Press Releases
Warner Joins Colleagues in Plan to Expand Health Care Coverage & Affordability During COVID-19
May 22 2020
WASHINGTON - Today, U.S. Sen. Mark R. Warner (D-VA) joined Sens. Jeanne Shaheen (D-NH), Tina Smith (D-MN), Ron Wyden (D-OR) and Patty Murray (D-WA) in releasing a Senate Democratic plan to expand health care coverage and affordability during the COVID-19 pandemic. In a white paper, the senators outline a series of common sense legislative priorities that the Senate should take up immediately, including expanding premium support through subsidies and tax credits, incentivizing Medicaid expansion in hold-out states, and a special open enrollment period. Their proposal also calls for all COVID-19 treatment costs to be covered, including for the uninsured.
“Access to health care has never been more important,” said Senator Shaheen. “As our country faces the worst public health crisis in a century, millions are facing furloughs and job losses that make affordable health care coverage an even greater struggle. Americans are sick and tired of the partisan excuses for why health care can’t be more affordable and accessible. There is absolutely no reason why Republicans can’t join Democrats to get this done. This crisis demands bipartisan cooperation – the American people will accept nothing less.”
“We need to rise to the challenge of solving America’s health care coverage and affordability problems, which have only been exacerbated by the pandemic,” said Senator Smith. “This plan will help more people access comprehensive health care coverage, and at a more affordable cost. We need to move this plan forward because these investments are critical—especially at a time when millions of Americans are on furlough or have lost their jobs."
“Families across the nation are struggling with the economic consequences of the pandemic, and that includes disruption to their health care access,” Senator Wyden said. “The last thing Americans need right now is to face questions about where they will get health care if they get sick. This proposal outlines practical steps that Congress could pass immediately and give families peace of mind during the pandemic.”
“For families in need, access to quality, affordable health care isn’t a partisan issue—it’s a life and death one. It shouldn’t take a historic global pandemic for Republicans to understand that, but for them to continue ignoring the health care needs of families in the middle of this crisis would be truly inexcusable,” said Senator Murray. “The absolute least we can do in the middle of an unprecedented public health crisis is help people get the health care they need—and Republicans have no excuse to continue playing politics or dragging their feet on getting these common-sense steps done. We need to act now.”
A brief overview of the policies included in the proposal:
· Cover all costs for COVID-19 treatment, including for the uninsured;
· Deliver subsidies for the cost of COBRA premiums for the newly unemployed;
· Expand and increase access to premium tax credits that help families afford monthly premiums;
· Incentivize Medicaid expansion in remaining states that have not yet expanded;
· Establish a federal special enrollment period;
· Ban the sale of junk plans;
· Restore funding for marketplace outreach and enrollment support;
In addition to Sen. Warner, the proposal is also supported by Sens. Debbie Stabenow (D-MI), Chris Van Hollen (D-MD), Michael Bennet (D-CO), Tom Carper (D-DE), Richard J. Durbin (D-IL), Maggie Hassan (D-NH), Sherrod Brown (D-OH), Richard Blumenthal (D-CT), Senate Minority Leader Charles Schumer (D-NY), Sheldon Whitehouse (D-RI), Dianne Feinstein (D-CA), Ben Cardin (D-MD), Patrick Leahy (D-VT), Tim Kaine (D-VA), Jack Reed (D-RI), Jacky Rosen (D-NV), Jeff Merkley (D-OR), Kamala Harris (D-CA), Robert Menendez (D-NJ), Tammy Baldwin (D-WI), Bob Casey (D-PA), Amy Klobuchar (D-MN), Tammy Duckworth (D-IL), Martin Heinrich (D-NM), Chris Coons (D-DE), Doug Jones (D-AL), Tom Udall (D-NM) and Catherine Cortez Masto (D-NV).
The proposal can be read in full here.
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Warner, Colleagues Outline Priorities to Support First Responders in Next COVID-19 Relief Bill
May 19 2020
WASHINGTON — U.S. Sen. Mark R. Warner (D-Va.) joined Sens. Chris Coons (D-Del.), Susan Collins (R-Maine) and nine of their colleagues on a bipartisan letter to Senate Leadership encouraging additional support for first responders in the next COVID-19 relief package.
In addition to Sens. Warner, Coons and Collins, the letter was joined by Senators Tom Carper (D-Del.), Dick Durbin (D-Ill.), Richard Blumenthal (D-Conn.), Angus King (I-Maine), Jon Tester (D-Mont.), Chris Van Hollen (D-Md.), Ron Wyden (D-Ore.), Bob Casey (D-Pa.), and Amy Klobuchar (D-Minn.).
The lawmakers detailed the following priorities for first responders:
- Bolster Assistance to Firefighter Grant, Staffing for Adequate Fire and Emergency Response (SAFER), and Department of Justice grant funding, including for the Community Oriented Policing Services program, so that state and local police, fire, and EMS departments can access resources to purchase and be reimbursed for PPE and other COVID-19 related expenses, recruit and retain employees and volunteers, and cover overtime, backfill costs, authorized hazard pay, and COVID-19-related paid sick leave during the crisis.
- Require that the Secretary of the Department of Homeland Security waive the cost share and maintenance of expenditure requirements for Assistance to Firefighter Grants for reimbursement of COVID-19-related expenses through FY21.
- Require that the Secretary of the Department of Homeland Security grant waivers to SAFER grant recipients for employee retention to aid staffing shortages through FY21. In addition, any legislation should retroactively require that the Secretary grant such waivers for FY19 and FY20 SAFER funds.
- Waive the prohibition on hazard pay for federal firefighters under 5 U.S.C. §?5545b(d)(1) for purposes of COVID-19 response, provide funding to federal agencies sufficient to cover hazard pay to frontline federal firefighters and law enforcement officers when appropriate, extend overtime pay to U.S. Probation Officers, and waive the federal firefighter and law enforcement officer overtime cap under 5 U.S.C. §?5547.
- Address the gap in paid sick leave coverage for first responders by requiring that the employing agency, not the employee, provide up to 80 hours of paid sick leave should these departments order the employee to self-quarantine in accordance with Centers for Disease Control and Prevention guidelines due to potential COVID-19 exposure.
- Create a presumption in the Public Safety Officers’ Benefits Program that a public safety officer’s infection of COVID-19 resulted from their employment to clearly establish eligibility for benefits due to the pandemic.
- Prevent the taxation of state and local incentives for volunteer firefighters and EMS personnel beyond 2020 in order to help departments continue to recruit and retain volunteer personnel.
The lawmakers’ effort is supported by the Fraternal Order of Police, the National Association of Police Organizations, the Federal Law Enforcement Officers Association, the International Association of Fire Fighters, the National Volunteer Fire Council, and the Congressional Fire Services Institute.
The full text of the letter is available here and below.
Dear Leader McConnell and Leader Schumer:
We appreciate your work to provide support for our nation’s police officers, firefighters, and emergency medical services (EMS) personnel in the Coronavirus Aid, Relief, and Economic Security Act. However, additional assistance is needed during this crisis. As Congress considers further legislation in response to the COVID-19 pandemic, we urge you to include additional support for our nation’s first responders who work in some of the highest risk occupations for COVID-19 exposure.[i] First responders are routinely in physical contact with potentially infected persons and are facing unprecedented volumes of dispatch calls in severely impacted areas.[ii]
A short supply of personal protective equipment (PPE) for first responders to guard against disease exposure has left many police officers, firefighters, and EMS personnel exposed to the dangers of this crisis. This has resulted in too many first responders across our nation contracting COVID-19 and being forced to self-quarantine, which has led to staffing shortages.[iii] As of April 1, more than 1,400 New York City Police Department employees have contracted COVID-19, with 6,100 in total in quarantine, and 282 New York City Fire Department employees have contracted COVID-19, with 950 in total in quarantine.[iv] While New York City is the current epicenter of the U.S. outbreak, many other cities and states with developing outbreaks such as New Jersey, Florida, Detroit, Seattle, Washington D.C., and several additional states and cities across the nation[v] have reported a significant number of first responders contracting COVID-19 or requiring self-quarantine.
As this outbreak continues, many more first responders will undoubtedly contract COVID-19 or be forced to self-quarantine. To support our nation’s police officers, firefighters, and EMS personnel serving on the front lines of this pandemic, we urge action on the below items.
- Bolster Assistance to Firefighter Grant, Staffing for Adequate Fire and Emergency Response (SAFER), and Department of Justice grant funding, including for the Community Oriented Policing Services program, so that state and local police, fire, and EMS departments can access resources to purchase and be reimbursed for PPE and other COVID-19 related expenses, recruit and retain employees and volunteers, and cover overtime, backfill costs, authorized hazard pay, and COVID-19-related paid sick leave during the crisis.
- Require that the Secretary of the Department of Homeland Security waive the cost share and maintenance of expenditure requirements for Assistance to Firefighter Grants for reimbursement of COVID-19-related expenses through FY21.
- Require that the Secretary of the Department of Homeland Security grant waivers to SAFER grant recipients for employee retention to aid staffing shortages through FY21. In addition, any legislation should retroactively require that the Secretary grant such waivers for FY19 and FY20 SAFER funds.
- Waive the prohibition on hazard pay for federal firefighters under 5 U.S.C. §?5545b(d)(1) for purposes of COVID-19 response, provide funding to federal agencies sufficient to cover hazard pay to frontline federal firefighters and law enforcement officers when appropriate, extend overtime pay to U.S. Probation Officers, and waive the federal firefighter and law enforcement officer overtime cap under 5 U.S.C. §?5547.
- Address the gap in paid sick leave coverage for first responders by requiring that the employing agency, not the employee, provide up to 80 hours of paid sick leave should these departments order the employee to self-quarantine in accordance with Centers for Disease Control and Prevention guidelines due to potential COVID-19 exposure.
- Create a presumption in the Public Safety Officers’ Benefits Program that a public safety officer’s infection of COVID-19 resulted from their employment to clearly establish eligibility for benefits due to the pandemic.
- Prevent the taxation of state and local incentives for volunteer firefighters and EMS personnel beyond 2020 in order to help departments continue to recruit and retain volunteer personnel.
During a time of crisis, communities rely on local first responders as the first line of defense for protection and emergency response. As you continue to develop further legislation in response to the COVID-19 pandemic, we urge you to include the above items so that our nation’s first responders can operate at full capacity as we fight the COVID-19 pandemic.
Sincerely,
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Amid COVID-19, Warner, Alexander Introduce Legislation to Help Rural Hospitals Stay Open
May 08 2020
WASHINGTON – U.S. Sens. Mark R. Warner (D-VA) and Lamar Alexander (R-TN) introduced bipartisan legislation to ensure rural hospitals in Virginia can keep up with the cost of providing care amid the novel coronavirus (COVID-19) outbreak. The Fair Medicare Hospital Payments Act would help curb the trend of hospital closures in rural areas by making sure hospitals are fairly reimbursed for their services by the federal government. This legislation comes at a crucial time as hospitals in Virginia continue to lose needed revenue despite playing an essential role in serving their communities and providing lifesaving care during the biggest public health crisis in a century.
“The current payment policy has long placed some of Virginia’s most rural hospitals at a disadvantage and made it more difficult to provide quality care in communities that need it most,” said Sen. Warner. “The COVID-19 public health emergency has made it more important than ever to do everything we can to support our rural hospitals and this legislation is absolutely critical in doing that.”
“Last year, the Trump Administration updated the formula that determines how much Medicare will reimburse hospitals for patient care, taking into account, among other things, the cost of labor in that geographic area – called the Medicare Area Wage Index. And because of this change, Alan Levine, who leads Ballad, announced a $10 million investment in pay increases to nurses. However, these changes are temporary and will expire in three years, and many hospitals are concerned that hospital reimbursements could revert to the lower rates,” said Sen. Alexander. “Given COVID-19 impacts on rural hospitals, any changes that lower reimbursement would have significant impact. Tennessee has the second highest rate of hospitals closures in the country, with 13 hospitals having closed since 2010, and this is, in large part, due to lower reimbursements. This legislation will help keep up with the cost of providing care and help curb the trend of Tennessee rural hospital closures by setting an appropriate national minimum for the Medicare Area Wage Index.”
The Medicare Area Wage Index, a formula used by Medicare to reimburse hospitals, is much lower for states like Virginia and Tennessee, due to the fact that the formula is based on labor costs, which vary across the country. This flawed formula often results in disproportionately low Medicare reimbursement payments to hospitals in rural and low-wage areas.
Specifically, the legislation would establish an appropriate national minimum (0.85) for the Medicare Area Wage Index and ensure that rural hospitals are paid for the care they provide, while preserving the existing reimbursements for urban hospitals. This legislation would also help ensure fairness in reimbursements for hospitals across the country – including the many hospitals that are facing closures in rural areas – and fix severe and disproportionate disadvantages that unfairly penalize hundreds of communities and hospitals across the United States.
At a minimum, 14 Virginia hospitals would benefit from this legislation, with the number of beneficiaries growing in future years. The 14 hospitals that would immediately benefit include:
|
Locality: |
Hospital: |
|
Buchanan County |
Buchanan General Hospital |
|
Franklin |
Southampton Memorial Hospital |
|
Galax |
Twin County Regional Hospital |
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Halifax County |
Sentara Halifax Regional Hospital |
|
Mecklenburg County |
Community Memorial Hospital |
|
Norton |
Norton Community Hospital |
|
Pulaski County |
Lewisgale Hospital Pulaski |
|
Russell County |
Russell County Hospital |
|
Smyth County |
Smyth County Community Hospital |
|
Tazewell County |
Clinch Valley Medical Center |
|
Tazewell County |
Carilion Tazewell Community Hospital |
|
Washington County |
Johnston Memorial Hospital |
|
Wise County |
Lonesome Pine Hospital |
|
Wythe County |
Wythe County Community Hospital |
According to the American Hospital Association, Medicare accounts for about 43 percent of reimbursements for hospitals nationally, underscoring the role that Medicare payments play in keeping hospitals open and functioning – particularly in Virginia’s underserved and economically-struggling regions.
In addition to Sens. Warner and Alexander, the legislation was introduced by Sens. John Cornyn (R-TX), Doug Jones (D-AL), Marsha Blackburn (R-TN), Tim Kaine (D-VA), David Perdue (R-GA) and Richard Shelby (R-AL).
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Warner, Colleagues Urge Trump to Immediately Use DPA to Manufacture PPE, COVID-19 Testing Supplies
May 07 2020
WASHINGTON – Today, U.S. Sen. Mark R. Warner (D-VA) joined Sen. Chris Van Hollen (D-MD) and seven of their Senate colleagues in urging the President to expand his use of Title III of the Defense Production Act (DPA) in order to dramatically increase domestic production capacity for personal protective equipment (PPE) and COVID-19 testing supplies.
“An analysis by Harvard University researchers found that the United States must, at minimum and under the best-case scenario, double the number of tests being conducted each week,” wrote the Senators. “In many cases, even when state and local governments are able to get some supplies into the hands of their frontline medical personnel, they go unused because of shortages in other key supplies.”
They continued, “Congress appropriated $57.6 billion to address critical needs such as these, including $16 billion to purchase medical supplies for distribution through the Strategic National Stockpile and at least $11 billion to support efforts to expand testing by states, localities, and tribes. But it is clear that these widespread shortages will not be fully resolved until the nation’s production capacity can be dramatically scaled up, and despite unprecedented global demand, private sector companies have been reticent to expand production capacity without support and direction from the federal government. For that reason, is imperative that the federal government fully use its authority to support and expand production of PPE and testing supplies.”
Section 301 and 302 of Title III authorize the President to reduce current or projected shortfalls of industrial resources, critical technology items, or essential materials needed for national defense purposes. Meanwhile, Section 303 gives the President the authority to create, maintain, protect, expand, or restore domestic industrial base capacity, which includes purchasing or making purchase commitments of industrial resources or critical technology items, making subsidy payments for domestically produced materials, and installing and purchasing equipment for government and privately-owned industrial facilities to expand their production capacity.
In their letter, the Senators note that Title III has only been used twice by the government to respond to this health crisis and urge the President to immediately expand production and deliveries of PPE and testing supplies by using Title III of the Defense Production Act and any other appropriate authority.
Sen. Warner has long called for an increase in testing and PPE production in the Commonwealth. In March, he joined his colleagues in introducing the Free COVID-19 Testing Act, legislation that would expand free tests to confirm coronavirus (COVID-19) infections. He has also introduced legislation to require the president to utilize all available authorities under the Defense Production Act to mobilize a federal response to the pandemic through an equitable and transparent process. Additionally, he has pressed the Administration to outline how it plans to use Defense Production Act powers to increase production of testing supplies and equipment needed for the pandemic response.
Joining Sens. Warner and Van Hollen on the letter are Sens. Angus King (I-ME), Gary Peters (D-MI), Kamala Harris (D-CA), Mazie Hirono (D-HI, Patrick Leahy (D-VT), Debbie Stabenow (D-MI), and Jack Reed (D-RI).
The full text of the letter is available here and below.
Dear President Trump:
We write in response to the release of your administration’s blueprint for State testing plans and rapid response programs to urge you to broaden your use of Title III of the Defense Production Act (DPA) and other appropriate authorities to expand domestic production capacity for personal protective equipment (PPE) and COVID-19 testing supplies.
On April 27, you announced that your administration had “successfully scaled a robust testing regime that is able to meet the massive needs of a nationwide pandemic.” On the same day, an analysis by Harvard University researchers found that the United States must, at minimum and under the best-case scenario, double the number of tests being conducted each week. Nationwide shortages continue to prevent the United States from conducting enough tests to safely reopen.
In many cases, even when state and local governments are able to get some supplies into the hands of their frontline medical personnel, they go unused because of shortages in other key supplies. In Maryland, for example, the state has secured a large number of testing kits, but the kits cannot be used without the necessary swabs and viral transport media—both of which have been in short supply.
Similarly, the nation continues to face critical shortages of PPE. This has led to dangerous rationing and efforts by medical providers to disinfect, reuse, or fashion their own equipment. Reports from across the country paint a bleak picture: staff at the Henry Ford Health System in Michigan made their own face shields using plastic sheets, elastic bands, and tongue depressors. Providence Health in Washington did the same using supplies from Home Depot. Elsewhere, medical staff are soliciting donations of homemade cloth masks and constructing makeshift decontamination systems to reuse their PPE.
Before any state in the country can reopen responsibly, PPE and testing needs must be met. Congress appropriated $57.6 billion to address critical needs such as these, including $16 billion to purchase medical supplies for distribution through the Strategic National Stockpile and at least $11 billion to support efforts to expand testing by states, localities, and tribes. But it is clear that these widespread shortages will not be fully resolved until the nation’s production capacity can be dramatically scaled up, and despite unprecedented global demand, private sector companies have been reticent to expand production capacity without support and direction from the federal government. For that reason, is imperative that the federal government fully use its authority to support and expand production of PPE and testing supplies.
Section 301 and 302 of Title III authorize you to issue loan guarantees and direct loans to reduce current or projected shortfalls of industrial resources, critical technology items, or essential materials needed for national defense purposes. Section 303 grants you a range of authorities to create, maintain, protect, expand, or restore domestic industrial base capacity. These include purchasing or making purchase commitments of industrial resources or critical technology items, making subsidy payments for domestically produced materials, and installing and purchasing equipment for government and privately owned industrial facilities to expand their production capacity. In short, these authorities allow you to provide a company the financing and equipment they need to expand their production capacity and guarantee a buyer for their products once that capacity comes online.
As part of the CARES Act, Congress appropriated $1 billion for the primary purpose of expanding domestic production of medical supplies to respond to COVID-19. We appreciated your executive order on March 27, 2020 to delegate authority to the Secretaries of Health and Human Services and Homeland Security, allowing each to make use of DPA Title III to expand production capacity. However, to date, Title III has been used just twice as part of the government’s response to the COVID-19 pandemic. On April 11, 2020, the Department of Defense announced that it would use Title III to secure a $133 million investment resulting in the production of 39 million additional N95 masks. On April 29, DOD announced a Title III award to expand the production of swabs by Puritan Medical Supplies in Maine.
These measures are totally inadequate to meeting the challenge we face. This crisis requires faster, more coordinated action to limit loss of life in the near term and over the next year. We urge you to act immediately to expand production and deliveries of PPE and testing supplies using Title III of the Defense Production Act and any other appropriate authority.
Sincerely,
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The bipartisan group of Senators wrote to the Cybersecurity and Infrastructure Security Agency (CISA) and United States Cyber Command after reports that Russia, China, Iran, North Korea, and criminal groups have launched hacking campaigns targeting the U.S. health care and medical research sectors in recent weeks. These malicious campaigns included ransomware attacks hitting hospitals, disinformation about health related to COVID-19, and spying on U.S. medical response and research.
“[O]ur country’s healthcare, public health, and research sectors are facing an unprecedented and perilous campaign of sophisticated hacking operations from state and criminal actors amid the coronavirus pandemic,” wrote the Senators in a letter to CISA Director Christopher Krebs and Cyber Command Commander Paul Nakasone. “Disinformation, disabled computers, and disrupted communications due to ransomware, denial of service attacks, and intrusions means critical lost time and diverted resources. During this moment of national crisis, the cybersecurity and digital resilience of our healthcare, public health, and research sectors are literally matters of life-or-death.”
The Senators urged the agencies to make cyber threat information public to enable better defensive efforts, as well as raise public alarm and issue statements putting adversaries on notice. The Senators also called on the agencies to provide technical assistance to help states in their cybersecurity efforts, convene stakeholders in the medical sector to make sure they have the necessary resources, and engage in deterrence actions as necessary.
The full text of the letter is available here and copied below.
Dear Mr. Krebs and General Nakasone,
We write to raise our profound concerns that our country’s healthcare, public health, and research sectors are facing an unprecedented and perilous campaign of sophisticated hacking operations from state and criminal actors amid the coronavirus pandemic. These hacking attempts pose an alarming risk of disrupting or undermining our public health response at this time of crisis. We write to urge the Cybersecurity and Infrastructure Security Agency (CISA), in coordination with United States Cyber Command, and its partners to issue guidance to the health care sector, convene stakeholders, provide technical resources, and take necessary measures to deter our adversaries in response to these threats.
In recent weeks, Russian, Chinese, Iranian, and North Korean hacking operations have targeted the health care sector and used the coronavirus as a lure in their campaigns. In March, the cyber security firm FireEye reported that a Chinese hacking group, APT41, carried out one of the broadest hacking campaigns from China in recent years, beginning at the onset of the pandemic.[1] According to researchers, APT41 is a sophisticated Chinese state sponsored group that specializes in espionage against healthcare, high-tech, and political interests.[2] This latest campaign sought to exploit several recent vulnerabilities in commonplace networking equipment, cloud software, and office IT management tools—the same systems that we are now more reliant on for telework and telehealth during this pandemic. Included in the new Chinese espionage campaign are the healthcare and pharmaceutical nonprofits and companies bracing to respond to the coronavirus. APT41’s campaign also appears to reflect a broader escalation from Chinese groups in recent weeks.[3]
China is not alone in exploiting the coronavirus pandemic against our interests. Russian, Iranian, and North Korean government hackers have reportedly targeted international health organizations and the public health institutions of U.S. allies.[4] Additionally, the State Department has identified disinformation operations from Russia, Iran, and China that sought to spread false information about coronavirus to undermine the nation’s response to the pandemic.[5] Unless we take forceful action to deny our adversaries success and deter them from further exploiting this crisis, we will be inviting further aggression from them and others.
The cybersecurity threat to our stretched and stressed medical and public health systems should not be ignored. Prior to the pandemic, hospitals had already struggled to defend themselves against an onslaught of ransomware and data breaches. Our hospitals are dependent on electronic health records, email, and internal networks that often heavily rely on legacy equipment. Even a minor technical issue with the email services of the Department of Health and Human Services meaningfully frustrated efforts to coordinate the federal government’s service.[6] Disinformation, disabled computers, and disrupted communications due to ransomware, denial of service attacks, and intrusions means critical lost time and diverted resources. During this moment of national crisis, the cybersecurity and digital resilience of our healthcare, public health, and research sectors are literally matters of life-or-death.
The Cybersecurity and Infrastructure Security Agency and Cyber Command are on the frontlines of our response to cybersecurity threats to our critical infrastructure. Hospitals, medical researchers, and other health institutions need the expertise and resources your agencies have developed defending against these same sophisticated threats. We urge you to take all necessary measures to protect these institutions during the coronavirus pandemic, including:
1.) Provide private and public cyber threat intelligence information, such as indicators of compromise (IOCs), on attacks against the healthcare, public health, and research sectors, including malware and ransomware.
2.) Coordinate with the Department of Health and Human Services, the Federal Trade Commission, and the Federal Bureau of Investigation on efforts to increase public awareness on cyberespionage, cybercrime, and disinformation targeting employees and consumers, especially as increased telework poses new risks to companies.
3.) Provide threat assessments, resources, and additional guidance to the National Guard Bureau to ensure that personnel supporting state public health departments and other local emergency management agencies are prepared to defend critical infrastructure from cybersecurity breaches.
4.) Convene and consult partners in the healthcare, public health, and research sectors, including its government and private healthcare councils, on what resources and information are needed to reinforce efforts to defend healthcare IT systems, such as vulnerability detection tools and threat hunting.
5.) Consider issuing public statements regarding hacking operations and disinformation related to the coronavirus for public awareness and to put adversaries on notice, similar to the joint statement on election inference issued on March 2nd.
6.) Evaluate further necessary action to defend forward in order to detect and deter attempts to intrude, exploit, and interfere with the healthcare, public health, and research sectors.
We stand ready to work with you to provide any further resources necessary in this effort. Thank you for your attention to this urgent matter.
Sincerely,
###
WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA), Tim Kaine (D-VA), Michael Bennet (D-CO), Sherrod Brown (D-OH), and Jack Reed (D-RI) sent a letter to the U.S. Department of Veterans Affairs (VA) pushing for more information regarding the personal protective equipment (PPE) available to its employees at hospitals, clinics and other facilities during the COVID-19 health crisis, as well as whether the Centers for Disease Control (CDC) guidelines are sufficient enough to protect its employees. The Senators are raising the alarm following reporting that indicates a serious shortage of PPE at VA facilities across the country, directly contradicting VA leadership’s claim that they have enough PPE at their facilities. In addition, the Senators have heard directly from their constituents who are VA facility employees concerned for their well-being while on-the-job.
“We write to request information about the use of personal protective equipment (PPE) by Department of Veterans Affairs (VA) employees at hospitals, clinics, and other facilities, and whether the VA’s guidance to its employees, based on guidelines from the Centers for Disease Control and Prevention (CDC), is sufficiently robust in safeguarding staff. With more than 1,600 positive COVID-19 cases among VA staff nationwide, and more than a dozen employee deaths, the Department must take every possible action to protect staff and veterans,” the Senators wrote in a letter to VA Secretary Robert Wilkie.
According to the VA, they have instructed their employees to adhere to the CDC guidelines, which allows for the reuse of single-use masks for multiple days, as well as the ability to disinfect and reuse those masks. However, some VA staff who are not interacting directly with COVID-19 patients are working without PPE.
“The Wall Street Journal reports that VA internal memos caution that a ‘serious shortage’ of PPE masks exists and rationing may be reduced to one mask per day for providers. Additional Wall Street Journal reporting suggests that the Department has only a two-week PPE supply and workers must use the same mask as they move from patient to patient. We have also heard from a number of our constituents who are employees at VA facilities, who think they are not being provided adequate PPE in their jobs and fear for their personal health and safety. Employees report being asked to use one N95 mask for up to a week, which manufacturers recommend be changed each shift at a minimum. These employees report that they are being asked to store surgical or procedural masks in paper bags, and that some masks begin disintegrating after too many days of use,” they continued.
In their letter, the Senators underscored the need for VA medical facility staff, as well as clinical and administrative employees, to have the appropriate PPE to protect their health and the health of the veterans they serve during the current health crisis. Following recent reporting that some VA employees are being penalized for following guidance from public health authorities, the Senators are also calling on the VA to allow flexibility for their employees by providing administrative leave if required to self-quarantine.
Additionally, the Senators requested answers to the following questions:
- Are VA healthcare providers using the same PPE for multiple encounters with patients, even though these devices are not approved by the Food and Drug Administration for reuse?
- How many medical facilities have instituted PPE rationing processes that require providers to use single-use PPE for multiple patients?
- How often are employees being provided new PPE, including masks, at these facilities?
- Are VA facilities relying on CDC guidance regarding the extended use of PPE to modify standards, ration equipment, or determine that adequate PPE supplies exist?
- If single-use masks are used for multiple patients, what procedures are in place to protect both provider and patient health?
- What is the maximum number of patients that providers are permitted to care for while using the same single-use PPE?
- If sufficient essential supplies are present, do providers need to reuse single-use PPE or use PPE for extended periods?
- If single-use PPE must be reused, what methods for decontamination and reuse are being followed?
- Of the $14.4 billion included in the CARES Act for PPE, please provide us with a breakdown of how much has VA spent on PPE supplies and equipment. And if additional funding is required, has Congress been explicitly notified of this need?
- Have multiple-use face masks or other alternatives designed for routine decontamination been considered instead of single-use PPE?
- If PPE levels are not sufficient, what is the VA’s plan to ensure large-scale national-level PPE purchases and distribution to facilities in-need?
A copy of the letter can be found here and below.
The Honorable Robert Wilkie
Secretary of Veterans Affairs
U.S. Department of Veterans Affairs
810 Vermont Avenue NW
Washington, D.C. 20420
Dear Secretary Wilkie:
We write to request information about the use of personal protective equipment (PPE) by Department of Veterans Affairs (VA) employees at hospitals, clinics, and other facilities, and whether the VA’s guidance to its employees, based on guidelines from the Centers for Disease Control and Prevention (CDC), is sufficiently robust in safeguarding staff. With more than 1,600 positive COVID-19 cases among VA staff nationwide, and more than a dozen employee deaths, the Department must take every possible action to protect staff and veterans.
We understand from media reports, as well as discussions with VA employees and leadership, that the VA is adhering to CDC guidelines, which allows for the reuse of single-use masks for multiple days, disinfecting and reusing masks, and no masks for some staff who are not interacting directly with COVID-19 patients. VA leadership has asserted that they have enough PPE at their facilities and that their employees have access to the necessary PPE, given these guidelines. We are concerned that this guidance may be driven not by best practices for VA staff and patients, but by PPE shortages throughout the system.
The Wall Street Journal reports that VA internal memos caution that a “serious shortage” of PPE masks exists and rationing may be reduced to one mask per day for providers. Additional Wall Street Journal reporting suggests that the Department has only a two-week PPE supply and workers must use the same mask as they move from patient to patient. We have also heard from a number of our constituents who are employees at VA facilities, who think they are not being provided adequate PPE in their jobs and fear for their personal health and safety. Employees report being asked to use one N95 mask for up to a week, which manufacturers recommend be changed each shift at a minimum. These employees report that they are being asked to store surgical or procedural masks in paper bags, and that some masks begin disintegrating after too many days of use.
In addition, Government Executive recently reported that some VA medical facility staff are not permitted to wear masks. A medical support assistant was placed on absent without leave status when she stayed home with symptoms consistent with COVID-19 while waiting several weeks for test results. Upon being able to return to work she was prohibited from wearing a mask until the VA later provided one mask per week.
Ensuring that VA medical facility staff, as well as clinical and administrative employees, have the appropriate PPE to protect their health and the health of the veterans they serve is essential to countering the pandemic. Additionally, when staff take the appropriate steps to self-quarantine, VA should provide them with administrative leave and not require them to deplete their own sick leave bank.
To ensure VA staff are protected and that transparent information is available about PPE supplies, we ask that you provide a response to the following questions:
- Are VA healthcare providers using the same PPE for multiple encounters with patients, even though these devices are not approved by the Food and Drug Administration for reuse?
- How many medical facilities have instituted PPE rationing processes that require providers to use single-use PPE for multiple patients?
- How often are employees being provided new PPE, including masks, at these facilities?
- Are VA facilities relying on CDC guidance regarding the extended use of PPE to modify standards, ration equipment, or determine that adequate PPE supplies exist?
- If single-use masks are used for multiple patients, what procedures are in place to protect both provider and patient health?
- What is the maximum number of patients that providers are permitted to care for while using the same single-use PPE?
- If sufficient essential supplies are present, do providers need to reuse single-use PPE or use PPE for extended periods?
- If single-use PPE must be reused, what methods for decontamination and reuse are being followed?
- Of the $14.4 billion included in the CARES Act for PPE, please provide us with a breakdown of how much has VA spent on PPE supplies and equipment. And if additional funding is required, has Congress been explicitly notified of this need?
- Have multiple-use face masks or other alternatives designed for routine decontamination been considered instead of single-use PPE?
- If PPE levels are not sufficient, what is the VA’s plan to ensure large-scale national-level PPE purchases and distribution to facilities in-need?
We ask that you take all necessary steps to ensure that VA employees have the resources and guidance required for their safety and the safety of our veterans. We stand ready to help and appreciate your candor and consideration.
Sincerely,
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WASHINGTON – U.S. Sens. Mark R. Warner (D-VA) and Tim Scott (R-SC) are calling to protect at-risk Medicare beneficiaries and ensure access to potentially life-saving services by allowing for the full participation of CDC-recognized virtual suppliers in the Medicare Diabetes Prevention Program (MDPP) for at least the duration of the COVID-19 emergency.
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Warner, Durbin, Senators Press for Robust Federal COBRA Subsidies in the Next COVID-19 Legislation
Apr 17 2020
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) joined Sen. Dick Durbin (D-IL) and 16 Senators in a letter to Senate Majority Leader Mitch McConnell (R-KY) and Senate Democratic Leader Chuck Schumer (D-NY) to ensure that any forthcoming COVID-19 legislation includes robust federal subsidies so that individuals who lose their job as a result of this pandemic can maintain their employer-sponsored health coverage.
One option for Americans who lose their jobs, or drop below the hours necessary to be eligible for employer-sponsored health coverage, is COBRA. COBRA allows people to keep the employer-sponsored coverage that they selected for up to 18 months. However, instead of having employers contribute to the premium costs, individuals are responsible for having to pay the full insurance premium themselves—an average of $1,700 a month for a family plan—which is often unaffordable for those newly unemployed. In today’s letter, the Senators called on Congress to craft a bill that provides a robust federal COBRA premium subsidy for individuals who would otherwise lose their employer-sponsored coverage as a result of the COVID-19 pandemic.
“Allowing families to maintain the coverage they previously selected will help ensure continuity of care and limit disruption for both families and employers as our economy gets back on track,” the Senators wrote. “We stand ready and eager to work with you to ensure that the next COVID-19 relief package includes this important policy, which will ensure that millions of people losing their jobs as a result of this pandemic will not also suddenly become uninsured and at risk for catastrophic health care costs.”
In the U.S., over half of Americans receive their health coverage through their employer. Depending on the extent of unemployment as a result of the coronavirus pandemic, between 23 to 35 million workers could end up losing their employer-based health care coverage.
Along with Durbin, today’s letter is also signed by Senators Amy Klobuchar (D-MN), Tom Carper (D-DE), Jeanne Shaheen (D-NH), Sherrod Brown (D-OH), Jacky Rosen (D-NV), Catherine Cortez Masto (D-NV), Bob Menendez (D-NJ), Jack Reed (D-RI), Doug Jones (D-AL), Jeff Merkley (D-OR), Dianne Feinstein (D-CA), Michael Bennet (D-CO), Tammy Duckworth (D-IL), Debbie Stabenow (D-MI), Richard Blumenthal (D-CT), and Brian Schatz (D-HI).
Full text of the letter is available here and below:
Thank you for your efforts to date to ensure swift passage of multiple bipartisan pieces of legislation vital to helping our nation’s families, health care providers, and small businesses cope with the ongoing COVID-19 pandemic. Looking forward, we recognize that additional legislation will be necessary to improve the public health and America’s ailing economy. To that end, we strongly urge you to ensure that any forthcoming COVID-19 package include robust federal subsidies so that individuals can maintain on their employer-sponsored health coverage when they lose their jobs.
Over the last three weeks, approximately seventeen million people have filed unemployment claims in their state. However, this unprecedented number of filings only reflects claims filed through April 4. Many more Americans are likely out of work, or soon will be, because of the COVID-19 pandemic. Forecasters predict that as many as 20 million people could lose their jobs by the end of April. Compounding this problem is the fact that unemployment for these individuals and their families will also mean they will lose their existing employer-sponsored health insurance.
In the U.S., over half of Americans receive their health coverage through their employer. Of the seventeen million Americans who have recently lost their jobs due to COVID-19, it is estimated that more than six million of these individuals have also lost their employer-sponsored health care. Depending on the extent of unemployment, between 23 to 35 million workers could lose their coverage.
One option for Americans who lose their jobs, or drop below the hours necessary to be eligible for employer-sponsored health coverage, is COBRA. COBRA allows people to keep the employer-sponsored coverage that they selected for up to 18 months. However, people have to pay the full insurance premium—an average of $1,700 a month for a family plan—which is often unaffordable for those newly unemployed. Congress must step in and assist these individuals and families.
Following the 2008 financial crisis, the American Recovery and Reinvestment Act of 2009 (ARRA) was signed into law, which made COBRA continuation coverage more affordable and accessible to those who unexpectedly became unemployed. The law offered a 65 percent COBRA premium subsidy to individuals from September 1, 2008 to May 31, 2010. While well-intentioned and helpful to some, many individuals were unable to participate in the program because the remaining 35 percent insurance costs were still too expensive for them to cover.
We have heard from our constituents, as we know you have too. They are in dire economic circumstances. Despite government relief—in the form of extending monthly bill deadlines and increasing unemployment insurance—it will not be enough for most Americans to continue affording the health insurance policy they and their families elected through their employer’s plan. Allowing families to maintain the coverage they previously selected will help ensure continuity of care and limit disruption for both families and employers as our economy gets back on track. In order to provide our constituents adequate relief and to improve upon ARRA’s COBRA provision, we believe Congress must craft a bill that provides a robust federal COBRA premium subsidy for individuals who would otherwise lose their employer-sponsored coverage as a result of the COVID-19 pandemic.
We stand ready and eager to work with you to ensure that the next COVID-19 relief package includes this important policy, which will ensure that millions of people losing their jobs as a result of this pandemic will not also suddenly become uninsured and at risk for catastrophic health care costs.
Sincerely,
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WASHINGTON – Following concerns about worker safety in Virginia, U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) joined Senator Tammy Baldwin and 32 of their Senate colleagues in a letter to Senate Majority Leader Mitch McConnell and Democratic Leader Chuck Schumer calling for any future coronavirus response legislation to include a requirement that the Occupational Safety and Health Administration (OSHA) issue an Emergency TemporaryStandard (ETS) to guarantee protections for all essential workers.
“We write to request that any future COVID-19 pandemic legislation include language that ensures proper training and protection for workers on the front lines fighting this virus, and those working to provide the essential supplies and services for all of us during these unprecedented times. The single best way to do this is to require the Occupational Safety and Health Administration (OSHA) to issue an Emergency Temporary Standard (ETS) requiring employers to develop and implement a comprehensive plan to protect their workers. We feel strongly that employees need enforceable standards in place to be safe at work and for those they serve to be safe as well,” wrote the Senators in their letter to Senate leadership.
An ETS from OSHA would require all employers nationwide to implement a comprehensive plan to ensure proper training and protections for those workers who must continue going to work during the pandemic, including with personal protective equipment and access to hand sanitizer or adequate facilities to wash their hands.
“Millions of Americans are bravely going to work every day, helping in the direct response to COVID-19 and providing essential services to keep our country running. These frontline workers are doctors, nurses, and health care staff in our hospitals, emergency responders, grocery store workers, farmworkers, meat and poultry processing plant workers, construction workers, transit workers, and many more,” the Senators wrote. “Many of these workers are working shoulder to shoulder yet lack necessary personal protective equipment (PPE), access to hand sanitizer, or the facilities to wash their hands with warm water and soap as recommended by the Centers for Disease Control and Prevention (CDC). We feel strongly that the federal government has an obligation to protect employees during this public health emergency. There is a current lack of consistency surrounding the monitoring of symptoms, sanitation practices, social distancing, personal protective equipment standards, and communication requirements that must be addressed.”
The Senators highlighted the fact that the United Food and Commercial Workers union—which represents 1.3 million retail, food package/processing, and grocery workers—is reporting that at least 30 grocery store workers have died, and at least 3,000 have symptoms or have been exposed to COVID-19. Major meat processing companies such JBS USA in Colorado, Smithfield Foods in South Dakota, and Tysons Food Inc. in Iowa have temporarily shut down certain operations due to COVID-19 cases among employees and concerns that it may spread.
In addition to Warner, Kaine, and Baldwin, the letter was signed by Senators Tammy Duckworth (D-IL), Patty Murray (D-WA), Richard J. Durbin (D-IL), Richard Blumenthal (D-CT), Edward J. Markey (D-MA), Sherrod Brown (D-OH), Jack Reed (D-RI), Cory A. Booker (D-NJ), Robert Menendez (D-NJ), Chris Van Hollen (D-MD), Amy Klobuchar (D-MN), Robert P. Casey, Jr. (D-PA), Benjamin L. Cardin (D-MD), Elizabeth Warren (D-MA), Thomas R. Carper (D-DE), Dianne Feinstein (D-CA), Sheldon Whitehouse (D-RI), Ron Wyden (D-OR), Catherine Cortez Masto (D-NV), Kamala D. Harris (D-CA), Angus S. King, Jr. (D-ME), Jeffrey A. Merkley (D-OR), Tina Smith (D-MN), Bernard Sanders (I-VT), Kirsten Gillibrand (D-NY), Jacky Rosen (D-NV), Michael F. Bennet (D-CO), Jeanne Shaheen (D-NH), Mazie Hirono (D-HI), Maggie Hassan (D-NH), Chris Murphy (D-CT), and Gary Peters (D-MI).
The full letter is available here.
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WASHINGTON - U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) joined Sen. Elizabeth Warren to introduce the bicameral Equitable Data Collection and Disclosure on COVID-19 Act. The bill would require the Department of Health and Human Services (HHS) to collect and report racial and other demographic data on COVID-19 testing, treatment, and fatality rates, and provide a summary of the final statistics and a report to Congress within 60 days after the end of the public health emergency. It would require HHS to use all available surveillance systems to post daily updates on the CDC website showing data on testing, treatment, and fatalities, disaggregated by race, ethnicity, sex, age, socioeconomic status, disability status, county, and other demographic information.
The legislation comes as reports across the United States point to stark racial disparities in COVID-19 cases and fatalities. In Michigan, Black residents account for 33% of confirmed COVID cases and 40% of fatalities, despite making up only 14% of the state’s population. In Louisiana, 70% of those who have died from COVID-19 so far are Black, compared with 32% of the state’s population. Initial data from Boston shows that among people whose race was reported, more than 40% of people infected were Black, compared with only 25% of the population.
“It’s deeply troubling that the coronavirus is disproportionately impacting communities of color. It’s imperative that we get data to help us understand the scope of this crisis and take action to reduce racial disparities,” the Senators said.
Specifically, the Equitable Data Collection and Disclosure on COVID-19 Act would require the reporting of the following data disaggregated by race, ethnicity, sex, age, socioeconomic status, disability status, county, and other demographic information:
- Data related to COVID-19 testing, including the number of individuals tested and the number of tests that were positive.
- Data related to treatment for COVID-19, including hospitalizations and intensive care unit admissions and duration;
- Data related to COVID-19 outcomes, including fatalities.
The legislation would also authorize $50 million in funding for the CDC, state public health agencies, the Indian Health Service, and other agencies to improve their data collection infrastructure and create an inter-agency commission to make recommendations on improving data collection and transparency and responding equitably to this crisis.
The Equitable Data Collection and Disclosure on COVID-19 Act is endorsed by the National Urban League, Lawyer’s Committee on Civil Rights, Asian & Pacific Islander American Health Forum and National Action Network. In the House, the legislation is being introduced by Representative Ayanna Pressley (D-MA-07), Chair of the Congressional Black Caucus Health Braintrust Representative Robin Kelly (D-IL-02), Chair of the Congressional Black Caucus Representative Karen Bass (D-CA-37), Representative Barbara Lee (D- CA-13), and is co-sponsored by 80 of their colleagues.
Warner and Kaine also joined their colleagues in sending a letter to Vice President Pence regarding the racial health disparities among COVID-19 patients. The letter highlights racial disparities in the mortality rate of the virus, calls for disaggregated racial data in COVID-19 case reporting, asks the Administration for more information on its outreach to minority communities, and requests that COVID-19 vaccine and drug trials include diverse participants.
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Warner, Kaine Join Colleagues in Pushing for More Information, Transparency on Coronavirus Testing
Apr 13 2020
WASHINGTON – U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) joined Sen. Tina Smith (D-MN) and 43 other Senators in calling on the Coronavirus Task Force and the Federal Emergency Management Agency (FEMA) to conduct a national inventory of the coronavirus (COVID-19) diagnostic testing supply, publicly release data on testing results, and provide a detailed plan and timeline for addressing future shortages and gaps in the testing supply chain.
“Over three weeks after President Trump declared the COVID-19 outbreak a national emergency, we continue to hear from our states and Tribal Nations about the lack of supplies and testing kits to diagnose our constituents for the coronavirus,” wrote the Senators. “State departments of health, hospitals, health care providers, and first responders lack the tests and equipment—including personal protective equipment (PPE), testing swabs, and reagents—needed to conduct adequate public health surveillance to contain and stop the spread of coronavirus.
“Widespread diagnostic testing is crucial to controlling the COVID-19 outbreak. In the short term, quickly obtaining test results for hospitalized patients allows hospitals to preserve supplies of PPE and prevents unnecessary quarantines of front-line health care workers and first responders. In the long run, experts have argued that widespread testing will be needed to track and contain COVID-19 cases, allowing communities to slowly lift general social distancing restrictions without putting the public at risk.”
They continued, “We urge you to promptly develop a national, real-time, public-facing inventory of COVID-19 diagnostic tests and results. This resource will provide the transparency that our states and Tribal Nations need to anticipate the national testing supply chain and the information that the federal government needs to anticipate and proactively address any testing shortages.”
In their letter, the Senators also requested answers to the following series of questions:
- How many COVID-19 diagnostic tests are available on a daily basis, and to which states and Tribes are manufacturers sending these tests? How many of these tests screen for coronavirus antibodies?
- To which public health, academic, and commercial laboratories are COVID-19 diagnostic test manufacturers sending tests, and how many tests are being sent to these labs?
- Which laboratories—public health, academic, and commercial—can run COVID-19 diagnostic tests, and what is their daily capacity to run these tests? Please provide a breakdown of this information by lab type, test type, and state if possible.
- What is the wait time for laboratories to process and receive results for COVID-19 tests? Do providers have to wait minutes, hours, or days to receive their patients’ results?
- What supplies do America’s public health, academic, and commercial laboratories need on hand to run at full capacity to process COVID-19 tests? Which of these supplies are in shortage, and what steps is the Administration taking to expand the capacity of these supplies?
- In a March 10 interview, Secretary Azar referenced an “IT reporting system… to keep track of how many we’re testing.” What is the status of this system? What information is tracked in this system?
- Will the Task Force commit to making all collected information about testing capacity and volume publicly available with daily updates, and to release relevant information on testing results?
- Which federal agency is managing the supply chain and distribution of tests and testing supplies to states, territories, and Indian Tribes? Which official is leading the testing supply and distribution effort within that agency?
A copy of the letter is available here or below:
Vice President Michael Pence
The White House
1600 Pennsylvania Avenue N.W.
Washington, D.C. 20050
Dear Vice President Pence:
We write to urge the Coronavirus Task Force to direct the Department of Health and Human Services (HHS) and the Federal Emergency Management Agency (FEMA) to conduct a national inventory of the country’s COVID-19 diagnostic test supply, publicly release comprehensive data on testing results, and provide a detailed plan and timeline for addressing future shortages and gaps in the testing supply chain. Currently, the federal government is not meeting its responsibility to coordinate testing capacity among states and Indian Tribes and is failing to release crucial information to the public. We urge you to provide public transparency and leadership without delay.
Over three weeks after President Trump declared the COVID-19 outbreak a national emergency, we continue to hear from our states and Tribal Nations about the lack of supplies and testing kits to diagnose our constituents for the coronavirus. State departments of health, Indian Tribes, hospitals, health care providers, and first responders lack the tests and equipment—including personal protective equipment (PPE), testing swabs, and reagents—needed to conduct adequate public health surveillance to contain and stop the spread of coronavirus.
Widespread diagnostic testing is crucial to controlling the COVID-19 outbreak. In the short term, quickly obtaining test results for hospitalized patients allows hospitals to preserve supplies of PPE and prevents unnecessary quarantines of front-line health care workers and first responders. In the long run, experts have argued that widespread testing will be needed to track and contain COVID-19 cases, allowing communities to slowly lift general social distancing restrictions without putting the public at risk.
The lack of tests is reportedly forcing the administration, in concert with private actors, to funnel available supplies to certain areas. For example, Abbott Labs, which recently developed a rapid 5-minute COVID-19 diagnostic test, said it is, “working with the administration to deploy the tests to areas where they can have the greatest impact,” like COVID-19 hot spots. This may explain why, even though the Food and Drug Administration (FDA) has now issued emergency use authorizations (EUAs) for 32 COVID-19 diagnostic tests, many of our states and Tribal Nations have not seen the benefit of this rapid private-sector innovation. While it is important to provide tests for COVID-19 hot spots, tests cannot be limited to those areas. Without prompt and sufficient access to coronavirus tests, we risk exacerbating outbreaks and becoming a nation of hot spots.
Furthermore, the decentralized system of tracking tests and the corresponding lack of transparency into when and where these tests are being sent makes it challenging for our nation as a whole to systemically plan its public health response to the COVID-19 outbreak. Currently, hospitals are finding that some labs are working through significant backlogs, leaving samples untested for days or weeks, while others are able to turn results around quickly, within 24 to 48 hours. Without detailed information about the capacity and turnaround time for each lab, it is impossible to efficiently distribute testing capacity on the nationwide scale that is required by this crisis. Given the Administration’s track record of over-promising and under-delivering on testing for COVID-19, the public deserves full transparency about our national capacity for COVID-19 testing, including where tests are available, how many have been conducted, which patients have access to testing, and what the results of these tests revealed.
These persistent gaps in the availability of COVID-19 diagnostic tests and the lack of public transparency about where tests are available raise the need for a national inventory of COVID-19 diagnostic tests. The recently passed Coronavirus Aid, Relief, and Economic Security (CARES) Act granted HHS the authority to collect test results from any laboratory. Additionally, you recently wrote to hospitals asking them to report their internal test results to the Federal Emergency Management Agency (FEMA) on a daily basis, although this requirement does not apply to tests conducted by commercial and academic labs. We urge you to extend data collection efforts to commercial and academic labs, coordinate data collection between each agency, the Indian Tribes, and the states, and make the resulting information available to the public as rapidly as possible.
Specifically, this public-facing inventory should provide real-time data that answer the following questions:
- How many COVID-19 diagnostic tests are available on a daily basis, and to which states and Tribes are manufacturers sending these tests? How many of these tests screen for coronavirus antibodies?
- To which public health, academic, and commercial laboratories are COVID-19 diagnostic test manufacturers sending tests, and how many tests are being sent to these labs?
- Which laboratories—public health, academic, and commercial—can run COVID-19 diagnostic tests, and what is their daily capacity to run these tests? Please provide a breakdown of this information by lab type, test type, and state if possible.
- What is the wait time for laboratories to process and receive results for COVID-19 tests? Do providers have to wait minutes, hours, or days to receive their patients’ results?
- What supplies do America’s public health, academic, and commercial laboratories need on hand to run at full capacity to process COVID-19 tests? Which of these supplies are in shortage, and what steps is the Administration taking to expand the capacity of these supplies?
Additionally, we request answers to the following questions:
- In a March 10 interview, Secretary Azar referenced an “IT reporting system… to keep track of how many we’re testing.” What is the status of this system? What information is tracked in this system?
- Will the Task Force commit to making all collected information about testing capacity and volume publicly available with daily updates, and to release relevant information on testing results?
- Which federal agency is managing the supply chain and distribution of tests and testing supplies to states, territories, and Indian Tribes? Which official is leading the testing supply and distribution effort within that agency?
We urge you to promptly develop a national, real-time, public-facing inventory of COVID-19 diagnostic tests and results. This resource will provide the transparency that our states and Tribal Nations need to anticipate the national testing supply chain and the information that the federal government needs to anticipate and proactively address any testing shortages.
Sincerely,
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Warner Presses Trump Administration to Ensure Workers Receive Unemployment Benefits Amid COVID-19 Pandemic
Apr 13 2020
WASHINGTON – Today, U.S. Sen. Mark R. Warner (D-VA), a member of the Senate Finance Committee, joined his Senate Democratic colleagues in pressing the U.S. Department of Labor (DOL) to ensure workers Congress intended to be covered by the Pandemic Unemployment Assistance Program receive the benefits they deserve. The program, which was established in the CARES Act, is intended to make sure that individuals who would normally not qualify for unemployment benefits under state law, but are currently unemployed, unable, or unavailable to work as a direct result of the COVID-19 health crisis, are eligible to receive unemployment compensation.
“[P]arts of the guidance appear narrow or ambiguous, which could make states think they need to exclude workers who Congress clearly intended to receive unemployment compensation through the Pandemic Unemployment Assistance (PUA) program,” wrote the Senators in their letter to Secretary of Labor Eugene Scalia.
In the letter, the Senators are requesting the Department of Labor clarify its guidance pertaining to workers who have been diagnosed with COVID-19 without receiving a test, workers with COVID-19 who take time off of work, workers without child care options in summer months, workers unable to get to work due to stay-at-home orders, workers with underlying health conditions like asthma, and self-employed workers like gig workers who are unable to work due to plummeting demand for their services.
Earlier this month, Sen. Warner sent a letter to Secretary Scalia calling on the federal agency to streamline the Pandemic Unemployment Assistance (PUA) process by issuing additional, more comprehensive guidance to states so they can quickly implement the unemployment provisions in the CARES Act and ensure that gig workers are able to access unemployment benefits in the midst of the growing economic emergency. Among other recommendations, the letter called on the Department of Labor to take the lead with innovative technological solutions for administration of the PUA that states could use in order to facilitate the process and limit the need to stand up new state-level solutions.
In addition to Sen. Warner, today’s letter was led by Sen. Ron Wyden (D-OR), Minority Leader Chuck Schumer (D-NY) and co-signed by Sens. Patrick Leahy (D-VT), Sherrod Brown (D-OH), Patty Murray (D-WA), Chris Van Hollen (D-MD), Michael Bennet (D-CO), Ed Markey (D-MA), Doug Jones (D-AL), Sheldon Whitehouse (D-RI), Angus King (D-VT), Bob Menendez (D-NJ), Cory Booker (D-NJ), Ben Cardin (D-MD), Kirsten Gillibrand (D-NY), Mazie Hirono (D-HI), Amy Klobuchar (D-MN), Tom Carper (D-DE), Richard Blumenthal (D-CT), Debbie Stabenow (D-MI), Tina Smith (D-MN), Tammy Duckworth (D-IL), Bob Casey (D-PA), Elizabeth Warren (D-MA), Bernie Sanders (I-VT), Dianne Feinstein (D-CA), Dick Durbin (D-IL), Jeff Merkley (D-OR), Jack Reed (D-RI), Catherine Cortez Masto (D-NV), Jacky Rosen (D-NV), Maria Cantwell (D-WA), and Tom Udall (D-NM).
A copy of the letter can be found here and below. A list of Sen. Warner’s work to protect Americans amid the COVID-19 outbreak is available here.
The Honorable Eugene Scalia
Secretary of Labor
U.S. Department of Labor
200 Constitution Ave. NW
Washington, DC 20210
Dear Secretary Scalia:
Thank you for entering into agreements with states and territories and issuing some of the key guidance needed to implement new federal unemployment compensation programs on April 4 and April 5, 2020 (Unemployment Insurance Program Letter [UIPL] Numbers 15-20 and 16-20). This guidance is essential to start getting more unemployment benefits to workers across the country, including self-employed and other workers who are not covered by the traditional Unemployment Insurance (UI) program.
We understand that the examples of covered workers provided in the guidance are not intended to be exhaustive. However, parts of the guidance appear narrow or ambiguous, which could make states think they need to exclude workers who Congress clearly intended to receive unemployment compensation through the Pandemic Unemployment Assistance (PUA) program.
We request that the Department of Labor (the Department) issue additional guidance on the issues described below no later than Friday, April 17. Understanding that you are still working diligently to release guidance for several CARES Act programs, if you are unable to issue clarifying guidance by Friday, April 17, we request a written response to this letter providing a timeline for issuing clarifying guidance and detailing how you intend to address these issues.
- The Department’s guidance for sections 2102(a)(3)(A)(ii)(I)(aa), (bb), and (ff) reference circumstances under which an individual testing positive for COVID-19 is a possible qualification for a person receiving PUA. In the CARES Act, Congress deliberately used language referring to a “diagnosis” rather than “tested positive”, knowing testing shortages, delays in test results, and guidance instructing people to stay home rather than travel to medical facilities could make testing-based criteria difficult to meet. Furthermore, if someone suspects they have COVID-19 but can care for themselves at home, the Centers for Disease Control and Prevention (CDC) recommends they recover at home to avoid infecting others.
We are pleased that the language in the Department’s guidance says that someone may qualify for PUA if they have tested positive or received a diagnosis, but we request that the Department make crystal clear that while a positive test would be sufficient to qualify for PUA under these provisions, a qualifying diagnosis never requires a positive test. Any diagnosis from a health care provider, including one made via phone or telehealth, is also sufficient for a person to qualify for PUA.
- The two examples provided in UIPL 16-20 Attachment I (C)(1)(a) of the guidance for an individual who might qualify for unemployment benefits under section 2102(a)(3)(A)(ii)(I)(aa) of the CARES Act based on their own illness both involve an individual who must quit a job. This provision of the CARES Act also covers any individual who is forced to take unpaid time off work for the reasons described, regardless of whether their employment relationship is formally severed. The guidance should be clarified to ensure that such individuals are covered.
- Section 2102(a)(3)(A)(ii)(I)(dd) of the CARES Act says an individual may qualify for PUA if “a child or other person in the household for which the individual has primary caregiving responsibility is unable to attend school or another facility that is closed as a direct result of the COVID–19 public health emergency and such school or facility care is required for the individual to work.” The guidance in UIPL 16-20 Attachment I (C)(1)(d) provides accurate examples of situations in which a caregiver could qualify for PUA under this provision.
However, the guidance later states that “a school is not closed as a direct result of the COVID-19 public health emergency, for purposes of section 2102(a)(3)(A)(ii)(I)(dd), after the date the school year was originally scheduled to end.” Many families rely on child care, summer camp, or other facilities (including school facilities) to care for their children in the summer and those facilities may remain closed as a result of COVID-19. The guidance should be clarified to confirm that individuals may qualify under section 2102(a)(3)(A)(ii)(I)(dd) during the summer months, for families that rely on any of those facilities.
- Section 2102(a)(3)(A)(ii)(I)(ee) of the CARES Act says that an individual who is “unable to reach the place of employment because of a quarantine imposed as a direct result of the COVID–19 public health emergency” may qualify for PUA. The example of a quarantine provided in UIPL 16-20 Attachment I (C)(1)(e) of the Department’s guidance describes “a state or municipal order restricting travel” preventing an individual from getting to work. We are concerned that using the language of “restricting travel” may be too narrow to capture all of types of quarantine orders that are covered under this provision of the CARES Act. The guidance should clarify that such an order includes any stay-at-home, shelter-in-place, social distancing, or other order that requires individuals to stay home in quarantine to reduce the spread of COVID-19.
Similarly, UIPL 16-20 Attachment I (C)(1)(g) references a “state or municipal order restricting travel” with respect to section 2102(a)(3)(A)(ii)(I)(gg) of the CARES Act. This should also be clarified as described above.
- Section 2102(a)(3)(A)(ii)(I)(ff) of the CARES Act says that an individual who is “unable to reach the place of employment because the individual has been advised by a health care provider to self-quarantine due to concerns related to COVID–19” may qualify for PUA. The examples specified in the Department’s guidance describe a person who suspects they are infected with COVID-19 and a person who is immune-compromised because of a serious health condition.
The reference to a person “whose immune system is compromised by virtue of a serious health condition” in the guidance does not cover the wide range of reasons a health care provider may advise self-quarantine. For example, while the CDC considers older Americans more at risk of serious complications from COVID-19, states may not think they are covered under Department’s guidance. Furthermore, workers with certain health conditions (such as a respiratory condition) may not technically have a compromised immune system but would be at increased risk from COVID-19 and may need to self-quarantine. As we learn more about COVID-19, we may discover that there are other populations at risk too.
The Department needs to clarify that anyone advised by a health care provider to self-quarantine due to increased risk of COVID-19 should be covered by PUA, regardless of the underlying reason for their increased risk.
- We are pleased that the Secretary established additional criteria under section 2102(a)(3)(A)(ii)(I)(kk) of the CARES Act to clarify that self-employed individuals such as independent contractors who may not have one specific place of employment are covered by PUA, in keeping with the intent of the legislation. While we believe that such workers are covered by the text of the law, we appreciate the Department’s action to eliminate ambiguity and ensure these workers receive benefits.
However, to avoid any confusion about who should qualify under UIPL 16-20 Attachment I (C)(1)(k), the Department must clarify that an independent contractor who is unable to work and forced to suspend work activities because there is reduced demand for their services also qualifies for PUA benefits. Many independent contractors have seen demand for their services dry up as a direct result of COVID-19. In the example of a ride share driver, a driver should be able to claim PUA when they are forced to suspend their work because there are too few customers seeking rides. For an independent contractor, losing many or all of their customers overnight is analogous to an employee being laid off by an employer, or, as the Department’s guidance notes, their “place of employment” being closed. Congress created the PUA program with the intent to cover workers like independent contractors and gig workers who may not have traditional employment relationships, but who have suddenly lost their livelihoods during this time of crisis. We believe that that the CARES Act definitively covers such workers, and the Department should clarify its guidance to reflect this.
- The Department’s guidance says that “States should bear in mind that many of the qualifying circumstances described in section 2102(a)(3)(A)(ii)(I) are likely to be of short term duration.” Although we agree that some individuals may qualify for PUA for only a short period, many applicants will rely on PUA for longer periods, especially if this public health crisis persists. Furthermore, the way an individual qualifies for PUA may vary from week to week. For example, someone could first qualify if they get sick with COVID-19, then their child’s school may close as they recover, and they would qualify based on the new circumstance.
The Department’s guidance should encourage states to consider this as they create PUA application systems. It would be inefficient for both the claimant and the state workforce agency if individuals have to file a new initial application each time their qualifying circumstance changes. Individuals continue to qualify for benefits as long as they continue to meet at least one of the qualifying circumstances described in section 2102(a)(3)(A)(ii)(I), even if the precise provision under which they qualify changes.
- We have heard conflicting reports of whether the Department’s guidance allows for the addition of the $600 federal supplement to PUA benefits in U.S. territories that do not have UI programs. The guidance the Department has issued for Federal Pandemic Unemployment Compensation and PUA is ambiguous on this matter.
Section 2102(d) of the CARES Act says that for an individual who lives in these territories, “the assistance authorized under subsection (b) for a week of unemployment shall be calculated in accordance with section 625.6 of title 20, Code of Federal Regulations, or any successor thereto, and shall be increased by the amount of Federal Pandemic Unemployment Compensation under section 2104.” This language makes clear that the “amount of Federal Pandemic Unemployment Compensation” ($600) should be included in the PUA benefit amount for anyone qualifying for PUA in any of the territories. We would appreciate if the Department would clarify this matter to facilitate the administration and payment of benefits in these territories.
In addition to the concerns we have raised above, we know that states will have additional questions as they continue to implement PUA and other CARES Act programs. We urge the Department to respond to questions from states as quickly as possible to avoid causing any delay in the processing of benefits.
Thank you for your attention to this important matter.
Sincerely,
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Warner, Blumenthal, Eshoo Raise Concerns About Kushner Effort to Collect Americans' Health Information
Apr 10 2020
WASHINGTON – U.S. Sens. Mark R. Warner (D-VA) and Richard Blumenthal (D-CT) along with U.S. Rep. Anna Eshoo (D-CA) today sent a letter to White House Senior Advisor Jared Kushner, raising questions about reports that the White House has assembled technology and health care firms to establish a far-reaching national coronavirus surveillance system. In the letter, the members of Congress expressed concerns that the White House has not been fully transparent about the effort, particularly in light of the significant data privacy issues associated with sharing Americans’ personal health information with corporations that have a checkered history when it comes to protecting patient and user privacy.
“While we support greater efforts to track and combat the spread of COVID-19 – and have been alarmed by the notably delayed response to the crisis by this Administration – we have serious concerns with the secrecy of these efforts and their impact on the health privacy of all Americans. Your office’s denial of the existence of this effort, despite ample corroborating reporting, only compounds concerns we have with lack of transparency,” the members of Congress wrote to Mr. Kushner.
In the letter, the members noted that Health Insurance Portability and Accountability Act (HIPPA), which Congress passed in 1996, failed to foresee the recent boom in health technologies allowing medical data to be shared without patient or doctor consent, enabling companies that have previously been accused of privacy abuses to handle sensitive patient data without strong privacy protections. The reported establishment of far-reaching public health surveillance infrastructure in collaboration with large technology firms, against the backdrop of these failures of HIPAA, raises important privacy concerns.
“This growing health pandemic further exacerbates increasing concerns about the role large tech firms are starting to play in our health care sector. Health care entities are increasingly entering into secret data sharing partnerships with dominant technology platforms. These partnerships have bolstered the platforms’ ability to exploit consumer data and leverage their hold on data into nascent markets such as health analytics. Contrary to the fundamental, animating principle of HIPAA, this encroachment is occurring without the knowledge or consent of doctors or patients through opaque business agreements and exceptions. We fear that further empowering technology firms and providing unfettered access to sensitive health information during the COVID-19 pandemic could fatally undermine health privacy in the United States,” wrote the members of Congress.
Added Sen. Warner, Sen. Blumenthal and Rep. Eshoo, “Similarly, we have tragically seen that COVID-19 is following and exacerbating existing health disparities and inequalities among racial, ethnic, and socioeconomic groups. A public health surveillance system should be able capture these parameters in order to ensure our response addresses the heightened risk to these communities. Yet we must be cautious about the impact and further use of this sensitive information, which also poses fraught risk for bias and civil rights violations, as we have seen when algorithmic systems used in calculating health premiums, employment determinations, and credit evaluations have led to discriminatory outcomes.”
The members requested responses to the following questions:
- Which technology companies, data providers, and other companies have you approached to participate in the public health surveillance initiative and on what basis were they chosen?
- What measures will the Administration put into place to ensure that federal agencies and private sector partners do not misuse or reuse health data for non-pandemic-related purposes, including for training commercial algorithmic decision-making systems, and to require the disposal of data after the sunset of the national emergency? What additional steps have you taken to protect health data from their potential misuse or mishandling?
- What is the program described in the press meant to accomplish? Will it be used for the allocation of resources, symptom tracking, or contact tracing? What agency will be operating the program and which agencies will have access to the data?
- When will the federal government stop collecting and sharing health data with the private sector for the public health surveillance initiative? Will the Administration commit to a sunset period after the lifting of the national emergency?
- What measures will the Administration put into place to ensure that the public health surveillance initiative protects against misuse of sensitive information and mitigates discriminatory outcomes, such as on the basis of racial identity, sexual orientation, disability status, and income?
- Will the Administration commit to conducting an audit of data use, sharing, and security by federal agencies and private sector partners under any waivers or surveillance initiative within a short period after the end of the health emergency?
- What steps has the Administration taken under the Privacy Act, which limits the federal government's authority to collect personal data from third parties and imposes numerous other privacy safeguards?
- Will you commit to working with us to pass strong legal safeguards that ensure public health surveillance data can be effectively collected and used without compromising privacy?
Sen. Warner has previously raised concerns that enforcement of existing patient privacy law has not kept up with technological advancement when it comes to the use and sharing of confidential medical data and called for updating laws, including new protections to govern collection, processing, and retention of public health surveillance data.
A copy of the letter is available here, and the full text appears below. A list of Sen. Warner’s work to protect Americans amid the COVID-19 outbreak is available here.
April 10, 2020
Jared Kushner
Senior Advisor to the President
The White House
1600 Pennsylvania Ave NW
Washington, DC 20500
Dear Mr. Kushner:
We write you in the wake of reports that you have assembled a range of technology firms and health care providers to establish a far-reaching public health surveillance system in response to the COVID-19 pandemic. While we support greater efforts to track and combat the spread of COVID-19 – and have been alarmed by the notably delayed response to the crisis by this Administration – we have serious concerns with the secrecy of these efforts and their impact on the health privacy of all Americans. Your office’s denial of the existence of this effort, despite ample corroborating reporting, only compounds concerns we have with lack of transparency.
In response to the spread of COVID-19, the Department of Health and Human Services (HHS) has promulgated a number of guidance documents that attenuate or waive privacy protections normally attached to protected health information. Many of these measures, such as disclosure of a patient’s COVID-19 diagnosis to protect first responders, are warranted during this health emergency. However, we fear that – absent a clear commitment and improvements to our health privacy laws – these extraordinary measures could undermine the confidentiality and security of our health information and become the new status quo.
It is increasingly apparent that Health Insurance Portability and Accountability Act’s (HIPPA) Privacy and Security rules have not aged well. We have seen numerous examples of the limits of HIPAA undermining the strong protections we have come to expect of our sensitive health information. For example, there are rumors in the press that Administration is promoting a COVID-19 screening registration tool offered by Verily, which is owned by Google’s parent company Alphabet. That site is inexplicably not covered under HIPAA.
This growing health pandemic further exacerbates increasing concerns about the role large tech firms are starting to play in our health care sector. Health care entities are increasingly entering into secret data sharing partnerships with dominant technology platforms. These partnerships have bolstered the platforms’ ability to exploit consumer data and leverage their hold on data into nascent markets such as health analytics. Contrary to the fundamental, animating principle of HIPAA, this encroachment is occurring without the knowledge or consent of doctors or patients through opaque business agreements and exceptions. We fear that further empowering technology firms and providing unfettered access to sensitive health information during the COVID-19 pandemic could fatally undermine health privacy in the United States.
Given reports indicating that the Administration has solicited help from companies with checkered histories in protecting user privacy, we have serious concerns that these public health surveillance systems may serve as beachheads for far-reaching health data collection efforts that go beyond responding to the current crisis. Public health surveillance efforts must be accompanied by governance measures that provide durable privacy protections and account for any impacts on our rights. For instance, secondary uses of public health surveillance data beyond coordinating our public health response should be strictly restricted. Any secondary usage for commercial purposes should be explicitly prohibited unless authorized on a limited basis with appropriate administrative process and public input.
Similarly, we have tragically seen that COVID-19 is following and exacerbating existing health disparities and inequalities among racial, ethnic, and socioeconomic groups. A public health surveillance system should be able capture these parameters in order to ensure our response addresses the heightened risk to these communities. Yet we must be cautious about the impact and further use of this sensitive information, which also poses fraught risk for bias and civil rights violations, as we have seen when algorithmic systems used in calculating health premiums, employment determinations, and credit evaluations have led to discriminatory outcomes.
Our urgent and forceful response to COVID-19 can coexist with protecting and even bolstering our health privacy. If not appropriately addressed, these issues could lead to a breakdown in public trust that could ultimately thwart successful public health surveillance initiatives. We encourage you to think seriously about these issues. To that end, we request that you respond to the following questions we have on your current effort:
- Which technology companies, data providers, and other companies have you approached to participate in the public health surveillance initiative and on what basis were they chosen?
- What measures will the Administration put into place to ensure that federal agencies and private sector partners do not misuse or reuse health data for non-pandemic-related purposes, including for training commercial algorithmic decision-making systems, and to require the disposal of data after the sunset of the national emergency? What additional steps have you taken to protect health data from their potential misuse or mishandling?
- What is the program described in the press meant to accomplish? Will it be used for the allocation of resources, symptom tracking, or contact tracing? What agency will be operating the program and which agencies will have access to the data?
- When will the federal government stop collecting and sharing health data with the private sector for the public health surveillance initiative? Will the Administration commit to a sunset period after the lifting of the national emergency?
- What measures will the Administration put into place to ensure that the public health surveillance initiative protects against misuse of sensitive information and mitigates discriminatory outcomes, such as on the basis of racial identity, sexual orientation, disability status, and income?
- Will the Administration commit to conducting an audit of data use, sharing, and security by federal agencies and private sector partners under any waivers or surveillance initiative within a short period after the end of the health emergency?
- What steps has the Administration taken under the Privacy Act, which limits the federal government's authority to collect personal data from third parties and imposes numerous other privacy safeguards?
- Will you commit to working with us to pass strong legal safeguards that ensure public health surveillance data can be effectively collected and used without compromising privacy?
Thank you for your prompt attention and responses to these important questions.
Sincerely,
###
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) joines Sens. Gary Peters (D-MI), Maggie Hassan (D-NH), Chris Murphy (D-CT), Tim Kaine (D-VA) and the Senate Democratic Caucus in raising serious concerns about the Trump Administration’s reliance on private companies to distribute desperately needed medical supplies during the Coronavirus pandemic. Although the President has declared a national emergency and mobilized the Federal Emergency Management Agency (FEMA) to help distribute supplies, FEMA is currently relying on private companies to distribute masks, N95 respirators, gowns, gloves and other critical supplies to states, without clear guidance from the federal government on which areas or facilities should be prioritized. This practice raises serious questions about the use of taxpayer dollars, the government authorities delegated to private companies, and if their involvement could result in supplies not being delivered to the areas that need it most.
“While we agree that the existing supply chains and unique capabilities of the commercial market should be used to the greatest extent practicable, the process the task force has decided to use is, at best, opaque and inefficient,” the Senators wrote. “We are concerned that the federal government is using taxpayer dollars to bring supplies to the United States, just to have six private distributors step in and sell those very supplies to desperate states, tribes and health care systems for a profit. In the private market, states, tribes, federal agencies, hospitals, and other entities must all compete for the same supplies, where resources are allocated according to existing commercial relationships or the highest bidder instead of greatest need.”
In a letter, the Senators expressed concern that, without sufficient oversight, the Administration’s strategy for distributing medical supplies is vulnerable to waste, fraud, and abuse. Currently, only half of the supplies procured by the federal government are distributed to areas considered to be “hotspots” by medical experts, with the other half left to commercial distributors to deliver wherever they choose. Earlier this month, the Department of Defense transferred more than 5 million desperately needed N95 respirators to FEMA, which then turned them over to private companies for distribution, rather than working with state emergency management offices to coordinate delivery to localities with the greatest need. The Senators raised concerns that private businesses’ commercial interests could lead to allocation according to the highest bidder, rather than on a basis of need.
The Senators requested detailed information on how private distributors are allocating medical supplies to Coronavirus hotspots through programs like “Project Airbridge,” and how the Administration is using its authorities under the Defense Production Act to guide distribution efforts. The Senators are also seeking information on the oversight efforts conducted by FEMA – including details on how the federal government is ensuring the delivery of supplies to communities with the greatest need and the Administration’s strategy to prevent favoritism or price gouging by private companies.
Text of the letter is copied below and available here:
Vice President of the United States
- For the fifty percent of materials delivered to “hotspots,” how are private distributors allocating those medical supplies, such as those delivered to the United States through “Project Airbridge”?
a. Please provide all current state, county, and tribal priority lists that the Administration has developed for PPE and medical supplies.
b. How is a state, county, or tribe’s “need” for medical supplies determined?
c. Please describe each factor involved in any analysis for need and their relative weight in the allocation decisions, potentially including but not limited to infection rates, hospitalization rates, fatality rates, currently available medical supplies, and requests made.
d. How are the PPE needs of first responders and law enforcement being addressed in this analysis? - Why is the Administration giving supplies owned by the Department of Defense to private distributors to make decisions about where they go, instead of sending them directly to areas in need?
- Please list the distributors that are receiving supplies from medical supply acquisition efforts by the Administration, including through “Project Airbridge.” Additionally, please provide copies of any Memoranda of Understanding or similar agreements that the Supply Chain Stabilization Task Force or FEMA has executed with commercial distributors on the delivery of PPE for COVID-19 response.
- What oversight is FEMA conducting of medical supply distributions by the private sector?
a. When the Administration permits distributors to sell acquired supplies in the commercial market, how does it ensure that these distributors are not marking up prices and that they are delivering the supplies to critical hotspots?
b. How is FEMA ensuring that the commercial distributors selected are not prioritizing companies that they have existing or preferred business relationships with as opposed to those hospitals, nursing homes, or health care facilities with the greatest need?
c. How is FEMA directing PPE to areas or localities of the country that are not serviced by the commercial distributors it has selected to use?
d. How is FEMA ensuring that the distributors are not charging shipping costs for transport provided by FEMA from other countries to the United States? - How, if at all, is the Administration using the authorities granted by the Defense Production Act to direct private sector supply distribution efforts?
a. Has FEMA requested that the Department of Defense (DOD) use appropriated Defense Production Act Title III funds, authority, or expertise to expand the industrial base which could supply government and private sector PPE and other medical equipment needs in the upcoming months? If not, why not?
WASHINGTON – U.S. Sens. Mark R. Warner (D-VA) and Tim Scott (R-SC) members of the Senate Finance Committee, led a bipartisan letter to Secretary Azar and Administrator Verma encouraging both HHS and CMS to consider solutions to protect Medicare beneficiaries from high-risk settings and ensure safe access to care as we continue to work to combat COVID-19.
“As we seek additional options for protecting the lives of those most negatively affected by the pandemic, we are writing to encourage you to continue engaging with our offices and relevant stakeholders to build upon these productive steps through effective implementation, along with additional policy levers, as needed, in order to ensure that Medicare beneficiaries can access physician-administered Part B-covered infused and injectable medicines in the home setting during the COVID-19 public health emergency,” the senators wrote.
They continued, “We ask that, as you engage with patient advocates, providers, and other stakeholders, you seek out opportunities to further close remaining gaps and, as much as possible, pursue solutions that provide for continuity and consistency in care. These solutions must ensure beneficiary access to Part B drugs, provide appropriate payment for these drugs, and sufficiently reimburse for administration services rendered when provided in the home setting.”
Sens. Scott and Warner have been joined by Sens. Mike Crapo (R-ID), Tom Carper (D-DE), Pat Roberts (R-KS), Michael Bennet (D-CO), Mike Enzi (R-WY), Bob Casey (D-PA), John Cornyn (R-TX), Jeanne Shaheen (D-NH), John Thune (R-SD), Ben Cardin (D-MD), Richard Burr (R-NC), Chris Coons (D-DE), Rob Portman (R-OH), Chris Van Hollen (D-MD), Bill Cassidy (R-LA), Kyrsten Sinema (D-AZ), James Lankford (R-OK), Jon Tester (D-MT), Steve Daines (R-MT), Debbie Stabenow (D-MI), Cindy Hyde-Smith (R-MS), Maggie Hassan (D-NH), Susan Collins (R-ME), Marco Rubio (R-FL), Kelly Loeffler (R-GA), Thom Tillis (R-NC), Joni Ernst (R-IA), and Cory Gardner (R-CO).
Full text of the letter can be accessed HERE.
Statement of U.S. Senator Mark R. Warner on Senate Passage of Coronavirus Relief Legislation
Mar 25 2020
WASHINGTON – U.S. Sen. Mark R. Warner (D-VA) released the following statement after voting in favor of a $2 trillion bipartisan package to provide financial relief to businesses and families as well as hospitals and local governments during the novel coronavirus (COVID-19) pandemic:
“This is not the first step Congress has taken to deal with the COVID-19 pandemic, nor will it be the last. This bill provides significant financial relief to our families and businesses struggling with the effects of widespread closures and other public health measures. It greatly expands access to unemployment benefits – including, for the first time, gig workers, contractors and the self-employed – and includes tax credits and other incentives I negotiated with the Trump Administration to help small businesses keep workers on payroll and keep them from going out of business during this crisis. This bipartisan bill also includes a massive infusion of resources for hospitals, frontline caregivers, and states and localities dealing with the brunt of COVID-19. I strongly urge the House of Representatives to pass this bill without delay, so that we can get this urgently-required relief to those who so badly need it.
“This is a challenge unlike any we have faced in recent memory, but I believe that we as a country can and will get through this together. I will remain in close touch with state, local and health officials to ensure that we are doing everything possible to provide the resources needed to fight the coronavirus.”
Previously, the President signed a bipartisan $8.3 billion emergency funding bill that directed needed resources to federal, state and local agencies responding to coronavirus. This legislation immediately provided Virginia with $13.3 million in federal funding to help cover the costs of preparations for this public health emergency. It also included language based on Sen. Warner’s CONNECT for Health Act of 2019, which reduces restrictions on the use of telehealth for public health emergency response, as well as $500 million to facilitate its implementation.
On March 18, the President signed a second bipartisan coronavirus response bill that focused on the immediate economic impact of the coronavirus. This legislation expanded paid sick leave to many Americans, cut restrictions on unemployment insurance for workers who have lost their jobs or had their hours cut, and guaranteed freed coronavirus testing. It also included significant emergency funding for Medicaid, nutrition assistance, state unemployment programs, and coronavirus testing at Department of Veterans Affairs medical centers.
Today’s legislation provides for $1,200 in direct payments to most Americans, and includes billions of dollars in lending and grant programs designed to help businesses, workers and municipalities survive this crisis, along with strong transparency and accountability measures to make sure that federal funding doesn’t go towards stock buybacks or bonuses for corporate executives. Today’s bipartisan bill also provides for $150 billion for hospitals and other public health infrastructure, part of an unprecedented investment that Sen. Warner and other Democrats fought to include as our frontline responders struggle under the weight of the coronavirus pandemic. It also includes an important change to existing tax policy allowing employers, for the first time, to use pre-tax dollars to help pay down employees’ student debt – provision modeled after Sen. Warner’s bipartisan Employer Participation in Repayment Act.
A more comprehensive list of Sen. Warner’s work to protect Americans amid the coronavirus outbreak is available here.
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Washington, D.C. – U.S. Sen. Mark R. Warner joines Sens. Catherine Cortez Masto (D-Nev.), Senate Minority Leader Chuck Schumer (D-N.Y.), Finance Committee Ranking Member Ron Wyden (D-Ore.) and 24 Senate colleagues in calling on the Centers for Medicare & Medicaid Services (CMS) to withdraw the proposed Medicaid Fiscal Accountability Rule (MFAR), a dangerous proposal to disrupt state Medicaid financing. The rule’s complex technical changes would limit the types of financing mechanisms states can use to pay for their non-federal share of Medicaid costs. Moreover, the discretion reserved by CMS to approve or deny state proposals provides far too little clarity and certainty to states who must plan far ahead for program expenditures. Nevada hospitals have warned that it could cost the state’s hospitals between $21 million and $205 million depending on how its implemented.
In a time when state budgets are strained and Medicaid programs are set to take on new populations of unemployed Americans, this change would be devastating to providers across the country and the vulnerable low-income patients who rely on them.
The senators said in part, “We are writing to express our serious concern regarding the Centers for Medicare & Medicaid Services’ (CMS) recently proposed rule entitled, Medicaid Program; Medicaid Fiscal Accountability Regulation, 84 Fed. Reg. 63722 (Nov. 18, 2019). This proposed rule would have disastrous consequences for the Medicaid program and the millions of individuals it serves, and we request that CMS withdraw the proposed rule.”
The senators continued, “According to the National Governors Association, the proposed rule would ‘significantly curtail the longstanding flexibility states have to fund and pay for services in their Medicaid programs’ having ‘significant and broad impacts’ that will ‘result in decreased access to care for many vulnerable Americans.’”
In addition to Sens. Warner, Cortez Masto, Schumer, and Wyden, the letter was signed by Senators Sherrod Brown (D-Ohio), Robert P. Casey, Jr. (D-Pa.), Edward J. Markey (D-Mass.), Sheldon Whitehouse (D-R.I.), Angus King (I-Maine), Elizabeth Warren (D-Mass.), Maggie Hassan (D-N.H.), Tina Smith (D-Minn.), Jeanne Shaheen (D-N.H.), Dianne Feinstein (D-Calif.), Dick Durbin (D-Ill.), Debbie Stabenow (D-Mich.), Tammy Baldwin (D-Wis.), Patrick Leahy (D-Vt.), Jacky Rosen (D-Nev.), Gary Peters (D-Mich.), Richard Blumenthal (D-Conn.), Kamala Harris (D-Calif.), Ed Merkley (D-Ore.), Brian Schatz (D-Hawaii), Kirsten Gillibrand (D-N.Y.), Amy Klobuchar (D-Minn.), and Tim Kaine (D-Va.).
Full text of the letter can be found below.
Dear Administrator Verma:
We are writing to express our serious concern regarding the Centers for Medicare & Medicaid Services’ (CMS) recently proposed rule entitled, Medicaid Program; Medicaid Fiscal Accountability Regulation, 84 Fed. Reg. 63722 (Nov. 18, 2019). This proposed rule would have disastrous consequences for the Medicaid program and the millions of individuals it serves, and we request that CMS withdraw the proposed rule.
Medicaid provides comprehensive, affordable coverage for over 71 million Americans, including children, individuals living with disabilities, pregnant women, seniors, and low-income parents and adults. Ensuring the fiscal integrity of the program is vital to assuring the program can efficiently and effectively serve the millions of Americans who depend on it. Yet, this Administration continues to take actions to undermine this essential program. In addition to attempts to block grant and cap Medicaid, rescind important access protections, and promote policies that make it harder for individuals to get the health care they need, this proposed rule is yet another step in the Administration’s ongoing agenda to dismantle the financing structure of Medicaid and cut benefits, coverage, and access.
Numerous stakeholders including: the bipartisan National Governors Association; the independent Medicaid and CHIP Payment and Access Commission (MACPAC); states; providers including safety net hospitals, nursing homes, and academic medical institutions; managed care plans; children’s groups including the American Academy of Pediatrics and March of Dimes; disability advocates; groups representing millions of patients such as those with cancer and rare diseases; and the bipartisan National Association of Medicaid Directors have all expressed significant concern with the proposed rule.
According to the National Governors Association, the proposed rule would “significantly curtail the longstanding flexibility states have to fund and pay for services in their Medicaid programs” having “significant and broad impacts” that will “result in decreased access to care for many vulnerable Americans.” Organizations such as the American Hospital Association representing hospitals and providers across the country and the American Health Care Association representing nursing facilities nationwide have stated that under the rule, “[e]ntire communities could lose access to care . . . especially in rural areas where 15 percent of hospital revenue and nearly two-thirds of nursing facility revenue nationwide depend on Medicaid funding.” Groups representing patients with chronic health conditions and individuals with disabilities have said that CMS's proposed rule “will severely undermine the ability of Medicaid as a health insurer to effectively address the needs of patients,” and “make substantive changes to long-standing Medicaid policy that would jeopardize access to care for Medicaid beneficiaries with disabilities and chronic conditions.” Even the independent MACPAC, which provides policy and data analysis to Congress on a non-partisan basis, publicly expressed concern that the proposed rule “could reduce payments to providers in ways that could jeopardize access to care for Medicaid enrollees.” The Commission went further saying that “CMS should collect and rigorously examine data on the potential effects of such changes on beneficiary access,” an analysis “especially important given CMS’ previous proposal to rescind the requirement that states evaluate access before reducing or restricting provider payments.”
Such responses are representative of feedback from thousands of stakeholders who have weighed in warning of the calamitous impact CMS’s proposed Medicaid Fiscal Accountability Regulation would have on the Medicaid program, states, providers, and the millions of Americans Medicaid serves. To make matters worse, in issuing its proposed rule, the Administration failed to conduct a full fiscal impact analysis stating that the “fiscal impact on the Medicaid program from the implementation of the policies in the proposed is unknown.” This is one of the many reasons that independent organizations like MACPAC urged CMS “not to implement new limits for supplemental payments and financing arrangements at this time.” Such blatant administrative malpractice is completely unacceptable and one more item on a long list of reasons why the proposed rule must not move forward.
It is for these reasons that we request CMS withdraw the proposed Medicaid Fiscal Accountability Regulation and instead work with Congress to identify areas where additional transparency may improve efficiency, economy, and quality of care under the program to ensure the millions of American’s who rely on Medicaid for comprehensive coverage and care have access to the care and services to which they are entitled.
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WASHINGTON, D.C. – U.S. Senators Mark R. Warner and Tim Kaine joined their Democratic colleagues in a letter to President Donald J. Trump and Vice President Mike Pence demanding answers about supplies and equipment in the Strategic National Stockpile (SNS) critical to addressing the Coronavirus Disease 2019 (COVID-19) pandemic. The Senators asked the President and Vice President to confirm any relevant supply and equipment shortages in the SNS, to outline their strategy to close any such shortages, and to clarify how they plan to use Defense Production Act powers to increase production of supplies and equipment needed for the pandemic response. Senator Kaine also cosponsored legislation to expedite the procurement of medical equipment under the Defense Production Act to quickly produce and ensure access to supplies like Personal Protective Equipment (PPE) for health care workers on the frontlines of this pandemic.
“State, local, territorial, and tribal public health agencies are leading the response to the pandemic. These departments know their communities well and are making the best decisions they can to keep their citizens safe. However, our constituents working as health care providers and front line responders in hospitals, public health departments, and throughout their communities report the health care system is woefully under-resourced, especially in our rural, underserved areas and minority communities that are often overlooked. This problem is most acute with shortages of supplies and equipment that are desperately needed to test for and treat COVID-19 patients,” wrote the Senators in the letter.
The Senators continued, “Given the scale of the threat that COVID-19 poses to public health, responding to the outbreak is placing substantial strain on state, local, territorial, and tribal public health agencies’ already- limited resources. Furthermore, states and health care facilities who are trying to do as the President says and ‘get it yourself,’ find that the supply simply is not available. We urge you to be proactive and utilize the powers that you invoked on March 18, 2020, under the Defense Production Act (DPA) to mobilize private industry to manufacture the supplies and equipment needed to address this crisis.”
The Senators call on the President and Vice President to answer the following questions no later than March 24:
- What is the current status of supplies in the Strategic National Stockpile (SNS) that may be used in the COVID-19 response? Please include data on which, and the number of, pharmaceuticals, personal protective equipment, and any other medical supplies currently in the SNS that may be utilized in the response.
- What is the current nationwide status of supplies and equipment available to test for and treat COVID-19 and what is the quantity of supplies and equipment the administration has determined is necessary to fully provide states, local, and tribal organizations with what they need throughout the length of the pandemic? Please include the quantity of personal protective equipment (including N95 Respirators and Surgical Masks, gloves, gowns, face shields, eye protection), testing supplies (including reagents and swabs), and ventilators that is currently available and the quantity needed throughout the length of the pandemic.
- What is the current total nationwide COVID-19 diagnostic testing capacity for public health, commercial, and academic laboratories per day? What is your plan to increase testing capacity? When will testing capacity be sufficient to be fully responsive to the current outbreak?
- What is your plan to mobilize the private industry to manufacture supplies and equipment under the DPA and what is your timeline on invoking that power?
- What is your plan for using the MEP network to identify manufacturers with excess or idle production capacity? What are your plans for organizing MEP (Hollings Manufacturing Extension Partnership) and National Institute of Standards and Technology expertise and resources to optimize production?
The letter is available HERE and below.
March 21, 2020
Dear President Trump and Vice President Pence:
We appreciate the work that has been done so far to ensure that the states, local governments, and tribal organizations we represent in the United State Senate get the supplies and equipment they need to respond to and prepare for the Coronavirus Disease 2019 (COVID-19). On February 28, 2020, the first patient in the United States died due to COVID-19, and since then many more have died and thousands have tested positive for the virus. More widespread testing will hopefully provide a clearer picture of the true prevalence.
State, local, territorial, and tribal public health agencies are leading the response to the pandemic. These departments know their communities well and are making the best decisions they can to keep their citizens safe. However, our constituents working as health care providers and front line responders in hospitals, public health departments, and throughout their communities report the health care system is woefully under-resourced, especially in our rural, underserved areas and minority communities that are often overlooked. This problem is most acute with shortages of supplies and equipment that are desperately needed to test for and treat COVID-19 patients.
On the morning of March 16, 2020, President Trump told the nation’s governors on a phone call to get supplies themselves. Specifically, the President said, “respirators, ventilators, all of the equipment — try getting it yourselves. We will be backing you, but try getting it yourselves. Point of sales, much better, much more direct if you can get it yourself.”
Given the scale of the threat that COVID-19 poses to public health, responding to the outbreak is placing substantial strain on state, local, territorial, and tribal public health agencies’ already-limited resources. Furthermore, states and health care facilities who are trying to do as the President says and “get it yourself,” find that the supply simply is not available. We urge you to be proactive and utilize the powers that you invoked on March 18, 2020, under the Defense Production Act (DPA) to mobilize private industry to manufacture the supplies and equipment needed to address this crisis.
Additionally, the Hollings Manufacturing Extension Partnership (MEP) centers in every state and Puerto Rico represent an existing, high-quality network connecting small and medium manufacturers with technical experts to develop strategies for innovation, optimizing supply chains, and improving efficiency and productivity. Given that efficiency, productivity, and supply chain management are critical for rapidly manufacturing much-needed medical equipment, we urge that you utilize the capabilities and connections of the MEP network to expedite the search for excess manufacturing capacity.
We urge you to within 3 days, provide the members of the United States Senate and House of Representatives the answers to the following questions in a manner that does not compromise national security:
- What is the current status of supplies in the Strategic National Stockpile (SNS) that may be used in the COVID-19 response? Please include data on which, and the number of, pharmaceuticals, personal protective equipment, and any other medical supplies currently in the SNS that may be utilized in the response.
- What is the current nationwide status of supplies and equipment available to test for and treat COVID-19 and what is the quantity of supplies and equipment the administration has determined is necessary to fully provide states, local, and tribal organizations with what they need throughout the length of the pandemic? Please include the quantity of personal protective equipment (including N95 Respirators and Surgical Masks, gloves, gowns, face shields, eye protection), testing supplies (including reagents and swabs), and ventilators that is currently available and the quantity needed throughout the length of the pandemic.
- What is the current total nationwide COVID-19 diagnostic testing capacity for public health, commercial, and academic laboratories per day? What is your plan to increase testing capacity? When will testing capacity be sufficient to be fully responsive to the current outbreak?
- What is your plan to mobilize the private industry to manufacture supplies and equipment under the DPA and what is your timeline on invoking that power?
- What is your plan for using the MEP network to identify manufacturers with excess or idle production capacity? What are your plans for organizing MEP and National Institute of Standards and Technology expertise and resources to optimize production?
While Congress has provided supplemental funding for state, local, territorial, and tribal public health agencies, the need for additional support across the nation remains high. The large magnitude of this crisis requires an even larger response from our national leaders. Americans depend on this. We look forward to your prompt response.
Sincerely,
###
WASHINGTON, D.C. – U.S. Senators Mark R. Warner and Tim Kaine joined their Democratic colleagues in a letter to President Donald J. Trump and Vice President Mike Pence demanding answers about supplies and equipment in the Strategic National Stockpile (SNS) critical to addressing the Coronavirus Disease 2019 (COVID-19) pandemic. The Senators asked the President and Vice President to confirm any relevant supply and equipment shortages in the SNS, to outline their strategy to close any such shortages, and to clarify how they plan to use Defense Production Act powers to increase production of supplies and equipment needed for the pandemic response. Senator Kaine also cosponsored legislation to expedite the procurement of medical equipment under the Defense Production Act to quickly produce and ensure access to supplies like Personal Protective Equipment (PPE) for health care workers on the frontlines of this pandemic.
“State, local, territorial, and tribal public health agencies are leading the response to the pandemic. These departments know their communities well and are making the best decisions they can to keep their citizens safe. However, our constituents working as health care providers and front line responders in hospitals, public health departments, and throughout their communities report the health care system is woefully under-resourced, especially in our rural, underserved areas and minority communities that are often overlooked. This problem is most acute with shortages of supplies and equipment that are desperately needed to test for and treat COVID-19 patients,” wrote the Senators in the letter.
The Senators continued, “Given the scale of the threat that COVID-19 poses to public health, responding to the outbreak is placing substantial strain on state, local, territorial, and tribal public health agencies’ already- limited resources. Furthermore, states and health care facilities who are trying to do as the President says and ‘get it yourself,’ find that the supply simply is not available. We urge you to be proactive and utilize the powers that you invoked on March 18, 2020, under the Defense Production Act (DPA) to mobilize private industry to manufacture the supplies and equipment needed to address this crisis.”
The Senators call on the President and Vice President to answer the following questions no later than March 24:
- What is the current status of supplies in the Strategic National Stockpile (SNS) that may be used in the COVID-19 response? Please include data on which, and the number of, pharmaceuticals, personal protective equipment, and any other medical supplies currently in the SNS that may be utilized in the response.
- What is the current nationwide status of supplies and equipment available to test for and treat COVID-19 and what is the quantity of supplies and equipment the administration has determined is necessary to fully provide states, local, and tribal organizations with what they need throughout the length of the pandemic? Please include the quantity of personal protective equipment (including N95 Respirators and Surgical Masks, gloves, gowns, face shields, eye protection), testing supplies (including reagents and swabs), and ventilators that is currently available and the quantity needed throughout the length of the pandemic.
- What is the current total nationwide COVID-19 diagnostic testing capacity for public health, commercial, and academic laboratories per day? What is your plan to increase testing capacity? When will testing capacity be sufficient to be fully responsive to the current outbreak?
- What is your plan to mobilize the private industry to manufacture supplies and equipment under the DPA and what is your timeline on invoking that power?
- What is your plan for using the MEP network to identify manufacturers with excess or idle production capacity? What are your plans for organizing MEP (Hollings Manufacturing Extension Partnership) and National Institute of Standards and Technology expertise and resources to optimize production?
The letter is available HERE and below.
March 21, 2020
Dear President Trump and Vice President Pence:
We appreciate the work that has been done so far to ensure that the states, local governments, and tribal organizations we represent in the United State Senate get the supplies and equipment they need to respond to and prepare for the Coronavirus Disease 2019 (COVID-19). On February 28, 2020, the first patient in the United States died due to COVID-19, and since then many more have died and thousands have tested positive for the virus. More widespread testing will hopefully provide a clearer picture of the true prevalence.
State, local, territorial, and tribal public health agencies are leading the response to the pandemic. These departments know their communities well and are making the best decisions they can to keep their citizens safe. However, our constituents working as health care providers and front line responders in hospitals, public health departments, and throughout their communities report the health care system is woefully under-resourced, especially in our rural, underserved areas and minority communities that are often overlooked. This problem is most acute with shortages of supplies and equipment that are desperately needed to test for and treat COVID-19 patients.
On the morning of March 16, 2020, President Trump told the nation’s governors on a phone call to get supplies themselves. Specifically, the President said, “respirators, ventilators, all of the equipment — try getting it yourselves. We will be backing you, but try getting it yourselves. Point of sales, much better, much more direct if you can get it yourself.”
Given the scale of the threat that COVID-19 poses to public health, responding to the outbreak is placing substantial strain on state, local, territorial, and tribal public health agencies’ already-limited resources. Furthermore, states and health care facilities who are trying to do as the President says and “get it yourself,” find that the supply simply is not available. We urge you to be proactive and utilize the powers that you invoked on March 18, 2020, under the Defense Production Act (DPA) to mobilize private industry to manufacture the supplies and equipment needed to address this crisis.
Additionally, the Hollings Manufacturing Extension Partnership (MEP) centers in every state and Puerto Rico represent an existing, high-quality network connecting small and medium manufacturers with technical experts to develop strategies for innovation, optimizing supply chains, and improving efficiency and productivity. Given that efficiency, productivity, and supply chain management are critical for rapidly manufacturing much-needed medical equipment, we urge that you utilize the capabilities and connections of the MEP network to expedite the search for excess manufacturing capacity.
We urge you to within 3 days, provide the members of the United States Senate and House of Representatives the answers to the following questions in a manner that does not compromise national security:
- What is the current status of supplies in the Strategic National Stockpile (SNS) that may be used in the COVID-19 response? Please include data on which, and the number of, pharmaceuticals, personal protective equipment, and any other medical supplies currently in the SNS that may be utilized in the response.
- What is the current nationwide status of supplies and equipment available to test for and treat COVID-19 and what is the quantity of supplies and equipment the administration has determined is necessary to fully provide states, local, and tribal organizations with what they need throughout the length of the pandemic? Please include the quantity of personal protective equipment (including N95 Respirators and Surgical Masks, gloves, gowns, face shields, eye protection), testing supplies (including reagents and swabs), and ventilators that is currently available and the quantity needed throughout the length of the pandemic.
- What is the current total nationwide COVID-19 diagnostic testing capacity for public health, commercial, and academic laboratories per day? What is your plan to increase testing capacity? When will testing capacity be sufficient to be fully responsive to the current outbreak?
- What is your plan to mobilize the private industry to manufacture supplies and equipment under the DPA and what is your timeline on invoking that power?
- What is your plan for using the MEP network to identify manufacturers with excess or idle production capacity? What are your plans for organizing MEP and National Institute of Standards and Technology expertise and resources to optimize production?
While Congress has provided supplemental funding for state, local, territorial, and tribal public health agencies, the need for additional support across the nation remains high. The large magnitude of this crisis requires an even larger response from our national leaders. Americans depend on this. We look forward to your prompt response.
Sincerely,
###
Warner, Kaine Urge VA Medical Centers to Protect Veterans, Health Providers Amid COVID-19 Outbreak
Mar 20 2020
WASHINGTON – Today, U.S. Sens. Mark R. Warner and Tim Kaine (both D-VA) urged four Department of Veterans Affairs (VA) medical centers to expend every effort to ensure that veterans and the health providers who care for them are safe amid the novel coronavirus (COVID-19) outbreak. In letters to the Hunter Holmes McGuire VA Medical Center, the Salem VA Medical Center, the Hampton VA Medical Center, and the Washington DC VA Medical Center, the Senators asked for more information on each facility’s efforts to address the spread of COVID-19 while ensuring the health of VA employees.
“Many of Virginia’s veterans are particularly susceptible to COVID-19 due to age and underlying health conditions,” wrote the Senators, who have heard from veterans and VA employees concerned about the effect of the COVID-19 outbreak on VA medical centers. “As the Commonwealth of Virginia and the federal government respond to the spread of COVID-19 in the United States and around the world, we urge the VA to expend every effort to ensure that veterans will be appropriately cared for during the outbreak of this deadly disease, and to seek further assistance when required.”
They continued, “As the VA works to care for our nation’s veterans with COVID-19 and to reduce the spread of this disease, the VA must also prioritize the protection of its employees – the health care providers, administrators, support staff, and others – who are on the frontlines in the battle against COVID-19, and who risk daily exposure to the virus.”
In their letters, the Senators urged each medical center to allow individuals to telework whenever possible, as in the case of hospital administrators who may be able to perform their duties remotely. They also urged the facilities to make every effort to provide employees with appropriate personal protective equipment in order to safely support patients and help prevent healthcare workers from getting sick.
They also requested that the hospitals provide more information on their efforts to reduce the transmission of COVID-19. Specifically, they asked for details on each facility’s ability to test patients and staff for COVID-19; whether any steps were being taken to train and protect medical staff from the virus; whether each medical center is allowing employees to telework when possible; whether facilities believe they can meet the growing demands during this crisis; and whether any steps have been taken to ensure that each facility can handle a surge of patients with possible or confirmed COVID-19 patients.
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Warner, Blumenthal Raise Alarm about Google Ads that Continue to Monetize COVID-19 Fears
Mar 17 2020
WASHINGTON – Today, U.S. Sens. Mark R. Warner (D-VA) and Richard Blumenthal (D-CT) expressed deep concern that Google – despite claiming to ban ads that capitalize on novel coronavirus (COVID-19) fears – continues to run ads for products such as face masks and hand sanitizer, which not only exploit fear for profit but also serve to trigger shortages of essential health care products at a time of critical need. In their letter to the Federal Trade Commission (FTC), the Senators slammed Google’s inattention to the misuse of its advertising platform and urged the FTC to intervene in order to protect the public and the nation’s supply chains.
“Browsing in incognito mode across a range of different devices, our staffs were consistently served dozens of ads for protective masks and hand sanitizer – in each case while on a page related to COVID-19,” the Senators wrote. “Scrutinizing the targeting information that Google provides pursuant to the AdChoices program, it became clear that these ads were targeted to users specifically because they were browsing articles on COVID-19. In other words, using browsing data that Google collects through its third-party web trackers, unscrupulous and predatory advertisers were able to directly target consumers browsing content on the outbreak in order to exploit their fear for profit.”
“Google has made repeated representations to consumers that its policies prohibit ads for products such as protective masks. Yet the company appears not to be taking even rudimentary steps to enforce that policy, such as easily automated and scalable actions like flagging ads with relevant terms in the outbound URL. These misrepresentations generate direct harm to consumers, exploiting their legitimate fears over the COVID-19 outbreak to over-charge them for products. They also create widespread social harms to our nation’s response to this crisis, such as by contributing to shortages of products essential to the health care workers on the front lines of the COVID-19 response,” they continued. “Consumers should be able to rely on representations regarding a company’s business practices – particularly in cases, such as this, where Google has acknowledged that offending ads pose harm to consumers. If consumers cannot rely on a company’s representations, then the FTC must intervene.”
Earlier this month, the Department of Health and Human Services (HHS) announced that in light of the COVID-19 outbreak, it would need roughly 300 million N95 respirator masks – 270 million more masks than it currently has stockpiled. Due to this shortage, the U.S. Surgeon General urged the public to stop buying protective masks in order to ensure that health care workers have access to the resources they need to stay safe.
On March 10, after several outlets reported that Google was serving these ads despite a policy that prohibits content that capitalizes off sensitive events, Google stated that it would formally ban ads for protective facemasks. However Google’s advertising platform continues to be exploited for fraudulent activity with these ads continuing to run, notably even on news articles reporting Google’s new policies.
In their letter, the Senators also highlighted previous efforts to encourage the FTC to address Google’s inattention to abuse and expressed disappointment with the FTC’s inaction.
A copy of the letter is available here and below. A list of Sen. Warner’s work to protect Americans amid the coronavirus outbreak is available here.
The Honorable Joseph J. Simons
Chairman
Federal Trade Commission
600 Pennsylvania Avenue, NW
Washington, D.C. 20530
Dear Chairman Simons,
The COVID-19 pandemic has impaired the global supply chain in myriad ways, but perhaps most notably by creating a shortage of products like protective face masks, which are needed by health care workers responding to this crisis. Major manufacturers like 3M are ramping up production in the wake of consumer-led shortages that are impacting supplies for the health care sector. In early March, the Department of Health and Human Services stated that while the U.S. has a stockpile of roughly 30 million N95 respirator masks, it needs roughly 300 million as the COVID-19 outbreak worsens. In light of this, the U.S. Surgeon General has urged the public to stop buying protective masks.
Despite these pleas, a range of bad actors have continued to exploit fears surrounding the COVID-19 crisis for monetary gain. Earlier this month, CNBC and other outlets reported that Google was continually serving ads for products marketed as precautions for COVID-19 (including protective masks and hand sanitizer), despite a policy prohibiting content that capitalizes off of “sensitive events” such as natural disasters, conflicts, or death. On March 10th, Google announced a formal ban on ads for protective face masks and claimed it would “take action as needed to protect users.”
Almost immediately, however, our staffs became aware that Google continued to serve ads for these masks – including, notably, on news articles reporting Google’s new policies. Browsing in incognito mode across a range of different devices, our staffs were consistently served dozens of ads for protective masks and hand sanitizer – in each case while on a page related to COVID-19. Scrutinizing the targeting information that Google provides pursuant to the AdChoices program, it became clear that these ads were targeted to users specifically because they were browsing articles on COVID-19. In other words, using browsing data that Google collects through its third-party web trackers, unscrupulous and predatory advertisers were able to directly target consumers browsing content on the outbreak in order to exploit their fear for profit.
These ads, from a range of different advertisers, were served by Google on websites for outlets such as The New York Times, The Boston Globe, The Washington Post, CNBC, The Irish Times, and myriad local broadcasting affiliates. In several hours of testing, our staffs were not served a single ad for such masks from other advertising platforms – yet generated several dozen from Google. Reporting by CNBC appears to confirm that other ad platforms seemed not to be serving such predatory ads.
Upon contacting the company, Google claimed it would need a full click string to detect these violations – a request that seemed odd in light of the sheer number of ads violating these policies and the ease with which our staffs were able to generate offending ads, across multiple devices and sites. Most disturbingly, the ad content included explicit references to “Protective Masks” and included a range of representations such as “Medical-Grade N95 filter mask.” The majority of these ads also suggested that consumers should take immediate action in light of “limited supplies.” Virtually every single outbound URL associated with these ads also contained clear indications that the ads violated the company’s policies – with “N95,” “mask,” “medical-grade,” and “3M-Mask” explicitly in the URL string. In addition to the social harm associated with contributing towards scarcity of these masks, the ads also appear to engage in price-gouging – with individual masks in many ads selling for $9.99 or $12.99.
For several years now, we have encouraged the FTC to address Google’s inattention to abuse, harmful activity, and fraud within the ad ecosystem that it largely dominates. As one of us wrote your agency in 2018, “The FTC’s failure to act has had the effect of allowing Google to structure its own market; through a series of transactions, the company has accomplished a level of vertical integration that, in effect, allows it to act as the equivalent of market-maker, commodities broker, and commodities exchange for digital advertising… While the company controls each link in the supply chain and therefore maintains the power to monitor activity in the digital advertising market from start to finish, it has continued to be caught flat-footed in identifying and addressing digital ad fraud.”
Google’s inattention to the misuse of its advertising platform extends beyond digital ad fraud and predatory ads: in 2012, the Department of Justice announced one of the largest forfeitures in U.S. history, forcing Google to disgorge $500 million generated by unlawful ads marketing opioids to Americans. Unfortunately, we have continued to see Google’s advertising platform exploited for abusive and fraudulent activity.
Google has made repeated representations to consumers that its policies prohibit ads for products such as protective masks. Yet the company appears not to be taking even rudimentary steps to enforce that policy, such as easily automated and scalable actions like flagging ads with relevant terms in the outbound URL. These misrepresentations generate direct harm to consumers, exploiting their legitimate fears over the COVID-19 outbreak to over-charge them for products. They also create widespread social harms to our nation’s response to this crisis, such as by contributing to shortages of products essential to the health care workers on the front lines of the COVID-19 response.
Consumers should be able to rely on representations regarding a company’s business practices – particularly in cases, such as this, where Google has acknowledged that offending ads pose harm to consumers. If consumers cannot rely on a company’s representations, then the FTC must intervene. The FTC routinely pursues enforcement actions against companies that don’t live up to the self-regulatory commitments they make, including in a 2012 case against Google for failing to follow the National Advertising Initiative code of conduct.
Given the Department of Justice (DOJ)’s successful work in combatting similar misuse of the company’s advertising platform, we have provided a carbon copy of this letter to the DOJ to address this pattern of misbehavior in light of the FTC’s inaction.
Sincerely,
Cc:
Attorney General William Barr
Commissioner Rohit Chopra
Commissioner Rebecca Slaughter
Commissioner Noah Phillips
Commissioner Christine Wilson
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WASHINGTON – Today, U.S. Sen. Mark R. Warner (D-VA) released the following statement after the Center for Medicare and Medicaid Services (CMS) announced plans to pay clinicians across the country for telehealth services to Medicare beneficiaries during the coronavirus outbreak. This decision was enabled by passage earlier this month of provisions from Sen. Warner's bipartisan CONNECT for Health Act of 2019, as part of the initial $8.3 billion coronavirus response package.
“I am relieved that Medicare is quickly moving to take advantage of the telehealth authorities Congress has given it through my legislation. There is no doubt that, if properly implemented, this technology will be a crucial tool for protecting American seniors during the coronavirus outbreak,” said Sen. Warner. ”The key now is for Medicare to take clear and decisive steps to swiftly put this technology in the hands of doctors and seniors at this critical moment in the COVID-19 outbreak. While it is unfortunate that it took a public health crisis to push these important telehealth provisions through, I am hopeful that, with proper implementation, this experience will eventually lead to a full expansion of telehealth for Medicare beneficiaries through passage of the bipartisan CONNECT for Health Act.”
The Warner-authored language in the first coronavirus response bill cuts restrictions on Medicare's use of telehealth for the COVID-19 public health emergency response. CMS Administrator Seema Verma announced Medicare's telehealth expansion yesterday at the White House during a Coronavirus Task Force press conference.
“These changes allow seniors to communicate with their doctors without having to travel to a healthcare facility so that they can limit risk of exposure and spread of this virus,” Administrator Verma said at the press conference. “Clinicians on the frontlines will now have greater flexibility to safely treat our beneficiaries.”
The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2019 builds on the progress made in recent years to increase the use of telehealth through Medicare. Specifically, the legislation would:
- Provide the Secretary of Health and Human Services (HHS) the authority to waive telehealth restrictions when necessary;
- Remove geographic and originating site restrictions for services like mental health and emergency medical care;
- Allow rural health clinics and other community-based health care centers to provide telehealth services; and
- Require a study to explore more ways to expand telehealth services so that more people can access health care services in their own homes.
Sen. Warner has been a longtime advocate for increased access to health care through telehealth. Last year, he successfully included a provision to expand telehealth services for substance abuse treatment in the Opioid Crisis Response Act of 2018. In 2003, then-Gov. Warner expanded Medicaid coverage for telemedicine statewide, including evaluation and management visits, a range of individual psychotherapies, the full range of consultations, and some clinical services, including in cardiology and obstetrics. Coverage was also expanded to include non-physician providers. Among other benefits, the telehealth expansion allowed individuals in medically underserved and remote areas of Virginia to access quality specialty care that isn’t always available at home.
A list of Sen. Warner’s work to protect and support Virginians during the coronavirus outbreak is available here.
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WASHINGTON, D.C. – U.S. Senators Mark R. Warner and Tim Kaine joined more than 30 of their Democratic colleagues to press the Coronavirus Task Force on their preparedness and response plans for seniors and individuals with disabilities. The Senators sent three letters to the Trump Administration regarding the safety of people living in nursing homes, the ability of seniors living in the community to maintain critical services including delivered meals and home care, and ensuring that up-to-date and accurate information is easily accessible to seniors and people with disabilities.
“As this pandemic continues to spread, the health of seniors and individuals with disabilities is increasingly at risk,” Warner and Kaine said. “It’s crucial that the Administration address the growing threat to our most vulnerable communities.”
In an effort to guard against the spread of the virus in nursing homes, the Centers for Medicare and Medicaid Services took the unprecedented step of directing states to suspend nearly all nursing home inspections and oversight unrelated to infection control or instances of abuse and neglect.
The Senators requested information on steps that are being taken to protect nursing home residents, staff, and their families. They also urged the Trump Administration to outline its plans for ensuring that older adults who receive services in their homes and communities through their local Area Agencies on Aging, senior centers, and other community organizations will remain safe from the virus, and to what extent the Administration is taking action to ensure that information about the virus is accessible to everyone, including people who are deaf or have limited English proficiency.
Read the letter on nursing homes here.
Read the letter on home and community-based services here.
Read the letter on accessible information for people with disabilities here.
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WASHINGTON, D.C.—Today, U.S. Senators Mark R. Warner and Tim Kaine joined their colleagues in introducing the Free COVID-19 Testing Act, legislation that would expand free tests to confirm coronavirus (COVID-19) infections.
The Free COVID-19 Testing Act would waive cost-sharing for COVID-19 diagnostic testing and related health care services for individuals enrolled in private health plans, Medicare, Medicare Advantage, Medicaid, CHIP, TRICARE, VA as well as for federal civilians, American Indians and Alaska Natives. Private insurers would be barred from imposing limits like prior authorization for testing. For uninsured individuals, this legislation would cover the cost of lab fees, and states would have the option and new incentives to cover COVID-19 diagnostic testing and related health care services through their Medicaid programs.
“Costs should never be a barrier to accessing potentially life-saving testing,” Warner and Kaine said. “This legislation ensures any Virginian can get tested without the fear of a medical bill they can’t afford. The Senate must immediately pass this critical legislationto help mitigate the spread of the coronavirus and protect public health.”
This legislation was led by Senators Tina Smith (D-Minn.), Gary Peters (D-Mich.), Democratic Minority Leader Chuck Schumer (D-N.Y.), Patty Murray (D-Wash.), and Ron Wyden (D-Ore.). In addition to Warner and Kaine, this legislation is also cosponsored bySens. Amy Klobuchar (D-Minn.), Bob Casey (D-Pa.), Doug Jones (D-Ala.), Sherrod Brown (D-Ohio), Tammy Duckworth (D-Ill.), Jon Tester (D-Mont.), Sheldon Whitehouse (D-R.I.), Bernie Sanders (I-Vt.), Tammy Baldwin (D-Wis.), Jack Reed (D-R.I.), Chris Murphy (D-Conn.), Mazie Hirono (D-Hawaii), Brian Schatz (D-Hawaii), Debbie Stabenow (D-Mich.), Angus King (I-Maine), Chris Coons (D-Del.), Cory Booker (D-N.J.), Dianne Feinstein (D-Calif.), Kamala Harris (D-Calif.), Tom Udall (D-N.M.), Maggie Hassan (D-N.H.), Kirsten Gillibrand (D-N.Y.), Martin Heinrich (D-N.M.), Jeanne Shaheen (D-N.H.), Jacky Rosen (D-Nev.), Elizabeth Warren (D-Mass.), Tom Carper (D-Del.), Dick Durbin (D-Ill.), Chris Van Hollen (D-Md.), Ed Markey (D-Mass.), Richard Blumenthal (D-Conn.), Michael Bennet (D-Colo.), and Bob Menendez (D-N.J.).
You can access text of the bill here.
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WASHINGTON – Today, U.S. Sen. Mark R. Warner (D-VA) sounded the alarm regarding America’s overreliance on Chinese- and foreign-made pharmaceutical products and supplies, and highlighted the dangerous consequences of this dependence on the wellbeing of Americans and on U.S. national security. In a letter to the U.S. Department of Health and Human Services, Sen. Warner requested that HHS develop a short-term strategy to ensure Americans have access to necessary medical products, and a long-term plan to reduce reliance on foreign supply chains.
“For millions of Americans, access to their drug supply can mean life or death. Yet increasingly, the United States produces very few of these products domestically,” wrote Sen. Warner. “For example, the active ingredients for medicines treating breast and lung cancers and the antibiotic Vancomycin are made almost exclusively in China. China is also the largest supplier of medical devices, such as MRI equipment, surgical gowns and other equipment that measures oxygen levels in the blood.”
“As the outbreak for COVID-19 has occurred, the risks of our dependence are growing. Our reliance on Chinese and other foreign API manufacturing facilities during this crisis is already beginning to compromise the U.S. drug supply, creating drug shortages and manufacturing quality problems. Some countries have increased restrictions on the export of their pharmaceuticals to the United States and other countries as they work to protect their own populations. For example, India recently decided to place restrictions on exporting Tylenol and the common antibiotic metronidazole to ensure Indian citizens have the pharmaceuticals they need,” he continued. “The nation’s dependence on foreign countries for medical products points to a much larger challenge that the United States must be prepared to address: China’s growing dominance in the health sector, including the biotechnology and pharmaceutical industries, and its collection of vast amounts of biomedical and other data, with potential long-term privacy risks for Americans.”
In the letter, Sen. Warner cited the testimony of Janet Woodcock, the Director of the Center for Drug Evaluation and Research who testified before the House Committee on Energy and Commerce about the growing U.S. reliance on foreign sources of active pharmaceutical ingredients (APIs). According to Director Woodcock, only 28 percent of manufacturing facilities making APIs for the U.S. market are in the United States, and three of the “essential medicines” identified by the World Health Organizations have API manufacturers that are based only in China.
Additionally, Sen. Warner requested a briefing and a written response to the following questions:
- What actions has HHS taken to address the dependence on Chinese or other foreign manufacturers of drugs, APIs, or other pharmaceutical products and medical supplies and equipment since the outbreak of the COVID-19?
- What is your strategy to ensure that Americans get the pharmaceuticals they need if significant shortages occur?
- As the coronavirus continues to spread, what actions has HHS taken to ensure that patients can still access the drugs they need without access to drug components manufactured overseas?
- What is your analysis of what drugs or ingredients cannot be made without supplies from China and other foreign countries?
- What is your plan to ensure that medical facilities, medical personnel and first responders have a reserve of necessary medical supplies and equipment as they continue to be on the front lines of efforts to prevent the spread of COVID-19?
- Congress recently passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, which includes more than $2 billion for the Biomedical Advanced Research and Development Authority (BARDA) to invest in platform-based technologies with U.S-based manufacturing for vaccines and therapeutics. How will HHS ensure these funds effectively reduce our short and long-term reliance on foreign manufacturers of drugs, APIs, or other pharmaceutical products and medical supplies and equipment?
A copy of the letter is available here and below. A list of Sen. Warner’s work on coronavirus is available here.
Secretary Alex Azar
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Azar:
As the novel coronavirus (COVID-19) continues to spread globally, I write to convey my significant alarm over American overreliance on Chinese – and foreign-manufactured pharmaceutical products and medical supplies and the consequent dangerous impacts – both for the health and well-being of Americans and for U.S. national security. I ask the Department of Health and Human Services to monitor the potential impact of this overreliance, and develop a strategy to ensure Americans have access to these medical products in the short-term while determining a longer-term plan to reduce U.S. reliance on foreign supply chains for these products.
As you are well aware, the COVID-19 was first detected in Wuhan, China and has now spread to more than 104 countries. There have been more than 109,000 cases confirmed and more than 3,800 deaths. For some time, experts both in and outside of the government have expressed serious concerns about the United States outsourcing medical products to foreign companies and the vulnerabilities resulting from this dependence. The outbreak of COVID-19 has put in stark relief the health, economic, and strategic risks of the current approach.
For millions of Americans, access to their drug supply can mean life or death. Yet increasingly, the United States produces very few of these products domestically. For example, the active ingredients for medicines treating breast and lung cancers and the antibiotic Vancomycin are made almost exclusively in China. China is also the largest supplier of medical devices, such as MRI equipment, surgical gowns and other equipment that measures oxygen levels in the blood.
During her October 30, 2019 testimony before the House Committee on Energy and Commerce, the Director of the Center for Drug Evaluation and Research, Janet Woodcock, asserted that the U.S. reliance on Chinese and other foreign sources of active pharmaceutical ingredients (APIs) was only growing. She described a set of startling statistics— while the United States has become a world leader in drug discovery and development over the past decade, it is no longer in the forefront of drug manufacturing. In particular, manufacturers of APIs, including statins and penicillin are increasingly foreign-made– with only 28 percent of the manufacturing facilities making APIs for the U.S. market in the United States; thirteen percent of these manufacturers are located in China. The U.S. pharmaceutical sector relies on China for components, materials, and finished products. In fact, three World Health Organization (WHO) “Essential Medicines” have API manufacturers that are based only in China. For drugs used to combat biological threats, China has 37 API manufacturing facilities, while the U.S. has 19, compared to 117 facilities in the rest of the world.
As the outbreak for COVID-19 has occurred, the risks of our dependence are growing. Our reliance on Chinese and other foreign API manufacturing facilities during this crisis is already beginning to compromise the U.S. drug supply, creating drug shortages and manufacturing quality problems. Some countries have increased restrictions on the export of their pharmaceuticals to the United States and other countries as they work to protect their own populations. For example, India recently decided to place restrictions on exporting Tylenol and the common antibiotic metronidazole to ensure Indian citizens have the pharmaceuticals they need.
The nation’s dependence on foreign countries for medical products points to a much larger challenge that the United States must be prepared to address: China’s growing dominance in the health sector, including the biotechnology and pharmaceutical industries, and its collection of vast amounts of biomedical and other data, with potential long-term privacy risks for Americans.
It is essential that the United States develop strategies to reduce U.S. reliance on China and other countries for drugs critical to American patients. I appreciate your willingness to work with Congress to further strengthen our response capabilities and emergency preparedness.
I respectfully request a briefing [and a written response] with answers to the following questions no later than March 23, 2020.
- What actions has HHS taken to address the dependence on Chinese or other foreign manufacturers of drugs, APIs, or other pharmaceutical products and medical supplies and equipment since the outbreak of the COVID-19?
- What is your strategy to ensure that Americans get the pharmaceuticals they need if significant shortages occur?
- As the coronavirus continues to spread, what actions has HHS taken to ensure that patients can still access the drugs they need without access to drug components manufactured overseas?
- What is your analysis of what drugs or ingredients cannot be made without supplies from China and other foreign countries?
- What is your plan to ensure that medical facilities, medical personnel and first responders have a reserve of necessary medical supplies and equipment as they continue to be on the front lines of efforts to prevent the spread of COVID-19?
- Congress recently passed the Coronavirus Preparedness and Response Supplemental Appropriations Act, which includes more than $2 billion for the Biomedical Advanced Research and Development Authority (BARDA) to invest in platform-based technologies with U.S.-based manufacturing for vaccines and therapeutics. How will HHS ensure these funds effectively reduce our short- and long-term reliance on foreign manufacturers of drugs, APIs, or other pharmaceutical products and medical supplies and equipment?
I appreciate your immediate attention to this matter. I look forward to working together on this critical issue moving forward.
Sincerely,
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