/ en Mon, 28 Apr 2025 01:27:28 -0500 Wed, 23 Oct 24 15:14:04 -0500 <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Medicare & Medicaid Services (CMS) yesterday released interpretive <a href="https://www.cms.gov/files/document/qso-25-05-hospitals-cahs.pdf">guidance</a> providing additional details for the hospital respiratory data condition of participation (CoP). The new CoP, which takes effect on Nov. 1, requires all Medicare- and Medicaid-participating hospitals and critical access hospitals (CAHs) (other than inpatient psychiatric hospitals (IPFs), inpatient rehabilitation hospitals (IRFs), and distinct part unit psychiatric hospitals and rehabilitation hospitals) to electronically submit certain COVID-19, influenza and respiratory syncytial virus (RSV) data to the Centers for Disease Control and Prevention (CDC) weekly. This includes data on confirmed infections of COVID-19, influenza and RSV among hospitalized patients, hospital bed census and capacity, and limited patient demographic information. IPFs, IRFs, psychiatric hospital distinct part units, and rehabilitation hospital distinct part units will report once — annually — beginning in January 2025.</p><p>This guidance also outlines CMS’s multi-step notification and enforcement process and describes additional data elements to be reported during a public health emergency (PHE).</p><h2>KEY HIGHLIGHTS</h2><ul><li>Most Medicare- and Medicaid-participating hospitals and CAHs will begin submitting weekly data reports related to COVID-19, influenza and RSV for the week beginning on Nov. 3.</li><li>IRFs and IPFs (including distinct part unit IRFs and IPFs) will begin reporting once — annually — in January 2025.</li><li>Hospitals will report the data using the CDC’s National Healthcare Safety Network (NHSN), and CMS instructs hospitals to follow the reporting protocols provided by the CDC.</li><li>Hospitals will have two options for reporting data — “daily” reporting, in which hospitals submit reports containing daily data values for the previous week, or a “weekly” option, in which hospitals submit cumulative weekly totals of new admissions for COVID-19, influenza and RSV along with one-day-per-week snapshots of other data. Regardless of the option hospitals choose, the data must be submitted by 11:59 p.m. PT every Tuesday.</li><li>Compliance will be assessed based on 28-day periods covering four reporting weeks. The CDC will provide CMS with reports detailing the timeliness and completeness of reports submitted each 28 days.</li><li>Hospitals and CAHs that do not comply with the requirements will receive a series of incomplete reporting notification letters. Continued non-compliance may result in termination of the provider’s participation in the Medicare program.</li></ul><p><strong>Reporting Processes. </strong>Hospitals will have two options for submitting data into NHSN once per week, thereby fulfilling the requirements of the CoP. The reporting week is defined as Sunday through Saturday, with the first reporting week starting Sunday, Nov. 3, and ending Saturday, Nov. 10.</p><ul><li><em>Daily Reporting. </em>Under this option, hospitals and CAHs must electronically submit daily values for all data fields weekly to the CDC through the NHSN system.</li><li><em>Weekly Reporting.</em> Under this option, hospitals would report new admissions of patients with confirmed respiratory illnesses, including COVID-19, influenza and RSV, as cumulative weekly totals by age group, instead of submitting data for each weekday. Other data elements (e.g., staffed bed capacity and occupancy) should be reported as one-day-a-week snapshots. The NHSN protocol indicates that the snapshot day should be the Wednesday of the reporting week. For example, for the reporting week starting Sunday, Nov. 3, hospitals should report data from Wednesday, Nov. 6.</li></ul><p>The NHSN <a href="https://www.cdc.gov/nhsn/psc/hospital-respiratory-reporting.html">website</a> includes a reporting <a href="https://www.cdc.gov/nhsn/pdfs/pscmanual/HRD-Protocol-Final.pdf">protocol</a> and other information describing the reporting process and data elements in detail. For the weekly reporting option, the reporting protocol and website also describe which data elements should be reported as cumulative weekly totals or snapshots.</p><p><strong>Notification and Enforcement Process for Non-Compliance. </strong>CMS will assess compliance with the new CoP over 28-day periods covering four reporting weeks. Following the fourth submission for each 28 days, the CDC will provide CMS with a report detailing the timeliness and completeness of submissions made during each such period. Hospitals and CAHs that fail to submit complete and timely reports will receive an incomplete reporting notification letter from CMS. Continued non-compliance will be followed with additional notification letters and may lead to enforcement action against the hospital or CAH.</p><p>For the first reporting period in November 2024, hospitals and CAHs that have not demonstrated compliance with the new requirements will receive an initial warning letter explaining the reporting requirements and process, along with CDC contact information for the hospital or CAH to request technical assistance. This letter will only be used for the first month of reporting under the new CoP.</p><p>For hospitals and CAHs that have not met the reporting requirements in subsequent 28-day periods, CMS will issue a series of notification letters that may be followed by enforcement action against the provider.</p><ol><li>For the first 28-day period a hospital or CAH does not demonstrate compliance, CMS will issue an initial warning letter notifying providers that they will have the next 28-day period to demonstrate complete and timely reporting of the specified data elements.</li><li>Failure to demonstrate compliance during a second subsequent reporting period will result in a second warning letter issued by CMS.</li><li>Failure to demonstrate compliance during a third subsequent reporting period will result in a third warning letter issued by CMS.</li><li>Failure to demonstrate compliance during a fourth subsequent reporting period will result in a final warning letter issued by CMS. This final letter will also notify providers that failure to demonstrate compliance in the 30 days following the issuance of this letter may result in the termination of the provider’s Medicare agreement.</li></ol><p>Providers subject to termination of their Medicare agreement may appeal the determination in accordance with part 498 of title 42, Code of Federal Regulations. Providers terminated for failure to report that submit a new application for initial certification to participate in the Medicare program will be subject to a 30-day reasonable assurance period. If a provider believes they have received a warning letter in error, the provider may submit evidence of complete reporting to the CDC within five business days of receipt of the letter.</p><p><strong>Additional Reporting During a PHE. </strong>In the event a national, state or local PHE is declared for an acute infectious illness, hospitals and CAHs will be required to electronically submit additional data elements to the CDC through the NHSN system. These elements include facility structure and infrastructure operational status, such as hospital or emergency department diversion status, staffing or supply shortages, and medical countermeasures and therapeutics, as applicable.</p><h2>FURTHER QUESTIONS</h2><p>The CDC’s reporting protocol, data collection forms and fact sheets, and other training materials and resources are available on the <a href="https://www.cdc.gov/nhsn/psc/hospital-respiratory-reporting.html">CDC hospital respiratory data website</a>. Hospitals may send questions to <a href="mailto:NHSN@cdc.gov">NHSN@cdc.gov</a> using the subject line “Hospital Respiratory Data.”</p><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>, or Akin Demehin, AHA’s senior director of quality and patient safety policy at <a href="mailto:ademehin@aha.org">ademehin@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2024/10/cms-releases-interpretive-guidance-on-hospital-respiratory-data-condition-of-participation-bulletin-10-23-2024.pdf"><img src="/sites/default/files/inline-images/cover-cms-releases-interpretive-guidance-on-hospital-respiratory-data-condition-of-participation-bulletin-10-23-2024.png" data-entity-uuid="c7b1fa90-a6a6-4ce0-b4fd-68bbe461c669" data-entity-type="file" alt="Image Special Bulletin: CMS Releases Interpretive Guidance on Hospital Respiratory Data Condition of Participation" width="640" height="834"></a></div></div></div> Wed, 23 Oct 2024 15:14:04 -0500 Conditions of Participation <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Disease Control and Prevention (CDC), in an Oct. 16 webinar, provided updates on the new hospital respiratory data condition of participation (CoP). During the webinar, representatives from the CDC and the Centers for Medicare & Medicaid Services (CMS) confirmed that most hospitals and critical access hospitals (CAHs) will be required to begin submitting weekly COVID-19, influenza and respiratory syntactical virus (RSV) data starting the week of Nov. 3. Freestanding and hospital-based inpatient rehabilitation facilities (IRFs) and inpatient psychiatric facilities (IPFs) will report annually, beginning January 2025.</p><p>The CDC strongly encouraged hospitals to access the agency’s National Healthcare Safety Network (NHSN) system to voluntarily report data before enforcement begins. CDC asked that hospitals submit only accurate data, not test data. Data collection forms and instructions, including the hospital respiratory data protocol, are available on the <a href="https://www.cdc.gov/nhsn/psc/hospital-respiratory-reporting.html">CDC website</a> and should be reviewed prior to reporting. CMS expects to release guidance in the next few days with additional information on its compliance assessment and enforcement. AHA will share information on this guidance with members as soon as it is available.</p><h2>BACKGROUND</h2><p>In 2020, CMS adopted a CoP requiring hospitals and CAHs to submit certain data related to COVID-19 and other acute respiratory illnesses (i.e., influenza) to the CDC for the duration of the COVID-19 public health emergency (PHE). In 2022, CMS updated the CoP to require reporting from the conclusion of the PHE through April 30, 2024. Following the expiration of that CoP, CMS stated that it continues to need to monitor the impact of acute respiratory illnesses across the country to inform federal surveillance efforts.</p><p>In August, CMS <a href="/system/files/media/file/2024/08/inpatient-pps-final-rule-for-fy-2025-advisory-8-14-2024.pdf">finalized</a> a new permanent CoP requiring hospitals and CAHs to report certain COVID-19, influenza and RSV data to assist with these surveillance efforts and inform hospital-level infection control and prevention efforts. Beginning in November, CMS will require hospitals and CAHs (other than IRFs and IPFs) to report data once per week on confirmed infections of COVID-19, influenza and RSV among hospitalized patients, hospital capacity and limited patient demographic information, including age. IRFs and IPFs will report annually, starting in January 2025.</p><h2>WHAT YOU CAN DO</h2><ul><li>Share this Special Bulletin with leaders responsible for regulatory compliance and quality and infection data reporting, such as your chief quality, medical or nursing officers.</li><li>Review the reporting information on the CDC’s NHSN website.</li><li>Watch for CMS’ forthcoming guidance and any reporting updates from CDC NHSN.</li></ul><h2>FURTHER QUESTIONS</h2><p>The CDC’s reporting protocol, data collection forms and fact sheets, and other training materials and resources are available on the <a href="https://www.cdc.gov/nhsn/psc/hospital-respiratory-reporting.html">CDC hospital respiratory data website</a>. Hospitals may send questions to <a href="mailto:NHSN@cdc.gov">NHSN@cdc.gov</a> using the subject line “Hospital Respiratory Data.”</p><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>, or Akin Demehin, AHA’s senior director of quality and patient safety policy, at <a href="mailto:ademehin@aha.org">ademehin@aha.org</a>.</p></div><div class="col-md-4"><a href="/system/files/media/file/2024/10/cdc-provides-updates-on-new-hospital-respiratory-data-condition-of-participation-bulletin-10-17-2024.pdf"><img src="/sites/default/files/inline-images/cover-cdc-provides-updates-on-new-hospital-respiratory-data-condition-of-participation-bulletin-10-17-2024.png" data-entity-uuid="6017e5ff-ddb8-4e7f-8e0a-391f899166a6" data-entity-type="file" alt="Image Special Bulletin Cover Page" width="679" height="878"></a></div></div></div> Thu, 17 Oct 2024 14:56:41 -0500 Conditions of Participation <div class="container"><div class="row"><div class="col-md-8"><p>The Centers for Medicare & Medicaid Services (CMS) July 10 released its calendar year (CY) 2025 outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) <a href="https://public-inspection.federalregister.gov/2024-15087.pdf" target="_blank" title="Federal Register: Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities">proposed rule</a>. The rule would increase OPPS rates by a net 2.6% in CY 2025 compared to CY 2024. The rule also includes proposals for new conditions of participation (CoPs) focused on obstetrical services and maternal care, separate payment for high-cost diagnostic radiopharmaceuticals and three years of separate payment for certain non-opioid drugs and devices that provide pain relief.</p><p>The final rule will be published on or around Nov. 1 and take effect Jan. 1, 2025. CMS will accept comments on the proposed rule through Sept. 9.</p><div class="panel module-typeC"><div class="panel-heading"><h2>Key Highlights</h2><p>CMS’ proposed rule would:</p><ul><li>Increase Medicare hospital OPPS rates by a net 2.6% in CY 2025.</li><li>Pay separately for diagnostic radiopharmaceuticals with per-day costs above $630.</li><li>Exclude qualifying cell and gene therapies from comprehensive ambulatory payment classification (C-APC) packaging in CY 2025.</li><li>As required by law, implement temporary additional payments for certain non-opioid treatments for pain relief dispensed in the hospital outpatient department (HOPD) and ASC settings.</li><li>Adopt three new measures related to health equity for the Outpatient, ASC and rural emergency hospital (REH) Quality Reporting Programs.</li><li>Establish a new obstetrical services CoP and update existing quality assessment performance improvement (QAPI), emergency readiness and discharge planning CoPs for hospitals and critical access hospitals.</li><li>Extend virtual direct supervision of cardiac rehabilitation (CR), intensive cardiac rehabilitation (ICR) and pulmonary rehabilitation (PR) services and diagnostic services furnished to hospital outpatients through Dec. 31, 2025.</li><li>Remove barriers to providing certain clinic services outside the four walls of a clinic, which could improve access for some Medicaid beneficiaries.</li></ul></div></div><h2>AHA Take</h2><p>We are disappointed that CMS again proposed an inadequate update to hospital payments. This increase for outpatient hospital services of only 2.6% would come despite the fact that many hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging. Hospitals and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, and we urge CMS to provide additional support in the final rule.</p><p>In addition, we fully share CMS’ goals of improving maternal health outcomes and reducing inequities in maternal care. However, we are deeply concerned by CMS’ continued and excessive use of CoPs to drive its policy agenda. We believe a less punitive and more collaborative and flexible approach is far superior. We will carefully review CMS’ proposals to determine whether they are feasible, sufficiently flexible for the wide variety of hospitals to which they would apply and do not inadvertently exacerbate maternal care access challenges.</p><h2>What You Can Do</h2><ul><li><strong>Participate in an AHA members-only webinar on Aug. 6 at 2:30 p.m. ET</strong> to share your questions and feedback on this regulation for AHA’s comment letter to CMS. <a href="https://aha.adobeconnect.com/cy2025oppsasc/event/registration.html" target="_blank" title="AHA: Members-ONLY Webinar for the CY 2025 OPPS/ASC Proposed Rule">Register for this 90-minute webinar.</a></li><li><strong>Share this advisory with your senior management team</strong> and ask your chief financial officer to examine the impact of the proposed payment changes on your Medicare revenue for CY 2025. Spreadsheets comparing the proposed changes in the APC payment rates and weights from 2024 to 2025 are available on the <a href="/topics/outpatient-pps">AHA’s OPPS webpage</a>. To access these, you must be logged on to the website.</li><li><strong>Share this advisory with your billing, medical records, quality improvement and compliance departments and your clinical leadership team</strong> to apprise them of the proposals around the APCs, CoPs and quality measurement requirements.</li><li><strong>Submit comments to CMS with your specific concerns by Sept. 9 at </strong><a href="https://www.regulations.gov" target="_blank" title="Regulations.gov homepage"><strong>www.regulations.gov</strong></a><strong>.</strong></li></ul><p><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf">View the full Regulatory Advisory PDF</a> or use the table of contents below to navigate to specific sections.</p><h2>Contents</h2><ol><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=5">OPPS Proposed Rule Changes</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=5">OPPS Update and Linkage to Hospital Quality Data Reporting</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=5">Data Proposed for Use in CY 2025 OPPS and ASC Rate Setting</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=5">Proposed Site-neutral Payment Policies for Off-campus Provider-based Departments (PBDs)</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=6">Proposed Payments for Drugs, Biologicals and Radiopharmaceuticals</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=7">Proposed Payment Change for Diagnostic Radiopharmaceuticals</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=8">Add-on Payment for Radiopharmaceutical Technetium-99m</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=9">Request for Information on Cardiac computerized tomography Services</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=9">Proposed Recalibration and Scaling of APC Relative Weights</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=10">Area Wage Index</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=10">Rural Sole Community Hospital Adjustment</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=11">Cancer Hospital Adjustment</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=11">Comprehensive APCs</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=12">Proposed Non-Opioid Policy for Pain Relief Under the OPPS and ASC Payment System</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=13">Proposed Changes to the Inpatient-Only List</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=14">Hospital Outpatient Outlier Payments</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=14">Transitional Pass-through Payments</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=14">Beneficiary Coinsurance</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=14">Outpatient Quality Reporting Program 14</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=19">Proposed Payment for Intensive Outpatient and Partial Hospitalization Programs</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=20">Remote Services</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=20">Outpatient Therapy, Diabetes Self-management Training, and Medical Nutrition Therapy</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=21">Proposed Health and Safety Standards for Obstetrical Services in Hospitals and critical access hospitals</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=21">New and Updated CoPs Related to Maternal Health</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=22">ASC Proposed Rule Changes</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=22">ASC Payment Update</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=23">Proposed Changes to ASC Covered Procedures List</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=23">ASC Quality Reporting Program</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=26">REH Quality Reporting Program</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=27">Other Quality-Related Provisions</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=29">Other Issues</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=29">All-Inclusive Rate Add-on for High-Cost Drugs Provided by the Indian Health Service and Tribal Hospitals</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=29">RFI: Paying all IHS and Tribally Operated Clinics the IHS Medicare Outpatient AIR</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=30">Coverage Changes for Colorectal Cancer Screening Services</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=30">Request for Comment on Payment Adjustments under the Inpatient PPS and OPPS for Domestic Personal Protective Equipment</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=31">Payment for HIV Pre-Exposure Prophylaxis in HOPDs</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=31">Proposed Payment Policy for Devices in Category B Investigational Device Exemption, Clinical Trials Policy and Drugs with Medicare Coverage with Evidence Development Designation</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=32">Proposed Changes to Medicaid Clinic Services Four Walls Exceptions</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=32">Proposed Changes to the Review Timeframes for the HOPD Prior Authorization Process</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=33">Next Steps</a></li><li><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf#page=33">Further Questions</a></li></ol></div><div class="col-md-4"><p><a href="/system/files/media/file/2024/07/Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.pdf" target="_blank" title="Click here to download the Regulatory Advisory: Hospital Outpatient, Ambulatory Surgical Center Proposed Rule for CY 2025 PDF."><img src="/sites/default/files/inline-images/Page-1-Regulatory-Advisory-Hospital-Outpatient-Ambulatory-Surgical-Center-Proposed-Rule-for-CY-2025.png" data-entity-uuid="297c2a11-29ab-4be0-9750-bb2378d95325" data-entity-type="file" alt="Regulatory Advisory: Hospital Outpatient, Ambulatory Surgical Center Proposed Rule for CY 2025 page 1." width="695" height="900"></a></p></div></div></div> Tue, 23 Jul 2024 13:55:59 -0500 Conditions of Participation <div class="container"> <div class="row"> <div class="col-md-8"> <p>The Centers for Medicare & Medicaid Services (CMS) July 17 issued updated <a href="https://www.cms.gov/files/document/qso-23-19-hospitals.pdf" target="_blank">regulatory guidance</a> regarding requirements for hospitals to assess patients and hospital environments for risks of patient harm. The guidance will influence how surveyors evaluate hospital compliance with Medicare Conditions of Participation (CoP).</p> <div class="panel module-typeC"> <div class="panel-heading"> <h3>KEY Highlights</h3> <p>CMS’ proposed policies would:</p> <ul> <li>Hospitals need not have the same ligature risk abatement configurations throughout the facility as long as the specific needs and risks of individual patients are considered;</li> <li>Corrective actions should focus on addressing particular findings of deficiencies rather than universal or facility-wide remedies;</li> <li>Hospitals can demonstrate compliance with patient safety rights by outlining the processes they are taking to minimize risks in accordance with nationally recognized standards and guidelines; and</li> <li>Updates are effective immediately — the State Operations Manual will be revised to reflect these changes.</li> </ul> </div> </div> <h2>AHA TAKE</h2> <p>The AHA is pleased that CMS will allow hospitals to use clinical evidence and nationally recognized standards and guidelines to assess and manage risk within their facilities rather than leaving evaluation of what is safe up to the arbitrary judgment of surveyors. The AHA has urged CMS to issue this updated guidance for several years to ensure patients can receive care in safe settings with respect, dignity and comfort without adopting requirements that would be excessively burdensome and potentially impractical for hospitals to meet.</p> <h2>BACKGROUND</h2> <p>Under the Medicare Hospital CoP at §482.13(c)(2), hospitals — including freestanding psychiatric facilities — are required to uphold a patient’s right to receive care in a safe setting. To evaluate the implementation of this requirement regarding patient self-harm, CMS first issued a memo in December 2017 comprising interim guidance regarding general definitions for ligature “resistant” or ligature “free” environments, timeframes for corrections of ligature risk deficiencies, and qualifications for waivers from this CoP.<sup>1</sup></p> <p>While CMS originally announced that this guidance would be reviewed by a CMS psychiatric task force, the task force did not convene as planned in July 2018 because the agency determined that “the proposed psychiatric task force to address environmental risks is not the most appropriate vehicle.”<sup>2</sup> Instead, CMS announced it would incorporate outcomes of The Joint Commission’s Suicide Panel into its interpretive guidance; in the interim, the agency noted that state survey agencies and accrediting organizations “may use their judgment” in determining whether facilities were in compliance.</p> <p>This lack of clarity in how surveyors were to evaluate compliance led to multiple reports by facilities of citations by surveyors that would require expensive environmental updates to remediate. The AHA sent a <a href="/letter/2018-10-23-letter-aha-urges-cms-issue-ligature-risk-guidance-hospitals" target="_blank">letter</a> to CMS urging the agency to update the guidance in October 2018. In April 2019, CMS issued a draft update for comment.<sup>3</sup></p> <p>Although the AHA and others submitted <a href="/system/files/media/file/2019/06/cms-proposed-guidance-on-ligature-risk-6-17-2019.pdf" target="_blank">comments</a> on this guidance by the June 19, 2019, deadline, it was never finalized. This meant that surveyors have used been using their “judgment” to determine compliance ever since. In May 2023, the AHA issued a <a href="/lettercomment/2023-05-18-aha-expresses-concern-lack-clear-and-actionable-guidance-environmental-risk-mitigation" target="_blank">letter</a> to CMS Administrator Chiquita Brooks-LaSure urging CMS to issue updated guidance addressing these issues. Throughout this period, AHA staff has been engaged with CMS through direct conversation on the issue.</p> <h2>SUMMARY OF GUIDANCE</h2> <p>In a short (four-page) memo to state survey agency directors, the directors of CMS’ Quality, Safety & Oversite Group and Survey & Operations Group state that hospitals can demonstrate compliance with the CoP on patient safety rights through appropriate patient assessments, adequate staffing and monitoring, and mitigation of environmental risks (i.e. strangulation attachment points, harmful substances, access to medications, breakable windows, accessible light figures, plastic bags, oxygen tubing, bell cords, etc.).</p> <p>CMS clarifies that hospitals are not expected to apply the same ligature risk configuration throughout their facility; instead, hospitals should focus on the specific needs and risks of individual patients based on their clinical or psychiatric assessments. Along the same lines, surveyors should focus corrective actions in response to deficiencies or adverse events on appropriately addressing particular findings or failures “rather than universal remedies.” The agency provides the example of the attempted use of a door as a ligature point, and notes that this would not mean that all patient doors throughout the facility need to be replaced.</p> <p>Instead, surveyors should concentrate their investigation on underlying causes of lapses in safe patient care, such as insufficient monitoring or patient assessment, and consider all contributing factors in initiating corrective actions. Concordantly, patient safety issues should be cited at the appropriate CoP depending on the specific type of non-compliance; these include (but are not limited to) Patient Rights, Physical Environment, and Nursing Services.</p> <h3>Elements of Patient Safety Assessments</h3> <p>CMS lists three main elements that hospitals should consider in ensuring patient safety related to ligature risks. They include:</p> <ol> <li>Patient Assessment: although CMS does not require or endorse the use of a particular patient assessment tool, the agency does suggest hospitals review recommendations and resources from the 2018 <a href="https://theactionalliance.org/sites/default/files/action_alliance_recommended_standard_care_final.pdf" target="_blank">report</a> “Recommended Standard Care for People with Suicide Risk” from the National Action Alliance for Suicide Prevention, on which multiple AHA staff serve as advisors.<br>  </li> <li>Staffing/Monitoring: CMS notes that hospitals have the flexibility to provide the appropriate level of education and training to staff regarding the identification of risks and mitigation strategies. “Staff” is not limited to direct employees. Hospitals are expected to provide education and training to all new staff upon orientation and whenever policies and procedures change, and CMS recommends ongoing training at least every two years.<br>  </li> <li>Environmental Risk: Risk assessments should be appropriate to each unit, the specific care environment and the specific patient population. These strategies may not be the same in all hospitals or hospital units.</li> </ol> <h2>FURTHER QUESTIONS</h2> <p>Please contact Caitlin Gillooley, AHA’s director of behavioral health and quality policy, at <a href="mailto:mailto:cgillooley@aha.org" target="_blank">cgillooley@aha.org</a> or (202) 626-2267 with any questions.</p> <p>__________</p> <p class="Default"><span><span><span><span><sup>1</sup> </span><span>S&C Memo: 18-06 Hospitals, “Clarification of Ligature Risk Policy,” December 8, 2017. </span><span><span>https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-18-06.pdf </span></span></span></span></span><br> <span><span><span><sup><span>2 </span></sup><span>QSO: 18-21 All Hospitals, “CMS Clarification of Psychiatric Environmental Risks,” July 20, 2018. </span><span><span>https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO18-21-Hospitals.pdf </span></span></span></span></span><br> <span><span><span><sup><span><span>3 </span></span></sup><span><span>Ref: DRAFT-QSO-19-12 Hospitals, “DRAFT ONLY –Clarification of Ligature Risk Interpretive Guidelines – FOR ACTION,” April 19, 2019. <span>https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/QSO-19-12-Hospitals.pdf </span></span></span> </span></span></span></p> </div> <div class="col-md-4"><a href="/system/files/media/file/2023/07/cms-issues-updated-guidance-on-ligature-risk-and-assessment-in-hospitals-bulletin-7-18-2023.pdf" target="_blank"><img alt="Cover CMS Issues Updated Guidance on Ligature Risk and Assessment in Hospitals" data-entity-type="file" data-entity-uuid="9551377b-9ad6-46b8-a4c6-d74b178e8a7d" src="/sites/default/files/inline-images/cover-cms-issues-updated-guidance-on-ligature-risk-and-assessment-in-hospitals-bulletin-7-18-2023.png" width="510" height="659"></a></div> </div> </div> Tue, 18 Jul 2023 09:55:38 -0500 Conditions of Participation /lettercomment/2022-08-26-aha-comments-cms-proposed-conditions-participation-rural-emergency <p>August 26, 2022</p> <p>The Honorable Chiquita Brooks-LaSure<br /> Administrator<br /> Centers for Medicare & Medicaid Services<br /> 7500 Security Blvd<br /> Baltimore, MD 21244</p> <p><em><strong>RE: Comments on Conditions of Participation for Rural Emergency Hospitals and Critical Access Hospital Conditions of Participation Updates (CMS-3419-P)</strong></em></p> <p>Dear Administrator Brooks-LaSure:</p> <p>On behalf of our nearly 5,000 member hospitals, health systems and other health care organizations, including our rural and critical access hospitals (CAHs), 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) appreciates the opportunity to provide comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed conditions of participation (CoPs) for rural emergency hospitals (REHs) and CAHs.</p> <p>Ensuring all communities have access to high quality health care is a top priority for the AHA and its members. While this commitment is true for all communities, it is clear that particular focus must be paid to rural communities. Rural hospitals and CAHs struggle to attract and retain sufficient numbers of physicians, nurses and other health care providers; they frequently are the only available source of urgent and emergent care for many miles; they have to stretch available resources due to financial constraints, especially for the past several years; and they face new challenges as a result unprecedented workforce burnout. These difficulties, compounded by the COVID-19 pandemic, played key roles in a record number of rural hospital closures in 2020 with 19 rural hospitals closing in that year alone.</p> <p>We remain dedicated to making sure every community has access to critical health care services. As we continue to look for ways to meet the health care needs of rural communities, we appreciate CMS’ efforts to assist rural providers as they navigate these exceptionally difficult times. We support the agency’s proposal to allow rural providers to continue to serve their communities by becoming an REH. This new model will help preserve necessary health care services in already underserved areas. We also are supportive of CMS’ proposal to update certain CoPs for CAHs including embracing a system-level compliance approach for certain requirements, establishing a patient’s bill of rights and streamlining the CAH distance determination process.</p> <p>Through this proposed rule, CMS is taking important steps to assist America’s rural hospitals and health systems. We look forward to continuing to work with the agency to ensure a seamless and thoughtful implementation of these changes.</p> <p>View AHA's detailed comments below.</p> Fri, 26 Aug 2022 12:50:56 -0500 Conditions of Participation <p>The Centers for Medicare & Medicaid Services (CMS) yesterday <a href="https://public-inspection.federalregister.gov/2022-14153.pdf">released</a> a proposed rule seeking comment on potential Conditions of Participation (CoPs) for certain rural and Critical Access Hospitals (CAHs) seeking to convert from their current status to be designated as a Rural Emergency Hospital (REH). In addition, the agency’s proposal would update certain CAH CoPs, which include changes to primary road and distance requirements, establishing a patient’s rights CoP and allowing for unified and integrated systems for certain requirements if the CAH is a part of a health system. The deadline to submit comments on these proposals is Aug. 29, 2022.</p> <h2>AHA TAKE</h2> <p>Ensuring that communities across the country have access to high quality, critical health care services is a top priority for the AHA and particular attention must be paid to the nation’s rural communities given the unique challenges rural providers face. The AHA supports CMS’ efforts to provide another avenue for rural providers to continue to serve their communities through the newly established REH designation, and we look forward to continuing to work with CMS on implementation of this program. The REH designation would enable providers to continue to provide essential services in their communities at a time when meeting rural health care needs is especially challenging. Rural hospitals often struggle with their remote location, limited workforce and constrained resources. Indeed, a record number of rural hospital closures occurred in 2020. In addition, while we continue to review the proposed updates to CAH CoPs in more detail, we are encouraged by and supportive of the agency’s interest in and recognition of the benefit of allowing a system-level approach for compliance with certain requirements.</p> <h2>HIGHLIGHTS FROM THE PROPOSED RULE</h2> <h3>Rural Emergency Hospitals</h3> <p>REHs were established as a new provider type by the Consolidated Appropriations Act of 2021 in an effort to address concerns that certain rural hospitals would not be able to sustain operations and communities would suffer from a loss of critical health care services. Under the new REH designation, CAHs and certain rural hospitals have the opportunity to convert to a REH, allowing those entities to continue to provide certain essential health care services to the communities they serve without providing the full suite of inpatient acute care services. If a CAH or rural hospital coverts to a REH, they are permitted to provide emergency services, observation care and certain additional medical and health outpatient services if the provider chooses. However, <strong>the annual per patient average stay may <u>not</u> exceed 24 hours.</strong></p> <p>Given the unique nature of REHs, CMS, in its proposed rule, lays out several REH-specific CoPs that seek to align with certain CAH and ambulatory surgical center CoPs already in existence. These include aligning governing body and organizational structure requirements with those that currently apply to CAHs; aligning the provision of services CoP with current CAH requirements; requiring REHs to comply with both the CAH and hospital emergency services CoPs; aligning laboratory and radiological services requirements with current CAH CoPs; and creating a new pharmaceutical services CoP that aligns with current requirements for CAHs, among others.</p> <p>While many of the proposed compliance standards for REHs align with standards already in place for CAHs, CMS is seeking comment on several proposed REH-specific provisions, which include:</p> <ul> <li>The ability of a REH to provide low-risk childbirth-related labor and delivery services;</li> <li>Whether the agency should require that a REH choosing to provide labor services also provide outpatient surgical services in the event that surgical labor and delivery intervention is necessary; and</li> <li>Whether it is appropriate for a REH to allow a doctor of medicine or osteopathy, physician assistant, nurse practitioner or clinical nurse specialist, with training or experience in emergency medicine, to be on-call and immediately available by telephone or radio contact and available on site within a specified timeframe.</li> </ul> <p>Finally, the REH provisions in this proposed rule focus solely on CoPs. <strong>Provisions pertaining to payment, quality measurement, program designation and enrollment will be included in separate rulemaking, which we expect to be the agency’s Calendar Year 2023 Outpatient Prospective Payment System proposed rule</strong>, which has not yet been released.</p> <h3>Proposed Updates to CAH CoPs</h3> <p>In its proposed rule, CMS seeks comment on updates to certain CoPs for CAHs, including:</p> <p><strong>Location and distance requirements</strong>. CMS proposes adding a definition for “primary roads” to its location and distance requirements and clarifying that the location distance for a CAH is more than a 35-mile drive on primary roads from a hospital or another CAH. Under the proposal, “primary road” would be specified as “a numbered Federal highway; or a numbered state highway with two or more lanes each way.”</p> <p>If finalized, CMS intends to establish a centralized, data-driven review process of all hospitals and CAHs within a 50-mile radius of the CAH with a follow-up investigation on expanded health care capacity and access within a 35-mile radius of the CAH. CAHs with no new hospitals in a 50-mile radius will be automatically recertified, while those with new hospitals within the 50-mile radius will be subject to additional review.</p> <p><strong>Patient’s Rights</strong>. CMS proposes to establish a CoP for patient’s rights that would set forth the rights of all patients to receive care in a safe setting and provide protection for a patient’s emotional health and safety and physical safety. This CoP would include requirements for the CAH to inform patients of their rights; address privacy and safety; adhere to the confidentiality of patient records; ensure appropriate use of restraint and seclusion; and adhere to patient visitation rights.</p> <p><strong>Allowing for Unified and Integrated Systems for Certain Requirements</strong>. The agency proposes to allow CAHs that are part of a system containing more than one hospital or CAH to utilize a system-level approach to comply with CoPs for infection control and prevention and antibiotic stewardship programs; medical staff; and quality assessment and performance programs. These updates would align CAH opportunities for a system-level approach with hospital standards currently in place. In these instances, the single governing body for a system would be responsible for ensuring each separately certified CAH is in compliance with the applicable standards.</p> <h2>NEXT STEPS</h2> <ul> <li>Please share this Special Bulletin with your leadership team, chief compliance officer and other senior management.</li> <li>Inform AHA staff of any significant concerns associated with the proposed rule.</li> <li>The deadline for comments on the proposed rule is Aug. 29, 2022.</li> </ul> <h2>FURTHER QUESTIONS</h2> <p>If you have further questions, please contact Nancy Foster at <a href="http://mailto:nfoster@aha.org" target="_blank">nfoster@aha.org</a> or Mark Howell at <a href="http://mailto:mhowell@aha.org" target="_blank">mhowell@aha.org</a>.</p> Fri, 01 Jul 2022 11:24:20 -0500 Conditions of Participation /special-bulletin/2021-11-15-cms-issues-final-hospital-co-location-guidance <p>The Centers for Medicare & Medicaid Services (CMS) Nov. 12 issued <a href="https://www.cms.gov/files/document/qso-19-13-hospital-revised.pdf" target="_blank">revised final guidance</a> for hospitals interested in co-locating with other hospitals or health care facilities. The guidance is effective as of Nov. 12. Under the guidance, all hospitals will have increased flexibility when entering into co-location partnerships.</p> Mon, 15 Nov 2021 10:28:29 -0600 Conditions of Participation Tue, 08 Sep 2020 15:19:28 -0500 Conditions of Participation /lettercomment/2020-09-04-aha-cms-regarding-covid-19-data-reporting-requirements-hospitals-and <p>AHA urges the Centers for Medicare & Medicaid Services (CMS) to withdraw the condition of participation that hospitals report daily COVID-19 data. However, given the significant implications of this new requirement, if the agency is intent upon moving forward with this misguided policy, <strong>we request that CMS immediately release detailed interpretive guidance so hospitals can take the necessary steps to come into compliance. </strong>View details under key resources below.</p> Fri, 04 Sep 2020 12:20:07 -0500 Conditions of Participation /special-bulletin/2020-08-26-aha-summary-cms-interim-final-rule-covid-19-requirements-providers <div class="container"> <div class="row"> <div class="col-md-8"> <p class="text-align-center"><strong><a class="btn btn-primary btn-wide" href="/system/files/media/file/2020/08/cms-interim-final-rule-makes-hospital-covid-19-reporting-cop-enforces-new-testing-requirements-bulletin-8-26-20.pdf">Sign In to Download the Special Bulletin:<br /> CMS Interim Final Rule Makes Hospital COVID-19 Reporting a Condition of Participation and Enforces New Testing Requirements, Among Other Changes</a></strong></p> <p> </p> <p>The Centers for Medicare & Medicaid Services (CMS) yesterday released an <a href="https://www.cms.gov/files/document/covid-ifc-3-8-25-20.pdf">interim final rule</a> setting forth new COVID-19 related requirements for health care providers and laboratories, among other entities. The rule makes collecting and reporting COVID-19 data a condition of participation for hospitals to participate in the Medicare program, among other changes.</p> <p>The rule is effective upon publication in the Federal Register. CMS will accept comments for 60 days after it is published.</p> </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"> <p>CMS’s interim final rule:</p> <ul> <li>Makes the daily collection and reporting of COVID-19-related data a condition of participation for hospitals in the Medicare program, potentially subjecting hospitals to termination from participation in the Medicare and Medicaid programs for noncompliance.</li> <li>Implements new laboratory reporting requirements in accordance with the CARES Act, subjecting noncompliance to potential civil monetary penalties.</li> <li>Instructs surveyors to inspect nursing homes for adherence to new COVID-19 testing requirements with the potential for civil monetary penalties in instances of violations.</li> <li>Proposes to update the performance period for the SNF VBP program in light of the extraordinary circumstance exception extended to the value programs.</li> <li>Clarifies that CMS will not use any data from quarters 1 and 2 of 2020 in calculating performance in future years of certain Hospital Value Programs.</li> <li>Clarifies that insurers offering temporary premium credits to enrollees should report the actual premiums billed each month.</li> </ul> </div> </div> </div> </div> </div> Wed, 26 Aug 2020 15:26:01 -0500 Conditions of Participation