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.
UPDATED 9:00 AM ET ON WEDNESDAY, APRIL 15, 2020
The Latest News
- U.S. COVID-19 cases exceed 606,800 and 25,922 U.S. deaths. (Source: CDC) (Updated 4/15/20)
- U.S. stock market: Tuesday ended with the U.S. benchmarks gaining after Monday’s mixed results, with the Dow up 558 points, the S&P advancing 84 points, and the Nasdaq gaining 323 points. (New)
- On Tuesday night, the White House announced several “Great American Economic Revival Industry Groups” made up of business executives, economists, academics, and others to “chart the path forward toward a future of unparalleled American prosperity.” The groups include agriculture, banking, construction/labor/workforce, defense, energy, financial services, food and beverage, healthcare, hospitality, manufacturing, real estate, retail, tech, telecommunications, transportation, and sports. (New)
- Also, on Tuesday night, President Trump announced that he was halting funding of approximately $400 million per year to the World Health Organization due to criticisms of the organization’s response to COVID-19. (New)
- On Monday, the Census Bureau announced that it was temporarily suspending field data collection activities until June. The Census Bureau also requested from Congress a 120-day delay on some data reporting deadlines, including data necessary for congressional apportionment. (New)
COVID-19 Related Legislation
- Bill 4.0: Talks appear to be going nowhere on an interim 3.5 relief bill even as Administration officials confirm the small business loan funds will be depleted by weeks’ end. Congressional conversations continue on what should be included in the larger 4.0 emergency relief bill but the original goal by Speaker Pelosi and others to have 4.0 completed by May looks unlikely. The leadership of both bodies released schedule updates today noting they would not be back ‘in person’ until May 4.
- 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:
- A&B Summary – CARES Act Health Provisions
- A&B Overview – CARES Act Health Care Grants and Reimbursement Changes
- A&B Overview – CARES Act Key Health Care Appropriations
- A&B Analysis – CARES Act Funding Sources
- A&B Summary – CARES Act Small Business Provisions
- A&B Summary – CARES Act Educational Provisions and Appropriations
- A&B Summary – CARES Act Individual and Business Tax Provisions
- A&B Summary – CARES Act Unemployment Provisions
- A&B Summary – CARES Act Labor Provisions
- A&B Guide – how the CARES Act refundable Employer Retention tax credit for employers works
- A&B Hospital Provisions Tracking Document of COVID-19 Provisions Impacting Hospitals from all three emergency bills (Updated on 4/14/20)
- A&B Summary of oversight and enforcement provisions in the CARES Act
- 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.
Key Administrative and Regulatory Actions
- The White House unveiled (4/7/20) a new hashtag, #AmericaWorksTogether, that will be used to promote companies that are hiring employees during the economic crisis and donating food and other supplies to health care workers.
- President Trump invoked the Defense Production Act (4/2/20) for the 3rd time in ten days, ordering a ban on exports by 3M Co. of scarce supplies, including N95 respirators, surgical masks, and gloves.
- President Trump declared (3/13/20) a national emergency under the Stafford Act, which allows the federal government to marshal additional resources and authorize greater regulatory flexibility to respond to the coronavirus outbreak.
Department of Defense
- The Office of the Under Secretary of Defense released a memo (4/2/20) stating that DoD contracts contain clauses that provide “that a contractor will not be in default because of a failure to perform the contract if the failure arises beyond the control and without the fault or negligence of the contractor.”
- The President announced an executive order (3/30/20) to order up to 1 million Ready Reserve members to active duty for up to two years at a time to assist the nation in this national emergency.
- The Army Corps of Engineers has a website for businesses who wish to contract with the Corps on COVID-19 related projects – more information is available here.
Environmental Protection Agency
- The Environmental Protection Agency (EPA) revised (4/14/20) its prior amendment (dated 3/31/20) allowing manufacturers of already-registered EPA disinfectants on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 to obtain certain active ingredients from any supplier without checking with the agency for approval. In an announcement, the EPA stated that the revisions streamline the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment (New).
- EPA revised List N: Disinfectants for Use Against SARS-CoV-2 to include products on EPA’s List G: Products effective against norovirus, and List L: Products effecting against the Ebola virus, as EPA has determined that these products also meet its criteria for use against SARS-CoV-2.
- The EPA issued interim guidance on Friday (4/10/20) to the Agency’s regional offices to ensure that decisions about new or ongoing cleanup activities at sites across the country are made with the health and safety of communities as related to COVID-19. The interim guidance focuses on decision making at emergency response and longer-term cleanups sites where EPA is the lead agency or has direct oversight of, or responsibility for, the cleanup work. This includes, but is not limited to, Superfund cleanups, Resource Conservation and Recovery Act (RCRA) corrective actions, Toxic Substance and Control Act PCB cleanups, Oil Pollution Act spill responses, and Underground Storage Tank Program actions.
- EPA identified (4/7/20) approximately 225,000 pieces of personal protection equipment they will donate to state and local responders.
- EPA Administrator Wheeler outlined steps to protect against fraudulent disinfectant claims. (4/3/20)
- EPA issued an enforcement memo, “COVID-19 Implications for EPA’s Enforcement and Compliance Assurance Program” (3/26/20), detailing the Agency’s plan to exercise enforcement discretion for situations related to COVID-19. The policy is retroactive to March 13.
- EPA will not seek fines and penalties for missed deadlines in routine monitoring, testing, and reporting; settlement agreements; and consent decrees, and for excess emissions, so long as the company documents in detail that it was related to COVID-19 and takes every effort to meet compliance obligations. EPA must be notified of emission exceedances.
- EPA is allowing hazardous generators to store additional waste onsite, for longer periods of time, without requiring a permit or changing generator status.
- EPA also issued a warning to pesticide producers, manufacturers, distributors, and importers who claim their products can be used against COVID-19: ensuring companies comply with all applicable requirements for pesticide products – including prohibitions on false and misleading claims – will be the agency’s “focus” in order to protect public health.
- EPA created a website, Coronavirus and Drinking Water and Wastewater, which states that the risk to water supplies from the COVID-19 virus is low, and “Americans can continue to use and drink water from their tap as usual.”
Federal Communications Commission
- The Federal Communications Commission (FCC) issued (4/3/20) an order waiving the content sponsorship requirements during commercial advertising. The purpose of the order is to permit companies that have purchased advertising time to donate the time for the purpose of broadcast public service announcements prepared by the CDC or other governmental or public health agencies regarding COVID-19.
- The FCC provided relief on April 1 to enable rural broadband and phone providers to immediately waive consumer fees, including late payment and installation and cancellation fees, in order to help Americans work from home or access remote learning.
- The FCC adopted a program appropriating $200 million in COVID-19 telehealth grants (the COVID-19 Telehealth Program) and $100 million in grants through the Connected Care Pilot Program to assist hospitals, and other health care providers cover telehealth costs. The funds for both were authorized by the CARES Act. Also see the FCC’s Report and Order for more information.
- The FCC COVID-19 Telehealth Program Application Portal opened on April 13. See here for more information and the application via the portal.
- The Wireline Competition Bureau will review applications, select participants, make funding awards on a rolling basis, and will announce such information.
- On April 8, the FCC provided guidance to address common application questions.
- There are steps interested providers can take immediately to prepare to apply for the COVID-19 Telehealth Program:
- Obtain an eligibility determination by filing an FCC Form 460 with the Universal Service Administrative Company (USAC) (Applicants can still submit an application for the COVID-19 Telehealth Program while the Form 460 application is pending);
- Register to obtain an FCC Registration Number (FRN) in the Commission Registration System (CORES); and register with System for Award Management in order to receive funding.
- A copy of the application will be filed by the FCC’s Electronic Comment Filing System (ECFS).
- The FCC also provided additional details on the Connected Care Pilot Program. The selected pilot projects will be supported for a three-year funding period, with separate transition periods of up to six months before and after the funding period (up to four years total).
- Applicants must first obtain a USAC eligibility determination (Form 460, noted above). After confirming eligibility, the applicant must submit its pilot project proposal to the FCC.
- The FCC plans to provide an application form (“Connected Care Pilot Program Application”) that must be used when submitting project proposals to the FCC. Submitted applications must reference WC Docket No. 18-213. Applicants may file using the ECFS, but also must send a courtesy copy of the application via email to ConnCarePltProg@fcc.gov.
- The deadline for filing applications will be 45 days from the effective date of the Connected Care Pilot Program rules or 120 days from the release date of the Report and Order (whichever is later).
- Additional details on the application and evaluation process, including key information on eligibility, certain required certifications, and how the FCC will choose participants, are available in the Report and Order.
Department of Health and Human Services
- The Department of Health and Human Services (HHS) has a COVID-19 Resources page.
- Pursuant to the President’s Executive Order (3/25/20), HHS announced its initial list of health and medical resources that are subject to hoarding prevention measures. The list is subject to review and potential additions later. It includes several varieties of facial masks and other protective equipment, respirators, ventilators, drugs, and disinfectants.
- HHS announced five new contracts under ventilator production under the Defense Production Act, to General Electric, Hill-Rom, Medtronic, ResMed, and Vyaire, as well as two other contracts for ventilator production, to Hamilton and Zoll. HHS has finalized contracts to supply 6,190 ventilators for the Strategic National Stockpile by May 8 and 29,510 by June 1. (4/13/20) (New)
- HHS Administration for Children and Families (ACF) announced $6.3 billion in additional funding, $3.5 billion of which is for the Child Care and Development Block Grant. This funding will go to state, territory, and tribal Child Care and Development Fund (CCDF) programs and is intended to provide assistance to child care providers. HHS notes that this additional funding can also help support health care workers, first responders, and other essential workers. Additional resources are also available. To see the ACF summary of the relevant CARES Act section, here. (4/14/20) (New)
- Of note, ACF provides information on how “Lead Agencies” can estimate their CARES Act awards as follows:
- States: Calculate your State’s percentage share of total State FY2019 CCDF Discretionary funding from the State and Territory Allocation table on the OCC website. Total State FY2019 CCDF Discretionary funding was $4,840,730,000. 2. Apply this percentage to the CARES Act total amount for States of $3,376,138,000. This will provide a rough estimate of your CARES Act Discretionary allocation.
- Territories: Calculate your Territory’s percentage share of total Territory FY2019 CCDF Discretionary funding from the State and Territory Allocation table on the OCC website. Total Territory FY2019 CCDF Discretionary funding was $26,380,000. 2. Apply this percentage to the CARES Act total amount for Territories of $17,500,000. This will provide a rough estimate of your CARES Act Discretionary allocation.
- Tribes: Calculate your Tribe’s percentage share of total FY2019 Tribal CCDF Discretionary Per Child funding from the Tribal Allocation table on the OCC website. Total FY2019 Tribal CCDF Discretionary Per Child funding was $288,304,000. 2. Apply this percentage to the CARES Act total amount for Tribes of $96,250,000. This will provide a rough estimate of your CARES Act Discretionary allocation.
- HHS Secretary Alex Azar sent a letter to hospital Administrators on April 10 reinforcing the need for data and daily reports on testing, capacity, supplies, utilization and patient flows. The letter included a set of frequently asked questions that details federal government’s data needs, explains the division of reporting responsibility between hospitals and states, and provides clear, flexible options for the timely delivery of this critical information. The letter recognizes that many non-Federal entities may already be requesting this information from hospitals; therefore, the federal government has done its best to minimize the burden of sharing this data and to reduce further duplication of effort. (4/10/20) (New)
- The HHS Agency for Healthcare Research and Quality (AHRQ) announced that in recognition of the impact COVID-19 was having on their grantee recipient community that AHRQ will be doing providing some flexibility with SAM registration, application deadlines, no-cost extensions for expiring awards, allowability of costs not normally charged to awards, abbreviated non-competitive continuation requests, extensions of close-outs and other flexibilities. (4/13/20) (New)
- HHS posted a new tracking feature that allows public viewing of all COVID-19 HHS grant and cooperative agreement awards on its website at https://taggs.hhs.gov/coronavirus. The initial grants were distributed through programs in the Agency for Community Living, Centers for Disease Control and Prevention, National Institutes of Health, and Office for the Assistant Secretary for Emergency Preparedness.
- On Friday, the HHS Office of Human Research Protection (OHRP) released guidance for investigators, institutional review boards, and institutions conducting human subjects research during the coronavirus (COVID-19) pandemic. "The important thing to recognize is that our rules for protecting research subjects should not stop us from addressing this extraordinary public health crisis. We must be able to quickly move forward with ethical research studies that can lead to treatments for COVID-19," said Dr. Jerry Menikoff, Director of the Office for Human Research Protections in the OHRP release. (4/10/20)
- The HHS Office of Inspector General (HHS-OIG) issued (4/3/20) a policy statement regarding the application of previously issued blanket waivers to Anti-Kickback Statute
- OIG announced its decision to exercise its enforcement discretion to not impose administrative sanctions under the federal Anti-Kickback Statute (AKS) for certain renumeration related to COVID-19. Specifically, OIG is applying 11 of the 18 waivers previously issued by CMS for physician self-referral law sanctions to administrative sanctions.
- OIG Policy Statement Applies Only to the Following Blanket Waivers
- Waiver for personally performed services
- Waivers for certain rental rates
- Waivers for purchase of items and services
- Waivers for certain physician compensation arrangements
- HHS announced on Tuesday it is purchasing the ID NOW COVID-19 rapid point-of-care test for state, territorial and tribal public health lab use.
- The HHS Office of Civil Rights (OCR) released a notification (4/9/20) that it will exercise its enforcement discretion and will not impose penalties for violations of the HIPAA Rules against covered entities or business associates in connection with the good faith participation in the operation of COVID-19 testing sites during the COVID-19 nationwide public health emergency. This exercise of enforcement discretion is effective immediately but has a retroactive effect to March 13, 2020.
- The HHS OCR announced (4/2/20) that it will exercise its enforcement discretion and will not impose penalties for violations of certain provisions of the HIPAA Privacy Rule against health care providers or their business associates for the good faith uses and disclosures of protected health information (PHI) by business associates for the public health and health oversight activities during the COVID-19 nationwide public health emergency. This notice is effective immediately.
- The HHS Office of the Assistant Secretary for Health announced new guidance authorizing pharmacists to order and administer COVID-19 tests. (4/9/20)
Assistant Secretary for Preparedness and Response
- ASPR has updated its website to include additional information about the Strategic National Stockpile, including new pages on SNS ventilators being deployed in response to COVID-19. (4/13/20) (New)
- ASPR announced (3/24/20) it was providing $100 million in awards for health systems to prepare for COVID-19 patients.
- ASPR has created several resource sites for peers to share COVID-19 best practices on promising practices, plans, tools, or templates on supply chain, fatality management, and emergency departments.
Centers for Disease Control and Prevention
- For the most up to date CDC guidance click here. The CDC has also updated its infection prevention and control guidance for patients with suspected or confirmed COVID-19 in health care settings. (4/13/20) (New)
- The CDC announced new recommendations for cleaning and disinfecting your facility. (4/14/20) (New)
- CDC released new guidance on Decontamination and Reuse of Filtering Facepiece Respirators. This document summarizes research about decontamination of FFRs before reuse. (4/13/20) (New)
- The CDC has posted updated dental setting guidance to inform dentists and their patients. (4/13/20) (New)
- The CDC has launched a new COVID-19 surveillance webpage which includes links to all of the COVID-19 surveillance systems and other data sources CDC is using to track COVID-19 activity. The page includes information about COVID-19-related cases, hospitalization rates, mortality, and laboratory testing, as well as data visualizations based on the latest CDC publications, such as Morbidity and Mortality Weekly Reports (MMWRs). (4/13/20) (New)
- The CDC has also updated their guidance on what to do if you are sick. (4/14/20) (New)
- The CDC announced last Thursday an extension of its “No Sail” order for all cruise ships for at least 100 days.
- The CDC released new guidance (4/9/20) advising that critical infrastructure workers may be permitted to continue work following potential exposure to COVID-19, provided they remain asymptomatic and additional precautions are implemented to protect them and the community. A potential exposure means being a household contact or having close contact within 6 feet of an individual with confirmed or suspected COVID-19. The timeframe for having contact with an individual includes the period of time of 48 hours before the individual became symptomatic.
- The CDC issued (4/7/20) guidance for businesses and buildings on how to ensure that water systems are safe to use after prolonged shutdowns.
- The CDC updated (4/7/20) its personal protection equipment (PPE) burn rate calculator to help health care providers plan and optimize the use of PPE response to COVID-19.
- The CDC has released a report (4/7/20) on COVID-19 illness in children which includes topline findings on diagnosing and treating children with COVID-19.
- HHS announced (4/6/20) that the CDC would provide $186 million in funding to state and local jurisdictions to respond to COVID-19.
- For pharmacy staff, the CDC has posted information on strategies to minimize risk of exposure.
- The Centers for Disease Control and Prevention announced on Friday its recommendation that everyone use a simple cloth over one’s face to slow the spread of the virus. The cloth does not need to be a face mask (or N95) and can be fashioned from household items.
- The CDC updated its recommendations (4/3/20) on optimizing the supply of PPE.
- The CDC also released guidance on the collection and submission of postmortem specimens from deceased person with COVID-19, and last week multiple new areas of information was posted on: health care providers and pregnant women; pediatric providers and children; what law enforcement need to know; what school administrators need to know; and PPE for individuals caring for a COVID-19 patients.
Centers for Medicare & Medicaid Services
- The Centers for Medicare and Medicaid Services (CMS) created a website location for COVID-19 stakeholder call recordings and transcripts, and the most recent daily CMS COVID-19 news alert on all actions can be found here (last updated 4/14/20). The number of CMS conference calls and webinars keep a steady pace:
- CMS will hold a call on COVID-19 with Dialysis Facilities, Wednesday, April 15, 5:30pm EST. Attendee Dial-In: 833-614-0820, Conference ID: 3689246 and Web Link is here. (4/14/20) (New)
- CMS issued additional information on transferring patient between post-acute facilities which include skilled nursing facilities and nursing homes. (4/13/20) (New)
- On Monday (4/13/20), CMS announced the postponement of the 2019 benefit year HHS Risk Adjustment Data Validation (HHS-RADV) process. CMS intends to provide future guidance in the summer of 2020 on the updated timeline for 2019 benefit year HHS-RADV activities that are planned to begin in 2021. CMS previously announced a similar suspension of the Medicare Advantage RADV program. (New)
- CMS issued a release on Saturday (4/11/20) announcing new guidance expanding private insurance coverage to all COVID-19 diagnostic testing and related services at no co-pay, including antibody testing. The release was jointly issued with the Departments of Labor and the Treasury, and it included the guidance and FAQs.
- In a April 10 memo to Medicare Advantage (MA) plans, CMS clarified that MA plans can use diagnoses from telehealth visits in risk adjustment stating “[t]he 2019 Coronavirus Disease (COVID-19) pandemic has resulted in an urgency to expand the use of virtual care to reduce the risk of spreading the virus; CMS is stating that Medicare Advantage (MA) organizations and other organizations that submit diagnoses for risk adjusted payment are able to submit diagnoses for risk adjustment that are from telehealth visits when those visits meet all criteria for risk adjustment eligibility.” (4/10/20)
- CMS began distributing the initial $30 billion in COVID-19 relief funding to providers as part of the distribution of the $100 billion fund provided for the Public Health and Social Services Emergency Fund (PHSSEF) through the CARES Act. This initial distribution of funds will go to hospitals and providers currently enrolled in Medicare and take effect immediately.
- Facilities and providers are allotted a portion of the $30 billion based on their share of 2019 Medicare fee-for-service (FFS) reimbursements. These are payments, not loans, and will not need to be repaid. Fund recipients will be prohibited from balancing billing COVID-19 patients for related services. HHS is partnering with UnitedHealth Group to deliver the initial $30 billion provider distribution and providers will be paid via Automated Clearing House account information on file with UnitedHealth Group, UnitedHealthcare, or Optum Bank, or used for reimbursements from CMS. Additional details can be found here.
- A second phase of targeted distributions to providers is expected to follow soon and according to the Agency release will focus on providers in areas particularly impacted by the COVID-19 outbreak, rural providers, and providers of services with lower shares of Medicare FFS reimbursement or who predominantly serve the Medicaid population.
- CMS announced last Thursday that it had approved over $51 billion in accelerated or advance payments for Medicare providers in its first week.
- CMS temporarily suspended (4/9/20) a number of rules—effective immediately—so that hospitals, clinics, and other health care facilities can boost their frontline medical staffs by allowing them to work to the fullest extent of their licenses.
- As a result of CMS’s action:
- Doctors can now directly care for patients at rural hospitals, across state lines if necessary, via phone, radio, or online communication, without having to be physically present. Remotely located physicians, coordinating with nurse practitioners at rural facilities, will provide staffs at such facilities additional flexibility to meet the needs of their patients.
- Nurse practitioners, in addition to physicians, may now perform some medical exams on Medicare patients at skilled nursing facilities so that patient needs, whether COVID-19 related or not, continue to be met in the face of increased care demands.
- Occupational therapists from home health agencies can now perform initial assessments on certain homebound patients, allowing home health services to start sooner and freeing home-health nurses to do more direct patient care.
- Hospice nurses will be relieved of hospice aide in-service training tasks so they can spend more time with patients.
- CMS also released a fact sheet including additional information on the waivers announced on April 9.
- CMS issued (4/7/20) a “Dear Clinician” letter that outlining a summary of actions CMS has taken to ensure clinicians have maximum flexibility to reduce unnecessary barriers to providing patient care during the unprecedented outbreak of COVID-19. The summary includes information about telehealth and virtual visits, accelerated and advanced payments, and recent waiver information.
- A new COVID-19 ICD-10 diagnosis code was announced by CMS and is effective April 1.
- CMS updated (4/7/20) its recommendations to postpone non-essential surgeries and other procedures to conserve critical health care resources and limit exposure of patients and staff to COVID-19.
- CMS issued on Tuesday (4/6/20) a Medicare Advantage and Part D rate announcement for CY 2021 with an 1.66% average change in revenue relative to last year. The announcement does not catalog CMS’s actions regarding COVID-19, but these are explained in a summary included with the announcement.
- On April 2, CMS issued recommendations to nursing homes and state and local governments on infection control in long term care. The recommendations include:
- Nursing homes should immediately ensure that they are complying with all CMS and CDC guidance related to infection control.
- CMS/CDC urges State and local leaders to consider the needs of long-term care facilities with respect to supplies of PPE and COVID-19 tests.
- Nursing homes should immediately implement symptom screening for all staff, residents, and visitors – including temperature checks.
- Nursing homes should ensure staff are using appropriate PPE, to the extent PPE is available and per CDC guidance on conservation of PPE.
- CMS announced on March 30 that it will suspend audit activity, stating that, “The agency will continue to engage in oversight activities but will suspend requesting additional information from providers, healthcare facilities, Medicare Advantage and Part D prescription drug plans, and States.”
- On March 30, CMS released an Interim Final Rule, which made numerous regulatory changes to provide additional flexibility for health care providers and temporarily remove certain limitations on care delivery. These changes have retroactive applicability to March 1. While many of these changes were developed prior to the enactment of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), significant flexibility has been conferred on individuals and entities that provide health care services to Medicare beneficiaries during the COVID-19 public health emergency. Comments are due not later than June 1, 2020.
- On April 9, CMS issued FAQs regarding this interim final rule. See this A&B Summary for the key details of the Interim Final Rule. (4/8/20)
CMS CARES Act Guidance
- In response to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), CMS continues to release guidance required under the Act:
- On March 30, CMS announced sweeping changes in response to requirements of the CARES Act. The changes are summarized in this CMS release. The new waivers and flexibilities for health care providers are outlined by CMS in the following:
CMS new waivers and flexibilities:
- Summary of COVID-19 Emergency Declaration Waivers & Flexibilities for Health Care Providers (PDF)
- List of Blanket Waivers (4/3/20)
- Blanket waivers of Section 1877(g) of the Social Security Act
- Medicare IFC: Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC) (PDF)
- Graphic Overview of Flexibilities (PDF)
- Provider Burden Relief Frequently Asked Questions (PDF)
- Provider Enrollment Relief Frequently Asked Questions (PDF)
- Updates for State Surveyors and Accrediting Organizations (EMTALA and Infection Control)
- Reprioritization of PACE, Medicare Parts C and D Program, and Risk Adjustment Data Validation (RADV) Audit Activities (HPMS Memo)
- Provider-specific fact sheets on new waivers and flexibilities are available here.
- Need a deeper dive on these new waivers?
- The EMTALA waiver provides greater flexibility for hospitals to manage medical screening examinations (MSEs). For additional analysis, read this A&B advisory (4/1/20).
- CMS also announced blanket waivers of sanctions imposed under the physician self-referral laws. For a detailed discussion of this issue, read this A&B advisory (4/1/20).
- The telehealth expansion waiver, which was originally expanded in the Coronavirus Preparedness and Response Supplemental Act (1.0), was further expanded in the CARES
- CMS released an information bulletin (4/2/20) on telehealth for Medicaid substance use disorder services.
- Telehealth guidance (3/17/20) broadened access to Medicare telehealth service regardless of patient residence and covering a wide range of services. Factsheets related to these changes:
- CMS issued an electronic toolkit regarding telehealth and telemedicine for Long Term Care Nursing Home Facilities (3/28/20)
- CMS telehealth FAQs (3/17/20)
- HHS 1135 HIPAA waiver factsheet - HIPAA Security Rule safeguards
- HHS Notice of Enforcement Discretion factsheet
- HHS Office of Civil Rights bulletin
- Guidance on Business Associate Agreements
- Telehealth changes are discussed in this A&B advisory (3/27/20).
- The CARES Act required CMS to expand its accelerated and advance payment program, and on March 28 a statement and fact sheet providing guidance on the policy. For additional analysis, read this A&B advisory (3/30/20) on the CMS guidance.
- CMS announced the interest rate on overdue and delinquent debts for Q3 of Fiscal Year 2020 (April-June) – 625%. This updates the prior quarter’s interest rate of 10.25%, which is currently expected to apply to the Medicare Accelerated and Advance Payments Program (AAPP). In addition, CMS released a transmittal reflecting this change effective April 20, 2020 for Medicare overpayments and underpayments. Specifically, the transmittal instructs Medicare contractors to implement an interest rate of 9.625% to Medicare overpayments and underpayments. We will continue to monitor for additional information and any updates or changes with respect to the AAPP. (4/14/20) (New)
- CMS released a state-by-state list showing the breakdown of receipt of accelerated and advance payments as of April 4, 2020. (4/13/20) (New)
- CMS announced on 4/10/20 that it had delivered nearly $63 billion in the prior week to providers in addition to the $100 billion provided for in the CARES Act. CMS stated that it had approved 21,000 out of over 32,000 requests received in the first week. (New)
- On 1135 Waivers: Further information continues to be released on blanket waivers after the initial guidance (3/13/20) response to the national emergency executive order.
- CMS issued provider enrollment FAQs for 1135 blanket waiver, available here (3/22/20).
- In addition, there is an FAQ on telehealth services (Q11) and requirements if a practitioner seeks to furnish Medicare telehealth services from his or her home.
- CMS has approved 50 coronavirus 1135 waivers, and for more details and the full list CMS approved 1135 waivers can be found here.
- The National Uniform Billing Committee has provided guidance on claims for COVID-19 treatment and approved the use of DR (disaster related) condition code for services related to the coronavirus.
- CMS released several other alerts and guidance the week of March 23:
- Medicare Provider Enrollment Relief FAQs (see: FAQs).
- CMS posted guidance on Payment and Grace Period Flexibilities for issuers offering coverage on the federally-facilitated exchanges and state-based exchanges on the federal platform (see: guidance).
- CMS announced it will be exercising enforcement discretion so QHP issuers and SADPs can extend payment deadlines for initial binder payments and ongoing premium payments. CMS released FAQs on availability and usage of telehealth through private health insurance (see: FAQs).
- CMS released FAQs on prescription drugs and COVID-19 for health insurance issuers in individual and small group markets (see: FAQs).
- On April 14, the CMS Center for Medicaid and CHIP Services (CMCS) released additional FAQs that address enhanced federal Medicaid funding (FMAP) and related Medicaid issues under requirements from FFCRA and CARES Act. (4/14/20) (New)
- On April 8, the CMS Center for Medicaid and CHIP Services gave its approval of its first state disaster amendments to Children’s Health Insurance Program (CHIP) requirements allowing, in this case, the State of Maine to temporarily adjust cost-sharing requirements and other policies during the COVID-19 emergency. (4/8/20)
- CMS updated their Medicaid FAQs. (4/2/20)
- CMS posted notice (3/24/20) that it had withdrawn its proposed rule to tighten Medicaid eligibility
- CMS released guidance (3/24/20) implementing provisions of the FFCRA that provide states with enhanced federal Medicaid funding referred to as the Federal Medical Assistance Percentage (FMAP) funding during the COVID-19 emergency.
- CMS released new tools (3/20/20) for state Medicaid and Children’s Health Insurance Programs (CHIP) and updated FAQs (3/18/20). The tools include:
- 1115 Waiver Opportunity and Application checklist;
- 1135 Medicaid and CHIP Waiver checklist;
- 1915(c) Appendix K template; and
- Medicaid Disaster State Plan Amendment template.
Food and Drug Administration (Drugs and Devices)
- FDA provides a daily roundup on COVID-19 related actions. The latest update is here (Revised 4/14/20), here a listing of all announcements.
- The agency published a public database of drug shortages.
- The Drug Enforcement Administration (DEA) is adjusting 2020 production quotas for controlled substances in schedule II of the Controlled Substances Act, as well as quotas for the manufacture and importation of the Schedule I chemicals ephedrine, phenylpropanolamine and pseudoephedrine.
- On Tuesday (4/14/20), FDA announced the availability of two final guidances for industry: “Guidance on Chloroquine Phosphate” and “Guidance on Hydroxychloroquine Sulfate,” to ensure an adequate supply of these products (New). As a previous step, on March 28th, FDA issued an EUA to allow these products to be donated to the Strategic National Stockpile to be distributed and used for certain COVID-19 patients
- The FDA issued (4/10/20) an emergency use authorization (EUA) to the STERIS Corporation to allow the company to employ its system to decontaminate compatible N95 or N95 equivalent respirators for reuse by health care workers in hospital settings.
- Information regarding manufacturing, importing, or selling sterilizers, sanitizers, purifiers, and disinfectants is available in this A&B advisory (4/13/20) (New).
- FDA and FTC continue to issue Warning Letters to sellers of fraudulent COVID-19 products for prevention for COVID-19, including CBD products. FDA also issued a warning letter (4/8/20) to a seller that markets fraudulent and dangerous chlorine dioxide products.
- FDA has updated its EUA from April 3, 2020, applicable to Chinese manufacturers of PPE. The number of listed Chinese manufacturers increased from 2 to over 70 manufacturers (Updated 4/14/20).
- FDA issued (4/5/20) an FAQ on 3D printing of medical devices and other equipment during the COVID-19 pandemic.
- FDA has provided updated guidance (4/2/20) to address the need for blood donations during the coronavirus crisis, including immediate changes to the eligibility criteria.
- FDA announced (3/31/20) the Coronavirus Treatment Acceleration Program (CTAP), a new program to expedite the development of potentially safe and effective life-saving treatments.
- FDA has issued enforcement policies to increase the availability of ventilators and accessories, face masks and respirators, gowns, other apparel and gloves, sterilizers, disinfectant devices, and air purifiers, clinical electronic thermometers, infusion pumps and accessories, remote ophthalmic devices and monitoring devices, extracorporeal membrane oxygenation, cardiopulmonary bypass devices, and digital health devices for treating psychiatric disorders (Updated 4/14/20).
- The FDA updated its FAQs (4/2/20) on surgical masks and gown shortages.
- FDA has provided strategies to assist in the conservation of masks and gowns, as well as glove conservation strategies.
Food and Drug Administration and United States Department of Agriculture (Food-Related)
- On April 13, USDA’s Agricultural Marketing Service announced that for 60 days, beginning April 20, 2020, it will not take enforcement action against the retail sale of commodities that lack an appropriate country or origin or method of production label as required for covered commodities under COOL, provided the food does not make any country of origin or method of production claims (New).
- USDA announced (4/13/20) a resource guide for rural leaders on funding and partnership opportunities regarding COVID-19 (New).
- FDA has put out a factsheet on best practices for retail food stores, restaurants, and food pick-up and delivery services during the COVID-19 pandemic. This includes information on managing employee health, personal hygiene for employees, appropriate food safety protocols, and special safety considerations for pick-up and delivery. A visual summary info graph is also available.
- FDA released (4/6/20) guidance on the temporary flexibility regarding the Egg Safety Rule to permit producers who sell eggs to facilities for further processing to sell to the table egg market.
- And FDA issued (4/6/20) an FAQ from members of the animal food industry on COVID-19.
- On April 3, the FDA announced it will temporarily conduct remote importer inspections under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP).
- On April 1, FDA released a temporarily enforcement discretion policy to provide flexibility to chain restaurants and similar retail food establishment subject to FDA’s menu labeling requirements. Under its policy, FDA will not object if covered establishments do not comply with menu labeling requirements until “conclusion of the public health emergency.”
- In the midst of ongoing food safety concerns, DHS has included the food and agriculture sector as “essential critical infrastructure,” and a full analysis of these issues is available here.
- Both USDA FSIS and FDA have issued enforcement discretion policies to provide labeling flexibilities for products intended for food service going to retail.
- FDA has announced a temporary policy to not enforce Foreign Supplier Verification Program (FSVP) onsite audit requirements under specific circumstances, and both FDA and USDA have also been issuing guidance to industry that addresses food safety concerns. DHS has included the food and agriculture sector as “essential critical infrastructure,” and a full analysis of these issues is available here.
- Department of Agriculture (USDA): USDA Rural Development Division has launched a resource page to help rural residents, farmers, and businesses stay current on the Agency actions related to COVID-19.
- The Rural Development Office has posted a fact sheet of funding opportunities for rural residents, businesses and communities. (4/8/20)
- The Rural Development Division announced (4/3/20) it was opening a second application window for the Distance Learning and Telemedicine Grant program funding.
Health Resources and Services Administration
- On April 8, HHS, through the Health Resources and Services Administration (HRSA) awarded more than $1.3 billion that had been allocated under the CARES Act to 1,387 health centers as part of the COVID-19 pandemic response. HRSA-funded health centers may use the awards to help communities across the country detect coronavirus; prevent, diagnose, and treat COVID-19; and maintain or increase health capacity and staffing levels to address this public health emergency. The list of recipients is available here.
- HRSA updated its FAQs (4/2/20) for health centers with additional questions to address the Federal Tort Claims Act among other flexibilities that have been enacted.
- HRSA awards (3/24/20) $100 million to 1,381 health centers across the country with funding provided by the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020. The awards, by state, is available here.
Department of Homeland Security/FEMA
- The Department of Homeland Security (DHS) provides a weekly roundup of its response to COVID-19 (last updated 4/13/20).
- President Trump announced on Friday “countries that deny or unreasonably delay the acceptance of their citizens, subjects, nationals, or residents from the United States during the ongoing pandemic caused by SARS-CoV-2, will be subject to ‘visa sanctions’.” (4/10/20)
- DHS and Department of Justice announced on April 1 that they have extended the temporary postponement of Migrant Protection Protocols (MPP) hearings scheduled through May 1, 2020.
- The Cybersecurity and Infrastructure Agency (CISA) released updated guidance (3/28/20) on essential critical infrastructure workers.
- Federal Emergency Management Agency’s (FEMA) coronavirus website visit here.
- FEMA announced (4/14/20) the funding notice for $100 million in supplemental Emergency Management Performance Grant Program funds. The funds are available to all 50 states and six territories as part of the CARES Act. Applications are due by April 28 (New).
- Temporary FEMA rule will ban export of some medical equipment without approval. Some medical equipment needed to combat COVID-19 cannot be exported from the U.S. without the “explicit approval” of the Federal Emergency Management Agency, according a new rule set to take effect this week. The “temporary final rule” will be effective from April 10 through mid-August, according to a Federal Register notice. (4/10/20)
- FEMA issued (4/10/20) a temporary final rule to restrict the export of five types of personal protective equipment (PPE).
- FEMA issued an advisory (4/9/20) regarding the option to transition federal Community-Based Testing Sites (CBTS) to state management.
- FEMA announced (4/7/20) an initial set of grants, in this instance they have awarded $16.7 million in funding to Colorado to assist the state in its purchases in March and April of Personal Protective Equipment (PPE) such as disposable gowns, masks, face shields, safety glasses and gloves, sanitizer, respirators, and ventilators to assist hospitals, medical clinics, city and county governments, and certain private-non-profits across the state.
- FEMA Supply Chain Task Force has developed a four-pronged approach to securing needed coronavirus supplies. The four prongs are Preservation, Allocation, Acceleration, and Expansion. The details on the March 30 plan can be found here. In a related move, the FEMA Coronavirus Pandemic Supply Chain Stabilization Task Force (a joint FEMA and HHS initiative) has released a fact sheet.
- FEMA has established How to Help website for individuals and organizations interested in helping the effort to combat the spread of COVID-19. Examples of assistance offered include:
- To sell medical suppliesor equipment to the federal government, please submit a price quote under the COVID-19 PPE and Medical Supplies Request for Quotation. Full details can be found in the solicitation (Notice ID 70FA2020R00000011).
- This solicitation requires registration - information can be found at sam.gov. Registration must be “ACTIVE” at the time of award.
- Do you have medical supplies or equipment to donate?
- Do you want to produce a COVID-19 related product? – email email@example.com.
- If you are a healthcare provider in need of medical supplies, please contact your state, local, tribal or territory department of public health.
- Interested in doing business with FEMA and supporting the response to COVID- 19 with your company’s non-medical goods and/or services? Submit your inquiry to the DHS Procurement Action Innovative Response Team at DHSIndustryLiaison@hq.dhs.gov.
- FEMA provides guidance (updated regularly) to companies seeking to import or manufacture medical products to the COVID-19 response. A list of FEMA regional private sector contacts and state contacts can be found here.
Department of Justice/Federal Trade Commission/State Attorneys General Antitrust
- On April 13, DOJ and FTC issued a joint statement reminding companies – especially those in the health care or other essential sectors – of the criminal and civil antitrust risks for colluding or sharing excessive confidential information about employment topics in light of COVID-19 (including changes to salaries/wages/benefits, employment terms, “no poach” agreements, or even invitations to rivals on those topics). Both agencies have been active in the area in recent years following the issuance of guidance in the area in October 2016. So it comes as no surprise that while the agencies recognized “some cooperation” may be necessary in these times, Assistant Attorney General Makan Delrahim stated, “Even in times of crisis, we choose a policy of competition over collusion.” (New)
- For more information, review the A&B advisory (3/24/2020) on competitor collaborations and the A&B advisory (3/25/2020) on potential exemptions under United States and European Union antitrust law related to COVID-19.
- On April 6, Ian Conner, the director of the Federal Trade Commission’s (FTC) Bureau of Competition published a blog post about the importance of the agency “stay[ing] the course” when it comes to antitrust enforcement. Even as agency staff work remotely to review mergers and alleged anticompetitive conduct, Conner wrote, “We will not suspend our usual rigorous approach to ferreting out anticompetitive harm and seeking appropriate relief, even in the face of uncertainty. It might be tempting, for example, for parties to urge us to relax the rules in a time of crisis. But we know what the likely long-term negative consequences of such a reactionary policy would be: fewer competitors, reduced innovation, and higher prices.” In particular, Conner emphasized the FTC will not lower its standards for evaluating who will be effective third-party buyers of businesses or assets required to be divested to resolve FTC merger investigations.
- DOJ Antitrust Division and Federal Trade Commission (FTC) announced (3/24/20) they will be expediting their usual antitrust business review letter/informal opinion process on competitor collaborations to be done within 7 days (as opposed to the usual many months) of submission of information.
- The DOJ completed its first Business Review Letter under the new expedited review process on April 4, announcing that “it will not challenge collaborative efforts of McKesson Corporation, Owens & Minor Inc., Cardinal Health Inc., Medline Industries Inc., and Henry Schein Inc. to expedite and increase manufacturing, sourcing, and distribution of personal-protective equipment (PPE) and coronavirus-treatment-related medication.”
- In addition to the expedited BRL process, certain joint ventures and standard development organizations can also find some level of reduced antitrust risk through a seldomly used law—the National Cooperative Research and Production Act (“the NCRPA”).
- For more information about this announcement, review this A&B summary (4/6/20).
- On April 14, the FTC sent warning letters to ten businesses related to their marketing of products which promise to prevent, treat, or cure Coronavirus. The letters, issued to companies and the U.S. and abroad, warn the companies to cease making any unsubstantiated claims. The FDA has previously stated that there currently are no products that are scientifically proven to treat or prevent the virus. These warning letters are the latest to be issued by the FTC, and follow seven FTC-FDA letters announced on March 9 and additional joint warning letters sent since then. (New)
- On April 13, the Federal Bureau of Investigation (FBI) warned of health care fraud schemes related to COVID-19, including fake testing and treatment schemes (New).
- On April 9, the Federal Trade Commission (FTC) provided guidance regarding education technology uses for stay-at-home learning, the importance of protecting student privacy under the Children’s Online Privacy Protection Act (COPPA) as well as the Family Educational Rights and Privacy Act (FERPA) during the coronavirus pandemic.
- From January 1, 2020 through April 8, 2020, the FTC has reported receiving more than 14,227 COVID-19 related complaints with a total fraud loss of $10.04 million with a median fraud loss of $564.
- On April 2, the FTC and FDA sent letters to three companies for selling fraudulent COVID-19 products, as part of the agencies’ effort to protect consumers. (Letters available here, here, and here). This is the third time the FTC sent warning letters to companies for their actions related to the pandemic.
- On March 27, the FTC sent letters to nine VoIP providers and other companies warning them that “assisting and facilitating” illegal telemarketing or robocalls related to the Coronavirus pandemic, including by providing VoIP services, is against the law. Earlier in March, the FTC and FDA sent warning letters to seven companies about unsupported claims that products can treat or prevent Coronavirus.
- On April 1, the Department of Justice (DOJ) announced that it is making $850 million available to help public safety agencies respond to the coronavirus pandemic.
- The FTC issued a statement (3/26/20) outlining the agency’s efforts to protect consumers during the Coronavirus pandemic and acknowledging the challenges transporting goods and services to people across the country. It noted the agency would be “flexible and reasonable” in enforcing compliance requirements. He also announced an email address for businesses seeking guidance: firstname.lastname@example.org, noting FTC staff would respond to inquiries as quickly as possible.
State Enforcement Actions
- On April 14, the Ohio Attorney General filed a lawsuit against an individual from northeast Ohio and his co-conspirators for hoarding N95 respirator masks and selling them online for nearly 18 times the retail price. The hoarding of an item and the related increase in prices of that item (price gouging) constitute an unreasonable and unlawful restraint of trade under the Valentine Act – Ohio’s antitrust law. For guidance and tips on how businesses can respond if they are victims of price gouging, read this A&B advisory (New).
Department of Labor/EEOC
- Department of Labor (DOL) issued (4/14/20) a grant notice to help community-based organizations and public agencies to provide services to migrant and seasonal farmworkers and their dependents (New).
- The DOL provided FAQs further clarifying paid leave requirements under the new Families First Coronavirus Response Act (FFCRA).
- DOL published guidance (4/5/20) to states for the implementation of the Pandemic Unemployment Assistance (PUA) program. Under PUA, individuals who do not qualify for regulator unemployment compensation and are unable to continue working as a result of COVID-19, are eligible for up to 36 weeks of PUA benefits.
- The DOL issued (4/10/20) an updated unemployment insurance program letter explaining to state workforce agencies how to implement unemployment compensation provided for under the CARES Act.
- DOL released guidance (4/3/20) which includes a comprehensive webinar explaining which employers are covered by the new law, which workers are eligible, and what benefits and protections the law provides. The Wage and Hour Division (WHD) also added FAQs to its website in response to the questions most frequently received to-date through its extensive stakeholder engagement. To view the webinar and other guidance materials, visit here.
- WHD guidance (3/24/20) on Families First Coronavirus Response Act (FFCRA): Employee Paid Leave Rights.
- DOL issued (4/1/20) regulations implementing the paid leave requirements of the Emergency Paid Sick Leave Act and the Emergency Family and Medical Leave Expansion Act under the FFCRA.
- The State of New York filed (4/14/20) a lawsuit challenging several provisions of this regulation, including the provisions exempting from paid sick leave employees whose employers do not have any work for them, the broad definition of “health care provider,” the provisions regarding intermittent leave, and the documentation requirements for an employee to substantiate leave (New).
- A&B’s Labor and Employment Group provides an overview of the FFCRA and an updated collection of responses to some of the most common questions about employer obligations in this advisory (3/31/20).
- The DOL posted (3/26/20) the required employee notice that must be provided by covered employers to their employees regarding the new paid leave requirements as required by the FFCRA. The posted page contains the link to the poster itself, as well as a new Q&A that focuses exclusively on guidance about posting the notice, particularly in light of the fact that many employees are working remotely.
- The Equal Employment Opportunity Commission (EEOC) confirmed (4/8/20) that it has “temporarily suspended the issuance of charge closure documents” including right-to-sue notices unless requested by the employee.
Occupational Safety and Health Administration
- On April 13, OSHA issued its Interim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19). The April 13 Response Plan is enforcement guidance for OSHA personnel. It applies to all industries but is focused on what OSHA will look for when inspecting hospitals, emergency medical centers, and emergency response facilities (New).
- On April 10, OSHA issued its Enforcement Guidance for Recording Cases of Coronavirus Disease 2019 (COVID-19). The guidance provides that until further notice, for OSHA recordkeeping and reporting purposes, employers (other than employers in the health care industry, emergency response organizations, and correctional institutions) should consider COVID-19 cases to be “work-related” only where (1) there is objective evidence that the case may be work-related; or (2) where the evidence of work-relatedness “was reasonably available to the employer.”
- OSHA issued (4/13/20) guidance for package delivery workers to protect against COVID-19 (New). OSHA previously issued (4/6/20) a workplace poster on how to reduce the risk of exposure to coronavirus.
- OSHA’s enforcement guidance (4/3/20) on the use of respiratory protection equipment certified in other countries.
- OSHA released a statement (3/9/20) which includes an overview of key COVID-19 for employers and employees. OSHA’s website has been updated clarifying that no special precautions (beyond existing requirements) are required for municipal solid waste and recycling suspected or known to contain or be contaminated with COVID-19.
- OSHA’s practical guidance (3/21/20) to prevent the spread of COVID-19
- Trying to make sense of all these changes? A&B provides brief overviews of what you need to know:
- DOL has released additional questions and answers as guidance for the provisions required by FFCRA. A&B provides a complete overview and analysis (4/7/20).
- Large employers are assessing policies and potential liability to ensure a safe and secure workplace. The CDC has released (updated 3/21/20) guidance for employers related to employee information on COVID-19.
Securities and Exchange Commission
- On April 10, the Securities and Exchange Commission (SEC) announced that it would not recommend enforcement actions for failure to submit Forms 144 in paper if they are emailed instead.
- On April 8, SEC chairman and director of corporation finance released a statement encouraging earning disclosures and reports that timely, accurate, and robust. The SEC staff released a statement on the same topic on April 14 (New).
- For additional information on challenges regarding disclosures and COVID-19, review this A&B advisory (4/13/20) (New).
- The SEC issued updated guidance (4/7/20) on conducting shareholder meetings in light of COVID-19 concerns. Additionally, Delaware issued an executive order (4/6/20) that facilitates companies’ notice of a change in the format of an annual shareholder meeting by allowing notification to stockholders via an SEC filing and press release.
- For an analysis of changes the Institutional Shareholder Services (ISS) has made to its voting recommendations policies in light of the coronavirus pandemic see this A&B advisory. (4/10/20)
- The SEC Chairman confirmed in a statement (4/2/20) that the June 30, 2020 compliance date for the Regulation Best Interest (Reg BI) and Form CRS remains in effect. The A&B Financial Services & Products Group analyzes compliance with Reg BI and Form CRS mandates in this A&B advisory (4/2/20).
- The SEC issued an amended order (3/25/20) extending the relief available to some companies that cannot timely file their reports due to concerns, including the need to update risk disclosures in response to business threats.
- The SEC issued (4/6/20) two compliance and disclosure interpretations (here and here) regarding eligibility for relief under the amended order.
- The SEC issued Disclosure Guidance Topic No. 9 (3/25/20) on the SEC’s current views regarding disclosure and other securities law obligations that companies should consider with respect to COVID-19 and related business and market disruptions.
- The SEC expects filers to disclose the known, likely to be known, and unknown risks they face during the coronavirus pandemic and to better prepare, read these A&B questions to ask yourself (3/30/20).
- The SEC also issued a statement (3/24/20) regarding the authentication document retention requirements under the SEC rules in light of health, transportation, and other logistical issues raised by the spread of COVID-19.
Small Business Administration
- Small Business Administration (SBA) – In response to the CARES Act requirements, the SBA formally launched its Paycheck Protection Program for small businesses on April 3.
- The SBA issued (4/14/2020) a report providing a breakdown by industry, state, and loan size for the more than one million loans totaling over $247 billion approved through April 13 (New).
- The SBA has guidance (4/1/20) for loans under the Paycheck Protection Program, the Express Bridge Loan Pilot Program, the Economic Injury Disaster Loan Program for qualified entities that are impacted by COVID-19. The application for its economic injury federal disaster loans can be found here.
- The SBA, in consultation with the Treasury Department, updated its published FAQs addressing the Paycheck Protection Program. (Updated 4/8/20)
- The SBA released the interim final rule (4/2/20) implementing the Paycheck Protection Program.
- Complete details on the SBA CARES Act programs (Updated 4/9/20):
- For a top-line overview of the program CLICK HERE
- If you’re a lender, more information can be found HERE
- If you’re a borrower, more information can be found HERE
- PPP Borrower Application Form (Updated 4/2/20)
- PPP Lender Application Form
- PPP New Lender Application Form (Federally Insured Depository Institutions, Federally Insured Credit Unions, Farm Credit System Institutions)
- New Lender Application Form (Non-Bank and Non-Insured Depository Institution Lenders)
- Paycheck Protection Program – Interim Final Rule
- Paycheck Protection Program – Interim Final Rule on Affiliation
- Paycheck Protection Program – Applicable Affiliation Rules
- Find an eligible lender
- Frequently Asked Questions (Revised 4/14/20)
- For a deeper dive on the funding streams available for SBA loans in the CARES Act, review this A&B publication (4/1/20).
- Treasury and the SBA issued an interim final rule (4/14/20) on how self-employed and independent contractors can apply for PPP loans (New).
- For information on how fund managers can qualify for relief, review this A&B advisory (4/14/20) (New).
- A&B’s Financial Restructuring & Reorganization Group has provided proactive steps creditors can take now to prepare for whatever comes after the coronavirus pandemic subsides in this advisory (4/9/20). For more on how the CARES Act impacts the banking industry, including takeaways for lenders and on regulatory relief and mortgage-related provisions, read this A&B advisory (3/30/20).
- Businesses large and small are navigating the chaotic economic climate; find some important actions you can take now to better prepare here (3/30/20).
Department of Treasury
- The Department of Treasury website for CARES Act programs, including specific sections on assistance for American workers and families, small businesses, state and local governments, and preserving jobs for American industry (Revised 4/14/20).
- Last Friday, the U. Department of Treasury announced its “Get My Payment,” a free web app which will be found at IRS.gov and will allow taxpayers who filed their tax return in 2018 or 2019 but did not provide their banking information on their return to submit direct deposit information. Once completed, they will get their $1200 Economic Impact Payments direct deposit to their bank accounts (plus $500 for minor children), a process expected to begin on April 20. “Get My Payment” will also allow taxpayers to track the status of their payment. Guidance is also provided for non-filers of tax returns in 2018 or 2019. (4/10/20)
- The Federal Reserve announced (4/9/20) that it will launch a lending program for mid-sized businesses hurt by the coronavirus, called the Main Street Lending Program. The new program will provide up to $600 billion in loans to eligible businesses through two facilities.
- A brief overview and comparison of the two Main Street programs can be found here.
- For more information about the Main Street programs, review this A&B advisory (4/14/20) (New).
- The Federal Reserve provided details for the provision of up to $2.3 trillion in loans to support the economy on April 9.
- The Consumer Financial Protection Bureau (CFPB), Federal Reserve, Federal Deposit Insurance Corporation (FDIC), and the Office of the Comptroller of the Currency (OCC) issued an interagency statement (4/14/20) regarding an interim final rule to temporarily defer real estate appraisals and evaluations for up to 120 days after closing through 12/31/20 (New).
- The CFPB, Federal Reserve, FDIC, the National Credit Union Administration (NCUA), the OCC, and state banking regulators issued (4/3/20) a joint statement on supervisory and enforcement practiced regarding mortgage servicing rules regarding COVID-19 and the CARES Act. For additional details on the joint statement, review this A&B advisory (4/6/20).
- The Department of Treasury, Federal Reserve, and FDIC jointly announced (4/9/20) an interim final rule to encourage lending to small businesses through the SBA’s Paycheck Protection Program (PPP).
- The Federal Reserve Board announced (4/8/20) that it will temporarily modify the growth restrictions on Wells Fargo so that it can provide additional support to small businesses.
- The Federal Reserve announced (4/6/20) that it will establish a facility to facilitate lending to small businesses under the PPP by providing term financing backed by PPP loans.
- Treasury Secretary Steven Mnuchin and Small Business Administration Administrator Jovita Carranza announced (4/2/20) that the interest rate on what lenders could charge small businesses for loans in the Paycheck Protection Program would be raised from 0.5% to 1%.
- The FFCRA gives businesses with fewer than 500 employees funds to provide employees with paid sick leave and family and medical leave related to COVID-19. On April 1, the Department of Treasury and IRS released FAQs regarding the tax credits available under this Act.
- On April 1, the Treasury Department and the IRS launched the Employee Retention Credit, designed to encourage businesses to keep employees on their payroll. Eligible employers that have been financially impacted by COVID-19 can receive 50% of up to $10,000 in wages paid.
- The Treasury Department provided the details (4/6/20) on the Economic Impact Payments program up to $1,200 for individuals or $2,400 for married couples. Parents also receive $500 for each qualifying child. This program was also required by the CARES Act.
- The Department of Treasury and the IRS announced (4/8/20) that Social Security beneficiaries who are not typically required to file tax returns will not need to file an abbreviated tax return to receive an Economic Impact Payment. Instead, payments will automatically be deposited into their bank accounts.
- The Treasury Department announced (3/31/20) it was delaying tax payment due dates for wine, beer, distilled spirits, tobacco products, firearms, and ammunition excise taxes, to provide flexibility for businesses that have been negatively affected by COVID-19. The postponement of due dates applies to any tax payment with an original due date falling on or after March 1, 2020, through July 1, 2020.
- On Friday, Ginnie Mae announced an expansion of its Issuer assistance program to help mortgage servicers facing liquidity shortfalls to apply for assistance in meeting their contractual obligations. (4/10/20)
- The APM introduces a new version of the existing Pass-Through Assistance Program (PTAP) for use by issuers facing a temporary liquidity shortfall directly attributable to the COVID-19 National Emergency. The existing PTAP program had been tailored to natural disaster situations with more limited impact. The application of PTAP to the COVID-19 National Emergency (PTAP/C19) allows Issuers to apply for assistance in meeting their contractual obligation to make timely and in full principal and interest payments due mortgage-backed security (MBS) holders without being held in default under the Ginnie Mae Guaranty Agreement. This assistance is intended to minimize disruptions in the mortgage servicing and MBS capital markets as borrower forbearance and loss mitigation programs are implemented to provide relief to homeowners affected by the COVID-19 National Emergency.
- In a joint statement (3/22/20), the federal financial institution regulatory agencies and state banking regulators encouraged financial institutions to work constructively with borrowers affected by COVID-19 and provided additional information regarding loan modifications.
- The federal financial institution regulatory agencies issued a revised interagency statement providing additional information regarding loan modifications on April 7.
- To understand how federal regulators are clarifying the CARES Act interaction with previous statements on loan modifications and reporting read this A&B advisory. (4/9/20).
- Internal Revenue Service (IRS) granted further COVID-19 emergency relief in Notice 2020-18 (superseding its prior announcement) delaying the due date for filing Federal income tax returns and making Federal income tax payments from April 15, 2020 to July 15, 2020. The deadline is automatically postponed with no need for taxpayers to file Forms 4868 or 7004. Unlike prior guidance, there is no limitation on the amount of tax payments that may be deferred until July 15, 2020. Read here for both economic impact payments and "what you need to know" (updated 4/1/20) and for additional guidance and FAQs.
- The CARES Act allows employers to defer the deposit and payment of the employer's share of social security taxes and self-employed individuals to defer payment of certain self-employment taxes through December 31, 2020. These FAQs address specific issues related to the deferral of deposit and payment of these employment taxes. (4/9/20)
- Economic impact payments for non-filers, but full details are here.
- The IRS extended additional tax deadlines for estates, individuals, and businesses until July 15, 2020. As a result, the extensions generally now apply to all taxpayers that have a filing or payment deadline falling on or after April 1, 2020, and before July 15, 2020.
- The CARES Act provides a refundable tax credit for businesses of all seizes that experience economic hardship due to COVID-19. Click here for A&B’s guide to how the credit works.
- The IRS has an online resource for questions for information on Coronavirus tax relief, IRS operations during COVID-19, and filing and payment deadlines FAQs
- Responding to requests for relief from the Real Estate Roundtable and others, the IRS issued Revenue Procedure 2020-23on April 8 to address technical issues that would have limited the ability of partnerships and their partners to benefit from retroactive CARES Act provisions.
- For a deeper dive on this topic, see this A&B advisory (4/9/20).
- Department of Education (DOEd): The Department of Education announced (4/14/20) that over $3 billion in block grants would be provided to state governors under the CARES Act for K-12 education (New).
- DOEd announced on April 9 that more than $6 billion will be distributed immediately to colleges and universities to provide direct emergency cash grants to college students whose lives and educations have been disrupted by the coronavirus pandemic. The funding is available through the Higher Education Emergency Relief Fund authorized by the CARES Act. Additional details can be found in this FAQs on Dept. of Education grant funds.
- The Department of Education also released a proposed regulation on April 2 amending eligibility requirements for faculty and student interactions in online college programs.
- The Department of Education also announced (3/31/20) new federal deadline flexibility for Career and Technical Education leaders.
- Department of Housing and Urban Development (HUD): HUD announced (4/1/20) set of mortgage payment relief options for single family homeowners with FHA-insured mortgages who are experiencing financial hardship as a result of the coronavirus pandemic. Mortgage servicers are instructed to:
- Offer forbearance—deferred or reduced mortgage payment options—for up to six months to affected borrowers;
- Delay submitting Due and Payable requests for Home Equity Conversion Mortgages by six months; and
- Extend any flexibility they may have under the Fair Credit Reporting Act relative to negative credit reporting actions.
- Department of Transportation (DOT): On Friday, DOT announced the Agency was making over $1 billion available to the National Railroad Passenger Corporation (Amtrak) to support the railroad’s activities to respond to, prepare for, and prevent the spread of COVID-19. (4/10/20)
- DOT issued (4/7/20) a new rule regarding minimum service requirements and exemptions for airlines receiving financial assistance under the CARES Act.
- The DOT Pipeline and Hazardous Materials Safety Administration (PHMSA) issued (4/6/20) a notice of enforcement discretion regarding the filling of certain non-flammable gas cylinders to assist members of the medical and industrial gas industry.
- The DOT Federal Transit Administration (FTA) issued an Enforcement Notice on Friday clarifying airline refund requirements.
- The FTA issued (4/6/20) updated FAQs on the implementation of the CARES Act.
- The DOT announced (4/2/20) $25 billion in federal grant funding to help the nation’s public transportation systems under the CARES Act.
- The Federal Aviation Administration announced (4/14/20) the award of $10 billion in funds under the CARES Act for U.S. airports (New). A breakdown of the funding by airport is available here. The FAA updated its FAQs on these grants (Revised 4/13/20).
- It was reported (4/14/20) that the FAA is banning pilots from taking chloroquine or hydroxychloroquine, two drugs the President has suggested are effective against the coronavirus, for 48 hours before flying (New).
- Department of Veterans Affairs (VA): President Trump issued an executive order on Friday, directing the Department of Veterans Affairs to allow flexibility in federal contracts for “national security reasons.” (4/10/20)
- VA announced on April 3 that financial relief actions would be extended to veterans with COVID-19, include suspending all actions on Veteran debts under the jurisdiction of the Treasury Department and suspending collection action or extending repayment terms on preexisting VA debts, as the Veteran prefers.
- The United States Copyright Office announced (4/6/20) that in addition to previously announced extensions, it would provide emergency relief for mechanical royalty payments and notice requirements under Section 115 of the Copyright Act with respect to copyright owners who previously received these items in paper format.
- The S. Patent and Trademark Office (USPTO) announced (3/31/20) extensions to the time allowed to file certain patent-related and trademark-related documents and to pay certain required fees. For additional details on this topic, review this A&B advisory (4/2/20).
- Construction Industry: The coronavirus pandemic creates special problems for the construction industry which include site safety and contractor and subcontractor responsibilities for such. These issues and more are examined in this A&B advisory (3/31/20).
- Construction contracts: The availability of force majeure and other related doctrines to excuse contractual performance is examined here (3/23/20).
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
- Congressmen urge the USTR to be flexible with auto industry on USMCA. Citing complications sparked by the COVID-19 pandemic, a bipartisan group of 31 lawmakers is urging Lighthizer to allow the auto industry a flexible adjustment period for implementing the U.S.-Mexico-Canada Agreement’s (USMCA) rules of origin. In an April 10 letter, the lawmakers request a delay of the deal’s entry into force or more flexibility to allow the industry to avoid penalties once USMCA is in effect, “to account for delays” caused by COVID-19 (New).
- ITC starts investigation of imported products that could help in COVID-19 fight. The U.S. International Trade Commission (ITC) initiated an investigation that will identify imported products that may be needed to respond to the COVID-19 pandemic after two senior lawmakers requested it. In a statement on April 13, the ITC stated it would identify products and provide “trade-related information for them, including their source countries, tariff classifications, and applicable rates of duty.” The ITC expects to deliver the report to Congress and to the USTR by April 30, 2020 (New).
- Ex-Im Bank temporarily stops supporting U.S. exports of COVID-19 related medical products. The Export-Import Bank’s board of directors voted to temporarily stop providing financing support and insurance coverage to exports of medical products being used to combat the COVID-19 pandemic. The board of directors, which includes U.S. Trade Representative Robert Lighthizer and Commerce Secretary Wilbur Ross, unanimously voted in favor of the export financing and insurance restrictions. The restrictions will stay in place through September 30 unless a majority of the board votes to lift them sooner, according to the board resolution (New).
- OECD issues trade policy brief on COVID-19 issues. The Organization for Economic Cooperation and Development Secretariat issued the first of a series of policy briefs on trade issues related to the coronavirus pandemic. In its April 10 brief, the OECD stated that countries should focus on enhancing coordination on trade facilitation and digital trade to mitigate the economic harm of the COVID-19 outbreak (New).
- Cargo Volumes Through Port of Los Angeles at Lowest Since Depths of Great Recession. Container volumes through the Port of Los Angeles fell 30.9% year-on-year in March, marking the lowest amount of cargo moving through the port in a month since February 2009. The deep decline comes as a result not only of the COVID-19 pandemic, but also the ongoing trade war between the U.S. and China, said Gene Seroka, executive director of the port in a news release. Imports for the month decreased by 25.9% compared with March 2019, and exports by 23.8%. Empty containers declined by 44.5%, according to the news release (New).
- For a 50-state review of business interruption insurance related issues see this new COVID-19 Insurance Litigation and Regulatory Issues Tracker (4/12/20).
- On April 10 President Trump weighed in on the issue of business interruption coverage, stating during a two-hour coronavirus briefing that he “would like to see the insurance companies pay if they need to pay” and opining that while some policies may include exclusions for pandemics, in a lot of cases policies do not include such an exclusion (New).
- More auto insurers have joined in voluntarily returning some money to customers as the widespread government shutdowns result in a decline in driving as people shelter at home.
- A Pandemic Risk Insurance Act, modeled after the TRIA, has been under consideration by the U.S. House Financial Services Committee since Mid-March. The draft bill is currently in discussion draft (Updated 4/14/20).
- To date, Pennsylvania, South Carolina, Rhode Island, Louisiana, New York, New Jersey, Massachusetts, and Ohio proposals that would re-write business interruption coverage to force insurance companies to cover businesses that have shut down due to the novel coronavirus pandemic and, at least in some cases, override express policy exclusions for infectious diseases or virus contamination. Pennsylvania’s bill has bipartisan support from 37 members of the House. New Jersey’s bill was pulled from consideration prior to the General Assembly vote. (Updated 4/14/20).
- New lawsuits have been filed against insurers regarding business interruption coverage for claims arising out of the COVID-19 pandemic. These suits follow several other similar actions filed in both state and federal courts across the country. (Updated 4/14/20).
- On April 10, 2020, Crossville Fabric Chile S.A. initiated a class action against Zurich American Insurance Company in Indiana state court seeking a ruling that defendant owes insurance coverage for financial damages suffered by plaintiffs because of the COVID-19 pandemic.
- On April 13, 2020, DRA Inc. dba Pure Eatery filed suit in Indiana state court against its insurer Society Insurance alleging that Society wrongfully failed to pay plaintiffs for financial damages suffered as a result of the COVID-19 pandemic.
Additional Workplace (Stay-at-Home) Issues
- The CDC released new guidance (4/9/20) advising that critical infrastructure workers may be permitted to continue work following potential exposure to COVID-19, provided they remain asymptomatic and additional precautions are implemented to protect them and the community.
- Following the CDC’s recommendation of wearing face coverings as “additional, voluntary public health measure,” we are seeing a trend of local government orders mandating the use of facemasks or cloth face coverings in public and/or the workplace.
- Examples include several counties and municipalities in Southern California (including the City of Los Angeles), Hoboken, New Jersey, and Texas counties.
- Most mandate use by individuals when in public, but at least one local government (Los Angeles) is requiring employers to provide the face coverings for their employees.
- Most orders are careful not to require the use of surgical or N-95 face masks, which should be reserved for medical responders.
- We expect to see the trend of mandating the use of face coverings in public to spread to other local, and perhaps state, governments.
- Government Closure/Stay-at-Home orders have been released in multiple state and local jurisdictions. For the key Stay-at-Home order details in one document, view this A&B COVID-19 50-State Closure Tracker (Updated 4/14/20)
- To date, the only states that have not issued state-wide stay-at-home orders are Arkansas, Iowa, Oklahoma, Nebraska, North Dakota, South Dakota, Utah, and Wyoming.
- For those asking how to define “federal crucial infrastructure sectors” the Department of Homeland Security’s Cyber Infrastructures division outlines (last update 3/28/20) 16 sectors and provides additional guidance for businesses.
Cyber Security & Privacy
- The United States Senate held a “paper hearing” (4/9/20) on using big data in the fight against COVID-19. Opening statements and questions are available here.
- Governments world-wide are using location and other mobile device data to slow the spread of COVID-19. We analyze these efforts in this A&B advisory. (Updated 4/13/20)
- The U.S. Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA) and the United Kingdom’s National Cyber Security Centre (NCSC) issued a joint alert regarding COVID-19-related themes malicious cyber actors are using to attack vulnerable services and exploit COVID-19. The alert explains how malicious actors are making their attacks as well as steps businesses can take to protect themselves. (4/8/20)
- Government contractors and Federal employees are part of the newly remote workforce. The Department of Defense has issued new guidance (4/2/20) for its workers.
- The COVID-19 pandemic provides an opening for a variety of malicious cyber-attacks. The FBI details threats and ways to protect yourself (4/1/20)
- Go Video teleconferencing is the new normal for the remote workforce. But is it secure? The FBI offers tips (3/30/20) on how to protect yourself from being hijacked.
- This A&B advisory (4/7/20) discusses the current COVID-19 cybersecurity threat landscape, including scams that target individuals, attempts to compromise company systems, telework vulnerabilities, and business email compromise.
- The Cybersecurity and Infrastructure Security Agency (CISA) released guidance (3/19/20) to help state and local jurisdictions and the private sector identify and manage their essential workforce while responding to COVID-19.
- The Joint Commission on Accreditation for Healthcare Organizations (The Joint Commission) announced (3/17/20) it was suspending surveying in response to the coronavirus outbreak. The suspension is expected to last through April. For additional information and additional resources visit the joint Commission Coronavirus website.
- The Joint Commission released a statement for healthcare workers regarding the use of face masks brought from home.
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: U.S. Department of Health and Human Services:
Centers for Disease Control and Prevention:
What you should know:
Information for Businesses:
Information for Travel and Transportation:
Information for Health Care Providers, First Responders, and Research Facilities:
Information for Law Enforcement:
Information for Families and Households:
Information for Schools and Childcare Providers:
Information for Community Events and Gatherings:
Agency Resources and Information:
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