Buprenorphine Hydrochloride

The U.S. Drug Enforcement Administration has proposed draft guidance to establish a framework for prescribing controlled substances via telemedicine. The proposal introduces three types of special registrations. Telemedicine prescribing registration allows qualified practitioners to prescribe Schedule III-V controlled substances via telemedicine. Advanced telemedicine prescribing registration permits specialized practitioners, such as psychiatrists and hospice care physicians, to prescribe Schedule II-V controlled substances via telemedicine. And telemedicine platform registration enables online telemedicine platforms to dispense Schedule II-V controlled substances through registered practitioners. The guidance proposes allowing patients to receive a six-month supply of buprenorphine, used to treat opioid use disorder, through a telephone consultation with a provider. Subsequent prescriptions would require an in-person visit. Clinicians' responsibilities Practitioners would be required to conduct Prescription Drug Monitoring Program checks for the states where both the patient and the practitioner are located, as well as any other relevant states with PDMP reciprocity. Detailed records must be maintained for in-person evaluations, telehealth prescriptions and referrals. The proposal also includes safeguards for prescribing high-risk medications, such as Schedule II substances. These measures aim to expand patient access to controlled substances via telemedicine while implementing safeguards to prevent misuse and diversion. Dan Cohen, president of Adhere+, a vendor of remote therapeutic monitoring technology and services, says the DEA's draft language needs to be clarified that healthcare practitioners make treatment decisions – the DEA needs to limit its role to ensure patient safety and prevent misuse, not to dictate clinical decision making for practitioners. Clearly defining the role of the DEA "The concern here is about ensuring the role of the DEA is clearly defined when it comes to overseeing healthcare practitioners' treatment decisions, particularly in the context of prescribing Scheduled medications," Cohen explained. "The primary responsibility of healthcare practitioners – doctors, nurses, pharmacists, etc. – is to make clinical decisions based on their professional judgment, patient needs and medical guidelines. "If the DEA's role is not properly limited, there could be an overreach where the agency influences or even dictates how healthcare practitioners make these decisions, which could undermine the autonomy of medical professionals and potentially impact patient care," he continued. "The DEA's main mission should be to prevent drug misuse, addiction and illegal distribution while safeguarding patient safety. However, it should not be in the position of making clinical decisions or prescribing protocols for legitimate medical treatments." The language in any proposed regulation or legislation should therefore make it clear that while the DEA can enforce laws related to drug control and ensure that medications are prescribed and distributed safely and appropriately, healthcare practitioners remain the ones who make decisions about what treatment is appropriate for their patients, based on medical evidence, their expertise and individual patient needs, he said. Cohen contended that Congress make permanent COVID Public Health Emergency concessions, rather than renewing the concessions biannually. Several advantages to permanent concessions "Making the COVID-19 PHE concessions permanent, rather than renewing them biannually, could provide several advantages," he explained. "Doing so would provide stability and certainty, avoid legislative bottlenecks, enable continued access to healthcare, encourage long-term innovation, enable efficient use of resources, and continue lessons learned from the pandemic." On another note, telehealth encounters via electronic patient-reported outcomes (ePROs) should have clear, clinical content that develops over the treatment period for several key reasons, Cohen said. "This is because it tracks patient progress, improves clinical decision making, enhances patient-clinician communication, enables personalized treatment, improves outcome measurement, aids regulatory and reimbursement purposes, enables early identification of complications," he explained. "The lack of ePROs in a telehealth 'visit' compromises patient care," he continued. "Conversely, ePROs with clear, evolving clinical content are essential for monitoring patient progress, making informed clinical decisions, personalizing care, and improving overall treatment outcomes. They provide a comprehensive and accurate picture of the patient's health, which is critical for effective, evidence-based care." When AI helps with clinical decisions Cohen also offered views on how regulatory policies should be adapted and updated to allow for clinical decision making based in part on an artificial intelligence analysis of patients' ePROs data. Key regulatory policies for artificial intelligence and machine learning analysis of telehealth for the benefit of clinical decision making via evidence-based care include, Cohen detailed: Standards for AI/ML validation that offer clear guidelines for AI/ML models and continuous monitoring and updates. Data privacy and security regulations with robust data protection and transparency and consent management. Integration of AI/ML insights into clinical guidelines, including aligning AI/ML with evidence-based medicine and enabling clinical decision support systems. Definition of AI/ML's role in decision making, including clear delineation of AI's role and human oversight and accountability. Equity and mitigating of bias, including bias detection and mitigation and inclusion of diverse data. Clinical validation of AI-based decision tools, with post-market surveillance and clinical trials and testing. Patient-centered regulatory framework, including patient engagement and informed consent for AI use. Support for innovation and flexibility, with adaptive regulatory frameworks and fast-track for innovative AI tools. "For AI/ML analysis of ePROs data to be a valuable part of clinical decision making, regulatory policies need to ensure these tools are accurate, transparent, equitable, and integrated into a system that prioritizes patient safety and clinician oversight," Cohen said. "Establishing strong standards for validation, data security and bias mitigation, while fostering innovation and patient engagement, will be key to maximizing the benefits of AI/ML in healthcare." Follow Bill's HIT coverage on LinkedIn: Bill Siwicki Email him: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication. WATCH NOW: Mount Sinai's new CDIO offers an inside look at her very full plate