Corporate Compliance

Is your facility doing everything that it can to be compliant? With all of the updates in one place below, you can stay up to date on OIG guidance and the requirements of the Affordable Care Act standards. Also, learn about the most effective prevention tactics to protect your facility from non-compliance so that you can focus on what’s most important - caring for your residents.

  • CMS Urgent Call to Action: Staff, Managers Should Complete QSEP Nursing Home COVID-19 Training (11/20)

    By CMS - November 17, 2020

    Agency thanks nursing homes whose staff have completed free CMS training, but urges remaining homes to take advantage of this resource

    The Centers for Medicare & Medicaid Services (CMS) is publicly recognizing the 1,092 nursing homes at which 50% or more of their staff have completed CMS training designed to help staff combat the spread of coronavirus disease 2019 (COVID-19) in nursing homes. CMS applauds these facilities for taking this critical step to equip their staff with the latest information regarding infection control, vaccine distribution, and other topics.

    There are 125,506 individuals from 7,313 nursing homes who have completed the training. This represents approximately 12.5% of the approximately one million nursing home staff in the country. With today’s announcement, CMS is calling on nursing homes to take action, urging them to require their staff to take this free training, as part of the Trump Administration’s continued efforts to keep nursing home residents safe.

    “We’ve provided nursing homes with $20 billion in federal funding, millions of pieces of PPE, free testing machines and supplies, and significant technical assistance and on-the-ground support,” said CMS Administrator Seema Verma. “Ultimately, the ownership and management of every nursing must take it on themselves to ensure their staff is fully equipped to keep residents safe. With coronavirus cases increasing across the country and infection control identified as a major issue, we encourage all nursing homes to take advantage of this no-cost opportunity to train their staff.”

    The training includes multiple modules, with emphases on topics such as infection control, screening and surveillance, personal protective equipment (PPE) usage, disinfection of the nursing home, cohorting and caring for individuals with dementia during a pandemic. CMS developed this training in consultation with the Centers for Disease Control and Prevention (CDC) and expert stakeholders, and announced the training on August 25, 2020. For anyone interested, the training is free to access on a public CMS website; instructions on how to create an account and take the training are available at qsep.cms.gov/welcome.aspx.

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  • HHS Stark Law and Anti-Kickback Reforms to Support Coordinated, Value-Based Care Could Bring Opportunities for SNFs (11/20)

    By HHS - November 16, 2020
    The Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system into one that pays for value and promotes the delivery of coordinated care.

    The rules provide greater flexibility for healthcare providers to participate in value-based arrangements and to provide coordinated care for patients. The final rules also ease unnecessary compliance burden for healthcare providers and other stakeholders across the industry, while maintaining strong safeguards to protect patients and programs from fraud and abuse.

    The HHS Office of Inspector General (OIG) issued the final rule “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements,” and the Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations.” These rules are part of HHS’s Regulatory Sprint to Coordinated Care, which has examined federal regulations that potentially impede healthcare providers’ efforts that otherwise would advance the transition to value-based care and improve the coordination of patient care across care settings in Federal healthcare programs and the commercial sector. In addition to advancing value-based care, the CMS final rule clarifies and modifies existing policies to ease unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the physician self-referral law’s (often called the “Stark Law”) goal of protecting patients from unnecessary services and being steered to less convenient, lower quality, or more expensive services because of a physician’s financial self-interest.

    The new and amended regulations related to the federal Anti-Kickback statute and the civil monetary penalties law issued by OIG address stakeholder concerns that these laws unnecessarily limit the ways in which healthcare providers can coordinate care with and for federal healthcare program beneficiaries. OIG’s final rule modifies and clarifies the agency’s proposed rule in response to comments, as explained in the preamble to the final rule. 

    For example, OIG’s final rule clarifies how medical device manufacturers and durable medical equipment companies may participate in protected care coordination arrangements that involve digital health technology, and the final rule lowers the level of “downside” financial risk parties must assume to qualify under the new safe harbor for value-based arrangements that involve substantial downside financial risk. In recognition of the urgent problem of cyber threats to the healthcare industry, the rule also broadens the new safe harbor for cybersecurity technology and services to protect cybersecurity-related hardware. 

    OIG’s final rule, and the CMS final rule to the extent the Stark Law is applicable, would facilitate a range of arrangements to improve the coordination and management of patient care and the engagement of patients in their treatment if all applicable regulatory conditions are met, including the following examples:

    • To improve patient transitions from one care delivery point to the next, a hospital may wish to provide physician offices with care coordinators that furnish individually tailored case management services for patients requiring post-acute care.
    • A hospital may wish to provide support and to reward institutional post-acute providers for achieving outcome measures that effectively and efficiently coordinate care across care settings and reduce hospital readmissions.  Such measures would be aligned with a patient’s successful recovery and return to living in the community. 
    • A primary care physician or other provider may wish to furnish a smart tablet that is capable of two-way, real-time interactive communication between the patient and his or her physician.  The patient’s access to a smart tablet could facilitate communication through telehealth and the provision of in-home services.
    • A health system furnishes cybersecurity technology to physician practices to reduce harm from cyber threats to all their systems.
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  • OSHA COVID-19 Citations: Lessons Learned (11/20)

    By OSHA - November 13, 2020

    The Occupational Safety and Health Administration cites lessons learned from its COVID-19 inspections and citations, as well as noting nursing homes and other companies that have been fined since the COVID-19 pandemic began.

     Lessons Learned: Frequently Cited Standards Related to COVID-19 Inspections.(November 6, 2020).

    Common COVID-19 Citations: Helping Employers Better Protect Workers and Comply with OSHA Regulations. (November 6, 2020).

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  • OSHA Respiratory Protection Guidance for Nursing Homes (11/20)

    By Occupational Safety and Health Administration - November 03, 2020

    Respiratory Protection Guidance for the Employers of Those Working in Nursing Homes, Assisted Living, and Other Long-Term Care Facilities During the COVID-19 Pandemic

    This guidance is designed specifically for nursing homes, assisted living, and other long-term care facilities (LTCFs) (e.g., skilled nursing facilities, inpatient hospice, convalescent homes, and group homes with nursing care). While this guidance focuses on protecting workers from occupational exposure to SARS-CoV-2 (the virus that causes COVID-19 disease) by the use of respirators, primary reliance on engineering and administrative controls for controlling exposure is consistent with good industrial hygiene practice and with OSHA’s traditional adherence to a “hierarchy of controls.”

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  • Cybersecurity Alert: Ransomware Activity Targeting the Healthcare and Public Health Sector (10/20)

    By ASPR TRACIE - October 30, 2020
    The U.S. Department of Health and Human Services (HHS), the Cybersecurity and Infrastructure Security Agency (CISA), and the Federal Bureau of Investigation (FBI) have developed a cybersecurity alert related to an increased and imminent cybercrime threat to U.S. hospitals and healthcare providers: "Alert (AA20-302A) Ransomware Activity Targeting the Healthcare and Public Health Sector." This advisory describes the tactics, techniques, and procedures (TTPs) used by cybercriminals against targets in the Healthcare and Public Health Sector (HPH) to infect systems with Ryuk ransomware for financial gain. CISA, FBI, and HHS are sharing this information to provide warning to healthcare providers to ensure that they take timely and reasonable precautions to protect their networks from these threats.
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  • SNF ABN (Form CMS-10055): CMS Adds New Fillable PDF Version (10/20)

    By CMS - October 07, 2020

    Skilled Nursing Facilities (SNFs) must issue a notice to Original Medicare (fee for service - FFS) beneficiaries in order to transfer potential financial liability before the SNF provides:

    • an item or service that is usually paid for by Medicare, but may not be paid for in this particular instance because it is not medically reasonable and necessary, or
    • custodial care.

    For Part A items and services: SNFs use the SNF ABN as the liability notice.

    For Part B items and services: SNFs use the Advance Beneficiary Notice of Non-coverage (ABN), Form CMS-R-131. The ABN and information on this notice can be found at /Medicare/Medicare-General-Information/BNI/ABN.

    Note: The SNFABN process is separate from the expedited determination process. So the SNFABN does not replace the Notice of Medicare Noncoverage (NOMNC). Each notice is used to meet the requirements of the separate processes.

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  • COVID-19 Testing in Nursing Homes: Interim Final Rule Effective 9/02/20, Two QSO Memos With Related Survey Changes, & Algorithm for Interpreting Test Results (8/20)

    By CMS - August 30, 2020

    Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION: Interim final rule with comment period.

    SUMMARY: This interim final rule with comment period (IFC) revises regulations to strengthen CMS’ ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public health officials in detecting outbreaks and saving lives, and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services (Secretary)in such form and manner, and at such timing and frequency, as the Secretary may prescribe during the Public Health Emergency (PHE).

    DATES: Effective date: These regulations are effective on 09/02/20.


    QSO-20-38-NH

    Memorandum Summary

    • CMS is committed to taking critical steps to ensure America’s healthcare facilities continue to respond effectively to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE).

    • On August 25, 2020, CMS published an interim final rule with comment period (IFC). This rule establishes Long-Term Care (LTC) Facility Testing Requirements for Staff and Residents. Specifically, facilities are required to test residents and staff, including individuals providing services under arrangement and volunteers, for COVID-19 based on parameters set forth by the HHS Secretary. This memorandum provides guidance for facilities to meet the new requirements.

    • Revised COVID-19 Focused Survey Tool - To assess compliance with the new testing requirements, CMS has revised the survey tool for surveyors. We are also adding to the survey process the assessment of compliance with the requirements for facilities to designate one or more individual(s) as the infection preventionist(s) (IPs) who are responsible for the facility's infection prevention and control program (IPCP) at 42 CFR § 483.80(b). In addition, we are making a number of revisions to the survey tool to reflect other COVID-19 guidance updates.

     

    QSO-20-37-CLIA,NH

    Memorandum Summary

    • CMS is committed to taking critical steps to ensure America’s healthcare facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE).

    • On August 25, 2020, an interim final rule with comment period (IFC) went on display at the Federal Register.

    • CLIA regulations have been updated to require all laboratories to report SARS-CoV-2 test results in a standardized format and at a frequency specified by the Secretary.

    • Failure to report SARS-CoV-2 test results will result in a condition level violation of the CLIA regulation and may result the imposition of a Civil Money Penalty (CMP) as required under §§ 493.1804 and 493.1834.

    • Long-Term Care (LTC) Enforcement requirements at 42 CFR part 488 have been revised to include requirements specific to the imposition of a CMP for nursing homes that fail to report requisite COVID-19 related data to the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) per §483.80(g)(1) and (2).

    • LTC Facility Testing Requirements for Staff and Residents- Facilities are required to test staff and to offer testing to all nursing home residents.

     

    Considerations for Interpreting Antigen Test Results in Nursing Homes Algorithm pdf icon[PDF – 200 KB]  – August 26, 2020

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  • COVID-19 Testing: CDC Says Repeated Point Prevalence Surveys Can ID Asymptomatic Cases in SNFs (7/20)

    By CDC - July 01, 2020

    Initial and Repeated Point Prevalence Surveys to Inform SARS-CoV-2 Infection Prevention in 26 Skilled Nursing Facilities — Detroit, Michigan, March–May 2020

    Early Release / July 1, 2020 / 69

    Guillermo V. Sanchez, MSHS, MPH1; Caitlin Biedron, MD1; Lauren R. Fink, MPH2; Kelly M. Hatfield, MSPH1; Jordan Micah F. Polistico, MD3,4; Monica P. Meyer, MS, MPH3,4; Rebecca S. Noe, MN, MPH1; Casey E. Copen, PhD1; Amanda K. Lyons, MS1; Gonzalo Gonzalez, DNP2; Keith Kiama2; Mark Lebednick2; Bonnie K. Czander2; Amen Agbonze2; Aimee R. Surma, MS2; Avnish Sandhu, DO3,4; Valerie H. Mika, MS4; Tyler Prentiss, MA5; John Zervos, JD5; Donia A. Dalal2; Amber M. Vasquez, MD1; Sujan C. Reddy, MD1; John Jernigan, MD1; Paul E. Kilgore, MD4; Marcus J. Zervos, MD4,5; Teena Chopra, MD3,4; Carla P. Bezold, ScD2; Najibah K. Rehman, MD2 (View author affiliations)

    View suggested citation

    Summary

    What is already known about this topic?

    Symptom-based screening in skilled nursing facilities (SNFs) is inadequate to detect SARS-CoV-2 transmission. Repeated point prevalence surveys (serial testing of all residents and health care personnel at a health care facility irrespective of symptoms) can identify asymptomatic cases during outbreaks.

    What is added by this report?

    Repeated point prevalence surveys at 26 Detroit SNFs identified an attack rate of 44%; within 21 days of diagnosis, 37% of infected patients were hospitalized and 24% died. Among 12 facilities participating in a second survey and receiving on-site infection prevention and control (IPC) support, the percentage of newly identified cases decreased from 35% to 18%.

    What are the implications for public health practice?

    Repeated point prevalence surveys in SNFs can identify asymptomatic COVID-19 cases, inform cohorting and IPC practices, and guide prioritization of health department resources.

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  • Calendar Q2 2020 PBJ Staffing Data Due Aug. 14, 2020 and Five-Star/Nursing Home Compare Updates From CMS (6/20)

    By CMS - June 26, 2020

    Changes to Staffing Information and Quality Measures Posted on the Nursing Home Compare Website and Five Star Quality Rating System due to the COVID-19 Public Health Emergency

    Memo #QSO 20-34-NH

    Posting Date 2020-06-25

    Fiscal Year 2020

    Summary

    The Centers for Medicare & Medicaid Services (CMS) is committed to transparency about changes in publicly reported information on nursing homes during the COVID-19 public health emergency. Changes to the Nursing Home Compare Website and Five Star Quality Rating System:

    • Staffing Measures and Ratings Domain: On July 29, 2020, Staffing measures and star ratings will be held constant, and based on data submitted for Calendar Quarter 4 2019.

    o Also, CMS is ending the waiver of the requirement for nursing homes to submit staffing data through the Payroll-Based Journal System. Nursing homes must submit data for Calendar Quarter 2 by August 14, 2020.

    • Quality Measures: On July 29, 2020, quality measures based on a data collection period ending December 31, 2019 will be held constant.

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  • COVID-19: Many States Have Multiple State-Specific Section 1135 Waivers (6/20)

    By CMS - June 19, 2020

    CMS approved additional state Medicaid waiver requests under Section 1135 of the Social Security Act (Act). The waivers were approved within days of states’ submitting them, and offer states new flexibilities to focus their resources on combating the outbreak and providing the best possible care to Medicaid beneficiaries in their states. The waivers were approved within days of states' submitting them, and offer states new flexibilities to focus their resources on combating the outbreak and providing the best possible care to Medicaid beneficiaries in their states.

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  • CMS State Operations Manual Update Addresses Voluntary Terminations From Medicare/Medicaid (6/20)

    By CMS - June 12, 2020

    SUBJECT: State Operations Manual (SOM) Chapter 2, The Certification Process

    I. SUMMARY OF CHANGES: The SOM Chapter 2 sections that provide instructions on voluntary termination work is revised. The revisions are part of an effort to streamline the enrollment process for certified providers/suppliers. Certain certification functions performed by the CMS regional locations are transitioning to CMS’ Center for Program Integrity (CPI) Provider Enrollment Oversight Group (PEOG) and the Medicare Administrative Contractors (MACs). The voluntary termination work is the first phase of the certification work to transition. The MAC will process and finalize voluntary termination actions and will coordinate with the State Survey Agency directly as needed. The approval recommendation made to the CMS regional locations by the MAC has been removed. The MAC will notify the provider or supplier of approval of voluntary termination and send copies of the letter to the State Survey Agency, CMS regional locations and Accrediting Organizations. Additionally, Community Mental Health Center (CMHC) sections 2252A through 2252F are being deleted since they were mistakenly omitted from Transmittal 197.

     

    SUBJECT: State Operations Manual (SOM) Chapter 3, Additional Program Activities

    I. SUMMARY OF CHANGES: The SOM Chapter 3 sections that provide instructions on voluntary termination work is revised. The revisions are part of an effort to streamline the enrollment process for certified providers/suppliers. Certain certification functions performed by the CMS regional locations are transitioning to CMS’ Center for Program Integrity (CPI) Provider Enrollment Oversight Group (PEOG) and the Medicare Administrative Contractors (MACs). The voluntary termination work is the first phase of the certification work to transition. The MAC will process and finalize voluntary termination actions and will coordinate with the State Survey Agency directly as needed. The approval recommendation made to the CMS regional locations by the MAC has been removed. The MAC will notify the provider or supplier of approval of voluntary termination and send copies of the letter to the State Survey Agency, CMS regional locations and Accrediting Organizations.

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  • OIG Targets Monitoring Psychotropic Drug Use in Nursing Homes (5/20)

    By OIG - May 18, 2020
    Previous OIG work found that elderly nursing home residents who were prescribed antipsychotics, a type of psychotropic drug, were at risk for harm. In response, the Centers for Medicare & Medicaid Services (CMS) took steps to address the risk of harm to nursing home residents. One such step was introducing a quality measure to track the rates of antipsychotic drug use in residents without an appropriate diagnosis. Recently, CMS and researchers expressed concerns that some nursing homes underreport antipsychotic drug use and may inaccurately report certain patient diagnoses in order to avoid CMS monitoring. Additionally, research on antipsychotic drug use has highlighted the need to closely monitor all psychotropic drug use to accurately oversee drug use in nursing homes. We will determine the extent to which there are inconsistencies, if any, between (1) Medicare claims data for residents prescribed psychotropic drugs compared to nursing home self-reported data on residents who received psychotropic drugs, and (2) Medicare claims data as it relates to the diagnoses that exclude residents from monitoring in the antipsychotic quality measure compared to nursing home self-reported data on resident diagnoses.
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  • CMS COVID-19 Stakeholder Engagement Calls – Week of 5/18/20

    By CMS - May 18, 2020

    CMS hosts varied recurring stakeholder engagement sessions to share information related to the agency’s response to COVID-19. These sessions are open to members of the healthcare community and are intended to provide updates, share best practices among peers, and offer attendees an opportunity to ask questions of CMS and other subject matter experts.

    Call details are below. Conference lines are limited so we highly encourage you to join via audio webcast, either on your computer or smartphone web browser. You are welcome to share this invitation with your colleagues and professional networks. 

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  • LTCSP Survey F-Tag List by Regulatory Grouping UPDATED and Additional Resources (5/20)

    By CMS - May 17, 2020
    These resources from CMS include a list of F-tags by regulatory grouping used in the Long-term Care Survey Process (LTCSP) effective Nov. 28, 2017, and a crosswalk between old and new F-tags. CMS updated the tag list in May 2020.
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  • CMS Finetunes Targeted Infection Control Inspections; Tells SNFs/NFs to Complete Voluntary Self-Assessment With COVID-19 Focused Survey Tool (3/20)

    By CMS - March 23, 2020

    Memorandum Summary

     

    • On Friday, March 13, 2020, the President declared a national emergency, which triggers the Secretary’s ability to authorize waivers or modifications of certain requirements pursuant to section 1135 of the Social Security Act (the Act). Under section 1135(b)(5) of the Act, CMS is prioritizing surveys by authorizing modification of timetables and deadlines for the performance of certain required activities, delaying revisit surveys, and generally exercising enforcement discretion for three weeks.
    • During this three-week time frame, only the following types of surveys will be prioritized and conducted:
    • Complaint/facility-reported incident surveys: State survey agencies (SSAs) will conduct surveys related to complaints and facility-reported incidents (FRIs) that are triaged at the Immediate Jeopardy (IJ) level. A streamlined Infection Control review tool will also be utilized during these surveys, regardless of the Immediate Jeopardy allegation.
    • Targeted Infection Control Surveys: Federal CMS and State surveyors will conduct targeted Infection Control surveys of providers identified through collaboration with the Centers for Disease Control and Prevention (CDC) and the HHS Assistant Secretary for Preparedness and Response (ASPR). They will use a streamlined review checklist to minimize the impact on provider activities, while ensuring providers are implementing actions to protect the health and safety of individuals to respond to the COVID-19 pandemic.
    • Self-assessments: The Infection Control checklist referenced above will also be shared with all providers and suppliers to allow for voluntary self-assessment of their Infection Control plan and protections
    • During the prioritization period, the following surveys will not be authorized: Standard surveys for long term care facilities (nursing homes), hospitals, home health agencies (HHAs), intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and hospices. This includes the life safety code and Emergency Preparedness elements of those standard surveys; and revisits that are not associated with IJ.
    • Furthermore, for Clinical Laboratory Improvement Amendments (CLIA), we intend to prioritize immediate jeopardy situations over recertification surveys, and generally intend to use enforcement discretion, unless immediate jeopardy situations arise.
    • Finally, initial certification surveys will continue to be authorized in accordance within current guidance and prioritization.

     Additional Instructions for Nursing Homes

    We are disseminating the Infection Control survey developed by CMS and CDC so facilities can educate themselves on the latest practices and expectations. We expect facilities to use this new process, in conjunction with the latest guidance from CDC, to perform a voluntary self-assessment of their ability to prevent the transmission of COVID-19. This document may be requested by surveyors, if an onsite investigation takes place. We also encourage nursing homes to voluntarily share the results of this assessment with their state or local health department Healthcare-Associated Infections (HAI) Program. Contact information for each state’s health departments is identified on the Centers for Disease Control & Prevention’s (CDC’s) website at:https://www.cdc.gov/HAI/state-based/index.html.

    Furthermore, we remind facilities that they are required to have a system of surveillance designed to identify possible communicable diseases or infections before they can spread to other persons in the facility, and when and to whom possible incidents of communicable disease or infections should be reported (42 CFR 483.80(a)(2)(i) and (ii)). CDC recommends that nursing homes notify their health department about residents with severe respiratory infection, or a cluster of respiratory illness (e.g., > or = 3 residents or HCP with new-onset respiratory symptoms within 72 hours). Local and state reporting guidelines or requirements may vary. Monitor the CDC website for information and resources to help prevent the introduction and spread of COVID-19 in nursing homes (CDC Preparing for COVID-19: Long-term Care Facilities, Nursing Homes:https://www.cdc.gov/coronavirus/2019-ncov/healthcare-facilities/prevent-spread-in-long-term-care-facilities.html ).

    We urge providers to review the tools and implement actions to protect the health and safety of individuals to respond to the COVID-19 pandemic.

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