HHS Renews the Declaration of a Public Health Emergency

On July 23, HHS Secretary Alex M. Azar III renewed the COVID-19 Public Health Emergency declaration.

As a result of the continued consequences of Coronavirus Disease 2019 (COVID-19) pandemic, on this date and after consultation with public health officials as necessary, I, Alex M. Azar II, Secretary of Health and Human Services, pursuant to the authority vested in me under section 319 of the Public Health Service Act, do hereby renew, effective July 25, 2020, my January 31, 2020, determination that I previously renewed on April 21, 2020, that a public health emergency exists and has existed since January 27, 2020, nationwide.

Ambulance Crews and In-Home Care Providers Seek Collaboration

From Home Health Care News

Ambulance Crews and In-Home Care Providers Seek Collaboration—Not Competition

As hospitals continue to experience overcapacity challenges due to the COVID-19 emergency, 911 ambulance crews and community paramedics have found themselves treating more patients at home.

Historically, ambulance crews and community paramedics — both of which operate in the emergency medical services (EMS) space — have always provided some degree of care in the home setting. To do so, they’ve often worked alongside traditional home health and home care agencies, too.

“There’s been a certain amount of care [or treatment] in the home for many years,” Hanan Cohen, paramedic and director of corporate development at Empress EMS, told Home Health Care News. “On the 911 system, it’s not at all uncommon for an EMS crew to respond to a multitude of emergencies. After assessing and, sometimes, treating the person, … they may decide not to go to the hospital.”

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OCR Issues Guidance on Civil Rights Protections Prohibiting Race, Color, and National Origin Discrimination During COVID-19

News Release from the U.S. Department of Health and Human Services |  Monday, July 20, 2020

OCR Issues Guidance on Civil Rights Protections Prohibiting Race, Color, and  National Origin Discrimination During COVID-19

Yesterday, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) is issuing guidance to ensure that recipients of federal financial assistance understand that they must comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19. This Bulletin focuses on recipients’ compliance with Title VI of the Civil Rights Act of 1964 (Title VI).

To help ensure Title VI compliance during the COVID-19 public health emergency, recipients of federal financial assistance, including state and local agencies, hospitals, and other health care providers, should:

  • Adopt policies to prevent and address harassment or other unlawful discrimination on the basis of race, color, or national origin.
  • Ensure – when site selection is determined by a recipient of federal financial assistance from HHS – that Community-Based Testing Sites and Alternate Care Sites are accessible to racial and ethnic minority populations.
  • Confirm that existing policies and procedures with respect to COVID-19 related services (including testing) do not exclude or otherwise deny persons on the basis of race, color, or national origin.
  • Ensure that individuals from racial and ethnic minority groups are not subjected to excessive wait times, rejected for hospital admissions, or denied access to intensive care units compared to similarly situated non-minority individuals.
  • Provide – if part of the program or services offered by the recipient – ambulance service, non-emergency medical transportation, and home health services to all neighborhoods within the recipient’s service area, without regard to race, color, or national origin.
  • Appoint or select individuals to participate as members of a planning or advisory body which is an integral part of the recipient’s program, without exclusions on the basis of race, color, or national origin.
  • Assign staff, including physicians, nurses, and volunteer caregivers, without regard to race, color, or national origin. Recipients should not honor a patient’s request for a same-race physician, nurse, or volunteer caregiver.
  • Assign beds and rooms, without regard to race, color, or national origin.
  • Make available to patients, beneficiaries, and customers information on how the recipient does not discriminate on the basis of race, color, or national origin in accordance with applicable laws and regulations.

OCR is responsible for enforcing Title VI’s prohibitions against race, color, and national origin discrimination. As part of the federal response to this public health emergency, OCR will continue to work in close coordination with our HHS partners and recipients to remove discriminatory barriers which impede equal access to quality health care, recognizing the high priority of COVID-19 testing and treatment.

Roger Severino, OCR Director, stated, “HHS is committed to helping populations hardest hit by COVID-19, including African-American, Native American, and Hispanic communities.” Severino concluded, “This guidance reminds providers that unlawful racial discrimination in healthcare will not be tolerated, especially during a pandemic.

“Minorities have long experienced disparities related to the medical and social determinants of health – all of the things that contribute to your health and wellbeing. The COVID-19 pandemic has magnified those disparities, but it has also given us the opportunity to acknowledge their existence and impact, and deepen our resolve to address them,” said Vice Admiral Jerome M. Adams, Surgeon General, MD, MPH. “This timely guidance reinforces that goal and I look forward to working across HHS and with our states and communities to ensure it is implemented.”

To read the new OCR Bulletin, please visit: Title VI Bulletin – PDF

To learn more about non-discrimination on the basis of race, color, national origin, sex, age, and disability; conscience and religious freedom; and health information privacy laws, and to file a complaint with OCR, please visit: www.hhs.gov/ocr.

For more OCR announcements related to civil rights and COVID-19, please visit: https://www.hhs.gov/civil-rights/for-providers/civil-rights-covid19/index.html.

CNN | Contact Tracing Not Possible in the South

From CNN Health’s Contact tracing is no longer possible across the US South due to rapid coronavirus surges, health expert says on July 7, 2020

“The cases are rising so rapidly, that we cannot even do contact tracing anymore. I don’t see how it’s possible to even do that,” Dr. Peter Hotez, dean of tropical medicine at Baylor College of Medicine, told CNN’s Anderson Cooper Monday.
The rapid rise in cases is considered a surge, not a second wave, because the infection numbers never lowered to where officials hoped they would, director of the National Institute of Allergy and Infectious Diseases Dr. Anthony Fauci said in a Facebook and Twitter livestream Monday.

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WSJ | TX, AZ and FL have been some of the worst-hit states in recent days

From the Wall Street Journal on July 5

Some Hospitals in Southern, Western U.S. States Near Capacity Amid Coronavirus Outbreaks

Top officials in southern and western U.S. cities and states with growing coronavirus cases sounded the alarm Sunday, saying hospitals were near capacity and that stricter social-distancing enforcement was needed to stem the growing outbreaks.

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COVID-19 Testing for First Responders

From the Federal Healthcare Resilience Task Force’s EMS / Prehospital Team on July  2.

COVID-19 Testing for First Responders

Product (EMS42) Purpose

This document provides a brief overview of COVID-19 testing to inform decision-making for first responders including emergency medical service (EMS), Fire & Rescue, Law Enforcement and 911 telecommunicators.

Developed By

The Federal Healthcare Resilience Task Force (HRTF) is leading the development of a comprehensive strategy for the U.S. healthcare system to facilitate resiliency and responsiveness to the threats posed by COVID-19. The Task Force’s EMS/Pre-Hospital Team is comprised of public and private-sector EMS and 911 experts from a wide variety of agencies and focuses on responding to the needs of the pre-hospital community. This team is composed of subject matter experts from the National Highway Traffic Safety Administration (NHTSA) Office of Emergency Medical Services (OEMS), National 911 Program, Federal Emergency Management Agency (FEMA), U.S. Fire Administration (USFA), U.S. Army, U.S. Coast Guard (USCG), Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) and non-federal partners representing stakeholder groups. Through collaboration with experts in related fields, the team develops practical resources for field providers, supervisors, administrators, medical directors, and associations to better respond to the COVID-19 pandemic.

Intended Audience

State, Local, Tribal, and Territorial Governments (SLTTs), First Responders (Law Enforcement, Fire & Rescue, Emergency Medical Services (EMS) and 911 communication personnel).

Expected Distribution Mechanism

EMS.gov, Stakeholder Calls, EMS stakeholder organization’s membership distribution Email mechanisms, USFA website, Social Media posts. Request assistance distributing to FEMA/HHS RECs

Internal Routing Review

NRCC (for approval), All ESFs and HCRTF Teams & Threads (for SA only)

Primary Point of Contact

NHTSA Office of EMS, nhtsa.ems@dot.gov, 202-366-5440

Date Published: July 2, 2020

COVID-19 Testing for First Responders

Purpose: This document provides a brief overview of COVID-19 testing to inform decision- making for first responders including emergency medical service (EMS), Fire & Rescue, Law Enforcement and 911 telecommunicators.

1. Overview of testing for SARS-CoV-2 (the virus that causes the disease COVID-19):

The Food and Drug Administration (FDA) is the U.S. government entity responsible for regulating medical devices, including tests and devices like those being used to detect SARS-CoV-2. Because of the public health emergency caused by a previously unknown novel coronavirus, the FDA has issued multiple Emergency Use Authorizations (EUA) for various types of medical devices, including tests. Final validation of these tests still need to be completed through all of the normal FDA clearance criteria and received approval or clearance by the FDA under the traditional marketing pathways approval processes at this time. A list of tests which have been issued EUAs is available at EUA Information: gov.

2. Types of Testing:

  • Molecular: The molecular diagnostic tests look for evidence of an active infection by detecting either the genetic material of the pathogen or a unique marker of it. This type of test detects signs of the virus’s genetic material. One type of molecular testing uses is called a reverse transcriptase – polymerase chain reaction (RT-PCR) for pathogen detection. This approach requires only a small sample size of the pathogen (ex. from blood or saliva) and amplifies segments of the virus’ genetic code and replicates it in order to be show it is present more easily detected. A positive result indicates the presence of actual infectious viral material in the body. However, these results cannot alone determine if the pathogen remains viable (e.g., infective) or is dead and no longer infective. The presence of such material does not necessarily indicate if the patient is infectious (although for provider safety, patients with a positive test should be presumed infectious) but simply that such material is there. Test samples are usually obtained from humans using a special nasal swab designed for this
  • Antigen: The antigen diagnostic tests quickly detect fragments of pathogen proteins found on or within the virus from testing samples collected from humans, often from a swab of the nasopharyngeal cavity using swabs. However, antigen tests may not detect all active infections. Antigen tests are very specific for the virus but are often not as sensitive as molecular RT-PCR tests because of the certainty of positive samples used to develop the actual test. This means that while positive results from antigen tests are generally highly quite accurate, but there is also a higher chance of false negatives – which means falsely claiming absence of infection, thus negative results do not rule out infection. Until well-validated antigen testing is available, negative results from this approach may warrant confirmatory testing using a molecular test (i.e. an antigen test may need to be confirmed with a RT-PCR test prior to making treatment decisions or to help prevent the possible spread of the virus due to a false negative).
  • Serological: The serology tests look for the presence of antibodies, which are specific proteins made in response to an infection as part of the body’s attempt to fight that infection. It does not specifically indicate current (active) disease. It is important to remember that development of antibodies takes some time to develop after exposure to the infection, usually weeks. There are also different types of antibodies that are developed and can be tested for individually (ie. IgG, IgM). Depending on when someone was infected and the timing of the test, antibodies may not have developed in sufficient quantities to be detected by the test. We currently don’t know if detection of antibodies, and at what level, indicates immunity, and/or protection, from a future exposure. Similarly, there is also, another concern that any detected antibodies may instead reflect other strains of a more commonly occurring coronaviruses, such as those causing which causes some variations of the common

3. Testing Limitations: No test is 100% accurate 100% of the time.

  • Specificity: Specificity is a measures of a test’s ability to correctly generate a negative result for people who don’t have the condition that’s being tested for (also known as the “true negative” rate). A high-specificity test will correctly rule out almost everyone who doesn’t have the disease when the test is negative and won’t generate a high percentage of false-positive results. (Example: a test with 90% specificity will correctly return a negative result for 90% of people who don’t have the disease but will return a positive result — a false-positive — for 10% of the people who don’t have the disease and should have tested negative – which is termed a false positive )
  • Sensitivity: Sensitivity is a measures of how often a test correctly generates a positive result for people who have the condition that’s being tested for (also known as the “true positive” rate). A test that’s highly sensitive will identify almost everyone who has the disease and not generate many false-negative results. (Example: a test with 90% sensitivity will correctly return a positive result for 90% of people who have the disease but will return a negative result — a false-negative — for 10% of the people who have the disease and should have tested positive, or a false )
  • There are currently a variety of tests which have not been reviewed by FDA but may be purchased to test for COVID-19. The concern with false negatives relates to the higher potential for future transmission whereas the concern for a false positive relates to unnecessary additional diagnostic or medical procedures for the patient and wasted unnecessary PPE use for the provider and a false negative result could lead to additional exposure to contacts of the patient, including first responders and EMS personnel.

4. Testing Evaluation Tips:

Testing for first responders and EMS clinicians should be coordinated with the EMS Medical Director and other local/state public health

Check the FDA site (COVID-19 Testing EUA Recipients ) to determine whether the test you are considering purchasing has received an EUA by the

Work with the EMS Medical Director to identify the test error rate to determine whether the results can be relied upon and if actions can be made with the data

Purchase tests only through verified suppliers to ensure authenticity. There have been reports of counterfeit tests being sold to unsuspecting

Follow the test instructions exactly to avoid increasing the error rate and to achieve full test performance. Use Clinical Laboratory Improvement Amendments (CLIA)-certified labs for test processing, if required based on the specific

5. Research References:

CDC Serology Testing: https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html

Emergency Use Authorizations: https://www.fda.gov/medical-devices/emergency-use- authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use- authorizations-medical-devices

FAQs on Diagnostic Testing for SARS-CoV-2: https://www.fda.gov/medical-devices/emergency- situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

FDA Contact Information on Testing:

FDA Statement Regarding COVID-19 Antigen Testing: https://www.fda.gov/news-events/press- announcements/coronavirus-covid-19-update-fda-authorizes-first-antigen-test-help-rapid- detection-virus-causes

Serology Test FAQs: https://www.fda.gov/medical-devices/emergency-situations-medical- devices/faqs-diagnostic-testing-sars-cov-2#serology

CDC recommendations for the Testing of COVID 19: https://www.cdc.gov/coronavirus/2019- ncov/symptoms-testing/testing.html

Infectious Disease Society of America (IDSA) primer on serological testing : https://www.idsociety.org/globalassets/idsa/public-health/covid-19/idsa-covid-19-antibody- testing-primer.pdf*

Guidance on Interpreting COVID-19 Test Results: https://www.whitehouse.gov/wp- content/uploads/2020/05/Testing-Guidance.pdf

Study | Nationwide EMS Calls Have Dropped 26%, Attended Deaths Doubled

From the University at Buffalo News Center

Since early March and the start of the COVID-19 pandemic in the U.S., 911 calls for emergency medical services have dropped by 26.1 % compared to the past two years, a new study led by a University at Buffalo researcher has found.

But the study also found that EMS-attended deaths have doubled, indicating that when EMS calls were made, they often involved a far more serious emergency.

Study Details

Effect of the Coronavirus Disease 2019 (COVID‐19) Pandemic on the United States Emergency Medical Services System: A Preliminary Report
E. Brooke Lerner PhD
Craig D. Newgard MD, MPH
N. Clay Mann PhD, MS, MBA

CDC Chief Says COVID-19 Cases May be 10x Higher Than Reported

From the Washington Post on June 25

CDC chief says coronavirus cases may be 10 times higher than reported

The number of Americans who have been infected with the novel coronavirus is likely 10 times higher than the 2.3 million confirmed cases, according to the head of the Centers for Disease Control and Prevention.

In a call with reporters Thursday, CDC Director Robert Redfield said, “Our best estimate right now is that for every case that’s reported, there actually are 10 other infections.”

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6/25 | CMS Open Door Forum | Documentation Requirement Lookup Service

From the Centers for Medicare and Medicaid Services

Special Open Door Forum:  Medicare Documentation Requirement Lookup Service
Thursday, June 25, 2020 | 2:00-3:00 pm Eastern Time
Conference Call Only

The Centers for Medicare & Medicaid Services, Center for Program Integrity will host a series of Special Open Door Forum (SODF) calls to educate the public about a new initiative underway to develop a Medicare Fee for Service (FFS) Documentation Requirement Lookup Service prototype. Also, to allow physicians, suppliers, IT and Electronic Health Record (EHR) Developers and Vendors, and/or all other interested parties to provide feedback to CMS and inform how interested parties can get involved or track the progress of this initiative.

CMS is collaborating with ongoing industry efforts to streamline workflow access to coverage requirements, starting with developing a prototype Medicare FFS Documentation Requirement Lookup Service and is participating in two workgroups to promote development of standards that will support the Lookup Service. One workgroup is a private sector initiative hosted by Health Level Seven (HL7), the Da Vinci project. The second workgroup is The Office of the National Coordinator for Health Information Technology (ONC) Fast Healthcare Interoperability Resource (FHIR) at Scale Taskforce (FAST).

By working with HL7, ONC, other payers, providers, and EHR vendors, CMS is helping define the requirements and architect the standards-based solutions. In parallel, CMS is preparing to support pilots testing the information exchanges for Medicare FFS programs and possibly coordinate pilots with volunteer participants to verify and test the new FHIR based solutions.

The goals of the Documentation Requirement Lookup Service prototype are to reduce provider burden, reduce improper payments and appeals, and improve “provider to payer” information exchange. The prototype will be made accessible to pilot participants and will allow providers to be able to discover the following at the time of service and within their EHR or practice management system:

  • 1. If Medicare FFS requires prior authorization for a given item or service; and
  • 2. Documentation requirements for:
  • 3. Home Oxygen Therapy
  • 4. Continuous Positive Airway Pressure (CPAP) Devices
  • 5. Home Blood Glucose Monitors and Supplies
  • 6. Non-Emergency Ambulance Transportation (NEAT)
  • 7. Respiratory Assist Devices (RAD)

For more information and to access the slide presentation for the SODF, please visit our website: go.cms.gov/MedicareRequirementsLookup.

We look forward to your participation.

Special Open Door Participation Instructions

Participant Dial-In Number: 1-(888)-455-1397
Participant Passcode: 2900212

Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help.

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at http://www.cms.gov/OpenDoorForums/.

Software Enables EMS Agency Collaboration Despite COVID-19

Contact: Holly Taylor, Co-Owner / Client Services
June 22, 2020 Phone: 888-364-9995
Email: holly@ninthbrain.com, info@ninthbrain.com

 

SOFTWARE ENABLES EMS AGENCY COLLABORATION DESPITE COVID-19

Frankenmuth, MI – Ninth Brain Suite, LLC, has launched two new communication tools within their
Management Software focused on connecting first responders and healthcare leaders both globally and
locally.
As a response to COVID-19, the demand for communication software within the EMS industry is high.
This current landscape has challenged the way first responders work and communicate, which drove
Ninth Brain to develop two new innovative, adaptable solutions. “In talking with clients and being involved
with the associations of EMS, we realized there wasn’t a great way to share experiences and important
information collaboratively. We wanted to help bring EMS Agencies together. Ninth Brain is all about
providing tools to streamline operations to help these heroes do their job.” said Holly Taylor, a co-owner
of Ninth Brain.

NBS COMMUNITY
Ninth Brain’s new NBS Community tool is exclusive to healthcare leaders and allows for open dialogue
between Ninth Brain’s 200+ clients in the healthcare space. Ninth Brain has a large base of U.S. clients,
but also services clients as far away as Australia. First responders can connect to one another from
around the globe in a monitored forum.
As standards and protocols are frequently evolving due to COVID-19, the advantage of this online
community is the ability to tap into the knowledge of healthcare leaders from outside the client’s
immediate network.

DISCUSSION BOARD
The second communication tool available is an internal HIPAA-compliant discussion board designed to
provide direct communication between management teams and their employees.
Administrators can create forums and topics for dialogue around ideas and important issues to their crew.
This tool also allows for Management to collaborate over policies, protocol updates, and patient care.
Both tools are free to current and prospective clients.

###

About Ninth Brain: Ninth Brain Suite, LLC, is a team of imaginative professionals who in 2001 started
with an idea to design a better, quicker, safer and more accurate way to manage compliance and meet
regulatory requirements for the healthcare industry. Our team is committed to providing innovative
technology that brings simplicity to our clients’ working lives. Ninth Brain Suite is recognized as one of the
premier solutions for credential tracking, continuing education, workforce scheduling, and tracking
regulatory requirements. Visit ninthbrain.com for more information.

CDC | Testing Guidelines for Nursing Homes

On June 13, the Centers for Disease Control and Prevention issued updated guidance for COVID-19 testing in nursing homes. Thank you to the many  member organizations  providing this vitally important care to our nation’s vulnerable populations. Changes are summarized below:

  • Reorganized recommendations to address:
    • Viral testing of healthcare personnel (HCP)
    • Viral testing of residents
    • Viral testing in response to an outbreak
  • Changed “baseline” testing to “initial” testing, although these terms are interchangeable
  • Added the following recommendations:
    • Testing the same individual more than once in a 24-hour period is not recommended.
    • Clinicians are encouraged to consider testing symptomatic residents for other causes of respiratory illness, for example influenza, in addition to testing for SARS-CoV-2.

CDC Nursing Home Testing

US DOL Issues Guidance Impacting EMS Offices

U.S. Department of Labor Issues OSHA Guidance As Non-Essential Businesses Reopen and Employees Return to Work

WASHINGTON, DC—The U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) has issued guidance  to assist employers reopening non-essential businesses and their employees returning to work during the evolving coronavirus pandemic.

The guidance supplements the U.S. Department of Labor and U.S. Department of Health and Human Services’ previously developed  Guidance on Preparing Workplaces for COVID-19 and the White House’s  Guidelines for Opening Up America Again. The guidelines provide general principles for updating restrictions originally put in place to slow the spread of the coronavirus. During each phase of the reopening process, employers should continue to focus on strategies for basic hygiene, social distancing, identification and isolation of sick employees, workplace controls and flexibilities, and employee training.

Non-essential businesses should reopen as state and local governments lift stay-at-home or shelter-in-place orders and follow public health recommendations from the Centers for Disease Control and Prevention and other federal requirements or guidelines. Employers should continue to consider ways to use workplace flexibilities, such as remote work and alternative business operations, to provide goods and services to customers.

OSHA recommends that employers continually monitor federal, state, and local government guidelines for updated information about ongoing community transmission and mitigation measures, as well as for evolving guidance on disinfection and other best practices for worker protection.

Visit OSHA’s  coronavirus webpage  frequently for updates. For further information about the coronavirus, please visit the  Centers for Disease Control and Prevention.

Under the Occupational Safety and Health Act of 1970, employers are responsible for providing safe and healthful workplaces for their employees. OSHA’s role is to help ensure these conditions for America’s working men and women by setting and enforcing standards, and providing training, education and assistance. For more information, visit  www.osha.gov.

The mission of the Department of Labor is to foster, promote and develop the welfare of the wage earners, job seekers and retirees of the United States; improve working conditions; advance opportunities for profitable employment; and assure work-related benefits and rights.

Race Gaps in COVID-19 Deaths Are Even Bigger Than They Appear

From the Brookings Institute  on June 16

The COVID-19 pandemic has been like the flash of an X-ray, exposing the deep fractures in U.S. society – not least by race. New data from CDC shows that the death rates among Black and Hispanic/Latino people are much higher than for white people, in all age categories…

Stark inequalities in COVID outcomes exist for the American Indian and Alaska Native population as well, however information on death rates for these groups is incomplete. Here, we focus on the three largest racial/ethnic groups, white, Black, and Hispanic/Latino, for which data are more reliable and which account for 93% of all COVID deaths reported by the CDC (through June 6).

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NYT | Low-Cost Drug Reduces Coronavirus Deaths, Scientists Say

From the New York Time on June 16, 2020

LONDON — Scientists at the University of Oxford said on Tuesday that they had identified what they called the first drug proven to reduce coronavirus-related deaths, after a 6,000-patient trial in Britain showed that a low-cost steroid prevented the deaths of some hospitalized patients.

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Politico | Nursing Homes Go Unchecked As Fatalities Mount

From Politico on June 15, 2020 by Rachel Roubein and Maggie Severns

Thousands of nursing homes across the country have not been checked to see if staff are following proper procedures to prevent coronavirus transmission, a form of community spread that is responsible for more than a quarter of the nation’s Covid-19 fatalities.

Only a little more than half of the nation’s nursing homes had received inspections, according to data released earlier this month, which prompted a fresh mandate from Medicare and Medicaid chief Seema Verma that states complete the checks by July 31 or risk losing federal recovery funds.

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