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		<title>This Week In Policy and Medicine, January 19, 2025</title>
		<link>https://www.policymed.com/2025/01/this-week-in-policy-and-medicine-january-19-2025.html</link>
					<comments>https://www.policymed.com/2025/01/this-week-in-policy-and-medicine-january-19-2025.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Sun, 19 Jan 2025 11:44:46 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[FTC]]></category>
		<category><![CDATA[Opioids]]></category>
		<category><![CDATA[Pharmacy Benefit Managers]]></category>
		<category><![CDATA[This Week In Policy and Medicine]]></category>
		<category><![CDATA[DEA regulations]]></category>
		<category><![CDATA[FTC report]]></category>
		<category><![CDATA[GAO hospital transparency]]></category>
		<category><![CDATA[healthcare policy]]></category>
		<category><![CDATA[Healthcare Reform]]></category>
		<category><![CDATA[HHS AI plan]]></category>
		<category><![CDATA[Medical Regulations]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[PBMs]]></category>
		<category><![CDATA[Podcast]]></category>
		<category><![CDATA[Policy and Medicine]]></category>
		<category><![CDATA[specialty generics]]></category>
		<category><![CDATA[Spotify podcast]]></category>
		<category><![CDATA[Trump healthcare appointments]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17570</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1549" height="618" src="https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" fetchpriority="high" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast.jpg 1549w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-300x120.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-1024x409.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-768x306.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-1536x613.jpg 1536w" sizes="(max-width: 1549px) 100vw, 1549px" /></div>Welcome to this week’s edition of &#8220;This Week in Policy and Medicine, January 19, 2025,&#8221; your trusted source for the latest insights and updates from the intersection of healthcare policy and medicine. You can also find our episodes on Spotify and other favorite podcast platforms. DEA Issues New Regulations on Prescribing Controlled Substances The DEA [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1549" height="618" src="https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast.jpg 1549w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-300x120.jpg 300w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-1024x409.jpg 1024w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-768x306.jpg 768w, https://www.policymed.com/wp-content/uploads/2024/11/Policy-and-Medicine-Podcast-1536x613.jpg 1536w" sizes="(max-width: 1549px) 100vw, 1549px" /></div><p>Welcome to this week’s edition of &#8220;<a href="https://open.spotify.com/episode/0v1N5d4s0Yz9SW26qroHtr">This Week in Policy and Medicine</a><a href="https://open.spotify.com/episode/0v1N5d4s0Yz9SW26qroHtr">, January 19, 2025,</a>&#8221; your trusted source for the latest insights and updates from the intersection of healthcare policy and medicine. You can also find our episodes on <a href="https://open.spotify.com/show/thisweekinpolicyandmedicine">Spotify</a> and other favorite podcast platforms.</p>
<p><strong>DEA Issues New Regulations on Prescribing Controlled Substances</strong></p>
<p>The DEA has introduced stringent regulations affecting the prescribing of controlled substances. These changes aim to tighten the monitoring and distribution of high-risk medications in an effort to curb abuse. Key aspects include stricter ID checks and revised prescription limits. For more details on how these regulations could affect healthcare providers and patients, read the full article <a href="https://www.policymed.com/2025/01/dea-issues-new-regulations-on-prescribing-controlled-substances.html">here</a>.</p>
<p><strong>HHS Unveils AI Strategic Plan for 2025</strong></p>
<p>The Department of Health and Human Services (HHS) has released its AI Strategic Plan for 2025, focusing on integrating artificial intelligence to enhance healthcare delivery. The plan outlines initiatives aimed at improving disease diagnosis, patient care, and administrative efficiency. Explore the full scope of HHS&#8217;s vision <a href="https://www.policymed.com/2025/01/hhs-ai-strategic-plan-2025.html">here</a>.</p>
<p><strong>FTC&#8217;s Second Report on Pharmacy Benefit Managers (PBMs)</strong></p>
<p>The Federal Trade Commission has published its second report on Pharmacy Benefit Managers, with a particular focus on specialty and generic medications. The report scrutinizes the practices and impacts of PBMs in the pharmaceutical supply chain, proposing recommendations to enhance transparency and competition. Dive into the analysis <a href="https://www.policymed.com/2025/01/second-federal-trade-commission-report-on-pharmacy-benefit-managers-pbms-focuses-on-specialty-generics.html">here</a>.</p>
<p><strong>Transforming U.S. Healthcare: A Look at President Trump&#8217;s Leadership Appointments</strong></p>
<p>This article provides an in-depth analysis of the recent healthcare leadership appointments by President Trump and their potential implications on policy and practice. The appointments are expected to influence major healthcare reforms and strategic direction. Gain insight into these leadership dynamics <a href="https://www.policymed.com/2025/01/transforming-u-s-healthcare-an-in-depth-look-at-president-trumps-leadership-appointments.html">here</a>.</p>
<p><strong>GAO Report on Hospital Transparency Data</strong></p>
<p>A new report from the Government Accountability Office (GAO) indicates significant gaps in hospital transparency, particularly concerning the availability and accuracy of cost and service data for patients. This lack of transparency impedes consumer decision-making and regulatory oversight. Learn more about the GAO’s findings and recommendations <a href="https://www.policymed.com/2025/01/gao-finds-hospital-transparency-data-lacking.html">here</a>.</p>
<p>Stay informed with &#8220;<a href="https://open.spotify.com/episode/0v1N5d4s0Yz9SW26qroHtr">This Week in Policy and Medicine</a>&#8221; for your weekly dose of policy changes, strategic developments, and the ongoing conversations shaping healthcare today.</p>
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			</item>
		<item>
		<title>DEA Issues New Regulations on Prescribing Controlled Substances</title>
		<link>https://www.policymed.com/2025/01/dea-issues-new-regulations-on-prescribing-controlled-substances.html</link>
					<comments>https://www.policymed.com/2025/01/dea-issues-new-regulations-on-prescribing-controlled-substances.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 17 Jan 2025 09:11:45 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[Opioids]]></category>
		<category><![CDATA[American Telemedicine Association]]></category>
		<category><![CDATA[buprenorphine]]></category>
		<category><![CDATA[controlled substances]]></category>
		<category><![CDATA[DEA special registration]]></category>
		<category><![CDATA[drug abuse prevention]]></category>
		<category><![CDATA[healthcare innovation]]></category>
		<category><![CDATA[healthcare policy]]></category>
		<category><![CDATA[medical law]]></category>
		<category><![CDATA[NEW]]></category>
		<category><![CDATA[opioid crisis]]></category>
		<category><![CDATA[Patient safety]]></category>
		<category><![CDATA[prescription drugs]]></category>
		<category><![CDATA[remote prescribing]]></category>
		<category><![CDATA[Schedule II narcotics]]></category>
		<category><![CDATA[Schedule III drugs]]></category>
		<category><![CDATA[Telehealth]]></category>
		<category><![CDATA[telemedicine regulations]]></category>
		<category><![CDATA[virtual healthcare]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17558</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="453" height="555" src="https://www.policymed.com/wp-content/uploads/2025/01/DEA-telemedicine-rule.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" srcset="https://www.policymed.com/wp-content/uploads/2025/01/DEA-telemedicine-rule.jpg 453w, https://www.policymed.com/wp-content/uploads/2025/01/DEA-telemedicine-rule-245x300.jpg 245w" sizes="(max-width: 453px) 100vw, 453px" /></div>In the final days of the Biden administration the Drug Enforcement Administration (DEA) has issued new regulations on who can prescribe controlled substances.  This is the agencies third attempt at a proposed rule on the topic. These updates from the DEA have sparked a vigorous debate among stakeholders, highlighting the balance between innovation in healthcare [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="453" height="555" src="https://www.policymed.com/wp-content/uploads/2025/01/DEA-telemedicine-rule.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2025/01/DEA-telemedicine-rule.jpg 453w, https://www.policymed.com/wp-content/uploads/2025/01/DEA-telemedicine-rule-245x300.jpg 245w" sizes="auto, (max-width: 453px) 100vw, 453px" /></div><p>In the final days of the Biden administration the Drug Enforcement Administration (DEA) has issued new regulations on who can prescribe controlled substances.  This is the agencies third attempt at a proposed rule on the topic.</p>
<p>These updates from the DEA have sparked a vigorous debate among stakeholders, highlighting the balance between innovation in healthcare services and the stringent requirements to prevent substance misuse.</p>
<p><strong>DEA&#8217;s Proposed Rule for Telehealth Controlled Substance Prescribing</strong></p>
<p>The DEA recently proposed a rule aimed at regulating the telehealth prescribing of controlled substances. This rule is specifically designed to address the complexities of prescribing practices that have evolved significantly with the rise of telehealth services. The proposed rule, outlined in the <a href="https://public-inspection.federalregister.gov/2025-01099.pdf">Federal Register</a>, suggests a framework that would enable healthcare providers to prescribe controlled substances remotely under specific conditions.</p>
<p>The rule proposes to establish a special registration for telemedicine that allows practitioners to prescribe controlled substances without an in-person medical evaluation, provided certain conditions are met. These conditions aim to ensure that remote prescribing is conducted safely and in a manner that minimizes the risks of drug abuse and diversion. Specifically, the rule allows registered practitioners, who could be physicians, nurse practitioners, or physician assistants, depending on state law, to prescribe medications like opioids under stringent DEA oversight, incorporating measures such as verification of practitioner credentials and patient identity, as well as limitations on the quantity of substances prescribed.</p>
<p><strong>Summary of DEA Proposed Telehealth Prescribing Rules</strong></p>
<p>Here is a table summarizing the pathways and conditions for prescribing controlled substances via telehealth based on the proposed DEA rule:</p>
<table>
<thead>
<tr>
<td><strong>Patient Condition</strong></td>
<td><strong>Seen Medical Practitioner In Person</strong></td>
<td><strong>Controlled Substance Schedule</strong></td>
<td><strong>Telehealth Prescription Allowance</strong></td>
<td><strong>Notes</strong></td>
</tr>
</thead>
<tbody>
<tr>
<td><strong>General Condition</strong></td>
<td>Yes</td>
<td>Any</td>
<td>All prescriptions can be prescribed via telehealth</td>
<td>&#8211;</td>
</tr>
<tr>
<td><strong>Referred Patient</strong></td>
<td>Seen another practitioner in person</td>
<td>Any</td>
<td>All prescriptions can be prescribed via telehealth</td>
<td>Referred to a new medical practitioner</td>
</tr>
<tr>
<td><strong>Opioid Use Disorder</strong></td>
<td>No</td>
<td>Schedule III, IV, V</td>
<td>Prescription can be prescribed for 30 days via telehealth</td>
<td>Must see a medical practitioner in person before prescription for refill</td>
</tr>
<tr>
<td><strong>Need Medication or Narcotic</strong></td>
<td>No</td>
<td>Schedule II</td>
<td>Prescription cannot be prescribed via telehealth</td>
<td>Must see a medical practitioner in person before prescription</td>
</tr>
</tbody>
</table>
<p><strong>Stakeholder Responses</strong></p>
<p>Responses from various organizations highlight the contentious nature of the proposed rule. The American Telemedicine Association (ATA), a leading advocate for telehealth, has expressed significant concerns regarding the feasibility of the proposed regulations.</p>
<p><strong>American Telemedicine Association (ATA)</strong></p>
<p>The ATA has urged the incoming administration to reconsider the DEA’s draft, citing concerns over the operational challenges and potential setbacks in telehealth progress. Kyle Zebley, Senior Vice President of Public Policy at the ATA, emphasized the need for a framework that balances patient access to necessary medications with safeguards against the misuse of controlled substances. The ATA argues that the proposed rule could undermine advancements made in telehealth, particularly those initiated during the COVID-19 pandemic which allowed for the waiver of in-person requirements for controlled substance prescribing.</p>
<p><strong>Final Rule for Telehealth Buprenorphine Prescribing</strong></p>
<p>In contrast to the broader proposed rule, the DEA has finalized regulations specifically for the prescribing of buprenorphine via telehealth. Buprenorphine, a critical medication used in the treatment of opioid use disorder, can now be prescribed remotely under the new guidelines. This move is seen as a positive step towards increasing accessibility to essential treatments in the realm of addiction services, reflecting a nuanced approach to telehealth prescriptions. The final rule permits all DEA-registered practitioners, without the need for a special waiver, to prescribe buprenorphine for opioid use disorder treatment to patients they have not examined in person. This is particularly significant as it broadens the scope of providers able to contribute to the management of the opioid crisis remotely. The full details of this rule can be found in the <a href="https://public-inspection.federalregister.gov/2025-01049.pdf">Federal Register</a>.</p>
<p><strong>Conclusion</strong></p>
<p>The DEA&#8217;s evolving policies on telehealth and controlled substances prescribing reflect a complex landscape where regulatory frameworks strive to keep pace with technological advancements in healthcare. As these policies continue to develop, the input from organizations like the ATA will be crucial in shaping a regulatory environment that fosters the safe expansion of telehealth services while ensuring robust measures against the misuse of controlled substances.</p>
<p>Stakeholder feedback, such as that from the ATA, highlights the ongoing dialogue necessary to refine these regulations, ensuring they align with the realities of modern healthcare delivery and the needs of patients across the United States.</p>
<p>For more details on the ATA&#8217;s stance and actions, please visit <a href="https://www.americantelemed.org">American Telemedicine Association</a>.</p>
<p><strong>Additional Resources:</strong></p>
<ul>
<li><a href="https://public-inspection.federalregister.gov/2025-01099.pdf">Proposed Rule for Telehealth Controlled Substance Prescribing</a></li>
<li><a href="https://public-inspection.federalregister.gov/2025-01049.pdf">Final Rule for Telehealth Buprenorphine Prescribing</a></li>
</ul>
<p>&nbsp;</p>
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		<title>OptumRx Reaches $20 Million Settlement for Improper Opioid Dispensing, in Violation of the Controlled Substances Act</title>
		<link>https://www.policymed.com/2024/08/optumrx-reaches-20-million-settlement-for-improper-opioid-dispensing-in-violation-of-the-controlled-substances-act.html</link>
					<comments>https://www.policymed.com/2024/08/optumrx-reaches-20-million-settlement-for-improper-opioid-dispensing-in-violation-of-the-controlled-substances-act.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 28 Aug 2024 08:35:51 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=17013</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Optum Rx recently reached a $20 million settlement with the United States Department of Justice (DOJ) over allegations that it improperly filled opioid prescriptions in violation of the Controlled Substances Act (CSA). The settlement stems from a Drug Enforcement Administration (DEA) investigation into whether OptumRx improperly filled certain opioid prescriptions in combination with other drugs [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Optum Rx recently reached a $20 million settlement with the United States Department of Justice (DOJ) over allegations that it improperly filled opioid prescriptions in violation of the Controlled Substances Act (CSA).</p>
<p>The settlement stems from a Drug Enforcement Administration (DEA) investigation into whether OptumRx improperly filled certain opioid prescriptions in combination with other drugs such as benzodiazepines and muscle relaxants, commonly known as “trinity” prescriptions, between April 2013 and April 2015. The United States alleged that these combination prescriptions raised “red flags,” indicating that the prescriptions may not have been intended for legitimate medical use and could lead to abuse or diversion of highly addictive and powerful opioids. The United States further alleged that trinity prescriptions carry a significant risk of harm and that the red flags must be resolved before filling a controlled substance prescription.</p>
<p>Most of the prescriptions were dispensed from OptumRx’ mail order pharmacy operations located in Carlsbad, California. OptumRx closed that pharmacy during the DEA’s investigation.</p>
<p>OptumRx has reported that it has implemented protocols since the timeframe to reduce the number, dose, and duration of opioid prescriptions dispensed by the company. OptumRx also noted it implemented more robust concurrent drug utilization review procedures to help identify and not fill prescriptions for dangerous opioid combinations and excess dosing.</p>
<p>As we often see, the claims resolved under the settlement agreement are only allegations and no determination of liability has been made. Reuters <a href="https://www.reuters.com/legal/government/unitedhealths-optum-pay-20-mln-over-us-claims-it-ignored-opioid-red-flags-2024-06-27/">noted</a> that this settlement “appeared to be the first reached by the government with a pharmacy benefit manager (PBM) over allegedly illicit opioid prescriptions.”</p>
<p>“DEA registrants have an obligation to protect the public, not help fuel the opioid epidemic,” <a href="https://www.justice.gov/opa/pr/optumrx-agrees-pay-20m-resolve-allegations-it-filled-certain-opioid-prescriptions-violation">said Assistant Administrator Thomas W. Prevoznik of the DEA Diversion Control Division</a>. “The trinity style prescription combination helped fuel the start of the opioid addiction crisis and raises a red flag, which this registrant should have recognized and reacted to rather than putting profits before patients’ safety.”</p>
<p>“Pharmacies providing opioids and other controlled substances have a duty under the Controlled Substances Act to ensure that they fill prescriptions only for legitimate medical purposes,” <a href="https://www.justice.gov/opa/pr/optumrx-agrees-pay-20m-resolve-allegations-it-filled-certain-opioid-prescriptions-violation">said Principal Deputy Attorney General Brian M. Boynton</a>, head of the Justice Department’s Civil Division. “The department will continue to work with its law enforcement partners to ensure that pharmacies do not contribute to the opioid addiction crisis.”</p>
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		<title>DEA and HHS Extend Telehealth Flexibilities for Controlled Substances</title>
		<link>https://www.policymed.com/2024/01/dea-and-hhs-extend-telehealth-flexibilities-for-controlled-substances.html</link>
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		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 10 Jan 2024 09:28:12 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[HHS]]></category>
		<category><![CDATA[Telemedicine]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16568</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>The Drug Enforcement Administration (DEA) and the HHS announced they will extend pandemic-era telehealth prescribing flexibilities for controlled substances through 2024. The temporary extension marks the second time regulators have prolonged the relaxed prescribing rules for drugs like opioid use disorder medications or stimulants for ADHD, which allow clinicians to provide the drugs virtually without [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>The Drug Enforcement Administration (DEA) and the HHS announced they will extend pandemic-era telehealth prescribing flexibilities for controlled substances through 2024. The temporary extension marks the second time regulators have prolonged the relaxed prescribing rules for drugs like opioid use disorder medications or stimulants for ADHD, which allow clinicians to provide the drugs virtually without first conducting an in-person evaluation. The rule ensures “<a href="https://www.federalregister.gov/documents/2023/10/10/2023-22406/second-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled">a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions, as well as allowing adequate time for providers to come into compliance with any new standards or safeguards</a>,” the DEA and the HHS wrote. The DEA will work to write new regulations by the fall of 2024.</p>
<p><strong>More on Rule</strong></p>
<p>Without this temporary rule, COVID-19 telemedicine flexibilities would expire on November 11, 2023, with respect to practitioner-patient relationships established after that date. The temporary rule continues the temporary extension of the “full set” of DEA’s COVID-19 waivers for prescribing controlled substances via telemedicine. Those waivers, which have been in place since March 2020, are now extended through December 31, 2024.</p>
<p>The news of the rule’s extension arrives on the back of a recent public listening session in which the DEA heard commentary from various provider, advocacy, and patient stakeholders, among others, regarding their concerns over the DEA’s proposed final rule released in March 2023. The proposed final rule would claw back much of the flexibility allotted during the Public Health Emergency (PHE) and would, in effect, push the practice of telehealth back to pre-PHE times. Specifically, the proposed rule would largely restrict healthcare providers from prescribing controlled substances through virtual encounters by either limiting prescribers to a single fill of a controlled substance without an in-person visit; or requiring a complex series of referrals from another in-person practitioner before the prescriber could issue a prescription via electronic means.</p>
<p>The rule’s publication drew significant opposition from the provider stakeholder community, with the DEA receiving more than 38,000 comments in response, most of which scrutinized DEA’s perceived shortsightedness and burdensome requirements for typical prescribing relationships. As a result, the DEA was pressured to keep the status quo until November 11, 2023 while it heard from stakeholders and took the impact of the proposed rule into further consideration.</p>
<p>Now, with this additional perspective in hand, the DEA appears to be going back to the drawing board to further revise the final rule to balance providers’ concerns with the need to ensure that controlled substances are appropriately prescribed and monitored.</p>
<p>In addition to the onslaught of provider comments, the DEA’s additional reprieve may have also resulted, in part, from mounting congressional pressure. In a <a href="https://www.warner.senate.gov/public/_cache/files/b/8/b8e64a28-5195-423c-a00a-2033b7c883df/84F05A8588B19AF4266CC759F7F94DC6.2023.09.13-dea-telehealth-letter.pdf">bipartisan letter</a> sent to the DEA in September 2023, several senators expressed concerns over both the potential impact of the DEA’s proposed rule and the fact that the DEA has yet to develop a special registration process for teleprescribing despite multiple legislative actions permitting, and in fact requiring, it to do so.</p>
<p>As envisioned by Congress, the special registration process would allow registered healthcare providers to use their clinical judgment to determine when a medical examination may be conducted via telehealth—as opposed to in person—for the purposes of prescribing controlled substances.</p>
<p>Furthermore, the ATA applauded the temporary rule. Kyle Zebley, senior vice president for public policy at the ATA and executive director of ATA Action, <a href="https://www.americantelemed.org/press-releases/ata-and-ata-action-laud-dea-for-issuing-a-second-extension-of-the-remote-prescription-of-controlled-substances-flexibilities-through-2024/">said in a statement</a> that 2024 is “shaping up to be the Super Bowl for telehealth, with many of the telehealth flexibilities enacted during the public health emergency set to expire.” Organizations like the American Telemedicine Association and the <a href="https://www.aha.org/news/headline/2023-03-29-aha-comments-dea-telehealth-rules">American Hospital Association</a> have argued in-person requirements could limit access to care, particularly for opioid use disorders, which soared during the pandemic.</p>
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		<title>ATA Action Outlines Recommendations for DEA Telemedicine Special Registration Process</title>
		<link>https://www.policymed.com/2023/11/ata-action-outlines-recommendations-for-dea-telemedicine-special-registration-process.html</link>
					<comments>https://www.policymed.com/2023/11/ata-action-outlines-recommendations-for-dea-telemedicine-special-registration-process.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 13 Nov 2023 09:21:22 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[Telemedicine]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16356</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Recently, the American Telemedicine Association (ATA) Action submitted comprehensive recommendations to the United States Drug Enforcement Administration (DEA) regarding a Special Registration process for prescribing controlled substances via telemedicine encounters. ATA Action believes that the DEA should consider two principles when regulating the prescribing of controlled substances via telemedicine: (1) clinical practice should not be [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Recently, the American Telemedicine Association (ATA) Action <a href="https://www.americantelemed.org/policies/ata-action-recommendations-to-dea-on-a-special-registration-process/">submitted comprehensive recommendations</a> to the United States Drug Enforcement Administration (DEA) regarding a Special Registration process for prescribing controlled substances via telemedicine encounters.</p>
<p>ATA Action believes that the DEA should consider two principles when regulating the prescribing of controlled substances via telemedicine: (1) clinical practice should not be limited by non-clinical decision-makers and (2) telemedicine is not a type of care, but a modality. Therefore, the group argues that any rules made should account for the use of technology as a modality, without arbitrary restrictions.</p>
<p>ATA Action further noted that while minimum clinical standards, best practices, and quality should be factors, they should not vary across modalities for the same service, even though there may be advantages and disadvantages to receiving a service remotely. For example, advantages of remote service may include more standardized care across a national practice, which may lead to higher quality, more convenience, and accessibility for the patient and provider, as well as potentially reduced infrastructure costs, while a disadvantage to remote service may be the “increased reach that bad actors may have using technology, which speaks to DEA’s concerns or diversion and overprescribing.”</p>
<p>ATA Action outlined seven recommendations to the DEA for a Special Registration process for telemedicine prescribing of controlled substances without a prior in-person visit:</p>
<ol>
<li>The Special Registration process should work in conjunction with the current registration process.
<ul>
<li>Special Registration should be an optional supplemental form and should result in a modifier on a practitioner’s DEA number. The modified number is what will need to be used when issuing a prescription via telemedicine.</li>
</ul>
</li>
<li>Telemedicine providers should not be required to maintain local addresses for every state in which they practice.
<ul>
<li>The value of telemedicine is “only fully captured through the ability to practice across state lines” and improving access to care in more remote areas can only occur when technology can be used to bridge those gaps.</li>
</ul>
</li>
<li>Special Registration should include the elements that the DEA needs to monitor for illegitimate practitioners and illegal prescribing practices.
<ul>
<li>This includes personal/business information (address, phone, email, provider identification number), state authority (state practice licenses, state controlled substances registration, states of practice, proof of malpractice insurance), background check, and certain attestations.</li>
</ul>
</li>
<li>Special Registration should not be limited to specific specialties or treatment conditions. Additionally, Schedule II prescribing may involve additional oversight but should not include any additional restrictions.</li>
<li>Pharmacies and pharmacists should be able to identify prescribers who have a current Special Registration.
<ul>
<li>This is in response to the “red flags” that pharmacies and pharmacists have been trained to acknowledge in light of the opioid crisis. This Special Registration process should be used to help dispensers identify legitimate telemedicine prescribers and have confidence in prescriptions issued by Special Registration providers.</li>
</ul>
</li>
<li>The location of the patient should not require any registration unless otherwise required because controlled substances are dispensed or administered at that site.</li>
<li>The Special Registration process should not place any arbitrary limits on a clinician’s ability to practice within the scope of their authority.
<ul>
<li>This includes no limits to the number of patients a provider can treat or the time period for which a provider can issue prescriptions.</li>
</ul>
</li>
</ol>
<p>&#8220;ATA Action&#8217;s comments to DEA&#8217;s March 2023 proposed rules specifically detail why in-person mandates restrict access to care and how restricted access to telemedicine will increase patient harm and diversion risk. We appreciate DEA&#8217;s efforts to review and incorporate stakeholder feedback on those comments, including considering the creation of a Special Registration process,&#8221; noted Kyle Zebley, Executive Director, ATA Action, in the document submitted to the DEA. &#8220;We maintain that in-person requirements are not a clinically appropriate or effective way to limit diversion and our first preference would be to permanently waive the in-person requirement as done during the COVID-19 public health emergency.&#8221;</p>
<p>ATA Action also urged the DEA to “consider realistic timelines when implementing these new processes.”</p>
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		<title>DEA Seeking Input on Prescribing Controlled Substances via Telemedicine</title>
		<link>https://www.policymed.com/2023/09/dea-seeking-input-on-prescribing-controlled-substances-via-telemedicine.html</link>
					<comments>https://www.policymed.com/2023/09/dea-seeking-input-on-prescribing-controlled-substances-via-telemedicine.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Fri, 08 Sep 2023 08:21:25 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[Telemedicine]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16341</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>The United States Drug Enforcement Administration (DEA) announced that it is seeking public input “concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine.” To that end, the DEA will host two listening sessions: one on Tuesday, September 12, [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35.jpg 1200w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2022/08/stencil.default-35-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>The United States Drug Enforcement Administration (DEA) <a href="https://public-inspection.federalregister.gov/2023-16889.pdf">announced</a> that it is seeking public input “concerning the practice of telemedicine with regards to controlled substances and potential safeguards that could effectively prevent and detect diversion of controlled substances prescribed via telemedicine.” To that end, the DEA will host two listening sessions: one on Tuesday, September 12, 2023, and another on Wednesday, September 13, 2023, from 9:00 am – 5:30 pm.</p>
<p>The <a href="https://www.congress.gov/110/plaws/publ425/PLAW-110publ425.pdf">Ryan Haight Online Pharmacy Consumer Protection Act of 2008</a> requires that a prescribing practitioner (with certain exceptions) may only prescribe controlled substances to a patient if they have, at some point, performed an in-person evaluation of the patient. Once a provider has conducted at least one in-person medical evaluation, the Ryan Haight Act does not prohibit the practitioner from prescribing controlled substances.</p>
<p>During the COVID-19 Public Health Emergency, the DEA <a href="https://www.foley.com/en/insights/publications/2020/04/covid19-dea-samhsa-opioid-disorders-telehealth">granted temporary exceptions</a> to the Ryan Haight Act and the DEA’s implementing regulations, allowing the prescribing of controlled substances via telemedicine, irrespective of whether the provider has ever conducted an in-person medical evaluation. The DEA again <a href="https://www.federalregister.gov/documents/2023/05/10/2023-09936/temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled">extended that waiver</a> to avoid lapses in patient care.</p>
<p>Since then, and prior to the expiration of the COVID-19 PHE, the DEA and HHS promulgated <a href="https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities">two notices of proposed rulemaking</a> in the Federal Register that sought to expand patient access to controlled substance prescriptions via telemedicine while also maintaining effective controls against diversion. The DEA received 38,369 responses to the two NPRMs – among the highest number of public comments received on an NPRM in the DEA’s history.</p>
<p>Most of the comments expressed concern that the NPRMs placed limitations on the supply of controlled substances that could be prescribed via telemedicine before an in-person medical evaluation. Several hundred comments specifically raised the possibility of a separate Special Registration for practitioners who seek to prescribe controlled substances without conducting an in-person medical evaluation of patients at all.</p>
<p>The DEA is open to considering implementation of a Special Registration for telemedicine prescribing for patients without requiring the patient to ever have had an in-person medical evaluation at all. The agency is also considering that making some telemedicine flexibilities permanent would potentially create a new framework for medicine that expands access to controlled substances in a way that would necessitate a new framework for accountability based, in part, on increased data collection and visibility into prescription practices in order to ensure patient safety and prevent diversion in near-real-time. Before the DEA makes any decisions, the agency would like to gather additional information first.</p>
<p>Therefore, during the listening sessions, the DEA is specifically seeking input from interested individuals, including medical practitioners, patients, pharmacy professionals, industry members, law enforcement, and other third parties, focused on the following topics:</p>
<ul>
<li>advisability of permitting telemedicine prescribing of certain controlled substances without any in-person medical evaluation at all,</li>
<li>the availability and types of data that would be useful in detecting diversion of controlled substances via telemedicine that are either already reported or could be reported, and</li>
<li>specific additional safeguards that could be placed around the prescribing of schedule II controlled substances via telemedicine.</li>
</ul>
<p>The DEA requested that those wishing to give an oral presentation at the listening session pre-register and will review those requests to select a cross-section of persons and organizations to present at the listening sessions.</p>
<p>The listening sessions will be live streamed online. Interested parties who wanted to attend in person needed to have pre-registered with the DEA by August 21.</p>
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		<title>CCO MATE ACT DEA Resource Center Includes, Courses, Frequently Asked Questions (FAQ’s) and Additional Resources</title>
		<link>https://www.policymed.com/2023/06/clinical-care-options-launches-mate-act-dea-resource-center-includes-courses-frequently-asked-questions-faqs-and-additional-resources.html</link>
					<comments>https://www.policymed.com/2023/06/clinical-care-options-launches-mate-act-dea-resource-center-includes-courses-frequently-asked-questions-faqs-and-additional-resources.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Mon, 05 Jun 2023 08:04:48 +0000</pubDate>
				<category><![CDATA[CME]]></category>
		<category><![CDATA[DEA]]></category>
		<category><![CDATA[MATE Act]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16125</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="823" height="762" src="https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2.jpg 823w, https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2-300x278.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2-768x711.jpg 768w" sizes="auto, (max-width: 823px) 100vw, 823px" /></div>In December 2022, congress passed the MATE Act which starting June 27, 2023 will require all DEA certificate holders to have completed eight (8) hours of education on the diagnosis, management and treatment of patients with opioid and other substance abuse disorders in order to register for their DEA certificates. In an effort to assist [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="823" height="762" src="https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2.jpg 823w, https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2-300x278.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/06/Mate-Act-Course-2-768x711.jpg 768w" sizes="auto, (max-width: 823px) 100vw, 823px" /></div><p>In December 2022, congress passed <a href="https://www.policymed.com/2023/01/mate-act-becomes-law-dea-prescriber-license-holders-required-to-complete-8-hours-of-education-on-opioid-treatment.html">the MATE Act</a> which starting June 27, 2023 will require all DEA certificate holders to have completed <a href="https://clinicaloptions.com/content/dea-resource-center">eight (8) hours of education</a> on the diagnosis, management and treatment of patients with opioid and other substance abuse disorders in order to register for their DEA certificates.</p>
<p>In an effort to assist healthcare professionals in meeting and understanding the new DEA education requirements, Clinical Care Options has created a <a href="https://clinicaloptions.com/content/dea-resource-center">DEA Resource Center</a>.  The resource center includes resources such as frequently asked questions, access to on demand courses, live webinars and resources.</p>
<p>We have compiled <a href="https://clinicaloptions.com/content/dea-faqs">frequently asked questions (FAQ’s) around the MATE ACT</a>, we will be updating this information as we receive additional information.  More can be found at the <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA RESOURCE CENTER</a>.</p>
<p><strong>Who falls into the MATE Act requirement?</strong></p>
<p>All practitioners who are registered with the US Drug Enforcement Administration (DEA), except for practitioners who are solely veterinarians. This includes MDs, DOs, DDSs, DMDs, APRNs, ODs, and others who hold DEA prescriber registrations.</p>
<p><strong>What is the DEA training requirement?</strong></p>
<p>Under the MATE Act, DEA-registered physicians, dentists, and practitioners must have a total of 8 hours of training on the diagnosis, treatment, and management of patients with opioid or other substance use disorders. This training can be obtained by courses such as <a href="https://clinicaloptions.com/content/dea-resource-center">the CCO DEA compliant courses</a>.</p>
<p><strong>Do I have to take this course?</strong></p>
<p>Yes! To obtain or renew a DEA registration, DEA prescribers (including MDs, DOs, NPs, PAs, dental surgeons, dentists, and others with DEA prescriber registrations) must have a total of 8 hours of training on the diagnosis, treatment, and management of patients with opioid or other substance use disorders. Courses available including the <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA compliant courses</a> provides practical point-of-care access to training in multiple formats and resources to help you meet these DEA requirements.</p>
<p>Exceptions for this requirement include providers who are board certified in addiction medicine; providers who graduated from a United States medical, dental, APRN, or PA school in the 5 years prior to June 27, 2023; or providers who have taken the 8-hour DATA Waiver training.</p>
<p><strong>How much does the course cost?</strong></p>
<p>The cost for the <a href="https://clinicaloptions.com/content/dea-resource-center">course ranges from $299 to $399</a>, depending on how you take them: in a live online webinar or online at your own pace. The course covers all 8 hours of the requirement.</p>
<p><strong>Can I get all hours through CCO?</strong></p>
<p>Yes! You can claim up to 8 hours of credit by taking the <a href="https://clinicaloptions.com/content/dea-resource-center">CCO courses</a> to meet the DEA requirements for education on the management of patients with opioid or other substance abuse disorders.</p>
<p><strong>What is the deadline for satisfying this new training requirement?</strong></p>
<p>The deadline for satisfying this new training requirement is the date of a practitioner&#8217;s next scheduled DEA registration submission—regardless of whether it is an initial registration or a renewal registration—on or after June 27, 2023, for the next 3 years.</p>
<p><strong>How will practitioners be asked to report satisfying this new training requirement?</strong></p>
<p>Beginning on June 27, 2023, practitioners will be required to check a box on their online DEA registration form—regardless of whether a registrant is completing their initial registration application or renewing their registration—affirming that they have completed the new training requirement.</p>
<p><strong>When do I need to renew my DEA registration?</strong></p>
<p>DEA registrations are for 3 years. If you plan to obtain or renew your DEA license sometime between June 27, 2023, and June 26, 2026, you will need to have 8 hours of training on the treatment and management of patients with opioid or other substance abuse disorders.</p>
<p><strong>Who qualifies for the medical/dental/NP/PA school exemption?</strong></p>
<p>All practitioners who graduated in good standing from a medical (allopathic or osteopathic), dental, PA, or advanced practice nursing school in the United States within 5 years of June 27, 2023, and successfully completed a comprehensive curriculum that included at least 8 hours of training on treating and managing patients with opioid or other substance use disorders, including the appropriate clinical use of all drugs approved by the FDA for the treatment of a substance use disorder, or safe pharmacologic management of dental pain and screening, brief intervention, and referral for appropriate treatment of patients with or at risk of developing opioid and other substance use disorders.</p>
<p>Check with your professional school to provide documentation of completion of this requirement. Documentation of your participation may be required if you are ever inspected or audited.</p>
<p><strong>What if I graduated from a medical/dental/NP/PA school outside of the United States?</strong></p>
<p>The medical school “exemption” applies only to those who graduated from a school within the United States. All foreign medical school graduates are required to take courses to fulfill this requirement.</p>
<p><strong>Can the X waiver training count toward this requirement?</strong></p>
<p>Yes. Past DATA-waived training counts toward a DEA registrant&#8217;s 8-hour training requirement.</p>
<p><strong>What if I am board certified in addiction medicine?</strong></p>
<p>All practitioners who are board certified in addiction medicine or addiction psychiatry from the American Board of Medical Specialties, the American Board of Addiction Medicine, or the American Osteopathic Association are deemed to have satisfied this training.</p>
<p><strong>What if I have a DEA registration but don&#8217;t write opioid prescriptions? Do I still need to take the course?</strong></p>
<p>All DEA registrants irrespective of whether they actively prescribe opioids must meet this 8-hour training requirement and be prepared to show completion if ever inspected or audited.</p>
<p><strong>Do pathologists or radiologists need to take this course and meet DEA requirements, as they do not prescribe medications, especially narcotics?</strong></p>
<p>It depends. Practitioners must meet the requirements only if they hold a DEA prescribers&#8217; certificate. If you have a DEA certificate, this requirement applies to you, regardless of your prescribing history or intention.</p>
<p><strong>I have done the state-required courses on pain management and opioid prescribing. Does that education count toward my requirements?</strong></p>
<p>Yes. You can count your state-required courses toward this requirement. It is important to consider that the MATE Act focuses on courses on substance abuse disorder, and you must have the hours you claim addressing substance abuse disorder. Also, you will need a copy of the hours certificate available in the event you are subject to a DEA audit or inspection.</p>
<p><strong>Can other courses on opioid or other substance abuse disorders count toward this requirement?</strong></p>
<p>According to the DEA, past training on the treatment and management of patients with opioid or other substance use disorders can count toward a practitioner meeting this requirement. In other words, if you received relevant training (from one of the groups authorized to provide training) prior to the enactment of this new training obligation on December 29, 2022, that training can count toward the 8-hour requirement.</p>
<p><strong>Can I count courses that are required by my state under multiple licensing cycles toward this requirement?</strong></p>
<p>Unclear. Although you can count 1 year of courses toward this requirement, it was not the intention of Congress for DEA registrants to count the same course taken multiple times. Instead, the intent was that prescribers have education on substance abuse disorders and how to diagnose and refer those patients to the appropriate healthcare professional. Remember, you didn&#8217;t receive your medical degree by taking the same course over and over again! It is recommended that you complete one 8-hour course vs multiple separate courses.</p>
<p><strong>What if I hold licenses in multiple states? How do the DEA requirements apply?</strong></p>
<p>The requirements are the same regardless of where you hold your license. If you hold licenses in multiple states, you must complete the 8-hour substance abuse education requirement 1 time. It is important that you keep documentation of your course participation.  Note, if you hold multiple licenses you only have to meet the DEA requirement one time.</p>
<p><strong>If I completed 8 hours of courses in the past, is there an expiration date on those courses, and can I use them to meet this requirement?</strong></p>
<p>This is unclear, as the DEA has not made it clear how far back you can count a course. The DEA has said, however, that those who have graduated from a US-based medical school in the past 5 years with a curriculum on substance abuse and pain management would be able to count that education toward this requirement. Therefore, in the interest of safety, we suggest courses from no more than 5 years ago as the limit, but this is subject to change if additional guidance comes out from the DEA.</p>
<p><strong>Do all 8 hours have to be completed at once?</strong></p>
<p>No. You don&#8217;t have to complete the course all at once. It can be cumulative across multiple sessions, as long as it totals 8 hours of training on opioid or other substance abuse disorders. The <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA compliant courses</a> includes slides, audio, and text modules that allow you to take the course at your own pace.</p>
<p><strong>Do I have to complete the training in person?</strong></p>
<p>No. Training can occur in various formats, including classroom settings, seminars at professional society meetings, or virtual offerings. The <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA compliant courses</a> can be purchased as a live webinar or as an on-demand version (either text or slides with audio). In-person training is available to organizations that meet our criteria. Please reach out to us for more information.</p>
<p><strong>How do you comply, and what are the penalties?</strong></p>
<p>To comply with the DEA requirements, you must attest to your completion of 8 hours of training on opioid or other substance abuse disorders. You will do this by checking a box during your application or reapplication process. Know that if you submit false attestation to the DEA, you could face stiff penalties, including the following warning from the DEA website: 21 USC 843(d), states that any person who knowingly or intentionally furnishes false or fraudulent information in the application is subject to a term of imprisonment of not more than 4 years, and a fine under Title 18 of not more than $250,000, or both.</p>
<p><strong>Who can provide courses to meet this 8-hour requirement?</strong></p>
<p>The MATE Act allows many types of education providers to offer the course.   We have provided a list included in the legislation.</p>
<p>One simple way to meet this requirement is to take the <a href="https://clinicaloptions.com/content/dea-resource-center">CCO MATE ACT Course</a>.</p>
<p>Organizations that can provide this education include:</p>
<ul>
<li>The American Society of Addiction Medicine (ASAM)</li>
<li>The American Academy of Addiction Psychiatry (AAAP)</li>
<li>American Medical Association (AMA)</li>
<li>The American Osteopathic Association (AOA), or any organizations accredited by the AOA to provide continuing medical education.</li>
<li>The American Dental Association (ADA)</li>
<li>The American Association of Oral and Maxillofacial Surgeons (AAOMS)</li>
<li>The American Psychiatric Association (APA)</li>
<li>The American Association of Nurse Practitioners (AANP)</li>
<li>The American Academy of Physician Associates (AAPA)</li>
<li>The American Nurses Credentialing Center (ANCC)</li>
<li>Any other organization accredited by the Accreditation Council for Continuing Medical Education (AACCME) or the Commission for Continuing Education Provider Recognition (CCEPR),<br />
whether directly or through an organization accredited by a State medical society that is recognized by the ACCME or CCEPR</li>
<li>Any other organization approved or accredited by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR</li>
</ul>
<p><strong>How will the DEA verify my participation in these courses?</strong></p>
<p>According to the DEA, prescribers may be asked to show documentation in the form of a certificate that the education was taken in advance of their DEA registration.</p>
<p><strong>Do I need to keep records of completion?</strong></p>
<p>DEA recommends that license holders keep their documentation confirming course completion for the 8-hour requirement for courses on opioid and other substance abuse disorders. The documentation should be kept readily available in the event of an audit. It would be prudent to keep your records for at least the period of your current DEA registration.</p>
<p><strong>I have participated in substance abuse courses over the span of my practice. Can I count those courses toward this requirement?</strong></p>
<p>It depends. If you have records showing that you completed courses on opioid or other substance abuse disorders and have copies of those certificates, you may be able to claim those for meeting the requirement. If you don&#8217;t have documentation or those were many years in the past, it would be helpful for your patients for you to be up to date on substance abuse treatments, as those are continually updated. Chances are you may still need additional credits. The <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA compliant courses</a> allows you the flexibility of taking those hours that you still may need for the DEA 8-hour requirement.</p>
<p><strong>Is this a 1-time requirement?</strong></p>
<p>Per the MATE Act, this is a 1-time requirement for all DEA registrants for the next 3 years, starting June 27, 2023, based on your DEA registration renewal date.</p>
<p><strong>Is there reimbursement for diagnosis and referral of substance abuse disorders?</strong></p>
<p>Medicare, Medicaid, and private insurance all have reimbursement codes for Screening, Brief Intervention, and Referral to Treatment (SBIRT) for substance abuse disorders. The time spent directly with the patient to review their questionnaire and discuss referral and treatment options can be billed. In the “Overview of Substance Abuse” module of the <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA compliant courses</a>, we cover this information and provide you with codes you can use in your practice.</p>
<p><strong>Can we take the course for the whole office?</strong></p>
<p>You can take the class as a group. However, to receive “credit” for a course taken online, individuals must be registered separately to receive the course completion certificate.</p>
<p><strong>What do I do if I already have taken several hours of my state requirements?</strong></p>
<p>You can count those hours from the state requirement. The CCO DEA course is flexible in that you can claim up to 8 hours of credit, but you are able to claim less. We highly recommend that if you have met the state-required pain or controlled substance courses, you take the portion of our course on substance abuse disorders. Chances are you still may need additional credits. <a href="https://clinicaloptions.com/content/dea-resource-center">The CCO DEA compliant courses</a> allows you the flexibility of taking those hours that you still may need for the DEA 8-hour requirement.</p>
<p><strong>Will the CCO DEA course count toward specialty board MOC requirements?</strong></p>
<p>The <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA compliant courses</a> have been submitted to 21 specialty boards for MOC credit.</p>
<p><strong>Can I get MIPS Improvement Activity Credit for taking the </strong><a href="https://clinicaloptions.com/content/dea-resource-center"><strong>CCO DEA compliant course</strong></a><strong>?</strong></p>
<p>Yes. Completion of this accredited CME activity meets the expectations of an Accredited Safety or Quality Improvement Program (IA_PSPA_28) for the Merit-based Incentive Payment Program (MIPS).</p>
<p>An example of an activity that could satisfy this is an accredited continuing medical education program related to opioid analgesic Risk Evaluation and Mitigation Strategies (REMS) to address pain control (ie, acute and chronic pain).</p>
<p><strong>Do the </strong><a href="https://clinicaloptions.com/content/dea-resource-center"><strong>CCO DEA compliant courses</strong></a><strong> count toward my state license requirements?</strong></p>
<p>Depending on the state, we went to great lengths to meet most state requirements. Some states have a specific PDMP and other learning requirements not covered in the course. For Tennessee, we have included a state-required module in the coming weeks. For New Mexico our course has been approved by board of medicine.  We are working to provide a list of states where we meet the state requirements.</p>
<p><strong>What is the difference between the MAT Act and the MATE Act</strong></p>
<p>The MAT Act congress eliminated the requirement for eight hours of training on buprenorphine prior to being able to administer this drug for opioid use disorder and pain management.  The MAT Act also ended the restriction on the number of patients on buprenorphine a health care provider can treat.   The MAT ACT is the 8 hour requirement for classes on the screening, management and referral of patients with opioid or other substance abuse disorders.</p>
<p><strong>What is the purpose of this new DEA requirement in the MATE Act?</strong></p>
<p>With the United States facing a major addiction crisis, the congressional members who sponsored the MATE Act see educating healthcare professionals on substance abuse disorder as a possible solution.</p>
<p>Create a 1-time, nonrepetitive requirement for all DEA controlled substance prescribers (Schedule II, III, IV, or V) to complete training on treating and managing patients with opioid and other substance use disorders, unless the prescriber is otherwise qualified.</p>
<p>Allow accredited medical schools and residency programs, PA schools, and schools of advanced practice nursing to fulfill the training requirement through a comprehensive curriculum that meets the standards laid out in statute, without having to coordinate the development of their education with an outside medical society or state licensing body.</p>
<p>Normalize addiction medicine education across certain professional schools and phase out the need for these future practitioners to take a separate, federally mandated addiction course.</p>
<p><strong>Resource Center</strong></p>
<p>The resource center is designed to serve healthcare professionals in meeting this important DEA requirement.</p>
<p>For more information: <a href="https://clinicaloptions.com/content/dea-resource-center">CCO DEA RESOURCE CENTER</a></p>
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		<title>DEA Announces Extension of Telemedicine Flexibilities, Despite PHE Ending</title>
		<link>https://www.policymed.com/2023/05/dea-announces-extension-of-telemedicine-flexibilities-despite-phe-ending.html</link>
					<comments>https://www.policymed.com/2023/05/dea-announces-extension-of-telemedicine-flexibilities-despite-phe-ending.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 16 May 2023 08:12:24 +0000</pubDate>
				<category><![CDATA[COVID-19]]></category>
		<category><![CDATA[DEA]]></category>
		<category><![CDATA[Telemedicine]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16073</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2.jpg 1200w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>Just one day before the COVID-19 Public Health Emergency was set to expire, the United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” to temporarily extend telemedicine flexibilities. This announcement follows the March 1, 2023, [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2.jpg 1200w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2020/08/stencil.default-2-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>Just one day before the COVID-19 Public Health Emergency was set to expire, the United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the “<a href="https://www.federalregister.gov/documents/2023/05/10/2023-09936/temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled">Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications</a>” to temporarily extend telemedicine flexibilities.</p>
<p>This announcement follows the March 1, 2023, <a href="https://www.policymed.com/2023/03/dea-proposes-making-telemedicine-flexibilities-permanent.html">notices of proposed rulemakings</a> published by the DEA and Department of Health and Human Services (HHS), that would allow for the prescribing of certain controlled medications through telemedicine without requiring an in-person medical evaluation of the patient (under certain conditions that are consistent with public health, safety, and effective controls against diversion).</p>
<p>SAMHSA and DEA both “strongly support policies that promote access to effective and safe treatment for opioid use disorder,” including through the use of telemedicine, and ensuring that patients have continued access to their necessary prescribed medications past the COVID public health emergency.</p>
<p>The temporary rule took effect on May 11, 2023, and will extend the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency through November 11, 2023. Additionally, for practitioner-patient relationships that are (or will be) established prior to November 11, 2023, the full set of telemedicine flexibilities regarding prescribing controlled medications will be extended for an additional year, through November 11, 2024.</p>
<p>According to <a href="https://www.dea.gov/press-releases/2023/05/09/dea-samhsa-extend-covid-19-telemedicine-flexibilities-prescribing#:~:text=United%20States%20Drug%20Enforcement%20Administration,-Get%20Updates&amp;text=The%20temporary%20rule%20will%20take,%E2%80%93%20through%20November%2011%2C%202023.">DEA Administrator Milgram</a>, the DEA “received a record 38,000 comments on its proposed telemedicine rules” and understands “the importance of telemedicine in providing Americans with access to needed medications.” As a result, the agency is opting to extend the flexibilities “for six months while we work to find a way forward to give Americans that access with appropriate safeguards.”</p>
<p>Miriam E. Delphin-Rittmon, the HHS Assistant Secretary for Mental Health and Substance Use and the leader of SAMHSA, <a href="https://www.dea.gov/press-releases/2023/05/09/dea-samhsa-extend-covid-19-telemedicine-flexibilities-prescribing#:~:text=United%20States%20Drug%20Enforcement%20Administration,-Get%20Updates&amp;text=The%20temporary%20rule%20will%20take,%E2%80%93%20through%20November%2011%2C%202023.">notes that</a> “access to evidence-based treatment is a pillar of the HHS Overdose Prevention Strategy” and that “policies that promote access to effective and safe treatment for opioid use disorder, including through telemedicine platforms, and ensuring continued access to necessary controlled mediations past the COVID-PHE” are important.</p>
<p>The DEA will continue to evaluate the more than 38,000 comments received on the notices of proposed rulemaking and aims to produce a final rule that allows the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion. The temporary rule will allow for a smooth transition for patients and providers alike, as well as allow additional time for providers to become compliant with any new standards or safeguards published in future final rules.</p>
<p>This reversal highlights the importance of telemedicine in today’s healthcare arena. Between this extension and the DEA’s seeming commitment to considering the 38,000 comments submitted in response to the proposed rule, it will not be easy to put the “cat back in the bag,” so to speak. Telemedicine is proving that it is more than just a pandemic fad, but serves as an important tool for patients, particularly those in rural and underserved areas.</p>
<p>The American Telemedicine Association and ATA Action issued a statement commending the temporary rule, saying, “It is especially important and encouraging that these actions cover access to clinically appropriate prescriptions of controlled substances that patients need for a wide variety of medical circumstances, including for mental health and substance use disorders.”</p>
<p>&nbsp;</p>
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		<title>ATA Action Argues for Remote Prescribing of Controlled Substances</title>
		<link>https://www.policymed.com/2023/05/ata-action-argues-for-remote-prescribing-of-controlled-substances.html</link>
					<comments>https://www.policymed.com/2023/05/ata-action-argues-for-remote-prescribing-of-controlled-substances.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Tue, 09 May 2023 08:21:03 +0000</pubDate>
				<category><![CDATA[DEA]]></category>
		<category><![CDATA[Pharmacy]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16025</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div>ATA Action, the affiliated trade organization for the American Telemedicine Association (ATA), the only organization “completely focused on advancing telehealth,” recently sent two statements to the Drug Enforcement Administration (DEA) about the agency’s proposed rules (here and here) regarding the remote prescribing of controlled substances. Throughout the two letters, ATA Action outlined suggestions for ways [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="1200" height="800" src="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" srcset="https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77.jpg 1200w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-300x200.jpg 300w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-1024x683.jpg 1024w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-768x512.jpg 768w, https://www.policymed.com/wp-content/uploads/2023/01/stencil.default-77-450x300.jpg 450w" sizes="auto, (max-width: 1200px) 100vw, 1200px" /></div><p>ATA Action, the affiliated trade organization for the American Telemedicine Association (ATA), the only organization “completely focused on advancing telehealth,” recently sent two statements to the Drug Enforcement Administration (DEA) about the agency’s proposed rules (<a href="https://www.federalregister.gov/documents/2023/03/01/2023-04217/expansion-of-induction-of-buprenorphine-via-telemedicine-encounter">here</a> and <a href="eralregister.gov/documents/2023/03/01/2023-04248/telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had">here</a>) regarding the remote prescribing of controlled substances. Throughout the <a href="https://www.americantelemed.org/policies/ata-actions-letter-to-the-dea-re-expansion-of-induction-of-buprenorphine-via-telemedicine-encounter/">two letters</a>, ATA Action <a href=".americantelemed.org/policies/ata-actions-lette">outlined suggestions for ways</a> that the draft rules could be improved to maintain mechanisms to prevent diversion while also ensuring that patients do not lose access to their necessary treatments.</p>
<p>The ATA Action letters point to patients who either are unable to, or do not wish to, seek treatment in person. Those individuals “will fall through the cracks under these rules, creating a significant and avoidable public health crisis.”</p>
<p>&#8220;We appreciate DEA&#8217;s responsibility to write rules that provide effective controls against diversion and protect public health and safety but believe that the requirement that a patient see a clinician in-person is not an effective control against diversion and, instead, simply limits access to legitimate health care,&#8221; noted Kyle Zebley, Executive Director of ATA Action, in the letters to the DEA. &#8220;We are concerned that in-person requirements will exacerbate existing inequities in the health care system, as it will only serve patients who have the ability to see an in-person provider and misses the point that telehealth provides the unique ability to increase access to care to previously left-behind populations.&#8221;</p>
<p>The letters note that every state allows a clinician and provider to establish a valid relationship via telehealth and that a relationship established via technology is “just as legitimate as one established in-person” and that removing this option will harm patients. Instead, the letters argue, the DEA should allow state law and clinical practice standards to control while tracking and monitoring DEA-licensed telemedicine providers in the same way the agency already does for in-person providers.</p>
<p>Zebley also points to potential cost inefficiencies. If a patient has established a relationship with a virtual provider, to require them to establish care with an in-person prescriber just for the sake of a prescription, it may “drive unnecessary utilization of visits without clinical need simply to satisfy the requirement, thereby generating extra cost that could have been avoided.” A potential solution is having the telehealth provider attest that an in-person visit was not necessary for the service provided and ensure that is documented in the medical record.</p>
<p>The letters also note that the DEA should not limit the issuance of prescriptions to the FDA-approved indications contained in the FDA-approved labeling as “it is legal and common for clinicians to use their clinical judgment to prescribe medicines ‘off-label’” and by limiting clinical judgment in this way, it would not only not prevent diversion (which is the DEA’s goal) but it would also likely result in “diminished access to care for necessary medications.”</p>
<p>&#8220;We believe that not creating a special registration process for providers wanting to practice legitimate telemedicine is a missed opportunity for both expanded access to care and for DEA&#8217;s ability to identify providers operating legally and appropriately from those that are not. Under a special registration regime, DEA could track and manage legitimate providers and therefore more easily identify illegitimate ones,&#8221; Zebley concluded. &#8220;This could also solve the issue for pharmacists if they were able to access a list of prescribers who had registered with DEA. One course of action to support the removal of the in-person requirements would be to replace the in-person requirements with the statutorily required special registration process.”</p>
<p>The ATA Action Letter to the DEA regarding the Expansion of Induction of Buprenorphine via Telemedicine Encounter can be found <a href="https://www.americantelemed.org/policies/ata-actions-letter-to-the-dea-re-expansion-of-induction-of-buprenorphine-via-telemedicine-encounter/">here</a> and the ATA Action Letter to the DEA regarding Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Exam can be found <a href="https://www.americantelemed.org/policies/ata-actions-letter-to-the-dea-re-telemedicine-prescribing-of-controlled-substances-when-the-practitioner-and-the-patient-have-not-had-a-prior-in-person-medical-evaluation/">here</a>.</p>
<p>The comment period for the DEA proposed rules closed on March 31, 2023. More than 37,000 comments were submitted in response to the proposed rules.</p>
<p><strong>Other Responses</strong></p>
<p>The American Psychiatric Association (APA) also submitted letters in response to the two proposals (<a href="https://www.psychiatry.org/getattachment/4428f9f0-8fdf-4976-a9b8-e266b2cd5d4d/APA-Letter-to-DEA-Buprenorphine-Telemedicine-Docket-No-DEA-948-03312023.pdf">here</a> and <a href="https://www.psychiatry.org/getattachment/d00e8ef0-5e46-4f21-92c1-f620d23d250a/APA-Letter-to-DEA-Telemedicine-Prescribing-Docket-No-DEA-407-03312023.pdf">here</a>) as did <a href="chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https:/www.ashp.org/-/media/assets/advocacy-issues/docs/2023/ASHP-Comments-to-DEA-re-buprenorphine-RX-3-2023">the American Society of Health System Pharmacists</a> (ASHP).</p>
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		<title>DEA Publishes Requirements for MATE Act One Time Requirement for Eight Hours of Substance Abuse Disorder Training</title>
		<link>https://www.policymed.com/2023/04/dea-publishes-requirements-for-mate-act-one-time-requirement-for-eight-hours-of-substance-abuse-disorder-training.html</link>
					<comments>https://www.policymed.com/2023/04/dea-publishes-requirements-for-mate-act-one-time-requirement-for-eight-hours-of-substance-abuse-disorder-training.html#respond</comments>
		
		<dc:creator><![CDATA[Thomas Sullivan]]></dc:creator>
		<pubDate>Wed, 05 Apr 2023 08:05:04 +0000</pubDate>
				<category><![CDATA[CME]]></category>
		<category><![CDATA[DEA]]></category>
		<category><![CDATA[MATE Act]]></category>
		<category><![CDATA[Opioids]]></category>
		<category><![CDATA[Substance Abuse Disorders]]></category>
		<category><![CDATA[NEW]]></category>
		<guid isPermaLink="false">https://www.policymed.com/?p=16000</guid>

					<description><![CDATA[<div style="margin-bottom:20px;"><img width="243" height="207" src="https://www.policymed.com/wp-content/uploads/2023/04/online-cme-2023.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div>The United States Drug Enforcement Administration (DEA) recently published the requirements for training for the Medication Access and Training Expansion (MATE) Act. These requirements are tied to practitioners’ initial or renewal DEA registration starting June 27, 2023, and the only exception is a practitioner that is solely a veterinarian. Under the MATE Act, practitioners must [&#8230;]]]></description>
										<content:encoded><![CDATA[<div style="margin-bottom:20px;"><img width="243" height="207" src="https://www.policymed.com/wp-content/uploads/2023/04/online-cme-2023.jpg" class="attachment-post-thumbnail size-post-thumbnail wp-post-image" alt="" decoding="async" loading="lazy" /></div><p>The United States Drug Enforcement Administration (DEA) <a href="https://deadiversion.usdoj.gov/pubs/docs/MATE_Training_Letter_Final.pdf">recently published the requirements</a> for training for the Medication Access and Training Expansion (MATE) Act. These requirements are tied to practitioners’ initial or renewal DEA registration starting June 27, 2023, and the only exception is a practitioner that is solely a veterinarian.</p>
<p>Under the <a href="https://www.policymed.com/2023/01/mate-act-becomes-law-dea-prescriber-license-holders-required-to-complete-8-hours-of-education-on-opioid-treatment.html">MATE Act</a>, practitioners must complete at least eight hours of training on opioid or other substance use disorders, as well as the safe pharmacological management of dental pain. The education requirement can be met in one of three ways:</p>
<p style="padding-left: 40px;">(1) a total of eight hours of training from a range of training entities on opioid or other substance use disorders;</p>
<p style="padding-left: 40px;">(2) board certification in addiction medicine or addiction psychiatry from the American Board of Medical Specialties, American Board of Addiction Medicine, or the American Osteopathic Association; or</p>
<p style="padding-left: 40px;">(3) graduation within the last five years and in good standing from a medical, advanced practice nursing, or physician assistant school in the United States that included an opioid or other substance use disorder curriculum of at least eight hours.</p>
<p>For practitioners who hope to qualify under the third option, the medical/dental/APN or PA curriculum must have included teaching on the treatment and management of patients with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the Food and Drug Administration (FDA) for the treatment of a substance use disorder.</p>
<p><a href="https://clinicaloptions.com/content/dea-resource-center">The training</a> is a one-time training and the affirmation that the practitioner has completed the training will not be a part of future registration renewals after June 26, 2026, only the next scheduled DEA registration submission on or after June 27, 2023.</p>
<p><strong>How to Satisfy the Training Requirement </strong></p>
<p>For the practitioners who opt for the eight hours of training on opioid or other substance use disorders, the training does not have to occur in one session, it can be cumulative across multiple sessions, so long as the total number of hours equals eight hours of training. Additionally, past trainings on the treatment and management of patients with opioid or other substance use disorders can count toward the requirement and past DATA-Waived trainings count towards the eight hour requirement.</p>
<p>The DEA has noted that only certain groups may provide trainings that meet the requirement, including organizations accredited by the Accreditation Council for Continuing Medical Education (ACCME) or the Commission for Continuing Education Provider Recognition (CCEPR), whether directly or through an organization accredited by a State medical society that is recognized by ACCME or CCEPR. In addition, several medical associations and societies are permitted to provide trainings that meet the requirement, as are organizations otherwise approved or accredited by the Assistant Secretary for Mental Health and Substance Use, the ACCME, or the CCEPR.</p>
<p><strong>Clinical Care Options DEA MATE Act Requirements Course</strong></p>
<p><a href="https://clinicaloptions.com/">Clinical Care Options</a> is offering <a href="https://clinicaloptions.com/content/dea-resource-center">accredited courses</a> that will help practitioners meet the new DEA requirements.  This includes a <a href="https://clinicaloptions.com/content/dea-resource-center">DEA resource center</a> with MATE ACT courses, FAQ&#8217;s, Fact Sheets, and additional resources for practitioners.  For more information click <a href="https://pages.mycea.com/DEACourse.html">here</a>.</p>
<p><strong>SAMHSA Recommendations for Curricular Elements</strong></p>
<p>The Substance Abuse and Mental Health Services Administration (SAMHSA) also published <a href="https://www.samhsa.gov/medications-substance-use-disorders/provider-support-services/recommendations-curricular-elements-substance-use-disorders-training">recommendations</a> for curricular elements in substance use disorders training. SAMHSA further noted that while the Assistant Secretary for Mental Health and Substance Use has the authority to approve specific training organizations for the purpose of this training, SAMHSA has opted to not “undertake a lengthy rulemaking process” for that at this time, as the agency estimates that more than 2,000 organizations may already be eligible to provide the training.</p>
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