Coronavirus Information

IFFGD is closely monitoring the coronavirus outbreak (also referred to as COVID-19 and SARS-CoV-2) and relevant legislation changes in response to this public health emergency. For those seeking up-to-date information on this outbreak and relevant public health concerns, please refer to the Centers for Disease Control (CDC) and World Health Organization (WHO). The following material highlights key provisions of this legislation with links to the full text and materials on congress.gov. Congress has been working to build this emergency response legislation in phases. The Coronavirus Preparedness and Response Supplemental Appropriations was phase 1, introduced on March 4, 2020 and signed in law on the 6th. Phase 2, the Families First Coronavirus Response Act, was signed into law on March 18th. Phase 3, The Coronavirus Aid, Relief, and Economic Security (CARES) Act was signed into law on March 27, 2020.

The U.S. Food and Drug Administration (FDA) has created a webpage dedicated to addressing the relevant questions of patients and caregivers. Visit the Coronavirus Disease 2019 (COVID-19) Resources for Patients webpage to find information about FDA COVID-19 resources.

  • Find information on hand sanitizers, treatment options, and more.
  • Learn how to report a drug, biologic, or medical device product shortage
  • Find information on clinical trials and the FDA’s Expanded Access program.

 

Specific summaries for:

 

See Industry Expanded Patient Assistance and Industry Research and Trials on COVID-19 here

 

Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act

H.R. 6800

Phase 5

Status: Passed by the House of Representatives on 5/15/2020

On May 12th, the Democratic leadership of the House of Representatives released the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act. The proposal is comprehensive, totals nearly $3 trillion, and represents the fifth COVID-19 response package considered by Congress. The House is passed this response package on May 15th.

Key provisions include:

Emergency Supplemental Appropriations

Department of Health and Human Services

  • $4.75 billion for the National Institutes of Health (NIH) to assist with relevant research and to support biomedical research laboratories across the country.
  • $4.58 billion for the HHS Assistant Secretary for Preparedness and Response, including-
    • $3.5 billion for the Biomedical Research and Development Authority (BARDA) for therapeutic and vaccine development.
    • $500 million for BARDA to support U.S. “next generation” manufacturing facilities.
    • $500 million for BARDA to advance antibacterial research and development.
  • $175 billion for the Public Health and Social Services Emergency Fund to reimburse for healthcare related expenses or lost revenue, and to support testing and contact tracing, including-
    • $100 billion for reimbursement grants to hospitals and healthcare providers.
    • $75 billion for testing, contact tracing, and related response activities.
  • $3 billion for the Substance Abuse and Mental Health Services Administration, including-
    • $1.5 billion for Substance Abuse Prevention and Treatment Block Grants.
  • $7.61 billion for the Health Resources and Services Administration (HRSA), including-
    • $7.6 billion for Community Health Centers for testing and healthcare.
    • $10 million for Ryan White HIV/AIDS clinics to accommodate high risk patients. 
  • $2.1 billion for the Indian Health Service to support healthcare activities, including-
    • $1 billion to address lost revenue from reduced medical care.
    • $64 million to assist Urban Indian Organizations.
    • $10 million for sanitation, hydration, and hygiene.
    • $500 million for healthcare and telehealth.
    • $140 million for broadband and health IT.
    • $20 million to support victims of domestic violence.
    • At least $366 million to facilitate quarantine and social distancing
  • $25 million for the Centers for Medicare and Medicaid Services to support Healthcare Fraud and Abuse Control activities. 
  • $1.3 billion to assist the Federal Emergency Management Agency with response activities.
  • $900 million to assist tribal governments with response activities.
  • $125 million for the National Science Foundation to assist with response activities.

Department of Education

  • $90 billion for a State Fiscal Stabilization Fund at the U.S. Department of Education to support funding for public schools, including general expenditures for institutions related to service disruption.
  • $10.5 billion to alleviate COVID-19 related burdens for both schools and students, including-
    • $1.7 billion for Historically Black Colleges and Universities.
    • $20 million for Howard University.
    • $8.4 billion for other institutions of higher education.
  • Replaces the mandatory $62 million cap on funding for Historically Black Colleges and Universities (HBCUs) Capital Financing Program with “such sums”.
  • Extends the definition of “distance education” as proposed by the Department on April 2nd, 2020, to programs that begin after August 15th and effectively extends the provision to the end of the 2020-2021 award year.

Department of Justice

  • $200 million for the Bureau of Prisons to conduct response activities, including testing and medical services.

Healthcare Policy

Coverage and Access

  • Provides a 10% increase in federal payments to Medicaid programs for home and community-based services.
  • Provides a 14% increase in Federal Medical Assistance Payments to Medicaid programs.
  • Eliminates Medicaid cost-sharing for COVID-19 vaccines or treatments.
  • Provides a State option to cover for COVID-19 treatment for the uninsured through Medicaid.
  • Provides a 2.5% increase in Medicaid payments to Disproportionate Share Hospitals.
  • Provides no-cost sharing for individuals that receive care for COVID-19 through Medicare Part A or B.
  • Ensures that COVID-19 treatments are provided at no-cost through the Medicare Advantage Program.
  • Requires broad Medicare coverage of COVID-19 treatments without cost-sharing or utilization management protocols.
  • Creates a new special enrollment period for Medicare Part A and B, as well as through the federal exchanges for private coverage.
  • Ensures items and services needed to treat COVID-19 are provided with no cost-sharing through private insurance.
  • Makes the requirement for free COVID-19 testing retroactive to the start of the public health emergency.
  • Extends requirements for no-cost sharing to treat COVID-19 to TRICARE and the VA health system (including no-cost for preventative services within the VA).
  • Requires the appointment of a qualified Medical Supplies Response Coordinator to oversee supply chain logistics.

Proposed Studies

  • Asks the National Academies to conduct a review and make recommendations to encourage domestic manufacturing of critical drugs.
  • Asks the Government Accountability Office (GAO) to study the feasibility of a Strategic National Stockpile user-fee arrangement.
  • Asks the GAO to study and report on the diagnostic testing response. 

Testing

  • Requires HHS to issue a new and detailed (updated) plan for testing.
  • Requires every laboratory conducting COVID-19 tests to report daily results to HHS.
  • Authorizes $6 billion to modernize public health departments.
  • Authorizes $1 billion for the Centers for Disease Control and Prevention to modernize its public health infrastructure.
  • Requires CDC to establish a national system for testing and contact tracing, this includes issuing grants to State, local, and Tribal governments.
  • Deploys the Defense Production Act to increase production and supply of critical items, including diagnostic tests.

Public Health

  • Updates the ongoing blood donation public awareness campaign to also include the importance of the plasma supply.
  • Establishes a public health workforce loan repayment program.
  • Authorizes grants to medical schools in rural or underserved areas, or minority-serving institutions to expand ongoing activities or establish new schools.
  • Releases certain territories and localities from “Buy American” requirements, allowing them to source medical equipment from nearly any supplier.

Economic Stimulus Measures 

Non-Profit Assistance

  • Requires lenders participating in the Main Street Lending Program to provide at least one low cost loan option to small businesses and non-profits that does not have a minimum loan size limit.
  • Extends financial relief available for qualifying non-profits organizations to January 31st, 2021.
  • Provides a (up to) 50% refundable tax credit for fixed costs for employers impacted by COVID-19.
  • Temporary moratorium on small business and nonprofit debt collection during the COVID19 crisis, and for 120 days thereafter.

Personal Assistance

  • Provides (up to) $10,000 in debt relief for private student loan borrowers.
  • Extends loan relief for all federal student loan borrowers.
  • Extends unemployment benefits related to COVID-19.
  • Extends certain family and medical leave benefits related to COVID-19.
  • Makes certain adjustments to personal tax credits for 2020 filings.
  • Provides a (up to) 90% business interruption tax credit for self-employed individuals impacted by COVID-19.

State and Local Assistance

  • $500 billion to assist State governments with fiscal impacts.
  • $375 billion to assist local governments with fiscal impacts.
  • $20 billion to assist Tribal governments with fiscal impacts.
  • $20 billion for assist territorial governments with fiscal impacts.
  • $755 million to assist the District of Columbia with response efforts and fiscal impacts.

 

The Paycheck Protection Program and Health Care Enhancement Act

Public Law No. 116-139, previously known as H.R. 266

Phase 4

Status: Public Law on 4/24/2020

On April 21st, the Senate unanimously passed this additional coronavirus (COVID-19) response legislation, the House of Representatives passed the measure on April 23rd. The president signed the bill into law on April 24th. While totaling nearly $500 billion, this is a narrow response package targeted at further emergency supplemental appropriations and economic stimulus. Many members of Congress remain interested in a subsequent, comprehensive COVID-19 response package, but the political path forward for such a proposal is unclear at this time.

Key provision include:

Emergency Healthcare Appropriations

  • $25 billion in additional funding to research, develop, and administer testing.
  • $1.8 billion in additional funding for the National Institutes of Health (NIH) to advance research and assist in the development of tests, vaccines, and related countermeasures.
  • $22 million in additional funding for the Food and Drug Administration (FDA) to ensure meritorious new products can quickly reach those in need.
  • $1 billion in additional funding for the Biomedical Advanced Research and Development Authority (BARDA) to support research and response activities.
  • $1 billion in additional funding for the Centers for Disease Control and Prevention (CDC) to conduct surveillance, contact tracing, and additional public health activities.
  • $825 million in additional funding for Community Health Centers to support ongoing response activities.
  • $1 billion in additional funding to further provide testing for the uninsured.
  • $75 billion in additional funding to reimburse hospitals and healthcare providers to support ongoing response efforts and replace lost revenue.

Economic Stimulus Measures

  • Provides $310 billion to replenish the Paycheck Protection Program.
    • Sets aside $30 billion in loans for community banks and small lenders with less than $10 billion in assets.
    • Sets aside $30 billion in loans for medium-sized financial institutions and lenders with $10 to $50 billion in assets.
    • This program is designed to provide a direct incentive for small businesses to keep their workers on the payroll and the loan will be forgiven if all employees are kept on the payroll for eight weeks and the money is used for payroll, rent, mortgage interest, or utilities.
    • Applications can be made through any existing SBA 7(a) lender or through any federally insured depository institution, federally insured credit union, and Farm Credit System institution that is participating.
    • More information and the application can be found here: Paycheck Protection Program  
  • $10 billion in additional funding for Emergency Economic Injury Disaster grants.
    • Economic Injury Disaster Loans are awarded up to $10,000 for entities that are experiencing a temporary loss of revenue. Funds will be made available following a successful application and will not have to be repaid.
    • Eligible recipients are small business with less than 500 employees (including sole proprietorships, independent contractors and self-employed persons), private non-profit organization.
    • More information and the application can be found here: Emergency Economic Injury Disaster Program
  • $50 billion in additional funding for the Disaster Loans Program Account.
  • The Small Business Administration also has other options for relief and they can be found here: SBA Coronavirus Relief Options  

 

The Coronavirus Aid, Relief, and Economic Security (CARES) Act

Public Law No. 116-136, previously known as H.R. 748

Phase 3

Status: Public Law on 3/27/2020

Following swift negotiations, Congress and the administration reached agreement on a “phase 3” legislative package responding to coronavirus (COVID-19). The final package totals nearly $2 billion and represents a compromise between the competing bills recently put forward by Senate Republicans and House Democrats. The phase 3 response package remains a combination of emergency supplemental appropriations, health policy provisions, and economic stimulus measures.

On March 25, 2020, the Senate unanimously passed H.R. 748 (bill text here), the House quickly followed by passing the bill on March 27, 2020, and President Trump signed this legislation into law on March 27, 2020.

Key provisions of this legislation include:

Appropriations

  • $172 billion for Labor, Health and Human Services (HHS), and Education (Ed).
    • $127 billion for the Public Health and Social Services Emergency Fund.
      • $100 billion to address lost revenue and expenses for hospitals and healthcare providers responding to COVID-19.
      • $16 billion for the Strategic National Stockpile for personal protective equipment (PPE), ventilators, and other related medical supplies.
      • $3.5 billion for vaccines, therapeutics, diagnostics, and other medical preparedness. 
      • $275 million for the Health Resources and Services Administration (HRSA) to support related activities through rural health, community health centers, and the Ryan White program. 
    • $4.3 billion for the Centers for Disease Control and Prevention (CDC).
      • $1.5 billion for State and Local Preparedness ($2.5 billion in total additional funding when combined with previous supplemental funding).
      • $500 million for Global Health ($800 million in total additional funding when combined with previous supplemental funding).
      • $300 million for the Infectious Disease Funds ($600 million in total additional funding when combined with previous supplemental funding).
    • $945.5 million for the National Institutes of Health (NIH), this brings total additional funding for NIH up to $1.78 billion when combined with previous supplemental funding.
    • $425 million for the Substance Abuse and Mental Health Services Administration to conduct core activities that respond to COVID-19.
    • $30.9 billion for Education
      • $14.25 billion for institutes of higher education to support both institutions and students impacted by COVID-19 with specific funding for historically black colleges and universities (HBCUs).
      • $13 million in direct support for Howard University.
  • $35 billion for Agriculture, Rural Development, Food and Drug Administration (FDA) and Related Agencies.
    • $25 million for a new grant program to support distancing learning and telemedicine (through rural development activities).
    • $80 million for FDA to support development of therapies, diagnostic tools, vaccines, and medical countermeasures. 
  • $10.5 billion for the Department of Defense (DoD).
    • $1 billion for the Defense Production Act to support production of PPE and other critical items.
    • $1.8 billion for the Defense Health Program to support addressing additional medical costs as well as the acquisition of countermeasures and related equipment.
    • $1.6 billion for the Defense Health Program to expand care capacity and bolster treatment facilities.
    • $415 million for the development of vaccines, lab operations, and the procurement of diagnostic tests.
    • $628 million for non-medical protective equipment and other supplies.
  • $2 billion for Interior, Environment, and Related agencies.
    • $7 million to assist the Environmental Protection Agency with responding to COVID-19.
  • $20 billion for Military Construction, Veterans Affairs (VA), and Related Agencies.
    • $14.4 billion to support the delivery of VA medical services.
    • $606 million for the VA to advance alternative sites of care and mobile treatment centers.

Healthcare

  • Seeks to mitigate shortages of emergency products by prioritizing review of drug applications and providing additional incentives.
  • Places further reporting requirements on manufacturers related to drug shortages or production challenges (mainly related to products needed for emergency response of COVID-19).
  • Provides specific guidance for the coverage, reimbursement, and pricing related to COVID-19 diagnostic tests.
  • Supports an awareness campaign and related activities related to the safety of the blood supply and importance of blood donation. 
  • Provides rapid coverage by third party-payers for preventative services and vaccines.
  • Reauthorizes the Health Professions Workforce Programs (Title VII).
  • Enhanced reporting requirements for the discontinuation of medical devices needed for the emergency response. 
  • Provides access to telehealth services for individuals with high deductible plans and health savings accounts (without incurring out of pocket costs).
  • Further expands access to telehealth services to ensure patients have access to a broad range of providers.
  • Provides flexibility to allow community health centers and rural health clinics to provide telehealth services.
  • Provides flexibility for patients to access home health services.
  • Removes Medicare sequester through the end of the calendar year, but then extends the sequestration for an additional year.
  • Blocks scheduled reductions in Medicare payments for durable medical equipment.
  • Eliminates Medicare Part B cost-sharing requirements for COVID-19 vaccines.
  • Allows for a 90-day supply of covered medications under Medicare Part D.
  • Ensures Medicaid patients can receive a COVID-19 test and related services with no cost-sharing requirements.
  • Ensures Medicare beneficiaries can receive a test for COVID-19 under Medicare Part B with no cost-sharing requirements.
  • Prevents 2021 scheduled reductions in Medicare diagnostic tests for clinical laboratories.
  • Provides an extension of the Medicare accelerated payment programs for hospitals.
  • Extends funding for the National Quality Forum to carry out ongoing quality management and performance improvement measures.
  • Delays scheduled reductions to Medicaid payments for disproportionate share hospitals.
  • Extends the Health Careers Opportunity Grant program.
  • Extends authorization for and enhances funding for;
    • Community Health Centers,
    • the National Health Service Corps, and
    • Teaching Health Centers that operate GME programs.

Education

  • Provides campus-based aid waivers.
  • Deploys supplemental education opportunity grants for emergency aid to assist students with unexpected expenses.
  • Facilitates continuing education through distance learning at affected foreign institutions.
  • Provides national emergency educational waivers.
  • $62 million to provide capital financing to HBCUs.
  • Provides interest and payment relief for student loan borrowers.

Taxes

  • Creates a COVID-19 unemployment assistance program through the end of the calendar year and provides an overall increase to unemployment benefits.
  • Provides emergency unemployment relief to non-profits and government entities.
  • Provides a recovery rebate for individuals and families.
  • Provides flexibility to withdraw funds from retirement accounts.
  • Enhances deductions to charitable organizations (whether deductions are itemized or not). Further incentivises individuals and organizations to make charitable donations.
  • Provides an employee retention credit to business forced to shut down or reduce operations as a result of COVID-19.
  • Provides a variety of additional adjustments to the tax code.
  • Numerous modifications are made to the Family and Medical Leave Act, the Emergency Paid Family Leave Act, and the unemployment insurance program.

 

Families First Coronavirus Response Act

Public Law No: 116-127, previously known as H.R. 6201

Phase 2

Status: Public Law on 3/18/2020

On March 14th, the House of Representatives passed the Families First Coronavirus Response Act (H.R. 6201) with overwhelming bipartisan support. On March 18th, the Senate passed the House bill and the president quickly signed the measure into law. No substantive changes were made to H.R. 6201.

Testing

  • $1 billion to help cover the cost of coronavirus testing for the uninsured.
  • $82 million in resources for the Department of Defense to test military personnel and their families for coronavirus through the Defense Health Program.
  • $64 million in resources for the Indian Health Service to conduct coronavirus testing.
  • $60 million for the Veterans Administration to conduct coronavirus testing.
  • Cost-sharing requirements under Medicare for coronavirus testing are waived.
  • Cost-sharing requirements through Medicare Advantage are also waived and private insurance is required to provide access to coronavirus testing at no cost.
  • Medicaid and CHIP are directed to provide coronavirus testing at no cost.

Nutrition

  • Bolstered support for food banks and federal nutrition assistance programs, including assistance for children that normally receive meals through a school that has been closed.
  • Bolstered support for nutrition and meal delivery services that serve senior citizens.

Miscellaneous

  • Enhanced and targeted tax credits for relevant medical leave.
  • Numerous statutory changes related to how impacted individuals engage unemployment, medical leave, nutrition assistance, and related federal programs.

 

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020

Public Law No: 116-123, previously known as H.R. 6074

Phase 1

Status: Public Law on 3/06/2020

The Coronavirus Preparedness and Response Supplemental Appropriations Act (H.R. 6074) was introduced on March 4, 2020, passing the House the same day, and passing the Senate on March 5, 2020. On March 6th, President Trump signed this bill into law, allotting $8.3 billion in emergency spending for state and local governments, assistance for small businesses affected by the coronavirus, and funding for a robust international response.  

This funding measure includes:

  • $2.2 billion for the Centers for Disease Control and Prevention (CDC), supporting surveillance and testing, as well as both domestic and global health initiatives.
  • $2 billion for the Biomedical Advanced Research and Development Agency (BARDA), supporting the development of vaccines, therapeutics, and diagnostic.
  • $826 million for the National Institutes of Health (primarily NIAID), supporting research that advances efforts to develop vaccines, therapeutics, and diagnostics.
  • $1 billion for Healthcare Preparedness, Pharmaceuticals and Medical Supplies, and Community Health Centers to support medical surge capacity.
  • $435 million for the Global Health Response to support overseas efforts to prevent and respond to coronavirus.

 

Expressing the sense of the House of Representatives that there should be a direct emergency economic stimulus for individual Americans in response to COVID-19

H.Res. 897

This resolution was introduced in the House of Representatives on March 12, 2020, and referred to the Committee of Ways and Means that same day. H. Res. 897 communicates that the House strongly feels the federal government should create and provide an emergency payment of $1,000 per month for all Americans until HHS (the Department of Health and Human Services) declares that the COVID-19 outbreak is no longer considered a public health emergency. The considerations of this legislation were included in H.R. 748.

 

COVID-19 Health Care Worker Protection Act of 2020

H.R. 6139

This legislation was introduced in the House of Representatives on March 9, 2020. On the same day, this bill was referred to the Committees on Education and Labor, Ways and Means, and Energy and Commerce. Each committee was responsible for the consideration of provisions that fall within each jurisdiction. The considerations of this legislation were included in H.R. 748.

 

 

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