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 browse without violating the Ryan Haight Online Pharmacy Consumer Protection Act. The DEA and U.S. Health and Human Services announced they had extended the pandemic-era online dispensing of controlled substances a second time, two months after the NPRM was released. 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 distraction 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 membership enables skilled, board-certified specialists to write prescriptions for Schedule II-V controlled materials. Telemedicine Platform Registration- enables qualified covered online healthcare systems to deliver Schedule II-V controlled substances in their power as software practitioners. ” 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 behavior” is crucial, according to Kyle Zebley, executive producer of ATA Action and senior vice president of public coverage for the American Telemedicine Association, in a letter released 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. The agency, concerned about “doctor shopping,” claimed that” the lack of proper oversight and verification of clinician practitioners ‘ credentials” can open a door “bad actors” could take advantage of. DEA said in the notice that registering covered online telemedicine platforms under the third special registration is necessary. The Alliance for Connected Care said in a statement that it is “very concerned about the proposed rulemaking mandating what portion of patient care can be offered through telemedicine” and that it is “very concerned about telemedicine.”” 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, especially when such entities have financial incentives tied to prescriptions and/or do not adequately screen the clinician practitioners 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 need it most is undermined by restricting the geography in which telemedicine can be offered, according to the alliance. DEA is taking comments until March 15 regarding the proposed telehealth prescribing registry framework. 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 the access issues that many patients had before the pandemic, in addition to 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 required to create 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 via telemedicine encounter. The final rule, according to the American Hospital Association, will allow providers to use audio-only telemedicine to prescribe a six-month initial supply to treat opioid use disorder without requiring a prior in-person evaluation. The proposed special registration rule’s requirements won’t apply to clinicians who prescribe buprenorphine for OUD, according to AHA in a statement. DEA’s goal is to provide telehealth access to needed medications while ensuring patient safety and preventing the entry of drugs into the illegal drug market, Milgram said in a statement on Thursday. These regulations also make a significant step forward for patient safety by requiring online telemedicine platforms to register with the DEA and initiating a national Prescription Drug Monitoring Program, she added.” We understand the difficulties some patients have having access to medical providers in person. Andrea Fox is Healthcare IT News ‘ senior editor.
Email: afox@himss.org
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