Telemedicine prescribing of controlled substances has been a topic of discussion for the U.S. Drug Enforcement Administration, which recently proposed draft guidance to establish a framework for this practice. The proposal introduces three types of special registrations to regulate the prescribing of controlled substances via telemedicine.
The first type is telemedicine prescribing registration, which allows qualified practitioners to prescribe Schedule III-V controlled substances through telemedicine. The second type is advanced telemedicine prescribing registration, which permits specialized practitioners like psychiatrists and hospice care physicians to prescribe Schedule II-V controlled substances via telemedicine. The third type is telemedicine platform registration, which enables online telemedicine platforms to dispense Schedule II-V controlled substances through registered practitioners.
Under this proposed guidance, patients could receive a six-month supply of buprenorphine, used to treat opioid use disorder, through a telephone consultation with a provider. However, subsequent prescriptions would require an in-person visit to ensure proper monitoring and evaluation.
Practitioners would also have specific responsibilities under this framework, including conducting Prescription Drug Monitoring Program checks for relevant states where both the patient and practitioner are located. Detailed records must be maintained for in-person evaluations, telehealth prescriptions, and referrals, with safeguards in place for prescribing high-risk medications.
While the goal of these measures is to expand patient access to controlled substances via telemedicine, there are concerns about the role of the DEA in overseeing healthcare practitioners’ treatment decisions. It is crucial that the DEA’s involvement is limited to ensuring patient safety and preventing misuse, without dictating clinical decision-making for practitioners.
In addition, there is a call to make the COVID-19 Public Health Emergency concessions permanent, rather than renewing them biannually. This would provide stability, certainty, and continued access to healthcare, while also encouraging innovation and efficient resource utilization.
Furthermore, the integration of electronic patient-reported outcomes (ePROs) in telehealth encounters is vital for tracking patient progress, enhancing communication between patients and clinicians, and improving overall treatment outcomes. Clear, evolving clinical content in ePROs is essential for monitoring patient health and making informed clinical decisions.
As technology advances, there is a growing interest in using artificial intelligence (AI) for clinical decision-making based on ePROs data. Regulatory policies need to adapt to ensure accuracy, transparency, equity, and patient safety in the use of AI and machine learning in healthcare.
Overall, the goal is to establish strong standards for validation, data security, and bias mitigation in AI/ML analysis of ePROs data, while fostering innovation and patient engagement. By prioritizing patient safety and clinician oversight, the healthcare industry can maximize the benefits of AI/ML in improving patient care and treatment outcomes.
