COVID-19 employee Travel FAQ

Over the last week, we have received several questions from AAA members about various COVID-19 impacts on EMS organizations.  As the infection numbers around the country are on the rise, many new issues have arisen that are posing issues with many EMS employers.

  1. Travel Orders

What can I do when our employee voluntarily chooses to travel out of state and, due to state level travel orders which require mandatory quarantine for 14 days upon their return, the employee cannot work and is seeking to be paid emergency leave under the Families First Coronavirus Act (FFCRA) or take additional unpaid leave during the quarantine period?

As an employer, you have several options.  One of the most important things to know is that your employee does have to abide by any federal, state, or local quarantine order.  However, this does not mean that the employer is helpless in addressing this the issue of employee voluntary travel.  The last few months have been incredibly trying on all of us, particularly those who are on the front lines battling the COVID-19 pandemic, it is understandable that employees are looking to take vacations out of state.  While this is understandable, the employee is still making a decision that can impact their health and their employment, as well as, the health of their coworkers and patients.

Employer Option 1

As an EMS employer, the FFCRA specifically permitted EMS agencies the right to exclude emergency responders from the group of employees who are eligible to take emergency leave under the FFCRA. Despite this, many EMS employers have decided to provide their employees with emergency paid leave under the FFCRA.  The employer can choose to pay the employee emergency leave under the FFCRA during the mandatory travel quarantine.

Employer Option 2

As stated in Option 1, the FFCRA specifically permitted EMS agencies the right to exclude emergency responders from the group of employees who are eligible to take emergency leave under the FFCRA. Most of those employers who have decided to provide emergency leave under the FFCRA, their intent was to provide the emergency leave to employees who, through no fault of their own, were exposed to COVID-19 and required to quarantine.  However, an employer has the right to exclude some employees, such as those who decide to voluntarily travel outside state, and as a result, required to quarantine upon return.  The key is to ensure that you have an established policy, it is applied consistently, and has been meaningfully communicated to your employees.  This is the best practice for mitigating any discrimination or disparate treatment claims.

Employer Option 3

The employer can choose to discipline the employee for choosing to leave the state, despite the travel order.  If an employee knowingly travels out of state, despite the existence of a mandatory travel quarantine order, the employer can discipline that employee for any quarantine related attendance issues.  The employer cannot let that employee return to work unless they have abided by any travel orders.  Several of the states who have issued orders, include an option to avoid a 14-day quarantine order if they have a negative COVID-19 test within three days of returning to their home state.  Alternatively, they can end the 14-day quarantine period if they receive a negative test after returning to their home state.

Employer Best Practice

The best bet for employers is to contemplate the possible issues that could arise with your employees as a result of the local travel orders.  Employers should draft a policy that delineates the work-related implications of employee travel.  This policy should be communicated through multiple channels, and ideally, be acknowledged in writing by your employees.  This will provide your employees with a clear understanding of the implications of deciding to travel out of state during the pandemic.

  1. COVID-19 Parties

Several member organizations have asked what actions they can or should take when they learn that an employee has attended a COVID-19 party.  These events, which defy logic, particularly for those of us who consider EMS, healthcare and EMS personnel, healthcare workers, are parties where uninfected people go to a party with known infected people to mingle and see who becomes infected.

Option 1

Under the General Duty clause of the Occupational Health and Safety Act (OSHA), an employer has an obligation to provide a workplace which is “free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees”.  This includes if an employer is aware that there are employees who are engaging in behavior that may create a workplace hazard, like attending events such as a COVID-19 party.

If an employer discovers that an employee has attended an event like a COVID-19 party or a large scale event where protective measures were not taken, such as mandatory mask wearing and social/physical distancing, the employer has a duty to investigate and take action.  This would include requiring that the employee remain out of work for the recommended quarantine time or upon a negative COVID-19 test.  The employer could pay for this test but is not required to.  If the employee voluntarily took part in this event and the exposure was not work-related, they would not be obligated to pay for the COVID-19 test.

Option 2

For the many reasons stated above, the employer has an obligation to the rest of its workforce to ensure that this potentially infected employee does not expose the rest of the workforce.  The employer would be justified in addressing this issue through their disciplinary process.  As is always recommended, I recommend that employers communicate with their employees to let them know that the choices they make outside of the workplace have implications inside the workplace.  While this should be obvious to our employees, not all operate by the same playbook.

Employers should be aware that there are state laws that limit the level at which an employer can dictate an employee’s “off duty” time.  For example, an employer in New York cannot take work action against an employee for their personnel time political activities.  However, an employer may address the employee if that off duty conduct involves their employee’s failure to be safe by wearing a mask and maintaining social/physical distancing while attending a political event or political-based protest.  As previously mentioned, employers have obligation to provide a workplace that is free from “recognized hazards”.

Employer Best Practice

I recommend that employers consult with their local attorneys if they faced with taking work-related action for an employee’s off duty conduct if they are in a state with off duty conduct laws.  The best way to ensure you protect your workforce is to ensure that the organization has a comprehensive policy and procedure manual that is updated every year.  Additionally, all employees, including supervisory personnel, should sign an acknowledgement annually. Lastly, it is recommended that the organization highlight a few policies throughout the year.  Specifically, I recommend that organizations log all incidents, complaints, and discipline to permit trending of workplace activity which suggest which policies and procedures need to be highlighted.

CMS Releases CY 2021 Physician Fee Schedule

The Centers for Medicare & Medicaid Services (CMS) has released the Physician Fee Schedule Proposed Rule for Calendar Year (CY) 2021 which has traditionally included proposed changes to the Ambulance Fee Schedule for the same year. The American Ambulance Association (AAA) has confirmed with CMS that the reason there are no references to the Ambulance Fee Schedule in the Proposed Rule is because the temporary add-ons were built into the regulations themselves.  Thus, the governing regulations already indicate that the temporary add-on payments for ground ambulance transports are effective for services furnished through December 31, 2022.  The regulations are at 42 CFR §414.610 (c)(1)(ii) and 42 CFR §414.610 (c)(5)(ii).

The Proposed Rule also seeks to extend or make permanent several of the telehealth waivers CMS has implemented during the public health emergency.  Because CMS does not believe it has the authority to reimburse ambulance providers or suppliers for services provided without transportation also occurring, these waivers have not applied to ground ambulance.  However, we will review these provisions of the rule closely to identify potential opportunities to include ground ambulance providers and suppliers in these policies.

NEMSIS | HIPAA and Bidirectional Data Exchange White Paper

Prepared by Page, Wolfberg, and Wirth

Overview

Emergency Medical Service (EMS) agencies nationwide still widely report that hospitals and other healthcare providers refuse to share patient information with them, citing concerns under the Health Insurance Portability and Accountability Act (HIPAA).1 Misconceptions about HIPAA have created an  artificial barrier to legitimate, approved bidirectional data exchange between EMS and other providers. As a result, many healthcare systems are missing a critical opportunity to improve patient outcomes and advance evidence-based practices in prehospital care.

Download White Paper

 

Updated CDC Guidance for EMS

On July 15, 2020 the Centers for Disease Control issued an updated guidance for EMS personnel in response to the ongoing Public Health Emergency.

Summary of Key Changes for the EMS Guidance:

  • Reorganized recommendations into 2 sections:
    • Recommended infection prevention and control (IPC) practices for routine activities during the pandemic.
    • Recommended IPC practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection.
  • Added recommendations that were included in healthcare IPC FAQs addressing:
    • Universal use of PPE for healthcare personnel working in communities with moderate to sustained transmission of SARS-CoV-2, the virus that causes COVID-19
    • Creating a process for responding to SARS-CoV-2 exposures among healthcare personnel and others.

Read the Full Guidance

Colorado Natural Hazards Center Grants

The Colorado Natural Hazards Center is offering three grants of $4000 for original research.

  • 1) Communications, the Pandemic, and Local Transportation Resources: What strategies are being implemented, and how effective are they? What are best practices in communicating and messaging by transportation organizations?
  • 2) Transportation, Vulnerable Populations, and COVID-19: What are best practices in providing useful and safe transportation for various socially and economically vulnerable population groups that are traditionally heavily reliant on public transit such as low-income people and racial and ethnic minorities? What about newly vulnerable populations, such as seniors, transportation workers, bus drivers, and so forth? How can the needs of all be met while assuring health and safety among particularly medically fragile or economically marginalized people?
  • 3) Transportation and Emergency Management Policy: How should transportation leaders and emergency managers work together to deliver community services? Including but also beyond ESF-1, what are innovative ways and best practices within and among communities and transportation services to accomplish community objectives during the pandemic? For example: transit agencies have launched food delivery services for vulnerable populations using their idled vehicles and drivers; state DOT facilities have been used a COVID-19 testing sites; Wi-Fi equipped vehicles have been used as local community hot spots.

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COVID Testing for EMS

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.

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 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 needs to be completed through all of the normal FDA clearance processes and receive approval by the FDA under the traditional marketing pathways approval processes. A list of tests that have been issued EUAs is available at EUA Information: FDA.gov.

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 is called a reverse transcriptase – polymerase chain reaction (RT-PCR). This method 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 show its presence and allow it to be 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 purpose.
  • Antigen: The antigen diagnostic tests quickly detect fragments of pathogen proteins found on or within the virus from human testing samples often from a swab of the nasopharyngeal cavity. 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. Positive results from antigen tests are highly accurate but there is also a higher chance of false negatives. As a result, 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 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 the development of antibodies takes some time, usually weeks, to develop after exposure to the infection. There are also different types of antibodies that are developed and can be tested for individually (i.e. IgG, IgM). Depending upon 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 future exposure. Similarly, there is another concern that any detected antibodies may instead reflect other strains of more commonly occurring coronaviruses, such as variations of the common cold.

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

a. Specificity: Specificity is a measure 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.)

b. Sensitivity: Sensitivity is a measure 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.)

c. 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 transmissions whereas the concern for a false positive relates to unnecessary diagnostic or medical procedures for the patent and wasted PPE use for the provider. A false negative result could lead to additional exposure to contacts of the patient, including first responders and EMS personnel.

Testing Evaluation Tips:

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

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

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

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

e. 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 test.

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:
• Toll-free line 24 hours a day: 1-888-INFO-FDA option *;
• Email to report shortages: deviceshortages@fda.hhs.gov;
Email applicable diagnostic tests: COVID19DX@FDA.HHS.GOV
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*

NYT | The Fullest Look Yet at the Racial Inequity of Coronavirus

From the New York Times on July 5, 2020 by By Richard A. Oppel Jr., Robert Gebeloff, K.K. Rebecca Lai, Will Wright and Mitch Smith

Early numbers had shown that Black and Latino people were being harmed by the virus at higher rates. But the new federal data — made available after The New York Times sued the Centers for Disease Control and Prevention — reveals a clearer and more complete picture: Black and Latino people have been disproportionately affected by the coronavirus in a widespread manner that spans the country, throughout hundreds of counties in urban, suburban and rural areas, and across all age groups.

Continue reading►

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

Final Rule for ACA Section 1557

On June 12, 2020, the Office of Civil Rights (OCR) of the Department of Health and Human Services (HHS) published the long-awaited final rule which significantly changes several of the anti-discrimination provisions of Section 1557 of the Affordable Care Act.  The final rule, which is a departure from the agency’s previous interpretation of the rules which were enacted 2016 during the Obama administration.  Since, the enactment of the 2016 rules, there have been numerous legal challenges to these provisions in federal court.  HHS believes that these final rules will reduce or eliminate provisions that they state were ineffective, unnecessary, and confusing and will save roughly covered entities roughly $2.9 billion in costs.

2016 Section 1557 Requirements

Section 1557 of the ACA were the anti-discrimination provisions geared at ensuring all individuals had access to essential benefits.  When originally released in 2016, the Section 1557 rules prohibited discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs or activities, including discrimination on the basis of pregnancy, gender identity, and sex stereotyping.  The 2016 Rule also required that covered entities:

  • Establish a written Grievance Procedure.
  • Identify and maintain a Compliance Coordinator.
  • Publish non-discrimination notices in the top 15 languages spoken in the covered entity’s state.
  • Publish taglines informing individuals of the availability of aides and services in the top 15 languages spoken in the covered entity’s state.
  • Make available assistance for individuals with Limited English Proficiency (LEP) and those with disabilities, including communications related disabilities.
  • Include the mailing of non-discrimination notices and taglines in every “substantial communication” with individuals.
  • Included non-discrimination protections for individuals “on the basis sex” which was interpreted by OCR to include gender identity, sexual orientation, and termination of pregnancy.

2020 Section 1557 Final Rule

The Final Rule eliminated several key provisions of the 2016 Rule. The provisions that were eliminated included:

  • Discrimination protections for individuals “on the basis of sex”
  • Specific non-discrimination provisions “on the basis of sex”, including gender identity, sexual orientation, and termination of pregnancy.
  • Written Grievance Procedure.
  • Compliance Coordinator.
  • Publishing of non-discrimination notices in top 15 languages informing individuals of aides and services for individuals with Limited English Proficiency (LEP).
  • Publishing of taglines in top 15 languages informing individuals of aides and services for individuals with Limited English Proficiency (LEP).

In addition to eliminating certain provisions, the final rule also relaxed the requirements relative to providing meaningful access to interpreter services for individuals with Limited English Proficiency (LEP).  Under the 2016 rule, the agency assessed compliance with the meaningful access requirement by whether a covered entity established and implemented a Language Access Plan.  This included providing access to interpreter services to individuals with LEP.  The 2020 final rule requires covered entities only make “reasonable efforts” to ensure meaningful access to aides and services for individuals with LEP.  However, the final rule does not change the requirements for meaningful access for individuals with disabilities or communication related disabilities.

The Bottom Line for EMS Providers

When the 2016 Section 1557 rule was enacted, the AAA sought guidance from OCR due to what we perceived to be compliance challenges for mobile-based healthcare providers.  Our concerns were related to how mobile-based healthcare providers can ensure that the public and the patients we serve receive adequate notice of the protections afforded under Section 1557.  As is often the case, when new regulations are enacted, they are enacted for standard “brick and mortar” healthcare providers, not ambulance services.  At the time, our guidance was to post the required notices and taglines on your organization’s website and in the patient signature areas of your patient care report.

From a practical perspective, the enactment of this final rule will have limited impact for ambulance providers.  Presuming an ambulance service’s compliance with the provisions of the 2016 rule, member companies can decide if they wish to eliminate their existing Compliance Coordinator position and Grievance Procedure.  However, OCR still requires a covered entity to have written process for handling discrimination complaints.  Therefore, it may be beneficial to simply maintain the 2016 requirements to ensure you can demonstrate compliance.

One welcome change is the elimination of the need to include the Section 1557 non-discrimination notices and taglines in every “substantial communication” with individuals.  Many members voiced that they incurred a significant expense mailing the nondiscrimination notice and tagline requirements in every invoice or patient communication.  This often added several additional pages to all patient communications which increased printing and postage costs substantially.  Our recommendation is for ambulance providers to continue to make the non-discrimination notices and taglines available on your organizational website and in any electronic communications as these mediums do not significantly increase costs.

Compliance Assistance

OCR has numerous compliance assistance documents on their website.  Additionally, members can contact the AAA for assistance with these regulatory changes.

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.

EEOC Guidance on COVID-19 Antibody Testing

The Equal Employment Opportunity Commission (EEOC) issued updated guidance yesterday titled, What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws yesterday.  The updated guidance addresses employers who wish to require employees to have a COVID-19 antibody tests prior to re-entering the workplace.  The guidance consists of seventeen pages of Frequently Asked Questions (FAQ) to assist employers as they navigate this truly unprecedented time for employers and employees during a pandemic.

The updated guidance alerts employers that they may not require employees to undergo COVID-19 antibody testing as this would constitute an unlawful “medical examination” under the Americans with Disabilities Act (ADA).  Under the ADA, employers are limited in the medical related inquiries that they can make of employees.  Medical related inquiries can be considered a Medical Examination and are strictly regulated under the ADA and the Rehabilitation Act.  Under the ADA, an employer “shall not require a medical examination and shall not make inquiries of an employee as to whether such employee is an individual with a disability or as to the nature and severity of the disability, unless such examination or inquiry is shown to be job-related and consistent with business necessity.” 29 CFR § 1630.14.  The reason certain medical examinations are prohibited is due to the likelihood that the examination may identify medical conditions that constitute a protected disability under the ADA.

The EEOC has issued previous guidance that permits COVID-19 viral testing in the employment setting.  The distinction between the antibody test and the viral test is the presence of active virus and the obligation of employers to provide a workplace that is free from known hazards.  The viral tests are generally administered prior to the employee entering the workplace and are considered “job related and consistent with business necessity.”  Additionally, employers may take the body temperatures of employees as they enter the workplace and at intervals during their shift.  However, employers must be aware that some individuals with COVID-19 are asymptomatic and may not have an elevated body temperature.  Additionally, the records related to taking employee temperatures are confidential and should be maintained with other employee medical records.

The best practice for employers, have a documented plan.  Ensure that all employees understand their role in controlling the spread of the virus.

Be sure employees:

  1. Monitor their own temperature and COVID-19 symptoms.
  2. Wear a face covering and practice social distancing, even in the workplace to the extent it is possible.
  3. Frequently wash their hands
  4. Stay home if they are sick or display symptoms;
  5. Let their employer know if they have a family member or significant other who has COVID-19 or is displaying symptoms.
  6. Regularly clean and disinfect any equipment they utilize, before, during, and at the conclusion of their workday.

Employers should:

  1. Be sure to provide employees with COVID-19 education.
  2. Place signage in the workplace to remind employees and visitors to wear facial coverings and maintain social distancing.
  3. Provide disposable face coverings for anyone entering the building who does not have a mask.
  4. Maintain a log of all individuals, employees or visitors, who enter the building. The log should include their name, organization, and a method of contact.
  5. Provide all visitors with contact information should they become ill or exhibit symptoms in the 14 days following a visit to your workplace.
  6. Limit meetings or gatherings of employees.
  7. If administering employee temperatures
    1. Communicate the process to employees
    2. Establish what temperature will be considered too high for working (CDC considers a fever to be at least 100.4 F)
    3. Ensure all individuals are wearing face masks and social distancing, to the extent possible
    4. If employer requires temperature taking, be sure that the time employees spend associated with this procedure is tracked and compensated.
    5. As stated previously, maintain records confidentially

If you have questions or your organization needs assistance in determining if you have the appropriate safeguards in place, be sure to reach out to the AAA for help.

MIT | What Does and Does Not Correlate With COVID-19 Death Rates

From the Massachusetts Institute of Technology Center for Energy and Environmental Policy Research

What Does and Does Not Correlate With COVID-19 Death Rates
Christopher R. Knittel and Bora Ozaltun
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Abstract
We correlate county-level COVID-19 death rates with key variables using both linear regression and negative binomial mixed models, although we focus on linear regression models. We include
four sets of variables: socio-economic variables, county-level health variables, modes of commuting, and climate and pollution patterns. Our analysis studies daily death rates from April 4, 2020 to May 27, 2020. We estimate correlation patterns both across states, as well as within states. For both models, we find higher shares of African American residents in the county are correlated with higher death rates. However, when we restrict ourselves to correlation patterns within a given state, the statistical significance of the correlation of death rates with the share of African Americans, while remaining positive, wanes. We find similar results for the share of elderly in the county. We find that higher amounts of commuting via public transportation, relative to telecommuting, is correlated with higher death rates. The correlation between driving into work, relative to telecommuting, and death rates is also positive across both models, but statistically significant only when we look across states and counties. We also find that a higher share of people not working, and thus not commuting either because they are elderly, children or unemployed, is correlated with higher death rates. Counties with higher home values, higher summer temperatures, and lower winter temperatures have higher death rates. Contrary to  past work, we do not find a correlation between pollution and death rates. Also importantly, we do not find that death rates are correlated with obesity rates, ICU beds per capita, or poverty rates. Finally, our model that looks within states yields estimates of how a given state’s death rate compares to other states after controlling for the variables included in our model; this may be interpreted as a measure of how states are doing relative to others. We find that death rates in the Northeast are substantially higher compared to other states, even when we control for the four sets of variables above. Death rates are also statistically significantly higher in Michigan, Louisiana, Iowa, Indiana, and Colorado. California’s death rate is the lowest across all states.

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Webinar 6/4 | Air and Ground Interfacility Transfers

Our partners at the HHS Office of the Assistant Secretary for Preparedness and Response are hosting a COVID-19 Clinical Rounds webinar next week. See below for more information and links to register. And be sure to access the latest COVID-19 information for EMS at the updated COVID-19 Resources for EMS.

Emergency Department: Air and Ground Interfacility Transfers

Thursday, June 4, 2020
12:00 PM EDT / 9:00 AM PDT

Webinar Agenda

Welcome and Introductions

Richard C. Hunt, MD, FACEP, HHS/ASPR National Healthcare Preparedness Programs

Air and Ground Interfacility Transfers

Patti Corbett, RN, BSN, CMTE, Director of Patient Safety, Air Methods Corporation

David P. Thomson, MS, MD, MPA, FACEP, FAEMS, FAsMA, CMTE, Clinical Professor of Emergency Medicine, East Carolina University; Medical Director, Vidant EastCare

Q & A and Discussion

Register Here

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OSHA | Revised Enforcement Guidance for COVID-19

OSHA Issues Revised Enforcement Guidance for Recording Cases of Coronavirus Disease 2019 (COVID-19)

This week, OSHA published revised guidance for employers on when they need to record the illness, of an employee who has contracted the Coronavirus, as a work-related illness for the purposes of OSHA’s work illness and injury recordkeeping requirements. Under OSHA’s recordkeeping requirements, COVID-19 is a recordable illness if:

  1. The case is a confirmed case of COVID-19, as defined by the Centers for Disease Control and Prevention (CDC);
  2.  The case is work-related as defined by 29 CFR § 1904.5; and
  3.  The case involves one or more of the general recording criteria set forth in 29 CFR § 1904.7.

Given the rate of infection and the ease with which the virus is transmitted, employers have found it particularly challenging to determine if an employee, who is diagnosed with COVID-19, contracted the virus at work. In making that determination, employers must make a “reasonable determination” of work-relatedness. In this guidance, OSHA outlines the criteria that Compliance Safety and Health Officers (CSHOs) will utilize to evaluate if the employer met the “reasonable determination”, as required by the Regulations. Those criteria include:

  1. The reasonableness of the employer’s investigation into work-relatedness
  2. The evidence available to the employer at the time of the work-relatedness determination
  3. The evidence that the illness was contracted at work

The guidance highlights that employers can make limited inquires to employees about their exposure provided they respect the employee’s privacy and keep the medical inquiries limited to the COVID-19 transmission factors. Additionally, the guidance provides some examples of the types of evidence an employer may consider in making a work-relatedness determination. These include if the employee has come in contact or worked in close proximity with an individual who has a confirmed diagnosis of COVID-19 or employees who have frequent contact with the public. However, employers can also consider if an employee has or had close contact outside of work with a family member or close friend who has a confirmed cased. In that instance, it may suggest that the illness is not work-related.

After conducting a reasonable investigation about work-relatedness, if the employer cannot make the determination that the employee’s illness is work-related, then they are not required to record the illness under OSHA’s recordkeeping requirements.

If you require assistance with this guidance or any other human resources or compliance matters, be sure to contact the AAA for assistance.

Critical Care Decontamination System (CCDS) for N95 Respirators

Prehospital Use of the Critical Care Decontamination System (CCDS) for
N95 Respirators

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PURPOSE:
Use of personal protective equipment (PPE) during the COVID-19 pandemic response is at unprecedented levels. In order to slow usage rates and maintain supply chain stability, the U.S. Food and Drug Administration (FDA) has authorized an Emergency Use Authorization (EUA) for the emergency use of an N95 respirator decontamination system. This is one of several EUAs for decontamination technologies granted by the FDA. This document is intended to provide basic information on the Critical Care Decontamination System (CCDS) for pre-hospital use.

MANUFACTURER SYSTEM REQUIREMENTS

  • Method: vapor phase hydrogen-peroxide (VPHP)
  • For use in decontaminating N95 or N95-equivalent respirators
  • Respirators can undergo up to 20 decontamination cycles with the CCDS.
  • Due to incompatibility, the CCDS is not authorized for use with respirators containing cellulose-based materials.
  • All compatible N95 respirators provided to CCDS must be free of any visual soiling or contamination (e.g., blood, bodily fluids, makeup).
  • If N95 respirators are soiled or damaged, they will be disposed of and not returned after decontamination.
  • Healthcare personnel should follow the instructions provided by the CCDS program in Instructions for Healthcare Personnel
  • There is not a cost for use of the system
  • First responders will have access to the system(s) in their region
  • Healthcare facilities and first responder agencies need to request a Site Location Code from the CCDS program.
  • The Site Location Code must be placed by the healthcare facility or first responder agency on each of their N-95 respirators.
  • This is not a one-for-one exchange program –if the N95 cannot be disinfected, it will not be replaced. Decontaminated N95s will be returned to the healthcare facility with the designated facility code and chain-of-custody forms.

LOCATIONS
The CCDS location for your area can be found by contacting your state or local EMS agency/public health agency / Emergency Operations Center (EOC).

NOTE: If there is not one in your area, a request can be submitted through your local EOC to
utilize others.

Further information can be found on the CCDS Site

JEMS | Paramedicine Strategic Planning

By Brian J Maguire, Dr.PH, MSA, EMT-P, Scot Phelps, JD, MPH, Paul Maniscalco, PhD(c), MPA, MS, EMT/P, LP, Daniel R. Gerard, MS, RN, Andy Gienapp, NRP, Kathleen A. Handal, MD and Barbara J. O’Neill, PhD, RN

… Many of the system deficiencies can be traced to three main factors. First, there is no single U.S. federal agency solely charged with supporting paramedicine operations. Second, no legislative mandate exists to engage in paramedicine operational research. Third, there is no paramedicine-specific financial support to advance core initiatives at the federal, state, tribal and local levels…

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NYT | Paramedics, Strained in the Hot Zone, Pull Back From CPR

From the New York Times on May 10, 2020

Around the country, in cities and counties in the grip of the pandemic, emergency medical technicians have had to do something they’re not used to: think of their own well-being before that of their patients. With so many paramedics falling ill, emergency units have changed their practices to limit exposure to the virus.

The most unsettling change, according to interviews with paramedics in a half-dozen of the most affected states, is the decision to suspend, or limit, resuscitation in cases when the odds of survival are near zero.

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