Today, at President Trump’s direction, the Centers for Medicare & Medicaid Services (CMS) today is issuing an unprecedented array of temporary regulatory waivers and new rules to equip the American healthcare system with maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic. Made possible by President Trump’s recent emergency declaration and emergency rule making, these temporary changes will apply immediately across the entire U.S. healthcare system for the duration of the emergency declaration. This allows hospitals and health systems to deliver services at other locations to make room for COVID-19 patients needing acute care in their main facility.

The changes complement and augment the work of FEMA and state and local public health authorities by empowering local hospitals and healthcare systems to rapidly expand treatment capacity that allows them to separate patients infected with COVID-19 from those who are not affected.

CMS’s temporary actions announced today empower local hospitals and healthcare systems to:

• Increase Hospital Capacity – CMS Hospitals Without Walls;
• Rapidly Expand the Healthcare Workforce;
• Put Patients Over Paperwork; and
• Further Promote Telehealth in Medicare

You can find a copy of the full press release here:  https://www.cms.gov/newsroom/press-releases/trump-administration-makes-sweeping-regulatory-changes-help-us-healthcare-system-address-covid-19

For additional background information on the waivers and rule changes, go to: https://www.cms.gov/newsroom/fact-sheets/additional-backgroundsweeping-regulatory-changes-help-us-healthcare-system-address-covid-19-patient

For more information on the COVID-19 waivers and guidance, and the Interim Final Rule, please go to the CMS COVID-19 flexibilities webpage: https://www.cms.gov/about-cms/emergency-preparedness-response-operations/current-emergencies/coronavirus-waivers.

These actions, and earlier CMS actions in response to COVID-19, are part of the ongoing White House Coronavirus Task Force efforts. To keep up with the important work the Task Force is doing in response to COVID-19, visit www.coronavirus.gov.  For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.

On March 27, 2020, Congress passed and the President signed the CARES Act, a $2 trillion relief package that provides much needed economic relief for American families and businesses who are hurting through no fault of their own. This legislation will provide assistance to America’s heroic healthcare workers who are on the frontlines of this outbreak, including $100 billion which will go to healthcare providers, including hospitals on the front lines of the COVID-19 pandemic, $27 billion which will go to bolstering life-saving capabilities, including developing vaccines and the development, purchase, and distribution of critical supplies and $45 billion which will go to the Federal Emergency Management Agency Disaster Relief Fund, more than doubling the amount available to support the President’s Emergency and Disaster Declarations to empower State, local, and tribal leaders to effectively respond.

See below for updates for releases from March 27:

Continued Efforts to Expedite Testing: Initially, nasopharyngeal swab were the only recommended swabs to be used for diagnostic testing of COVID-19. Subsequently, FDA identified a number of other swabs that were available to collect samples. Now, FDA has newly released information that recommends for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity. This would provide COVID-19 testing that is more comfortable for patients, allows self-collection of samples at collection sites, and that can be performed with a simpler and more readily available swab.

Expansion of Diagnostics to Test for COVID-19: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 17 emergency use authorizations have been issued for diagnostic tests, including the AvellinoCoV2 test, which is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. Additionally, FDA has been notified that more than 100 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

Expanding Face Masks for General Use and Conserving N95 for Health Care Workers: FDA issued an immediately in effect guidance on an Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency. The FDA believes the policy set forth in this guidance may help address urgent public health concerns by helping to expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals.

Repurposing Ventilators: FDA has issued guidance allowing ventilators from outpatient surgical centers and clinics to be modified by changing a vent. This policy will assist states with being able to identify a whole new range of ventilators that could be easily converted, add to their supply, and focused at the point of the need in their states. Anesthesiologists Patient Safety Foundation (APSF)/American Society of Anesthesiologists (ASA) has issued guidance on purposing anesthesia machines as ICU ventilators.

Maintaining Essential Health Services During an Outbreak: The WHO released Operational Guidance for Maintaining Essential Health Services During an Outbreak. This document provides guidance on a set of targeted immediate actions that countries should consider at national, regional, and local level to reorganize and maintain access to high-quality essential health services for all.

Public-Private Partnership to Develop a New Screening Tool: In partnership with the White House Coronavirus Task Force, the Department of Health and Human Services, and the Centers for Disease Control and Prevention (CDC), Apple released an app and website that guides Americans through a series of questions about their health and exposure to determine if they should seek care for COVID-19 symptoms.  The screening tool provides CDC recommendations on next steps including guidance on social distancing and self-isolating, how to closely monitor symptoms, recommendations on testing, and when to contact a medical provider.

Extending the Supply of and Providing Consumer Information on Hand Sanitizer: FDA issued guidance for the temporary manufacture of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products. The FDA posted questions and answers related to consumer use of hand sanitizer during the COVID-19 public health emergency. The FDA wants to make consumers aware of the steps the agency is taking to increase the supply of hand sanitizer during this public health emergency. The questions also discuss hand washing, expiration dates and other frequently asked questions by consumers on hand sanitizer.

Avoid All Non-Essential International Travel: CDC issued a travel warning today for all individuals to avoid all non-essential international travel in an effort to curb the ongoing transmission of COVID-19.

CMS Continuing to Provide State Flexibilities: CMS has now approved 34 Section 1135 Medicaid waivers in states. CMS also approved 8 state requests to invoke emergency flexibilities in their programs that care for the elderly and people w/ disabilities in their homes & communities.

Providing Telehealth Resources for Long-Term Care and Nursing Home Facilities: CMS has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. This toolkit will aid and provide information to facilities utilizing the new telehealth flexibilities.

HRSA Gives Flexibilities to Grantees: HRSA has adopted all 13 administrative flexibilities outlined as available by OMB and has released an FAQ on these flexibilities for grantees.

Flexibility Regarding Nutrition Labeling: The FDA issued guidance on a Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency. The FDA is issuing this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic. For example, restaurants may have purchased ingredients that they can no longer use to prepare restaurant food and instead wish to sell to their customers.

March 27, 2020

HRSA Grant Recipients,

As a nation, we continue to adjust to the impact Coronavirus 2019 (COVID-19) is having on our lives, our communities, our friends and loved ones.

As Federal awarding agencies address recipients and applicants directly affected by COVID-19, we want to assure you that we fully recognize the significant impact this situation is having on you, and we are working as quickly as we can to help relieve some of that burden.

On March 19, 2020, OMB issued Memorandum M-20-17, Administrative Relief for Recipients and Applicants of Federal Financial Assistance Directly Impacted by the Novel Coronavirus (COVID-19) due to Loss of Operations. When compared to OMB’s March 9, 2020, Memorandum (M-20-11), the newer memorandum provides similar administrative relief but to an expanded scope of recipients.

To ease the programmatic difficulties brought about by the COVID-19 pandemic, HRSA is integrating all 13 of the administrative flexibilities provided in the latest OMB memorandum.

So you have information as quickly as possible, we developed a list of Frequently Asked Questions  that addresses the OMB flexibilities. You likely received a link to the FAQs in our March 24, 2020 message to all active HRSA recipients. Please bookmark this page for future reference and watch for updates.

Due to the impact of the COVID-19 outbreak, we want to assure you that HRSA will do our part to help you continue your extraordinary work.

Thank you for your partnership and patience as we work together to ensure our nation’s health and safety. From all of us at HRSA, we wish you, your families and colleagues the best as we continue to monitor the immense impact COVID-19 is having on our country and the world.

If you have questions or concerns, please reach out to your assigned HRSA Project Officer or Grants Management Specialist. They are eager to assist you through this complicated period.

Sincerely,

Tom Engels, Administrator

Health Resources and Services Administration (HRSA)

As part of the National Institute for Occupational Safety and Health’s (NIOSH) efforts to keep stakeholders up to date on the CDC and NIOSH coronavirus disease 2019 (COVID-19) response, below is a summary of new information posted the the week of March 23, 2020 for workers.

Personal Protective Equipment (PPE) Burn Rate Calculator
CDC recognizes that healthcare and nonhealthcare systems may experience unprecedented strains on demand for PPE due to COVID-19. CDC designed a tool to help healthcare and nonhealthcare systems, such as correctional facilities, track how quickly PPE will be used at those facilities. The tool is based on input provided by healthcare systems on the use of PPE during responses to infectious disease outbreaks.

Guidance for Businesses and Employers

• Interim Guidance for Businesses and Employers to Plan and Respond to Coronavirus Disease 2019 (COVID-19)
  CDC developed guidance to help employers decrease the spread of COVID-19 and lower the impact of COVID-19 on the workplace. This interim guidance may help prevent workplace exposures to COVID-19 in nonhealthcare settings. This guidance also provides planning and response considerations for community spread of COVID-19.
• Environmental Cleaning and Disinfection Recommendations
  Recommendations for the cleaning and disinfection of rooms or areas where individuals with suspected or with confirmed COVID-19 have visited is available on the CDC website. These guidelines are focused on community, nonhealthcare facilities, such as schools, offices, and businesses.

Resources for First Responders and Law Enforcement

• Interim Guidance for Emergency Medical Services (EMS) Systems and 911 Public Safety Answering Points (PSAPs) for COVID-19 in the United States
  Guidance for first responders, including law enforcement, fire services, emergency medical services, and emergency management officials, who anticipate close contact with persons with confirmed or possible COVID-19 in the course of their work.
• What Law Enforcement Personnel Need to Know About Coronavirus Disease 2019
  This new CDC fact sheet provides recommendations for personnel who may come in contact with someone with confirmed or suspected COVID-19.
• Infectious Diseases and Circumstances Relevant to Notification of Emergency Response Employees: Implementation of Sec. 2695 of the Ryan White HIV/AIDS Treatment Extension Act of 2009
  NIOSH has updated the List of Potentially Life-Threatening Infectious Diseases to which Emergency Response Employees May be Exposed to include the addition of COVID-19, the disease caused by the virus SARS-CoV-2, and the definition of “emergency response employee (ERE).” The list and accompanying guidelines, originally published in a 2011 Federal Register notice, are republished in this document with these updates.

To stay up to date on the response please visit the COVID-19 webpage or sign up for the COVID-19 newsletter.

On March 27, CMS issued an electronic toolkit regarding telehealth and telemedicine for Long Term Care Nursing Home Facilities. Under President Trump’s leadership to respond to the need to limit the spread of community COVID-19, CMS has broadened access to Medicare telehealth services so that beneficiaries can receive a wider range of services from their doctors without having to travel to a healthcare facility. This document contains electronic links to reliable sources of information regarding telehealth and telemedicine, including the significant changes made by CMS over the last week in response to the National Health Emergency.  Most of the information is directed towards providers who may want to establish a permanent telemedicine program, but there is information here that will help in the temporary deployment of a telemedicine program as well. There are specific documents identified that will be useful in choosing telemedicine vendors, equipment, and software, initiating a telemedicine program, monitoring patients remotely, and developing documentation tools. There is also information that will be useful for providers who intend to care for patients through electronic virtual services that may be temporarily used during the COVID-19 pandemic.

On March 22, 2020, CMS announced relief for clinicians, providers, hospitals and facilities participating in quality reporting programs in response to the 2019 Novel Coronavirus (COVID-19). This memorandum and factsheet supplements and provides additional guidance to health care providers with regard to the announcement. CMS has extended the 2019 Merit-based Incentive Payment System (MIPS) data submission deadline from March 31 by 30 days to April 30, 2020. This and other efforts are to provide relief to clinicians responding to the COVID-19 pandemic. In addition, the MIPS automatic extreme and uncontrollable circumstances policy will apply to MIPS eligible clinicians who do not submit their MIPS data by the April 30, 2020 deadline.

You can find a copy of the memo here:  Memo

You can find a copy of the fact sheet here:  Fact Sheet

On March 28,  the Centers for Medicare & Medicaid Services (CMS) announced an expansion of its accelerated and advance payment program for Medicare participating health care providers and suppliers, to ensure they have the resources needed to combat the 2019 Novel Coronavirus (COVID-19). This program expansion, which includes changes from the recently enacted Coronavirus Aid, Relief, and Economic Security (CARES) Act, is one way that CMS is working to lessen the financial hardships of providers facing extraordinary challenges related to the COVID-19 pandemic, and ensures the nation’s providers can focus on patient care.

You can find a copy of the fact sheet here: www.cms.gov/files/document/Accelerated-and-Advanced-Payments-Fact-Sheet.pdf

You can find a copy of the press release here: https://www.cms.gov/newsroom/press-releases/trump-administration-provides-financial-relief-medicare-providers

On March 27, in keeping with its commitment to ensure states have the necessary tools to respond to the 2019 Novel Coronavirus (COVID-19) pandemic, the Centers for Medicare & Medicaid Services (CMS) approved an additional five state Medicaid waiver requests under Section 1135 of the Social Security Act (Act), bringing the total number of approved Section 1135 waivers for states to thirty four.  The waivers offer states new flexibilities to focus their resources on combatting the outbreak and providing the best possible care to their Medicaid beneficiaries. These waivers support President Trump’s commitment to operating a COVID-19 response that is locally executed, state managed and federally supported. All Section 1135 approval letters will be posted here as they are issued.  Additional information about all of the Section 1135 Waivers that CMS has approved can be found here.

CMS approved waivers for the following states today:

• Connecticut
• Delaware
• Minnesota
• Pennsylvania
• Wyoming

CMS provides guidance to states on how to apply for Section 1135 waivers through the Medicaid Disaster Response Tool Kit, which can be found here. To further the agency’s efforts, CMS has developed checklists and tools to expedite requests and approvals for waivers and other commonly requested flexibilities.  CMS will continue to expeditiously review and approve, as appropriate, all Section 1135 waivers and other requests that the agency receives to ensure that we are providing our state partners with the maximum flexibility they need to care for their Medicaid beneficiaries during the public health emergency.

These waivers, and earlier CMS actions in response to COVID-19, are part of the ongoing White House Task Force efforts. To keep up with the important work the Task Force is doing in response to COVID-19, visit www.coronavirus.gov. For a complete and updated list of CMS actions, and other information specific to CMS, please visit the Current Emergencies Website.  Additionally, CMS has launched a dedicated, Medicaid.gov, COVID-19 resource page that will be continually updated with relevant information.

March 27, 2020

WASHINGTON – USDA Rural Development has launched a COVID-19 resource page to keep our customers, partners, and stakeholders continuously updated on actions taken by the Agency to help rural residents, businesses, and communities impacted by the COVID-19 outbreak.

Visit www.rd.usda.gov/coronavirus for information on Rural Development loan payment assistance, application deadline extensions, and more.