/ en Fri, 25 Apr 2025 21:21:16 -0500 Mon, 16 Dec 24 13:45:26 -0600 <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Medicare & Medicaid Services (CMS) Nov. 21 issued <a href="https://www.cms.gov/files/document/qso-25-09-all.pdf">updated guidance</a>, effective immediately, for surveyors, hospitals, and other providers and suppliers on identifying and citing instances of noncompliance with health and safety regulations that rise to the level of “immediate jeopardy.” The guidance defines immediate jeopardy, explains the elements surveyors must establish to issue serious citations, and requires surveyors to use a standardized template to document the circumstances and evidence supporting a finding of immediate jeopardy. The guidance also outlines required hospital actions to remove immediate jeopardy status and avoid termination from the Medicare program. Training for surveyors, state agencies, providers and suppliers on <a href="https://qsep.cms.gov/pubs/ClassInformation.aspx?cid=0CMSIJBT_ONL">identifying immediate jeopardy</a> is available through CMS’s Quality, Safety & Education Portal.</p><h2>AHA TAKE</h2><p>Immediate jeopardy citations are rare but have significant consequences for hospitals and health systems. The AHA believes the updated guidance provides greater clarity, consistency and transparency to the process of issuing and enforcing immediate jeopardy citations. We appreciate CMS’ use of a standardized template and its explicit articulation of the process for hospitals to resolve any immediate jeopardy citations.</p><h2>WHAT YOU CAN DO</h2><ul><li>Share <a href="https://www.cms.gov/files/document/qso-25-09-all.pdf">this guidance</a> with key quality, compliance and clinical leadership (e.g., chief clinical, physician, quality, nursing and compliance officers) to inform them of the updated guidance, including new standards for determining immediate jeopardy.</li><li>Review the <a href="https://qsep.cms.gov/pubs/ClassInformation.aspx?cid=0CMSIJBT_ONL">basic immediate jeopardy training</a> offered by CMS.</li><li>Share information on the guidance in relevant staff educational efforts.</li></ul><h2>IMMEDIATE JEOPARDY</h2><p>In the context of Medicare Conditions of Participation (CoPs), immediate jeopardy is a situation in which CMS believes a hospital’s failure to comply with regulations has placed the health and safety of its patients at risk for serious injury, serious harm, serious impairment or death. Although rare, CMS cites hospitals and other providers for immediate jeopardy when it determines that severe harm has occurred or is likely to occur, and immediate action is required to prevent additional harm. It is the most serious citation a hospital can receive and, if not corrected within the timeframe prescribed by CMS, will result in a hospital’s termination from the Medicare program.</p><p>The type of harm CMS believes may warrant a finding of immediate jeopardy can be physical, mental or psychosocial, such as the loss of a limb or other disfigurement; avoidable pain that is excruciating and ongoing; a significant decline in a patient’s physical, mental or psychosocial status not due to the typical progression of a disease or aging; or death. Situations that present a likelihood of severe harm may also warrant a citation resulting in immediate jeopardy, even if actual harm has not yet occurred.</p><h3>Key Changes from Prior Immediate Jeopardy Guidance</h3><p>The updated guidance on immediate jeopardy includes four key changes to the definitions and requirements for determining whether a situation meets the threshold for immediate jeopardy:</p><ul><li>To cite a hospital for immediate jeopardy, the survey team must show that there is a “likelihood,” or a reasonable expectation, that an instance of noncompliance has resulted or will result in serious harm. This is a change from previous guidance which only required surveyors to demonstrate the “potential” for serious harm.</li><li>Surveyors will no longer need to find culpability to decide that immediate jeopardy is warranted.</li><li>Surveyors may use the “reasonable person” standard to assist with situations where mental or psychosocial harm may be difficult to determine or contrary to an expected outcome, considering how a reasonable person would be impacted by the non-compliance.</li><li>The interpretive guidance clarifies that there are no situations in which an “automatic” finding of immediate jeopardy could occur. Surveyors are responsible for investigating and finding supporting evidence for each instance or situation that may necessitate a citation for immediate jeopardy.</li></ul><p>The guidance also reminds hospitals that they are responsible for the actions of all employees, as well as contractors, consultants and volunteers. A “rogue” employee, contractor, consultant or volunteer acting in a manner inconsistent with or contrary to hospital policy would not serve as a defense to an immediate jeopardy finding. The guidance further explains that even in situations where there is no longer a threat of immediate harm, hospitals may be cited for immediate jeopardy if the survey team determines noncompliance continues to create a likelihood of serious harm to other patients.</p><h3>Process for Determining Immediate Jeopardy</h3><p>When a surveyor identifies a situation in which immediate jeopardy could be warranted, the survey team will gather evidence of noncompliance through observation, interviews immediate jeopardy, the survey team must establish three elements:</p><ul><li>There was noncompliance on the part of the hospital.</li><li>The noncompliance caused or created a likelihood of serious injury, serious harm, serious impairment or death to one or more patients, which occurred or may reoccur.</li><li>Immediate action is required to prevent the occurrence or reoccurrence of serious injury, serious harm, serious impairment or death to one or more patients in the hospital’s care.</li></ul><p>All three elements must be established and supported by evidence. The type of harm may be physical, mental or psychosocial and must be documented by surveyors using a new template provided in the updated guidance. In documenting noncompliance, the guidance clearly states that each element must have its own supporting evidence, and surveyors are not permitted to reuse the same justification to support multiple elements or instances of noncompliance. The guidance also notes that a finding of noncompliance in one area does not necessarily mean noncompliance exists in other areas.</p><p>Once all three elements have been established, the survey team must contact the state agency (and/or regional office, as applicable) to review the team’s findings. If the state agency agrees with the team’s findings, the survey team must immediately notify the hospital administrator that the hospital has been placed in immediate jeopardy status and provide the hospital with a copy of the completed template.</p><h3>Removing Immediate Jeopardy Status</h3><p>Upon notification of the finding of immediate jeopardy, the hospital is responsible for developing a Removal Plan to address immediately the ongoing or future threats to patients and submitting this plan to the state agency for review. The Removal Plan must include the following information:</p><ul><li>Identification of the patient(s) who have, or are likely to have, suffered as a result of the noncompliance.</li><li>A clear description of the immediate action(s) the hospital will take to address the noncompliance, including the date by which the hospital expects all such action(s) will be fully implemented and the harm, or likelihood of harm, will no longer exist.</li><li>A detailed account of how the hospital will keep patients safe and free from future risks, including specific action(s) the hospital will take to alter any processes or system failures to prevent a serious adverse event from occurring or reoccurring.</li><li>In the case of harm that cannot be remedied, such as the death of a patient, a plan for how additional serious harm will be prevented.</li></ul><p>Once the Removal Plan has been approved by the state agency and fully implemented, CMS requires surveyors to perform on-site verification before the hospital’s immediate jeopardy status may be removed. Surveyors must determine that all elements of the Removal Plan were, in fact, carried out and were effective and that the immediate (or future) threat of serious harm is no longer present. This verification can — but does not have to — take place before the conclusion of the survey that precipitated an immediate jeopardy finding.</p><p>CMS notes that the official removal date is the date on which all elements of the Removal Plan were fully implemented and the immediate threat no longer exists, as confirmed by the on-site survey team. This date may not be the same as the date a hospital includes on its Removal Plan or the date on which the survey team revisited the hospital. Removal of immediate jeopardy status does not mean that all instances of noncompliance have been addressed; it simply means that the hospital is no longer in immediate jeopardy status and is not subject to termination from the Medicare program.</p><h2>FURTHER QUESTIONS</h2><p>If you have further questions, please contact Adrienne Thomas, AHA’s senior associate director for standards and care delivery, at <a href="mailto:athomas@aha.org">athomas@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2024/12/cms-issues-updated-guidance-on-immediate-jeopardy-regulatory-advisory-12-16-2024.pdf"><img src="/sites/default/files/inline-images/cover-cms-issues-updated-guidance-on-immediate-jeopardy-regulatory-advisory-12-16-2024.png" data-entity-uuid="e7884161-2b2b-4b41-bedd-88ed001bdc64" data-entity-type="file" alt="Cover Image CMS Issues Updated Guidance on Immediate Jeopardy" width="679" height="878"></a></div></div></div> Mon, 16 Dec 2024 13:45:26 -0600 Compliance /lettercomment/2023-08-01-ftc-urged-extend-comment-period-draft-merger-guidelines <p>August 1, 2023 </p> <p>April Tabor <br /> Secretary <br /> Federal Trade Commission <br /> 600 Pennsylvania Avenue NW Suite CC-5610 (Annex C) <br /> Washington, DC 20580 </p> <p><strong>Re: Request for Extension on Comments for Draft Merger Guidelines (FTC-2023-0043) </strong></p> <p>Dear Ms. Tabor: </p> <p>The undersigned organizations request that the Federal Trade Commission and the Department of Justice extend the comment period for the Draft Merger Guidelines for a minimum of an additional 60 days. Collectively our associations represent a wide range of members that report transactions that undergo merger review. </p> <p>An extension would serve the interests of both the public and the agencies by allowing adequate time for more fulsome responses to the proposed revisions to the merger guidelines, which are designed to reshape U.S. merger policy and capital markets. A typical year sees more than 2,000 mergers, whose aggregate value approaches $3 trillion. The draft merger guidelines have the potential to impact all of these transactions. </p> <p>As evidence of the importance and complexity of these issues, the agencies themselves took around fifteen months to complete the draft merger guidelines after the close of the previous comment period in March 2022. The length of time it has taken the agencies to produce this draft demonstrates that any urgency to the issue is outweighed by the importance of careful consideration of these complex issues. Further, the agencies have also proposed sweeping revisions to the HSR Rule, with a comment period that significantly overlaps the comment period to respond to the draft merger guidelines. </p> <p>The agencies are best served if they receive quality feedback. To allow sufficient time for detailed comments, we ask that you grant an extension of at least 60 days. </p> <p>Thank you for your consideration of this matter.</p> <p>Sincerely,</p> <p>American Coatings Association<br /> ���������� Association<br /> American Investment Council<br /> Alternative Investment Management Association<br /> Biotechnology Innovation Organization (BIO)<br /> Business Roundtable<br /> Consumer Technology Association (CTA)<br /> Consumer Brands Association<br /> Computer & Communications Industry Association<br /> Engine<br /> Federation of ����������s<br /> Information Technology Industry Council (ITI)<br /> NACS I Advancing Convenience & Fuel Retailing<br /> National Association of Manufacturers<br /> Metals Service Center Institute<br /> Pharmaceutical Research and Manufacturers of America (PhRMA)<br /> Retail Industry Leaders Association<br /> Software & Information Industry Association (SIIA)<br /> TechNet<br /> US Chamber of Commerce</p> Tue, 01 Aug 2023 13:42:53 -0500 Compliance /lettercomment/2023-07-17-aha-expresses-concern-lack-clear-and-actionable-guidance-environmental-risk-mitigation <p>July 17, 2023</p><p>April Tabor<br>Secretary<br>Federal Trade Commission<br>600 Pennsylvania Avenue NW Suite CC-5610 (Annex C)<br>Washington, DC 20580</p><p><strong>Re: Request for Extension on Proposed Rulemaking for the HSR Filing Process (Matter No. P239300) </strong></p><p>Dear Ms. Tabor:</p><p>On behalf of our members, we request that the Federal Trade Commission and the Department of Justice extend the comment period to the above-referenced rulemaking (the "Proposal") for an additional 60 days. Collectively, our associations represent a wide range of members that routinely evaluate and file HSR-reportable transactions as prospective purchasers, sellers, investors, or facilitators.</p><p>An extension would serve the interests of both the public and the agencies by allowing adequate time for more fulsome responses on a proposal that could reshape U.S. merger policy, business activity, and capital markets. A typical year sees more than 2,000 mergers whose aggregate transaction value approaches $3 trillion. The Proposal acknowledges that the new forms would almost quadruple average preparation time in each instance, imposing costs that "would be significant and impose additional burden on some filing parties." In its 133 pages, the Proposal solicits feedback on numerous specific ideas that touch upon complex questions of markets, labor, capital, regulatory costs, and attorney-client privilege. Every question could, by itself, easily produce a highly substantive and lengthy response.</p><p>The agencies are best served if the Proposal receives quality feedback. To allow sufficient time for detailed comments, we ask that you grant an extension.</p><p>Thank you for your consideration of this matter.</p><p>Sincerely,</p><p>American Coatings Association<br>���������� Association<br>American Hotel & Lodging Association<br>American Investment Council<br>Alternative Investment Management Association<br>Biotechnology Innovation Organization (BIO)<br>Business Roundtable<br>Consumer Brands Association<br>Consumer Technology Association (CTA)<br>Engine<br>Federation of ����������s<br>ITI — Information Technology Industry Council<br>Managed Funds Association<br>Metals Service Center Institute<br>NACS | Advancing Convenience & Fuel Retailing<br>Pharmaceutical Research and Manufacturers of America (PhRMA)<br>Retail Industry Leaders Assocation<br>Securities Industry and Financial Markets Association<br>SIFM Asset Management Group<br>Software & Informaiton Industry Association (SIIA)<br>TechNet<br>US Chamber of Commerce</p> Mon, 17 Jul 2023 14:52:51 -0500 Compliance <p>The Department of Justice in February abruptly withdrew three policy statements on health care antitrust enforcement. The policies, which are familiar to many hospital and health system executives and lawyers, include:</p> <ul> <li>a 1993 statement describing circumstances under which DOJ and the Federal Trade Commission would not challenge certain hospital mergers and health care joint ventures</li> <li>a 1996 statement on health care provider networks; and</li> <li>a 2011 statement regarding accountable care organizations participating in the Medicare Shared Savings Program.</li> </ul> <h2>AHA TAKE</h2> <p>It is unfortunate that DOJ chose to add to the challenging environment hospitals and health systems are experiencing by withdrawing all of the policy statements without notice to or consultation with the health care field. Moreover, the FTC has not followed DOJ in withdrawing the policy statements, which adds to the confusion. While DOJ’s withdrawal does not change the law itself, to the extent it signals DOJ’s enforcement intentions, those new intentions should be clearly shared with providers.</p> <p><strong>The AHA has developed a <a href="/white-papers/2023-04-05-dojs-surprise-withdrawal-health-care-antitrust-policy-statements" target="_blank">new white paper</a> containing background on the policy statements and why they are important; DOJ’s stated reasons for withdrawing the policy statements; and other information about the withdrawal’s potential impact.</strong></p> <h2>WHAT YOU CAN DO</h2> <ul> <li>Please review the white paper and share it with your executive, legal and compliance teams, as well as your board.</li> <li>Watch for additional updates from the AHA.</li> </ul> <h2>FURTHER QUESTIONS</h2> <p>If you have further questions, please contact Mindy Hatton, AHA’s general counsel and secretary, at <a href="mailto:mailto:mhatton@aha.org">mhatton@aha.org</a> or Chad Golder, AHA’s deputy general counsel, at <a href="mailto:cgolder@aha.org.">cgolder@aha.org</a>.</p> Wed, 05 Apr 2023 13:07:28 -0500 Compliance <div class="container"> <div class="row"> <div class="col-md-8"> <p>The AHA today <a href="/lettercomment/2022-11-04-aha-comments-national-labor-relations-boards-notice-proposed-rulemaking-regarding-standard-determining" target="_blank">urged</a> the National Labor Relations Board to withdraw a notice of proposed rulemaking regarding the standard for determining joint-employer status or, consistent with the board’s historical approach, exempt hospitals from compliance.</p> <p>“Critically, the National Labor Relations Board (NLRB) failed to properly investigate the particular economic and practical effects the proposed rule would have on hospitals and health systems,” AHA wrote. “Had it done so, it would have quickly become clear that the proposed rule would adversely impact an already over-burdened hospital field and create a collective bargaining quagmire that will harm hospitals, their patients, their employees, and the communities they serve. The NLRB’s failure to conduct this hospital-specific analysis requires withdrawal of the proposed rule for noncompliance with the Administrative Procedure Act. At a minimum, the NLRB must, consistent with decades of policy and practice, exempt hospitals from any final rule. Failure to do so risks compromising the hospital field and its very purpose: patient care.”</p> <p>A team of outside counsel from Littler Mendelson’s Workplace Policy Institute, led by Michael Lotito, Jim Paretti and Gregory Brown, assisted the AHA in preparing its comment letter.</p> <div class="panel module-typeC"> <div class="panel-body"> <h3><span>Key Highlights</span></h3> <p>Among other topics, the letter says the proposed rule:</p> <ul> <li>Exacerbates the significant financial challenges hospitals are currently facing;</li> <li>Fails to account for how it will impact federal health care regulations, such as the market basket;</li> <li>Runs contrary to NLRB’s historical treatment of hospitals and congressional intent;</li> <li>Would create chaos for hospitals and is inimical to collective bargaining.</li> </ul> </div> </div> <h2>WHAT YOU CAN DO</h2> <ul> <li>Review AHA’s comments on the proposed rule.</li> <li>Share them with your leadership team and legal counsel.</li> <li>Should you decide to submit comments on the rule, they are due Dec. 7.</li> </ul> <h2>FURTHER QUESTIONS</h2> <p>If you have further questions, please contact Mindy Hatton, AHA’s general counsel and secretary, at <a href="mailto:mailto:mhatton@aha.org">mhatton@aha.org</a> or Chad Golder, AHA’s deputy general counsel, at <a href="mailto:mailto:cgolder@aha.org">cgolder@aha.org</a>.</p> </div> </div> </div> Fri, 04 Nov 2022 14:20:24 -0500 Compliance /lettercomment/2022-09-26-hhs-asked-postpone-information-blocking-compliance-deadline <p>September 26, 2022</p> <p>The Honorable Xavier Becerra<br /> Secretary<br /> U.S. Department of Health and Human Services<br /> 200 Independence Avenue, SW<br /> Washington, DC, 20201</p> <p>Dear Secretary Becerra:</p> <p>The undersigned organizations represent a broad range of providers and clinicians from across the healthcare continuum. We appreciate the Department of Health and Human Services’ (HHS’) ongoing efforts to advance health data exchange and interoperability while advancing health equity for all.</p> <p>Pursuant to provisions contained in the 21st Century Cures Act (Cures Act) healthcare providers, health IT developers, health information exchanges (HIEs), and health information networks (HINs) are prohibited from engaging in “information blocking” practices. Beginning October 6th these actors must be able to share all electronic protected health information (ePHI) in a designated record set, as defined under the Health Insurance Portability & Accountability Act (HIPAA). Prior to this data sharing mandates are limited to what is contained in the USCDI.</p> <p>Our members have been working diligently towards meeting the upcoming – and rapidly approaching – October 6th information blocking deadline with the expanded electronic health information (EHI) definition. They are making every feasible effort, many with scarce resources, to ensure that they are prepared to be in compliance – from both a vendor readiness standpoint, as well as from a comprehension standpoint. The below organizations and their members understand and strongly support patients’ need to access their information in a digital format. Despite our best efforts to educate our members, significant knowledge gaps and confusion still exist within the provider and vendors communities with respect to implementation and enforcement of information blocking regulations.</p> <p>Based upon feedback from our members that continues to build, it is evident that both healthcare providers, clinicians and vendors are not fully prepared for the October 6th deadline. Therefore, we are respectfully requesting that HHS consider both postponing for a period of one-year the information blocking compliance deadlines – including October 6th, as well using corrective action warning communications to providers/clinicians prior to imposing any monetary disincentives or beginning a formal investigation.</p> <p>View the detailed letter below. </p> Mon, 26 Sep 2022 14:58:12 -0500 Compliance /news/headline/2022-09-26-hhs-asked-postpone-information-blocking-compliance-deadline <p>A coalition of organizations, including the AHA, today urged the Department of Health and Human Services to consider postponing for one year the Oct. 6 deadline for health care providers to begin sharing all electronic protected health information in a designated record set, as defined under HIPAA, to ensure they understand the requirements and have the technology to support them. HHS currently requires sharing only United States Core Data for Interoperability, but its final rule implementing 21st Century Cures Act provisions to prevent information blocking expanded the data sharing mandate. While the organizations are committed to facilitating patient access to their records, they said there remains no clear definition of electronic health information or technical infrastructure to support its secure exchange.</p> <p>“Based upon feedback from our members that continues to build, it is evident that both healthcare providers, clinicians and vendors are not fully prepared for the October 6th deadline,” the coalition <a href="https://aha.org/lettercomment/2022-09-26-hhs-asked-postpone-information-blocking-compliance-deadline" target="_blank">wrote</a>. “Therefore, we are respectfully requesting that HHS consider both postponing for a period of one-year the information blocking compliance deadlines – including October 6th, as well using corrective action warning communications to providers/clinicians prior to imposing any monetary disincentives or beginning a formal investigation.”</p> Mon, 26 Sep 2022 14:52:30 -0500 Compliance /news/headline/2022-08-23-aha-cms-proposed-rule-risks-weakening-clias-high-regulatory-standards <p>The AHA, in a <a href="/lettercomment/2022-08-23-aha-cms-proposed-rule-risks-weakening-clias-high-regulatory-standards" target="_blank">letter</a> today to the Centers for Medicare & Medicaid Services, cautioned against softening standards designed to maintain the safety and quality of laboratory testing in the U.S., including those regulating the professionals who staff the nation’s Clinical Laboratory Improvement Amendments-certified labs. CMS in July proposed adding nursing degrees as a means for qualifying to become high-complexity testing personnel. “We are concerned that this would weaken CLIA’s regulatory structure and its ability to continue to ensure the highest quality of laboratory testing,” AHA wrote. </p> <p>AHA did express support for a separate CMS proposal that would make permanent COVID-19-era waivers that expanded the agency’s ability to deploy alternative sanctions for non-compliance in certificate of waiver laboratories; such flexibility is already provided for CLIA-certified labs, but not for certificate of waiver labs. </p> Tue, 23 Aug 2022 15:14:39 -0500 Compliance /news/headline/2022-06-09-cms-announces-first-penalties-under-hospital-price-transparency-rule <p>The Centers for Medicare & Medicaid Services yesterday announced the first civil monetary penalties under its hospital price transparency rule, fining two hospitals for alleged failure to make public their list of standard charges. </p> <p>The rule took effect Jan. 1, 2021. It requires hospitals to disclose the rates they privately negotiate with health plans, as well as their self-pay and charge master rates, and provide an online patient cost estimator tool or negotiated rate information for at least 300 “shoppable” services, or face penalties ranging from $300 to $5,500 per day, depending on the hospital’s size. <br />  </p> Thu, 09 Jun 2022 14:06:53 -0500 Compliance /news/headline/2022-03-08-osha-assessing-covid-19-readiness-certain-hospitals-skilled-nursing <p>The Occupational Safety and Health Administration will conduct focused inspections through June 9 to assess compliance and readiness at certain hospitals and skilled nursing facilities that treat or handle COVID-19 patients, the agency <a href="https://www.osha.gov/news/newsreleases/trade/03072022-0">announced</a> yesterday. The <a href="https://www.osha.gov/laws-regs/standardinterpretations/2022-03-02">initiative</a> will supplement OSHA enforcement under the COVID-19 National Emphasis Program by focusing on previously inspected or investigated facilities, the agency said. </p> Tue, 08 Mar 2022 14:21:06 -0600 Compliance