The following LPG Weekly Health Care Watch provides a summary update of legislative and regulatory health care activities from May 3–10. Where available, hyperlinks are included to the relevant documents. Please let us know if you have any questions or would like additional information on the items below.
NON-CORONAVIRUS LEGISLATIVE UPDATE
Senate
On May 7, the Senate confirmed, by voice vote, the U.S. Department of Health & Human Services (HHS) Assistant Secretary for Health Brett Giroir to be the U.S. Representative on the executive board of the World Health Organization.
The Senate is aiming to conclude markups of all 12 FY2021 appropriation bills by July 4. GOP appropriators met privately on May 6 to discuss subcommittee allocations and a markup schedule.
House
On May 4, Oversight & Reform Chair Carolyn Maloney (D-NY) and Rep. Jackie Speier (D-CA) sent a letter to Jaguar Health requesting that the drug manufacturer provide all communications pertaining to a sharp price increase of its HIV drug Mytesi. In early April, the company raised the price of from $688.52 to $2,206.52 per bottle of pills. Jaguar is working with the National Institute of Allergy & Infectious Diseases (NIAID) to assess Mytesi’s effectiveness against COVID-19.
House appropriators are aiming to pass all 12 appropriation bills by the end of June, according to Appropriations Labor-HHS-Education Subcommittee Chair Rosa DeLauro (D-CT).
The House may return to session the week of May 11, although many members prefer to further delay returning to Washington.
NON-CORONAVIRUS REGULATORY UPDATE
On May 6, the Office of Management & Budget (OMB) received a Centers for Medicare & Medicaid Services (CMS) proposed rule, “CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements.”
On May 7, CMS issued its “Patient Protection and Affordable Care Act (ACA); HHS Notice of Benefit and Payment Parameters for 2021; Notice Requirement for Non-Federal Governmental Plans” final rule, summarized here. The Payment Notice finalizes standards for issuers, Exchanges, and excepted benefit health reimbursement arrangements sponsored by non-Federal governmental plan sponsors. Notably, the rule finalizes a policy to allow insurers to not count drug manufacturer coupons towards patients’ out-of-pocket (OOP) costs in the Exchanges.
On May 7, the Food & Drug Administration (FDA) terminated a proposal that would have allowed device manufacturers to receive market authorization for devices referencing drugs (i.e., devices labeled for use with an FDA-approved drug) without the consent from companies owning the referenced drugs. The policy was first introduced in 2017 and challenged by industry groups such as the Pharmaceutical Research & Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO).
On May 7, OMB concluded its review of CMS’s proposed rule, “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; the Long-Term Care Hospital Prospective Payment System; and FY2021 Rates.” The rule will likely be released early next week.
On May 7, U.S. Department of Justice (DOJ) announced it has reached a settlement with Apotx over charges that the generic drug company fixed prices of its cholesterol drug pravastatin. Under the deal, Apotx must admit to participating in an effort to artificially raise the price of the drug and pay a $24.1 million criminal penalty.
CORONAVIRUS UPDATE
White House Update
On May 3, President Donald Trump held a coronavirus town hall at the Lincoln Memorial. He suggested the U.S. may have a vaccine by the end of 2020: “We're building supply lines; we even have the final vaccine.” He added that several companies are close to developing the vaccine, naming Johnson & Johnson specifically. However, on May 5, he walked back his statement by clarifying that “you can never be convinced.” In addition, President Trump said his Administration will begin preparing for an economic recovery, such as by modifying tax and regulatory policies.
On May 3, Secretary of State Mike Pompeo said that there is “enormous evidence” to validate the theory that SARS-CoV-2 originated in the Wuhan Institute of Virology.
On May 4, the Administration informed Congress that members of its Coronavirus Task Force, will not be permitted to testify until June. According to White House spokesperson Judd Deere, it is “counter-productive” to require officials leading the response effort to appear at Congressional hearings. Accordingly, the Administration denied the Energy & Commerce Committee’s request to hear testimony from CMS Administrator Seema Verma and HHS Secretary Alex Azar. However, NIAID Director Anthony Fauci is scheduled to testify before the Senate HELP Committee on May 12.
On May 5, Vice President Mike Pence said the Administration is considering phasing out the Coronavirus Task Force in the coming weeks: “We’re going to start to look at the Memorial Day window to transition back to having our agencies manage our response in a more traditional manner.” However, on May 6, the President claimed the Task Force will “continue on indefinitely,” though the group’s membership and focus may evolve. Specifically, he claimed the Task Force will shift its priorities to reopening the country and developing vaccines and therapeutics.
On May 8, it was reported that the Administration is considering appointing a “therapeutics czar” to coordinate the development therapies and vaccines. Former National Institutes of Health (NIH) Director Elias Zerhouni appears to be the leading choice.
On May 8, Katie Miller, Press Secretary for Vice President Pence, announced she has tested positive for COVID-19. Later that day, FDA Commissioner Stephen Hahn began a 14-day self-quarantine due to being exposed to Miller. On May 9, it was reported that NIAID Director Anthony Fauci and Centers for Disease Control & Prevention (CDC) Director Robert Redfield were also self-quarantining after being exposed to a COVID-19-positive White House staffer.
Legislative Update
On May 4, House Ways & Means Committee Chairman Richard Neal (D-MA) requested that the Trump administration suspend all tariffs on products relevant to addressing the pandemic for 90 days. In addition, based on a U.S. International Trade Commission report, the Committee outlined short and long-term solutions to address deficiencies in the medical supply chain.
On May 4, Senate HELP Ranking Member Patty Murray (D-WA) sent a letter to HHS and the U.S. Department of Labor (DOL) advocating for the departments to collaborate and coordinate a “mechanism to shift unemployed workers from across the country into an expanded public health workforce” focused on identifying, tracing, and isolating spread.
On May 4, House Minority Leader Kevin McCarthy (R-CA) outlined “Four Strategies to Reopen Congress and Restore America’s Vote.”
On May 5, House Judiciary Antitrust Subcommittee Chairman David Cicilline (D-RI), along with six progressive House members, sent a letter to House Speaker Nancy Pelosi (D-CA) and Minority Leader McCarthy requesting that the next relief package include language precluding mergers that do not include the purchase of a severely distressed company.
On May 5, the American Health Care Association and the National Center for Assisted Living sent a letter to HHS and the Federal Emergency Management Agency (FEMA) requesting an additional $10 billion for long-term care facilities to pay for staffing, testing, and Personal Protective Equipment (PPE).
On May 5, Sens. Bill Cassidy (R-LA) and Chris Coons (D-DE) introduced a bill to establish a national service program to support state and local health departments test, trace, and (potentially) vaccinate their communities. The “Pandemic Response and Opportunity Through National Service Act” includes funding for 150,000 workers. Rep. David (D-NC) and Doris Matsui (D-CA) have introduced companion legislation in the House.
On May 6, the House Appropriations Labor-HHS-Education Subcommittee held a hearing entitled COVID-19 Response. Chair Rosa DeLauro and Ranking Member Tom Cole (R-OK) agreed to consider a proposal introduced by former CDC Director Tom Frieden that would exempt funding for health defense operations from the Budget Control Act’s spending cap. In addition, Ranking Member Cole said he regretted that NIAID Director Fauci was not cleared to testify, noting that input from the Administration is critical to the Subcommittee’s work. On May 5, a group of retired lawmakers, public health officials, and former CDC directors sent Congressional leaders a letter urging them to create a “Health Defense Operations” fund.
On May 6, Sen. Elizabeth Warren (D-MA) and Rep. Jan Schakowsky (D-IL) sent HHS, the U.S. Department of Defense, and Vice President Pence a letter advocating for the federal government to coordinate domestic manufacturing efforts to produce COVID-19 medical products. The lawmakers also requested information on the federal government's capacity to develop and manufacture therapeutics and vaccines.
On May 6, Sens. Warren and Patty Murray (D-WA) asked FDA to explain its procedure for tracking the safety and efficacy of products that receive an Emergency Use Authorization (EUA). So far, the agency has approved over 100 EUAs for COVID-19-related products.
On May 7, the Senate HELP Committee held a hearing entitled Shark Tank: New Tests for COVID-19. In the Coronavirus Aid, Relief & Economic Security (CARES) Act, Congress included $1.5 billion to the NIH to launch a competitive program to encourage the development of new tests, as well as $1 billion to the Biomedical Advanced Research & Development Authority (BARDA) to accelerate the production of such tests. According to Chairman Alexander, “all roads back to work and back school lead through testing.” He claimed creating a testing supply to match the extraordinary demand relies on developing new testing technology. Ranking Member Murray stressed the importance of a national testing strategy. Witnesses included: Francis Collins, Director, NIH; and Gary Disbrow, Acting Director, BARDA.
On May 8, Sens. Kamala Harris (D-CA), Bernie Sanders (I-VT), and Ed Markey (D-MA) proposed the “Monthly Economic Crisis Support Act,” which would send a monthly allowance of 2,000 to adults making less than $120,000 per year, plus $2,000 for each dependent (up to three). The payments would be retroactive to March and continue three months after HHS declares the conclusion of the public health emergency.
House Democrats are aiming to vote on their yet-to-be-released “CARES 2.0” proposal the week of May 11 or May 18. The proposal could cost upwards of $2 trillion, an outline or summary of which could be released early the week of May 11. Funding for state and local governments is expected to be the core of the bill, but Speaker Pelosi has also indicated the package will expand unemployment and Supplemental Nutrition Assistance Program benefits. Thus far, the GOP-controlled Senate has shown little appetite to consider this legislation and some moderate House Democrats have expressed concern about the size of this package.
Regulatory Update
On May 3, FDA granted Roche Holding an EUA for its antibody test, which is 99.8% “specific” (a measure of how often it correctly produces positive results) and a 100% “sensitive” (a measure of how often it correctly produces negative results).
On May 4, the FDA revised its policy for regulating antibody tests. Now, manufacturers must apply for an EUA within 10 days after their product is marketed. In addition, tests must be at least 90% sensitive and 95% specific. The updated policy is intended to avoid fraudulent or inaccurate test from reaching consumers.
On May 5, former Director of the BARDA Rick Bright filed a whistleblower complaint alleging that the HHS failed to take early action to mitigate the threat of the virus and unfairly removed him from his post because he challenged the endorsement of unproven treatments, such as hydroxychloroquine. On May 8, the Office of Special Counsel recommended that Bright be reinstated for 45 days while it investigates his complaint. The Energy & Commerce Health Subcommittee will hold a hearing on May 14 on Bright’s allegations. On May 14, HHS rebutted his complaint.
On May 5, CMS released COVID-19 FAQs for state Medicaid and CHIP Agencies to guide their response efforts.
On May 6, the CDC posted data on recipients of the Public Health & Social Services Emergency Fund (Provider Relief Fund) from HHS’ $50 billion general distribution. On May 8, CDC posted additional data on providers that received a portion of the $12 billion earmarked for “hotspots.”
On May 6, the FDA issued final guidance detailing protocol for device manufacturers to inform the agency of potential shortages. Manufacturers must now alert FDA at least six months in advance of a permanent termination or interruption in producing devices that is likely to cause a shortage in U.S. markets. If six months is not feasible, then FDA requires notification “as soon as is practicable,” or at least seven days after manufacturing is discontinued or interrupted. The guidance was required by the CARES Act.
On May 6, CMS sent State Survey Agencies new guidance on nursing homes’ requirement to notify CDC of confirmed and suspected COVID-19 cases among residents and staff.
On May 7, HHS extended providers’ deadline for accepting the terms and conditions associated with Provider Relief Fund payments to 45 days, up from 30. If the funds are not returned with 45 days, HHS will infer providers agree to the terms and conditions.
On May 7, HRSA released a portal for providers to submit claims for treating uninsured COVID-19 patients.
On May 7, DOL reported that for the week ending on May 2, an additional 3.2 million Americans filed for unemployment. Since lockdown orders were established in mid-March, 33.5 million have filed for unemployment.
On May 7, FDA issued an EUA for Sherlock Biosciences’ CRISPR rapid diagnostic test. The test can produce results in approximately one hour.
On May 8, the FDA granted an EUA for at-home use of Rutgers’ saliva diagnostic test, which it already cleared for use at testing sites. The test will sell for around $100.
On May 8, the Treasury Department signaled to lawmakers that it does not support state-level legislation requiring insurers to cover COVID-19 costs retroactively. Specifically, Treasury Principal Deputy Assistant Secretary Frederick Vaughan wrote that “While insurers should pay valid claims, we share your concerns that these proposals fundamentally conflict with the contractual nature of insurance obligations and could introduce stability risks to the industry.”
On May 9, the FDA issued an EUA for the first COVID-19 antigen test, Quidel’s Sofia 2 SARS Antigen FIA, which could be used in labs and patient-care settings, such as hospitals and physician offices.
Other
On May 3, New York, New Jersey, Massachusetts, Connecticut, Pennsylvania, Rhode Island and Delaware announced a regional consortium to reduce competition when purchasing PPE.
On May 3, Gilead CEO Daniel O'Day said that his company has donated its entire supply of Remdesivir (1.5 million doses) to the federal government; HHS and FEMA will determine how the antiviral is distributed across the country. On May 8, White House Press Secretary Kayleigh McEnany said Deborah Brix will participate in determining the distribution process. Gilead has not issued a list price for the drug. However, a group of 10 lawmakers, including Rep. Schakowsky, are preparing letters to HHS and Gilead advocating for the drug to be sold at a “fair and reasonable” price. The Institute for Clinical and Economic Review suggests the drug should be valued at $4,500 per treatment course, based on the assumption of mortality benefit.
On May 3, presidential nominee Joe Biden and Sen. Warren penned an op-ed endorsing more stringent oversight of Congressionally-approved coronavirus funding.
On May 4, Health Affairs published a blog on “What CMS’s Response to COVID-19 Means for Front Line Clinicians.” The blog was written by Michael J. Lipp, Chief Medical Officer for the Center for Medicare & Medicaid Innovation and Shari M. Ling, CMS Deputy Chief Medical Officer.
On May 4, the New York Times published an internal CDC document that projects by June 1, the U.S. will experience a spike in new daily cases from about 25,000 to 200,000 and an increase in daily deaths from approximately 1,750 to 3,000. The document is based on a model created by Johns Hopkins professor Justin Lessler.
On May 4, the University of Washington’s School of Medicine Institute for Health Metrics and Evaluation updated its projections for U.S. COVID-19 deaths by early August from 72,000 to 134,000. The White House has relied on this model to predict the severity of the pandemic.
On May 4, the Urban Institute published a study analyzing how the sharp uptick in unemployment will impact health insurance coverage. Their findings estimate between 25-43 million Americans could lose their employer-sponsored coverage and over half of the newly jobless will be eligible for Medicaid coverage in expansion states, compared to a third in non-expansion states.
On May 5, Pfizer and BioNTech announced human testing for their vaccine candidate (BNTI62) has begun in the U.S. and Germany.
On May 5, America’s Essential Hospitals (AEH) sent a letter to HHS urging the Department to allocate $20 billion of the Provider Relief Fund to hospitals that disproportionately serve Medicaid beneficiaries and other low-income patients.
On May 5, Gov. Mike DeWine (R) said he will cut Ohio’s Medicaid program by $210 million over the next two months due to declining tax revenues triggered by the pandemic. Alaska, Colorado, Georgia, and New York previously announced cuts to their Medicaid budgets because of the pandemic.
On May 6, Express Scripts announced it is capping OOP costs for generic drugs at $25 and branded medications at $75 for new customers that lost their jobs because of the pandemic. The temporary price limits apply to drugs for asthma, diabetes drug, glaucoma, heart disease, migraine, reproductive health, seizures and thyroid conditions.
On May 7, Moderna Therapeutics announced that FDA has cleared its vaccine candidate (mRNA-1273) for Phase II trials. Moderna previously said it could begin offering its vaccine to health care workers this fall on an experimental basis; now, it estimates it could begin Phase III trials by early summer.
On May 7, the Infectious Diseases Society of America and the HIV Medicine Association sent a letter to Vice President Pence advocating for transparency in the Administration’s process for determining the distribution of remdesivir, as well as ensuring fair distribution to states and hospitals based on confirmed cases and hospitalization rates.
On May 7, AEH sent Administrator Verma a letter urging that CMS re-open the comment period of its proposed Medical Fiscal Accountability Regulation in light of the pandemic. AEH argues that “CMS cannot responsibly move forward with consideration of the rule without accounting for COVID-19” because “now, more than ever, massive cuts to the Medicaid program would devastate providers, states, and patients alike.”
As of May 9, the U.S. had 1,283,929 confirmed COVID-19 cases resulting in 77,180 deaths, according to the Johns Hopkins University & Medicine Coronavirus Resource Center.
Axios posted a running document outlining which providers have collected from the Provider Relief Fund.
RULES AT THE WHITE HOUSE OMB
Pending Review
HHS-CMS
Conditions for Coverage for End-Stage Renal Disease Facilities—Third Party Payments (CMS-3337-P); Proposed Rule; Received 6/6/2019
International Pricing Index Model for Medicare Part B Drugs (CMS-5528-P); Proposed Rule; Received 6/20/2019
Medicare Coverage of Innovative Technologies (CMS-3372-P); Received 7/30/2019
Medicaid & CHIP Managed Care (CMS-2408-F); Final Rule; Received 9/26/2019
Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value Based Payments (VBP) for Drugs Covered in Medicaid (CMS-2482-P); Proposed Rule; Received 12/27/19
Strengthening Oversight of Accrediting Organizations (AO) and Preventing AO Conflict of Interest, and Related Provisions (CMS-3367); Proposed Rule; Received 2/18/20
Specialty Care Models to Improve Quality of Care and Reduce Expenditures (CMS-5527); Proposed Rule; Received 3/10/20
Amendments to the HHS-operated Risk Adjustment Data Validation under the Patient Protection and ACA’s HHS-operated Risk Adjustment Program (CMS-9913); Proposed Rule; Received 3/11/20
Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage (CMS-1739); Proposed Rule; Received 3/12/20
CY2021 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Rates (CMS-1736); Proposed Rule; Received 4/21/20
Payment Policies for Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) (CMS-1738); Proposed Rule; Received 4/28/20
Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Medicaid, Medicare Cost Plans, and PACE Programs (CMS-4190); Final Rule; Received 4/29/20
CY 2021 Home Health Prospective Payment System Rate Update and Quality Reporting Requirements (CMS-1730); Proposed Rule: 5/6/2020
HHS-FDA
Annual Summary Reporting Requirements Under the Right to Try Act; Proposed Rule; Received 3/31/20
HHS-OCR
Nondiscrimination in Health and Health Education Programs or Activities; Final Rule; 4/23/2020
HHS-SAMHSA
Coordinating Care and Information Sharing in the Treatment of Substance Use Disorders; Final Rule; 3/16/20
REPORTS
Government Accountability Office (GAO)
On May 8, GAO sent a report to the Senate HELP and House Energy & Commerce Committee chairman entitled Biomedical Research: HHS Has Not Yet Used New Authorities to Improve Recruitment and Retention of Scientists. According to the report, HHS has long struggled to recruit and retain personnel for science and technical roles. Therefore, the 21st Century Cures Act provided the Department additional hiring and retention authority, including allowing HHS to hire up to 2,000 scientists with certain specialized graduate degrees and increasing top pay for employees. GAO concludes that HHS has issued regulations but has not actually used their new authorities for biomedical research scientists.
HHS Office of Inspector General (OIG)
On May 4, OIG posted a report entitled Selected Health Care Coalitions (HCCs) Increased Involvement in Whole Community Preparedness But Face Developmental Challenges Following New Requirements in 2017. As reviewed by OIG, HCCs help prepare their community health care systems to respond to public health emergencies, such as natural disasters. In their sample of 20 HCCs, OIG found that nearly all of them expanded their membership since the Assistant Secretary for Preparedness & Response (ASPR) and CMS implemented new preparedness requirements in 2017. OIG made several recommendations for ASPR and CMS to clarify certain guidances to remove barriers for HCCs to develop.
On May 5, OIG released a report entitled Medicare Made $11.7 Million in Overpayments for Nonphysician Outpatient Services Provided Shortly Before or During Inpatient Stays. OIG conducted an audit to determine whether Medicare payments to hospital outpatient providers were correct for nonphysician outpatient services provided within three days before the date of admission, on the date of admission, or during IPPS stays for CYs 2016 and 2017. It concluded that Medicare made incorrect payments for 40,984 services during this time period, amounting to $11.7 million in incorrect payments paid by the program and $2.7 million in beneficiary OOP costs. OIG recommends that CMS update its Common Working File (which it claims caused the incorrect payments), recover overpayments to providers, and refund overpayments made by beneficiaries.
On May 8, OIG released a report entitled HHS Operating Division Needs to Improve Security Controls to More Effectively Prevent Cyberattacks. Due to the public health emergency and heightened cyber-activity, OIG is only posting the title of cybersecurity audits.
UPCOMING HEARINGS
Senate
HELP Committee
COVID-19: Getting Back to Work and Back to School
May 12, 10:00 a.m., 106 Dirksen Senate Office Building
Witnesses include: CDC Director Robert Redfield; Assistant Secretary for Health Brett Giroir; FDA Commissioner Stephen Hahn; and NIAID Director Fauci.
Judiciary Committee
May 12; 2:30 p.m.; G50 Dirksen Senate Office Building
Examining Liability During the COVID-19 Pandemic
Witnesses include: Kevin Smartt, CEO, Kwik Chek Convenience Stores; Anthony Perrone, International President, United Food and Commercial Workers International Union; Rebecca Dixon, Executive Director, National Employment Law Project; Leroy Tyner, Jr, General Counsel, Texas Christian University; Professor David Vladeck, A.B. Chettle Chair In Civil Procedure Georgetown University Law Center; and Helen Hill, CEO, Explore Charleston.
House
Energy & Commerce Health Subcommittee
May 14; 10:00 a.m.; 2123 Rayburn House Office Building
Protecting Scientific Integrity in the COVID-19 Response
Former BARDA Director Bright will be the sole witness.
OTHER HEALTH POLICY NEWS
On May 4, the U.S. 9th Circuit Court ruled 2-1 to maintain the nationwide injunction of the Trump administration’s policy to require immigrants to attain health insurance within 30 days of their arrival, or else prove they are capable of paying OOP costs for their care. A different panel on the 9th Circuit will determine if the policy is constitutional.
On May 5, the DOJ filed an amicus brief under Texas v. Azar, which challenges the constitutionally of the ACA’s individual mandate. In the brief, DOJ maintains its support of a lower court’s decision that deemed the individual mandate and, by extension, the entire law unconstitutional. It was widely reported that Attorney General William Barr tried to persuade Administration officials, including Vice President Pence, to change the Administration’s position and defend at least some parts of the ACA. The Supreme Court will consider the case in the fall.
On May 6, the Supreme Court heard oral arguments over the telephone for Little Sisters of the Poor v. Pennsylvania, in which an order of Catholic Nuns and the Trump administration defended a 2017 rule change that permits virtually any employer to circumvent the ACA’s so-called “contraception mandate” because of moral or religious objections. Pennsylvania and New Jersey challenged the Trump administration’s authority to broaden this policy. Overall, there did not appear to be a clear consensus among the justices about whether the 2017 policy revision should survive, though Chief Justice John Roberts’ line of question did overlap with the Court’s left-leaning members. Justice Ruth Bader Ginsburg joined the call from the hospital as she recovered from gallbladder treatment.
On May 6, it was reported that President Trump named Derek Lyons to be the Acting Domestic Policy Council (DPC) Director once Joe Grogan departs in late May. Lyons is currently the White House Staff Secretary – a position he is expected to maintain while also serving as the new Acting DPC Director.
On May 7, the U.S. District Court for the District of Columbia held oral argument over the telephone for American Hospital Association v. Azar. At issue is CMS’s rule that requires providers to disclose their negotiated charges with health insurers by January 2021. U.S. District Court Judge Carl Nichols appeared sympathetic to the Trump administration’s rule but also questioned its impact on providers’ administrative burden.
On May 7, Maryland Gov. Larry Hogan (R) vetoed legislation that would have created a fee on drug companies to pay for the state’s prescription drug affordability board. Gov. Hogan argued the proposal was “misguided” and would levy fees “at a time when already many are out of work and financially struggling.”