Buprenorphine Hydrochloride

The U.S. Drug Enforcement Agency has released its notice of proposed rulemaking for a framework to permit medically necessary controlled substances without an in-person visit without violating the Ryan Haight Online Pharmacy Consumer Protection Act. WHY IT MATTERS The NPRM comes two months after the DEA and U.S. Health and Human Services announced they extended the pandemic-era virtual prescribing of controlled substances a third time . The most recent extension of COVID-19 flexibilities for prescribing runs through 2025. "DEA has determined that the best course of action to ensure patient access to care, while maintaining sufficient safeguards to prevent and detect diversion of controlled substances, is to establish and maintain a regulatory scheme," the agency said in the notice published Wednesday. To prevent patients from losing access to their telehealth-prescribed medications, the DEA is offering three types of special registration: Telemedicine Prescribing Registration: authorizes qualified clinician practitioners to prescribe Schedule III-V controlled substances. Advanced Telemedicine Prescribing Registration: authorizes qualified specialized clinician practitioners to prescribe Schedule II-V controlled substances. Telemedicine Platform Registration: authorizes qualified covered online telemedicine platforms – in their capacity as platform practitioners – to dispense Schedule II-V controlled substances. "Once properly registered under the Special Registration framework, clinician practitioners would be considered clinician special registrants and covered online telemedicine platforms, in their capacity as platform practitioners, would be considered platform special registrants," DEA explained. While DEA has been "diligent" in its efforts, getting the framework "right for the millions of patients impacted by these actions" is critical, Kyle Zebley, senior vice president of public policy for the American Telemedicine Association and executive director of ATA Action, said in a letter Tuesday. The letter, to DEA Administrator Anne Milgram and Tom Prevoznik, assistant administrator for diversion control, calls on the agency to establish a workgroup to create the framework. "While we are still digesting the DEA’s Special Registration framework, and will have a comprehensive analysis shortly, it is clear that these updates carry significant implications for the telehealth community," Zebley said in a written reaction to the NPRM Wednesday. "Early indications suggest the proposed rule includes elements that represent significant operational challenges," he noted. DEA said in the notice that registering covered online telemedicine platforms under the third special registration "is necessary given the pivotal role they sometimes play in the delivery of healthcare through telemedicine." The agency, concerned about "doctor shopping," said that "the lack of proper oversight and verification of clinician practitioners’ credentials" can open a door "bad actors" could take advantage of. "While these covered online telemedicine platforms may improve healthcare accessibility by connecting patients with clinician practitioners, their emergence also brings more, and sometimes easier, avenues to divert or abuse controlled substances, particularly when such entities have financial incentives tied to prescriptions and/or do not adequately screen the clinician practitioners utilizing their system or platform." The Alliance for Connected Care said in a statement that it is "very concerned to see language in the proposed rulemaking mandating what portion of patient care can be offered through telemedicine" and deemed it an inappropriate guardrail. "Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the patient’s medical history and condition than can be done remotely," DEA said in the NPRM. "Restricting the geography in which telemedicine can be offered undermines the value of creating virtual access for those patients who need it most," the alliance said. DEA is accepting comments on the proposed telehealth prescribing registry framework through March 15. THE LARGER TREND Without a third extension before the end of 2024 , the expiration of telehealth prescribing flexibilities would have required patients to have an in-person visit with a provider within 30 days or lose access to medications. Lawmakers urged the agency to act in an October letter addressed to Milgram. Along with numerous industry groups, lawmakers have also been concerned that restrictions would result in a return to access barriers many patients experienced before the pandemic. DEA's initial 2023 draft rule to make some telehealth prescribing flexibilities permanent would have required affected patients to have in-person exams, but a litany of healthcare industry groups and observers argued a return to pre-pandemic prescribing rules would risk patient harm. Industry groups and lawmakers have also long questioned why a registry for telemedicine providers similar to the existing prescribing of controlled substances system had not already been created. They have said that the agency has a responsibility to create one under the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act. In 2023, the agency held Telemedicine Listening Sessions to facilitate stakeholder engagement centered on what would be needed to create a special registration for telehealth prescribers and held a second comment period on its draft rule. According to DEA’s docket, Telemedicine Prescribing of Controlled Substances has received 35,470 comments. On Friday, DEA said it will also publish a rulemaking on Expansion of Buprenorphine Treatment via Telemedicine Encounter . According to the American Hospital Association, the final rule will allow providers to prescribe a six-month initial supply to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. "Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD," AHA said in a statement . ON THE RECORD "DEA’s goal is to provide telehealth access for needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market," said Milgram Thursday in a statement. "We understand the difficulties some patients have accessing medical providers in-person, and we want to ease this burden while also providing safeguards to keep patients safe. "These rules also mark a significant step forward for patient safety by requiring online telemedicine platforms to register with DEA and taking steps to establish a nationwide Prescription Drug Monitoring Program," she added. Andrea Fox is senior editor of Healthcare IT News. Email: afox@himss.org Healthcare IT News is a HIMSS Media publication.

The Drug Enforcement Administration on Wednesday issued a long-awaited proposed rule that would create a permanent process for clinicians to more easily prescribe controlled drugs online. The proposal would create a special registration process allowing telehealth doctors and mid-level practitioners to prescribe potentially addictive controlled substances without seeing a patient in person first, as federal law typically requires. Prescribing online without an initial in-person evaluation has been permitted by the DEA since the start of the Covid-19 public health emergency, thanks to several temporary extensions. A number of venture-backed telehealth companies grew rapidly as a result. Most recently, in November, the agency extended this flexibility until the end of 2025, after industry groups sounded the alarm that patients were poised to lose access to needed treatments. The proposed rule would essentially set that flexibility in stone for certain clinicians and add new requirements the DEA says are meant to expand access to care while allowing the agency better oversight. But some industry groups representing health systems, telehealth companies and other organizations that provide online care said the proposed rule may be too restrictive. In a statement, Kyle Zebley, senior vice president of public policy for the American Telemedicine Association, said that the proposed rule looks to contain “elements that represent significant operational challenges.” “All stakeholders need time to carefully review this important proposal, which appears to incorporate valuable elements and other potentially unworkable restrictions that focus on maintaining compliance with patient verification, electronic recordkeeping, and ongoing monitoring,” Zebley said. Meanwhile, the Alliance for Connected Care said it’s concerned that the proposal places limits on what portion of patient care can be offered through telemedicine and the geographies in which telemedicine can be offered. Comments on the rule are due in 60 days. Separately, the DEA and several other federal agencies finalized a rule Wednesday that allows DEA-registered clinicians to prescribe a six-month supply of buprenorphine, a controlled drug used to treat opioid use disorder, without seeing the patient in person. Those clinicians could write the buprenorphine prescription without having a special registration. Notably, the proposed rule discusses the challenges and risks associated with the recent rise of direct-to-consumer, prescription-writing telemedicine platforms. It proposes requiring companies that act as intermediaries in dispensing controlled substances to register with the DEA just like clinicians. “Although the telemedicine flexibilities during the PHE allowing practitioners to prescribe controlled substances without prior in-person medical evaluations were necessary to prevent lapses of care amid a global pandemic, it also facilitated the emergence of concerning business models engaged in the widespread diversion of controlled substances, taking advantage of the flexibilities established during the COVID-19 PHE,” the rule states. Though it doesn’t name any companies in the rule, the DEA last year fined mental health startup Cerebral for encouraging prescriptions of ADHD medications and other controlled drugs. The founder and head clinician of another startup, Done Global, were arrested and charged in June for inappropriate stimulant prescribing, according to the Justice Department. The proposed rule would create three types of special registrations: one for clinicians prescribing Schedule III through V controlled substances , which include anything from testosterone and ketamine to benzodiazepines like Xanax; another for specialized clinicians, such as psychiatrists and hospice care doctors, prescribing those and Schedule II drugs, such as stimulants and pain medication that have a higher risk of addiction and abuse; and one for telemedicine platforms dispensing Schedule II through V controlled substances. Each special registration would last for three years. In addition, the DEA would require clinicians to obtain from the agency another “state telemedicine registration” for every state in which they plan to prescribe controlled substances online. The proposed rule states that clinicians would also be subject to heightened requirements for prescriptions. For example, clinicians would need to check prescription drug monitoring programs (PDMPs) in all 50 states before writing a controlled substance prescription, though that requirement would go into effect three years after the rule is finalized. Before then, clinicians would be required to conduct a more limited PDMP check. The DEA also proposes placing limits on prescriptions for Schedule II controlled substances. It would require that the clinician with a special registration be physically located in the same state as the patient being treated. The proposed rule would also require that the clinician prescribe less than 50% of their average number of monthly prescriptions for Schedule II controlled substances through telemedicine. “Limiting the proportion of Schedule II prescriptions issued through telemedicine would help to manage the risks associated with the prescribing of Schedule II controlled substances by ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more comprehensive assessment of the patient’s medical history and condition than can be done remotely,” the proposed rule states. (This story is from our Health Tech newsletter. If you’d like to sign up, just click here. )