The U.S. Drug Enforcement Agency has made its suggested rulemaking public. It would allow users to use managed elements without making an in-person attend without violating the Ryan Haight Online Pharmacy Consumer Protection Act. The DEA and U.S. Health and Human Services announced a second time that they would extend the pandemic-era online prescribing of controlled materials. The most recent improvement of COVID-19 prescribing flexibility extends through 2025. Establishing and maintaining a regulatory scheme is the best course of action, according to the agency’s announcement released on Wednesday, to ensure persistent access to care while maintaining enough protection to minimize and detect the escape of controlled substances. To avoid patients from losing exposure to their telehealth-prescribed medications, the DEA is offering three types of unique subscription: Telemedicine Prescribing Registration- authorizes qualified physician practitioners to administer Schedule III-V controlled substances. Advanced Telemedicine Prescribing Registration- enables qualified, specialized clinicians to write prescriptions for Schedule II-V controlled materials. In their capability as software professionals, qualified covered online healthcare systems are authorized to dispense Schedule II-V controlled substances through Telemedicine Platform Registration. ” Once properly registered under the Special Registration model, doctor practitioners may be considered professional special registrants and covered online healthcare platforms, in their power as platform practitioners, may be considered platform specific registrants”, DEA explained. While DEA has been “diligent” in its work, getting the model “right for the thousands of people impacted by these activities” is crucial, according to Kyle Zebley, senior vice president of public coverage for the American Telemedicine Association and executive director of ATA Action, in a text on 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. It is obvious that these updates have significant implications for the telehealth community, Zebley said in a written response to the NPRM on Wednesday.” While we are still digesting the DEA’s Special Registration framework, we will have a comprehensive analysis soon. Early indications suggest the proposed rule contains elements that pose significant operational challenges, he said. According to the notice,” the crucial role they sometimes play in the delivery of healthcare through telemedicine” requires the organization to register covered online telemedicine platforms under the third special registration, which “is necessary given the pivotal role they occasionally play in the delivery of healthcare through telemedicine.” The Alliance for Connected Care stated in a statement that it is “very concerned about the proposed rulemaking mandating what portion of patient care can be offered through telemedicine” and deemed it an inappropriate guardrail. However, their emergence also brings more, and sometimes easier, avenues to divert or abuse controlled substances, especially when these entities have financial incentives tied to prescriptions and/or do not adequately screen the clinician practitioners utilizing their system or platform. By ensuring that a significant portion of these prescriptions are issued following in-person medical evaluations, which can provide a more thorough assessment of the patient’s medical history and condition than can be done remotely, DEA said in the NPRM,” Limiting the proportion of Schedule II prescriptions issued through telemedicine would help manage the risks associated with the prescribing of Schedule II controlled substances.” The value of providing virtual access to those patients who are most in need of it is undermined by restricting the geographic options, according to the alliance. DEA is accepting suggestions for a proposed telehealth prescribing registry through March 15. THE LARGER TRENDWithout a third extension before the end of 2024, patients would have had to make an in-person visit with a doctor within 30 days or lose access to medications due to the expiration of telehealth prescribing flexibilities. Lawmakers urged the agency to act in an October letter addressed to Anne Milgram, the DEA’s administrator. Legislators have also expressed concern that restrictions will lead to a return to access barriers that many patients faced before the pandemic, along with numerous industry groups. A litany of healthcare industry groups and observers argued a return to pre-pandemic prescribing regulations would have put the patient at risk. However, the initial DEA draft rule for 2023 to make some telehealth prescribing flexibilities permanent would have required affected patients to have in-person exams. Industry organizations and lawmakers have long questioned the existence of a registry for telemedicine providers that would be comparable to the current system of controlled substances prescribing. According to them, the organization is obligated to establish one under the 2018 Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act ( SUPPORT Act ). In order to encourage stakeholder engagement, the organization held Telemedicine Listening Sessions in 2023 to discuss what would be required to establish a special registration for telehealth prescribers. Additionally, the organization held a second comment period on its draft rule. According to DEA’s docket, Telemedicine Prescribing of Controlled Substances has received 35, 470 comments. The DEA announced on Friday that it would also publish a rulemaking on the expansion of buprenorphine use through telemedicine encounter. The final rule, according to the American Hospital Association, 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. The proposed special registration rule’s requirements “would not apply to clinicians prescribing buprenorphine for OUD,” according to AHA in a statement. ON THE RECORD” DEA’s goal is to provide telehealth access to needed medications while ensuring patient safety and preventing the diversion of medications into the illicit drug market,” Milgram said on Thursday in a statement. These regulations, which require online telemedicine platforms to register with the DEA and set up a nationwide Prescription Drug Monitoring Program, “welcome the challenges some patients face when accessing medical providers in person.” Andrea Fox is Healthcare IT News ‘ senior editor.
Email: afox@himss.org
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