants in its proposed telehealth prescribing rule set to air in September.
If the pandemic prescribing flexibilities lapse—or the Drug Enforcement Administration leaves out Schedule IIN drugs in its upcoming telehealth prescribing rule—patients may be required to see providers in person to receive their medications.
Over half of counties lack local qualified prescribers.
The American Psychiatric Association presented at the White House meeting and told the administration it should not create a blanket in-person visit requirement for the prescription of controlled stimulant medications like Adderall, Concerta and Ritalin. It also urged it to deliver the proposed telemedicine rulemaking before there are more complications for practices.
“Any further delay in the rule could pose challenges for a lot of practices and organizations,” a member of APA's Committee on Telepsychiatry and practicing psychiatrist, Shabana Khan, told Fierce Healthcare.
Schedule IIN substances were not included in the last version of the proposed telehealth prescription of controlled substances rulemaking, which the DEA put out in March 2023. In response to a near-record-breaking 38,000 comments from providers, patients and other stakeholders, the DEA held public listening sessions in September 2023 and announced it would propose a new rule.
The new proposed rule is likely to be a version of a special telehealth registration system. The agency has skirted the creation of a telehealth registration system despite its requirement to do so in the 2008 Ryan Haight Act Online Pharmacy Consumer Protection Act.
“For ADHD, [Schedule IIN substances are] the first line treatment. Our patients often have comorbidities, so it's not just ADHD,” Khan told Fierce Healthcare. “They may have a mood disorder. They may have OCD, anxiety, depression … If we can't prescribe a first line, evidence-based treatment for one psychiatric condition, then we can't pick and choose. We do want to provide comprehensive care for our patients.”
APA also urged the administration to continue to pursue telehealth providers that are overprescribing the medication and to prevent diversion and misuse of non-narcotic stimulants. Khan and others penned a letter to the DEA in June asking for the inclusion of Schedule IIN controlled substances in the rule.
Khan said her practice has been in conversations with patients about the possible return to in-person visits to obtain controlled substance prescriptions for the last year and a half amid the regulatory uncertainty following the end of the COVID-19 public health emergency. Other practices stopped accepting new telehealth patients.
Khan said patients have mixed reactions to the news. More-resourced patients might not have an issue switching care modalities and seeing Khan’s team in-person. Patients in rural and underserved areas may struggle to find a local in-person psychiatrist from whom to get their prescriptions. Khan said 55% of counties do not have a psychiatrist and 70% do not have a child psychiatrist. Pediatricians in rural and underserved areas are already overburdened as well.
“Ultimately, we can try to find someone locally, try to look into resources, but even if we do that, there may not be that option locally,” Khan said. “Ultimately, it has been a call on patients to be able to find that care.”
Scheduling telehealth visits has also been a challenge for Khan’s and other APA members’ practices due to the regulatory uncertainty. Practices also feel mixed about continued investment in their telehealth infrastructure because of the possible end to virtual stimulant prescribing.
Khan emphasized that there are safeguards in place such as state prescription drug monitoring programs (PDMPs), state medical laws and malpractice insurance to protect the integrity of virtual prescribing of controlled substances without an in-person visit requirement.