Regulatory Relief https://www.aha.org/ en AHA comments on proposed rule to reduce Medicare participation burdens https://www.aha.org/news/headline/2018-11-19-aha-comments-proposed-rule-reduce-medicare-participation-burdens <span class="title">AHA comments on proposed rule to reduce Medicare participation burdens</span> <span class="uid"><span>gdiesing</span></span> <span class="created">Nov 19, 2018</span> <div class="body"><p>AHA today commended the Centers for Medicare &amp; Medicaid Services’ efforts to reduce unnecessary burdens and reporting requirements with regard to Medicare Conditions of Participation, but said the agency should continue to require ambulatory surgery centers to have a written transfer agreement with a nearby hospital. “While rare, complications do occur in ambulatory surgery patients, and when they do, the patient’s life can depend on the existence of a plan in which the ASC team takes appropriate steps in the moment to both stabilize the patient to the extent possible and transfer the patient to a nearby hospital where additional appropriate treatment can occur,” <a href="https://www.aha.org/letter/2018-11-19-letter-aha-cms-re-proposed-rule-reducing-burden-conditions-participation">the association wrote</a>, commenting on a proposed rule to reduce CoP burden and increase efficiency and transparency. AHA also urged CMS to retain the 30-day requirement for preoperative medical history and physical examination requirements for hospitals and ASCs until more evidence-based guidelines become available. Among other comments, the association voiced support for allowing health care systems to take a system-wide approach to Quality Assurance and Performance Improvement and Infection Control, and for proposed changes to Medicare reapproval requirements for transplant centers and emergency preparedness testing requirements for hospitals.</p> </div> <div class="field_topics"> <div><a href="/topics/regulatory-relief" class="topic" hreflang="en">Regulatory Relief</a></div> <div><a href="/taxonomy/term/392" hreflang="en">AHA</a></div> <div><a href="/topics/medicare" hreflang="en">Medicare</a></div> </div> <div class="field_type">Headline</div> Mon, 19 Nov 2018 20:46:58 +0000 gdiesing 65349 at https://www.aha.org Regulatory Burden on Hospitals & Health Systems https://www.aha.org/videos/2017-11-10-regulatory-burden-hospitals-health-systems <span class="title">Regulatory Burden on Hospitals &amp; Health Systems</span> <span class="uid"><span>aha</span></span> <span class="created">Nov 10, 2017 - 01:12 PM</span> <div class="body"><p><iframe allowfullscreen="" frameborder="0" height="315" src="https://www.youtube.com/embed/T48grQoIuUQ" width="560"></iframe></p> <p>The data presented in this video is from the American Hospital Association report <a href="/guidesreports/2017-11-03-regulatory-overload-report">Regulatory Overload Report: Assessing the Regulatory Burden on Health Systems, Hospitals and Post-acute Care Providers</a>.</p> </div> <div class="field_featured_image featured-image"> <img src="/sites/default/files/styles/large/public/2017-11/Zenty1.jpg?itok=MSQtj2cC" width="900" height="600" alt="test" /> </div> <div class="field_media_featured_image"><article> <div class="field_media_image"> <img src="/sites/default/files/2017-11/Zenty1.jpg" width="1620" height="1080" alt="Zenty1" /> </div> </article> </div> <div class="field_topics"> <div><a href="/topics/regulatory-relief" class="topic" hreflang="en">Regulatory Relief</a></div> </div> <div class="field_type"> <div>Type</div> <div><a href="/type/videos" hreflang="en">Videos</a></div> </div> <div class="field_access_level"> <div>Access Level</div> <div><a href="/taxonomy/term/278" hreflang="en">Public</a></div> </div> <div class="field_paragraphs_text_with_heade"> <div> <div class="paragraph paragraph--type--paragraphs-text-with-headers- paragraph--view-mode--default"> </div> </div> </div> <div class="field_lead"><p>Reducing regulatory requirements will allow providers to focus on patients, not paperwork.</p> </div> <div class="field_promoted_search_terms"> <div>Promoted Search Terms</div> <div>regulatory relief, reg relief</div> </div> <div class="field_search_promotion"> <div>Search Promotion</div> <div>Not Promoted</div> </div> <div class="field_archived"> <div>Archived</div> <div>Off</div> </div> Fri, 10 Nov 2017 19:12:55 +0000 aha 2858 at https://www.aha.org 2021 Rural Advocacy Agenda https://www.aha.org/rural-advocacy-agenda <span class="title">2021 Rural Advocacy Agenda</span> <span class="uid"><span>dsamuels_drupal</span></span> <span class="created">Feb 16, 2021 - 05:53 PM</span> <div class="body"><div class="container"> <div class="row"> <div class="col-md-8"> <p>Rural hospitals and health systems have been on the front lines of the COVID-19 pandemic, working to provide quality care for patients, families and communities. Despite unprecedented financial and health care challenges, rural hospitals remain committed to ensuring local access to high-quality, affordable health care during the pandemic and beyond.</p> <p><a href="https://www.aha.org/system/files/media/file/2021/02/2021-rural-advocacy-agenda.pdf"><img src="/sites/default/files/2021-02/2021-rural-advocacy-agenda-cover-r.png" /></a></p> </div> <div class="col-md-4"> <div class="external-link spacer"><font size="4px"><font size="4px"><a class="btn btn-wide btn-primary" href="/advocacy/2020-01-27-rural-advocacy-agenda-archives" target="_blank">View the Rural Advocacy Agenda Archives </a></font></font></div> </div> </div> </div> </div> <div class="field_topics"> <div><a href="/topics/rural-issues" class="topic" hreflang="en">Rural issues</a></div> <div><a href="/topics/regulatory-relief" hreflang="en">Regulatory Relief</a></div> <div><a href="/topics/access-health-coverage" hreflang="en">Access &amp; Health Coverage</a></div> <div><a href="/topics/health-information-technology-hit" hreflang="en">Health Information Technology (HIT)</a></div> <div><a href="/topics/ahaorg-advocacy-homepage-block" hreflang="en">AHA.org Advocacy Homepage Block</a></div> </div> <div class="field_type"> <div>Type</div> <div><a href="/taxonomy/term/109" hreflang="en">Advocacy</a></div> </div> <div class="field_access_level"> <div>Access Level</div> <div><a href="/taxonomy/term/278" hreflang="en">Public</a></div> </div> <div class="field_audience_type_of_hospital"> <div>Audience - Type of hospital</div> <div> <div><a href="/taxonomy/term/147" hreflang="en">Small and Rural</a></div> <div><a href="/taxonomy/term/144" hreflang="en">Critical Access</a></div> <div><a href="/taxonomy/term/262" hreflang="en">Rural</a></div> </div> </div> <div class="field_paragraphs_text_with_heade"> <div> <div class="paragraph paragraph--type--paragraphs-text-with-headers- paragraph--view-mode--default"> </div> </div> </div> <div class="field_promoted_search_terms"> <div>Promoted Search Terms</div> <div>rural advocacy agenda</div> </div> <div class="field_search_promotion"> <div>Search Promotion</div> <div>Not Promoted</div> </div> <h4 class="page-header">Key Resources</h4> <div class="field_related_files file file--mime-application-pdf file--application-pdf"> <div> <article> <div class="field_media_file"><span class="file file--mime-application-pdf file--application-pdf"><a href="https://www.aha.org/system/files/media/file/2021/02/2021-rural-advocacy-agenda.pdf" type="application/pdf; length=51780" title="2021 Rural Advocacy Agenda">2021 Rural Advocacy Agenda</a></span> </div> </article> </div> </div> <div class="field_archived"> <div>Archived</div> <div>Off</div> </div> Tue, 16 Feb 2021 23:53:00 +0000 dsamuels_drupal 18028 at https://www.aha.org CMS launches web tool for waiver requests https://www.aha.org/news/headline/2021-01-12-cms-launches-web-tool-waiver-requests <span class="title">CMS launches web tool for waiver requests</span> <span class="uid"><span>tjordan_drupal</span></span> <span class="created">Jan 12, 2021</span> <div class="field_media_featured_image"><article> <div class="field_media_image"> <img src="/sites/default/files/styles/900x400/public/2018-06/cms-nh-work-for-medicaid.jpg?itok=5tx450lO" width="900" height="400" alt="cms-nh-work-for-medicaid" /> </div> </article> </div> <div class="body"><p><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">Health care providers can now <a href="https://cmsqualitysupport.servicenowservices.com/cms_1135">apply online</a>&nbsp;for Section 1135 waivers related to the COVID-19 pandemic or other public health emergencies, the Centers for Medicare &amp; Medicaid Services <a href="https://www.cms.gov/files/document/qso-21-11-all.pdf">announced</a>. CMS expects the tool to reduce the burden on providers by streamlining how they document and submit 1135 waiver requests and PHE-related inquiries.<b> </b></span></span></p> </div> <div class="field_topics"> <div><a href="/topics/regulatory-relief" class="topic" hreflang="en">Regulatory Relief</a></div> <div><a href="/topics/novel-coronavirus-sars-cov-2covid-19" hreflang="en">Novel Coronavirus (SARS-CoV-2/COVID-19)</a></div> </div> <div class="field_type">Headline</div> Tue, 12 Jan 2021 20:41:29 +0000 tjordan_drupal 675015 at https://www.aha.org Comments on HHS Proposal to Sunset the Regulatory Review Schedule https://www.aha.org/lettercomment/2020-12-07-comments-hhs-proposal-sunset-regulatory-review-schedule <span class="title">Comments on HHS Proposal to Sunset the Regulatory Review Schedule</span> <span class="uid"><span>Matthew Diener</span></span> <span class="created">Dec 07, 2020 - 11:23 AM</span> <div class="body"><div class="container"> <div class="row"> <div class="col-md-8"> <p>December 4, 2020</p> <p>The Honorable Alex M. Azar<br /> Secretary<br /> U.S. Department of Health and Human Services<br /> 200 Independence Avenue, S.W. Washington, D.C. 20201</p> <p><strong>Re: HHS-OS-2020-0012, Securing Updated and Necessary Statutory Evaluations Timely; Proposed Rule (Vol. 85, No. 214), November 4, 2020.</strong></p> <p>Dear Secretary Azar:</p> <p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners – including more than 270,000 affiliated physicians, 2 million nurses and other caregivers – and the 43,000 health care leaders who belong to our professional membership groups, the American Hospital Association (AHA) appreciates the opportunity to comment on the Department of Health and Human Services’ (HHS) proposed rule on regulatory review.</p> <p>In this rule, HHS proposes to set expiration dates for its regulations (subject to certain exceptions), unless the department periodically assesses the regulations to determine if they are subject to review, and if they are, performs a review. Subject to this review, HHS would be able to unilaterally retain, modify or eliminate the regulation. <strong>While we appreciate that this process has the potential to alleviate some regulatory burden for our hospital and health system members, we have substantial concerns that it does not provide an adequate mechanism for obtaining public input on the substance of regulations being reviewed.</strong> HHS has approximately 18,000 regulations, the vast majority of which would be subject to review under this rule. They encompass a massive range of topics and affect a huge number of providers, beneficiaries and citizens; robust public input is critical. <strong>As such, the AHA urges HHS to withdraw this rule.</strong></p> <p>Under its proposal, HHS would be required to “assess” a regulation every 10 years to determine if it has a significant economic impact upon a substantial number of small entities. For regulations that have been in effect for more than 10 years at the time of the effective date of this proposed rule, HHS would have to undertake this assessment within two years. If the regulation has a significant economic impact, the department would then “review” that regulation to determine if it should be retained, modified or eliminated. If HHS does not “assess” a regulation in a timely manner, it would automatically expire. However, despite these potentially drastic results, there would be limited opportunities for the public to provide input into HHS’ assessments and reviews. Specifically, while the public would be able to comment on regulations that HHS states are in the process of assessment or review, it would not be in response to any proposal for action; thus, commenters would be without any context or indication of the department’s thoughts on the substance of a regulation, any indication of what, if any, modifications it may be considering, or any indication of whether HHS is even considering modifications or deletion at all. Instead, the public would be commenting in a vacuum. This would not constitute a meaningful opportunity to comment.</p> <p>As justification for this insufficient comment process, HHS states that “in this rulemaking process, which amends department regulations through the notice-and-comment rulemaking process, the department is considering the important factors” with regard to whether a regulation should be retained, modified or deleted. However, this claim is absurd on its face. The proposal sets forth a <em>process</em> for assessing and reviewing all of HHS’ regulations, which is not a substitute for a thorough, public, transparent consideration of the <em>substance</em> of individual regulations. Thus, this rule does not constitute a meaningful opportunity to comment on potential changes to specific regulations. HHS cannot override the public’s ability to meaningfully comment on regulations simply by creating another regulation that says it can do so. If notice-and-comment rulemaking was necessary to create a regulation, it also is necessary to modify or delete a regulation.</p> <p>In addition, we have serious concerns about the proposal to remove any regulation for which an assessment is not completed in a timely manner. HHS states that the risk of a regulation inadvertently expiring is outweighed by the benefit of institutionalizing retrospective review. We strongly disagree. We also believe that the department’s “risk mitigation” strategy – a website where, if the deadline for publishing an assessment or review is nearing, and HHS has not announced that it has undergone these activities, the public can submit a comment requesting that the assessment or review begin – is inappropriate and inadequate. It would be difficult, if not impossible, for the public to accurately determine whether a regulation is subject to assessment, and if so, the deadline for informing the agency and commenting. Thus, there very well may be scenarios where a regulation was not assessed, but it is unclear whether it has expired or was exempt from this regulatory review process and is still in place. At best, this would leave those subject to the regulation with no guidance on what is expected of them. At worst, there would be serious consequences of inadvertently removing rules, with negative impacts on beneficiaries, consumers and the public in general.</p> <p>Examples of the above-mentioned confusion and consequence abound. First, CMS has recognized that under its alternative payment models, the waiver of certain payment regulations is essential so that participants may coordinate care and ensure that it is provided in the right place at the right time. For example, regulations at 42 CFR 425.612 identify the circumstances under which specific payment regulations are waived under the accountable care organization (ACO) program. These include the skilled-nursing facility 3-day rule, and the telehealth originating site requirement. Payment waivers are valuable tools that help ACOs achieve success under the program – namely, increasing quality of their beneficiary care and reducing unnecessary costs for Medicare. If HHS unilaterally, and without public input, removed these waivers, modified them in an inappropriate manner, or let them inadvertently expire, it would cause confusion for participants and beneficiaries alike, and likely lead to failures of the program to achieve its goals.</p> <p>Second, many Medicare Advantage (MA) and Part D marketing regulations protect Medicare beneficiaries from misleading and high-pressure marketing tactics that could result in enrollment in an inappropriate or inadequate health plan or result in the purchase of unnecessary ancillary products or services. A substantial number of these regulations were established shortly after the passage of the Medicare Modernization Act with the core marketing regulations finalized in 2008, well beyond the 10-year timeline contemplated by this rule, and remain just as vital today as when they were adopted. For example, regulations at 42 CFR 422.2268 establish standards for marketing by MA plans. Health plans may not, among other things, induce beneficiaries to buy their products through cash payments, discriminate against lower income beneficiaries by concentrating marketing in higher income areas only, or use aggressive outreach techniques, such as showing up at beneficiaries’ homes unsolicited. If HHS unilaterally and without public input, removed any of these regulations, modified them in an inappropriate manner, or let them inadvertently expire, it would be problematic. Beneficiaries would no longer enjoy these protections and the Centers for Medicare &amp; Medicaid Services (CMS) would no longer be able to take any enforcement action against MA or Part D plans violating the rules. That is unacceptable.</p> <p>In addition, each year, the agency issues updated MA and Part D marketing guidelines. This is subregulatory guidance that provides additional information on how to interpret and operationalize the regulations. It is unclear, however, whether this guidance suffices as “review” of the underlying regulations under this regulatory review proposal. Diverting agency attention to review each of these regulations would severely curtail agency resources for doing what matters: ensuring health plans are adhering to these regulations.</p> <p>As another example, Medicare’s quality measurement and value programs rely on regulations that have been implemented incrementally. For example, statutes do not require that CMS has an extraordinary circumstances exception (ECE) policy for natural disasters and other circumstances, but CMS has written such policies into all of its programs through regulation (for example, see 42 CFR 412.140(c)(2) for the inpatient quality reporting (IQR) program and 42 CFR 412.160(c)(1)-(4) for the value-based purchasing program). There is good reason to have ECE policies – extraordinary circumstances can make it impossible for hospitals and other providers to submit quality data, or render the data they have unrepresentative of their true quality performance. In fact, that is precisely why CMS already has invoked ECE policies for its measurement programs during the COVID-19 pandemic. If HHS unilaterally removed these regulations, modified them in an inappropriate manner, or let them inadvertently expire, it would remove critical certainty from hospitals’ disaster planning. In fact, having the ECE policies stand unless and until there are revisions through a transparent rulemaking process gives the field important stability. The COVID-19 pandemic, and the numerous natural disasters like wildfires, hurricanes, tornadoes and floods that our nation has faced in recent years only underscore that hospitals need to be able to count on relief from reporting requirements, and not worry that an arbitrary timeline would simply wipe away the policies.</p> <p>In addition, specific quality measures for Medicare programs have been implemented through regulation, such as 42 CFR.140(c)(1) for the IQR and 42 CFR 412.152 for the Hospital Readmissions Reduction Program. We have long urged Medicare to focus on using “measures that matter” in these programs, and believe all quality measurement program measures sets should be reviewed regularly to identify opportunities to streamline them. In fact, we have recommended a multi-factorial approach to decide when to remove measures from programs, including whether measure performance is topped out, has sufficient evidence to warrant its use, and has any negative unintended consequences. CMS has codified this approach in so-called “measure removal factors,” as exemplified by policies adopted for the IQR (see 83 Federal Register 41540 through 41544). If HHS unilaterally, and without public input, removed these regulations, modified them in an inappropriate manner, or let them inadvertently expire, it could set-back quality measurement by decades.</p> <p>Regarding Medicaid and the Children’s Health Insurance Program (CHIP), a combination of federal statute, regulations and subregulatory guidance outline parameters including who is eligible for benefits, what those benefits include, how the programs are administered and financed, and how beneficiaries are assured access to safe, quality care. Little of the law is “self-implementing,” and the regulations and other guidance provide critical details – and even expand – on the requirements in the law. For example, section 1905(r) of the Social Security Act (the Act) establishes the requirement that state Medicaid programs cover periodic screening and treatment for Medicaid eligible children. Regulations at 42 C.F.R. § 441.62 require that states also assure transportation to this medically necessary care, and regulations at 42 C.F.R. § 440.170(a) provide the definition for what constitutes transportation services, e.g., ambulance, taxicab, common carrier or other appropriate means, as well as meals and lodging for both the child and necessary attendant. These particular regulations have stood the test of time since the early 1980s and continue to be entirely relevant today. If HHS unilaterally, and without public input, removed any of these regulations, modified them in an inappropriate manner, or let them inadvertently expire, it would be devastating – health care coverage would be on the line for the more than 70 million Medicaid enrollees and over 6 million CHIP enrollees, the preponderance of which are children.</p> <p>Finally, legislation including the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 and the ACA require parity between mental health or substance use disorder (SUD) benefits and medical/surgical benefits. Parity applies with respect to financial requirements and treatment limitations under group health plans and group and individual health insurance coverage. Essentially, plans and issuers are prohibited from imposing financial requirements or treatment limitations on mental health and SUD benefits that are more restrictive than those that apply to medical/surgical benefits. Examples of the regulations that help implement these provisions include 42 CFR Parts 146 and 147. These regulations go beyond the legislation to provide specific guidance on the application of non-quantitative treatment limitations (NQTLs) – which put limits on the scope or duration of treatment that are not expressed numerically, such as prior authorization. While the statutes prohibit payers from imposing NQTLs more stringently to mental health or SUD benefits than to comparable medical/surgical benefits, the regulations are necessary to clarify details around exactly how these NQTLs may and may not be imposed.</p> <p>Despite the law and regulations, payers continue to struggle to operationalize these requirements and, therefore, we continue to urge for greater government oversight to ensure compliance. For example, we know both anecdotally and from independent studies that mental health and SUD services are often subject to NQTLs, especially prior authorization, more often than medical/surgical benefits. If HHS unilaterally, and without public input, removed any of these regulations, modified them in an inappropriate manner, or let them inadvertently expire, it would leave the department unable to pursue enforcement action, which could cause a drastic and devastating reduction in patient access to care.</p> <p>We appreciate your consideration of these issues. Please contact me if you have questions or feel free to have a member of your team contact Joanna Hiatt Kim, vice president of payment policy, at <a href="mailto:jkim@aha.org?subject=Regulatory Sunset Rule Comment Letter">jkim@aha.org</a>.</p> <p>Sincerely,</p> <p>/s/</p> <p>Thomas P. Nickels<br /> Executive Vice President</p> </div> <div class="col-md-4"> <p><a href="/system/files/media/file/2020/12/Regulatory-Sunset-Rule-Comment-Letter-12_4_20.pdf" target="_blank"><img alt="Comments on HHS Proposal to Sunset the Regulatory Review Schedule page 1" data-entity-type="file" data-entity-uuid="3d6f94d0-2389-4a1b-99ab-5019797f69bc" src="/sites/default/files/inline-images/Regulatory-Sunset-Rule-Comment-Letter-12_4_20_Page_1.jpg" style="border: solid 1pt black;" /></a></p> <center> <h4><a href="/system/files/media/file/2020/12/Regulatory-Sunset-Rule-Comment-Letter-12_4_20.pdf" target="_blank">Download the Letter PDF</a></h4> </center> </div> </div> </div> </div> <div class="field_topics"> <div><a href="/topics/advocacy-public-policy" class="topic" hreflang="en">Advocacy &amp; Public Policy</a></div> <div><a href="/topics/regulatory" hreflang="en">Regulatory</a></div> <div><a href="/topics/regulatory-relief" hreflang="en">Regulatory Relief</a></div> </div> <div class="field_type"> <div>Type</div> <div><a href="/taxonomy/term/113" hreflang="en">Letter/Comment</a></div> </div> <div class="field_paragraphs_text_with_heade"> <div> <div class="paragraph paragraph--type--paragraphs-text-with-headers- paragraph--view-mode--default"> </div> </div> </div> <div class="field_search_promotion"> <div>Search Promotion</div> <div>Not Promoted</div> </div> <h4 class="page-header">Key Resources</h4> <div class="field_related_files file file--mime-application-pdf file--application-pdf"> <div> <article> <div class="field_media_file"><span class="file file--mime-application-pdf file--application-pdf"><a href="https://www.aha.org/system/files/media/file/2020/12/Regulatory-Sunset-Rule-Comment-Letter-12_4_20.pdf" type="application/pdf; length=446672" title="Comments on HHS Proposal to Sunset the Regulatory Review Schedule">Comments on HHS Proposal to Sunset the Regulatory Review Schedule PDF</a></span> </div> </article> </div> </div> <div class="field_archived"> <div>Archived</div> <div>Off</div> </div> Mon, 07 Dec 2020 17:23:29 +0000 Matthew Diener 674385 at https://www.aha.org HHS: Laboratory developed tests do not require FDA approval or authorization https://www.aha.org/news/headline/2020-08-21-hhs-laboratory-developed-tests-do-not-require-fda-approval-or <span class="title">HHS: Laboratory developed tests do not require FDA approval or authorization</span> <span class="uid"><span>tjordan_drupal</span></span> <span class="created">Aug 21, 2020</span> <div class="field_media_featured_image"><article> <div class="field_media_image"> <img src="/sites/default/files/styles/900x400/public/2018-04/FDA%20product%20update.jpg?itok=fxs3OT8L" width="900" height="400" alt="FDA product update" /> </div> </article> </div> <div class="body"><p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">In an <span style="color:black">effort to reduce regulatory burden, the&nbsp;Food and Drug Administration&nbsp;will not require developers to submit a premarket approval application, premarket notification or emergency use authorization for laboratory developed tests, the Department of Health and Human Services </span></span></span><a href="https://www.hhs.gov/coronavirus/testing/recission-guidances-informal-issuances-premarket-review-lab-tests/index.html" style="color:#0563c1; text-decoration:underline"><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">announced</span></span></a><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif"><span style="color:black"> this week. </span></span></span></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">Laboratories opting to use these tests would not be eligible for </span></span><a href="https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx" style="color:#0563c1; text-decoration:underline"><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">Public Readiness and Emergency Preparedness Act</span></span></a><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif"> coverage and would <span style="color:black">remain subject to regulation by the Centers for Medicare &amp; Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988 and its implementing regulations, HHS said.&nbsp;LDT developers may voluntarily apply for&nbsp;approval, clearance or an EUA, and FDA will adjudicate those submissions.</span></span></span></span></span></p> <p><span style="font-size:11pt"><span style="font-family:Calibri,sans-serif"><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">LDTs are developed, validated and performed by individual laboratories, including hospital laboratories, when commercial diagnostic tests do not exist or meet clinical needs. </span></span><a href="https://www.aha.org/letter/2015-02-02-aha-comments-fda-re-draft-framework-regulatory-oversight-laboratory-developed" style="color:#0563c1; text-decoration:underline"><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif">AHA has repeatedly&nbsp;urged</span></span></a><span style="font-size:12.0pt"><span style="font-family:&quot;Arial&quot;,sans-serif"> the agency not to regulate LDTs as medical devices, which would reduce patient access to many critical tests and hinder technological and clinical innovation.</span></span></span></span></p> </div> <div class="field_topics"> <div><a href="/topics/regulatory-relief" class="topic" hreflang="en">Regulatory Relief</a></div> </div> <div class="field_type">Headline</div> Fri, 21 Aug 2020 19:07:03 +0000 tjordan_drupal 632105 at https://www.aha.org HHS finalizes strategy to reduce health IT burdens https://www.aha.org/news/headline/2020-02-21-hhs-finalizes-strategy-reduce-health-it-burdens <span class="title">HHS finalizes strategy to reduce health IT burdens</span> <span class="uid"><span>tjordan_drupal</span></span> <span class="created">Feb 21, 2020</span> <div class="field_media_featured_image"><article> <div class="field_media_image"> <img src="/sites/default/files/styles/900x400/public/2018-11/ONC.jpg?itok=mmsyd1LM" width="900" height="400" alt="ONC" /> </div> </article> </div> <div class="body"><p>The Department of Health and Human Services today finalized its strategy to reduce regulatory and administrative burdens for health care providers using electronic health records and other health information technology. Required by the AHA-supported 21st Century Cures Act of 2016, the <a href="https://www.healthit.gov/topic/usability-and-provider-burden/strategy-reducing-burden-relating-use-health-it-and-ehrs">report</a>&nbsp;by HHS’ Office of the National Coordinator for Health IT outlines a series of policies the agency may enact over the next several years to reduce burdens related to clinical documentation, health IT usability, and EHR and public health reporting. Commenting on the draft report last year, AHA <a href="https://www.healthit.gov/topic/usability-and-provider-burden/strategy-reducing-burden-relating-use-health-it-and-ehrs">urged</a>&nbsp; the agency to look at EHR clinical documentation, prior authorization and the ongoing lack of interoperability between EHR systems, among other concerns.</p> </div> <div class="field_topics"> <div><a href="/topics/electronic-health-records-ehrs-meaningful-use" class="topic" hreflang="en">Electronic Health Records (EHRs) - Meaningful Use</a></div> <div><a href="/topics/interoperability" hreflang="en">Interoperability</a></div> <div><a href="/topics/regulatory-relief" hreflang="en">Regulatory Relief</a></div> </div> <div class="field_type">Headline</div> Fri, 21 Feb 2020 20:33:49 +0000 tjordan_drupal 488348 at https://www.aha.org CMS to streamline survey process for psychiatric hospitals https://www.aha.org/news/headline/2020-01-13-cms-streamline-survey-process-psychiatric-hospitals <span class="title">CMS to streamline survey process for psychiatric hospitals</span> <span class="uid"><span>mcostello_drupal</span></span> <span class="created">Jan 13, 2020</span> <div class="field_media_featured_image"><article> <div class="field_media_image"> <img src="/sites/default/files/styles/900x400/public/2018-04/CMS%20Update%20pic.jpg?itok=Jki06v3V" width="900" height="400" alt="CMS Update pic" /> </div> </article> </div> <div class="body"><p>Beginning in March, the Centers for Medicare &amp; Medicaid Services will implement a streamlined survey and certification process for psychiatric hospitals, the agency <a href="https://www.cms.gov/newsroom/fact-sheets/cms-reduces-psychiatric-hospital-burden-new-survey-process">announced</a>&nbsp;today. Under the new process, state survey agencies will perform one comprehensive survey to review compliance with both hospital and psychiatric hospital participation requirements instead of two, allowing inspectors to take a broader view of a psychiatric hospital’s operations and better identify systemic quality issues, the agency said. “The policy of multiple inspections for psychiatric hospitals is emblematic of the absurd status quo in health care,” said CMS Administrator Seema Verma. “For too long, fragmented and misaligned processes have increased burden and administrative costs.” For more on the announcement, see the <a href="https://www.cms.gov/httpswwwcmsgovmedicareprovider-enrollment-and-certificationsurveycertificationgeninfoadministrative/informational-notice-forthcoming-integration-psychiatric-hospital-program-hospital-program-and-state">CMS memorandum</a>.</p> </div> <div class="field_topics"> <div><a href="/topics/regulatory-relief" class="topic" hreflang="en">Regulatory Relief</a></div> <div><a href="/topics/psychiatric-pps" hreflang="en">Psychiatric PPS</a></div> <div><a href="/topics/quality-oversight" hreflang="en">Quality Oversight</a></div> </div> <div class="field_type">Headline</div> Mon, 13 Jan 2020 20:43:06 +0000 mcostello_drupal 457946 at https://www.aha.org AHA Model Letter to Submit Comments to CMS on Proposed Rule on Stark Law https://www.aha.org/lettercomment/2019-12-11-aha-model-letter-submit-comments-cms-proposed-rule-stark-law <span class="title">AHA Model Letter to Submit Comments to CMS on Proposed Rule on Stark Law</span> <span class="uid"><span>dsamuels_drupal</span></span> <span class="created">Dec 11, 2019 - 08:24 AM</span> <div class="body"></div> <div class="field_topics"> <div><a href="/topics/physician-self-referral-lawstark-law" class="topic" hreflang="en">Physician Self-Referral Law/Stark law</a></div> <div><a href="/topics/regulatory-relief" hreflang="en">Regulatory Relief</a></div> </div> <div class="field_type"> <div>Type</div> <div><a href="/taxonomy/term/113" hreflang="en">Letter/Comment</a></div> </div> <div class="field_access_level"> <div>Access Level</div> <div><a href="/taxonomy/term/280" hreflang="en">Member Non-Fed</a></div> </div> <div class="field_search_promotion"> <div>Search Promotion</div> <div>Not Promoted</div> </div> <h4 class="page-header">Key Resources</h4> <div class="field_related_files file file--mime-application-pdf file--application-pdf"> <div> <article> <div class="field_media_file"><span class="file file--mime-application-vnd-openxmlformats-officedocument-wordprocessingml-document file--x-office-document"><a href="https://www.aha.org/system/files/media/file/2019/12/aha-model-letter-to-submit-comments-to-cms-on-proposed-rule-on-stark-law.docx" type="application/vnd.openxmlformats-officedocument.wordprocessingml.document; length=41618" title="AHA Model Letter to Submit Comments to CMS on Proposed Rule on Stark Law">AHA Model Letter to Submit Comments to CMS on Proposed Rule on Stark Law</a></span> </div> </article> </div> </div> <div class="field_archived"> <div>Archived</div> <div>Off</div> </div> Wed, 11 Dec 2019 14:24:43 +0000 dsamuels_drupal 425872 at https://www.aha.org CMS issues final rules on burden reduction, discharge planning https://www.aha.org/news/headline/2019-09-25-cms-issues-final-rules-burden-reduction-discharge-planning <span class="title">CMS issues final rules on burden reduction, discharge planning</span> <span class="uid"><span>gdiesing</span></span> <span class="created">Sep 25, 2019</span> <div class="field_media_featured_image"><article> <div class="field_media_image"> <img src="/sites/default/files/styles/900x400/public/2018-04/CMS%20Final%20Rule.jpg?itok=s72Z-1O8" width="900" height="400" alt="CMS Final Rule" /> </div> </article> </div> <div class="body"><p>The Centers for Medicare &amp; Medicaid Services today issued final rules reducing some regulatory burdens for providers participating in the Medicare and Medicaid programs, and revising discharge planning requirements for hospitals, critical access hospitals and home health agencies.<br /> &nbsp;<br /> The burden reduction <a href="https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-20736.pdf">rule</a>, proposed last year, allows health systems to use a unified/central staff across multiple hospitals for Quality Assessment and Performance Improvement and Infection Control Programs, rather than have individual staff for each separately certified hospital; lends assistance to Medicare re-approval procedures for transplant centers; allows hospitals to review their emergency preparedness plans every two years rather than annually; and removes certain other requirements for CAHs, hospitals with swing beds, home health agencies and ambulatory surgical centers.<br /> &nbsp;<br /> The discharge planning <a href="https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-20732.pdf">rule</a>, proposed in 2015, finalizes provisions requiring hospitals and CAHs to create discharge planning evaluations for patients who are likely to suffer adverse health consequences in the absence of adequate discharge planning, and when a patient, their representative or physician requests such a plan. The rule also requires hospitals, CAHs and home health agencies to provide certain medical information to the receiving facility when transferring patients. CMS did not finalize its proposal to require hospitals and CAHs to establish a post-discharge follow-up process for at least some patients discharged to home. Recognizing that hospitals already are doing this according to specific situations and patient needs, the agency encouraged providers to continue following evidence-based best practices to establish an appropriate process.</p> </div> <div class="field_topics"> <div><a href="/topics/medicaid" class="topic" hreflang="en">Medicaid</a></div> <div><a href="/topics/medicare" hreflang="en">Medicare</a></div> <div><a href="/topics/regulatory-relief" hreflang="en">Regulatory Relief</a></div> </div> <div class="field_type">Headline</div> Wed, 25 Sep 2019 20:32:37 +0000 gdiesing 326832 at https://www.aha.org