Dykema’s Post

After significant backlash surrounding an August POLITICO report that the Drug Enforcement Administration was considering final rule that would have dramatically limited the ability to prescribe controlled substances via telemedicine, the DEA has instead kicked the can down the road (again) and continued the existing COVID-19-era flexibilities. That means that, until December 31, 2025, Schedule II-V controlled substances may be prescribed via telemedicine without the prescriber having first conducted an in-person evaluation of the patient. A final rule will now be considered by the next administration. #DEA #Telemedicine

Earlier today, the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) released two rules related to the prescription of controlled substances via telemedicine. The first is a final rule entitled, “Expansion of Buprenorphine Treatment via Telemedicine Encounter,” which creates requirements for the prescription of certain controlled substances via telemedicine and audio-only telemedicine for treatment of opioid use disorder. Read the full final rule here: https://lnkd.in/g8fgWR6N The second is a proposed rule entitled, “Special Registrations for Telemedicine and Limited State Telemedicine Registrations,” which would establish three Special Registrations that create a pathway for certain healthcare professionals to prescribe certain controlled substances via telemedicine. This is the first time the agency has proposed a Special Registration since the passage of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, when it was originally required. Read the full proposed rule here: https://lnkd.in/gacVKyiE We will continue to review the proposed rule and will provide a more detailed summary in the coming days. For more background on DEA requirements for prescribing of controlled substances and recent agency action, see this +Insight: https://lnkd.in/guhDMaxi #telehealth #virtualcare

On October 6, 2023, the Drug Enforcement Administration extended temporary flexibility for #telehealth prescribing through December 31, 2024. Special registration to prescribe controlled substances through #telemedicine was originally called for in the Ryan Haight Act of 2008. After 15 years of several congressional mandates to promulgate regulations related to a Special Registration for Telemedicine, the DEA has still not issued permanent policy. To ensure permanent and uninterrupted access to virtual care, the Drug Enforcement Administration must promptly release a revised proposed rule to permit and regulate the prescribing of controlled substances through telehealth. This rule is crucial to preserving virtual access to treatment for #mentalhealth conditions, #substanceusedisorders, and many other medication needs. #MakeTelehealthPermanent Learn more about the Alliance's advocacy here: https://lnkd.in/gkpzpmGY

In the final days of President Joe Biden’s tenure, the Drug Enforcement Administration (DEA) announced three new rules to allow medical providers to prescribe controlled substances via telehealth. These rules would make temporary flexibilities—enacted in 2020 following difficulties getting prescriptions during the Covid-19 pandemic—permanent. #telehealth #telehealthpolicy #prescribing https://lnkd.in/g4FKCqk3

The Drug Enforcement Administration (DEA) in concert with the Department of Health and Human Services (HHS) has issued a third extension of telemedicine flexibilities for the prescribing of controlled medications through December 31, 2025. Under this new regulation, providers can continue prescribing Schedule II-V controlled substances via telemedicine without having conducted an in-person evaluation of the patient, if certain conditions are met. Learn more in our latest blog: https://lnkd.in/etS8iWkf "

As decentralized clinical trials become more common, sites and principal investigators are treating telemedicine in clinical trials like it's all about just using Zoom or Apple’s camera to talk to patients. It’s not!! You have to remember that there is a patchwork of state laws on informed consent, malpractice, privacy, and even who gets to conduct those meetings—whether it’s doctors, PAs, or others which plays a role in telemedicine. Ignoring these details leads to non-compliance and major legal risks. Let’s talk about why this matters! Are your sponsors even aware or is everyone simply trying to follow the FDA guidance? #ClinicalTrials #Telemedicine #Compliance #LegalRisks #Pharma #KulkarniLawFirm #klf

📢 Update on Buprenorphine Prescriptions! 📢 The HHS and DEA have finalized a rule expanding telemedicine prescribing of buprenorphine for opioid use disorder. Key points: -Telemedicine Expansion: Up to a six-month supply can be prescribed via telemedicine, including audio-only. -PDMP Review: Practitioners must check PDMP data before prescribing. #Healthcare #Telemedicine #OpioidCrisis #AddictionTreatment #Buprenorphine

𝐈𝐂𝐃𝐑𝐀: 𝐇𝐞𝐚𝐥𝐭𝐡 𝐌𝐢𝐧𝐢𝐬𝐭𝐞𝐫 𝐬𝐚𝐲𝐬 𝐌𝐞𝐝𝐓𝐞𝐜𝐡 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲 𝐢𝐧 𝐈𝐧𝐝𝐢𝐚 𝐢𝐬 𝐛𝐞𝐢𝐧𝐠 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐞𝐝 The MedTech industry in India is being regulated considering the importance of medical devices in health care delivery, said JP Nadda, Union Health, and Family Welfare Minister, at the inauguration of the 19th International Conference of Drug Regulatory Authorities. During the five-day conference, a significant focus will be placed on the regulation of medical devices, including IVDs, where experts will discuss trends in global and regional regulatory frameworks. For complete news: https://lnkd.in/gDjPMGQd #MedTech #industry #medical #devices #IVD #regulatory #frameworks

Alive in transition. More time to get IVDReady. 🔬 Manufacturers of in vitro diagnostics (IVD) will likely have more time to comply with the stricter requirements set by the #IVDR. Yesterday the EU Parliament voted in favour of a proposal by the EU Commission to extend the transition periods. The Council still needs to adopt the measure, but this is expected to be a formality now. The amendment is an important step to secure and improve the availability of IVD on the EU market. The additional time depends on the type of device: - 12/2027 for high individual and public health risk devices (class D); - 12/2028 for high individual and/or moderate public health risk devices (class C); - 12/2029 for lower risk devices (class B). Companies are well advised to check whether they fulfill the conditions necessary to profit from these extended periods and to take appropriate steps to secure continuous IVDR compliance. #lifesciences #healthcare #regulatory #ivd #medicaldevice #mdr #cmslaw

Proposed DEA Regulations Would Allow Remote Prescribing of Controlled Substances On January 16, the Drug Enforcement Administration (DEA) announced a notice of proposed rulemaking to establish special registrations that would allow physicians and mid-level practitioners (“Clinician Practitioners”) to prescribe controlled substances through telemedicine visits without an in-person medical evaluation when there is a legitimate need. For example, Clinician Practitioners could have a legitimate need for a special registration when their patients face significant challenges that would make in-person medical evaluations difficult or unadvisable, such as severe weather conditions, living in remote or distant areas, or having communicable diseases. Read more here: https://lnkd.in/gk47pjeH #DEA #telemedicine #healthcarelaw