Coronavirus Flash Update June 8, 2020

Coronavirus Flash Update: June 8, 2020

Alston & Bird’s Coronavirus Flash provides updates on policy and regulatory actions under consideration across many important industries being monitored by our teams. Links to key government and legal resources are provided throughout the report.

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The Latest News

  • U.S. COVID-19 cases exceed 1,935,848 and 109,009 U.S. deaths. (Source: CDC) (Updated 6/8/20)
  • U.S. stock market: On Friday the markets ended the week with large gains, with the Dow rising 829 points, the S&P 500 up 81 points, and the Nasdaq gaining 198 points. Weekend trading in stock futures were pointing to more gains as of Sunday night. (New)
  • On June 4, the President announced an executive order to allow federal agencies to use COVID-19 emergency authority to bypass environmental regulation, including “provisions of major environmental laws such as the National Environmental Policy Act (NEPA), Endangered Species Act (ESA), and Clean Water Act (CWA) and their implementing regulations.” The order directs the agencies to compile reports to be submitted within 30 days identifying projects these emergency and other authorities may be used for to facilitate economic recovery. (6/4/20) (New)
  • In addition, the order directs:
    • Federal agencies to accelerate permitting for important infrastructure projects while providing appropriate protection for public health and safety.
    • The Department of Transportation will use their existing emergency authority to expedite the construction of highway and transportation projects.
    • The Interior Department, Agriculture Department, and the Army Corps of Engineers are also directed to use their emergency authorities to accelerate projects.
  • To understand the Executive Order’s impact on infrastructure investments and environmental regulations read this A&B advisory. (6/5/20) (New)
  • On June 4, the Department of Labor’s Bureau of Labor Statistics released its weekly unemployment benefits report showing 1.9 million new claims bringing the total to 42.6 million in 11 weeks. Also, on June 4 the Congressional Budget Office (CBO) released its analysis on the "Economic Effects of Additional Unemployment Benefits of $600 per Week". The CBO study was requested by Senate Finance Committee Chairman Charles Grassley (R-IA). The CARES Act granted a temporary increase of $600 per week in the benefit amount provided by unemployment programs through July 31, 2020. In discussions around the next emergency stimulus bill, some congressional leadership have pushed to extend this temporary increase through the end of the year. (6/4/20) (New)
  • The Medicaid and CHIP Payment and Access Commission (MACPAC) commissioned Mathematica to catalog telehealth policies pre-COVID-19 and changes during the pandemic. MACPAC is an advisory arm of Congress and its role is to provide policy and reimbursement analysis and recommendations. (6/5/20) (New)

COVID-19 Federal & State Legislation   

  • Bill 4.0: On Friday, June 5, the President signed into law the Paycheck Protection Flexibility Act, (H.R. 7010), a bill to allow new Paycheck Protection Program flexibility by extending the loan period and timeline for repayment. The bill also revises some requirements for loan forgiveness. (6/5/20) (New)
  • To learn more, see this A&B Summary of the Paycheck Protection Flexibility Act. (6/5/20) (New)
  • For the full details on the HEROES Act, H.R. 6800, which passed the House on May 15:
  • Bill 3.5: Paycheck Protection Program and Health Care Enhancement Act, (R. 266) was enacted on April 24. Also available are a section-by-section summary and an overview of the health care provisions.
  • A&B detailed summaries are below:
    • A&B Summary5 Small Business Provisions
    • A&B Summary5 Health Care Enhancement Provisions
  • Bill 3.0: Coronavirus Aid, Relief, and Economic Security (CARES) Act, (R. 748) passed on March 27. A congressional section by section summary is available here.
  • A&B detailed summaries are below:
  • Congress has passed three coronavirus emergency response bills and the first two are below:
  • Bill 1.0: Coronavirus Preparedness and Response Supplemental (CPPRS) (R. 6074) passed on March 5
  • Bill 2.0: Families First Coronavirus Response Act (FFCRA) (R. 6201) passed on March 18

Transition to “Reopening”   

Federal Communications Commission   

  • The FCC has approved another $16.46 million in telehealth funding to health care providers. (6/3/20)

Department of Health and Human Services   

  • The Department of Health and Human Services (HHS) Coronavirus toolkit page has been updated. (Updated 6/3/20)
  • HHS has a tracking feature that allows public viewing of all COVID-19 HHS grants and cooperative agreement awards on its website. The grants were distributed through programs in the ACF, ACL, ASPR, CDC, DHHS/OS, HRSA, IHS, NIH, and SAMHSA. (Updated 6/4/20)
  • The Substance Abuse and Mental Health Services Administration (SAMHSA) awarded $66 million in grants to provide training, education, and resources to improve the delivery of mental and substance use disorder treatment, especially for those impacted by COVID-19. (6/5/20) (New)
  • The HHS BARDA Office announced it was expanding its partnership with MODERNATIX, Inc to increase the domestic manufacturing capacity of Moderna’s mRNA-1273 vaccine. (6/5/20) (New)
  • The HHS Administration on Children and Families (ACF) sent a letter to grantees to announce certain flexibilities as a result of the pandemic. (6/5/20) (New)
  • The HHS ACF announced $750 million in aid for Head Start as authorized by the CARES Act. The dollars are intended to support programs for low-income children who have experienced disruption of services during the pandemic. (6/4/20) (New)
  • HHS released new guidance requiring all laboratories, non-laboratory testing locations, and other facilities offering point-of-care testing or in-home testing to report race, ethnicity, age and sex along with the test results. (6/4/20) (New)
  • Jointly, the CDC released an update on the effects of COVID-19 on the health of racial and ethnic minorities. (6/4/20) (New)
  • The HHS BARDA Office announced a partnership with Evidation Health to monitor health care workers and first responders by leveraging de-identified, patient-generated health data from existing wearable devices as an early warning of COVID-19. (6/4/20) (New)
  • The HHS Office of the Assistant Secretary for Response and Preparedness (ASPR) released a resource document for hospitals during civil unrest. (6/3/20)
  • ASPR releases a document providing health care resources for secondary disasters. (6/3/20)
  • ASPR has released guidance on visitation to retirement communities. (6/3/20)
  • ASPR has released a fact sheet on rural health and COVID-19. ASPR also posted this more detailed document on rural health and COVID-19. (6/3/20)

Centers for Disease Control and Prevention  

Centers for Medicare & Medicaid Services  

  • The Centers for Medicare and Medicaid Services (CMS) latest news alerts. (Updated 6/4/20)
  • And for the latest COVID-19 related CMS guidance and FAQs visit the CMS Current Emergencies webpage. (Updated 6/5/20)
  • CMS had posted the first set of nursing home COVID-19 data resulting from data reporting and inspections. They also provided FAQs to explain the data. (6/4/20) (New)
  • CMS released a notice that additional flexibilities would be provided for Centers for Medicare and Medicaid Innovation payment models in response to the COVID-19 pandemic. A fact sheet summarizes the changes for each CMMI payment model. (6/3/20)
  • CMS has updated it Medicare Fee-for-Service Billing FAQs. (6/3/20)
  • CMS has released new testing guidance for the uninsured. This guidance includes information on enrollment, claiming and data reporting, and eligibility. CMS also has a FAQs on the uninsured and state flexibilities. (6/3/20)
  • CMS has announced enhanced enforcement actions based on nursing home data and inspection. (6/2/20)

HHS/CDC/CMS/HRSA CARES Act Provider Relief Funds   

  • The CDC has posted an updated dataset of provider recipient specific payment from the Provider Relief Fund general distribution high impact targeted allocation and/or rural targeted allocation. The dataset includes who has attested to receiving one or more payments and agreed to the terms and conditions as of June 3. $49.875 billion of the $72 billion allocated to these distribution pools has been attested to. (Updated 6/5/20)
  • HHS - the CARES Act Provider Relief Fund (PRF) FAQs (Updated 6/3/20) have been updated and capture numerous modifications. These modifications include (New):
    • Providers that affirmatively attested to PRF payments received may reject those funds and retract the attestation by calling the provider support line (866-569-3522).
    • Providers that did not submit revenue information (i.e., an application) for the $20 billion (i.e., Round 2) General Distribution by June 3 are no longer eligible for a Round 2 payment. These providers will still be considered for future PRF payments.
    • HHS provided clarity that the June 3 deadline to submit revenue information was only for providers who wanted to be considered for the Round 2 payment. Providers were not required to attest to Round 2 payments by June 3. HHS reminds providers that they have 90 days from the receipt of Round 2 payment to attest and agree to the Terms and Conditions (this 90-day time period to attest and agree to the Terms and Conditions applies to all PRF payments).
      • By extension, this guidance indicates that providers were not required to submit revenue information by June 3 if they were not seeking a Round 2 payment.
      • While submitting revenue information appears to be required for all PRF payment recipients, HHS has not announced a specific deadline by which they must do so.
    • HHS Provider Relief Fund webpage. (Webpage Updated 6/4/20)
    • HHS released Indian Health Service Provider Relief Fund allotment Terms and Conditions. (6/2/20)
    • The COVID-19 Provider Relief Fund – the A&B General Distribution Attestation and Application Process Guide has been updated. (Updated 5/27/20)
    • HHS released a statement extending the Provider Relief Fund attestation deadline for an additional 45 days. This allows providers 90 days from the date they received a payment to accept the Terms and Conditions or return the funds. (5/22/20)
    • The CARES Provider Relief Fund hotline is (866) 569-3522.

Food and Drug Administration  

  • FDA provides a daily roundup on COVID-19 related actions. The latest announcements. (Updated 6/5/20)
    • FDA updated its FAQs on Testing for SARS-CoV-2, including posting a list of antibody tests that are being removed from the “notification list” of tests being offered. (Updated 6/5/20)
    • FDA maintains its COVID-19 FAQs for the general public. (Updated 6/3/20)
    • FDA webpage for health professionals. (6/2/20)
    • The agency also maintains a public database of drug shortages. (Updated 6/5/20)
  • The FDA reissued an emergency use authorization revising which types of respirators can be decontaminated for reuse. (6/7/20) (New)
  • The FDA has developed a resource on testing supply substitution strategies. (6/5/20) (New)
  • The FDA announced a webinar series on respirators for health care personnel use. The webinars begin on June 9, 2020, 12:00pm – 1:00pm ET. (6/5/20) (New)
  • The FDA announced it had issued an emergency use authorization to Roche Diagnostics for Elecsys IL-6, an in vitro diagnostic test for the quantitative measurement of IL-6 in human serum and plasma. (6/5/20) (New)
  • The FDA approved a new antibiotic to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. (6/5/20) (New)
  • The FDA approved a new drug to treat ventilated patients. (6/5/20) (New)
  • The FDA is launching a new webpage to highlight resources to protect public health during COVID-19. (6/4/20) (New)
  • FDA released a notification for health professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular block agents which have been in increased use for ICU patients during the pandemic. (6/4/20) (New)
  • FDA updated its guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency. (6/4/20) (New)
  • The FDA has added two ventilators developed by NASA to the list of authorized ventilators, ventilators tubing connectors, and ventilators accessories. The same list notes a new emergency resuscitator for the Fitbit Flow. (6/3/20)
  • The FDA has released updated guidance for institutional review boards to expand patient access during the COVID-19 emergency. (6/3/20)
  • FDA Resources for Healthcare Professionals. (6/3/20)

Health Resources and Services Administration   

  • The Health Resources and Services Administration (HRSA) has awarded $20.3 million to expand addiction workforce in underserved communities where the pandemic has increased the need. (6/2/20)
  • HRSA provides COVID-19-related information, resources, and FAQs here. HRSA has updated its progress reports including FAQs on health center reporting. (Updated 6/4/20)

Department of Homeland Security/FEMA/DOD   

  • The Department of Homeland Security (DHS) posts a weekly update of its response to COVID-19. (Updated 6/1/20)
  • FEMA has released a fact sheet on COVID-19 and historic preservation compliance. (6/5/20) (New)
  • FEMA releases the latest state-by-state data on PPE. (6/5/20) (New)
  • Department of Justice/Federal Trade Commission/Litigation   
  • The Department of Justice maintains an anti-price gouging & anti-fraud webpage with information on reporting complaints and resources on prevention. (Updated 6/6/20)
  • Litigation: On May 29, a Georgia woman pled guilty for violating the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) by selling an unregistered pesticide, “Toamit Virus Shut Out,” which she claimed protected against viruses, such as COVID-19 on eBay. The pesticide took the form of a card-shaped device to be worn around the user’s neck and was marketed as a “layer of safety protection effect, thus reducing the risks and probability of infection and transmission.” The FIFRA authorizes the Environmental Protection Agency (EPA) to regulate the production, sale, distribution, and use of pesticides in the United States. The Environment and Natural Resources Division’s Environmental Crimes Section prosecuted the defendant because Toamit Virus Shut Out was not registered with EPA, and it is illegal to distribute or sell unregistered pesticides. Defendant imported the pesticide from Japan and later sold it to individuals around the United States. Defendant will be sentenced June 29.

Small Business Administration   

  • Small Business Administration (SBA) – In response to the CARES Act requirements, the SBA Paycheck Protection Program (PPP) website has updated its FAQs for lenders and borrowers. (Updated 5/27/20)
  • The SBA released the Paycheck Protection Program Loan Forgiveness process, which includes the application and instructions. (5/15/20)
    • The SBA, jointly with the Department of Treasury, released an interim final rule on eligibility of certain telephone cooperatives. (6/5/20) (New)
    • The SBA, jointly with the Department of Treasury, released the interim final rule for the PPP loan forgiveness process. (5/22/20)
    • The SBA also released the interim final rule the PPP loan review procedures and borrowing responsibilities. (5/22/20)
    • Summary of Paycheck Protection Program Lending (Updated 6/1/20)

Department of Treasury/IRS/Federal Reserve   

  • The Department of Treasury website for CARES Act business assistance programs.
  • The Internal Revenue Service has released guidance on COVID-19 related tax relief for Qualified Opportunity Funds (QOFs). (6/4/20) (New)
  • The Federal Reserve announced an expansion in the number and type of entities eligible to directly use its Municipal Liquidity Facility program. Under the new terms all states will be able to have at least two cities or counties eligible to directly issue notes to the Municipal Liquidity Facility regardless of population. (6/3/20)
  • The Internal Revenue Service (IRS) announced a temporary administrative relief to help certain retirement plan participants or beneficiaries who need to make plan elections remotely by allowing remote signatures. (6/3/20)
  • A&B Federal Tax Group provides guidance on a little-known rule that could allow disaster losses from 2020’s COVID-19 pandemic to be used as losses for 2019. Read more here. (6/1/20)

Other Agencies   

  • The U.S. Department of Agriculture (USDA) has posted an update, First Coronavirus Food Assistance Program which remains open for applications until August 28, 2020. The webpage also provides updated FAQs on the program. (6/1/20) (New)
  • The Department of Education has announced it will set aside nearly $3 billion authorized by the CARES Act Education Stabilization Fund to award grants to governors for elementary and secondary education. (6/4/20) (New)
  • The Environmental Protections Agency’s (EPA) Office of Enforcement and Compliance Assurance issued a compliance advisory on products claiming to kill coronavirus. The advisory states that products claiming to kill viruses are pesticides and must be registered with EPA. The advisory also notes that EPA is receiving tips and complaints about pesticidal products with potentially false or misleading claims and is considering enforcement actions. (5/29/20) (New)
  • The Department of Housing and Urban Development’s Federal Housing Administration (FHA) announced a new, temporary policy that provides guidance for lenders to obtain FHA insurance endorsements on mortgages where the borrower has requested or obtained a COVID-19 forbearance. (6/4/20) (New)
  • The U.S. Department of Transportation released a statement on Adjustment to Service Obligations, finalizing its tentative decisions to allow air carriers to incrementally adjust their service obligations in light of ongoing challenges due to COVID-19. (6/4/20) (New)
  • The Department of Veteran’s Affairs has announced it will resume committal services starting on June 9 in nearly all VA national cemeteries. (6/5/20) (New)

Trade and International Business Issues   COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle COVID-19: global supply chains to expect major reshuffle

  • S. Customs and Border Protection (CBP) seizing counterfeit and unapproved COVID-19 Treatment Products. CBP continues to identify and seize large numbers of counterfeit or unapproved COVID-19 treatment products. Through June 1, CBP seized more than 107,300 FDA-prohibited COVID-19 test kits, 750,000 counterfeit face masks, 2,500 prohibited anti-virus lanyards, and 11,000 FDA-prohibited chloroquine tablets. (6/5/20) (New)
  • The USTR: “A post-coronavirus pandemic U.S. industrial policy” S. Trade Representative Robert Lighthizer said the United States should establish a post pandemic industrial policy, such as by increased tariffs and subsidies, to restore supply chains in a time of crisis to achieve more independence on material that is “really important to the country,” during a webinar hosted by the Economics Club of New York on June 4. (6/4/20) (New)
  • World Trade Organization (WTO) looks at impact of COVID-19 pandemic on trade in services, such as tourism, transport, retail, and health. A WTO report highlighted that the pandemic has led to greater reliance on online services in many sectors as consumers develop new habits with social distancing measures. The report noted that disruption in the supply of services had an impact on social and economic inclusiveness, as well as that trade of services such as telecommunications and computing will be key to economic recovery globally. (5/28/20) (New)
  • The North Atlantic Treaty Organization (NATO) issued a statement on the “destabilizing and malicious cyber activities” directed against the health care sector during the pandemic. (6/3/20)

Insurance Issues   

  • For a 50-state review of business interruption insurance related issues see this new COVID-19 Insurance Litigation and Regulatory Issues tracker. The tracker is updated weekly. (Updated 6/5/20)
  • New claims pertaining to COVID-19 and business interruption losses continue to be filed, while dispositive motion practice has kicked off in some previously-filed actions. Notable filings and orders include:
  • On May 29, In-N-Out Burgers filed suit against its insurer Zurich American Insurance Company in the Central District of California, alleging that it was prohibited by government order to provide dine-in services, that it suffered business interruption losses despite being able to continue drive-through operations, and that Zurich wrongfully denied its claims for business interruption coverage. In-N-Out argues that its policy “expressly includes coverage for many type of contamination, including . . . virus, pathogen, or pathogenic organism, and disease-causing illness or agent.” In-N-Out seeks damages for breach of contract and a declaratory judgment outlining the scope of Zurich’s obligation to pay under the policy. The case is IN-N-Out Burgers v. Zurich Am. Ins. Co., No. 8:20-cv-1000 (C.D. Cal.). (New)
  • On June 2, Geragos & Geragos APC (“Geragos”) moved to dismiss the declaratory judgment action filed by Travelers Casualty Insurance Company of America in the Central District of California. Geragos argues that dismissal is warranted because Travelers has engaged in forum shopping by filing the action in federal court after Geragos had filed several suits on behalf of itself and various clients in California state court, and that the Central District should decline to entertain the suit as it raises “novel and unsettled questions of state law” better resolved by the state courts. The case and docket entry are Travelers Cas. Ins. Co. of Am. v. Geragos & Geragos APC, No. 2:20-cv-03619-PSG-E (C.D. Cal.), Dkt. 16. (New)
  • On June 3, Flor Expo LLC and Kendal Floral Supply, LLC filed suit against their insurer Travelers Property Casualty Company of American in the Southern District of California, alleging that the insurer used COVID-19 as a pretense to deny Plaintiffs claims for physical loss of flower inventory in a form-denial letter, despite Plaintiffs allegedly not having referenced either COVID-19 or business interruption in their claim submissions. Instead, Plaintiffs allege that government orders prohibited Plaintiffs from accessing their warehouses where imported flowers were stored, and Plaintiffs were unable to move their inventory before it perished. Plaintiffs seek declaratory relief and damages for breach of contract and breach of the covenant of good faith and fair dealing. The case is FlorExpo LLC et al. v. Travelers Prop. Cas. Co. of Am., No. 3:20-cv-01024-JLS-DEB (S.D. Cal.). (New)

For background and the most up-to-date information, please visit the Centers for Disease Control and Prevention Coronavirus Disease 2019 website: HERE. The additional federal agency links are provided by the White House Coronavirus Task Force:   What You Should Know:

Information for Businesses:

Information for Travel and Transportation:

Information for Healthcare Providers, First Responders, and Research Facilities:

Information for Community Events and Gatherings:

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