Coupled with IRS Notice 2020-18, the CARES Act further changes this year’s tax landscape. Net business interest deductions, noncorporate tax payments and employee wages are a few of the issues that the Act will alter. These topics and more are addressed in our earlier Duane Morris Alert.

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If you have any questions about this Alert section, please contact David A. Sussman, Maximilian Viski-Hanka, any of the attorneys in our Private Equity Group or the attorney in the firm with whom you are in regular contact.

The CARES Act contains a number of provisions that will impact an employer’s qualified retirement plans and executive compensation arrangements. Employers are encouraged to identify the provisions of the Act that will help their employees and implement them. Our summary of the changes are detailed in a previous Alert.

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If you have any questions about this Alert section, please contact W. Michael Gradisek, Timothy B. Collins, any of the attorneys in our Employee Benefits and Executive Compensation Group or the attorney in the firm with whom you are in regular contact.

The CARES Act addresses key issues for the pharmaceutical and life science industry posed by COVID-19 that relate to: (1) potential drug and medical device supply shortages and (2) delays in the approval or availability of replacement drugs and devices.

Avoiding a Medicine Shortage

Among other things, the legislation: (1) directs the Secretary of Health and Human Services to prioritize and expedite the review of NDA supplements, ANDAs and ANDA supplements that could mitigate or prevent a shortage of drugs critical to the public health during a current public emergency (Section 3111) and (2) alters the OTC monograph review process such that currently marketed drugs will be treated as “generally recognized as safe and effective” (GRASE)—and not as a new drug or a drug requiring application and approval—as long as specified requirements are met (Section 3851).

The Act is not specific as to how the policies will actually be implemented. For instance, the required prioritization of agency review of drug applications and supplements is to be implemented by the Secretary of HHS “as appropriate” without further explanation, leaving ultimate prioritization determinations up to, in this case, FDA.

Implications

The amendment of the Federal Food, Drug, and Cosmetic Act (FDCA) requiring prioritization of review of drug applications and supplements for drugs that could reduce the impact of a drug shortage during the public health emergency, incentivizes pharmaceutical manufactures to focus on developing potentially life-saving medications given the fast-tracked review process. The change also increases the likelihood that safe and effective COVID-19 drugs may be brought to market sooner than they would otherwise, given their prioritization by FDA.

As for the change to the OTC monograph review process, the Act safeguards the availability of certain nonprescription drugs currently marketed without an approved drug application. Without this change, these nonprescription drugs might otherwise be deemed misbranded in violation of the FDCA.

Impacted parties should be on the lookout for agency guidance documents or departmental emergency regulations; while the CARES Act provides a general menu of solutions that may be explored, the nuts and bolts of actually implementing the changes is less certain, and is essentially left up to HHS.

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If you have any questions about this Alert section, please contact Sandra G. Stoneman, Frederick R. Ball, Patrick C. Gallagher, Ph.D., Justin M. L. Stern, any of the attorneys in our Life Sciences and Medical Technologies Industry Group or the attorney in the firm with whom you are in regular contact.

Among the most crucial aspects of the CARES Act are the measures to assist the health response to the COVID-19 pandemic.

Healthcare providers need to be aware of:

Coverage of Testing and Preventive Services

Sections 3201 through 3203 of the CARES Act require group health plans and health insurance issuers offering group or individual health insurance to provide coverage for diagnostic testing for COVID-19, as well as any qualifying preventive services. This coverage must be without cost-sharing obligations to patients. Additionally, providers of diagnostic tests must make the price for such tests publicly available on the internet.

Supplemental Awards for Health Centers

The CARES Act appropriates $1.32 billion in supplemental funding for federally qualified health centers (FQHCs). These funds are earmarked for the detection of SARS-CoV-2 or the prevention, diagnosis and treatment of COVID-19, and are subject to the Public Health Service Act requirements applicable to FQHCs.

Public Health and Social Services Emergency Fund

In addition to the funding for FQHCs, the CARES Act appropriates $100 billion to reimburse eligible healthcare providers, through grants or other mechanisms, for healthcare-related expenses or lost revenues that are attributable to coronavirus and not reimbursed or required to be reimbursed by other sources.

Adjustment of Sequestration

Section 3709 suspends the sequestration of Medicare funds until the end of 2020. The sequestration would have reduced spending on benefits by 2 percent. 

Expansion of Quality Improvement Grant Programs

Section 3213 allows for-profit rural healthcare providers to qualify for “quality improvement grant programs” under 42 USC 254c. Previously, only nonprofits and government-owned facilities could apply.

Medicare Add-On Payments

Section 3710 increases add-on payments for Medicare payments through the COVID-19 emergency. Discharges during the emergency with a primary or secondary diagnosis of COVID-19 will have an increased weighing factor of 20 percent. Additionally, states operating under Section 1115A waivers may implement similar adjustments.

Medicare Hospital Accelerated Payment Program

In Section 3719, the CARES Act expands the Medicare Hospital Accelerated Payment Program during the COVID-19 crisis to additional types of hospitals including children’s hospitals, cancer hospitals and critical access hospitals. This increases the amount of payment that would otherwise be made to hospitals under the program up to 100 percent (or 125 percent for critical access hospitals). Hospitals may also request that the Secretary of Health and Human Services provide up to 120 days before claims are offset to recoup the accelerated payment and allow at least 12 months from the date of the first accelerated payment before requiring the payment of the outstanding balance in full.

Limitation on Liability for Volunteer Healthcare Professionals

Section 3215 of the CARES Act grants immunity to healthcare professionals providing volunteer services in response to the public health emergency. Although this provision expressly preempts conflicting state or local laws, volunteers must be acting within the scope of their license, registration or certification. 

Opportunity for Provider Input

Under Section 3101, the Secretary of HHS is directed to enter into an agreement with the National Academies of Sciences, Engineering and Medicine to evaluate and report on the security of the medical device and pharmaceutical supply chain. This directive provides an opportunity for input, indicating that the National Academies shall consult with relevant stakeholders including health care providers and state-based societies, among others.

Telehealth

Sections 3703 through 3708 expand telehealth access and direct the Secretary of HHS to promulgate regulations to that effect. The changes include payment rate amendments; temporary waiver of face-to-face requirements for home dialysis patients; and allowing physicians to use telehealth to conduct face-to-face encounters for recertification of eligibility for hospice care during the emergency period.

Post-Acute Care

Section 3711 increases access to post-acute care during the outbreak. The inpatient rehab facility (IRF) three-hour rule requiring 15 hours of therapy per week is waived during the emergency. The following long-term care hospital (LTCH) site-neutral payment rate provisions are waived: (1) the 50 percent rule relating to payment adjustments for LTCHs that do not have a discharge payment percentage for the period that is at least 50 percent and (2) site-neutral inpatient prospective payment system (IPPS) payment rate if admission is during the emergency period and is in response to the public health emergency.

Several of these provisions will take immediate effect, while others will phase in over time or through the implementation of regulations by administrative agencies. Stakeholders should consider these changes in consultation with legal counsel so that they are poised to take action as these iniatives become effective.

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If you have any questions about this Alert section, please contact Erin M. Duffy, Delphine O'Rourke, any of the attorneys in our Health Law Practice Group or the attorney in the firm with whom you are in regular contact.

Small business benefits and protection were at the heart of the CARES Act, specifically with the new Paycheck Protection Program and the Keeping American Workers Paid and Employed Act. These topics are both addressed in our earlier Duane Morris Alert. The Small Business Administration’s Economic Injury Disaster Loan (EIDL) Program is also topic of a previous Alert.

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If you have any questions about this Alert section, please contact Sandra G. Stoneman, Nanette C. Heide, any of the attorneys in our Emerging Businesses Group or the attorney in the firm with whom you are in regular contact.

Below are some of the key consumer benefits of the CARES Act and other COVID-19 relief measures.

Recovery Rebates

The IRS will send recovery rebates in the amount of $1,200 to individuals and $2,400 to couples filing joint tax returns, plus an additional $500 per child. The rebates will be reduced for individuals with adjusted gross income (AGI) above $75,000 and for couples with AGI above $150,000. There are no rebates for individuals with AGI above $99,000 and for couples with AGI above $198,000. To determine income, the IRS will use the taxpayer’s 2019 return if filed, or in the alternative, the taxpayer’s 2018 return. No action is required on the part of the taxpayer to claim the rebate.

Expanded Federal Unemployment Compensation

The CARES Act expands federal unemployment compensation in three primary ways. First, by offering an additional 13 weeks of unemployment compensation benefits for participating states. Second, by increasing unemployment checks by $600 per week for four months for participating states. Third, by extending unemployment benefits to previously ineligible workers, including self-employed workers, people seeking part-time work, workers who cannot reach their place of employment as a result of COVID-19 and those who do not have sufficient work history to otherwise qualify for unemployment compensation benefits.

No Required Minimum IRA Distribution of Age 72

Individuals 72 and older are no longer required to take the previously required IRA minimum distributions from their retirement accounts. It is hoped that this will help such individuals who do not currently need such funds regain what they have lost as the markets recover.

Added Charitable Deduction

The Act provides for a $300 above-the-line tax deduction. This means consumers who do not itemize their tax contributions will receive a financial benefit from some of their charitable donations.

Federal Tax Filing Date Extended to July 15, 2020

The Treasury Department and IRS have announced that the federal income tax filing due date was automatically extended from April 15, 2020 to July 15, 2020. Taxpayers do not need to file any additional forms or call the IRS to qualify for this automatic extension.

Waiver of 10 Percent Penalty for Early IRA Distributions

Anyone under the age of 59½ (with death and disability exceptions) is normally subject to a 10 percent penalty for taking early distributions from any IRA. The CARES Act waives this penalty for early distributions related to COVID-19 for amounts not to exceed $100,000. Distributions that qualify as being related to COVID-19 include those made by: (i) an individual who is diagnosed with COVID-19; (ii) an individual whose spouse or dependent has been diagnosed with COVID-19; and/or (iii) an individual who has experienced certain adverse financial consequences related to COVID-19 between now and the end of the year, such as being quarantined, furloughed, laid off, having work hours reduced and/or being unable to work due to lack of child care. Such distributions will still be subject to regular income tax but the tax can be spread out over three years.

Maximum Loan Amount from Workplace Retirement Plans Increased to $100,000

The maximum loan one can take from a workplace retirement plan is increased from $50,000 to $100,000.

Drug Shortage Reporting Requirements

With many medical manufacturers shifting production to combat COVID-19, such manufacturers will now be required to adopt additional reporting and contingency plans to prevent/mitigate interruptions in the supply of drugs to consumers.

For More Information

If you have any questions about this Alert section, please contact Robert B. Hopkins, Allison M. Midei, any of the attorneys in our Product Safety, Compliance and Recalls Group or the attorney in the firm with whom you are in regular contact.

As the need for personal protective equipment (PPE) to combat the COVID-19 pandemic has dramatically increased, the suppliers and manufacturing capabilities for these items are under significant strain. Along with the surge in demand, there is also the increased risk of legal liability relating to manufacturing or design defects, as well as other potential theories of liability, especially as the general public seeks out PPE in a widespread effort to avoid COVID-19.

Background

In 2005, Congress passed the Public Readiness and Emergency Preparedness Act (PREP Act), which provided broad immunity to “covered persons” (defined to include, among others, manufacturers, distributors and their agents) under state or federal law with respect to losses allegedly caused by “covered countermeasures.” These covered countermeasures included “qualified pandemic or epidemic products” approved or cleared by the FDA, which included surgical N95 respirators used in healthcare settings only. In the March 18 Families First Coronavirus Response Act, Congress broadened “covered countermeasures” to include all “personal respiratory protective devices” which are approved for use by the National Institute for Occupational Safety and Health (NIOSH), and were included in the March 2, 2020 Emergency Use Authorization (EUA) issued by the FDA, or subsequent EUAs, issued during the COVID-19 pandemic. This immunity covers uses of this equipment between January 27, 2020, and October 1, 2024, as a result of the COVID-19 outbreak. This measure expanded immunity to numerous other types of respirator masks approved by the NIOSH, but not the FDA.

Changes Under the CARES Act

Section 3103 of the CARES Act eliminates the requirement that NIOSH-approved “personal respiratory protective devices” must be included in an EUA issued under the Food, Drug and Cosmetic Act in order to qualify for immunity, and instead permits the Secretary of Health and Human Services to include such devices as “covered countermeasures” through a determination that they are “a priority for use” during a PREP Act-declared emergency. Section 3103 also removes the temporal limitation on immunity contained in the Families First Coronavirus Response Act.   

This statutory enactment is limited to personal respiratory protection devices only, and not to other kinds of PPE. Whether such equipment would be a “covered countermeasure” and thus covered by PREP Act immunity therefore depends upon whether it meets the preexisting PREP Act criteria.

Implications

These changes ensure that manufacturers and distributors of all approved respiratory masks will have broad federal and state immunity for any claims of manufacturing or design defect. This is critical given the significant usage of these respirators during the COVID-19 pandemic, especially outside of the healthcare setting, as millions of people will likely use these masks for the foreseeable future to avoid infection.

Both the Families First Coronavirus Response Act and the CARES Act do not eliminate or otherwise restrict the sole exception for immunity contained in the PREP Act for willful misconduct causing death or serious physical injury. Therefore, such liability still exists notwithstanding Congress’ expansion of the list of covered countermeasures under the PREP Act.

For More Information

If you have any questions about this Alert section, please contact Brian J. Slipakoff, Beatrice O'Donnell, any of the attorneys in our Products Liability and Toxic Torts Group or the attorney in the firm with whom you are in regular contact.

The CARES Act provides over $10 billion in new appropriations for the Department of Defense and the military branches “to prevent, prepare for, and respond to coronavirus, domestically or internationally.” The majority of the money is earmarked for Defense Production Act procurement ($1 billion); Defense Working Capital Funds ($1.45 billion), Defense Health Programs ($3.8 billion) and TRICARE ($1.1 billion). Most of the remaining funds are designated for ongoing “operation and maintenance” for the Army, Navy, Marine Corps, Air Force as well as Reserve and National Guard components. In addition to appropriating large sums, Congress also loosened some of the preexisting statutory controls over how this money can be spent and accounted for by the Department of Defense.

Expenditure Leeway

To facilitate the military’s ability to spend the newly appropriated funds, the CARES Act waives certain Defense Production Act funding limits, congressional reporting requirements and loan/guarantee limits. Similarly, certain statutory Defense Working Capital funding limit restrictions are waived. Finally, some 10 USC § 2326 restrictions on undefinitized contract actions are waived, meaning that the military may enter into certain contracts “which the contractual terms, specifications, or price are not agreed upon before performance is begun under the action.”

While the Department of Defense is granted wide discretion over how it may spend the funds to deal with the COVID-19 national emergency, no new procedural or structural safeguards are put in place to ensure that the money is spent for its intended purposes. While the TRICARE and Defense Health Programs authorizations presumably will go to preventative care and treatment of military personnel and their dependents, there is no direction in the CARES Act as to how the $1 billion in Defense Production Act funds may be spent, other than the most general of guidance.

Implications

The only express limits on the use of the $10 billion in new Defense appropriations is that it must be used “to prevent, prepare for, and respond to coronavirus, domestically or internationally.” As worded, this appropriation language provides the military with a significant discretion as to how it can use the new funds―particularly given the congressional authorization to allow the funds to “be transferred to, and merged with, other applicable appropriations of the Department of Defense… for expenses incurred in preventing, preparing for, or responding to coronavirus, including expenses of the Department of Defense incurred in support of other Federal Departments and agencies, and State, local, and Indian tribal governments.” In short, the CARES Act provides the military with significant discretion to use its appropriation to address any number of COVID-19 related contingencies or situations.

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If you have any questions about this Alert section, please contact Michael J. Schrier, any of the attorneys in our Government Contracts and International Trade Group or the attorney in the firm with whom you are in regular contact.

The CARES Act provides aid for charitable and nonprofit organizations, while also encouraging individuals to support charitable organizations.

First, the CARES Act allocates $75 million the National Endowment of the Arts and $75 million to the National Endowment for the Humanities for grants to prepare for and respond to COVID-19; 40 percent of these funds are for state agencies and 60 percent may be used for direct grants.

Second, the stimulus bill establishes a nonprofit lending program with interest rates at no more than 2 percent for nonprofits with 500 to 10,000 employees. Nonprofits can also apply for forgivable Small Business Administration loans to keep people employed.

Finally, to encourage taxpayers to support charities, the Act will allow taxpayer who do not itemize deductions to deduct up to $300 in contributions to charitable organizations. The Act also raises the annual cap on the deduction for cash charitable contributions for those who itemize, increasing it (for 2020 only) from 50 percent to 100 percent of adjusted gross income. For corporations, the Act increases the annual limit from 10 percent to 25 percent of taxable income, for 2020 only.

For More Information

If you have any questions about this Alert section, please contact Lisa C. Merrill, any of the attorneys in our Corporate Practice Group or the attorney in the firm with whom you are in regular contact.

The CARES Act is designed to expand the availability and speed of broadband internet service and availability of broadband devices, particularly to healthcare providers (to promote remote treatment and monitoring of patients), schools (to allow distance learning) and rural areas. A related issue is providing broadband service and devices at reduced rates, or for free, to low-income households.

Fund Allocation and Implementation

The CARES Act gives the FCC $200 million for its Connected Care Pilot Program to enable healthcare providers to use telecommunications services, information services (like broadband internet) and devices (smartphones, tablets) to provide telehealth treatment. To address rural issues, the bill gives the Department of Agriculture $25 million for its Distance Learning and Telemedicine program for rural areas, and $100 million for its ReConnect Program to promote broadband deployment in rural areas. The bill also authorizes the Secretary of Veterans Affairs to enter short-term contacts with telecommunications companies to expand mental health service to veterans through telehealth programs.

The details of implementation are left to the agencies that oversee existing programs, so the stimulus bill does not address precisely how the money will be allocated to specific entities. A key issue that is not addressed is extra funding for the FCC’s Lifeline program to expand broadband and wireless service to low-income customers, though there will be a push to address that in the next stimulus bill. Another open issue is whether express congressional permission is needed before the FCC can use funds from its E-Rate Program to pay for broadband devices used outside school grounds (a legal issue on which the FCC is split).

Implications

The changes should accelerate broadband coverage in rural areas and improve broadband speed in other areas, but there will certainly be a push for more funding in future bills. The current funding will provide an opportunity for broadband providers to be the first to serve new areas where deployment previously was uneconomic. Given the potential long-term business gains from being first in an area, competition for the funds may be fierce.

For telecommunications providers, the stimulus could present an opportunity to expand their broadband footprint and improve speeds at lower cost. However, providers should be prudent and recognize the cost of maintaining such an expanded footprint over the long term.

For More Information

If you have any questions about this Alert section, please contact J. Tyson Covey, Sandra A. Jeskie, any of the attorneys in our Technology, Media and Telecom Industry Group or the attorney in the firm with whom you are in regular contact.

The COVID-19 pandemic raises immediate and pressing issues as to whether certain insurance policies will provide coverage for COVID-19-related losses. Specifically, it is anticipated that policyholders will seek business interruption coverage (often part of commercial property insurance policies), event cancellation coverage and liability coverage due to the cancellation of events, shuttering of businesses and other claims.

Additionally, in the health insurance arena, there are issues of whether treatment and diagnostics will be covered under health insurance plans.

Requirements for Health Insurers

Under the precursor to the CARES Act, the March 18 Families First Coronavirus Response Act, health insurers are required to cover testing for COVID-19 without imposing cost-sharing on policyholders, including deductibles, coinsurance and copayments. 

The CARES Act goes further, requiring health insurers to cover “qualifying coronavirus preventive service[s]” without cost sharing.  “Qualifying coronavirus preventive service[s]” is defined to include “an item, service, or immunization that is intended to prevent or mitigate coronavirus disease 2019.” In other words, vaccines and other preventive services or items will be covered by health insurers to the extent they receive a passing grade by the specified regulatory agencies.

Litigation Expected

As reported by our attorneys on the Duane Morris Insurance Law blog, the first lawsuit concerning business interruption coverage for COVID-19-related losses was filed March 17, and state legislatures are attempting to require retroactive business interruption coverage for small businesses. However, the CARES Act does not address these issues. Thus, at the present time, it appears that these issues will be litigated in the court system under state law unless there is legislative intervention, which would undoubtedly also be challenged in court.

Implications

With passage of the CARES Act and the Families First Coronavirus Response Act, insured patients can be reassured that their preventive treatment, testing and future vaccines will be covered by their health insurance without the added stressor of having to worry about copayments and deductibles. This is critical given the rate of transmission and the anticipated timeline of this pandemic.

Neither the Families First Coronavirus Response Act nor the CARES Act provides guidance as to whether business interruption coverage, event cancellation coverage or other relevant coverage will function to cover COVID-19-related losses. State laws will determine how language under these policies is interpreted and ultimately whether coverage is available for COVID-19-related losses. Impacted parties should monitor these rapidly changing developments, including the progress of coverage lawsuits and legislative action.

For More Information

If you have any questions about this Alert section, please contact Dominica C. Anderson, Gina M. Foran, any of the attorneys in our Insurance & Reinsurance Group or the attorney in the firm with whom you are in regular contact.

The cruise line industry has been particularly hard hit by COVID-19. Most lines, which have high fixed costs, have suspended operations. The CARES Act provides for over $500 billion for loans or guarantees but at present it is still unclear whether cruise lines will benefit.

Many major cruise lines that initiate voyages out of U.S. ports are not incorporated in the United States, operate vessels flagged in other countries and often employ non-U.S. citizens as vessel crew. However, many American jobs are supported by the cruise line industry, including port workers, travel agents, vessel supply workers, longshoremen, nonseaman staff working aboard such ships and crews employed aboard tugs and barges that assist cruise ships in U.S. ports. The Cruise Lines International Association estimates that over 421,000 American jobs are supported by cruise lines.

The Act specifically states that a company must be “created or organized in the United States or under the laws of the United States” and “have significant operations in and a majority of its employees based in the United States.” Although President Trump has indicated he wants to help the cruise line industry, the fact that such lines are incorporated outside the U.S. likely means that such cruise lines will not qualify for any relief.

For More Information

If you have any questions about this Alert section, please contact Robert B. Hopkins, any of the attorneys in our Maritime, Shipping and International Trade Group or the attorney in the firm with whom you are in regular contact.

The CARES Act provides unprecedented relief to help employers stay in business and retain their employees, while expanding some benefits to the “gig-economy” workforce. A summary of these new measures and the strict obligations they carry is available in a separate Alert.

For More Information

If you have any questions about this Alert section, please contact Eve I. Klein, any of the attorneys in our Employment, Labor, Benefits and Immigration Practice Group or the attorney in the firm with whom you in regular contact.

Although the CARES Act does not specifically provide relief to the construction and engineering sector for delayed or cancelled projects because of COVID-19, the industry may still benefit from the Act’s wide range of benefits and financial resources available to businesses of all kinds. Additionally, construction and engineering companies should examine their contracts and carefully document delays to protect their interests. Our sepatate Alert summarizes the CARES Act provisions and our recommendations.

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If you have any questions about this section of the Alert, please contact Jeffrey L. Hamera, Benton T. Wheatley, Michelle Ranello, any of the attorneys in our Construction and Engineering Industry Group or the attorney in the firm with whom you are in regular contact.

The transportation industry, commercial airlines in particular, has been decimated in the wake of COVID-19. The CARES Act provides more than $100 billion in assistance to commercial and cargo carriers, as well as rail companies like Amtrak and transit workers, as detailed in our separate Alert.

For More Information

If you have any questions about this section of the Alert, please contact Alan C. Kessler, Michael E. Barnicle, Jamie E. Brown, any of the attorneys in our Transportation, Automotive and Logistics Industry Group or the attorney in the firm with whom you are in regular contact.