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					<title>Health Law Advisor - Laws and Regulations Affecting Health Care and Life
Sciences - Featuring HEAL® | Epstein Becker Green</title>
					<link>https://www.healthlawadvisor.com/category/access-to-health-care</link>
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					<description><![CDATA[The latest updates to Health Law Advisor - Laws and Regulations Affecting Health Care and Life Sciences - Featuring HEAL®.]]></description>
					<lastBuildDate>Sun, 12 Jul 2026 23:31:00 -0700</lastBuildDate>
					
				<item>
				<title>At the Half: No Free Kicks in FDA’s 2026 Enforcement</title>
				<link>https://www.healthlawadvisor.com/at-the-half-no-free-kicks-in-fdas-2026-enforcement</link>
<dc:creator>Megan  Robertson</dc:creator>
<guid isPermaLink='false'>at-the-half-no-free-kicks-in-fdas-2026-enforcement</guid>

					<pubDate>Tue, 30 Jun 2026 09:00:01 -0700</pubDate>
					<description><![CDATA[<p>As the World Cup has captured the attention of viewers around the globe, so has the Food and Drug Administration (FDA) when it comes to taking enforcement action against regulated companies around the globe. We are at the midpoint of 2026, and several patterns are emerging based on FDA&rsquo;s activity so far. Based on our own weekly tracking and analysis, we are sharing some of the key themes that have bubbled up as priorities for regulated industries and their stakeholders to watch as 2026 progresses.</p>]]></description>
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				<title>Federal Embryo Adoption Program Raises Potential Legal Questions for
Reproductive Health</title>
				<link>https://www.healthlawadvisor.com/federal-embryo-adoption-program-raises-potential-legal-questions-for-reproductive-health</link>
<dc:creator>Erin  Sutton</dc:creator>
<guid isPermaLink='false'>federal-embryo-adoption-program-raises-potential-legal-questions-for-reproductive-health</guid>

					<pubDate>Thu, 25 Jun 2026 09:00:02 -0700</pubDate>
					<description><![CDATA[<p>In June 2026, the Trump administration announced nearly $2 million in federal grant funding for an <a href="https://opa.hhs.gov/grant-programs/embryo-adoption-awareness">Embryo Adoption Awareness and Services (EAA) program</a> administered through the Department of Health and Human Services (HHS). While embryo adoption programs have existed at the federal level since 2002, the <a href="https://files.simpler.grants.gov/opportunities/167d140c-52a1-4ebb-99be-ecddf378082d/attachments/13b771a1-4ca4-4420-a526-efabdbccb0da/PA-EAA-26-001_EAA_NOFO.pdf">new grant notice</a> contains language that may have far-reaching implications for reproductive health law, in vitro fertilization (IVF) regulation, and the ongoing legal debate over fetal personhood.</p>]]></description>
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				<item>
				<title>CMS Announces Nationwide Moratoria on New Medicare Enrollment for Hospices,
Home Health Agencies</title>
				<link>https://www.healthlawadvisor.com/cms-announces-nationwide-moratoria-on-new-medicare-enrollment-for-hospices-home-health-agencies</link>
<dc:creator>Mark E. Lutes, David E. Matyas, Timothy J. Murphy, John W. Eriksen</dc:creator>
<guid isPermaLink='false'>cms-announces-nationwide-moratoria-on-new-medicare-enrollment-for-hospices-home-health-agencies</guid>

					<pubDate>Fri, 15 May 2026 09:00:03 -0700</pubDate>
					<description><![CDATA[<p>On May 13, 2026, the Centers for Medicare and Medicaid Services (CMS) <a href="https://www.cms.gov/newsroom/press-releases/cms-announces-aggressive-nationwide-crackdown-fraud-six-month-hospice-home-health-agency-enrollment">announced</a> an aggressive nationwide crackdown on fraud&mdash;with the start of six-month moratoria on new Medicare enrollment for hospices and home health agencies (HHAs) and on changes in majority ownership that would require a new enrollment under <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-424/subpart-P/section-424.550">42 C.F.R. &sect;450(b).</a></p>]]></description>
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				<title>Medicaid Behavioral Health Investigations and Payment Suspensions in D.C.
Are Increasing – How Providers Can Limit Risk</title>
				<link>https://www.healthlawadvisor.com/medicaid-behavioral-health-investigations-and-payment-suspensions-in-d-c-are-increasing-how-providers-can-limit-risk</link>
<dc:creator>Sarah M. Hall, Chloe T. Hillard, Clifford E. Barnes</dc:creator>
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					<pubDate>Thu, 14 May 2026 09:00:04 -0700</pubDate>
					<description><![CDATA[<p>Behavioral health providers in the District of Columbia (&ldquo;District&rdquo; or &ldquo;D.C.&rdquo;) are operating in an environment of heightened government scrutiny. In recent months, federal and District authorities have signaled an intensified focus on Medicaid fraud in the behavioral health space, combining criminal prosecutions by the U.S. Attorney&rsquo;s Office with aggressive program integrity actions by the D.C. Department of Health Care Finance (&ldquo;DHCF&rdquo;). These efforts have included criminal and civil investigations into alleged billing irregularities and, at an increasing rate, the suspension of Medicaid payments to providers based on suspected fraud. Such suspensions are implemented in almost all cases, as permitted by regulations, before any final determination on the merits. These developments raise significant legal, financial, and operational risks for behavioral health providers in D.C.</p>]]></description>
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				<title>GUARD and GLOBE Pricing Models Could Test Manufacturer Rebates for Medicare
Part B and D Drugs</title>
				<link>https://www.healthlawadvisor.com/guard-and-globe-pricing-models-could-test-manufacturer-rebates-for-medicare-part-b-and-d-drugs</link>
<dc:creator>Constance A. Wilkinson</dc:creator>
<guid isPermaLink='false'>guard-and-globe-pricing-models-could-test-manufacturer-rebates-for-medicare-part-b-and-d-drugs</guid>

					<pubDate>Thu, 12 Feb 2026 09:00:05 -0800</pubDate>
					<description><![CDATA[<p>As 2025 drew to a close, the Centers for Medicare &amp; Medicaid Services (&ldquo;CMS&rdquo;) issued proposed rules for two mandatory pricing models aiming to reduce out-of-pocket costs for Medicare drugs.</p>]]></description>
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				<title>OIG Issues Guidance, Request for Information on DTC Programs</title>
				<link>https://www.healthlawadvisor.com/oig-issues-guidance-request-for-information-on-dtc-programs</link>
<dc:creator>Alan J. Arville, Anjali N.C. Downs, Carrie  Valiant, Constance A. Wilkinson</dc:creator>
<guid isPermaLink='false'>oig-issues-guidance-request-for-information-on-dtc-programs</guid>

					<pubDate>Tue, 10 Feb 2026 09:00:06 -0800</pubDate>
					<description><![CDATA[<p>Last week, the OIG posted two important issuances on Direct to Consumer drug programs, including TrumpRx &ndash; a Special Advisory Bulletin and a Request for Information (RFI). These issuances follow the announcement of Most Favored Nation Direct to Consumer pricing last May in White House Executive Order 14297, &ldquo;Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients&rdquo; (May 12, 2025).</p>]]></description>
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				<title>ACCESS Model: CMMI’s New Technology-Enabled Chronic Care Model</title>
				<link>https://www.healthlawadvisor.com/access-model-cmmis-new-technology-enabled-chronic-care-model</link>
<dc:creator>Devon  Minnick, Marjorie T. Scher, Arthur J. Fried</dc:creator>
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					<pubDate>Tue, 06 Jan 2026 15:15:00 -0800</pubDate>
					<description><![CDATA[<p>The Center for Medicare and Medicaid Innovation (CMMI) recently announced a voluntary, 10-year Medicare payment and service delivery model: Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model.</p>
<p>The ACCESS Model tests whether a new payment methodology, Outcome Aligned Payments (OAPs) can better support technology-enabled care, improve health outcomes, and lower overall Medicare spending for high-prevalence, high-cost chronic conditions that affect more than two-thirds of people enrolled in Medicare.</p>
<p>The ACCESS Model will focus on chronic conditions including high blood pressure, diabetes, chronic musculoskeletal pain, and depression.</p>]]></description>
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				<title>State Insurance Department Statements Scrutinize MA and MedSupp Unfair
Trade Practices</title>
				<link>https://www.healthlawadvisor.com/state-insurance-department-statements-scrutinize-ma-and-medsupp-unfair-trade-practices</link>
<dc:creator>Matthew P. Sprankle, Elena M. Quattrone, Helaine I. Fingold</dc:creator>
<guid isPermaLink='false'>state-insurance-department-statements-scrutinize-ma-and-medsupp-unfair-trade-practices</guid>

					<pubDate>Wed, 19 Nov 2025 09:00:08 -0800</pubDate>
					<description><![CDATA[<p>Practices related to enrollment in Medicare Advantage plans continue to draw scrutiny from government regulators. Over the last few weeks, and simultaneous with Medicare&rsquo;s Annual Open Enrollment Period, six states issued statements regarding recent Medicare Advantage and MedSupp (or &ldquo;Medigap&rdquo;) carrier actions related to enrollment and marketing accessibility.&nbsp; Specifically, regulators from state insurance departments in the states of <a href="https://insurance.delaware.gov/wp-content/uploads/sites/15/2025/10/DF-No-162-and-PA-No-39.pdf">Delaware</a>, <a href="https://doi.idaho.gov/wp-content/uploads/ID/B25-06.pdf">Idaho</a>, <a href="https://csimt.gov/wp-content/uploads/2025/11/2025-11-06-Advisory-Memorandum-Unfair-Trade-Practices.pdf">Montana</a>, <a href="https://mm.nh.gov/files/uploads/nhid/documents/20251106-ins-25-082-ab-medicare-conduct.pdf">New Hampshire</a>, <a href="https://www.insurance.nd.gov/sites/www/files/documents/Bulletins/2025/Bulletin%202025-2%20Medicare_%20Med%20Advt_%20Med%20Supp%20Enrollment%20Practices.pdf">North Dakota</a> and <a href="https://www.oid.ok.gov/wp-content/uploads/2025/11/2025-11-07-25-1084-BUL-TPT-Formatted-Bulletin-HC-Unfair-Trade-Fraud51.pdf">Oklahoma</a>, have indicated that the following acts, if taken by MA and MedSupp carriers, are considered unfair and deceptive under state law:</p>]]></description>
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				<title>Congress Creates Yet Another Cliff for Medicare Telehealth Extensions (and
We’re Running Out of Metaphors)</title>
				<link>https://www.healthlawadvisor.com/congress-creates-yet-another-cliff-for-medicare-telehealth-extensions-and-were-running-out-of-metaphors</link>
<dc:creator>Daniel L. Fahey, Audrey  Davis, Avery  Schumacher</dc:creator>
<guid isPermaLink='false'>congress-creates-yet-another-cliff-for-medicare-telehealth-extensions-and-were-running-out-of-metaphors</guid>

					<pubDate>Thu, 13 Nov 2025 15:00:00 -0800</pubDate>
					<description><![CDATA[<p>[UPDATE: <em>This post has been updated to reflect the Drug Enforcement Administration&rsquo;s November 10, 2025, notice of the upcoming Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.</em>]</p>
<p>The United States just made its latest move regarding <a href="https://www.healthlawadvisor.com/plunging-over-the-telehealth-cliff-now-what">Medicare telehealth flexibilities, which expired on September 30, 2025</a>.</p>
<p>On November 9, the Senate voted <a href="https://www.cbsnews.com/news/government-shutdown-senate-deal/">60-40</a> to end the then-nearly 40-day U.S. government shutdown, hammering out a <a href="https://www.appropriations.senate.gov/imo/media/doc/continuing_appropriations_act_2026_bill_text.pdf">continuing resolution (CR)</a> that would extend the telehealth flexibilities extended in the Consolidated Appropriations Act of 2023 through January 30, 2026. The House vote on November 12, <a href="https://www.cnbc.com/2025/11/12/government-shutdown-house-vote-trump.html">222-209,</a> <a href="https://www.congress.gov/bill/119th-congress/house-bill/5371">clinched the deal.</a></p>
<p>It&rsquo;s a welcome development. A <a href="https://cahpr.sph.brown.edu/sites/default/files/documents/Policy%20Briefs/2025/Research%20Brief_%20Medicare%20Telehealth%20Flexibilities%20at%20Risk%20of%20Expiration%20%281%29.pdf">research brief</a> updated on November 10, 2025, by the Center for Advancing Health Policy Through Research (CAHPR) and the Brown University School of Public Health reports that telemedicine visits declined by 24 percent in the first 17 days of October for Medicare fee-for-service beneficiaries, and by 13 percent for Medicare Advantage beneficiaries. This is compared to visits from the start of July to the end of September, when the U.S. government&rsquo;s failure to extend Medicare telehealth coverage sent practitioners and patients alike over what is now commonly termed a telehealth policy &ldquo;cliff.&rdquo;</p>]]></description>
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				<title>Podcast: Current Tailwinds in Women’s Health - What Do They Mean for Your
Business? – Diagnosing Health Care</title>
				<link>https://www.healthlawadvisor.com/podcast-current-tailwinds-in-womens-health-what-do-they-mean-for-your-business-diagnosing-health-care</link>
<dc:creator></dc:creator>
<guid isPermaLink='false'>podcast-current-tailwinds-in-womens-health-what-do-they-mean-for-your-business-diagnosing-health-care</guid>

					<pubDate>Fri, 31 Oct 2025 13:05:00 -0700</pubDate>
					<description><![CDATA[<p><em>New from the <a target="_blank" title="Visit the Diagnosing Health Care Podcast Episode Page" rel="noopener noreferrer" href="https://www.ebglaw.com/dhc90">Diagnosing Health Care Podcast</a>:&nbsp;</em>Why is <em>now</em> the moment for women&rsquo;s health?</p>
<p>On this episod<em>e</em>,&nbsp;E<span>pstein </span>B<span>ecker </span>G<span>reen</span> attorneys<span>&nbsp;</span><a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/rachel-snyder-good">Rachel Snyder Good</a>,&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/elizabeth-scarola">Beth Scarola</a>, and&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/laura-j-deponio">Laura DePonio</a>&nbsp;sit down with <strong>Sheila Biggs</strong>, Vice President of <a href="https://jarrardinc.com/">Jarrard</a>, to explore how women&rsquo;s health is evolving from a niche focus <span>in</span>to a mainstream industry priority. They discuss the forces accelerating growth, the opportunities for change, and the challenges that still need to be addressed across outcomes, access, and patient experience.</p>
<p>This episode unpacks<span> several key topics, including</span>:</p>
<ul>
<li><strong><span>w</span>hat &ldquo;women&rsquo;s health&rdquo; really means</strong> today&mdash;far beyond fertility and reproductive care<span>;</span></li>
<li><strong><span>h</span>ow decades of underinvestment</strong> created new opportunities for innovation, equity, and growth<span>;</span></li>
<li><strong><span>w</span>hy investors and policymakers</strong> are turning their attention to this space, and what&rsquo;s driving <span>the </span>momentum<span>;</span></li>
<li><strong><span>t</span>he biggest gaps still to close</strong> in outcomes, access, and patient experience<span>;</span></li>
<li><strong><span>h</span>ow storytelling and strategy</strong> can help reshape the public narrative around women&rsquo;s health<span>; and</span></li>
<li><strong><span>w</span>here the industry is headed next</strong>&mdash;including insights <span>related to </span>the upcoming Women&rsquo;s Health Innovation Summit<span>.</span></li>
</ul>
<p>Tune in to find out what&rsquo;s driving unprecedented momentum across policy, investment, and innovation in the women<span>&rsquo;</span>s health space.</p>]]></description>
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				<title>California Governor Signs AB 1415 Compromise Legislation Regulating Private
Equity and Hedge Fund Activity</title>
				<link>https://www.healthlawadvisor.com/california-governor-signs-ab-1415-compromise-legislation-regulating-private-equity-and-hedge-fund-activity</link>
<dc:creator>Daniel L. Fahey, Timothy J. Murphy, Joshua J. Freemire, Jeremy A. Avila,
John M. Puente</dc:creator>
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					<pubDate>Thu, 16 Oct 2025 15:00:00 -0700</pubDate>
					<description><![CDATA[<p>On October 11, California Governor Gavin Newsom signed <a href="https://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=202520260AB1415">AB 1415,</a> which regulates private equity and hedge fund activity by expanding the Office of Health Care Affordability&rsquo;s (OHCA) jurisdiction and notice requirements. Though the law is a compromise from last session&rsquo;s AB 3129&mdash;which the Governor vetoed on September 28, 2024&mdash;it nevertheless represents <a href="https://www.ebglaw.com/insights/publications/jeremy-avila-answers-will-ab-1415-finally-bring-private-equity-in-healthcare-under-control">a significant change for private equity groups, hedge funds, and management services organizations (MSOs)</a> in the state.</p>]]></description>
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				<title>CMS Proposes Mandatory Ambulatory Specialty Model to Advance Value-Based
Care for Chronic Conditions</title>
				<link>https://www.healthlawadvisor.com/cms-proposes-mandatory-ambulatory-specialty-model-to-advance-value-based-care-for-chronic-conditions</link>
<dc:creator>Devon  Minnick, Christine Burke Worthen</dc:creator>
<guid isPermaLink='false'>cms-proposes-mandatory-ambulatory-specialty-model-to-advance-value-based-care-for-chronic-conditions</guid>

					<pubDate>Tue, 05 Aug 2025 11:10:00 -0700</pubDate>
					<description><![CDATA[<p>On July 10, 2025, the Centers for Medicare &amp; Medicaid Services (CMS) <a href="https://www.cms.gov/priorities/innovation/innovation-models/asm">announced</a> a proposed rule to establish the <a href="https://www.federalregister.gov/documents/2025/07/16/2025-13271/medicare-and-medicaid-programs-cy-2026-payment-policies-under-the-physician-fee-schedule-and-other">Ambulatory Specialty Model (ASM)</a>&mdash;a mandatory value-based payment model for specialists who treat patients with heart failure or low back pain.</p>
<p>CMS selected heart failure and low back pain because these chronic conditions represent roughly 6% of total, annual spend for traditional Medicare. The model is scheduled to run from 2027 through 2031 and represents an expansion of CMS&rsquo;s strategy to integrate specialty care into its broader efforts to manage chronic disease and control Medicare spending.</p>
<p>CMS is <a href="https://www.regulations.gov/commenton/CMS-2025-0304-0009">accepting public comments</a> on the proposal through September 12, 2025, offering stakeholders an opportunity to help shape the model&rsquo;s design and implementation.</p>]]></description>
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				<title>Podcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing
Health Care</title>
				<link>https://www.healthlawadvisor.com/podcast-breaking-down-the-shifting-vaccine-policy-landscape-diagnosing-health-care</link>
<dc:creator></dc:creator>
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					<pubDate>Thu, 24 Apr 2025 10:05:00 -0700</pubDate>
					<description><![CDATA[<p><em>New from the <a target="_blank" title="Visit the Diagnosing Health Care Podcast Episode Page" rel="noopener noreferrer" href="https://www.ebglaw.com/dhc88">Diagnosing Health Care Podcast</a>:&nbsp;</em>Important changes are unfolding in the vaccine space.</p>
<p>How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health agency funding cuts?</p>
<p>On this episode, Epstein Becker Green attorneys <a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/richard-h-hughes-iv">Richard Hughes</a>,&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/spreeha-choudhury">Spreeha Choudhury</a>,&nbsp;and&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/william-will-walters">Will Walters</a>,&nbsp;as well as&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/anna-larson">Anna Larson</a>&nbsp;of&nbsp;<a target="_blank" rel="noopener" href="https://www.ebgadvisors.com/">EBG Advisors</a>,&nbsp;discuss vaccine-related topics ranging from the measles outbreak and the reduction of the federal workforce to decreased government funding of public health programs.&nbsp;</p>]]></description>
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				<title>DEA Telemedicine Rules Further Delayed Until (Nearly) 2026</title>
				<link>https://www.healthlawadvisor.com/dea-telemedicine-rules-further-delayed-until-nearly-2026</link>
<dc:creator>Alan J. Arville, Daniel L. Fahey, Avery  Schumacher, Audrey  Davis, Erin 
Sutton, David  Shillcutt</dc:creator>
<guid isPermaLink='false'>dea-telemedicine-rules-further-delayed-until-nearly-2026</guid>

					<pubDate>Mon, 24 Mar 2025 13:15:00 -0700</pubDate>
					<description><![CDATA[<p>Those waiting anxiously for the rules expanding the prescribing of buprenorphine via telemedicine and the controlled substance prescribing for patients at the Department of Veterans Affairs to officially go into effect will now have to wait until New Year&rsquo;s Eve&mdash;<strong><u>December 31, 2025</u></strong>.</p>
<p>Practitioners will, however, be allowed to continue prescribing via telemedicine without first having an in-person visit with the patient, owing to COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications, in effect through the same end-of-year date.</p>
<p>A <a href="https://public-inspection.federalregister.gov/2025-05007.pdf">seven-page document</a> released by the Department of Justice&rsquo;s Drug Enforcement Administration (DOJ, DEA) and Department of Health and Human Services (HHS)&mdash;scheduled to be <a href="https://www.federalregister.gov/public-inspection/2025-05007/expansion-of-buprenorphine-treatment-via-telemedicine-encounter-and-continuity-of-care-via">published in the Federal Register on March 24</a>&mdash;further delays the effective dates of the <a href="https://www.federalregister.gov/documents/2025/01/17/2025-01049/expansion-of-buprenorphine-treatment-via-telemedicine-encounter">&ldquo;Expansion of Buprenorphine Treatment via Telemedicine Encounter&rdquo; Final Rule</a> and the <a href="https://www.federalregister.gov/documents/2025/01/17/2025-01044/continuity-of-care-via-telemedicine-for-veterans-affairs-patients">&ldquo;Continuity of Care for Veterans Affairs Patients&rdquo;</a> Final Rule, both dated January 17, 2025 .</p>]]></description>
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				<title>Effective Dates of DEA Final Rules for Telemedicine Prescribing Delayed</title>
				<link>https://www.healthlawadvisor.com/effective-dates-of-dea-final-rules-for-telemedicine-prescribing-delayed</link>
<dc:creator>Alan J. Arville, Daniel L. Fahey, Avery  Schumacher, Audrey  Davis, Erin 
Sutton, David  Shillcutt</dc:creator>
<guid isPermaLink='false'>effective-dates-of-dea-final-rules-for-telemedicine-prescribing-delayed</guid>

					<pubDate>Tue, 18 Feb 2025 17:14:00 -0800</pubDate>
					<description><![CDATA[<p>On Friday, February 14, 2025, the Drug Enforcement Administration (&ldquo;DEA&rdquo;) and the U.S. Department of Health and Human Services (&ldquo;HHS&rdquo;) <a href="https://www.federalregister.gov/public-inspection/2025-02793/expansion-of-buprenorphine-treatment-via-telemedicine-encounter-and-continuity-of-care-via">announced</a>&nbsp;that the effective dates for two recently published final rules involving telemedicine prescribing of controlled substances &ndash; the&nbsp;<a href="https://www.federalregister.gov/documents/2025/01/17/2025-01049/expansion-of-buprenorphine-treatment-via-telemedicine-encounter">final rule</a> titled &ldquo;Expansion of Buprenorphine Treatment via Telemedicine Encounter&rdquo; and the <a href="https://www.federalregister.gov/documents/2025/01/17/2025-01044/continuity-of-care-via-telemedicine-for-veterans-affairs-patients">final rule</a> titled &ldquo;Continuity of Care via Telemedicine for Veterans Affairs Patients&rdquo; (collectively referred to herein as the &ldquo;Buprenorphine and VA Telemedicine Prescribing Rules&rdquo;) &ndash; are delayed from February 18, 2025, until at least March 21, 2025 (see our <a href="https://www.healthlawadvisor.com/at-long-last-deas-remote-prescribing-rules-2-0-are-really-here-pending-further-consideration-by-the-incoming-administration#:~:text=DEA's%202025%20Rules%20*%20A%20Telemedicine%20Prescribing,result%20in%20the%20prescribing%20of%20these%20medications.">previous post</a> on the Buprenorphine and VA Telemedicine Prescribing Rules).</p>
<p>The final rule delaying the effective dates of these final rules is scheduled for publication to the Federal Register on Wednesday, February 19, 2025.</p>
<p>The delays stem from the Presidential Memorandum titled &ldquo;<a href="https://www.whitehouse.gov/presidential-actions/2025/01/regulatory-freeze-pending-review/">Regulatory Freeze Pending Review</a>,&rdquo; (the &ldquo;Freeze Memo&rdquo;) issued on January 20, 2025. The Freeze Memo orders all executive departments and agencies to &ldquo;consider postponing&rdquo; the effective dates of all rules published to the Federal Register that have not yet taken effect, such as the Buprenorphine and VA Telemedicine Prescribing Rules, until at least March 21, 2025 (sixty days from the issuance of the Freeze Memo), to allow review of any questions of fact, law, and/or policy raised by the rule, and to &ldquo;consider opening&rdquo; a comment period for stakeholders to comment on those questions. Accordingly, the DEA is also soliciting comments on: 1) the extension of the effective dates, 2) whether the effective dates should be further extended, and 3) questions of fact, law, and policy raised by these rules, for consideration by officials of the two agencies. Comments are due by February 28, 2025.</p>]]></description>
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				<title>At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here!
(Pending Further Consideration by the Incoming Administration . . .)</title>
				<link>https://www.healthlawadvisor.com/at-long-last-deas-remote-prescribing-rules-2-0-are-really-here-pending-further-consideration-by-the-incoming-administration</link>
<dc:creator>Alan J. Arville, Audrey  Davis, Daniel L. Fahey, Avery  Schumacher, David 
Shillcutt, Erin  Sutton</dc:creator>
<guid isPermaLink='false'>at-long-last-deas-remote-prescribing-rules-2-0-are-really-here-pending-further-consideration-by-the-incoming-administration</guid>

					<pubDate>Tue, 21 Jan 2025 18:00:00 -0800</pubDate>
					<description><![CDATA[<p>Remote prescribing via telemedicine continues to be a huge area of interest among prescribers and other health care providers.</p>
<p>After publishing a Notice of Proposed Rulemaking (&ldquo;NPRM&rdquo;) in March 2023 on the prescribing of controlled substances via telemedicine that was widely criticized for being far more restrictive than temporary waivers then in place under the COVID-19 public health emergency, the Drug Enforcement Administration (&ldquo;DEA&rdquo;) went back to the drawing board.</p>
<p>Additional time and a new year has brought renewed focus. Published <a href="https://www.federalregister.gov/agencies/drug-enforcement-administration">January 17</a> in the Federal Register as one NPRM and two final rules (collectively referred to herein as the &ldquo;DEA&rsquo;s 2025 Rules&rdquo;), the DEA&rsquo;s 2025 Rules seek, as DEA indicates in its <a href="https://www.dea.gov/press-releases/2025/01/16/dea-announces-three-new-telemedicine-rules-continue-open-access">press release</a>, to &ldquo;focus[] on the patient to ensure telemedicine is accessible for medical care.&rdquo;</p>]]></description>
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				<title>D.C.’s Certificate of Need (CON) Process Could See Improvement with
Proposed Legislation</title>
				<link>https://www.healthlawadvisor.com/d-c-s-certificate-of-need-con-process-could-see-improvement-with-proposed-legislation</link>
<dc:creator>John W. Eriksen, Ashley A. Creech</dc:creator>
<guid isPermaLink='false'>d-c-s-certificate-of-need-con-process-could-see-improvement-with-proposed-legislation</guid>

					<pubDate>Tue, 29 Oct 2024 14:40:00 -0700</pubDate>
					<description><![CDATA[<p>In September 2024, a group of Washington, D.C., legislators introduced the <a href="https://lims.dccouncil.gov/downloads/LIMS/56148/Introduction/B25-0948-Introduction.pdf?Id=197205">Certificate of Need (CON) Improvement Act of 2024</a>, B25-0948. If passed, the measure will reform the requirements and process for health establishments in the District to obtain CONs from D.C.&rsquo;s State Health Planning and Development Agency (SHPDA).</p>
<h2>Background</h2>
<p>D.C.&rsquo;s CON requirements were originally established in 1980 to ensure that access to health care services is available to all D.C. residents and to contain the costs of such health care services. D.C. regulators have more recently argued that D.C. was experiencing an overabundance of primary care providers, which has led regulators to apply the CON process in an overly broad manner to prevent a doctor on every block.<sup><a name="_ftnref1" href="#_ftn1"><span>[1]</span></a></sup> The CON requirements have been applied in an inconsistent manner such that similarly situated providers may or may not have a CON depending on enforcement by regulators. Stakeholders within the D.C. community have contested the overly broad interpretation and enforcement of the CON law in D.C. and have argued that such interpretations are in fact creating provider shortages, increasing health care costs, and decreasing access to care.</p>
<p>In addition, the time and expense of complying with the CON requirements is enough of a barrier to potentially send independent physician practices across the border into Maryland and Virginia.<sup><a name="_ftnref2" href="#_ftn2"><span>[2]</span></a></sup> Stakeholders have asserted that rather than decrease health care costs and increase access to care, the CON laws have had the opposite effect.</p>
<p>Lastly, the current requirements for institutional and physician providers to apply for a CON for even routine projects or activities is unnecessary and overly burdensome. For example, hospitals must wait months to a year following the CON process to get non-patient improvements like heating, ventilation, and air conditioning (HVAC). Furthermore, under the current interpretation by regulators, a physician group could subject itself to requiring a CON simply by hiring a non-owner physician or maintain a separate room to perform non-surgical procedures.</p>]]></description>
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				<title>Medical Diagnostic Equipment Accessibility Regulations Announced by DOJ
Under Title II of ADA</title>
				<link>https://www.healthlawadvisor.com/medical-diagnostic-equipment-accessibility-regulations-announced-by-doj-under-title-ii-of-ada</link>
<dc:creator>Joshua A. Stein, Shira M. Blank, Stephen Strobach</dc:creator>
<guid isPermaLink='false'>medical-diagnostic-equipment-accessibility-regulations-announced-by-doj-under-title-ii-of-ada</guid>

					<pubDate>Wed, 14 Aug 2024 15:30:00 -0700</pubDate>
					<description><![CDATA[<p>To honor the 34th anniversary of the Americans with Disabilities Act (ADA), on July 26, 2024, the U.S. Department of Justice (DOJ) signed a <a href="https://www.justice.gov/opa/pr/justice-department-publish-final-rule-improve-access-medical-care-people-disabilities">long-awaited final rule</a> to improve access to medical diagnostic equipment (MDE) for people with disabilities (the &ldquo;MDE Regulations&rdquo;). Stressing that accessible MDE is essential for people with disabilities to have equal access to medical care and avoid poor health outcomes, the MDE Regulations, which were published by the <a href="https://www.federalregister.gov/documents/2024/08/09/2024-16889/nondiscrimination-on-the-basis-of-disability-accessibility-of-medical-diagnostic-equipment-of-state"><em>Federal Register</em> on August 9, 2024</a>, amend Title II of the ADA (&ldquo;Title II&rdquo;) and apply to hospitals and health care clinics operated by state or local governments. The MDE Regulations create enforceable minimum standards for accessible design (as initially issued by the U.S. Access Board) covering MDE, including examination tables, weight scales, dental chairs, x-ray machines, mammography machines, and other radiological equipment commonly used for diagnostic purposes by health care professionals.</p>
<p>In full, the MDE Regulations and the accessibility standards they incorporate stand well in excess of 100 pages. To help our clients more readily understand what the MDE Regulations do and do not require, we are answering some of the most commonly asked questions here.</p>]]></description>
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				<title>Podcast: Unveiling Gender-Affirming Care: Why It Matters and What’s at
Stake – Diagnosing Health Care</title>
				<link>https://www.healthlawadvisor.com/podcast-unveiling-gender-affirming-care-why-it-matters-and-whats-at-stake-diagnosing-health-care</link>
<dc:creator></dc:creator>
<guid isPermaLink='false'>podcast-unveiling-gender-affirming-care-why-it-matters-and-whats-at-stake-diagnosing-health-care</guid>

					<pubDate>Thu, 16 May 2024 11:00:00 -0700</pubDate>
					<description><![CDATA[<p><em>In this episode of the <a target="_blank" title="Visit the Diagnosing Health Care Podcast Episode Page" rel="noopener noreferrer" href="https://www.ebglaw.com/dhc76">Diagnosing Health Care Podcast</a>: </em>Gender-affirming care has become the latest flashpoint in state legislatures and state and federal courts across the nation.</p>
<p>States are divided, with some passing laws that seek to restrict access to gender-affirming care and others aiming to protect access.</p>
<p>What is gender-affirming care? What risks does it pose to providers and patients? On this episode, Epstein Becker Green attorneys <a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/jennifer-jenny-m-nelson-carney">Jenny Nelson Carney</a>,&nbsp;<a href="https://www.ebglaw.com/people/lisa-pierce-reisz">Lisa Pierce Reisz</a>,&nbsp;and&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/erin-sutton">Erin Sutton</a> dissect gender-affirming care: what it is, what it isn't, and what is at stake for everyone involved.</p>]]></description>
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				<title>Podcast: Health Equity – Behind the Buzzwords – Diagnosing Health Care</title>
				<link>https://www.healthlawadvisor.com/podcast-health-equity-behind-the-buzzwords-diagnosing-health-care</link>
<dc:creator></dc:creator>
<guid isPermaLink='false'>podcast-health-equity-behind-the-buzzwords-diagnosing-health-care</guid>

					<pubDate>Thu, 14 Dec 2023 09:00:20 -0800</pubDate>
					<description><![CDATA[<p><em>In this episode of the <a target="_blank" rel="noopener noreferrer" href="https://www.ebglaw.com/dhc74">Diagnosing Health Care Podcast</a>: </em>Under the Biden administration, the Centers for Medicare &amp; Medicaid Services published a health equity framework that drastically changed the playing field for health plans and other risk-bearing entities.</p>
<p>In the wake of these changes, how can health plans, accountable care organizations, and other similar stakeholders successfully create and administer social determinants of health interventions as a means to advance health equity?</p>
<p>On this episode, Epstein Becker Green attorneys <a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/jackie-selby">Jackie Selby</a>,&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/kevin-j-malone">Kevin Malone</a>, and&nbsp;<a target="_blank" rel="noopener" href="https://www.ebglaw.com/people/marjorie-t-scher">Marjorie Scher</a><span>&nbsp;</span>discuss the recent national focus on health equity, the actionable interventions behind the concept, and the responsibility of stakeholders in making care delivery more equitable.</p>]]></description>
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