Telemedicine / en Fri, 25 Apr 2025 20:16:46 -0500 Fri, 21 Mar 25 14:52:00 -0500 DEA, HHS delay implementation of buprenorphine final rule until Dec. 31 /news/headline/2025-03-21-dea-hhs-delay-implementation-buprenorphine-final-rule-until-dec-31 <p>The Drug Enforcement Administration and Department of Health and Human Services yesterday <a href="https://www.federalregister.gov/public-inspection/2025-05007/expansion-of-buprenorphine-treatment-via-telemedicine-encounter-and-continuity-of-care-via" target="_blank">announced</a> that the effective date for the final rule regarding telemedicine prescribing of buprenorphine will be further delayed from March 21 to Dec. 31. The original effective date was Feb. 18 before the <a href="/news/headline/2025-02-14-dea-and-hhs-delay-implementation-buprenorphine-final-rule?utm_source=newsletter&utm_medium=email&utm_campaign=aha-today" target="_blank">first delay</a> to March 21. As outlined in the Jan. 20 <a href="https://www.whitehouse.gov/presidential-actions/2025/01/regulatory-freeze-pending-review/" target="_blank">White House memorandum</a> announcing the regulatory freeze, the agencies decided to delay the implementation of rules to review any questions of fact, law and policy.</p><p>The waiver provisions outlined in the <a href="https://www.federalregister.gov/documents/2024/11/19/2024-27018/third-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled" target="_blank">third extension</a> of telemedicine flexibilities for prescribing controlled substances will remain in effect to waive in-person visit requirements through Dec. 31.</p><p>Once implemented, the final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation.</p> Fri, 21 Mar 2025 14:52:00 -0500 Telemedicine AHA comments on DEA proposed rule on special registrations for telemedicine prescribing /news/headline/2025-03-18-aha-comments-dea-proposed-rule-special-registrations-telemedicine-prescribing <p>The AHA today <a href="/lettercomment/2025-03-18-aha-comments-dea-proposed-rule-special-registrations-telemedicine-prescribing" target="_blank">commented</a> on the Drug Enforcement Administration's <a href="https://www.federalregister.gov/documents/2025/01/17/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrations" target="_blank">proposed rule</a> for special registrations for telemedicine prescribing of controlled substances. The proposal outlines three types of registration for providers to replace in-person visit requirements prior to virtual prescribing of controlled substances, as well as a state registration for every state in which a patient is treated by the special registrant. The DEA also proposed that providers be required to review prescription drug monitoring programs in all 50 states and territories after three years.  </p><p>The AHA expressed support for the concept of a special registration process replacing in-person requirements before the prescribing of controlled substances, but it also noted concerns that the current proposal would be inefficient and unnecessarily burdensome. The AHA recommended a streamlined process enabling prescribers to register as part of the existing licensure framework, among other recommendations.  </p><p>The AHA also urged the DEA to provide at least a one-year pre-implementation period after the rule is finalized to ensure practitioners can appropriately prepare for changes. </p> Tue, 18 Mar 2025 16:04:10 -0500 Telemedicine AHA Comments on DEA Proposed Rule on Special Registrations for Telemedicine Prescribing /lettercomment/2025-03-18-aha-comments-dea-proposed-rule-special-registrations-telemedicine-prescribing <p>March 18, 2025</p><p>Acting Administrator Derek Maltz<br>Drug Enforcement Administration<br>ATTN: DEA Federal Register Representative<br>8701 Morrissette Dr.<br>Springfield, VA 22152</p><p><em><strong>Re: Docket No. DEA-407 Special Registrations</strong></em><br><em><strong>for Telemedicine and Limited State Telemedicine Registrations</strong></em></p><p>Dear Acting Administrator Maltz: </p><p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations; our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the Association (AHA) appreciates the opportunity to share our comments regarding the Drug Enforcement Administration’s (DEA’s) proposed rule for Special Registrations for Telemedicine and Limited State Telemedicine Registrations.</p><p><strong>The AHA continues to support the concept of a special registration process to waive in-person evaluations prior to the prescribing of controlled substances. However, we are concerned that the proposed process would be inefficient and unnecessarily burdensome. We recommend the agency adopt a more streamlined process that would enable prescribers to register as part of the existing licensure framework. This approach would achieve the agency’s crucial goal of mitigating diversion while minimizing excessive burdens on our already overtaxed clinical workforce.</strong> Specifically, we urge the agency to:</p><ul><li>Expand the existing DEA registration forms to collect the information sought instead of creating separate registration forms and fees.</li><li>Expand the list of providers eligible for advanced telemedicine prescribing.</li><li>Remove the requirement for Prescription Drug Monitoring Program (PDMP) reviews for every state and territory.</li><li>Remove the requirement for Schedule II prescribers to be physically located in the same state as the patient.</li><li>Remove the requirement for Schedule II prescribers to have less than 50% of Schedule II prescriptions issued as special registration prescriptions.</li><li>Remove certain recordkeeping and reporting requirements, including the requirement to maintain a photographic record of patient identity verification.</li></ul><p><strong>Given the scope of the proposed changes, we also encourage the DEA to extend the timeline for implementation, which we recognize would also</strong><em><strong> </strong></em><strong>require extension of the relevant waiver flexibilities until the final rule is published and in effect. </strong>Patients, practitioners, platforms, pharmacies and other stakeholders must have adequate pre-implementation periods to prepare for changes in process.</p><p>Below are our detailed comments.</p><p><strong>Background</strong></p><p>The Ryan Haight Act of 2008 established specific requirements for in-person evaluations prior to the prescribing of controlled substances. This law also outlined seven categories of instances in which telemedicine, rather than in-person evaluations, could be utilized. One of these categories was a special registration process, and the law specified that the Attorney General <em>shall</em> promulgate regulations specifying circumstances in which a special registration for telemedicine prescribing may be issued as well as the procedures for obtaining such a special registration. The SUPPORT Act of 2018 again mandated that the DEA, in coordination with the Department of Health and Human Services (HHS), promulgate special registration regulations. The law specified: (1) the circumstances in which a special registration for telemedicine may be issued that authorizes prescribing of controlled substances without an in-person evaluation; and (2) the procedures for obtaining a special registration.</p><p>The AHA has continuously supported a special registration process to waive in-person visit requirements for those prescribers who register. Indeed, a streamlined special registration process that ensures appropriate tracking of virtual prescribers would help safely ensure access to critical services. As such, we have recommended that the DEA establish such a process based on the existing registration process<sup>.1</sup> Over the last five years, waivers of in-person visits and broad utilization of virtual prescribing have demonstrated significant benefits to patients in accessing lifesaving medication. Meanwhile, data have indicated no increased risk for diversion. <strong>As such, we support the agency’s pursuit of a permanent pathway for practitioners to waive in-person visit requirements. However, we have both concerns with and recommendations to improve the agency’s proposed special registration process.</strong></p><h2>TYPES OF SPECIAL REGISTRATION</h2><p>The DEA proposes three types of special registration:</p><ul><li>Telemedicine prescribing registration, which would authorize qualified clinician practitioners to prescribe Schedule III-V controlled substances via telemedicine.</li><li>Advanced telemedicine prescribing registration, which would authorize certain practitioners to prescribe select Schedule II-V controlled substances via telemedicine.</li><li>Telemedicine platform registration, which would authorize online telemedicine platforms to dispense Schedule II-V controlled substances.</li></ul><p>Under the proposed framework, clinician practitioners would be considered clinician special registrants, and platform practitioners would be considered platform special registrants.</p><p>In general, we urge the agency to issue clarifying guidance on how post-graduate hospital trainees (also known as residents) would register under this scheme. Residents typically utilize a hospital DEA registration number when prescribing controlled substances in accordance with their residency program. The proposed rules did not address applications in training settings, and therefore we request clarifying.</p><p>Additional feedback on the proposed registration types follows.</p><p><u>Advanced Telemedicine Prescribing Registration.</u> In addition to demonstrating a legitimate need for this type of special registration, the DEA proposes that only certain clinician practitioners would be eligible. These include:</p><ul><li>Psychiatrists.</li><li>Hospice care physicians.</li><li>Palliative care physicians.</li><li>Physicians rendering treatment at long-term care facilities.</li><li>Pediatricians.</li><li>Neurologists.</li><li>Mid-level practitioners and physicians from other specialties who are board-certified in the treatment of psychiatric or psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to the treatment and management of pain.</li></ul><p>The list does not include other specialties or clinical applications that serve patients who would benefit from virtual prescribing flexibilities. For example, a geographically remote patient with cancer receiving pain medications from an oncologist and a home-bound patient with a sleep disorder receiving sleep medication from a pulmonologist could both benefit greatly from access to these services. In these instances, seeing a practitioner in person is simply not an available option. As such, virtual prescription pathways should also be available to these practitioners and patients. <strong>Therefore, we urge the agency to expand the list of eligible providers able to register for advanced telemedicine special registration to include all practitioners who can prescribe these medications in person. </strong>Doing so also would include, for example, oncologists or pulmonologists registered with the DEA.</p><p><u>Telemedicine Platform Registration.</u><em><u> </u></em>The DEA proposes a separate process for telemedicine platform registration, which would authorize virtual practitioners practicing only on telemedicine platforms (as opposed to seeing some patients in person and some via telemedicine) to prescribe controlled substances. <strong>While we agree that it would be beneficial to track these practitioners separately, we urge the agency to issue clarification on this registration process. </strong>We agree that platform providers should maintain certain records of clinicians who enter into a platform relationship (including disciplinary actions and complaints). However, we disagree that the threshold for clinical need should be lower for this category. Specifically, in the proposed rule, platform providers under this designation would be able to prescribe Schedule II-V drugs, the same as advanced registration clinicians; however, the requirements to demonstrate need are aligned instead with the standard telemedicine registration clinicians who are able to prescribe only Schedule III-V drugs. It is unclear why platform special registrants would be held to a different, less rigorous standard than advanced special registrants. This essentially penalizes clinicians leveraging hybrid models of care (in-person and virtual appointments). <strong>If the intent was for platform practitioners to also register as either general or advanced telemedicine prescribers in addition to platform registrants, then we request that the DEA issue such a clarification. Otherwise, we encourage the agency to adopt parallel requirements based on the schedule of drug prescribed. </strong></p><h2>STATE REGISTRATION</h2><p>In addition to the aforementioned special registration categories, the DEA proposes that practitioners would need to complete a state registration for every state in which they treat a patient. The agency proposes that the state registration would be a novel, separate and ancillary credential administered by the DEA (not the states). <strong>We are concerned that this additional layer of licensure is overly burdensome without providing clear benefit, particularly considering existing licensure standards. </strong>Specifically, to require practitioners to submit separate registration forms for each state in which a patient is located is redundant, since the same information is already provided on other forms. That is, the existing general DEA registration process already asks for information on state medical licenses; the proposed process would duplicate efforts without providing additional safeguards.</p><p>It is unclear what purpose registering for each individual state would serve given the existing DEA registration process, the proposed special registration questions and state medical licensure processes. If the purpose is to track the states that a telemedicine practitioner is not only licensed in but also wishes to prescribe certain controlled substances to, then a question about this could be added to the general registration form. For example, the DEA could add a question to the existing general registration form such as, “In which states do you have patients that you will virtually prescribe special-registration controlled substances? (check all that apply).”<strong> To avoid unnecessary and duplicative administrative burden, we urge the DEA to remove the requirements for practitioners to complete state-specific registration forms and adopt this approach instead.</strong></p><p>If the agency does move forward with this proposal, we request it provide guidance on state responsibility for enforcement as the proposed rule also does not address the notification and enforcement process for state registrations. Specifically, it does not address enforcement responsibilities in states where practitioners are licensed and in good standing through state medical boards, are registered and in good standing with the DEA, and have completed the general special registration process but are not registered for an individual state.<strong> Enforcement activities are often complex, involving the DEA, state medical boards and state law enforcement. If this policy is adopted, we request further guidance on both agency and state responsibilities for enforcement. </strong></p><h2>SPECIAL REGISTRATION AND STATE REGISTRATION APPLICATIONS</h2><p>The DEA proposes two new forms (224S and 224S-M for modifications) that practitioners completing special registration and state registration would need to submit. However, as we previously noted, the establishment of a separate form would be redundant, creating undue administrative burden for both practitioners and the DEA, which would need to develop separate systems for processing and tracking the new forms. Specifically, practitioners, hospitals, clinics, pharmacies and others are already required to complete applications for registration and renewal of registrations for prescribing controlled substances through forms 224 and 224a. This process has established guardrails that build upon state medical licensure processes and Medicare reporting. State medical boards screen applicants for education and training as part of licensure processes and are responsible for investigating complaints, monitoring compliance and disciplining providers when necessary. Given the DEA’s unique role in mitigating risk of diversion for controlled substances, the registration process complements existing state-based processes. The DEA collects supporting information from physicians about state licensure, locations and adverse actions on the existing applications. <strong>Therefore, rather than creating a novel and separate process or form, we urge the DEA to add any additional information it needs on special registration to the forms 224 and 224a that are already in use.</strong> This way, the special registration process would include both key elements that providers already report — such as practitioner contact information, employer, practice address, state medical licenses, liability history, etc. — and providers could add unique attestations. Indeed, the proposed rule highlighted that the special registration would be contingent on good standing of other DEA registrations and that the special registration location would need to already be registered with the DEA. As such, it would make sense to link special registration questions to the existing form.</p><h2>SPECIAL REGISTRATION PRESCRIPTIONS</h2><p>In addition to abiding by state laws where the provider is located, the patient is located and the practitioner is registered with the DEA, under the agency’s proposal, providers also would need to follow several provisions related to the prescriptions administered under special registration.</p><p><u>Nationwide PDMP Review.</u><em> </em>The DEA proposes that for the first three years after the rule is finalized, providers would need to complete PDMP checks for the states where the patient is located, the clinician is located and for any state with a reciprocity agreement to the patient/clinician locations. After three years, the DEA proposes that providers would need to review the PDMPs of all 50 states and territories when prescribing a controlled substance via telemedicine for each patient.</p><p><strong>While PDMPs can provide useful information on patients’ prescription histories, the proposal to perform PDMP reviews for all 50 states and territories is simply operationally infeasible and is unlikely to offer additional protection against diversion. </strong>Performing a PDMP check for all 50 states is not as easy as visiting one website, entering a patient’s name and receiving a list of results.<strong> </strong>First, interoperability infrastructure does not currently exist to support providers reviewing information across all 50 states and territories from a single platform. Interstate data-sharing partnerships vary, with some states limiting data sharing to noncontiguous states. Additionally, “ownership” of the PDMP within state health departments or other agencies (like law enforcement) can also hinder accessibility and data transfer across state lines. According to the Assistant Secretary for Technology Policy, only 31 states reported sharing data with more than 30 states through data-sharing systems like RxCheck or PMP InterConnect.<sup>2</sup> This lack of data sharing means that physicians would have to maintain separate logins for different state PDMP portals, which is incredibly burdensome. In addition, 10 territories do not have PDMPs. There also are large gaps in integration with electronic health records (EHRs). Interfaces between state PDMP databases and EHRs minimize resource requirements, since physicians can seamlessly access prescription histories while reviewing the patient’s medical record. However, building PDMP/EHR interfaces can be resource intensive and requires providers to leverage an EHR of sufficient size and scope to support multi-state PDMP interfaces or interfaces with data-sharing systems (like the ones mentioned above). This lack of interoperability means that most physicians would need to manually check individual state PDMP portals, which would, in effect, negate their ability to use this waiver.</p><p>Second, PDMP reviews themselves are often time consuming and administratively burdensome. Research (which typically involved just one state) shows that these reviews vary based on specialty. Using psychiatrists as an example, the estimated amount of time used to retrieve PDMP reports is around 22 hours annually.<sup>3 </sup>Extrapolating to all 50 states and 14 territories means that the physician would need over 1,400 hours annually just to perform PDMP reviews. That equates to 1,400 fewer patient hours and a cost of over $174,000 per year per prescriber to retrieve this information (using the Bureau of Labor Statistics’ average hourly rate for psychiatrists of $124).<sup>4 </sup>It is unlikely any provider could absorb this level of burden, especially given the already high degree of burnout among physicians. </p><p>Finally, barriers to accessing and interpreting PDMP data are not limited to data interoperability and time challenges. Indeed, the specific data elements, standards and formats also vary from state to state. For example, while there are some common reporting elements, specific data elements are dictated by state-level statute and regulation. This variation hampers the ability of physicians to have a holistic view across all PDMP reports. Also, some states have the ability to create aggregate and custom reports to summarize data longitudinally, whereas others do not and the onus is on the physician to manually aggregate the data. Again, this highlights the cumbersome nature of PDMP review in the current environment.</p><p>To be clear, PDMPs are helpful state-level interventions that can improve surveillance on inappropriate prescriptions; however, as we noted in our response to the Assistant Secretary for Planning and Evaluation’s <a href="/system/files/media/file/2019/08/hhs-rfi%20ensuring-patient-access-and-effective-drug-enforcement-8-23-2019.pdf" target="_blank">Request for Information</a> on Ensuring Patient Access and Effective Drug Enforcement, there is significant room for improvement in each state’s PDMP and serious limitations on interoperability across state programs<strong>. As such, we once again urge DEA to coordinate with HHS and other agencies to develop strategies to enhance the data interoperability of PDMPs. This will maximize the utility of PDMP data in the long term and better support physicians in mitigating risk of diversion. In the meantime, we urge the DEA to remove the requirements for additional PDMP reviews beyond current standards for in-person prescribing of controlled substances and limit the requirement to the state where the provider and patient are located. </strong></p><p><u>Special Registration Audio-Video. </u>In the proposed rule, the DEA would mandate that a clinician special registrant utilize both audio and video components of an audio-video telecommunications system to prescribe under the special registration framework. This unnecessarily restricts patients’ access to virtual prescribing when video technology may not be available. CMS has identified the services that are eligible for audio-only encounters. <strong>Similarly,</strong> <strong>we encourage the DEA to provide parameters or exceptions where audio-only prescribing may be appropriate.</strong></p><p><u>Schedule II Special Registration Prescriptions.</u> The agency proposes two additional requirements for special registration prescriptions of Schedule II drugs. First, the agency proposes that clinician special registrants prescribing Schedule II drugs be physically located in the same state as the patient. However, this arbitrary requirement defeats the purpose of virtual prescribing flexibilities and limits patient choice. Physician shortages are impacting some states and specialties more acutely than others. For example, Texas has over 13 million people living in mental health care provider shortage areas and would need 614 additional practitioners to remove that designation.<sup>5 </sup>Restricting special registration practitioners to prescribing these drugs only to patients in their state would not help with existing shortages such as these. Often practitioners are simply not available in some communities, and telemedicine provides options for patients to access geographically dispersed practitioners located in other states. So long as practitioners are abiding by federal and state statute and conforming to standards issued by state licensing boards, we urge the DEA to not arbitrarily limit access to services. <strong>As such, we ask that the DEA remove the requirement for providers and patients to be located in the same state for prescribing of Schedule II drugs.</strong></p><p>Additionally, the agency proposes to require that the number of special registration Schedule II drugs constitute less than 50% of the total number of Schedule II drugs issued by the clinician in their telemedicine and non-telemedicine practice in a calendar month. <strong>We are unclear from the discussion in the rule why the agency proposed this standard, and without further rationale, we recommend removing it.</strong> There is no evidence to suggest that requiring practitioners to prescribe less than 50% of drugs virtually would mitigate risk of diversion. Rather, the agency relies on a general assumption that because controlled substances can be misused, an increase in access results in increased risk.</p><h2>RECORDKEEPING AND REPORTING</h2><p>The DEA also proposes additional recordkeeping and reporting requirements. For example, it proposes that clinician special registrants be required to capture a photographic record of the patient presenting federal- or state-issued identification cards. If the patient does not feel comfortable with the clinician taking a picture, the patient could provide a copy of their ID. <strong>We are concerned that this requirement could raise fair concerns by patients about their privacy, while at the same time not adding additional protection against diversion. </strong>Telehealth providers generally document in the medical record an attestation that patient identification was verified. There are also standards at the state level on types of data fields required for identity verification, some of which may not be on a state or federal ID card. Therefore, having photographic evidence of identity presentation is unnecessary and adds administrative burden to take and preserve a photo in the medical record. This detracts from the clinical time that the practitioner is engaging with the patient, is costly to maintain and poses unnecessary risk (i.e., capture and maintenance of additional sensitive data). Just as a practitioner would not be expected to take a picture of a patient in an exam room to verify identity, the same standard applies to virtual appointments. Finally, there is no evidence to suggest that this added requirement would minimize risk of diversion. <strong>As such, we urge the DEA to defer to state requirements for identity verification and not impose additional requirements. </strong></p><p>We also are concerned that additional reporting requirements, like the requirement for pharmacies to generate monthly reports of special registration prescriptions filled and the requirement for practitioners to generate annual special registrant reports, are overly burdensome and will not lead to reduced risk of diversion. According to the proposed rule, the DEA would require pharmacies to report aggregate data within the first seven days of every month on the special registration prescriptions filled during the preceding month for each Schedule II controlled substance and certain Schedule III-V controlled substances. These requirements could result in further limiting access since providers may simply elect to no longer virtually prescribe medications or fill telemedicine prescriptions since it is too burdensome to keep up with the recordkeeping and reporting requirements. This has already been an issue with “red flags” for prescriptions issued in remote geographies, where pharmacists have declined filling prescriptions for controlled substances from outside states. There are many reasons a virtual prescription may be filled in a remote state or geography: a patient is on vacation, a student is in college, a patient is maintaining the same provider after moving out of state, a patient is seeing a specialist in a different state when they cannot find a doctor locally, etc. Nonetheless, distance from the prescriber and patient has been identified as a “red flag” and has hampered access as many pharmacies are simply opting to not fill virtual prescriptions. The potential risk to access in these cases may outweigh potential risk of diversion.<strong> In addition to removing the requirements for additional annual and monthly reports, we urge the agency to also remove reference to geography as a red flag for risk of diversion.</strong></p><p><strong>Given the scope of a new special registration process and breadth of potential changes, we also urge the agency to delay implementation to allow adequate time for stakeholders to prepare. Specifically, we request that the DEA provide at least a one-year pre-implementation period after rules are finalized to ensure that practitioners can appropriately prepare for changes. Simultaneously, we urge the agency to extend the current in-person visit waivers to avoid gaps in access until rules are finalized.</strong></p><p>We thank you for considering our comments on this proposed rule. If you have any questions concerning our comments, please feel free to contact me or have a member of your team contact Jennifer Holloman, AHA’s senior associate director of policy, at jholloman@aha.org or Caitlin Gillooley, AHA’s director of behavioral health and quality policy, at cgillooley@aha.org.</p><p>Sincerely,</p><p>/s/</p><p>Ashley Thompson<br>Senior Vice President<br>Public Policy Analysis and Development</p><div><hr><div id="ftn1"><p><small class="sm"><sup>1</sup></small><a href="/system/files/media/file/2023/03/aha-comment-letter-to-dea-on-telemedicine-prescribing-of-controlled-substances-proposed-rule-3-29-23.pdf" target="_blank"><small class="sm">/system/files/media/file/2023/03/aha-comment-letter-to-dea-on-telemedicine-prescribing-of-controlled-substances-proposed-rule-3-29-23.pdf</small></a><small class="sm">.</small></p></div><div id="ftn2"><p><small class="sm"><sup>2</sup></small><a href="https://www.healthit.gov/buzz-blog/health-it/physicians-have-widespread-access-to-state-pdmp-data-but-data-sharing-varies-across-states" target="_blank"><small class="sm">https://www.healthit.gov/buzz-blog/health-it/physicians-have-widespread-access-to-state-pdmp-data-but-data-sharing-varies-across-states</small></a><small class="sm">.</small></p></div><div id="ftn3"><p><small class="sm"><sup>3</sup></small><a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC6176751/" target="_blank"><small class="sm">https://pmc.ncbi.nlm.nih.gov/articles/PMC6176751/</small></a><small class="sm">.</small></p></div><div id="ftn4"><p><small class="sm"><sup>4</sup></small><a href="https://www.bls.gov/oes/2023/may/oes291223.htm" target="_blank"><small class="sm">https://www.bls.gov/oes/2023/may/oes291223.htm</small></a><small class="sm">.</small></p></div><div id="ftn5"><p><small class="sm"><sup>5</sup></small><a href="https://www.kff.org/other/state-indicator/mental-health-care-health-professional-shortage-areas-hpsas/" target="_blank"><small class="sm">https://www.kff.org/other/state-indicator/mental-health-care-health-professional-shortage-areas-hpsas/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Practitioners%20Needed%20to%20Remove%20HPSA%20Designation%22,%22sort%22:%22desc%22%7D</small></a><small class="sm">.</small></p></div></div> Tue, 18 Mar 2025 15:41:23 -0500 Telemedicine AHA podcast: Bridging Distances with AI and Telemedicine /news/headline/2025-03-03-aha-podcast-bridging-distances-ai-and-telemedicine <p>In this conversation, Dave Newman, M.D., vice president and chief medical officer for virtual care at Sanford Health, discusses how innovative virtual care models and artificial intelligence-powered solutions are breaking down barriers, improving patient outcomes and enhancing provider efficiency. <a href="/advancing-health-podcast/2025-03-03-bridging-distances-ai-and-telemedicine" target="_blank"><strong>LISTEN NOW</strong></a> </p><div></div> Mon, 03 Mar 2025 15:24:05 -0600 Telemedicine Bridging Distances with AI and Telemedicine /advancing-health-podcast/2025-03-03-bridging-distances-ai-and-telemedicine <p>Sanford Health, America’s largest rural health system, is revolutionizing care delivery with telemedicine and AI. In this conversation, Dave Newman, M.D., vice president and chief medical officer for virtual care at Sanford Health, discusses how innovative virtual care models and AI-powered solutions are breaking down barriers, improving patient outcomes and enhancing provider efficiency.</p><hr><div></div><div class="raw-html-embed"> <details class="transcript"> <summary> <h2 title="Click here to open/close the transcript."> <span>View Transcript</span><br>   </h2> </summary> <p> 00:00:00:20 - 00:00:33:17<br> Tom Haederle<br> Welcome to Advancing Health. South Dakota-based Sanford Health is America's largest rural health care system. But even with its hundreds of locations, some patients still face voyages of hundreds of miles to access the care they need. In today's podcast, recorded at one of the world's largest digital health conferences, we hear how Sanford is innovating with both telehealth and artificial intelligence - AI - to shrink those vast distances and deliver quality medical care to all who need it, regardless of where they are. </p> <p> 00:00:33:19 - 00:01:00:21<br> Chris DeRienzo, M.D.<br> Hi again everyone, this is Dr. Chris DeRienzo, AHA’s chief physician executive and I am super excited to be here on the sidelines of one of the world's largest digital health conferences with Dr. Dave Newman. Dave and I have known each other for a while now. He is an endocrinologist up at Sanford Health in the Dakotas, and he is the chief medical officer of virtual care for a health system that knows a little bit something about how to serve rural and frontier populations. </p> <p> 00:01:00:24 - 00:01:11:20<br> Chris DeRienzo, M.D.<br> And you can hear in the background, we are on the sidelines of this, this large conference, and both of us happen to be talking innovation. We got you to agree to jump on the podcast with us and talk a little bit more about it. </p> <p> 00:01:11:20 - 00:01:12:26<br> Dave Newman, M.D.<br> Yeah, thanks for having me, I appreciate it. </p> <p> 00:01:13:03 - 00:01:27:22<br> Chris DeRienzo, M.D.<br> So for you all, innovation is really grounded in your need to serve your population. So remind our listeners a little bit about Sanford Health and the populations you serve and why innovation has been so core to what you do from the beginning. </p> <p> 00:01:27:25 - 00:01:47:25<br> Dave Newman, M.D.<br> Yeah. So at Sanford Health, we're the nation's largest rural health care system. We range all the way from Wyoming to Michigan. We have lots of hospitals. We have got big hospitals. You got small hospitals, we've got critical access hospitals. You've got clinics. We've got a health network. We've got a nursing home. One thing that we don't have, though, is a problem that a lot of rural America has is enough providers. </p> <p> 00:01:47:28 - 00:01:53:03<br> Dave Newman, M.D.<br> We realize that we have to jump to innovative care models to survive because our patients really need it. </p> <p> 00:01:53:03 - 00:02:11:09<br> Chris DeRienzo, M.D.<br> Well, it's innovative care models and you need providers, but you also have patients who are spread far and wide. I mean, you all were incredibly generous with your time. We spent some time together, in the fall and you showed me what it really is like in parts of rural North Dakota where your patients live. </p> <p> 00:02:11:10 - 00:02:24:00<br> Chris DeRienzo, M.D.<br> Talk to us about that. And then you will return to given that this is who you all serve, and it really is a sacred mission that you have, the kinds of innovative approaches that you're taking, both with virtual care and with AI. </p> <p> 00:02:24:03 - 00:02:45:21<br> Dave Newman, M.D.<br> Yeah. So when I say rural, I mean really rural. So in, North Dakota, I live in Fargo, North Dakota. I'm the only andrologist for the state of North Dakota. And Fargo is in on the eastern part of the state. And, a lot of my patients come from western North Dakota or even Montana. It is a 400 mile drive one way to get to see me. </p> <p> 00:02:45:23 - 00:02:46:25<br> Chris DeRienzo, M.D.<br> Whoa. </p> <p> 00:02:46:27 - 00:02:49:16<br> Dave Newman, M.D.<br> And oftentimes it's for a 15 minute appointment. </p> <p> 00:02:49:19 - 00:02:50:10<br> Chris DeRienzo, M.D.<br> Oh my goodness. </p> <p> 00:02:50:10 - 00:03:10:22<br> Dave Newman, M.D.<br> And so if they're coming to see me for their hypogonadism or infertility or another thing, I'm the only option in town. You can imagine how frustrating it is if there is a blizzard, or even if there's not a blizzard for them to have to drive that far, take a day off of work, have multiple tanks of gas, to missed time away from their loved ones, to do something that can be easily done virtually. </p> <p> 00:03:10:24 - 00:03:25:27<br> Chris DeRienzo, M.D.<br> And that might even be two days, because I could imagine, you know, if that's an appointment you've been waiting on and you described a little bit about what you do, but remind our listeners what an andrologist is in just a moment. Yeah, yeah. You know, I mean, I would drive 400 miles and spend the night just so I don't, I don't miss that. </p> <p> 00:03:25:28 - 00:03:28:24<br> Chris DeRienzo, M.D.<br> That can be such a key conversation in in a family's life. </p> <p> 00:03:29:01 - 00:03:36:20<br> Dave Newman, M.D.<br> Right. Absolutely. Yeah. So andrology is sex hormone. So it's a lot of, if your testosterone is low or if you're having troubles, reproducing. Yeah. </p> <p> 00:03:36:20 - 00:04:00:26<br> Chris DeRienzo, M.D.<br> From a health perspective, even having one provider like that in that part of North Dakota is great, but you need to reach a massively spread out population. So, obviously you're the CMO of virtual care. Let's talk a little bit about how Sanford and you think about the kinds of virtual care options that allow a provider with your experience to reach people who are hundreds, if not a thousand miles away. </p> <p> 00:04:00:27 - 00:04:17:11<br> Dave Newman, M.D.<br> Yeah. So we've really been listening to patients and what they want. So one of the big things we heard is that they don't want to be transferred to our flagship hospitals. So we've got lots and smaller hospitals that feed the larger hospitals. One of the big issues is the lack of some of the pediatric subspecialties in the smaller hospitals. </p> <p> 00:04:17:15 - 00:04:26:19<br> Dave Newman, M.D.<br> So, for example, pediatric infectious disease. If a patient needs a pediatric infectious disease consult, they often had to be transferred to Fargo or Sioux Falls for the higher level of care. </p> <p> 00:04:26:20 - 00:04:27:11<br> Chris DeRienzo, M.D.<br> Wow. </p> <p> 00:04:27:13 - 00:04:56:06<br> Dave Newman, M.D.<br> You can think about as a parent, if your child is transferred, you're missing work. You have other children that you can't attend to. It's a big burden. So now leveraging technology and leveraging virtual care, we can beam our own providers, our own pediatric infectious disease doctors into their hospitals. We can keep the patients there. Sometimes you can just see how relieved the patients are knowing that they're not going to be transferred, and knowing that they still get the same high quality specialty care in their hometown hospital. </p> <p> 00:04:56:11 - 00:05:21:13<br> Chris DeRienzo, M.D.<br> Let's talk a little bit about follow up, because it's not just in-hospital care. And we got to visit Dickinson, North Dakota. And one reason that that you all took me there is that it made national news. The virtual care setup that you had in Dickinson was such that patients who had, pediatric patients actually, who had, you know, chronic conditions that were requiring them to drive a 1100 miles roundtrip to see subspecialists, you could now set them up in that building </p> <p> 00:05:21:13 - 00:05:33:27<br> Chris DeRienzo, M.D.<br> so now maybe it's an hour's drive from the ranch that they live to Dickinson rather than seven hours each way. That doesn't happen accidentally. You've got to be very intentional about designing a system to work like that. How do you do it? </p> <p> 00:05:33:29 - 00:05:50:02<br> Dave Newman, M.D.<br> Yeah. So a lot of it is, is what the patient wants, and from provider buy-in. And so we've had some champions that have driven this. And we have failed fast on a lot of these models that didn't work. For our hub and spoke model, it's the easy button for the patient. So if they're not tech savvy they can go to the clinic. </p> <p> 00:05:50:04 - 00:06:07:17<br> Dave Newman, M.D.<br> They can have a nurse, room them in a regular exam room, and then the provider beams into the room. So it's just like a normal visit. One of the great things about that is they're already there for labs. So if a patient needs an X-ray, they're there. Yeah. If they need blood test, they're there. And it is their trusted provider. </p> <p> 00:06:07:19 - 00:06:12:18<br> Dave Newman, M.D.<br> Those labs are going to go straight to their in-basket and they're going to have follow up there. So it's defragmented care. </p> <p> 00:06:12:18 - 00:06:32:09<br> Chris DeRienzo, M.D.<br> I love this example because that medicine is always a spectrum. I'm a neonatologist, you're an endocrinologist. You know I see babies at the super, you know, critical hyper-acute end of the spectrum and you know, out in follow up care. And telemedicine is no different, right? There are telemedicine visits you can do in a patient's home with the technology that just exists on their phone. </p> <p> 00:06:32:09 - 00:06:50:15<br> Chris DeRienzo, M.D.<br> But these kinds of visits that we're describing here, you need really special setup so that, for example, a pediatric pulmonologist can know what they need to know about, you know, a child who has a chronic condition, to say, no, you're good. You don't have to make the thousand mile round trip drive this month. That's sort of one part of an innovation. </p> <p> 00:06:50:21 - 00:07:04:11<br> Chris DeRienzo, M.D.<br> We're both here at this conference and innovation takes lots of forms. I know you all are early users of any number of AI enabled solutions. Where are you seeing an impact today? Either for your physicians and APPs or for patients? </p> <p> 00:07:04:14 - 00:07:22:25<br> Dave Newman, M.D.<br> Yes. So one of the best use cases of AI that I've seen in my career has been artificial intelligence for diabetes. In my previous career, I treated a lot of type 1 diabetes. And patients had an insulin pump, which you can imagine is like a cell phone that they wear in their belt that talks to a sensor, which is a sticker on your skin that continuously checks your blood glucose. </p> <p> 00:07:22:27 - 00:07:39:06<br> Dave Newman, M.D.<br> There is an artificial intelligence algorithm that tells you when you need more insulin and when you need less insulin, and it will do it for you. Wow. It's the easy button. So that was really cool technology that came out several years ago, but the software was clunky, so they had to come to a major diabetes center to download it. </p> <p> 00:07:39:06 - 00:07:55:06<br> Dave Newman, M.D.<br> Okay. With our feedback, a lot of the companies have been able to bring this into the patient's home. So there's an app or a program on their home computer that they can use, and we can do all their work virtually. So for a condition like type 1 diabetes, it is like a part time job. </p> <p> 00:07:55:13 - 00:07:56:02<br> Chris DeRienzo, M.D.<br> Yeah. </p> <p> 00:07:56:03 - 00:08:15:00<br> Dave Newman, M.D.<br> That it is four hours a day. We have completely revolutionized it. So sometimes I see a patient once a year for their type 1 diabetes. Once a year. Yeah. So it's partnering with the technology. We firmly believe that artificial intelligence is going to be a tool that we use. It's not going to replace doctors, but it's going to be absolutely kind of the stethoscope of 2025. </p> <p> 00:08:15:02 - 00:08:36:27<br> Chris DeRienzo, M.D.<br> I mean, for those, you know, listening to the podcast, that's the type of diabetes that you're typically are diagnosed with when you're young. And for generations that meant, you know, throughout childhood and your adolescent years, your blood sugars were way off. And so that that changed the trajectory of sort of the health band that you could live in for the rest of your life. </p> <p> 00:08:36:29 - 00:08:47:13<br> Chris DeRienzo, M.D.<br> Getting to press this easy button for patients with type 1 diabetes who are much younger, I mean, help me understand, you're talking about generational shifts in health outcomes. </p> <p> 00:08:47:13 - 00:09:03:26<br> Dave Newman, M.D.<br> Absolutely. So these patients are now not dying from their diabetes. It is giving them their life back, that they're no longer in the road for appointments, that they're able to go on cruises, they're able to go to on family trips, they're able to do those things, and they're able to be normal kids and normal adults. You use the term easy button. </p> <p> 00:09:03:26 - 00:09:18:27<br> Dave Newman, M.D.<br> So we are fully committed to not just our patients but our providers, leveraging technology to make things easier. Yeah. That if the solution is to add something more to our patients or my providers, I'm not interested in it. I'm interested in taking things away. I'm interested in making life simpler. </p> <p> 00:09:19:03 - 00:09:40:24<br> Chris DeRienzo, M.D.<br> And it doesn't have to be in cities with 8 million people. You're making life simpler for patients who get to stay where they want to live with their families for more of the time now. I don't think we think about this burden enough in health care. But we have patients who  - it's days, it's weeks. It's months of their life, you know, to be able to access our services. </p> <p> 00:09:40:24 - 00:10:01:26<br> Chris DeRienzo, M.D.<br> And we are we are experts in lots of different things. You're almost turning that around, by being able to project care into people's homes using technology. But let's talk about the providers for a minute, because I've been there right with you as a CMO of a health system before joining AHA. You don't want every new innovation to workflow to be an addition. </p> <p> 00:10:01:28 - 00:10:14:27<br> Chris DeRienzo, M.D.<br> And I, frankly, is one of the technological revolutions I'm seeing that actually is beginning to deliver a little bit on what you said, which is we can actually take some things away that have been layered on. Got any examples of those? </p> <p> 00:10:14:27 - 00:10:32:06<br> Dave Newman, M.D.<br> Oh yeah. So the best example is one that's really hot right now is ambient listening. Yeah. So we rolled this out recently and I cannot believe how well it works. So for the listeners, this is an AI program that the provider, during your clinic visit with them will turn on their phone and it'll listen to you and it will write their note for them. </p> <p> 00:10:32:09 - 00:10:53:09<br> Dave Newman, M.D.<br> One of my buddies is a pediatric oncologist. Really a good guy, he was really bad at writing his notes. So he was always on the naughty list, is what he called it. So he was getting messages from the CMO saying, you need to close your charts. And he did this for 12 years. We opened ambient listening to him, and he texted me the other day and he said, Dave, I didn't miss my daughter's recital. </p> <p> 00:10:53:12 - 00:10:57:01<br> Dave Newman, M.D.<br> I'm not on the naughty list. Like, this is giving me my life back. </p> <p> 00:10:57:01 - 00:11:20:00<br> Chris DeRienzo, M.D.<br> A little bit depressing, frankly. The baseline it's just an expectation that, yeah, I'm going to miss the recital. That's what you and I, that's the that's the culture that we've grew up. It doesn't have to be that way anymore. And I'm hearing the same things. I've now heard from multiple systems in multiple states on multiple different platforms that, on average, ambient listening seems to be decreasing in EMR time by double digits. </p> <p> 00:11:20:01 - 00:11:21:26<br> Chris DeRienzo, M.D.<br> Some sort of high double digits. </p> <p> 00:11:21:26 - 00:11:22:13<br> Dave Newman, M.D.<br> Absolutely. </p> <p> 00:11:22:13 - 00:11:28:06<br> Chris DeRienzo, M.D.<br> And that time is being returned to us to do the things that the human part of health care. </p> <p> 00:11:28:06 - 00:11:46:10<br> Dave Newman, M.D.<br> Yeah. So it was interesting. I was talking with a patient the other day, who was in a clinic visit with one of their providers that was using this. And they had a real conversation. Because now being a provider, it's harder. You're always ordering things on a computer. You're looking at labs, you're trying to type your note as you go, and it's lost the human element. </p> <p> 00:11:46:10 - 00:11:49:05<br> Dave Newman, M.D.<br> Ambient listening has given that human element a chance. </p> <p> 00:11:49:07 - 00:12:07:26<br> Chris DeRienzo, M.D.<br> I mean, we shifted to electronic technologies for all of the right reasons, you know, and it certainly led to some positive outcomes, for sure. But you're exactly right. Health care is and always has been and always will be a uniquely human experience. And we need to keep threading that thread of humanity through the needle of technology. </p> <p> 00:12:07:26 - 00:12:31:01<br> Chris DeRienzo, M.D.<br> If we're going to be able to experience the stuff that brings us joy as doctors, right? Getting to spend time with our patients, getting home and getting to our kids recitals. You know, as long as we've got folks like you, Dave, out there, leading the innovation, I tell you what, I am incredibly optimistic, about the current generation of trainees walking into a practice of medicine and of nursing, respiratory therapy and lab techs and all of the professions. </p> <p> 00:12:31:04 - 00:12:36:16<br> Chris DeRienzo, M.D.<br> That is only going to keep getting better. Thank you so much for joining the podcast. It's been a total privilege. </p> <p> 00:12:36:21 - 00:12:38:03<br> Dave Newman, M.D.<br> Thank you, Chris. </p> <p> 00:12:38:05 - 00:12:46:16<br> Tom Haederle<br> Thanks for listening to Advancing Health. Please subscribe and rate us five stars on Apple Podcasts, Spotify or wherever you get your podcasts. </p> </details></div> Sun, 02 Mar 2025 23:36:09 -0600 Telemedicine Telemedicine Prescribing of Controlled Substances <div class="container"><div class="row"><div class="col-md-8"><p>The Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) Jan. 15 released a <a href="https://www.federalregister.gov/documents/2025/01/17/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrations">proposed rule</a> on special registration for prescribing of controlled substances and a <a href="https://federalregister.gov/d/2025-01049">final rule</a> on telemedicine prescribing of buprenorphine. The special registration proposed rule outlines a process to waive in-person visit requirements prior to prescribing controlled substances as directed by the Ryan Haight Act and Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) Act. The final rule for telemedicine prescribing of buprenorphine enables practitioners to prescribe a six-month supply of buprenorphine via audio-only modalities.</p><div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2><p>In the proposed special registration rule, the DEA would:</p><ul><li>Establish three types of special registration and state special registration to waive in-person visits prior to prescribing controlled substances.</li><li>Codify the use of a new form (224S) for practitioners to submit for any of the three types of special registration and each state where a patient is located.</li><li>Charge practitioners an application fee ($888) for each special registration and state special registration.</li><li>Require practitioners to complete a national review of all state Prescription Drug Monitoring (PDMP) programs after three years.</li><li>Mandate new documentation requirements for special registration prescriptions, such as the special registration number.</li><li>Require that special registration virtual encounters be via audio and video.</li><li>Limit the types of practitioners able to register to prescribe schedule II drugs via telemedicine to certain specialties and locations. </li></ul><p>In the final rule on telemedicine prescriptions of buprenorphine for the treatment of opioid use disorder (OUD), the DEA will:</p><ul><li>Allow practitioners to issue six months of buprenorphine for the treatment of OUD in the absence of a prior in-person medical evaluation.</li><li>Require practitioners to check the PDMP of the state where the patient is located prior to issuing a prescription.</li><li>Require pharmacists to verify the identity of the patient receiving the prescription prior to filling it.</li></ul></div></div><h2>WHAT YOU CAN DO</h2><ul><li><strong>Watch </strong>for additional updates pending the Administration transition.</li><li><strong>Share </strong>this advisory with your senior management team members, key physician leaders and nurse managers to examine potential changes for your hospital.</li><li><strong>Assess </strong>the potential impact of the proposed policy changes on your operations.</li><li><strong>Submit comments to DEA regarding the proposed special registration process with specific concerns by March 15 at 5 p.m. ET via </strong><a href="http://www.regulations.gov"><strong>www.regulations.gov</strong></a><strong>.</strong></li></ul><h2>SPECIAL REGISTRATIONS FOR TELEMEDICINE AND LIMITED STATE TELEMEDICINE REGISTRATIONS</h2><h3>Background</h3><p>The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 amended the Controlled Substances Act to require in-person evaluations prior to prescribing controlled substances except in certain circumstances. The Ryan Haight Act identified seven circumstances that would exempt practitioners from the in-person visit requirement:</p><ul><li>Treatment in a hospital or clinic.</li><li>Treatment in the physical presence of a DEA-registered practitioner.</li><li>Treatment by Indian Health Service or Tribal practitioners.</li><li>Treatment during a public health emergency (PHE) as declared by the HHS Secretary.</li><li>Treatment by a practitioner who has obtained a “special registration.”</li><li>Treatment by Department of Veterans Affairs practitioners during a medical emergency.</li><li>Other circumstances specified by regulation.<sup>1</sup></li></ul><p>While the DEA enacted flexibilities to waive the in-person visit requirements during the COVID-19 PHE, this proposed rule would create a pathway outside PHEs to waive in-person-visit requirements through a special registration process (as identified in the fifth bullet above).</p><p>The agency clarifies that the proposed special registration process would not apply to instances where a provider has had a prior in-person evaluation at any point in the provider-patient relationship as special registration would not be required in those instances. </p><h3><strong>Types of Special Registration</strong></h3><p>The DEA proposes three types of special registration:</p><ul><li>Telemedicine prescribing registration, which would authorize qualified clinician practitioners to prescribe schedule III-V controlled substances via telemedicine.</li><li>Advanced telemedicine prescribing registration, which would authorize certain practitioners to prescribe select schedule II-V controlled substances via telemedicine.</li><li>Telemedicine platform registration, which would authorize online telemedicine platforms to dispense schedule II-V controlled substances.</li></ul><p>Once properly registered under the framework, the DEA proposes that clinician practitioners would be considered clinician special registrants, and platform practitioners would be considered platform special registrants.</p><p><u>Telemedicine Prescribing Registration.</u><em> </em>The agency proposes that to be eligible for telemedicine prescribing registration, clinician practitioners would need to demonstrate a legitimate need. Specifically, physicians and board-certified mid-level practitioners would be eligible when they anticipate that in-person visits may impose significant burdens on bona fide provider-patient relationships.</p><p><u>Advanced Telemedicine Prescribing Registration.</u><em> </em>In addition to demonstrating a legitimate need for this type of special registration, the DEA proposes that only certain clinician practitioners would be eligible. These practitioners would include:</p><ul><li>Psychiatrists.</li><li>Hospice care physicians.</li><li>Palliative care physicians.</li><li>Physicians rendering treatment at long-term care facilities.</li><li>Pediatricians.</li><li>neurologists.</li><li>Mid-level practitioners and physicians from other specialties who are board-certified in the treatment of psychiatric or psychological disorders, hospice care, palliative care, pediatric care, or neurological disorders unrelated to the treatment and management of pain.</li></ul><p>The DEA proposes that clinician practitioners would need to demonstrate specialized training in the aforementioned areas. Mid-level practitioners would need to be board-certified.</p><p><u>Telemedicine Platform Registration.</u><em> </em>The DEA proposes that platform registrants would need to demonstrate a legitimate need in the same way as described above for telemedicine registration.</p><h3>State Registration </h3><p>In addition to the aforementioned special registration categories, the DEA proposes that practitioners would need to complete a state registration for every state in which a patient is treated by the special registrant. The agency proposes that the state registration would be a separate ancillary credential administered by the DEA (not the states). The DEA proposes two exemption categories — one for Department of Defense practitioners and another for Veterans Affairs practitioners.</p><h3>Special Registration and State Registration Application</h3><p>The agency proposes a new form (224S) that practitioners completing special registration and state registration would need to submit. The DEA proposes a tiered application fee structure and a three-year renewal cycle for registrants.</p><p><u>Application Fees.</u><em> </em>For any one of the three types of special registration, the DEA proposes that the application fee would be $888. The agency proposes that state registrations would also be $888 for platform practitioners, while clinician practitioners would receive a $50 discount for each state they sought a state registration. Practitioners would be required to apply for every state where a patient is located.</p><p><u>Application Requirements.</u><em> </em>In the proposed rule, applicants would be required to designate an existing registered location for the special registration, serving as the primary contact for inquiries and compliance actions. The DEA also proposes that this be the location where special registration records are maintained. </p><p>In addition to the registrant location, the DEA proposes that practitioners be required to provide certain disclosures and attestations on form 224S. For example, clinician practitioners would need to attest to all employment, contractual relationships and professional affiliations, including but not limited to those with covered online telemedicine platforms. The agency proposes that all registrants would be required to attest that they have devised and are committed to maintaining anti-diversion policies and procedures. Advanced telemedicine prescribing registrants would be required to disclose practice specialties.</p><p><u>Changes to Applications.</u> The DEA proposes that practitioners would need to notify the agency of any changes to the information in their special registration application within 14 days through a new form 224S-M.</p><p><u>Approval and Denial of Special Registration Applications.</u> Under the proposed rule, the agency would issue a certificate of registration (form 223) that would include the practitioner’s name, registration location, registration type, registration number, activity authorized, controlled substances code number, amount of fee paid and expiration date.  The DEA proposes that practitioners would need to maintain copies of the special registration certificate at the registered location in a readily retrievable manner to permit inspection of the certificate by the DEA or enforcement entity.</p><p><u>Suspension and Revocation.</u> The DEA proposes that special registration would be contingent on the good standing of the registrant’s other DEA registrations. The suspension or revocation of any DEA registration would trigger the automatic suspension or revocation of any special registration.</p><h3>Special Registration Prescriptions</h3><p>In addition to abiding by state laws where the provider is located, the patient is located, and the practitioner is registered with the DEA, the agency also proposes several provisions related to the prescriptions administered under special registration.</p><p><u>Prescription Origination in the U.S.</u><em> </em>The DEA proposes a requirement that the clinician special registrant be physically present in the United States when conducting a telemedicine encounter and issuing a special registration prescription.</p><p><u>Electronic Prescribing for Controlled Substances (EPCS).</u> Additionally, the DEA proposes that all special registration prescriptions be issued through EPCS.</p><p><u>Nationwide Prescription Drug Monitoring Program (PDMP) Check.</u><em> </em>For the first three years after the rule is finalized, the DEA proposes that providers would need to complete PDMP checks for the states where the patient is located, the clinician is located and for any state with a reciprocity agreement to the patient/clinician locations. After three years, the DEA proposes that providers would need to review the PDMPs of all 50 states and territories.</p><p><u>Special Registration Prescriptions and Audio Video.</u> In the proposed rule, the DEA would mandate that a clinician special registrant utilize both audio and video components of an audio-video telecommunications system to prescribe under the special registration framework. The agency clarifies that this restriction would not apply to instances where audio-only is used to prescribe buprenorphine for OUD (described further in the telemedicine prescribing of buprenorphine section).</p><p><u>Schedule II Special Registration Prescriptions.</u> The agency proposes two additional requirements for special registration prescriptions of schedule II drugs. First, the agency proposes that clinician special registrants be physically located in the same state as the patient. Additionally, the agency proposes to require that the average number of special registration prescriptions for schedule II controlled substances constitute less than 50% of the total number of schedule II prescriptions issued by the clinician special registrant in their telemedicine and non-telemedicine practice in a calendar month.</p><p><u>Additional Elements.</u> The DEA proposes that in addition to standard data elements, practitioners would need to add the special registration number and state special registration number to the prescription. Pharmacists would be able to verify this information on the DEA’s Controlled Substances Act Registration Validation Tool.</p><h3>Recordkeeping and Reporting</h3><p><u>Patient Verification Photographic Record.</u> DEA proposes that clinician special registrants be required to capture a photographic record of the patient presenting federal or state-issued identification cards for identity verification. If the patient does not feel comfortable with the clinician taking a picture, the patient could provide a copy of their ID.</p><p><u>Encounter Record.</u> The agency proposes to require that clinician special registrants maintain a record of the date and time of the telemedicine encounter, the address the patient is at during the telemedicine encounter, and the home address of the patient. This special registration encounter record would need to be maintained for two years.</p><p><u>Credential Verification and Conduct Related Documentation.</u><em> </em>In the proposed rule, platform special registrants would also be required to maintain records related to clinician special registrants with whom they enter a covered platform relationship. This record would include verification of credentials, employment contract and disciplinary actions.</p><p><u>Pharmacy Reporting.</u> DEA would require pharmacies to report aggregate data, within the first seven days of every month, for the special registration prescriptions filled during the preceding month for each schedule II controlled substance and certain schedule III-V controlled substances,</p><p><u>Annual Reporting.</u><em> </em>In the proposed rule, platform and clinician registrants would be required to report data on the total number of new patients for which they issued a new prescription for controlled substances and the total number of prescriptions issued. These data would need to be reported annually.</p><h2>EXPANSION OF BUPRENORPHINE TREATMENT VIA TELEMEDICINE ENCOUNTERS</h2><p>In separate rulemaking, the DEA and HHS issued final amendments to existing regulations to expand the circumstances under which DEA-registered prescribers may prescribe schedule III-V controlled substances specifically for the treatment of opioid use disorder via telemedicine.</p><h3>Background</h3><p>Buprenorphine is a schedule III narcotic controlled substance. It is a long-acting partial opioid agonist and is commonly used to treat OUD as it lessens acute opioid withdrawal symptoms. Buprenorphine is classified as schedule III because it is widely accepted in medical use and has less potential for misuse than controlled substances in schedules I or II. It is the only schedule III-V narcotic drug approved by the FDA for the treatment of OUD.</p><p>In response to the COVID-19 PHE, the DEA issued temporary waivers of the Ryan Haight Act that allowed authorized practitioners to prescribe schedule III-V controlled substances approved by the FDA for the treatment of OUD via audio-only (that is, telephone call) telemedicine encounters when the prescribing practitioner had never conducted an in-person examination of the patient. These waivers are in place through 2025.</p><p>Throughout this period, DEA and HHS have addressed buprenorphine for the treatment of OUD separately from other controlled substances. This is due to the unique nature of buprenorphine (as the only schedule III-V narcotic drug approved by the FDA for treatment of OUD) and because, while there is some risk of diversion as with any controlled substance, data demonstrates that the efficacy of buprenorphine for treating OUD and the outcomes of improving access to this treatment far outweigh the negative consequences, such as overdoses from buprenorphine.<sup>2</sup></p><p>In a notice of proposed rulemaking published on March 1, 2023, the DEA proposed to authorize practitioners to prescribe buprenorphine for maintenance treatment and detoxification treatment of OUD via telemedicine encounter, including via audio-only, under certain conditions. The key provision of the proposed rule was that practitioners could only prescribe an initial 30-day supply of buprenorphine until an initial in-person medical evaluation could be conducted. For more details on this proposed rule, see AHA’s <a href="/special-bulletin/2023-03-01-dea-releases-proposed-rules-prescribing-controlled-substances-through-telemedicine?check_logged_in=1" target="_blank" title="AHA Special Bulletin">Special Bulletin</a>. In response to this proposed rule, the AHA <a href="/lettercomment/2023-03-29-aha-comment-letter-dea-telemedicine-prescribing-controlled-substances-proposed-rule" target="_blank" title="AHA Comment Letter">advocated</a> against the proposed imposition of burdensome restrictions and additional administrative requirements on providers and patients, which we believed would adversely impact patient access to medically necessary treatments, and provided several recommendations to improve the policy.</p><h3>Regulatory Revisions</h3><p>After reviewing comments on the proposed rule, the DEA will allow for a six calendar month supply to be prescribed, rather than limiting the initial supply of buprenorphine to 30 days. Further, the agencies removed the requirement that an in-person medical evaluation be conducted for additional prescriptions and instead will allow for additional prescriptions to be issued following other telemedicine encounters. Details of the final provisions are described below.</p><p><u>Review of PDMP.</u><strong> </strong>Prior to issuing a prescription for buprenorphine via a telemedicine encounter, the prescribing practitioner must review the PDMP data of the state in which the patient is located and annotate the date and time of this review in the patient’s record. Specifically, the practitioner must review the data for the last year.</p><p>If for any reason the practitioner cannot review the PDMP data (for example, if the state PDMP is inaccessible due to technological issues), the practitioner must note the reason why not in the patient’s record. In this case, the prescribing practitioner may only prescribe an initial seven-day supply of buprenorphine. The practitioner may provide additional seven-day supply prescriptions but must continue to attempt and notate unsuccessful attempts to access the PDMP.</p><p><u>Length of Prescription.</u><strong> </strong>Buprenorphine prescriptions issued via a telemedicine encounter without a prior in-person medical evaluation are limited to a period ending no later than six calendar months after the date of the first prescription. The practitioner may not prescribe a six-month supply all at once but rather must split the supply across multiple prescriptions or refills as the practitioner deems medically appropriate. After this period, the practitioner may issue additional prescriptions following either an in-person evaluation or a telemedicine evaluation where the patient is being treated by a practitioner and is physically located in a registered hospital or clinic. Following an in-person medical evaluation, the practitioner no longer must adhere to the telemedicine prescribing requirements — in other words, the requirements in this rule only apply when the prescribing practitioner has never conducted an in-person examination of the patient.</p><p><u>Identification Requirement for Pharmacists.</u><strong> </strong>Prior to filling a prescription issued via telemedicine without a prior in-person evaluation, the pharmacist must verify that the identity of the individual picking up the prescription matches the name of the patient listed on the prescription. This entails inspecting the patient’s government-issued photographic identification card or any other form of documentation demonstrating a match. The form of identification does not need to contain the patient’s address.</p><p><u>Scope Clarification.</u> Finally, the agencies clarify that this rule and its requirements apply to buprenorphine prescriptions issued for the treatment of OUD only. In other words, a prescriber would be subject to additional restrictions (such as those proposed in the special registration process described above) if issuing a prescription of a schedule III-V controlled substance for other purposes, such as pain management, even if the substance was FDA-approved for treatment of OUD. In addition, this rule only applies to practitioners already registered to dispense buprenorphine.</p><h2>FURTHER QUESTIONS</h2><p>If you have further questions regarding special registrations for telemedicine prescribing of controlled substances, please contact Jennifer Holloman, AHA’s senior associate director of policy, at <a href="mailto:jholloman@aha.org">jholloman@aha.org</a>. If you have further questions regarding the expansion of buprenorphine treatment via telemedicine, please contact Caitlin Gillooley, AHA’s director of quality and behavioral health policy, at <a href="mailto:cgillooley@aha.org">cgillooley@aha.org</a>.</p><div><p>__________</p><div id="ftn1"><p><small class="sm"><sup>1 </sup></small><a href="https://www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf"><small class="sm">https://www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf</small></a><small class="sm"> </small><br><small class="sm"><sup>2</sup> LJ Tanz, et al. </small><a href="https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fjamanetwork.com%2Fjournals%2Fjamanetworkopen%2Ffullarticle%2F10.1001%2Fjamanetworkopen.2022.51856%3Futm_source%3DFor_The_Media%26utm_medium%3Dreferral%26utm_campaign%3Dftm_links%26utm_term%3D012023&data=05%7C01%7Colib%40od.nih.gov%7C26df4139bf2b48ec388b08dafa588de4%7C14b77578977342d58507251ca2dc2b06%7C0%7C0%7C638097555652380084%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Jc4GNBUISVxDQcHYr%2FGfi6tqnV6%2BIBv0kMzadWib7AA%3D&reserved=0"><small class="sm">Trends and Characteristics of Buprenorphine-Involved Overdose Deaths Prior to and During the COVID-19 Pandemic</small></a><small class="sm">. </small><em><small class="sm">JAMA Network Open. </small></em><small class="sm">DOI: 10.1001/jamanetworkopen.2022.51856 (2023).</small></p></div></div></div><div class="col-md-4"><a href="/system/files/media/file/2025/01/telemedicine-prescribing-of-controlled-substances-advisory-1-22-2025.pdf"><img src="/sites/default/files/inline-images/cover-telemedicine-prescribing-of-controlled-substances-advisory-1-22-2025.png" data-entity-uuid="af0a1d83-c005-47f7-9859-bca1a858a7e6" data-entity-type="file" alt="Cover of Regulatory Advisory" width="640" height="834"></a></div></div></div> Wed, 22 Jan 2025 15:51:57 -0600 Telemedicine HHS, DEA release rules related to telemedicine prescribing of controlled substances /news/headline/2025-01-15-hhs-dea-release-rules-related-telemedicine-prescribing-controlled-substances <p>The Department of Health and Human Services and Drug Enforcement Administration published a series of rules Jan. 15 related to telemedicine prescribing of controlled substances, including a <a href="https://www.federalregister.gov/public-inspection/2025-01099/special-registrations-for-telemedicine-and-limited-state-telemedicine-registrations" target="_blank">special registration proposed rule</a> and a <a href="https://www.federalregister.gov/public-inspection/2025-01049/expansion-of-buprenorphine-treatment-via-telemedicine-encounter" target="_blank">final rule on telemedicine prescribing of buprenorphine</a>. </p><p>The proposed rule for special registration outlines three types of registration to waive in-person visit requirements prior to virtual prescribing of controlled substances and a state registration for every state in which a patient is treated by the special registrant. Providers would need to apply for the special registrations. The DEA also proposes that providers be required to review nationwide prescription drug monitoring programs after three years. Comments on the proposed rule are due March 15. </p><p>The DEA’s final rule for the telemedicine prescribing of buprenorphine will enable practitioners to prescribe a six-month initial supply of Schedule III-V medications to treat opioid use disorder via audio-only telemedicine interaction without a prior in-person evaluation. Practitioners can then prescribe additional medication via other telemedicine encounters (real-time, two-way audio-visual) or after an in-person encounter. The agency finalized a stipulation that providers will need to complete a review of the PDMP for the state where the patient is located. Requirements for the special registration proposed rule would not apply to clinicians prescribing buprenorphine for OUD.</p> Wed, 15 Jan 2025 15:30:52 -0600 Telemedicine DEA and HHS Extend Waivers Prescribing Controlled Substances through Telemedicine <div class="container"><div class="row"><div class="col-md-8"><p>The Drug Enforcement Administration (DEA) and Department of Health and Human Services (HHS) on Nov. 15 published a <a href="https://public-inspection.federalregister.gov/2024-27018.pdf">rule</a> to extend waiver flexibilities for prescribing controlled substances via telemedicine.</p><div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2><p>The rule extends current telemedicine waiver flexibilities for prescribing controlled substances through Dec. 31, 2025. Specifically, the rule:</p><ul><li>Allows for the prescribing of schedule II-V controlled substances (including schedule III-V medications approved by the Food and Drug Administration for treatment of opioid use disorder) via audio-video telemedicine without a prior in-person medical evaluation.</li><li>Applies these flexibilities to all practitioner-patient relationships, not just those established during the COVID-19 public health emergency.</li></ul></div></div><h2>AHA TAKE</h2><p>We applaud the DEA and HHS for taking action to extend waivers allowing for the prescribing of controlled substances via telemedicine without a prior in-person evaluation, as we have continuously <a href="/2024-10-04-aha-requests-flexibility-extension-dea-telemedicine-prescribing" target="_blank">urged</a>. Indeed, we agree with the agencies that extending these flexibilities will prevent harmful interruptions in patient care.</p><p>Extending these flexibilities also provides additional time for rulemaking, which we urge the agencies to use to establish a permanent pathway to waive in-person visit requirements for prescribing controlled substances. As a solution, the AHA has <a href="/lettercomment/2022-12-01-aha-letter-dea-regarding-request-release-special-registration-telemedicine-regulation" target="_blank">supported</a> the statutory mandate that the DEA establish a special registration process to create a pathway to waive in-person evaluations prior to prescribing controlled substances for practitioners who register with the DEA. Notably, such a process could be included in the existing DEA registration process to enable prescribers to register as part of the existing licensure framework. We look forward to working with the agencies during the waiver timeframe to accomplish these goals.</p><h2>EXTENSION OF TELEMEDICINE FLEXIBILITIES FOR CONTROLLED MEDICATION PRESCRIPTION</h2><p>The rule extends telemedicine flexibilities for prescribing controlled substances through Dec. 31, 2025, to:</p><ul><li>Prevent reduction in access to care.</li><li>Mitigate backlogs for in-person evaluations after the expiration of flexibilities.</li><li>Address ongoing public health needs for access to buprenorphine as medication for opioid use disorder in the context of the continued opioid public health crisis.</li><li>Allow time to prepare for implementing future rules that apply to prescribing controlled medications via telemedicine.</li><li>Enable DEA to continue reviewing stakeholder feedback.</li><li>Allow time for DEA and HHS to issue additional rulemaking.</li></ul><p>The rules allow for DEA-registered practitioners to prescribe schedule II-V controlled substances via telemedicine without a prior in-person exam so long as certain conditions are met. Specific conditions that must be met include the following:</p><ul><li>The prescription must be issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice.</li><li>The prescription must be issued pursuant to a communication between a practitioner and a patient using an interactive telecommunications system.</li><li>The practitioner must be authorized under their registration to prescribe the basic class of controlled substance specified on the prescription or exempt from obtaining a registration to dispense controlled substances.</li><li>The prescription must be consistent with all other legal and regulatory requirements.</li></ul><h2>FURTHER QUESTIONS</h2><p>If you have further questions regarding telemedicine prescribing of controlled substances, please contact Jennifer Holloman, AHA’s senior associate director of policy, at <a href="mailto:jholloman@aha.org">jholloman@aha.org</a> or Caitlin Gillooley, AHA’s director of quality and behavioral health policy, at <a href="mailto:cgillooley@aha.org">cgillooley@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2024/11/dea-and-hhs-extend-waivers-prescribing-controlled-substances-through-telemedicine-11-18-2024.pdf"><img src="/sites/default/files/2024-11/cover-dea-and-hhs-extend-waivers-prescribing-controlled-substances-through-telemedicine-11-18-2024.png" data-entity-uuid data-entity-type="file" alt="Special Bulletin Cover Image" width="640" height="828"></a></div></div></div> Mon, 18 Nov 2024 14:52:22 -0600 Telemedicine AHA Requests Flexibility Extension on DEA Telemedicine Prescribing /2024-10-04-aha-requests-flexibility-extension-dea-telemedicine-prescribing <p>October 4, 2024</p><p>The Honorable Anne Milgram<br>Administrator<br>Drug Enforcement Administration<br>800 K Street N.W., Suite 500<br>Washington, D.C. 20001</p><p><em>Submitted Electronically</em></p><p><em><strong>Re: </strong></em><a><em><strong>Telemedicine Prescribing of Controlled Substances </strong></em></a><em><strong>When the Practitioner and the Patient Have Not Had a Prior In-person Medical Evaluation</strong></em></p><p>Dear Administrator Milgram,</p><p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners — including more than 270,000 affiliated physicians, 2 million nurses and other caregivers — and the 43,000 health care leaders who belong to our professional membership groups, the Association (AHA) appreciates the Drug Enforcement Administration’s (DEA) efforts to support the safe prescribing of controlled substances via telehealth. Indeed, during the COVID-19 public health emergency (PHE), the DEA enacted certain flexibilities to ensure patients could continue to receive lifesaving medications via telehealth while minimizing exposure and preserving provider capacity. This included waiving the in-person visit requirement prior to the prescribing of controlled substances.</p><p>We applaud the quick actions that were taken in the midst of the pandemic. However, with the expiration date fast approaching, we are concerned that the DEA has not yet issued rules to either extend the current waiver or provide a permanent pathway to telemedicine prescribing of controlled substances as mandated by Congress. The current waivers will expire at the end of the year, and, without an extension of the current waiver or rules implementing a special registration for telemedicine prescribing, patients and their providers will experience profound negative impacts. <strong>As such, we urge the agency to extend its waiver of the in-person visit requirement before the prescribing of controlled substances to provide DEA additional time to develop a final rule (at a minimum an additional two years).<sup>1</sup> Crucially, this will prevent harmful interruptions in the delivery of necessary patient care dependent on continued virtual prescribing of controlled substances without a prior in-person evaluation, as well as ensure adequate time for rulemaking to establish a permanent pathway.</strong></p><h2>STATUTORY REQUIREMENT FOR PERMANENT PATHWAY</h2><p>The Ryan Haight Act of 2008 outlined specific requirements for in-person evaluations prior to the prescribing of controlled substances. However, this law also outlined seven categories where telemedicine could be utilized, including, but not limited to PHEs (the basis for the waiver during COVID-19), pursuant to a special registration obtained from the Attorney General, and other circumstances to be defined by regulation. The Ryan Haight Act went on in Sec. 311(h)(2) to specify that the Attorney General <em>shall </em>promulgate regulations specifying circumstances in which a special registration for telemedicine prescribing may be issued and the procedures for obtaining such a special registration.</p><p>The SUPPORT Act of 2018 again mandated that the DEA, in coordination with HHS, promulgate special registration final regulations specifying: (1) the circumstances in which a special registration for telemedicine may be issued that authorizes prescribing of controlled substances without an in-person evaluation; and (2) the procedure for obtaining a special registration. The COVID-19 pandemic offered an opportunity for the DEA to utilize lessons learned from the broad utilization of telemedicine prescribing to set forth policies and pathways for providers to continue to safely administer prescriptions virtually, even after the PHE period ended. <strong>Unfortunately, despite the Ryan Haight Act requirement that the DEA establish a special registration process </strong><em><strong>nearly 16 years ago</strong></em><strong>, and subsequent reinforcement of this requirement over five years ago in the SUPPORT Act, the agency still has not created one.</strong></p><h2>STATUS OF RULES</h2><p>Last year, the DEA proposed two sets of rules for the telemedicine prescribing of controlled substances and the telemedicine prescribing of buprenorphine. However, these rules were overly restrictive and burdensome and established arbitrary timelines for when in-person visits would still be required. The inadequacy of these proposed rules was demonstrated by the groundswell of responses, with the agency receiving over 38,000 comments (including from the AHA).<sup>2,3</sup> The DEA extended existing waivers through 2024 to permit adequate time to review and address comments. <strong>As such, there is precedent for extending the waivers to allow for appropriate rulemaking, and the DEA has the authority to extend waivers again.</strong></p><p>A related rule has been at OMB since June and has yet to be released. The AHA met with OMB to express the urgency of releasing rules expeditiously, given the timelines for rulemaking and the pending expiration of waiver flexibilities. Indeed, there is now a limited amount of time to finalize a path forward, as the in-person visit waivers expire in December. Specifically, there are less than 14 weeks until the end of the year, making a release of proposed and final rules untenable. This is especially true considering the time providers would need to make operational changes before the new year. Many specialty areas are already booking appointments in the new year, particularly in areas with provider shortages, further rendering implementation of new rules operationally unfeasible. <strong>Therefore, we strongly urge the DEA to extend the waivers for the in-person visit requirement for prescribing controlled substances until it can, with appropriate stakeholder input, develop and propose a framework for a special registration process for prescribing controlled substances via telemedicine that fully addresses the comment letters it received.</strong></p><h2>POTENTIAL ACCESS IMPLICATIONS</h2><p>The progression to a permanent pathway for waiving in-person visits has been delayed by fears of diversion risk. We recognize and appreciate the important role that the DEA plays in mitigating the risk of diversion. However, there are no data demonstrating that access to these substances for medically appropriate treatment via telemedicine poses an increased risk for diversion or any other increased risk for that matter. Rather, the agency relies on a general assumption that because controlled substances <em>can</em> be misused, an increase in access results in increased risk. This assumption not only overstates the risk of diversion but also fails to consider the millions of Americans who may be adversely impacted by an inability to access medically necessary medication through virtual prescribing. <strong>In many cases, seeing a provider in person is simply not an option for some patients whether due to physician shortages, mobility issues, or transportation challenges.</strong></p><p>For example, there is a national shortage of psychiatrists and other behavioral health providers. Indeed, 123 million people live in a mental health provider shortage area according to the Health Resources and Services Administration (HRSA), and the American Psychiatric Association (APA) projects a shortage of over 12,000 psychiatrists by 2030.<sup>4,5</sup> Therefore, remote services are becoming increasingly important to link geographically dispersed patients to prescribers for medications like buprenorphine. There are other examples, for which virtual prescribing may be clinically appropriate and may support improved treatment adherence such as:</p><ul><li>A home-bound palliative care patient receiving opioids for pain management.</li><li>A person with cancer who has transportation limitations receiving pain medications.</li><li>A person with epilepsy living in a remote area receiving anti-seizure medication.</li><li>A patient with MS receiving controlled substances for fatigue virtually due to mobility limitations.</li><li>A child receiving ADHD medication virtually due to a lack of a pediatric psychiatrist in the immediate service area.</li></ul><p><strong>The potential harm in restricting access for patient populations such as these by not extending waivers for in-person visits very well may outweigh the potential risk for diversion from bad actors.</strong></p><h2>SPECIAL REGISTRATION PROCESS</h2><p><em><strong>As a solution</strong></em><strong>, the AHA has supported — including most recently through formal comment letters to the DEA and CMS — the statutory mandate that the DEA establish a special registration process to create a pathway to waive in-person evaluations prior to the prescribing of controlled substances for practitioners who register with the DEA.<sup>6</sup></strong></p><p><strong>Notably, such a process could be included in the existing DEA registration process to enable prescribers to register as part of the existing licensure framework.</strong></p><p>For example, practitioners, hospitals, clinics, pharmacies and others are currently required to complete applications for registration and renewal of registrations for prescribing controlled substances (namely forms 224 and 224a). This process has established guardrails that build upon state medical licensure processes and Medicare reporting. Rather than creating a novel and separate process or form, the DEA could add fields to those forms that providers already use. This way, the “special registration process” would include key elements that providers already report, such as practitioner contact information, employer, practice address, state medical licenses, liability history, etc., <em>and</em> could add unique attestations on patient identification verification via telemedicine, drug monitoring, diversion control and emergency protocols. We encourage the DEA to <em>not</em> require reporting of home addresses if practitioners are administering telehealth from their home addresses, due to privacy concerns, as we have expressed previously.<sup>7</sup></p><p>We thank you for considering our request. If you have any questions concerning our comments, please feel free to contact me, or have a member of your team contact Jennifer Holloman, AHA’s senior associate director of policy, at <a href="mailto:jholloman@aha.org">jholloman@aha.org</a>, or Caitlin Gillooley, AHA’s director of behavioral health and quality policy, at <a href="mailto:cgillooley@aha.org">cgillooley@aha.org</a>.</p><p>Sincerely,<br>/s/<br>Ashley Thompson<br>Senior Vice President, Public Policy </p><p>__________</p><p><small class="sm"><sup>1 </sup>The agency extended waivers in 2023 for one year to provide time for new rulemaking but has yet to release new rules for comments. As such, stakeholders can surmise that one year was insufficient to develop, revise, finalize and operationalize rules. Also, previous iterations of rules generated over 38,000 comments, and therefore it is anticipated that there will be a significant volume of feedback again requiring additional time to process.</small><br><small class="sm"><sup>2 </sup></small><a class="ck-anchor" href="/lettercomment/2023-03-29-aha-comment-letter-dea-buprenorphine-telemedicine-prescribing-proposed-rule" id="/lettercomment/2023-03-29-aha-comment-letter-dea-buprenorphine-telemedicine-prescribing-proposed-rule"><small class="sm">/lettercomment/2023-03-29-aha-comment-letter-dea-buprenorphine-telemedicine-prescribing-proposed-rule</small></a> <br><small class="sm"><sup>3 </sup></small><a class="ck-anchor" href="/lettercomment/2023-03-29-aha-comment-letter-dea-telemedicine-prescribing-controlled-substances-proposed-rule" id="/lettercomment/2023-03-29-aha-comment-letter-dea-telemedicine-prescribing-controlled-substances-proposed-rule"><small class="sm">/lettercomment/2023-03-29-aha-comment-letter-dea-telemedicine-prescribing-controlled-substances-proposed-rule</small></a><br><small class="sm"><sup>4</sup> </small><a class="ck-anchor" href="https://data.hrsa.gov/topics/health-workforce/shortage-areas" id="https://data.hrsa.gov/topics/health-workforce/shortage-areas"><small class="sm">https://data.hrsa.gov/topics/health-workforce/shortage-areas</small></a> <br><small class="sm"><sup>5</sup> </small><a class="ck-anchor" href="https://www.psychiatry.org/psychiatrists/advocacy/federal-affairs/workforce-development" id="https://www.psychiatry.org/psychiatrists/advocacy/federal-affairs/workforce-development"><small class="sm">https://www.psychiatry.org/psychiatrists/advocacy/federal-affairs/workforce-development</small></a> <br><small class="sm"><sup>6</sup> </small><a class="ck-anchor" href="/lettercomment/2022-12-01-aha-letter-dea-regarding-request-release-special-registration-telemedicine-regulation" id="/lettercomment/2022-12-01-aha-letter-dea-regarding-request-release-special-registration-telemedicine-regulation"><small class="sm">/lettercomment/2022-12-01-aha-letter-dea-regarding-request-release-special-registration-telemedicine-regulation</small></a><br>7 <a class="ck-anchor" href="/lettercomment/2024-03-20-aha-urges-cms-remove-telehealth-provider-home-address-reporting-requirements" id="/lettercomment/2024-03-20-aha-urges-cms-remove-telehealth-provider-home-address-reporting-requirements"><small class="sm">/lettercomment/2024-03-20-aha-urges-cms-remove-telehealth-provider-home-address-reporting-requirements</small></a></p><p> </p><p> </p><p><br> </p><p> </p> Fri, 04 Oct 2024 10:59:37 -0500 Telemedicine Innovative Care: The Value of the Virtual Nurse in a Pediatric Hospital /education-events/innovative-care-value-virtual-nurse-pediatric-hospital-sept-11 <div class="TTevent"> /* Forces the event Content Type to be 100% */ .container .row .col-md-8{ width: 100% } .event-registration-link a{ margin-left: auto; margin-right: auto; display: block; text-align: center; } .event-registration-link a.btn-block { max-width: 300px; } .TTevent h3{ color:#002855; } .TTeventBonus{ color:#9d2235; font-weight:700; font-style: italic; } .TTeventdate{ font-weight: 700; font-size: 18px; color: #555555bb; line-height: 20px; } .TTeventSponsor img{ max-height:100px; } <p class="TTeventdate">September 11, 2024</p><p>The virtual nurse has been successful in adult hospitals but has limited utilization in pediatric hospitals. With a review of evidence and extensive planning, Nemours Children’s Health created an enterprise virtual nursing model. Our presenters share the process of introducing the virtual nurse, highlighting the involvement of clinical nurses, administrative requirements, job description, fiscal impact and outcomes. They also review the responsibilities of the virtual nurse including completion of admission and discharge processes, patient education, chart audits, emergency response and mentoring. Finally, this webinar highlights how the incorporation of the virtual has positively contributed to outcomes related to nurse and patient satisfaction with decreased readmission rates and improved communication with non-English speaking families.</p><h4>Learning Objectives:</h4><ul><li>Identify opportunities for virtual nursing models</li><li>Demonstrate knowledge of the process to initiate a virtual nursing program</li><li>Evaluate outcomes for the virtual nursing program</li></ul><div class="row"><div class="col-md-5"><h4>Speakers:</h4><ul><li><strong>Sophy J. Rodriguez, MSN, RN, CPN</strong><br><em>Director, Patient Flow and Innovation,</em> Nemours Children’s Health</li><li><strong>Elizabeth Johnson-Salerno, MSN, RN, PCNS-BC, NEA-BC</strong><br><em>AVP Acute Care, Day Medicine and Infusion Services,</em> Nemours Children’s Health</li></ul><p class="text-align-center"><a class="btn btn-wide btn-primary" href="/system/files/media/file/2024/09/AHA_Team_Training_Webinar_Slides_Sept_2024.pdf" target="_blank">Download the slides</a></p> <div class="col-md-6"> <h4>SPONSORED BY:</h4> </div> <div class="col-md-6"> <p><a href="https://q-reviews.com/q-reviews/" target="_blank"><img alt="Quality Reviews logo" data-entity-type="" data-entity-uuid="" src="/sites/default/files/2021-01/Quality_Reviews_transparent_logo_200.png" /></a></p> </div> </div>--></div><div class="col-md-7"><div></div></div></div></div><div class="raw-html-embed"> <div data-embed-button="webform_embed" data-entity-embed-display="view_mode:webform.token" data-entity-type="webform" data-entity-uuid="0b43a680-6f37-4d3f-9bf9-4cd6c7c7ddc5" data-langcode="en" data-entity-embed-display-settings="[]" class="embedded-entity"> <div id="edit-processed-text" class="js-form-item form-item js-form-type-processed-text form-item- js-form-item- form-no-label"> <div class="TTwebinarHide"> .webform-submission-form { max-width: 700px; } .TTwebinarHide{ display:none } .event-content.panel .TTwebinarHide { display:block; background-color: #fff; padding: 15px 15px 15px 15px; border: solid 2px #307FE2; text-align: center; } <p><a href="/center/team-training">Team Training</a> offers a variety of webinars - view our <a href="/center/team-training/webinars">current offering(s)</a> or browse the <a href="/center/team-training/webinars/library">library</a>.</p> </div> </div> </div> </div> Thu, 08 Aug 2024 15:17:17 -0500 Telemedicine