/ en Mon, 28 Apr 2025 04:59:43 -0500 Thu, 10 Apr 25 15:26:14 -0500 /news/headline/2025-04-10-trump-administration-issues-executive-orders-reducing-anti-competitive-barriers-repealing-unlawful <p>The Trump administration yesterday released executive orders on reducing anti-competitive regulatory <a href="https://www.whitehouse.gov/presidential-actions/2025/04/reducing-anti-competitive-regulatory-barriers/" title="EO on barriers">barriers</a> and repealing certain <a href="https://www.whitehouse.gov/presidential-actions/2025/04/directing-the-repeal-of-unlawful-regulations/" title="EC on regs">regulations</a> deemed unlawful.  </p><p>  </p><p>The order on reducing anti-competitive barriers directs federal agencies to review all regulations subject to their rulemaking authority and identify those that create de facto or de jure monopolies, create barriers to entry for new market participants, create or facilitate licensure or accreditation requirements that unduly limit competition, or otherwise impose anti-competitive restraints or distortions in the market.   </p><p>  </p><p>The order on repealing unlawful regulations is linked to a Feb. 25 <a href="https://www.federalregister.gov/documents/2025/02/25/2025-03138/ensuring-lawful-governance-and-implementing-the-presidents-department-of-government-efficiency" title="Feb 5 EO">executive order</a> that directed agencies within 60 days to identify unlawful and potentially unlawful regulations to be repealed. The new order instructs agencies to take steps to immediately repeal regulations and provide justification within 30 days for any identified as unlawful but have not been targeted for repeal, explaining the basis for the decision not to repeal.</p> Thu, 10 Apr 2025 15:26:14 -0500 Regulatory Compliance /news/headline/2025-03-03-hhs-rescinds-long-standing-richardson-waiver-policy-public-participation <p>The Department of Health and Human Services Feb. 28 <a href="https://www.federalregister.gov/documents/2025/03/03/2025-03300/policy-on-adhering-to-the-text-of-the-administrative-procedure-act" target="_blank">announced</a> that it is rescinding its Nixon-era policy on inviting public participation when making rules and regulations related to public property, loans, grants, benefits or contracts.</p><p>“The extra-statutory obligations of the Richardson Waiver impose costs on the Department and the public, are contrary to the efficient operation of the Department, and impede the Department’s flexibility to adapt quickly to legal and policy mandates,” the notice said.</p><p>The department will now follow a notice-and-comment process only as required by the Administrative Procedure Act, which exempts rules related to public property, loans, grants, benefits or contracts from the law’s notice-and-comment requirements.</p> Mon, 03 Mar 2025 15:36:50 -0600 Regulatory Compliance /education-events/quality-safety-and-regulatory-requirements-practical-recommendations-hospital-board <h3><small>Speaker</small></h3><p><strong>Sue Ellen Wagner</strong>, VP Trustee Services, ���������� Association</p> Wed, 03 Jul 2024 08:56:18 -0500 Regulatory Compliance <div class="container"> <div class="row"> <div class="col-md-8"> <p>The Centers for Medicare & Medicaid Services (CMS) Nov. 15 issued a final rule requiring the disclosure of ownership, managerial and other information for skilled-nursing facilities (SNFs) and nursing facilities (NFs). The rule also finalizes definitions of certain types of ownership entities that will apply to all institutional providers, including hospitals.</p> <div class="panel module-typeC"> <div class="panel-heading"> <h2>Key Highlights</h2> <p>CMS’ final rule:</p> <ul> <li>Requires SNFs and NFs to report additional information in their CMS 855A Provider Enrollment Form disclosing ownership and additional disclosable parties.</li> <li>Adopts final definitions for private equity company (PEC), real estate investment trust (REIT), additional disclosable party, organizational structure and others.</li> <li>Clarifies that all providers and suppliers, including hospitals, will be required to disclose their ownership interests in compliance with these updated definitions when completing form 855A.</li> </ul> </div> </div> <h2>What You Can Do</h2> <ul> <li><strong>Share this advisory with your senior management team</strong> and your team responsible for completing the CMS Medicare Enrollment Form 855A.</li> </ul> <h2>Final Rule Changes</h2> <h3>Disclosures of Ownership and Additional Disclosable Parties for SNFs and Nursing Facilities</h3> <p>In this final rule, CMS implements portions of section 6101 of the Affordable Care Act (ACA), requiring the disclosure of certain ownership, managerial and other information regarding Medicare SNFs and NFs, including those that are hospital based. Specifically, the agency will require SNFs and NFs to report the following information:</p> <ul> <li>Each member of the facility’s governing body, including the name, title and period of service of each member.</li> <li>Each person or entity who is an officer, director, member, partner, trustee or managing employee of the facility, including the name, title and period of service of each such person or entity.</li> <li>Each person or entity who is an additional disclosable party of the facility.</li> <li>The organizational structure of each additional disclosable party of the facility and a description of the relationship of each such additional disclosable party to the facility and to one another.</li> </ul> <p>SNFs and NFs will be required to report this information when initially enrolling in Medicare or Medicaid, during changes of ownership and when revalidating their enrollment. Further, they will be required to disclose any changes to the information within the currently required timeframes.</p> <p>Also, since CMS and the states already collect some of the data required by section 6101 of the ACA, CMS finalizes its proposal that Medicare SNFs will not have to report this same information twice on the same CMS 855A Medicare enrollment application submission. States will have the discretion to adopt a similar policy. Further, the agency says that per its statutory mandate, it will make the reported information publicly available within one year of it being reported.</p> <p>In its proposed rule, CMS also set forth several definitions to guide providers in their reporting of various entities. These included definitions of PEC, REIT, additional disclosable party, organizational structure and several others. The agency finalizes its definition of PEC with one minor modification to include the language “direct or indirect” prior to the words “ownership share” to capture any interest more broadly in the SNF or NF. Further, it adopts a different definition of REIT than proposed. Specifically, rather than its proposed definition, CMS adopts the definition of REIT found in 26 U.S.C. §856, which is used by the Internal Revenue Service. CMS says this would be a narrower and more consistent definition than the one it had originally proposed. CMS finalizes all other definitions as proposed.</p> <h3>Medicare Provider and Supplier Disclosure of PECs and REITs</h3> <p>In the FY 2024 Inpatient Prospective Payment System (IPPS) proposed rule, CMS proposed to apply the same definitions of PEC and REIT that it included in the SNF and NF proposed rule (discussed above) to all providers and suppliers that complete the Medicare enrollment forms, not just SNFs. It did not address this proposal in the FY 2024 IPPS final rule. Instead, in this final rule, the agency finalizes the above definitions of PEC and REIT to apply to all institutional providers who complete form 855A. <strong>Therefore, all providers and suppliers, including hospitals, will be required to disclose their ownership interests in compliance with these updated definitions when completing form 855A.</strong> To that end, on Nov. 17, CMS <a href="https://www.cms.gov/medicare/cms-forms/cms-forms/downloads/cms855a.pdf" target="_blank">posted a revised form 855A</a> that collects this PEC and REIT data.</p> <h2>Further Questions</h2> <p>Please contact Roslyne Schulman, AHA’s director of policy, at <a cms disclosure finalizes href="mailto:rschulman@aha.org?subject=" of ownership regulatory rules snf>rschulman@aha.org</a> with any questions.</p> </div> <div class="col-md-4"> <p><a href="/system/files/media/file/2023/11/Regulatory-Advisory-CMS-Finalizes-SNF-Disclosure-of-Ownership-Rules-Applies-Definitions-to-Hospital-Enrollment.pdf" target="_blank" title="Click here to download the Regulatory Advisory: CMS Finalizes SNF Disclosure of Ownership Rules, Applies Definitions to Hospital Enrollment PDF."><img alt="Regulatory Advisory: CMS Finalizes SNF Disclosure of Ownership Rules, Applies Definitions to Hospital Enrollment page 1." data-entity-type="file" data-entity-uuid="ad9fe541-3115-49f4-8a67-a65a8628f016" src="/sites/default/files/inline-images/Page-1-Regulatory-Advisory-CMS-Finalizes-SNF-Disclosure-of-Ownership-Rules-Applies-Definitions-to-Hospital-Enrollment.png" width="695" height="900"></a></p> </div> </div> </div> Mon, 20 Nov 2023 15:15:47 -0600 Regulatory Compliance <div class="container"> <div class="row"> <div class="col-md-8"> <p>The Food and Drug Administration (FDA) on October 3 published a <a href="https://www.govinfo.gov/content/pkg/FR-2023-10-03/pdf/2023-21662.pdf" target="_blank">proposed rule</a> that would regulate laboratory developed tests (LDTs) as devices. Many hospitals and health care systems develop and use LDTs, particularly larger hospitals and academic medical centers (AMCs).</p> <p>LDTs are diagnostic tests that are not commercially distributed to other laboratories but, instead, are developed, validated and performed in-house by individual laboratories, including hospital laboratories. They range from routine tests such as blood counts to more complex molecular and genetic tests in cancer, heart disease, and rare and infectious diseases. LDTs provide timely patient access to accurate and high-quality testing for many conditions for which no commercial test exists or where an existing test does not meet current clinical needs. They also provide physicians with important clinical information to diagnose and treat patients and are critical in the practice of all areas of medicine. These tests are typically developed at the request of, and in close collaboration with, clinical caregivers.</p> <p>The FDA states that, to date, it has generally been exercising its enforcement discretion and has not enforced applicable FDA regulations with respect to LDTs. However, due to changes in the complexity and use of LDTs over time and the associated increased risks to patients, the FDA no longer believes enforcement discretion is appropriate.</p> <p>Therefore, the proposed rule would phase out, over four years, the FDA’s general enforcement discretion approach for most LDTs. Once the enforcement discretion approach is fully phased out, the agency would require all in-vitro diagnostic product (IVD) manufacturers, including those that make LDTs, to meet applicable device requirements, except where meeting certain requirements under the Clinical Laboratory Improvement Amendments (CLIA) regulations can be leveraged.<sup><a href="#fn1">1</a></sup></p> <p>The rule also seeks comments on alternative enforcement approaches for some LDTs, including for AMC laboratories. It also seeks comment on continuing the current general enforcement discretion approach with respect to premarket review and quality system (QS) requirements for some or all currently marketed LDTs and a longer phase-out period for small laboratories.</p> <p>The FDA will accept comments on the proposed rule through December 4.</p> <h2>AHA Take</h2> <p>LDTs provide great value to caregivers and patients. As such, any regulatory framework must establish a pathway tailored to the dynamic nature of LDTs by ensuring that the technological and clinical innovation that is essential to their development remains unrestricted, their quality and reliability is maintained at the highest levels possible, and existing and future LDTs continue to be widely accessible to patients. However, the FDA’s proposed rule, while well intentioned, would inappropriately impose regulations meant for medical devices on LDTs, a regulatory framework which we believe is incompatible with laboratory operations. It would cause confusion and delays and ultimately prevent hospital and health care system laboratories from continuing to develop cutting-edge LDTs in response to immediate clinical care needs. Rather than finalizing this proposed rule, the AHA strongly urges the FDA to work with Congress to enact an updated version of the Verifying Accurate Leading-Edge IVCT Development (VALID) Act. This legislation would establish a diagnostic-specific, risk-based framework that recognizes the essential role of clinical laboratories in preserving and fostering innovation and maintaining access to critical testing services that physicians and patients rely on every day.</p> <h2>What You Can Do</h2> <ul> <li><strong>Share this advisory with your senior management team, clinical leadership team and clinical laboratory leadership.</strong> Ask them to examine the impact of the proposed rule on your laboratory operations, particularly as it relates to any LDTs your hospital or health system has developed and uses in clinical care.</li> <li><strong>Submit comments to FDA with your specific concerns by December 4 at <a href="http://www.regulations.gov/" target="_blank">www.regulations.gov</a>.</strong></li> </ul> <h2>Summary of Key Highlights</h2> <h3>Proposed Enforcement Policy</h3> <p>The FDA proposes to gradually phase out through five key stages the agency’s general enforcement discretion approach to regulating LDTs. As a result, following the phase-out period, LDTs generally would be expected to meet all the applicable FDA device regulations. The agency notes that, regardless of the phase-out timeline and continued enforcement discretion approach, it would retain the discretion to pursue enforcement action at any time against LDTs when deemed appropriate.</p> <p>The table below describes each of the phase-out stages in further detail. For each stage, the FDA proposes a period for laboratories to come into compliance with the described device rules. The agency encourages laboratory manufacturers to work toward compliance with requirements sooner rather than wait until the end of the specified timeframes.</p> table, th, td { border: 1px solid; } table { margin-top: 20px; margin-bottom: 20px; } <table> <tbody> <tr> <th>Stage</th> <th>Deadline for Compliance</th> <th>FDA Device Requirements</th> </tr> <tr> <td>1</td> <td>1 year after final rule issued</td> <td> <ul> <li>Medical device reporting (MDR) requirements</li> <li>Correction and removal reporting requirements</li> </ul> </td> </tr> <tr> <td>2</td> <td>2 years after final rule issued</td> <td> <p>All of Stage 1 requirements and:</p> <ul> <li>Registration and listing requirements,</li> <li>Labeling requirements, and</li> <li>Investigational use requirements</li> </ul> </td> </tr> <tr> <td>3</td> <td>3 years after final rule issued</td> <td> <p>All of Stage 1 and 2 requirements and:</p> <ul> <li>Device Current Good Manufacturing Policies (CGMP) in the quality systems (QS) requirements including: <ul> <li>manufacturing activities,<sup><a href="#fn2">2</a></sup></li> <li>design controls,</li> <li>purchasing controls (including supplier controls),</li> <li>acceptance activities (receiving, in-process, and finished device acceptance),</li> <li>corrective and preventative actions, and</li> <li>records requirements</li> </ul> </li> </ul> </td> </tr> <tr> <td>4</td> <td>3 ½ years after final rule issued but not before Oct. 1, 2027</td> <td> <p>All of Stage 1 through 3 requirements and:</p> <ul> <li>Premarket review requirements for high-risk IVDs offered as LDTs (i.e., those IVDs that may be eligible for classification into class III)<sup><a href="#fn3">3</a></sup></li> </ul> </td> </tr> <tr> <td>5</td> <td>4 years after final rule issued but not before April 1, 2028</td> <td> <p>All of Stage 1 through 4 requirements and:</p> <ul> <li>Premarket review requirements for moderate risk IVDs offered as LDTS (IVDs that may be eligible for classification into class II) and low risk IVDs offered as LDTs (IVDs that may be eligible for classification into class I)</li> </ul> </td> </tr> </tbody> </table> <p>The FDA also intends to consider providing more targeted guidance, including making additional resources available on specific topics, such as compliance with applicable labeling requirements. In addition, it notes that it has adopted, and intends to continue adopting, enforcement discretion policies for certain types of IVDs in certain circumstances. For example, the FDA issued guidance documents with enforcement discretion policies for certain COVID-19 and Mpox tests at the beginning of each declared emergency. The FDA seeks comments on whether specific enforcement discretion policies would be appropriate for other public health scenarios.</p> <h3>Scope</h3> <p>The FDA also proposes to broaden its proposed phase-out policy to apply to certain IVDs that do not strictly meet the FDA’s definition of LDTs. Specifically, it would apply the above policy to IVDs that are manufactured and offered as LDTs by laboratories that are certified under CLIA and that meet the regulatory requirements under CLIA to perform high complexity testing, <em>even if those IVDs do not fall within the FDA’s traditional understanding of an LDT because they are not designed, manufactured and used within a single laboratory.</em> Throughout the proposed rule, it refers to these IVDs as ‘‘IVDs offered as LDTs,’’ and under the rule, they would be regulated as devices after the phase-out period is complete. The FDA is proposing such a broadened phase-out approach to avoid undue disruption to the testing market.</p> <p>Although the FDA proposes this broader scope, it does not intend to include certain tests that were excluded from the general enforcement discretion approach due to their compliance patterns, multiple public FDA actions and communications, or both. These include blood donor screening or human cells, tissues, and cellular and tissue-based products donor screening tests required for infectious disease testing. They also include tests for the determination of blood group and Rh factors; tests for emergencies, potential emergencies or declared material threats under section 564 of the FD&C Act; and direct-to-consumer tests.<sup><a href="#fn4">4</a></sup> For these categories of tests, the FDA has generally expected applicable requirements to be met and does not propose to change that approach.</p> <p>In addition, the FDA notes that in past proposals for regulating LDTs as devices, it had indicated support for less oversight of other categories of LDTs, such as low-risk tests (class I devices), tests currently on the market and tests for rare diseases. However, the agency has collected information in the intervening years that has convinced it that these categories should be treated similarly to other FDA-regulated tests. For example, it has found high variability in the performance of some LDTs currently on the market. The agency believes that requiring compliance with its device regulations for such tests would help assure that they work as intended and enable keeping track of these tests, among other benefits. Therefore, its proposal would include these categories of LDTs in its phase-out approach.</p> <p>Finally, for certain other categories of tests, the FDA proposes to continue to apply its current general enforcement discretion approach going forward. These include:</p> <ul> <li><strong>“1976-Type LDTs”.</strong> These tests use manual techniques (without automation) performed by laboratory personnel with specialized expertise, components legally marketed for clinical use and are designed, manufactured and used within a single CLIA-certified laboratory that meets the requirements under CLIA for high complexity testing. These tests might include, for example, immunohistochemistry tests that involve no automated preparation or interpretation.</li> <li><strong>Certain Human Leukocyte Antigen (HLA) Tests.</strong> Such tests are designed, manufactured and used in a single laboratory certified under CLIA that meets the requirements to perform high-complexity histocompatibility testing when used in connection with organ, stem cell and tissue transplantation for HLA allele typing, HLA antibody screening and monitoring, or conducting real and “virtual” HLA crossmatch tests. The FDA has determined that these tests are unique in that they are generally developed and performed in urgent, life-saving situations for the patient and the tests are often individualized within each medical facility. It notes that the general enforcement discretion approach would not apply to HLA tests used for blood transfusion, as such tests are highly standardized across institutions, and it intends to continue to enforce applicable requirements for these HLA tests.</li> <li><strong>Tests Intended Solely for Forensic (Law Enforcement) Purposes.</strong> The FDA’s enforcement discretion for these tests has been in place for over 20 years and applies to such tests regardless of whether they are offered as LDTs. Tests used in the law enforcement setting are subject to protections and requirements associated with the judicial process that mitigate risk related to test accuracy and sample collection and that generally are not available in the home, workplace, insurance and sports settings.</li> <li><strong>Tests Used Exclusively for Public Health Surveillance.</strong> These tests are distinct from other tests because they are intended solely for use on systematically collected samples for analysis and interpretation of health data in connection with disease prevention and control, and test results are not reported to patients or their health care providers.</li> </ul> <h3>Request for Comments on Alternative Approaches</h3> <h4>“Grandfathering” Currently Marketed LDTs</h4> <p>For stakeholders who support continuing the current general enforcement discretion approach for premarket review and some or all QS requirements for currently marketed LDTs, the FDA requests that commenters provide the public health rationale for doing so. This includes if commenters are requesting general enforcement discretion for only a subset of LDTs (e.g., low and moderate risk LDTs) currently on the market.</p> <h4>Small Laboratories</h4> <p>The FDA recognizes that the phase out of the general enforcement discretion approach may have a relatively greater impact on small laboratories. Therefore, it seeks comment on whether there is a public health rationale to have a longer phase-out period for LDTs offered by laboratories with annual receipts below a certain threshold (e.g., $150,000). If so, it requests relevant data and alternative recommended timelines.</p> <h4>AMCs</h4> <p>Similarly, some AMCs have requested that their LDTs be exempted from certain device regulations. They assert that their laboratories operate under unique circumstances (such as being integrated into direct patient care) and their tests should be treated differently than tests manufactured by other laboratories. In the proposed rule, the agency notes that there is no established definition of an AMC laboratory but suggests that AMC laboratories may be described as:</p> <ul> <li>Having a certificate in effect under CLIA and that meet the requirements under CLIA to perform high-complexity tests;</li> <li>Being part of an accredited public or nonprofit private AMC that has a medical residency training program or fellowship program related to test development, application and interpretation; and</li> <li>Being integrated into the direct medical care for a patient, including specimen collection, testing, interaction with the treating provider and, as appropriate, patient treatment based on the test, all at the same physical location.</li> </ul> <p>The FDA seeks comments on the following.</p> <ul> <li>What are the characteristics of AMC laboratories? Do the characteristics included above accurately describe AMC laboratories and in fact distinguish them from other laboratories?</li> <li>Should the FDA continue the general enforcement discretion approach with respect to any requirements, such as premarket review requirements, for tests manufactured by AMC laboratories? If the FDA should continue the general enforcement discretion approach, are there any additional considerations that should be considered, such as whether an FDA cleared or approved test is available for the same intended use as the test manufactured by an AMC laboratory?</li> <li>If the FDA adopts a different policy for AMC laboratories, what would be the public health rationale? For example, if integration of an AMC laboratory into direct patient care is included as a basis for a different policy, the agency requests including a public health rationale when explaining why and how such integration supports the different policy, and how integration could ensure that there is a reasonable assurance of safety and effectiveness.</li> <li>If the FDA should have a different policy for AMC laboratories, is there evidence to support such a policy?</li> </ul> <h4>Leveraging Established Laboratory Evaluation Programs</h4> <p>The FDA also is interested in and seeks comment on leveraging programs such as the New York State Department of Health Clinical Laboratory Evaluation Program or those within the Veterans Health Administration, as appropriate. The agency requests comment on whether it may be appropriate to continue the general enforcement discretion approach, such that it generally would not enforce any applicable device requirements, where outside programs can be leveraged. If the FDA should continue to exercise enforcement discretion under these circumstances, it asks the following.</p> <ul> <li>What specific characteristics of and activities within these programs justify such an approach?</li> <li>Should the scope of such a policy be more limited for each program in question? For example, should the FDA continue enforcement discretion for premarket review requirements and intend to enforce other requirements, such as reporting adverse events?</li> <li>Are there any additional considerations that should be brought to the FDA’s attention?</li> </ul> <h2>Next Steps</h2> <p>The AHA urges hospitals and health systems to submit comments to FDA on this proposed rule. Comments are due by Dec. 4, and may be submitted electronically at www.regulations.gov. Follow the instructions for “Comment or Submission” and enter the Docket No. FDA–2023–N–2177 for “Medical Devices; Laboratory Developed Tests.”</p> <h2>Further Questions</h2> <p>Please contact Roslyne Schulman, AHA’s director of policy, at <a href="mailto:rschulman@aha.org?subject=RE: FDA Proposes to Regulate Laboratory Developed Tests as Medical Devices Regulatory Advisory">rschulman@aha.org</a> if you have further questions.</p> <hr> <ol> <li id="fn1">IVDs are diagnostic test systems that are performed on samples taken from the human body for the purpose of detecting diseases or other conditions, monitoring a person’s overall health, identifying patients who are likely to benefit from specific therapies, or otherwise helping to diagnose, cure, mitigate, treat or prevent disease. Some IVDs are manufactured by conventional manufacturers for use by other entities such as laboratories or health care providers. Other IVDs are manufactured by laboratories for use by the same or other laboratories. These types of IVDs include LDTs.</li> <li id="fn2">For laboratories that are CLIA-certified to perform high complexity testing, and for which the LDT is developed and used only within a single laboratory, compliance with the CLIA requirements for laboratory operations could substitute for compliance with the FDA’s QS requirements for manufacturing activities.</li> <li id="fn3">The Federal Food, Drug and Cosmetic (FD&C) Act includes a comprehensive system for the regulation of devices that are intended for human use. It establishes three categories (referred to as “classes”) of devices depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval). The number and complexity of controls are cumulative from class I to class III.</li> <li id="fn4">Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device or biological product intended for use in an actual or potential emergency when the Secretary of the Department of Health and Human Services has declared that circumstances exist justifying the authorization of emergency use.</li> </ol> </div> <div class="col-md-4"> <p><a href="/system/files/media/file/2023/10/FDA-Proposes-to-Regulate-Laboratory-Developed-Tests-as-Medical-Devices.pdf" target="_blank" title="Click here to download the Regulatory Advisory: FDA Proposes to Regulate Laboratory Developed Tests as Medical Devices PDF."><img alt="Regulatory Advisory: FDA Proposes to Regulate Laboratory Developed Tests as Medical Devices page 1." data-entity-type="file" data-entity-uuid="3e0964bd-0c44-40a6-b1de-b305aaf395e1" src="/sites/default/files/inline-images/Page-1-FDA-Proposes-to-Regulate-Laboratory-Developed-Tests-as-Medical-Devices.png" width="695" height="900"></a></p> </div> </div> </div> Mon, 09 Oct 2023 08:54:49 -0500 Regulatory Compliance <div class="container"> <div class="row"> <div class="col-md-8"> <p>The Environmental Protection Agency (EPA) on April 11 <a href="https://www.epa.gov/newsreleases/epa-proposes-new-standards-protect-public-health-reduce-exposure-ethylene-oxide" target="_blank">proposed new standards</a> for commercial sterilization facilities and certain health care organizations that use ethylene oxide (EtO). This Special Bulletin reviews the highlights of these proposals and provides additional background and insight on the issue and potential impact for hospitals and health systems.</p> <div class="panel module-typeC"> <div class="panel-heading"> <h3 class="panel-title">Key Highlights</h3> </div> <div class="panel-body"> <p>The proposals would:</p> <ul> <li>Establish new mitigation requirements focused on protecting and keeping safe individuals working in an EtO setting.</li> <li>Require health care facilities that use EtO sterilization devices to implement certain engineering controls to reduce worker exposure.</li> <li>Require EPA to work with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) to ensure that the new standards do not negatively impact the medical device supply chain.</li> </ul> <p>The EPA estimates these proposals would lead to an 80% reduction in EtO emissions from commercial sterilizers.</p> </div> </div> <h2>AHA Take</h2> <p>Providing high-quality patient care, and protecting, strengthening and advancing the health of communities, are top priorities for America's hospitals and health systems. Medical devices are essential in providing many types of services to patients, and effective sterilization significantly mitigates the risk of infections. As the EPA takes steps to update important environmental controls and reduce the levels of EtO in the medical device sterilization process, we are encouraged by the agency’s ongoing collaboration with the FDA, CDC and the Occupational Health and Safety Administration. Working together, we hope that each of these agencies will contribute valuable insight and expertise that is focused on ensuring the new requirements protect workers and local communities while not disrupting an already fragile medical supply chain.</p> <p>Moving forward, the AHA remains committed to supporting short-term and long-term solutions that allow for the safe and effective sterilization of vital medical equipment. In the short term, this means achieving the lowest possible level of emission of EtO while still sterilizing essential medical equipment. Longer term, this will require additional options for effective sterilization of equipment and strategies for reducing and ultimately eliminating harmful emissions, as well as the development of new devices that can be sterilized in different, less risky ways.</p> <h2>What You Can Do</h2> <ul> <li>Share this information with your leadership team and supply chain professionals.</li> <li>Confirm whether or not your organization uses EtO in any in-house sterilization process.</li> <li>Reach out to the AHA with any questions, including regarding engagement on this issue.</li> </ul> <h2>Proposed Ethylene Oxide Standards</h2> <h3>Background</h3> <h4>What is Ethylene Oxide?</h4> <p>EtO is a flammable, colorless gas that is used in a variety of ways, including the sterilization of medical supplies that cannot be effectively sterilized using other methods, like steam. EtO currently is used to sterilize about 50% of the medical devices used in the U.S., which equates to approximately 20 billion devices annually. These devices include essential equipment for care delivery, like various types of tubing, heart valves, surgical kits, pacemakers, syringes and catheters. While some hospitals still use EtO in a limited capacity, most have adopted other methods of in-house sterilization, meaning the bulk of EtO-based sterilization of medical supplies is performed by the 86 commercial sterilization facilities across the country.</p> <h4>What is EPA’s Role in Regulating Medical Supplies?</h4> <p>The EPA is charged with protecting the health and safety of the public by appropriately regulating the public’s exposure to toxic chemicals. In this instance, the EPA is focused on reducing the exposure to potential harmful levels of EtO emissions found in the air in communities near sterilization facilities, as well as properly mitigating exposure in workplaces that use EtO. According to the agency’s analysis, heightened levels of exposure to EtO for both workers and local communities can lead to elevated cancer risks. Given the heightened potential risk to those communities and workers, the agency is utilizing authorities under the Clean Air Act (CAA) to require a reduction in EtO emissions from commercial sterilizers with a focus on ensuring local communities are not subjected to unnecessary levels of EtO in the air. Further, because EtO technically is classified as a pesticide, the agency is using the authorities provided under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to strengthen worker protection requirements with the goal of ensuring that workplaces using EtO are safe for employees.</p> <h3>Proposed New and Updated Standards under the Clean Air Act</h3> <p>Under the CAA, the EPA is proposing new and updated requirements for all commercial sterilization facilities that use EtO. Once fully implemented, the proposals are slated to reduce EtO emissions for commercial sterilization facilities by about 80%. In addition to the targeted emissions reductions, EPA anticipates that the new and updated standards will reduce local community risk levels related to EtO to levels at or below the benchmark for lifetime cancer risk set out in the CAA.</p> <p>Specifically, if finalized, the agency’s proposal would require commercial sterilizers to:</p> <ul> <li>Install pollution controls within 18 months of release of the final rule;</li> <li>Continuously monitor air pollution at the facility to ensure that control equipment is operating effectively;</li> <li>Revise and establish standards for sterilization chamber vents and aerating room vents and establish standards to specifically address EtO emissions from chamber exhaust vents and room air;</li> <li>Revise standards for emissions during startup, shutdown and malfunction; and</li> <li>Require electric reporting of pollution control monitoring data.</li> </ul> <p>Moving forward, the EPA estimates that the capital costs associated with the proposed rule would be $220 million with annualized costs projected to be $68 million. <em>While some commercial sterilizers already have made these investments, the increased cost associated with compliance could create challenges for facilities that have yet to invest in new emissions reduction-focused equipment and technology.</em></p> <h3>Requirements Included in the Proposed Interim Decision under the Federal Insecticide, Fungicide, and Rodenticide Act</h3> <p>EtO can be designated as a pesticide when used to sterilize certain equipment, including some medical devices when those devices cannot be sterilized using alternative methods such as steam or radiation. Given this designation, the EPA has authority under FIFRA to take actions to ensure the safety and protection of individuals who may use EtO in the workplace to limit exposure to the sterilizing agent over long periods of time given the potential cancer risks.</p> <p>To achieve its stated goal, the EPA is proposing to require <strong>new engineering controls for health care facilities that use EtO.</strong> Those requirements are:</p> <ul> <li>Separating EtO sterilization spaces from other work areas to reduce the broader circulation of EtO;</li> <li>Implementing negative air pressure in rooms containing EtO sterilization devices to ensure that air will not flow to other areas in the health care facility;</li> <li>Using abatement devices to remove EtO from exhaust air and reduce discharge to the environment; and</li> <li>Discharging exhaust air from EtO sterilization devices through exterior ventilation stacks after passing through abatement devices to reduce the amount of EtO re-entrained into the building.</li> </ul> <p>In addition to new requirements for health care facilities that use EtO, the proposal would require a series of engineering controls for worker protection in commercial sterilization facilities. Among other requirements, the proposal calls for ventilation of storage areas, requiring sterilization and aeration to occur in the same EtO chamber, and automation and HVAC updates. Further, commercial sterilization facilities will have to implement real-time monitoring capable of detecting levels at or below 10 parts per billion (ppb) of EtO in the air. In instances where levels surpass 10 ppb, the agency’s proposed personal protective equipment requirements must be met. Moving forward, the agency intends to use the data that is collected to advance additional worker protections in the future.</p> <h2>AHA Actions Related to the EPA Proposals</h2> <p>The AHA is planning to comment on these proposals. Our prior comments have emphasized the need to balance the important goal of keeping the air we breathe safe with ensuring our medical devices are sterile so that we can safely provide needed care for patients. We continue to speak with representatives from various group purchasing organizations, device manufacturers and commercial sterilizers to better understand any implications that these proposals may have for the medical device supply chain. Should members have concerns, we would appreciate hearing from you. Comments are due June 12, 2023.</p> <h2>Further Questions</h2> <p>If you have further questions, please contact Mark Howell, AHA’s director of policy and patient safety, at <a href="mailto:mhowell@aha.org?subject=Special Bulletin: EPA Proposes New Standards for Ethylene Oxide Commercial Sterilization Facilities">mhowell@aha.org</a>.</p> </div> <div class="col-md-4"> <p><a href="/system/files/media/file/2023/04/Special-Bulletin-EPA-Proposes-New-Standards-for-Ethylene-Oxide-Commercial-Sterilization-Facilities.pdf" target="_blank" title="Click here to download the Special Bulletin: EPA Proposes New Standards for Ethylene Oxide Commercial Sterilization Facilities PDF."><img alt="Special Bulletin: EPA Proposes New Standards for Ethylene Oxide Commercial Sterilization Facilities page 1." data-entity-type="file" data-entity-uuid="b02d6cf2-3475-40c0-82fe-1fac15169e07" src="/sites/default/files/inline-images/Page-1-Special-Bulletin-EPA-Proposes-New-Standards-for-Ethylene-Oxide-Commercial-Sterilization-Facilities.png" width="695" height="900"></a></p> </div> </div> </div> Mon, 24 Apr 2023 09:39:04 -0500 Regulatory Compliance /news/headline/2022-05-19-aha-calls-increased-cms-oversight-doj-action-hold-medicare-advantage-plans <p>The AHA today urged the Centers for Medicare & Medicaid Services to “take swift action to hold Medicare Advantage plans accountable for inappropriately and illegally restricting beneficiary access to medically necessary care,” citing in part a <a href="/news/headline/2022-04-28-oig-medicare-advantage-coverage-denials-raise-health-care-access-concerns">recent report</a> from the Department of Health and Human Services’ Office of Inspector General that found an estimated 13% of prior authorization denials and 18% of payment denials should have been granted.</p> <p>“Inappropriate and excessive denials for prior authorization and coverage of medically necessary services is a pervasive problem among certain plans in the MA program,” AHA <a href="/lettercomment/2022-05-19-aha-urges-cms-hold-medicare-advantage-plans-accountable-inappropriately">wrote</a>. “This results in delays in care, wasteful and potentially dangerous utilization of fail-first imaging and therapies, and other direct patient harms. In addition, they add financial burden and strain on the health care system through inappropriate payment denials and increased staffing and technology costs to comply with plan requirements. … The findings of the HHS-OIG report, as well as the broader experience of MA beneficiaries, hospitals, and health systems, clearly indicates that greater oversight of MA plans is needed to ensure appropriate beneficiary access to care.”</p> <p>AHA recommended CMS take certain steps to increase MA plan oversight, improve patient access to care and address the issues raised in the OIG report. It also requested a meeting with CMS to further discuss these concerns.  <br />  <br /> <strong>AHA calls for task force to investigate False Claims Act violations </strong><br />  <br /> In a <a href="/lettercomment/2022-05-19-aha-department-justice-re-false-claims-act-investigations">separate letter</a>, AHA urged the Justice Department to establish a task force to conduct False Claims Act investigations into commercial health insurance companies that are found to routinely deny patients access to services and deny payments to health care providers. <br />  <br /> “It is time for the Department of Justice to exercise its False Claims Act authority to both punish those [Medicare Advantage Organizations] that have denied Medicare beneficiaries and their providers their rightful coverage and to deter future misdeeds,” AHA told the agency. “… And it is time for the Civil Division to focus more directly on the commercial insurers who commit this fraud. The AHA therefore urges you to create a ‘Medicare Advantage Fraud Task Force’ to investigate those MAOs that are failing to live up to the commitments they make to the federal government and the Medicare beneficiaries they have been entrusted to serve.” <br />  <br /> For more on the issue, see the recent <a href="/advancing-health-podcast/2022-05-12-special-edition-medicare-advantage-new-trends-raise-concerns">AHA Advancing Health podcast</a>, which examines how commercial insurers are impacting patient care through their policies. </p> Thu, 19 May 2022 15:25:20 -0500 Regulatory Compliance /lettercomment/2021-08-11-letter-guidance-documents-implementing-no-surprises-acts-provisions-notice <p>August 11, 2021</p> <p>William N. Parham<br /> Director, Paperwork Reduction Staff<br /> Regulations Development Group<br /> Office of Strategic Operations and Regulatory Affairs<br /> Centers for Medicare & Medicaid Services<br /> 7500 Security Boulevard, Mailstop: C4-26-05<br /> Baltimore, MD 21244</p> <p><strong>Subject: CMS Form Number 10780: OMB Control Number: 0938-XXXX, Requirements Related to Surprise Billing Regulations: Standard Notice and Consent Documents and Model Disclosure Notice Regarding Patient Protections Against Surprise Billing Instructions for Providers and Facilities</strong></p> <p>Dear Mr. Parham:</p> <p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, our clinician partners – including more than 270,000 affiliated physicians, 2 million nurses and other caregivers – and the 43,000 health care leaders who belong to our professional membership groups, the ���������� Association (AHA) thanks you for this opportunity to comment on the Centers for Medicare & Medicaid Services’ (CMS) guidance documents implementing the No Surprises Act’s provisions related to notice and consent and public disclosure. The focus of these comments are specific to these instructions and forms. We will provide in a separate letter more extensive comments pertaining to the underlying policies for the notice and consent and public disclosure requirements included in the July 13 interim final rule.</p> <p>The No Surprise Act (NSA) requires that CMS develop guidance for providers and facilities on the notice-and-consent process to be used for patients choosing to waive their balance billing protections, as well as the public disclosure process to inform patients of these protections. In general, the guidance documents reflect the requirements in the law; however, they present some logistical and operational challenges for providers, particularly related to notice-and-consent documents. <strong>While we share the objective of ensuring patients have the information they need to make informed decisions about their care, we believe steps must be taken to accomplish this goal without adding unnecessary costs and burdens to the health care system. The AHA recommends that CMS, as it continues its work to implement the NSA, convene a stakeholder advisory group to look at not only the design of these standard forms, but how these forms are to be shared with patients and payers; with a specific focus on the development of standardized transmission protocols.</strong></p> <h2>Standard Notice and Consent Documents</h2> <p>Under the statute, there are limited circumstances in which patients can knowingly and voluntarily waive their balance billing protections and consent to be billed for out-of-network services. Those circumstances are limited to post-stabilization when provided by out-of-network providers and facilities and certain conditions are met, and to out-of-network providers furnishing services at in-network facilities. The notice-and-consent documents are critical to ensuring patients are protected from surprise medical bills while retaining the opportunity to choose their providers.</p> <p>In document instructions, CMS states that only in certain instances may providers and facilities modify the standard form to include such information as the identification of the out-of-network provider, the out-of-network provider’s good faith estimate for services and any care limitations imposed by the patient’s health plan. For post-stabilization patients, the facility is instructed to include lists of in-network providers who able to furnish the services described in the notice. The statute specifically requires that the patient sign and date the receipt of the notice and sign and date the form consenting to out-of-network services. The following are specific issues and recommendations with the standard notice and consent form.</p> <h3>Patient’s Signature and Date.</h3> <p>The law and regulations require two signatures – one when notice was provided and another for when consent is obtained – but there is only one signature line on the form. Specifically, the standard document does not include a separate line for the patient’s signature with the date to indicate that the patient received the notice. <strong>The AHA recommends that CMS modify the standard document to include a distinct signature line for when the notice was given, with a separate signature line confirming that consent has been provided.</strong> This would remove any confusion about compliance with the notice requirements.</p> <h3>Good Faith Estimates.</h3> <p>The statute requires that good faith estimates of the costs of services be included in the notice to fully inform patients of their potential out-of-pocket costs if they continue with care from out-of-network providers or facilities. The law further instructs such good faith estimates be conveyed using the expected billing and diagnostic codes for items and services. The standard form also requires that good faith estimates reflect the amount the out-of-network provider or facility expects to charge for furnishing such items or services, as well as include the service codes. However, the form does not stipulate which codes are to be used. Given that the underlying policy requires that providers and facilities follow the same rules that apply to the development of the good faith estimates established under another section of the NSA, we urge CMS to quickly release guidance on how providers are to calculate good faith estimates and to incorporate guidance on the specific codes to be used into this form.</p> <h3>Management of Notice and Consent Process.</h3> <p>The rule specifies that each out-of-network provider is responsible for the notice and consent process for the services they provide <em>unless</em> they have an agreement with a facility to manage the process on their behalf. We interpret this to mean that facilities can agree to manage the notice and consent process for some, but not all, of the out-of-network providers involved in a patient’s care. <strong>As such, the AHA recommends that the standard form and instructions should be modified to clarify that facilities can choose which out-of-network providers they plan to work with as part of their management of the notice and consent process and clearly state that this form may not encompass all potential out-of-network providers.</strong></p> <h3>Listing of Available In-Network Providers for Post-stabilization Patients.</h3> <p>For post-stabilization patients at in-network facilities for which consent is being sought, the notice must include a list of in-network providers at the facility that are able to furnish the services. Providers will need to either rely on the plan's provider directory or contact the plan directly to obtain information on alternative in-network providers. This process will not guarantee accurate information and will be highly burdensome for providers. For example, health plan provider directories are notorious for containing errors. Providers should not be held responsible if they rely on unknowingly erroneous directory information. In addition, there are nuances to how plan provider directories list facilities and providers. For example, the facility could be listed as in-network in the plan directory, but the plan chooses to exclude coverage for certain services performed at the facility, such as outpatient surgery, laboratory and diagnostic services, and specialty drug therapies. These health plan coverage nuances would make it nearly impossible for the in-network facility to know with any certainty which providers would be in- or out-of-network for specific services. <strong>For these reasons, the AHA believes the responsibility should not be placed with the in-network facility. AHA recommends that the standard form and instructions should instead direct the patient to their health plan to identify an alternative.</strong></p> <h3>Accessible Languages.</h3> <p>The regulations require that providers and facilities provide notice and consent in the top 15 languages in a state or geographic region in which the applicable facility is located. In addition, providers and facilities will need to translate the notice and consent form into the top 15 applicable languages. <strong>Because CMS intends to treat the adoption of the standard form as compliant with the law’s notice and consent requirements, the AHA recommends that CMS provide translations of the standard form in the top 15 nationally known languages.</strong> This would substantially lower the administrative burden on facilities and providers.</p> <h3>Transmitting of the Standard Form to Payers.</h3> <p>The regulations require that facilities and providers alert the patient’s health plan that the notice and consent process was used and to share with the health plan the signed consent form. Neither the regulations nor the standard form provide any guidance on how the signed notice and consent documents should be transmitted. <strong>Because there is currently no standard electronic transaction for this exchange of information, the AHA recommends that CMS adopt a standard process to ensure consistency and minimize the burden of alternate forms of transmission, such as faxing paper copies or use of health plan’s unique, proprietary portals. AHA further recommends that the agency expedite the adoption of standard electronic transactions for the exchange of this information between the provider, facility and plan, and that the agency modify the standard form to reflect these transaction standards.</strong></p> <h2>Model Disclosure Notice Regarding Patient Protections Against Surprise Billing</h2> <h3>Patient Notice.</h3> <p>As part of the public disclosure requirements, providers and facilities must publically post information about patient balance billing protections as well as provide patients with a one-page notice outlining these protections. By adopting the model form, providers and faculties will be considered compliant with the statute and rule. The implementing rule and the instructions for the model patient one-page notice stipulates that this notice be shared with the patient no later than at the time payment is requested or when claims are submitted to the patient’s health plan. <strong>The AHA recommends additional flexibility in the timing of when providers and facilities convey the disclosure notice to patients. Specifically, there are instances where patients will have ongoing treatment regimens that require multiple visits and/or courses of care. In these instances, we ask that providers not be required to provide the notice for either each visit or course of treatment. Instead, providers could be required to provide the notice at the outset, followed by periodic reminders, such as each quarter.</strong> This will allow for continued patient engagement on billing expectations without overburdening providers.</p> <p>Thank you for the opportunity to provide comments on the stand forms to be used in the in meeting the notice and consent and public disclosure requirements. Please contact me if you have questions, or have a member of your team contact Molly Collins Offner, AHA’s director of policy, at <a href="mailto:mcollins@aha.org">mcollins@aha.org</a>.</p> <p>Sincerely,</p> <p>/s/</p> <p>Ashley Thompson<br /> Senior Vice President<br /> Public Policy Analysis and Development</p> Wed, 11 Aug 2021 11:13:20 -0500 Regulatory Compliance <div class="container"> <div class="row"> <div class="col-md-8"> <p>The <a href="/advisory/2019-12-04-regulatory-advisory-administration-finalizes-rule-requiring-disclosure-hospital">Hospital Price Transparency rule</a> has been in effect since Jan. 1, 2021, requiring hospitals to disclose all of their privately negotiated rates with health plans, in addition to self-pay and chargemaster rates. Hospitals are also required to provide an online patient cost estimator tool or negotiated rate information for at least 300 “shoppable” services.</p> <p>The Centers for Medicare & Medicaid Services (CMS) in April began issuing <a href="/advisory/2021-05-03-cms-begins-issuing-warning-notices-hospitals-noncompliance-hospital-price">noncompliance warning letters</a> based on their own audit of hospital websites. CMS intends to continue to send warning letters on a rolling basis as the agency identifies hospitals that it deems to be out of compliance with the requirements. CMS will not make public the identities of the hospitals that have received warning letters. However, CMS will identify on the agency’s website hospitals that receive a civil monetary penalty due to noncompliance.</p> <p>Currently, CMS can issue penalties of up to $300 per day for noncompliance. The agency recently <a href="/advisory/2021-07-30-cy-2022-hospital-oppsasc-proposed-rule-including-modifications-price">proposed an increase of that amount</a> on a sliding scale based on bed count. Under the proposed policy, the maximum civil monetary penalty would range from a minimum of $300/day for small hospitals (30 or fewer beds) and would grow by an additional $10/bed/day for larger hospitals, with a daily cap of $5,500. CMS also proposes additional updates to these regulations, including prohibiting specific barriers to accessing the machine-readable files.</p> <p>While CMS has not yet provided any official assessment of hospitals’ national rate of compliance, there are a number of external reports that purport to do so. These reports are separate and apart from the CMS review, but receive regular coverage in national and local media outlets, thus serving as proxies for compliance in stories on the Hospital Price Transparency rule and, more generally, price transparency. This Special Bulletin includes an attachment with updated talking points to assist hospitals and health systems with managing patient and press inquiries on these topics.</p> <p>In addition, as a reminder, the <a href="/special-bulletin/2020-10-29-administration-finalizes-rule-requiring-health-plans-disclose">Transparency in Coverage rule</a> goes into effect on Jan. 1, 2022, in which health plans will be required to publish their negotiated rates with hospitals and other providers, as well as out-of-network allowed amounts. As part of this rule, CMS established more stringent format requirements for the health plans’ machine-readable files, which, as a result, will likely result in additional third-party studies and comparative assessments.</p> <p>To help hospitals and health systems comply with these requirements and discuss the requirements with patients and the media, the AHA has a number of materials available on its <a href="/pricetransparencyrule">Price Transparency webpage</a> dedicated to this rule, including:</p> <ul> <li>Updated talking points (<a href="#attachment">see attachment</a>).</li> <li><a href="/system/files/media/file/2020/12/inforgraphic-price-transparency.pdf">Infographic</a> summarizing the two primary elements of the rule.</li> <li><a href="https://www.youtube.com/watch?v=vCzIXUi2GEo" target="_blank">Patient-focused template video</a> explaining hospitals’ commitment to help make costs understandable. For AHA members who want to use this video and add their own branding, click here to download.</li> <li>Tools to use to examine your price transparency communications to ensure they are patient-centered. Package includes <a href="/other-resources/2020-12-17-price-transparency-action-items">action items</a>, <a href="/assessment/2020-12-17-price-transparency-self-assessment">self-assessment</a>, <a href="/infographics/2020-12-22-hospital-price-transparency-infographic">patient communication infographic</a> and <a href="/other-resources/2020-12-17-price-transparency-secret-shopper-exercise">secret shopper exercise</a>.</li> <li>Webinars on implementation and compliance strategies and solutions from <a href="/webinars/2020-11-05-webinar-strategies-and-solutions-cleverley-associates-prepare-cmss-hospital">Cleverley + Associates</a>, <a href="/webinars/2020-11-05-webinar-strategies-and-solutions-para-healthcare-analytics-prepare-cmss">PARA Healthcare Analytics</a>, and <a href="https://aviahealthinnovation.zoom.us/rec/play/X1jytuRlrriT9np6MLgNeyKsOT7PuPsHZN6N0vqZ6qVielWRFjTsTRfTqh8WUSzb3NCuD_zWdkpRPnGH.pluDldINDeHoG2o3?startTime=1600887611000" target="_blank">Deloitte and AVIA</a>.</li> <li><a href="/2020-10-27-patient-cost-estimator-toolkit">Patient Out-of-pocket Cost Estimator Toolkit</a> including Members in Action case studies</li> </ul> <h2>Further Questions</h2> <p>If you have questions, please contact AHA at <a href="tel:1-800-424-4301">800-424-4301</a>.</p> <hr /></div> <div class="col-md-4"> <div class="panel module-typeC"> <div class="panel-heading"> <h3 class="panel-title">Key Takeaways</h3> </div> <div class="panel-body"> <ul> <li>The Hospital Price Transparency rule took effect Jan. 1, 2021.</li> <li>CMS began issuing noncompliance warning letters in April.</li> <li>Current noncompliance penalties are up to $300 per day.</li> <li>The agency has proposed to increase penalties on a sliding scale based on bed count.</li> <li>External reports have generated media attention and found wide variation in rates of compliance.</li> </ul> </div> </div> </div> </div> </div> <h2 id="attachment">Attachment: Updated Talking Points</h2> <p><strong>Health insurance is complicated. We are here to help.</strong></p> <ul> <li>We want to give patients the answers they need about the costs of hospital treatment so they can plan ahead.</li> <li>We recognize some people are facing higher out-of-pocket costs due to high deductibles and other health plan cost-sharing requirements.</li> <li>Patients’ out-of-pocket costs are based on a number of factors, including: <ul> <li>Their health insurance plan’s benefit design; and</li> <li>How much of their deductible they have met.</li> </ul> </li> </ul> <p><strong>Patients deserve the best possible information about what they should expect to pay for a scheduled service.</strong></p> <ul> <li>Hospitals and health systems are committed to helping patients access cost estimates.</li> <li>The field is embracing new technologies, like online calculators, that make accessing such estimates easier than ever.</li> <li>Insurers are a key partner in developing patient-specific cost estimates because patient costs will differ depending on their health plan features and cost-sharing requirements.</li> <li>Cost estimates can change as the course of treatment changes.</li> </ul> <p><strong>AHA and hospitals urge caution when looking at the data from privately negotiated rates.</strong></p> <ul> <li>Numbers in the spreadsheets do not necessarily reflect the patient experience or their course of treatment. <ul> <li>Rather, these numbers reflect base contracted terms agreed upon with health insurers.</li> <li>The final amount a hospital should expect to be paid by the patient and health plan is based on a number of factors, including the patient’s course of treatment and additional contract terms (e.g., volume discounts, quality bonuses, and whether multiple services are provided at the same time).</li> <li>There is no way to capture all of those factors in a single “negotiated rate.”</li> </ul> </li> <li>We urge patients to contact their hospital directly or use their hospital’s patient cost estimator tool for the most accurate estimate of their costs.</li> </ul> Wed, 11 Aug 2021 10:23:06 -0500 Regulatory Compliance /special-bulletin/2021-03-22-fema-updates-its-covid-19-policy-medical-care-eligible-public <p>The Federal Emergency Management Agency (FEMA) recently updated its <a href="https://www.fema.gov/sites/default/files/documents/fema_public-assistance-covid-19-medical-care-v2-with-equity-job-aid_policy_3-15-2021.pdf">policy</a> on “Coronavirus (COVID-19) Pandemic: Medical Care Eligible for Public Assistance.” This interim policy defines the framework, policy details and requirements for determining the eligibility of medical care work and costs for FEMA public assistance (PA) funding during the COVID-19 emergency. The updated policy includes a number of important changes and additions, described below, compared to the previous version of this policy issued in May 2020.</p> <h2>AHA Take</h2> <p>Hospitals can use FEMA as an additional source of funding for the extraordinary expenses they have faced throughout the pandemic. While FEMA PA applications and funding require substantial documentation, the program can provide reimbursement that may not otherwise be available through other federal programs.</p> <p>Highlights of the updated FEMA policy follow.</p> <h2>HIGHLIGHTS OF FEMA’S UPDATED COVID-19 PUBLIC ASSISTANCE POLICY</h2> <p><u>Federal Cost Share Increased to 100%</u>. Consistent with recent Presidential <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/02/02/memorandum-maximizing-assistance-from-the-federal-emergency-management-agency/">memoranda</a>, FEMA increases the federal cost share for the eligible emergency protective measures to 100%, retroactive to Jan. 20, 2020 and continuing through Sept. 30, 2021, including costs associated with the treatment of and vaccination against COVID-19 that are not covered by other sources.</p> <p><u>Requires FEMA PA Funding to Focus on Equitable COVID-19 Response and Recovery</u>. As a condition of receiving this financial assistance, recipients must focus the use of FEMA funding on the highest-risk communities and underserved populations as determined by established measures of social and economic disadvantage (e.g., the Center for Disease Control and Prevention (CDC) Social Vulnerability Index). This includes communities of color and other underserved populations, including members of the LGBTQI+ community, persons with disabilities, those with limited English proficiency, and those living at the margins of our economy. Failure to prioritize funding for these purposes could result in funding reductions and/or delays. A separate <a href="https://www.fema.gov/sites/default/files/documents/fema_public-assistance-covid-19-medical-care-v2-with-equity-job-aid_policy_3-15-2021.pdf">part of the policy</a> titled, “Equitable COVID-19 Response and Recovery: Recipient and Subrecipient Job Aid” further describes the steps that recipients of FEMA funds must take to document this prioritization.</p> <p><u>Eligibility of Costs Associated with COVID-19 Vaccination</u>. The updated policy includes a new section on COVID-19 vaccination. FEMA notes that while the federal government provides the vaccine itself at no cost, there may be additional costs eligible for PA funding that are incurred by providers to support the distribution and administration of the vaccine.</p> <p>Eligible work and costs in this category include:</p> <ul> <li>community vaccination centers;</li> <li>personal protective equipment (PPE), other equipment, and supplies required for storing, handling, distributing/transporting, and administering COVID-19 vaccinations;</li> <li>facility support costs, including leasing space for storage and/or administration of vaccines, utilities, maintenance, and security;</li> <li>additional staff, if necessary, including medical and support staff not paid for by another funding source and consistent with FEMA PA labor policies;</li> <li>onsite infection control measures and emergency medical care for COVID-19 vaccination administration sites;</li> <li>resources to support mobile COVID-19 vaccination in remote areas and/or transportation support for individuals with limited mobility or lack of access to transportation, when reasonable and necessary;</li> <li>vaccine-related costs incurred by a federally qualified health center, rural health clinics and critical access hospitals that are not covered by the Department of Health and Human Services or another funding source;</li> <li>communications to disseminate public information regarding vaccinations, including translation and interpretation services as necessary;</li> <li>information technology equipment and systems, when reasonable and necessary, for patient registration and tracking, vaccine-related inventory management, and/or analytics and reporting needs; and</li> <li>training and technical assistance specific to the proper storage, handling, distribution, and administration of COVID-19 vaccinations in accordance with CDC guidance.</li> </ul> <p><u>Summary of Other Eligible Medical Care Work and Costs</u>. The following categories eligible for FEMA COVID-19 funding are not new in this updated policy but are included here for completeness.</p> <p><em>Primary Medical Care Facility.</em> For medical care provided in a primary medical care facility, work must be directly related to the treatment of COVID-19 patients. Work may include both emergency and inpatient treatment of patients with confirmed and suspected COVID-19 disease.</p> <p>The following medical care activities and associated costs are eligible in primary medical care facilities:</p> <ul> <li>emergency and inpatient clinical care for COVID-19 patients;</li> <li>purchase, lease, and delivery of specialized medical equipment necessary to respond to COVID-19;</li> <li>purchase and delivery of PPE, durable medical equipment, and consumable medical supplies necessary to respond to COVID-19; and</li> <li>medical waste disposal related to COVID-19.</li> </ul> <p>Furthermore, certain labor costs associated with medical staff providing treatment to COVID-19 patients may be eligible as well. However, labor costs for medical staff that are included in patient billing and/or otherwise covered by another funding source are not eligible for PA. Otherwise, the following labor costs may be eligible:</p> <ul> <li>overtime for budgeted medical staff providing treatment to COVID-19 patients;</li> <li>straight time and overtime for temporary medical staff providing treatment to COVID-19 patients; and</li> <li>straight time, overtime, and other necessary costs for contract medical staff providing treatment to COVID-19 patients.</li> </ul> <p><em>Temporary and Expanded Medical Facilities.</em> FEMA may approve work and costs associated with temporary medical facilities or expanded medical facilities, when necessary, in response to the COVID-19 public health emergency. These facilities may be used to treat COVID-19 patients, non-COVID-19 patients, or both, as necessary.</p> <p>Eligible costs for temporary and expanded medical facilities include:</p> <ul> <li>all eligible items and stipulations included above for primary medical care facilities, as described above, but applicable to both COVID-19 and non-COVID-19 patients;</li> <li>lease, purchase, or construction costs, as reasonable and necessary, of a temporary facility as well as reasonable alterations to a facility necessary to provide medical care services;</li> <li>mobilization and demobilization costs associated with setting up and closing the temporary or expanded medical facility;</li> <li>operating costs including equipment, supplies, staffing, wraparound services, and clinical care not covered by another funding source; and</li> <li>maintenance of a temporary or expanded medical facility in an operationally ready but unused status available for surge capacity for COVID-19 readiness.</li> </ul> <p>The entire compilation of FEMA COVID-19 PA policies can be found at: <a href="https://www.fema.gov/media-collection/public-assistance-disaster-specific-guidance-covid-19-declarations">Public Assistance Disaster-Specific Guidance - COVID-19 Declarations | FEMA.gov</a>.</p> <h2>NEXT STEPS</h2> <p>The AHA will continue to track FEMA’s updates on COVID-19 PA policy. If you have further questions, contact Roslyne Schulman, AHA director of policy, at <a href="mailto:rschulman@aha.org">rschulman@aha.org</a>.</p> Mon, 22 Mar 2021 11:33:42 -0500 Regulatory Compliance