Stakeholders push DEA to solidify virtual prescribing flexibilities

More than 200 virtual care stakeholders, including trade associations, healthcare providers, and telehealth companies, have signed a letter urging the United States Drug Enforcement Administration (DEA) to release a revised proposed rule allowing virtual prescribing of controlled substances soon.

The letter states that a revised rule permanently allowing controlled substances to be prescribed via telehealth without a prior in-person examination “is crucial for access to mental health, substance use disorder, and other telehealth care.”

Before the COVID-19 pandemic, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 required healthcare practitioners to conduct an in-person medical evaluation before allowing them to prescribe controlled substances through telehealth. This requirement was waived during the COVID-19 pandemic.

In early 2023, the DEA issued a proposal to permanently extend providers’ ability to remotely prescribe a 30-day supply of Schedule III-V non-narcotic controlled medications and a 30-day supply of buprenorphine for treating opioid use disorder (OUD) with a prior in-person examination. The proposal did not extend this flexibility to Schedule II controlled substances like Adderall, Oxycodone, Vicodin, and Ritalin.

After receiving nearly 38,000 comments on its proposed rule and conducting listening sessions with stakeholders, the DEA extended the waiver, allowing virtual prescribing of all controlled substances without a prior in-person exam through December 31, 2024.  

In the new letter, stakeholders provided five reasons why the DEA should propose a new rule that makes the waiver permanent well before the expiration date:

• First, acting now would ensure stakeholders have adequate time to provide feedback on any policy proposals.
• Second, stakeholders need significant operational lead time to implement a new special registration process. The Ryan Haight Act called for creating a special registration process that would allow healthcare providers to use telehealth to prescribe controlled substances without a prior in-person examination. Several industry groups and healthcare providers have called for the DEA to create such a process. ATA Action, the advocacy arm of the American Telemedicine Association (ATA), submitted recommendations for the process last year.
• Third, proposing a rule at the end of the year that does not preserve the virtual prescribing flexibility could disrupt patient access to care, particularly in the mental health and substance use disorder spaces, which are facing widespread provider shortages.
• Fourth, proposing a rule earlier in the year would give pharmacies and other parts of the healthcare delivery system sufficient time to meet operational and staff training needs for managing telehealth-based prescriptions of controlled substances.
• Fifth, a proposed rule would provide federal guidance for more consistent definitions and aligned requirements from state regulatory bodies.

The Alliance for Connected Care, ATA and ATA Action, the Consumer Technology Association, and the Healthcare Information and Management Systems Society co-led the effort to write and submit the letter. Mass General Brigham, Stanford Health Care, Texas Tech University Health Sciences Center, Doxy.me, Ro, Bicycle Health, and Amazon are among the 214 stakeholders that signed the letter.

Many of these stakeholders also signed a letter to Congress urging action on telehealth regulations early in the year. Many pandemic-era regulatory flexibilities expanding access to telehealth, such as eliminating geographic restrictions on originating sites for telehealth services and allowing continued coverage of audio-only telehealth services, are set to expire on December 31, 2024.

The letter states that if Congress takes action on telehealth policy well before the expiration date, it will reassure Medicare beneficiaries, help strengthen the healthcare workforce by allowing for the creation of flexible virtual staffing models, and support continued investment in telehealth tools and infrastructure, particularly among smaller healthcare providers.

This latest letter to the DEA also comes a little over a month after the ATA and virtual care companies sent a letter to the agency asking it to provide explicit guidance to the pharmacy community that geography should not be considered a “red flag” when the prescription is written during a telehealth visit.

Geography refers to the location of the prescriber in relation to the patient or the pharmacy. Pharmacists consider geography when filling virtual prescriptions to ensure they are legitimate amid concerns about the overprescription of controlled substances fueling the opioid epidemic.