On March 6, 2020, President Trump signed into law the Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020. This $8.3 billion package provides funding for the country’s response to coronavirus, including amongst its many provisions an emergency telehealth waiver, vaccine development, support for state and local governments, and assistance for affected small businesses.
Highlights from the bill include:
Emergency Telehealth Waiver ($500 million estimated cost)
This emergency waiver allows the Secretary of Health and Human Services (HHS) to waive certain Medicare telehealth restrictions during the coronavirus public health emergency. These waivers allow Medicare providers to furnish telehealth services to Medicare beneficiaries regardless of whether the beneficiary is in a rural community.
Specifically, the bill gives the secretary of the U.S. Department of Health and Human Services (HHS) the authority to waive the “originating site requirement” for telehealth services provided to Medicare beneficiaries located in any identified emergency area during emergency periods by a qualified provider. It allows Medicare beneficiaries to receive telehealth services from home, without the potential risk of exposure associated with visits to medical care facilities.
Telehealth services can be provided to Medicare beneficiaries via phone if the phone allows for audio-video interaction between the provider and the beneficiary.
Funding for the Food and Drug Administration (FDA) - $61 million
Funds are provided to:
- Facilitate the development and review, both pre-market and post-market, of medical countermeasures, devices, therapies, and vaccines
- Help FDA maintain the national drug and device product inventory through extensive outreach to medical product manufacturers to identify and mitigate potential supply chain interruptions
- Assist FDA’s enforcement work against counterfeit and misbranded products and its review of emergency use authorizations for medical products, such as diagnostics
- Enable FDA to build on its efforts to strengthen the U.S. medical product manufacturing sector by supporting efforts to foster more investment and innovation in advanced manufacturing methods for drugs, devices, vaccines, and other therapies
Funding for the Centers for Disease Control and Prevention (CDC) – $2.2 billion
Funds are provided to support federal, state, and local public health agencies to prevent, prepare for, and respond to the coronavirus, including:
- To support states, localities, territories, and tribes to conduct public health activities ($950 million) such as:
- surveillance for coronavirus
- laboratory testing to detect positive cases
- contact tracing to identify additional positive cases
- infection control at the local level to prevent additional cases
- migration in areas with person-to-person transmission to prevent additional cases
- other public health preparedness and response activities
For the above, $475 million must be allocated within 30 days.
- Support CDC's repatriation and quarantine efforts, laboratory testing, emergency operations, epidemiological investigations, public information, and surveillance and data analysis
- Replenish the Infectious Diseases Rapid Response Reserve Fund, which supports immediate response activities during outbreaks ($300 million)
- Global disease detection and emergency response (at least $300 million)
Funding for the National Institute of Environmental Health Sciences- $10 million
Funds provide for worker-based training through the National Institute of Environmental Health Sciences to prevent and reduce exposure of hospital employees, emergency first responders, and other workers who are at risk of exposure to coronavirus through their work duties.
In General: Vaccines, Therapeutics, and Diagnostics (>$3 billion)
Funds are provided for the research and development of vaccines, therapeutics, and diagnostics to prevent or treat the effects of coronavirus, including funding for the following:
- Biomedical Advanced Research and Development Authority (BARDA) to support advanced research and development of vaccines, therapeutics, and diagnostics, prioritizing platform-based technologies with U.S.-based manufacturing capabilities (>$2 billion)
- National Institutes of Health (NIH) to support basic research and development of vaccines, therapeutics, and diagnostics ($826 million)
- Contingency funding for procurement of vaccines, therapeutics, and diagnostics ($300 million)
The law also requires that vaccines, therapeutics, and diagnostics developed using taxpayer funds must be available for purchase by the Federal government at a fair and reasonable price and allows the Secretary of Health and Human Services (HHS) to ensure that vaccines, therapeutics, and diagnostics developed using taxpayer funds be affordable in the commercial market.
In General: Healthcare Preparedness, Pharmaceuticals and Medical Supplies, and Community Health Centers (~$1 billion)
Provides funding for procurement of pharmaceuticals and medical supplies, to support healthcare preparedness and Community Health Centers, and to improve medical surge capacity. Includes:
- Procurement of pharmaceuticals, masks, personal protective equipment, and other medical supplies, which can be distributed to state and local health agencies in areas with a shortage of medical supplies (~$500 million)
- Health services through Community Health Centers, which will support smaller health clinics across the country in under-served urban and rural areas ($100 million)
- Funding for medical surge capacity, which will increase the supply of biocontainment beds at additional health facilities
- Continues support for healthcare preparedness, including the National Ebola and Special Pathogens Training and Education Center (NETEC), regional, State and local special pathogens treatment centers, and hospital preparedness cooperative agreements
Also included in the supplemental funding law is a requirement to reimburse $136 million to programs across HHS that were temporarily transferred to support emergency preparedness and response activities at the CDC and the Assistant Secretary for Preparedness and Response (ASPR) and $2 million for the HHS Office of Inspector General to conduct oversight of activities related to coronavirus preparedness and response.
In addition, there is a general provision requiring reimbursement of State or local costs incurred for coronavirus preparedness and response activities between January 20 and the date of enactment of the emergency supplemental (March 6, 2020) and a proviso to allow funds to be used for construction or renovation of facilities to improve preparedness and response capabilities at the State and local level. HHS has been given authority to hire public health experts, as quickly as necessary, to perform critical work relating to coronavirus.
The law allows $1 billion in loan subsidies to be made available to help small businesses, small agricultural cooperatives, small aquaculture producers, and nonprofit organizations which have been impacted by financial losses as a result of the coronavirus outbreak. This funding could enable the Small Business Administration to provide an estimated $7 billion in loans to these entities.
Other provisions ensure that the President cannot use funds appropriated in this bill for any other purpose, except for repayment of transfers within the Department of Health and Human Services and require enhanced Government Accountability Office oversight of funds appropriated in this bill.
Remaining provisions may be summarized as follows:
- State operations – for consular operations, emergency evacuations of State Department staff and dependents, and other emergency preparedness needs at embassies around the world ($264 million)
- Increases transfer threshold for emergency evacuations from $10 million to $100
- Global Health Response – to support health systems overseas to prevent, prepare and respond to the coronavirus ($435 million incl. $200 million for the Emergency Reserve Fund)
- Humanitarian Assistance – to respond to humanitarian needs arising in countries coping with a coronavirus disease outbreak ($300 million)
- Economic and Security Stabilization – to protect against the effects of an outbreak including economic, security, and stabilization requirements ($250 million)
- Oversight – for the USAID Inspector General to perform oversight of coronavirus response activities ($1 million)
- Allows for increased flexibility to transfer funds to respond to the coronavirus
- Requires a comprehensive strategy to respond to the coronavirus outbreak and regular reporting on the use of funding
For more information on activities related to COVID-19, visit ASCO in Action.