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

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.

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

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/.

Updated CMS FAQs on the Ambulance Data Collection

Updated CMS FAQs on the Ambulance Data Collection System and Reporting Requirement Delay

As we recently reported, CMS announced that it will be delaying the implementation of the statutorily mandated ambulance data collection system.  CMS has released a new set of Frequently Asked Questions (FAQs) clarifying the delay.  In sum, ambulance organizations selected to provide cost data for 2020 will now be required to report 2021 data in Year 2.  CMS will also add a new set of ambulance organizations for Year 2 reporting as well.  This means that twice as many ambulance organizations will be reporting 2021 data in Year 2 and there will be no data reported for 2020.  Any organization selected that does not report data will be subject to the 10 percent penalty, unless an exception applies.  In addition to addressing concerns about reporting during the pandemic, the FAQs suggest that CMS is concerned that 2020 data “may not be reflective of typical costs and revenue associated with providing ground ambulance services.”

The complete list of these questions, as well as previous ambulance FAQs for COVID-19 on Medicare Fee-for-Service (FFS) Billing can be found here.  The new data collections are below.

Data Collection and Reporting Requirements for the Medicare Ground Ambulance Data Collection System

 1. Question: CMS requires selected ground ambulance organizations to collect cost, revenue, utilization, and other information through the Medicare Ground Ambulance Data Collection System. The collected information will be provided to MedPAC, which is required to submit a report to Congress on the adequacy of Medicare payment rates for ground ambulance services and geographic variations in the cost of furnishing such services. Will the data collection and reporting requirements for the Medicare Ground Ambulance Data Collection System be delayed due to COVID-19?

Answer: Yes. CMS has issued a blanket waiver: https://www.cms.gov/files/document/summary-covid-19-emergency-declaration- waivers.pdf due to the PHE for the COVID-19 pandemic. CMS is modifying the data collection period and data reporting period, as defined at 42 CFR §414.626(a), for ground ambulance organizations that were selected by CMS to collect data beginning between January 1, 2020, and December 31, 2020 (Year 1).

Under this modification, these ground ambulance organizations can select a new data collection period that begins between January 1, 2021, and December 31, 2021; collect the necessary data during their selected data collection period; and submit the data during the data reporting period that corresponds to their selected data collection period.

CMS is modifying this data collection and reporting period to increase flexibilities for ground ambulance organizations that would otherwise be required to collect data in 2020–2021 so that they can focus on their operations in support of patient care.

As a result of this modification, ground ambulance organizations selected for year 1 data collection and reporting will collect and report data during the same period of time that will apply to ground ambulance organizations selected by CMS under §414.626(c) to collect data beginning between January 1, 2021, and December 31, 2021 (year 2) for purposes of complying with the data reporting requirements described at §414.626.

For additional information on the Medicare Ground Ambulance Data Collection System, please visit the Ambulances Services Center website at

https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center.

New: 6/16/20

2. Question: Will the 10 percent payment reduction still apply to ground ambulance organizations that are now required to collect and report data under the modified data collection and reporting period but do not sufficiently report the required data?

Answer: Yes. The 10 percent payment reduction described at 42 CFR §414.610(c)(9) will still apply if a ground ambulance organization is selected to collect and report data under the modified data collection and reporting timeframe, but does not sufficiently submit the required data according to the modified timeframe and is not granted a hardship exemption. The payment reduction will be applied to payments made under the Medicare Part B Ambulance Fee Schedule for services furnished during the calendar year that begins following the date that CMS provides written notification that the ground ambulance organization did not submit the required data.

New: 6/16/20

3. Question: The modification states that the ground ambulance organizations that were selected by CMS to collect data beginning between January 1, 2020, and December 31, 2020 (year 1) can select a new continuous 12-month data collection period that begins between January 1, 2021, and December 31, 2021. Do the ground ambulance organizations that were selected in year 1 have an 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?

Answer: No. The ground ambulance organizations that were selected for year 1 do not have an option and must select a new data collection period that begins in 2021. CMS cannot permit this option because the data collected in 2020 during the PHE may not be reflective of typical costs and revenue associated with providing ground ambulance services. New: 6/16/20

4. Question: Does the guidance mean that there will be no data reporting in 2021 and that both the ground ambulance organizations that were selected for year 1 and the ground ambulance organizations that will be selected for year 2 will collect and report data during the same time periods?

Answer: Yes. Under the modification, ground ambulance organizations that are selected for year 1 will not collect data in 2020. These ground ambulance organizations will select a new data collection period that begins in 2021 and must submit a completed Medicare Ground Ambulance Data Collection Instrument during the data reporting period that corresponds to their selected data collection period. As a result of the modification, year 1 and year 2 selected ground ambulance organizations will collect and report data during the same time periods. New: 6/16/20