CMS Updates Medicare COVID-19 Snapshot

From CMS on October 2, 2020

Today, the Centers for Medicare & Medicaid Services (CMS) released our monthly update of data that provides a snapshot of the impact of COVID-19 on the Medicare population. The updated data show over 1 million COVID-19 cases among the Medicare population and over 284,000 COVID-19 hospitalizations.

Other key findings:

  • The rate of COVID-19 cases among Medicare beneficiaries grew 30% since the August release to 1,562 cases per 100,000 beneficiaries.
  • Similarly, the rate of COVID-19 hospitalizations among Medicare beneficiaries grew 32% since the August release to 444 hospitalizations per 100,000 beneficiaries.
  • The rate of COVID-19 cases and hospitalizations grew the most among rural beneficiaries, Hispanic beneficiaries, and Medicare-only beneficiaries (those who are not dually eligible for Medicaid).
  • Medicare Fee-for-Service (Original Medicare) spending associated with COVID-19 hospitalizations grew to $4.4 billion or just under $25,000 per hospitalization.
  • Data on discharge status and length of stay for COVID-19 hospitalizations remained similar to previously reported figures in the August release. 31% of beneficiaries went home at the end of their hospital stay and 22% died. Nearly half of the hospitalizations lasted 7 days or less while 5% lasted more than 31 days.

The updated data on COVID-19 cases and hospitalizations among Medicare beneficiaries covers the period from January 1 to August 15, 2020. It is based on Medicare Fee-for-Service claims and Medicare Advantage encounter data CMS received by September 11, 2020.

HHS Funding Portal Open for Tranche 3

The online portal for ambulance service providers and suppliers to submit applications for additional funding under the HHS Provider Relief Fund is now open.

Access Portal Now

Apply Soon for Funds!

While providers and suppliers have until November 6 to apply for funding, we strongly recommend that AAA members submit applications as soon as you are prepared as funding is on a first-come, first-served basis. HHS allocated a total of $20 billion for this round of funding.

Attend Today’s AAA Funding Webinar

The AAA will be hosting a webinar today, Monday, October 5, at 11:00 am (eastern), on how to apply for the funds and what information you will need in applying.

Register for the Webinar

Thank You AAA Members!

As reported by the AAA on October 1, the additional funds are a direct result of the efforts of the AAA and our members and we thank all of you who reached out to the White House or your members of Congress advocating for the funds.

 

 

 

America First Healthcare Executive Order on Surprise Coverage

President Trump’s “An America-First Healthcare Plan” Executive Order on Surprise Billing Policy

by Kathy Lester, J.D., M.P.H.

As the American Ambulance Association (AAA) reported yesterday, President Trump issued an Executive Order (EO) “An America-First Healthcare Plan.”  The EO includes several provisions, including related to drug importation generally and for insulin specifically.  It also includes statements that indicate if the Congress does not act before the end of the year, the President will have the Department of Health and Human Services (HHS) “take administrative action to prevent a patient from receiving a bill for out-of-pocket expenses that the patient could not have reasonably foreseen.”  It does not mention ground ambulances.

In addition to suggesting action if the Congress does not pass legislation, the EO also states that within 180 days, the Secretary will update the Medicare.gov Hospital Compare website to inform beneficiaries of hospital billing quality, including:

  • Whether the hospital is in compliance with the Hospital Price Transparency Final Rule;
  • Whether, upon discharge, the hospital provides patients with a receipt that includes a list of itemized services received during a hospital stay; and
  • How often the hospital pursues legal action against patients, including to garnish wages, to place a lien on a patient’s home, or to withdraw money from a patient’s income tax refund.

The narrative related to balance billing (surprise coverage) reads as follows:

My Administration is transforming the black-box hospital and insurance pricing systems to be transparent about price and quality.  Regardless of health-insurance coverage, two‑thirds of adults in America still worry about the threat of unexpected medical bills.  This fear is the result of a system under which individuals and employers are unable to see how insurance companies, pharmacy benefit managers, insurance brokers, and providers are or will be paid.  One major culprit is the practice of “surprise billing,” in which a patient receives unexpected bills at highly inflated prices from providers who are not part of the patient’s insurance network, even if the patient was treated at a hospital that was part of the patient’s network.  Patients can receive these bills despite having no opportunity to select around an out-of-network provider in advance.

On May 9, 2019, I announced four principles to guide congressional efforts to prohibit exorbitant bills resulting from patients’ accidentally or unknowingly receiving services from out-of-network physicians.  Unfortunately, the Congress has failed to act, and patients remain vulnerable to surprise billing.

In the absence of congressional action, my Administration has already taken strong and decisive action to make healthcare prices more transparent.  On June 24, 2019, I signed Executive Order 13877 (Improving Price and Quality Transparency in American Healthcare to Put Patients First), directing certain agencies — for the first time ever — to make sure patients have access to meaningful price and quality information prior to the delivery of care.  Beginning January 1, 2021, hospitals will be required to publish their real price for every service, and publicly display in a consumer-friendly, easy-to-understand format the prices of at least 300 different common services that are able to be shopped for in advance.

We have also taken some concrete steps to eliminate surprise out‑of-network bills.  For example, on April 10, 2020, my Administration required providers to certify, as a condition of receiving supplemental COVID-19 funding, that they would not seek to collect out-of-pocket expenses from a patient for treatment related to COVID-19 in an amount greater than what the patient would have otherwise been required to pay for care by an in-network provider.  These initiatives have made important progress, although additional efforts are necessary.

Not all hospitals allow for surprise bills.  But many do.  Unfortunately, surprise billing has become sufficiently pervasive that the fear of receiving a surprise bill may dissuade patients from seeking appropriate care.  And research suggests a correlation between hospitals that frequently allow surprise billing and increases in hospital admissions and imaging procedures, putting patients at risk of receiving unnecessary services, which can lead to physical harm and threatens the long-term financial sustainability of Medicare.

Efforts to limit surprise billing and increase the number of providers participating in the same insurance network as the hospital in which they work would correspondingly streamline the ability of patients to receive care and reduce time spent on billing disputes.

The AAA will continue to advocate for the resources necessary to sustain life-saving mobile healthcare.

CARES Act Reporting Requirements Released

All recipients of payments from the Department of Health and Human Services’ Provider Relief Fund (PRF) are required to comply with the reporting requirements described in the Terms and Conditions and specified in future directions issued by the Secretary.

Providers that received more than $10,000 in grants will have to report on how they spent funds on coronavirus-related expenses and lost revenue in 2020 by Feb. 15, 2021. If providers do not spend all their grant funds by the end of 2020, they will be required to submit a final report on the remaining funds by July 31, 2021.

Any recipient of PRF payments may be subject to auditing to ensure the accuracy of the data submitted to HHS for payment.  Any recipients identified as having provided inaccurate information to HHS will be subject to payment recoupment and other legal action.

For more details, please refer to the Terms and Conditions associated with each payment distribution and the Reporting Requirements and Auditing FAQs.

Read more from HHS

CMS Updates Medicare COVID-19 Snapshot

From CMS on September 3, 2020

Today, the Centers for Medicare & Medicaid Services (CMS) released our monthly update of data that provides a snapshot of the impact of COVID-19 on the Medicare population. The updated data show over 773,000 COVID-19 cases among the Medicare population and nearly 215,000 COVID-19 hospitalizations.

Other key findings:

  • The rate of COVID-19 cases among Medicare beneficiaries grew 40% since the July release to 1,208 cases per 100,000 beneficiaries.
  • Similarly, the rate of COVID-19 hospitalizations among Medicare beneficiaries grew 33% since the July release to 338 hospitalizations per 100,000 beneficiaries.
  • Weekly counts of COVID-19 cases and hospitalizations reached the lowest point to date in late June and began to increase in July.
  • The rate of COVID-19 cases and hospitalizations grew the most among disabled beneficiaries, Hispanic beneficiaries, and Medicare-only beneficiaries (those who are not dually eligible for Medicaid).
  • Medicare Fee-for-Service (Original Medicare) spending associated with COVID-19 hospitalizations grew to $3.5 billion or just over $25,000 per hospitalization.
  • Data on discharge status and length of stay for COVID-19 hospitalizations remained similar to previously reported figures in the July release. 29% of beneficiaries went home at the end of their hospital stay and 24% died. Nearly half of the hospitalizations lasted 7 days or less while 5% lasted more than 31 days.

The updated data on COVID-19 cases and hospitalizations among Medicare beneficiaries covers the period from January 1 to July 18, 2020. It is based on Medicare Fee-for-Service claims and Medicare Advantage encounter data CMS received by August 14, 2020.

For more information on the Medicare COVID-19 data, visit: https://www.cms.gov/research-statistics-data-systems/preliminary-medicare-covid-19-data-snapshot

For an FAQ on this data release, visit: https://www.cms.gov/files/document/medicare-covid-19-data-snapshot-faqs.pdf

Public Comment Requested for COVID-19 Vaccine Allocation

On September 1, 2020, the National Academies of Sciences, Engineering, and Medicine invited public comment on the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine, commissioned by the Centers for Disease Control and the National Institutes of Health. Input from the public, especially communities disproportionately affected by the COVID-19 pandemic, is essential to produce a final report that is objective, balanced, and inclusive. The public comment period will be open for 4 days, from 12:00 p.m. ET on Tuesday, September 1, until 11:59 p.m. ET on Friday, September 4.

Learn More or Comment

NHTSA COVID PPE & Resource Reporting Tool

NHTSA asks EMS agencies across the U.S. to take a few minutes each week to report PPE, personnel status within their agency.

EMS and its public safety colleagues continue to serve at the frontlines in the fight against the COVID-19 pandemic. Resource procurement and distribution of personal protective equipment and staffing shortages continue to challenge EMS leaders. It is vital that local, State and Federal officials have the information they need to help address these issues.

The NHTSA Office of EMS, with support from the team at the NEMSIS Technical Assistance Center, has designed a reporting tool to allow for a consistent, real-time method of reporting PPE supply status and personnel shortages. Your participation in the EMS COVID Resource Reporting Tool provides objective evidence to ensure your local agency’s resource status is understood by State and National EMS leadership, and that your resource needs are being prioritized.

While this information will be available to State and Federal Officials, this reporting tool does not supersede coordination with local and state emergency management, public health, or healthcare coalitions. Organizations should still follow local and state procedures for reporting information and requesting supplies or other additional resource needs.

NHTSA is asking agencies to take a few minutes each week, preferably on Monday mornings, to complete the online form. You can find the form, as well as a video and other information explaining how the information is used and how to complete the form, here.

For questions regarding this process, please contact nemsis@hsc.utah.edu.

EMS COVID Resource Reporting Tool

Department of Health and Human Services Extends Deadline to Apply for Provider Relief Funds

The Department of Health and Human Services (HHS) recently announced that it would be extending the deadline for health care providers to apply to receive general distribution funding from the HHS Provider Relief Fund.  The deadline to apply for these funds was previously June 3, 2020.

Relevant Background

On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).  As part of that Act, Congress allocated $100 billion to the creation of a “CARES Act Provider Relief Fund,” which will be used to support hospitals and other healthcare providers on the front lines of the nation’s coronavirus response.  An additional $75 billion was allocated as part of the Paycheck Protection Program and Health Care Enhancement Act, bringing the total “Provider Relief Fund” up to $175 billion.  This $175 billion will be distributed to health care providers and suppliers to fund healthcare-related expenses or to offset lost revenue attributable to COVID-10.

HHS ultimately elected to allocate these funds through a $50 billion “general allocation,” and multiple smaller “targeted allocations.”

Under its general allocation program, HHS intended to provide health care providers with funds roughly equal to 2% of the provider’s 2018 “net patient revenue,” i.e., the provider’s total revenues from patient care minus provisions for bad debt, contractual write-offs, and certain other adjustments.   This general allocation was made in two tranches, with the first tranche being distributed to all providers in mid-April.  This first tranche was made based on provider’s 2019 Medicare revenues.  As a result, any provider that received payments from the Medicare Fee-for-Service Program in 2019 automatically received an initial relief payment.  However, HHS required providers to submit an application to receive relief funding as part of the second tranche.  The deadline for applying for the second tranche of relief funding was June 3, 2020.

Scope of New Extension

 HHS indicated that the new extension is limited to health care providers that missed the June 3, 2020 deadline to apply for the second tranche of relief funding.  The extension also applies to providers that were ineligible for the first tranche of relief funding due to a recent change of ownership.  The specific situations that HHS indicated would meet the requirements for the extension include:

  • Health care providers who were ineligible for the first tranche of relief funding because: (1) they underwent a change in ownership in calendar year 2019 or 2020 under Medicare Part A and (2) did not have Medicare Fee-for-Service revenues in calendar year 2019;
  • Health care providers who received a payment in the first tranche of funding but: (1) missed the June 3, 2020 deadline to submit revenue information or (2) did not receive funds in the first tranche that total approximately 2% of their net patient revenue; or
  • Health care providers who received a payment in the first tranche of funding, but who ultimately elected to refund that payment (e.g., because they did not believe they met the eligibility requirements), and who are now interested in reapplying.

Health care providers that meet one of the requirements listed above will have until August 28, 2020 to submit an application for additional relief funds.  This deadline aligns with the extended deadline for other eligible Phase 2 providers, such as Medicaid, Medicaid Managed Care, CHIP, and dental providers.

Applications should be submitted through the CARES Provider Relief Fund webpage, which can be found at: https://cares.linkhealth.com/#/.

HHS Report Calls for Congressional Action to Combat Surprise Billing

From HHS.gov on July 29, 2020

HHS Secretary’s Report Calls for Congressional Action to Combat Surprise Billing and Promote Price Transparency

Today, the U.S. Department of Health and Human Services released the HHS Secretary’s Report on Addressing Surprise Billing. The report, called for in Section 7 of President Trump’s Executive Order 13877, Improving Price and Quality Transparency in American Healthcare to Put Patients First, outlines critical steps, including Congressional action, to implement the Administration’s principles on surprise billing. Sound surprise billing legislation will not only protect patients but will encourage a fairer, more transparent, patient-centered healthcare system that benefits all Americans.

“Americans have the right to know what a healthcare service is going to cost before they receive it,” said HHS Secretary Alex Azar. “President Trump and his administration have done their part to deliver historic transparency around the prices of many procedures. Now it’s time for Congress to do what we all agree is necessary: combat surprise billing with an approach that puts patients in control and benefits all Americans.”

Surprise medical billing is a widespread and costly problem in the United States, and the need to address it has been highlighted during the Public Health Emergency (PHE) presented by COVID-19. Research shows that 41 percent of insured adults nationwide were surprised by a medical bill in the past two years alone, and that two thirds of adults worry about their ability to afford an unexpected medical bill.  At a time when Americans are increasingly seeking medical care, practices such as surprise billing leave many patients vulnerable to the financial burdens presented by a nationwide pandemic.

HHS has taken regulatory and administrative action to increase price transparency permanently. On June 24, 2019, President Trump signed Executive Order 13877. Following direction from this Executive Order, HHS published two rules supporting the Administration’s mission to improve accessibility of healthcare price information to help patients make informed decisions about their use of healthcare services. The first, poised to go into effect January 1, 2021, requires hospitals operating in the United States to establish, update, and make public, at least annually, a list of their standard charges for the items and services that they provide. The second companion proposed rule would demand similar transparency from most group health plans and issuers of health insurance coverage within both the individual and group markets.

To supplement this progress, Congress must take additional action to build on the achievements of the Administration to eliminate the threat of surprise billing once and for all. This should be accomplished with the following principles in mind, as laid out by the Trump Administration on May 9th, 2019:

  • Patients receiving emergency care should not be forced to shoulder extra costs billed by a care provider but not covered by their insurer;
  • Patients receiving scheduled care should have information about whether providers are in or out of their network and what costs they may face;
  • Patients should not receive surprise bills from out-of-network providers they did not choose; and
  • Federal healthcare expenditures should not increase.

If done swiftly, a remarkable burden will be lifted from the shoulders of millions of Americans. By building on the foundation placed by Executive Order 13877, there is an opportunity to fill the remaining gaps and solve comprehensively a longstanding flaw, equivalent to price-gouging, within our healthcare industry.

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.

HHS Non-discrimination During COVID-19 Guidelines

The Department of Health and Human Services (HHS) released guidance today intended to ensure that any healthcare provider who has received financial assistance, especially during the COVID-19 pandemic,  are compliant with the non-discrimination provisions of Title VI of the Civil Rights Act of 1964.  Consistent with the Affordable Care Act Section 1557’s non-discrimination provisions, Title VI ensures that no individual is denied access to benefits or otherwise discriminated against on the basis of race, color, national origin, disability, age, or sex.

HHS’ Office of Civil Rights (OCR) released this guidance to remind healthcare providers that Title VI prohibits both intentional and disproportionate or adverse impact discrimination.  Additionally, HHS is collecting nationwide data to identify the social, behavioral, and economic impacts on health disparities and vulnerable populations specific to the COVID-19 pandemic response.  The guidance specifically mentions ambulance service providers and suggests that they should:

  • Adopt policies to prevent and address harassment or unlawful discrimination;
  • Evaluate existing policies and procedures to ensure that their service delivery does not exclude or otherwise deny individuals based upon their belonging to a protected category;
  • Ensure that individuals are not subject to excessive wait times based upon their racial or ethnic minority group;
  • Provide services to all neighborhoods and individuals regardless of their race, color, or national origin;
  • Appoint individuals to planning or advisory bodies without regard to race, color, or national origin;
  • Provide culturally appropriate messaging to individuals with Limited English Proficiency (LEP)

Most EMS agencies already maintain an ACA Section 1557 Compliance Coordinator and have a Grievance Procedure for those who believe that they have been discriminated against in the provision of EMS mobile healthcare services.  It is recommended that EMS agencies review their current practices, as well as, their response coverage, times, and care provided in all the areas that they serve.  Further, I recommend that these efforts are documented and, if disparities are identified, a plan of correction is drafted, executed, and monitored, to ensure compliance.

Updated Interim CDC Guidance for EMS Services

The Centers for Disease Control (CDC) released updated Interim Guidance for Emergency Medical Services (EMS) Systems and 911 Public Safety Answer Points/Emergency Communication Center (PSAP/ECCs) in the United States During the Coronavirus Disease (COVID-19) Pandemic. The new twelve (12) page guidance is geared specifically for EMS and first responding agencies in response to the COVID-19 pandemic.  This is a summary of the highlights from the Interim Guidance and services are encouraged to review the document with your leadership team as this guidance impacts multiple aspects within an EMS organization.

1) Infection Prevention & Control (IPC) Practices

The CDC recommends that EMS agencies use additional infection prevention and control practices during the pandemic.  These practices are intended to augment your organization’s standard infection control practices with COVID-19 specific protective measures.  The recommendations include:

911 PSAPs Modified Call Queries

CDC recommends the development of modified caller queries to be developed in collaboration with your local state public health officials and your medical director.  The modified caller queries are geared towards identifying if the call concerns an individual who may have COVID-19 symptoms.  Additionally, the recommendations include pre-arrival instructions to include facial coverings, if patient condition permits, and communications with responding units to take the appropriate precautions.

2) Recommendations for EMS Personnel

The CDC identified numerous requirements for EMS Employers including:

  1. Development of IPC policies and procedures for safely donning and doffing PPE
  2. Job-specific education and training on preventing the transmission of infectious disease
  3. Employee training for the appropriate use of PPE, including OSHA required Fit testing
  4. EMS units must have adequate supplies of hand sanitizer, cleaning supplies, and disinfectants
  5. Require all employee to wear facial coverings when in the workplace, at all times. This includes breakrooms, day rooms, etc.
  6. Encourage employees not to change facial covers unless absolutely necessary to reduce exposure.

Screen all EMS Personnel for Signs or Symptoms of COVID-19 at the Start of Each Shift

The Interim Guidance calls for screening of all EMS personnel and visitors for symptoms consistent with COVID-19.  This screening should include active temperature screening and inquiring if they have been advised to quarantine due to exposure.  The guidance suggests restricting workplace access.

Assess all patients for COVID-19 Infection

EMS personnel should don the appropriate PPE when encountering patients, specifically those suspected of being infected with the virus.  The guidance suggests social distancing when possible and limiting how many providers make contact with the patient.  When appropriate, all patients should have the appropriate facial covering, this includes any family members or other persons accompanying the patient at the scene.

Encourage Physical Distancing

The CDC recommends limiting the number of EMS providers that accompany the patient in the ambulance patient compartment and suggests closing any walkthrough access to the driver’s compartment.  The guidance also suggests limiting or prohibiting family members from accompanying the patient in the ambulance.  The guidance also suggests that physical distancing be enforced in all workspaces, including break or eating areas where employees are going to be unmasked.

Implement Universal Use of Personal Protective Equipment

The CDC recommends that EMS personnel working in areas with moderate to substantial community transmission wear an N95 or equivalent or greater level respirator and eye protection.  For EMS personnel working in low transmission areas, the CDC recommends that N95 and eye protection are optional but that personnel should continue to follow the Standard and Transmission-Based Precautions based on any anticipated or suspected exposures.

Create a Process to Address to COVID-19 Exposures Among EMS Personnel & Others

The CDC recommends EMS agencies develop a process for notifying the health department about suspected or confirmed cases of COVID-19 and that each should develop a plan for investigating exposures.  This includes identifying:

  • An individual who is responsible identifying and notifying potentially exposed individuals.
  • How notifications will occur
  • The actions and follow-up required.

3) Recommend IPC practices when caring for a patient with suspected or confirmed COVID-19 infection

The CDC guidance also includes recommendations for the Personal Protective Equipment (PPE) that EMS personnel caring for suspected or confirmed COVID-19 infection should adhere to.  This includes:

  • Hand Hygiene
  • PPE Training
  • PPE Equipment, including:
    • Respirator or Facemask
    • Eye Protection
    • Gloves
    • Gowns

The guidance includes a warning regarding EMS personnel performing Aerosol-Generating Procedures.

4) EMS Transport of a Patient with Suspected or Confirmed COVID-19 Infection to a Healthcare Facility (Including Interfacility Transport)

Lastly, the CDC Interim Guidance included recommended actions when EMS personnel are transporting a patient who is suspected or confirmed to be infected with COVID-19.  It is recommended that the EMS crew notify the receiving healthcare facility prior to arrival to permit them to take the necessary precautions.  Additionally, the guidance suggests the following:

  • Document Patient Care

The patient care record should include documentation of a listing of all EMS personnel and public safety provided involved in the response, the level of contact with the patient, and if PPE was worn.

  • Cleaning EMS Transport Vehicles after Transporting a Patient with Suspected or Confirmed COVID-19 Infection.

The guidance includes additional information which includes guidelines for cleaning and maintaining EMS vehicles and equipment following the transport.

The updated CDC Interim Guidance included practices that most EMS organizations and personnel are practicing currently and have been since the outset of this pandemic.  However, it serves are an important reminder that the risks are very real and that EMS personnel must remain vigilant in their practices to ensure the safety of all individuals.

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

House Passes PPP Extension

On July 1, The U.S. House of Representatives unanimously passed a bill to extend the deadline to apply for forgivable small business loans through the Paycheck Protection Program. The legislation was previously passed by the Senate and President Trump is expected to sign the bill into law.

The bill extends the deadline to request Paycheck Protection Program loans to August 8 from June 30. The U.S. Small Business Administration (SBA), which oversees the program with the Treasury Department, stopped accepting loan applications at midnight Tuesday. The extension is intended to provide more time for small businesses to apply for the approximately $129 billion in PPP funding remaining.

The program provides forgivable loans that small businesses and other qualifying entities can use to cover payroll and other select costs.

The AAA will continue to press the Congress and federal agencies for help to ensure ambulance service organizations and our paramedics and EMTs serving on the front lines of the COVID-19 pandemic have the necessary resources and financial assistance to serve their communities.

Government Affairs Update: What We’re Working On

With the U.S. Senate on track to consider a fourth economic stimulus package before their August recess, the AAA is working hard to promote legislative language that positively impact the EMS industry and ambulance services across the country. Here is a snapshot of those current efforts.

Ambulance Funding in Response to COVID-19

As the Senate develops its next economic stimulus legislation to address the impact of COVID-19, the AAA has met with leaders and staff on Capitol Hill to increase the percentage of the general allocation of funds under the Public Health and Social Services Emergency Fund (PHSSEF) for ground ambulance services providers and suppliers to equal a total of $2.89 billion in funds for our industry. The $2.89 billion reflects $48,000 per ambulance with an estimated 60,000 registered vehicles. We greatly appreciate the recent payments under the Fund which will help with our current situation. However, the ground ambulance services industry is only 0.90% of Medicare fee-for-service annual outlays which resulted in $270 million for our industry in round one of PHSSEF payments. This figure is disproportional to the large role of ground ambulance service providers and suppliers in responding to COVID-19 and our increased costs and reduced revenues during the public health emergency (PHE).

The AAA has highlighted the increased costs, uncompensated care and lost revenue related to COVID-19 and hope to see ambulance-specific funding in the Senate’s 4th stimulus package.

Expand Public Safety Officer Benefits (PSOB)

Since the beginning of the pandemic, the AAA has advocated to add COVID-19 as an infectious disease under the Public Safety Officers’ Benefit (PSOB) and extend coverage during the pandemic to paramedics and EMTs employed by a private ambulance service who die from COVID-19.

On April 9, the AAA and the National Association of Emergency Medical Technicians (NAEMT) sent a letter to U.S. Attorney General William Barr requesting the Department of Justice extend coverage under the Public Safety Officers’ Benefits (PSOB) program to all paramedics and EMTs during the COVID-19 national health emergency.

On May 22, the AAA received a written response from the DOJ denying any expansion of the PSOB program stating that paramedics and emergency medical technicians employed by private for-profit EMS agencies do not meet the definition of “public safety officers” for purposes of PSOB eligibility.

To push for a legislative fix, AAA Staff and consultants have continued to advocate that all paramedics and EMTs be covered by the program regardless of their employer.

Expansion of Treatment in Place

The AAA has sent several letters asking the Centers for Medicare and Medicaid Services (CMS) to reimburse ground ambulance service providers and suppliers for performing protocol-driven treatments in place during the PHE.

This coverage will help limit the spread of COVID-19 by keeping patients with mild cases of COVID-19 at home and out of overcrowded hospitals or other facilities where they could expose others to the virus. With mostly positive response on our proposed regulatory fixes, the AAA will continue to follow up and address any roadblocks to full coverage of Treatment in Place.

Allow Private For-Profit EMS Providers to Apply Directly for FEMA Grants

The AAA has long advocated to allow private for-profit EMS agencies to apply directly to the Federal Emergency Management Agency (FEMA) for Public Assistance program grants during the PHE and waive the matching requirement for emergency response providers. During the COVID-19 pandemic, it is more necessary than ever that EMS agencies receive the funding the deserve for their role in the COVID-19 response. This will allow all EMS agencies to apply for financial assistance and for state and local governments to focus their limited resources on directly combating the pandemic.

We have been met with positive response from key Senators serving on Committees and Subcommittees of jurisdiction.

Other Legislation

The AAA was pleased to see the introduction of the Pandemic Responder Service Award Act (S. 3763) by Sen. Casey (D-PA) which provides front-line healthcare workers with awards up to $10,000 based on days of eligible service during the PHE. In the case of any qualified health care worker who was hospitalized or died as a result of contracting COVID–19, the award would be the full $10,000. This bill specifically includes private for-profit ambulance service providers, in a well-needed recognition of the work they provide on the frontlines of COVID-19. The AA will continue to work with Sen. Casey’s office as well as push for the inclusion of private for-profit providers in the House companion bill.

The AAA is also pleased to announce the introduction of H.R. 7292 by Rep. Marcy Kaptur (OH-09) which would provide forgiveness of certain accelerated and advanced payments under Medicare parts A and B. While the funding provided by the CARES Act was critical at keeping ambulance service providers operating, the Medicare Accelerated and Advanced Payment Program has the potential to cripple health care providers in the near future as Medicare payments are withheld until those advanced payments are repaid. H.R. 7292 would forgive the repayments and help ensure financial stability for ambulance service providers across the country.

The AAA will continue to press the Congress and federal agencies for help to ensure ambulance service organizations and our paramedics and EMTs serving on the front lines of the COVID-19 pandemic have the necessary resources and financial assistance to serve their communities.

 

CMS Launches the Office of Burden and Health Informatics

From Becker’s Health IT:
CMS launches new health informatics office to ease regulatory, administrative burdens: 5 details

CMS on June 23 unveiled the Office of Burden and Health Informatics, which will bridge tech and innovation initiatives with the agency’s efforts to reduce regulatory and administrative burdens for providers and beneficiaries.

“Specifically, the work of this new office will be targeted to help reduce unnecessary burden, increase efficiencies, continue administrative simplification, increase the use of health informatics, and improve the beneficiary experience,” CMS Administrator Seema Verma said in a news release.

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

From the Centers for Medicare and Medicaid Services

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

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

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

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

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

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

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

We look forward to your participation.

Special Open Door Participation Instructions

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

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

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