CMS Updates Cost Data Collection FAQs and Data Collection Instrument

The Centers for Medicare & Medicaid Services (CMS) has released printable version of the ground ambulance data collection instrument and an expanded FAQ. Both updated documents address some of the more common questions that CMS has heard over the past months, many of which the American Ambulance Association raised.  Importantly, CMS announces through the FAQs the registration process will begin December 2021.

The topics covered in the FAQs include:

  • General questions related to the rationale for collecting data, definitions, and how the information will be used and reported;
  • Sampling and notification questions related to how ground ambulance organizations will be selected to participate in the data collection system;
  • Data collection and reporting timelines and effort questions, which focus on the timelines for collecting and reporting the information, as well as the projected effort required;
    • There are three new FAQs in this section about the impact of the delay due to the pandemic (the questions and answers are below)
  • Requirement to report questions, which focus on the types of information that must be reported and responding to requests from MACs;
    • There is a new FAQ in this section about applying for a hardship exemption (the questions and answers is below)
  • Reporting information questions, which include who within an organization should report the information, the data tool, and how to address technical problems;
    • There are two new FAQ in this section about the pause in data collection due to the pandemic (the questions and answers are below)
    • Importantly, CMS announces that the registration will begin December 2021
  • Data collection scope and principles questions, which discuss the specific type of information and level of specificity that is required;
    • There are several new FAQs in this section about using current accounting practices, municipality practices, and accounting good and services provided by another organization (the questions and answers are below)
  • Reporting information on staffing and labor costs questions, which address issues such as volunteer staff, staff with multiple duties, calculating hours worked;
    • There are three new FAQs in this section about total hours worked, staff training, and paid time off (the questions and answers are below)
  • Reporting other information, such as service area, service mix/service volume, facilities, vehicles, equipment/supplies, and revenue.


New FAQs

 Question: Will the modification listed in the COVID-19 Emergency Declaration Blanket Waiver issued by CMS on May 15, 2020 allow ground ambulance organizations selected in year 1 the option to continue with their current data collection period that started in early 2020 or choose to select a new data collection period starting in 2021? [Added 7/31/2020]

    • Answer: No. The ground ambulance organizations that were selected in year 1 do not have an option and must select a new data collection period starting in 2021. CMS cannot permit this option because the data collected in 2020 during the public health emergency may not be reflective of typical costs and revenue associated with providing ground ambulance services.
  • Question: When will sampled organizations report information? [Updated 7/31/2020]
    • Answer: Sampled organizations will report information within a 5-month reporting period that starts at the end of the organization’s collection period. For example, if your organization begins collecting information on January 1, 2021, your organization’s collection period will run until December 31, 2021 and your organization must report information during the 5- month period between January 1, 2022 and May 31, 2022.
  • Question: How are data collection and reporting dates adjusted for organizations selected in Year 1 given the modification listed in the CMS COVID-19 Emergency Declaration Blanket Waiver? [Added 7/31/2020]
    • Answer: CMS issued a COVID-19 Emergency Declaration Blanket Waiver delaying data collection and reporting requirements for ground ambulance organizations selected in Year 1 by one year. The organizations selected in Year 1 will now collect data during a continuous 12-month period starting in 2021 (rather than 2020) and will now report information during a 5-month period starting in 2022 (rather than 2021). As an example, a Year 1 organization that previously would have collected information from January 1, 2020 to December 31, 2020 and reported information between January 1, 2021 to May 31, 2021 will now collect information from January 1, 2021 to December 31, 2021 and report information between January 1, 2022 and May 31, 2022. Organizations in the Year 1 sample will not report any information collected to date in 2020.
  • Question: Can you provide examples of different data collection periods and the data reporting periods depending on my accounting period start date? [Updated 7/31/2020]
    • Answer: Example of a Data Collection and Reporting Period for a Ground Ambulance Organization with a Calendar Year Accounting Period:

Examples of Data Collection and Reporting Periods for a Ground Ambulance Organization with Accounting Period not based on a Calendar Year:

  • Question: Can my organization request a hardship exemption from the payment reduction? [Updated 7/31/2020]
    • Answer: Yes. Organizations that did not report sufficient data due to a significant hardship, such as a natural disaster, bankruptcy, or other similar situations may request a hardship exemption. To request a hardship exemption after the ground ambulance organization receives notification that it will be subject to the 10 percent payment reduction as a result of not sufficiently submitting information under the data collection system, organizations should complete a request form that will be available at the end of the data reporting period on CMS’s Ambulances Services Center website at https://www.cms.gov/Center/Provider- Type/Ambulances-Services-Center.html. Organizations can request a hardship exemption within 90 calendar days of the date that CMS notified the organization that it would receive a 10 percent payment reduction as a result of not submitting sufficient information under the data collection system. Your organization will be asked to supply information such as reason for requesting a hardship exemption, evidence of the hardship (e.g., photographs, newspaper, other media articles, financial data, bankruptcy filing, etc.), and date when your organization would be able to begin reporting information. All hardship exemption requests will be evaluated based on the information submitted that clearly shows that they are unable to submit the required data.
  • Question: Where and how does my organization report information? [Updated 7/31/2020]
    • Answer: No information will be reported until 2022. As we stated in the CY 2020 Physician Fee Schedule Final Rule (84 FR 62867), a secure web-based data collection system will be available before the start of your data reporting period to allow time for users to register, receive their secure login information, and receive training from CMS on how to use the system. CMS will provide separate instructions on how to access the online Ground Ambulance Data Collection System. You can view a printable version of the ground ambulance data collection instrument at: https://www.cms.gov/Center/Provider- Type/Ambulances-Services-Center for the data collection requirements.
  • Question: My organization was selected in the first group to collect and report cost and other required data. When will we be able to register for the data collection system? [Updated 7/31/2020]
    • Answer: Registration for the system will begin in December 2021. Please check the Medicare Ambulance Services Center website at https://www.cms.gov/Center/Provider- Type/Ambulances-Services-Center.html for updates.
  • Question: Can my organization collect information using our current accounting practices? [Added 7/31/2020]
    • Answer: In general, you will be able to report information collected under your organization’s current accounting practices. CMS understands that some ground ambulance organizations use accrual-basis accounting while others use cash-basis accounting. Please follow the instructions in each instrument section.
  • Question: My ground ambulance organization is owned and/or operated by our local municipality. The municipality pays directly for some costs associated with our ground ambulance operations (e.g., facilities costs, utilities, fuel, benefits, etc.). Do we need to report on these costs? [Updated 7/31/2020]
    • Answer: Yes. You must work with your municipality to report the costs that are relevant to your ground ambulance service. Otherwise, the costs that you report will be incomplete and not reflect your organization’s total costs. This would also apply if your ground ambulance organization is part of a broader organization that pays directly for some of your organization’s costs (e.g., a hospital Medicare provider that also owns and provides ground ambulance services). The specific information that you will need to collect and report might include information on labor costs (Section 7); facilities costs (Section 8); Vehicle costs (Section 9); equipment, consumable, and supply costs (Section 10), and other costs (Section 11). If you are a fire, police, or other public safety-based ground ambulance organization, please report labor hours and compensation associated with both ground ambulance and other public safety roles per the data collection instrument instructions.
  • Question: How should we account for goods or services provided by another organization (e.g., hospital, local government)? [Added 7/31/2020]
    • Answer: Whether and how to account for costs realized by an entity other than your ground ambulance organization depends on the nature of the relationship with the other entity. CMS has heard that it is relatively common for some costs – for example dispatch, vehicle maintenance, or administrative costs – to be borne by an organization’s local municipality or a part of a local municipal government (such as a police department):
    • If your ground ambulance organization is part of or associated with a local municipality, you need to report these costs. For example, if dispatch services are provided by your municipality’s police department and your ground ambulance organization is part of or associated with the same municipality, then you must collect and report a share of dispatch costs associated with ground ambulance operations. See the related question “My ground ambulance organization is owned and/or operated by our local municipality. The municipality pays directly for some costs associated with our ground ambulance operations (e.g., facilities costs, utilities, ambulance fuel, benefits, etc.). Do we need to report on these costs?”
    • If your ground ambulance organization is NOT part of (i.e., owned or operated by) a local municipality, you do NOT need to report costs associated with services provided by your local municipality other than costs (if any) paid directly by your organizations for the service. If your municipality provides dispatch services for your community and your organization does not pay for this service, then no costs related to dispatch are reported. See the related question “My organization received donations during the data collection period (e.g., an ambulance donated by the community, medicines or medical consumables provided by hospitals, or cash donations). How should these donations be reported?” If your organization makes a payment in exchange for a service, report the payment as a cost under the appropriate section of the data collection instrument.

The same principles apply to similar cases, for example when the other entity is a hospital, non-profit organization, or other type of entity.

  • Question: Should hours on call be included in total hours worked? [Added 7/31/2020]
    • Answer: When reporting hours worked, whether for paid or volunteer staff, do not include hours on call toward hours worked.
  • Question: How should we report staff training in the data collection instrument? [Added 7/31/2020]
    • Answer: There are two ways that you can report training. If training is conducted by your organization’s staff, you would include hours worked and compensation for training staff in your calculations of total hours worked and total compensation. Employees would report hours spent and compensation (if any) for attending trainings. If the training is not just on ground ambulance topics, the reported total hours and compensation would reflect an estimate the percent of time related to ground ambulance. If you have other training expenses or pay money to an outside organization for training activities, these can be listed in Section 11, Question 3 under the category “Training and continuing education costs (e.g., costs for materials, travel, training fees, and labor).” Costs related to collecting and reporting data to the Medicare Ground Ambulance Data Collection System should not be reported.
  • Question: How should we report paid time off (PTO) in the data collection instrument? [Added 7/31/2020]
    • Answer: Paid time off (PTO) is not included in the hours worked section in the labor portion of the data collection instrument. However, PTO is a benefit that should be included in the total compensation questions of the labor section.
  • Service Area: Question: How should our organization define the primary and secondary service area for our particular circumstances? [Updated 7/31/2020]
    • Answer: For the purposes of this data collection effort, use your best judgement. In general, your primary service area is the area in which you are exclusively or primarily responsible for providing service at one or more levels and where it is highly likely that the majority of your transport pickups occur. A secondary service area is outside your primary service area, but one where you regularly provide services through mutual or auto-aid arrangements or at a different level of service compared to your primary service area. When reporting service areas using ZIP codes, it is possible that you will report the same ZIP code as belonging to both your primary and secondary service area, for example in a case where a town and a township share a ZIP code and your organization is primarily responsible for service within the town but has mutual or auto aid agreements with the surrounding township. Please list all ZIP codes in your service area, even if they cross over into another county or municipality. For the service volume section of the instrument, responses, transports, etc. to both primary and secondary service areas should be included in the totals reported.
  • Service Mix/Service Volume: Question: How should my organization count ground ambulance responses and/or transports if more than one vehicle is sent to the scene or if more than one patient is transported? [Added 7/31/2020]
    • Answer: If more than one vehicle is sent to the scene, count this as one response. Organizations should count the total number of patients transported. A single response may result in multiple transports in cases where multiple ambulances are deployed or when multiple patients are transported by the same ambulance.
  • Question: How should our organization report on situations where we respond to calls for service in conjunction with staff from another organization? [Added 7/31/2020]
    • Answer: In Section 5, Question 3, you can report that your organization responds to calls for service in conjunction with vehicles and/or staff from another organization. You must report payments that you make to the other organization (as “other costs” in Section 11) and payments received by your organization (as revenue in Section 13). You will not need to report specific labor or other costs from the other organization. Report the total revenue that your organization receives from payers and other sources, even if you later share the revenue with the other organization.
  • Facilities: Question: My organization does not record buildings as assets or calculate depreciation for buildings. Do we need to report depreciation for buildings? [Added 7/31/2020]
    • Answer: No.
  • Vehicles: Question: How should we calculate annual depreciation expenses for vehicles and capitalized equipment? [Updated 7/31/2020]
    • Answer: In general, you will be able to use your organization’s standard approach to calculating depreciation expenses. If your organization calculates depreciation expense for multiple purposes (e.g. depreciation for tax incentive purposes vs. Generally Accepted Accounting Principles (GAAP) for standard auditing purposes), please report the depreciation expense captured for standard auditing purposes. There are several presentations, such as the December 5, 2019 National Provider Call, that provide examples of reporting annual depreciation expenses in Section 8 (Facilities Costs), Section 9 (Vehicle Costs), and Section 10 (Equipment, Consumable, and Supply Costs) of the data collection instrument. These presentations are available on the Ambulances Services Center website at https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.html.
  • Equipment: Question: My organization uses a cash basis for accounting and does not depreciate equipment or supplies. Do we need to start calculating annual depreciation? [Added 7/31/2020]
    • Answer: No. If your department is a cash basis entity and doesn’t calculate depreciation, you do not have to report depreciation. Please report the entire purchase costs in the relevant sections.
  • Revenue: Question: How is revenue defined for the purposes of collecting and reporting data? [Added 7/31/2020]
    • Answer: Report gross/total revenue received from all sources during the data collection period. You may need to collect information from a billing company or your municipality in order to report this information. Do not report charges, billed amounts, or bad debt. Depending on your organization’s accounting practices, CMS understands that the revenue received during the data collection period may not perfectly align with the services provided during the data collection period.
  • Question: My organization is unable to separate revenue from payers related to transports and non-transport services. How should we report revenue for non-transport services? [Added 7/31/2020]
    • Answer: If possible, report only revenue from transports in Section 13, Questions 2-4. Report revenue from non-transport EMS and ground ambulance services in Section 13, Question 5.
  • Question: My organization shares revenue from billed service with another organization. Should we report the revenue we receive from payers or the share we retain? [Added 7/31/2020]
    • Answer: Report the revenue that you initially receive from payers. Do not subtract the amount that you share with another organization. Report the amount you do share in Section 11 (“Other Costs”) as a cost.

RHIhub | Rural Surge Toolkit

Developed by the Rural Health Information Hub: This toolkit provides rural communities with the information, resources, and materials they need to develop a community health program in a rural community.

Each of the toolkit’s six modules contains information that communities can apply to develop a rural health program, regardless of the specific health topic the program addresses. The toolkit also links to issue-specific toolkits for more in-depth information.

View Toolkit

 

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

 

NEMSAC Meeting August 18–19

From EMS.gov on July 29

Register Now for the National EMS Advisory Council Meeting Webcast Aug. 18-19
The National EMS Advisory Council will be holding a virtual meeting on Tuesday and Wednesday, August 18-19. Members of the public can register for the webcast and view the full agenda here.

The agenda for each day includes meetings of NEMSAC committees during the morning sessions, with the webcast beginning when the full council convenes at 1 pm EDT on Tuesday, August 18, 2020, and 12 pm EDT on Wednesday, August 19, 2020. Items on the council’s agenda include:

  • COVID-19 response and PPE tracking
  • The Emergency Triage, Treat and Transport Model (ET3)
  • Telemedicine
  • Civil unrest
  • Workforce mental health
  • EMS for Children
  • The National EMS Assessment
  • EMS and social determinants of health
  • The FICEMS strategic plan

Individuals registered for the meeting interested in addressing the council during the public comment periods must submit their comments in writing to Eric Chaney at eric.chaney@dot.gov by August 13, 2020.

Register Now

For more information about the National EMS Advisory Council, including previous meeting materials, advisories and a list of council members, visit ems.gov/nemsac.html.

JAMA | COVID-19 Medical Leave for EMS in NYC

From JAMA Network Open

Medical Leave Associated With COVID-19 Among Emergency Medical System Responders and Firefighters in New York City

In New York, New York, from March 1 to May 31, 2020, 201 102 individuals were diagnosed with coronavirus disease 2019 (COVID-19), resulting in 51 085 hospitalizations and 16 834 deaths.1 The Fire Department of the City of New York (FDNY), the largest in the US, responds to nearly 1.5 million emergency medical calls per year in a city of more than 8.4 million people. Active paid FDNY responders include 4408 emergency medical service (EMS) responders and 11 230 firefighters. These FDNY responders are required to don personal protective equipment before patient contact per US Centers for Disease Control and Prevention guidelines.2 In this cohort study, we compared medical leave of FDNY responders during the pandemic with prior years.

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Citation

Prezant DJ, Zeig-Owens R, Schwartz T, et al. Medical Leave Associated With COVID-19 Among Emergency Medical System Responders and Firefighters in New York City. JAMA Netw Open. 2020;3(7):e2016094. doi:10.1001/jamanetworkopen.2020.16094

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.”

Continue Reading

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/.

CISA: Emergency Services Sector Active Shooter Guide

The FBI designated 28 shootings in 2019 as active shooter incidents. The 28 incidents resulted in 247 casualties, 97 people killed, and 150 people wounded, excluding the shooters. No community appears immune from these potential incidents; therefore, it is important for every community to develop an Active Shooter Program.

The purpose of this guide is to provide emergency services personnel with the basic building blocks for developing an Active Shooter Program with communities. This guide highlights resources and planning considerations, which will enhance emergency services organizations’ ability to develop or improve community planning and preparedness for active shooter incidents.

Download Guide

For more information, email the Emergency Services Sector-Specific Agency at essteam@cisa.dhs.gov.

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.

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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.