Category: COVID-19

Monkeypox—Do Employers Need to Worry?

Several cases of monkeypox have now been found in the United States. We do not yet know whether employers will need to worry about monkeypox in the context of their workforces and workplace, but it may be wise to be informed.

Monkeypox is a viral illness that has symptoms including body aches, headaches, fatigue, and, notably, a bumpy skin rash. It is primarily found in Africa, most particularly in the Democratic Republic of the Congo. Monkeypox has an incubation period that generally lasts 7-14 days but can be as long as 5-21 days. It has now recently been found in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). The first case reported was in Massachusetts in a man who had been to Canada. The second was in New York City by another individual who had a virus similar to monkeypox. And the third was a “presumptive case” involving a Broward County, Florida, man who had traveled internationally, the CDC said.

Unlike what we have been through with COVID-19, wearing a mask will likely not be an issue with monkeypox. It is spread through infected animals, prolonged person-to-person contact, direct contact with lesion materials, or indirect contact through contaminated items, such as contaminated clothing. Avoiding these will help avoid the possibility of infection. Since frequent handwashing continues to be a good hygiene practice, continuing to make this an easy and frequent practice for employees is generally a good health practice, according to health officials.

Monkeypox has also recently been found in Australia, Belgium, Canada, France, Germany, Italy, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. According to public health officials, the risk of exposure remains low although there are expected to be more cases in the United States. Health officials believe the smallpox vaccination will offer some amount of protection from monkeypox.

Employers that have employees who are soon to travel internationally, either for personal or business reasons, may want to consider educating them on the symptoms, how the virus is transmitted, and the fact that they may wish to consult with their own healthcare practitioners about the smallpox vaccination. There is no indication that travel should be avoided or prohibited.

Article By Katherine Dudley Helms of Ogletree, Deakins, Nash, Smoak & Stewart, P.C.

For more labor and employment legal news, click here to visit the National Law Review.

© 2022, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

Medicare Advantage: OIG Report Finds Improper Denials

On April 27,2022, the Office of Inspector General of the Department of Health and Human Services (OIG), Office of Evaluations and Inspections, issued a report on the performance of Medicare Advantage Organizations (MAOs) in approving care and payment consistently with Medicare coverage rules. In its review, OIG found that 13% of MAO denials of prior authorization requests should have been approved and that 18% of payment requests from providers were improperly denied. OIG also made a number of recommendations to the Center of Medicare and Medicaid Services (CMS) with respect to its oversight of MAOs.

Purpose and Method of the Study

OIG undertook the study to assess whether MAOs are appropriately providing access to medically necessary services and making payment to providers consistently with Medicare coverage rules. Since CMS pays MAOs principally by capitation, MAOs have a potential incentive to increase their profits by denying access to care of beneficiaries or by denying payments to providers. CMS’s annual audits of MAOs have indicated some persistent problems related to inappropriate denials of service and payment. As enrollment in Medicare Advantage continues to grow, OIG viewed it as important to ensure that medically necessary care is provided and that providers are paid appropriately.

OIG conducted the review by randomly selecting 250 denials of prior authorization requests and 250 payment request denials by 15 of the largest MAOs during a week in June of 2019. OIG had coding experts review the cases and had physician reviewers examine the medical records. Based on these reviews, OIG estimated the rates at which MAOs issued denials of services or payment that met Medicare coverage rules and MAO billing rules. OIG also examined the reasons for the inappropriate denials and the types of services involved.

Standards

MAOs must cover items and services included in fee-for-service Medicare, and may also elect to include additional items and services. MAOs are required to follow Medicare coverage rules that define what items and services are covered and under what circumstances. As the OIG states in the Report, MAOs “may not impose limitations – such as waiting periods or exclusions from coverage due to pre-existing conditions — that are not present in original Medicare.” In following Medicare coverage rules, MAOs are permitted to use additional denial criteria that were not developed by Medicare when they are deciding to authorize or pay for a service, provided the clinical criteria are “no more restrictive than original Medicare national and local coverage policies.” MAOs may also have their own billing and payment procedures, provided all providers are paid accurately, timely, and with an audit trial.

MAOs utilize prior authorization requests before care is furnished to manage care and payment requests from providers to approve payment for services provided. Beneficiaries and providers may appeal such decisions, and beneficiaries and providers are successful in many of the appeals (for a one-time period, as many as 75% of the appeals were granted).

Findings

Prior Authorization Denials

In the study, OIG found that 13% of prior authorization denials were for services that met Medicare coverage rules, thus delaying or denying care that likely should have been approved. MAOs made many of the denials by applying MAO clinical criteria that are not part of Medicare coverage rules. As an example, a follow-up MRI was denied for a beneficiary who had an adrenal lesion that was 1.5 cm in size, because the MAO required the beneficiary to wait one year for such lesions that are under 2 cm in size. OIG’s experts found such a requirement was not contained in Medicare coverage rules and was therefore inappropriate. Rather, the MRI was medically necessary to determine if the lesion was malignant.

OIG also found instances where MAOs requested further documentation that led to a denial of care when it was not furnished, as such additional documentation was not required to determine medical necessity. OIG’s reviewers found that either sufficient clinical information was in the medical record to authorize the care or the documentation requested was already contained in the medical record.

Payment Denials

OIG found in the study that 18% of payment denials fully met Medicare coverage rules and MAO payment policies. As a result of these denials, payment was delayed or precluded for services that should have been paid.

OIG found that common reasons for these inappropriate payment denials were human error in conducting manual reviews (for example, the reviewer not recognizing that a skilled nursing facility (SNF) was an in-network provider), and inaccurate programming.

OIG also found that advanced imaging services (including MRIs and CT scans), stays in post-acute facilities (including SNFs and inpatient rehabilitation facilities), and injections were the services that were most prominent in the inappropriate denials that should have been authorized for care and payment in accordance with Medicare coverage rules.

OIG Recommendations

Based on the study, OIG recommended that:

  • CMS should issue new guidance on both the appropriate and inappropriate use of MAO clinical criteria that are not contained in Medicare coverage rules. In particular, OIG recommended that CMS should more clearly define what it means when it states that MAO clinical criteria may not be “more restrictive” than Medicare coverage rules.

  • CMS should update its audit protocols to address issues identified in the report such as MAO use of clinical criteria and/or examine particular service types that led to more denials. OIG suggests CMS should consider enforcement actions for MAOs that demonstrate a pattern of inappropriate payment denials.

  • CMS should direct MAOs to identify and address the reasons that led to human errors.

CMS reviewed the OIG report and concurred with each of OIG’s recommendations. Those recommendations can affect future coverage decisions as well as utilization of prior authorization tools. AHIP, a national association of health care insurers, challenged the OIG’s sample size as inappropriate to support the agency’s conclusions, and defended prior authorization tools.

Takeaways

Given CMS’s concurrence with the report’s findings, we recommend that MAOs track these issues over the next several months in advance of CMS’s Final Rate Announcement for CY 2024.

MAOs should also be aware of potential False Claims Act (FCA) exposure in this area. FCA exposure can arise when a company seeks and receives payments despite being out of compliance with the basic terms for its participation. If an MAO knew it was denying claims that should be paid because they would be covered under traditional Medicare, but the MAO was still collecting full capitation, it is possible that a whistleblower or the government may pursue FCA liability. This risk warrants attention because whistleblowers can bring qui tam suits under the FCA, with resulting high costs for defense and potentially high penalties if a violation is proven (or settled to avoid further litigation). That said, an FCA suit based on this theory would raise serious questions, including whether any non-payment actually met the FCA’s “knowingly” standard (which includes reckless disregard), or whether any non-payment met the materiality threshold necessary to demonstrate a violation of the FCA.

Article By Alexis Finkelberg Bortniker, C. Frederick Geilfuss II, Matthew D. Krueger, Maureen F. Kwiecinski, and Kinal M. Patel at Foley & Lardner LLP

For more health law and managed care news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

Alabama Enacts New Telemedicine Law

Alabama Governor Kay Ivey recently signed SB 272 into law, setting forth telemedicine practice standards and abolishing Alabama’s previous “special purpose license” that allowed physicians licensed in other states to practice across state lines into Alabama. The law is effective July 11, 2022.

The law creates a new article in the Code of Alabama (Sections 34-24-701 through 34-24-707 of Chapter 24, Title 34). The statutory language is lengthy, but the key provisions are summarized below.

Medical License

Unless the physician meets an exception to licensure (e.g., peer-to-peer consultations, irregular or infrequent services), a physician must obtain either a full Alabama medical license or a license via the Interstate Medical Licensure Compact in order to provide “telehealth medical services” to a patient located in Alabama.

  • Telehealth medical services means “[d]igital health, telehealth, telemedicine, and the applicable technologies and devices used in the delivery of telehealth. The term does not include incidental communications between a patient and a physician.
  • The term “irregular or infrequent” services refers to “telehealth medical services” occurring less than 10 days in a calendar year or involving fewer than 10 patients in a calendar year.

Defined Terms and Allowable Modalities

  • Telehealth is defined as “[t]he use of electronic and telecommunications technologies, including devices used for digital health, asynchronous and synchronous communications, or other methods, to support a range of medical care and public health services.”
  • Telemedicine is defined as “[a] form of telehealth referring to the provision of medical services by a physician at a distant site to a patient at an originating site via asynchronous or synchronous communications, or other devices that may adequately facilitate and support the appropriate delivery of care.” The term includes digital health, but does not include incidental communications between a patient and a physician.
  • Digital Health is defined as “[t]he delivery of health care services, patient education communications, or public health information via software applications, consumer devices, or other digital media.”
  • Asynchronous is defined as “[t]he electronic exchange of health care documents, images, and information that does not occur in real time, including, but not limited to, the collection and transmission of medical records, clinical data, or laboratory results.”
  • Synchronous is defined as “[t]he real-time exchange of medical information or provision of care between a patient and a physician via audio/visual technologies, audio only technologies, or other means.”

Physician-Patient Relationship

A physician-patient relationship may be formed via telehealth without a prior in-person exam.

Telemedicine Prescribing of Medications and Controlled Substances

A practitioner may prescribe a legend drug, medical supplies, or a controlled substance to a patient via telehealth. However, a prescription for a controlled substance may only be issued if:

  1. The telehealth visit includes synchronous audio or audio-visual communication using HIPAA compliant equipment;
  2. The practitioner has had at least one in-person encounter with the patient within the preceding 12 months; and
  3. The practitioner has established a legitimate medical purpose for issuing the prescription within the preceding 12 months.

In-Person Visit for Unresolved Medical Condition

If a physician or practice group provides telehealth medical services more than 4 times in a 12-month period to the same patient for the same medical condition without resolution, the physician must either see the patient in-person within 12 months or refer the patient to a physician who can provide the in-person care within 12 months. This in-person visit requirement does not apply to the provision of mental health services.

The Alabama Board of Medical Examiners and the Alabama Medical Licensure Commission are currently developing administrative rules in accordance with the new law.

Article By Kristen A. Murphy and Jacqueline N. Acosta of Foley & Lardner LLP

For more health law legal news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

COVID-19 Healthcare Enforcement Actions to Increase in 2022 and Beyond

“The Department remains committed to using every available federal tool—including criminal, civil, and administrative actions—to combat and prevent COVID-19 related fraud. We will continue to hold accountable those who seek to exploit the pandemic for personal gain, to protect vulnerable populations, and to safeguard the integrity of taxpayer-funded programs”

US Attorney General Merrick Garland – March 10, 2022, Remarks

The Biden Administration, US Department of Justice (DOJ), US Department of Health and Human Services Office of Inspector General (HHS-OIG), and other federal agencies have prioritized prosecuting COVID-19-related fraud since the pandemic began. Although the United States appears to be finally emerging from the pandemic, the government’s pandemic-related enforcement actions are here to stay for the foreseeable future. DOJ has made clear that the government’s COVID-19 enforcement efforts will accelerate, with a more significant focus on complex healthcare fraud cases and civil actions under the False Claims Act (FCA). As the federal government continues to devote additional resources towards its pandemic-related enforcement efforts, healthcare companies, hospital systems and providers should prepare for increased scrutiny.

Additional Resources Devoted to COVID-19 Fraud Enforcement Efforts

DOJ and other federal agencies have already devoted an unprecedented amount of resources to investigating and prosecuting pandemic-related fraud cases. These extensive efforts have led to immediate results. To date, DOJ has brought pandemic-related criminal charges against more than 1,000 individuals with the total alleged fraud losses exceeding $1 billion, and has seized more than $1.2 billion in fraudulently obtained relief funds.

DOJ’s pandemic-enforcement efforts show no sign of slowing down anytime soon. Less than a year after US Attorney General (AG) Merrick Garland established the COVID-19 Fraud Enforcement Task Force, the Biden administration announced that DOJ would appoint a chief prosecutor to expand on the Task Force’s “already robust efforts,” to focus on “most egregious forms of pandemic fraud” and to target particularly complex fraud schemes.

On March 10, 2022, DOJ announced that Kevin Chambers has been appointed as DOJ’s director for COVID-19 fraud enforcement. During his introductory remarks, Chambers said that DOJ would be “redoubling [its] efforts to identify pandemic fraud, to charge and prosecute those individuals responsible for it and whenever possible, to recover funds stolen from the American people.” He also indicated that DOJ would use “new tools” it has developed since the start of the pandemic to investigate such fraud.

In a March 2, 2022, speech before the American Bar Association’s Annual National Institute on White Collar Crime, AG Garland also announced that the Biden Administration will seek an additional $36.5 million in the 2022 budget for DOJ to “bolster efforts to combat pandemic-related fraud.” As evidence of this point, DOJ plans to hire 120 new prosecutors and 900 new Federal Bureau of Investigation agents who will focus on white-collar crime.

DOJ and HHS-OIG to Increasingly Focus on FCA Cases

For the past two years, officials from DOJ and HHS-OIG have identified civil and criminal healthcare fraud relating to COVID-19 as a high priority. As the effects of the pandemic subside, COVID-19-related civil enforcement actions targeting healthcare providers and healthcare companies seem set to increase.

During remarks at the Federal Bar Association’s annual Qui Tam Conference in February 2022, Gregory Demske, chief counsel to the inspector general for HHS-OIG, emphasized that COVID-19 remains a key enforcement priority. Demske indicated that HHS-OIG is focused on the use of COVID-19 to bill for medically unnecessary services, and fraud in connection with HHS’s Provider Relief Fund (PRF) and Uninsured Relief Fund. Demske also confirmed that HHS-OIG remains intensely focused on fraud in connection with telehealth services, the use of which increased exponentially during the pandemic. And, in March 2022, AG Garland reiterated that DOJ will use “every available federal tool—including criminal, civil, and administrative actions—to combat and prevent COVID-19 related fraud.”

The majority of pandemic-related healthcare enforcement actions to date have been criminal prosecutions involving truly blatant instances of fraud and abuse. Going forward, civil and administrative actions likely will be used to pursue cases that turn on lower mens rea requirements or involve more complex regulatory issues. These civil actions will include qui tam actions filed by whistleblowers, as well as FCA cases initiated directly by the DOJ.

In 2021, DOJ recovered more than $5 billion in connection with FCA cases involving the healthcare industry. Given the unprecedented amount of government funds expended to combat the COVID-19 pandemic, DOJ and HHS-OIG will undoubtedly rely on the FCA to maximize the government’s financial recovery. DOJ has already reached FCA settlements in several Paycheck Protection Program cases. It is only a matter of time before we see similar FCA investigations, complaints and settlements focused on relief funding to healthcare providers.

Pandemic-Related Healthcare Priorities

HHS’s PRF

The PRF was created as part of the Coronavirus Aid, Relief and Economic Security (CARES) Act to provide direct payments to “eligible health care providers for health care-related expenses [and] lost revenues that are attributable to coronavirus.” More than $140 billion has been disbursed to hospitals and healthcare providers under the PRF, which is administered by the Health Resources & Services Administration (HRSA).

Payments under the PRF are subject to specific terms and conditions. To retain PRF disbursements, providers must attest to “ongoing compliance” with these requirements and acknowledge that their “full compliance with all Terms and Conditions is material to the Secretary’s decision to disburse funds.” Notwithstanding ongoing concerns and confusion regarding the PRF program requirements, any noncompliance with the terms and conditions could result in criminal, civil and administrative enforcement actions. As recently as March 3, 2022, AG Garland identified fraud in connection with the PRF as a key DOJ enforcement priority.

To date, the Healthcare Fraud Unit of DOJ’s Criminal Division has already brought criminal charges against nine individuals for fraud relating to the PRF. These criminal cases, however, have almost exclusively focused on egregious allegations of fraud and abuses, such as misappropriating PRF disbursements and using the money for personal expenses. For example, in September 2021, DOJ charged five individuals with using PRF payments to gamble at Las Vegas casinos and purchase luxury cars.

DOJ, however, has long indicated that the FCA will also play a “significant role” in DOJ’s PRF enforcement efforts. It is now just a matter of time before such civil investigations and settlements emerge.

HRSA’s stated oversight plan includes post-payment analysis and review to determine whether HHS distributed PRF payments to eligible providers in the correct amounts; audits to assess whether recipients used the funds in accordance with laws, guidance, and terms and conditions; and the recovery of overpayments and unused or improperly used payments. Among other things, HRSA and HHS-OIG likely will evaluate ownership changes, double counting reimbursed expenses and losses, and compliance with the balanced billing requirements.

PRF oversight and enforcement actions have been delayed partly because of program complexities and extended reporting timelines. For example, the first report from PRF recipients on use of funds was not due until the end of 2021. Depending on the date funds were received, PRF recipients may have no reporting obligations through 2023. Entities that expended more than $750,000 in federal awards, including PRF payments, also must obtain an independent audit examining their financial statements; internal controls; and compliance with applicable statutes, regulations and program requirements. These independent audits of PRF payments must be submitted to the Federal Audit Clearinghouse, for nonprofit organizations, or the HRSA Division of Financial Integrity, for for-profit “commercial” organizations. Recipients also may be subject to separate audits by HHS, HHS-OIG or the Pandemic Response Accountability Committee to review copies of records and cost documentation and to ensure compliance with the applicable terms and conditions.

Finally, DOJ and HHS-OIG have increasingly relied on sophisticated data analytics to drive their healthcare enforcement efforts generally. Now that the first round of reports containing specific PRF data certifications are available to HRSA and HHS-OIG, we expect to see the use of such analytics, in conjunction with all the other available information, in connection with PRF enforcement.

Telehealth

Telehealth use expanded exponentially during the pandemic. A March 2022 HHS-OIG report showed that during the first year of the pandemic, more than 28 million Medicare beneficiaries (approximately 43% of all Medicare beneficiaries) used telehealth services—a “dramatic increase from the prior year” in which only 341,000 beneficiaries used telehealth. This increase was largely the result of HHS temporarily waiving statutory and regulatory requirements related to telehealth to allow Medicare beneficiaries to obtain expanded telehealth services.

Telehealth has been at the forefront of DOJ’s healthcare enforcement efforts for years now. For example, DOJ’s 2021 nationwide healthcare enforcement action included criminal charges against dozens of individuals for telehealth fraud schemes involving more than $1.1 billion in alleged loses. The majority of these telehealth enforcement actions to date have involved the use of telehealth to engage in traditional fraud healthcare schemes, such as illegal kickbacks and billing for medically unnecessary services and equipment.

DOJ, however, has increasingly pursued criminal enforcement actions directly related to the telehealth waivers HHS issued in response to the pandemic. For example, in November 2021, a defendant was sentenced to 82 months in prison for participating in a $73 million telehealth fraud scheme. The defendant owned laboratories that provided genetic testing and had paid his coconspirators to arrange for telehealth providers to order medically unnecessary genetic tests. The telehealth providers were not actually treating the beneficiaries, did not use the test results and often never even conducted the telemedicine consultation. Although this was primarily a traditional Anti-Kickback Statute/medical necessity case, DOJ also charged the defendant with using the COVID-19-related telehealth waivers to submit more than $1 million in false claims for sham telemedicine visits.

Similar criminal prosecutions and civil actions relating to the expanded telehealth waivers and sham telehealth encounters can be expected in the future. DOJ and HHS-OIG will likely focus on telehealth visits that resulted in claims for services and equipment with particularly high reimbursement rates, such as genetic testing and durable medical equipment. DOJ and HHS-OIG likely will use data analytics to focus on instances in which telehealth services were billed by providers with whom the beneficiary did not previously have a relationship.

Improper Billing Schemes

DOJ has also pursued criminal cases involving traditional healthcare fraud schemes that sought to take advantage of the COVID-19 pandemic. For example, in May 2021, DOJ announced criminal charges against numerous individuals who were improperly bundling COVID-19 tests with other more expensive laboratory tests, such as genetic testing, allergy testing and respiratory pathogen panel testing. DOJ has likewise pursued criminal cases in which defendants improperly used COVID-19 “emergency override” billing codes to circumvent preauthorization requirements and bill Medicare for expensive medications and treatments. Any improper billing schemes that relate to the pandemic will continue to be a focus of criminal and civil enforcement efforts going forward.

Key Takeaways and Recommendations

DOJ, HHS-OIG and other federal agencies remain focused on pursuing healthcare fraud relating to the COVID-19 pandemic. The best way for hospitals, health systems and other healthcare companies and providers to prepare for this increased enforcement activity and scrutiny is to ensure that they have a robust compliance program in place.

There is no one-size-fits-all approach to compliance, but companies can take several proactive and practical steps to minimize their enforcement risk:

  • Monitor federal and state regulatory and statutory changes. The rules, regulations and guidance relating to the COVID-19 pandemic, including for the PRF and expanded telehealth waivers, have repeatedly changed over the past two years and continue to evolve. Monitoring such changes will not only help prevent enforcement actions, but a company’s reasonable and good faith efforts to interpret and follow such rules and regulations can be a powerful defense should an investigation arise, as discussed in connection with the Allergan case, above. Further to that point, where regulatory requirements and associated guidance is ambiguous, a good documentary record of the basis for your entity’s interpretation of the rules is critical.
  • Incorporate data analytics into your compliance program. DOJ and HHS-OIG continue to rely heavily on sophisticated data analytics, including artificial intelligence, to identify and prosecute fraud. In March 2022, AG Garland emphasized DOJ’s use of “big data” to identify payment anomalies that are indicative of fraud. Healthcare companies already have access to vast amounts of data that they can and should use to proactively identify errors, monitor risk areas and address any potential misconduct.
  • Adapt your compliance program and internal controls, as appropriate, to support PRF compliance, reports and audits. Recipients should continue to practice good compliance hygiene and maintain contemporaneous records regarding the receipt and spending of federal funds. Doing so may involve implementing additional systems to track spending, recovery and relief to avoid overlapping use of funds among relief programs, or consulting with grant accounting and compliance advisors to augment existing infrastructure. Recipients also should periodically review policies, procedures and controls, particularly following major updates to program requirements and interpretations.
  • Ensure the accuracy of required PRF reports, certifications and submissions. Particularly in light of ongoing political pressure, HRSA and HHS-OIG likely will conduct extensive oversight of the PRF to identify potential errors, overpayments and improper use of funds. Recipients should carefully review guidance and instructions to avoid inadvertent errors and misstatements on all submissions. Recipients may consider revisiting prior submissions underlying significant disbursements to identify interpretative issues or compliance concerns that warrant additional supporting documentation or disclosure.
  • Carefully consider the implications before entering into arrangements with other parties. The biggest risk to healthcare companies often comes from those with whom they do business. Compliance programs should focus heavily on reducing the risk of entanglement with bad actors.
  • Be diligent in the design and oversight of marketing strategies. Healthcare companies and providers should regularly review their marketing strategies to ensure total transparency and compliance (both historic and prospective) with applicable state and federal anti-kickback statutes. Companies should confirm that patients are reached through appropriate channels. Although issues relating to COVID-19 may be the impetus for a government investigation, violations of the Anti-Kickback Statute frequently result in larger recoveries for the government.
  • Proactively examine coding and billing practices. Providers should immediately review and revisit their coding and billing practices to determine if their practices involved bundling COVID-19 testing with other claims, the use emergency override billing codes or billing for other COVID-19 related services with high reimbursement rates. There is a strong likelihood that the DOJ will review the claims data for any providers with statistically significant use of these billing and coding practices, particularly when the providers are located in geographical areas where the DOJ’s Healthcare Fraud Strike Force and HHS-OIG’s Medicare Fraud Strike Force operate.

Article By Julian L. André, Benton Curtis, and Dawn R. Helak of McDermott Will & Emery

For more health law legal news, click here to visit the National Law Review.

© 2022 McDermott Will & Emery

Return to Work Considerations – COVID and the ADA

Employers are contending with difficult challenges unlike any time in modern history. Even though many employees, especially in the manufacturing industry, returned to work after working from home during the COVID pandemic, the effects of the increased flexibility seen during the COVID era linger. Many employees enjoyed the benefits of working from home during the last two years, even if only part-time, and do not want to give up the benefit. By contrast, and especially as COVID restrictions ease, employers often desire their workforce return to work in a more consistent and routine capacity. These tensions are further complicated by an extremely competitive labor market. Recruiting and retaining employees is a challenge in the current environment. Against this backdrop, prudent employers will keep in mind employment law considerations when developing return-to-work and work-from-home policies.

Where should an employer look to determine what accommodations it should make for an employee who wishes to work from home, either due to a COVID diagnosis and/or a condition that places the employee at a heightened risk for severe COVID? Early in the pandemic, local or state health orders answered such questions regarding COVID-related leave. As the pandemic continued, many of those local health orders were rescinded or expired. As a result, employers are left without clear local guidance. When local requirements are of no assistance, employers should look to CDC guidance for quarantining and isolating guidelines.

In addition, employers should keep in mind that COVID may qualify as a “disability” depending on the symptoms and their severity. If an employee tests positive for COVID and is experiencing symptoms that require an absence from work that is longer than the CDC recommended quarantine period, employers should involve legal counsel to analyze whether the employee’s COVID diagnosis constitutes a disability under the ADA. If it does constitute a disability, the employer is then required to engage in the interactive process under the ADA with the employee to determine whether a reasonable accommodation for the disability can be made. Leave can be an accommodation under the ADA, as can working from home, in certain circumstance and for certain roles.

Likewise, some disabilities may heighten the risk of severe COVID symptoms. In the event that such a disabled employee requests an accommodation related to this heightened risk of COVID, the employer should treat the request as it would any request for accommodation under the ADA. As always, employers should seek legal counsel and check local requirements regarding COVID leave when considering accommodations for employees in these circumstances.

Employers have many competing and challenging considerations when determining a company’s return-to-work policy. While the labor shortage, industry, and specific role considerations certainly play a part in those decisions, employers should not lose sight of the ADA’s additional requirements. The ADA may play a role on an individual level and affect whether an employee may seek leave, work from home, or is entitled to other accommodations related to a COVID diagnosis or high-risk factors.

Article By Felicia S. O’Connor of Foley & Lardner LLP

For more labor and employment legal news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

Legal News Reach – Season 2, Episode 1: Immigration & Its Impacts on the U.S. Labor Market with Raymond Lahoud [PODCAST]

Welcome to our first episode of Season 2! Rachel and Jessica speak with Raymond Lahoud, a Member of Norris McLaughlin, P.A., focusing on immigration law. Immigration issues are complicated enough, but how does that factor into boosting the U.S. economy?  Listen to our last episode to find out more.

Be sure to also check out the latest episode of Mr. Lahoud’s podcast, “Immigration Matters.”

We’ve included a transcript of our conversation below, transcribed by artificial intelligence. The transcript has been lightly edited for style, clarity, and readability.

Full Transcript

INTRO  00:02

Hello and welcome to Legal News Reach, the official podcast for The National Law Review. Stay tuned for our discussion on the latest trends, legal marketing, SEO, law firm best practices, and more.

Rachel  00:15

Today’s episode is the first of the second season, where we’re broadening our focus to trending topics in the legal industry. Today we’re speaking with Ray Lahoud, Member of North McLaughlin about the impact of COVID-19 on immigration and labor shortages. Ray, would you like to tell our listeners a little bit about yourself?

Raymond Lahoud  00:30

Well, thanks for having me, Rachel. It’s really awesome to be here on this podcast and to talk about such an interesting area of law right now, in the world, particularly immigration law. I’m a partner at Norris McLaughlin, where I serve as the Chair of the Immigration Law Group here. I handle employment-based immigration matters, removal defense, employment, verification, I noncompliance all types of immigration matters, a broad spectrum with my great team of attorneys, paralegals, and assistants here at North McLaughlin. So thank you again for having me. It’s great to be here.

Rachel  01:05

One of the first topics we wanted to focus on here is immigration’s impact on labor shortages. You’ve written a lot about the impacts on the U.S. economy due to labor shortages. Can you explain how immigration can help remedy the situation?

Raymond Lahoud 01:18

I think we can all agree that without labor without employees, without people to go and work in whatever company, whatever organization, whatever place that exists out there that that needs to provide services or goods to the American public needs, needs employees. Without labor, there’s no economy, immigration right now is really a huge part of the employment demand, or the employment shortage share. There’s a lot of Americans who are able to legally work who just don’t want to work or have you know, taken different decisions or different approaches on life or what they want to do with their life. But we still need people to perform some of these essential functions from farming, to nursing care to handling, you know, mushroom picking to manufacturing, immigration is the way that has long proven to be a way to solve that through temporary visa programs through you know, green card programs that existed out there. And under the Trump administration. And when COVID hit, things really got hit pretty hard and really slowed down the ability for people to bring in international employees to the United States that fill that gap.

Rachel  02:29

This has been an ongoing issue. So are there any policy changes on your radar that will help solve this issue, either through immigration or otherwise?

Raymond Lahoud 02:38

The only way to solve this issue is through comprehensive immigration reform. For over a decade now, we’ve been using the number of 11 million people that are in the country without documentation, I think we can all agree that that number is significantly higher, probably 20, or 30 million people, step one is going to be trying to figure out how we handle those 20 to 30 million people or even Federalists 11 million people that 11 to 20 million people that we have the United States without documentation. And that means that some people are going to have to be deported, who you know, may have certain crimes may have certain issues in terms of their background, but a significant number of these individuals have been in the country for a long time, working without authorization, pleading taxes. So there has to be a process of legalization for those individuals, which is the big issue. We don’t what is legalization for them. And then there also has to be a secure border where people can’t just cross the border without any documentation. I mean, every country has borders, borders are important. We can all see how important borders are right now with what’s happening in Ukraine. You know, comprehensive immigration reform includes having an ability for individuals to come into the United States to work to claim asylum if they have to, to help our employers here in the United States who need employees because people are just not taking part or not applying to Americans are just not applying to take on these jobs. The great resignation has, for some reason taken over the United States and it continues. So what do we need? We need comprehensive immigration reform? How do we get there? It’s getting members of Congress to agree daily, I’m talking to clients who will arrive in Pennsylvania and they’ll say how do I start working here I just crossed the border assuming that because they heard on Facebook before they came up here are on TikTok are though like that it would be very easy for them to claim asylum. So I’m dealing with a lot of clients and potentials and individuals who have just recently crossed the border now feel that they’re stuck in the United States because they can’t leave because they have to go through proceedings and they can’t work. I mean, there’s also in this representation, let’s say that we keep hearing the numbers, millions are coming to the United States. There are millions of encounters. So you may have one person try to come to the United States four or five times and each one is considered an encounter. And this is a problem that we see from President to President, by the way, and this is why I say we need comprehensive immigration reform. Because let’s go back to 1986. Ronald Reagan was going to deal with the immigration problem we had, you know, millions of people here in the United States back then. And he did put three amnesty 1213 14 million people were granted permanent resident status, they say that cost the turn of California to a blue state once they became citizens top political. In the end, they’re like going back to that every President has made immigration, much tougher, actually very tough. Actually, it was the administration that puts some of the toughest policies when it comes to what’s called the public charge rule. The way our system is written right now is that the executive branch just has so much ability and authority discretionary ability and authority over what to do or what not to do, what they can do what they can’t do in terms of immigration. And then every time a new president comes in, something changes drastically. So you had Obama come in, then he puts in place DACA, you know, gives eight 900,000 people, you know, a temporary quote-unquote, status, and you have President Trump come in, and he takes it away. And then you have President Biden come in. Again, it goes back to comprehensive immigration reform. It’s all just been patchwork since after ’86. Now we have 11, 12, 13, 14, 20 million people here. So it’s-I think the distaste is, is that we’re going to grant people status, and it’s just going to happen, again, has to be a two-fold fix as to be true, comprehensive immigration reform where we’re not, you know, 10 years down the road, we don’t have another 15 million people that don’t have documentation here.

Rachel  06:34

What can companies do to help deal with this shortage of immigrant labor or just labor in general?

Raymond Lahoud 06:39

Every day, I probably field 20 to 30 calls from employers who cannot find employees. It’s the biggest problem. I think that’s facing our country right now. And I’m not sure where it comes from, I really don’t understand what this great resignation is, I don’t know how people can live. Right now, there are several legal immigration processes that are available. One is the H Tubi. system, which is a great way of bringing in seasonal employees for farms for landscaping, contractors, painters, manufacturing work, which we bring workers over here year after year. The H1-B lottery is another visa process. So there’s visa processes that are out there, it’s good to avail as an employer to not be afraid of these processes to you know, when you’re recruiting globally recruit, and when you find a candidate, seek out an immigration attorney and say, Hey, is there a way that I can bring this person over legally sponsor them? Is there a pathway and there are. You have companies like the bigger tech companies that are getting all the big H1-B visas, you have the bigger farming companies that are getting all the H2-B visas, because the smaller ones are not really availing themselves, the legalized programs that exist there, we have a lot of people who are coming into the country across the border, these individuals, they’re turning themselves into the Customs and Border Protection. So there’s an expectation at some time that, you know, some of them have fears of returning, I mean, that they’re going to start going through processes. These are individuals that will likely have employment authorization documents, within a year or so don’t forget about the American worker offer good wages, offer good benefits offer time off the world’s change right now in terms of how things work. So if there’s, you know, remote operations that you can offer, do that offer child care services, if you could, but you have to be creative.

Jessica  08:25

So I would love to get your perspective since you’ve been involved in immigration law for so long, and you definitely have a great grasp on the history of a lot of immigration policy changes. I know with COVID, you know, the legal industry got backed up in general; just court cases being rescheduled, I would really like to know what the last two years for immigration law has looked for you how has it changed because of the pandemic updates on border restrictions? I’d love to get your take on that.

Raymond Lahoud 08:52

When the pandemic hit immigration really became incredibly, incredibly busy from the travel restrictions to a title 42 at the border expulsions to people that were detained in immigration custody that were getting COVID It was a disaster for a long time for a lot of people. A lot of people out there who are stuck in other countries, you know, travel bans were coming up and moving and changing by the minute. And companies. You know, the companies that we represent, the employers that we represent that keep operating there were essential. They were central companies and they were healthcare companies. They were companies that do industrial manufacturing or handle electricity and the like, so they needed their employees here. So during COVID, we spent a lot of time trying to figure out the ways to bring a lot of these employees into the United States through the waivers that existed. They’re reaching out to the State Department to seek special exemptions. And then at the same time, you know, the immigration to the deportation defense part of it really came to a halt. court hearings were halted for all like non detained cases, which took an already incredibly backlogged immigration court system and took it about I have four more years behind now. So you’re probably looking at a good 10 years before an immigration judge for a trial. And after continuances and the, like 10 cases COVID really spread pretty heavily, we have to file lots of petitions and requests to try to get clients that were detained by immigration out of custody within the United States. So a lot happened during COVID. And when it came to immigration, in those days, there were nights where I was awake at, you know, two, three in the morning, making sure a client was able to get back in.

Jessica  10:34

We’re in such an interesting environment at this point, especially more recently with the Ukraine crisis, but we also had a changing of the hands in the White House, all the different elections. So there’s been a lot of transition period. And you know, we touched on it a little bit already. But the changes moving forward, I mean, now that the pandemic is having some type of release, besides needing that comprehensive immigration law changes, do you see any other changes now that we’re getting out of the pandemic, whether that’s Ukraine specifically, or just in general? What do you think is gonna happen here?

Raymond Lahoud 11:07

I think that we’ve, we’ve moved on to our next disaster with our next emergency, we’ll say, which is Ukraine right now. This is all that we hear about on the news, there aren’t COVID numbers at, you know, at the bottom, how do people are dying, how many people died and the like, I just feel that, you know, Ukraine has as taken over COVID. Now COVID brought on a time of remote hearings, which are still continuing now. The immigration courts, making fun of them with, you know, video, WebEx hearings in Zoom hearings, are able to move them quicker through the system and the like, and I have some serious issues. When it comes to remote hearings. You know, there’s huge due process concerns and having my client be able to testify in person where the judge can see his or her face. You know, there’s some very serious concerns in that. So they’re changes that, you know, came about from COVID, in terms of remote operations and the like, but I don’t know if they’re necessary to our benefit, even for, you know, immigrants work were coming in. And also, you would think that we really learned how to process things a lot faster. You know, what, we’re kind of hit with the crisis, and we just aren’t, you know, our embassies are still in a huge backlog when it comes to processing visas and, you know, fiance petitions and merit-based petitions and the like, but we are seeing movement here stateside within that, honestly, in terms of change. I mean, you just, it’s all patchwork.

Jessica  12:27

If memory serves me correctly, I know the Biden administration has put more emphasis on visas for STEM. I think people coming either for schooling or for employment, if I’m remembering correctly, do you think that’s a step in the right direction, I know it’s another “patch,” but…

Raymond Lahoud 12:43

 The United States has a huge number of international students in the United States, even locally here in what’s called the Lehigh Valley, Pennsylvania, Lehigh, Lafayette, Cedar Crest Moravian, their F huge international student populations and international student populations are critical to cultural diversity to you know, just to the growth of the school and it’s bringing the world together. So as part of it, so students will come here from abroad, Saudi Arabia, countries, China, Japan, Australia, they’ll come to the F1 visa complete their courses here to get a bachelor’s degree. And if they typically, if you come in under the f1 visa, regardless of your degree, you’ll get 12 months of what’s called occupational practical training. And that’s because you 12 months of just training in your, your area of of studies, when you were in school, if you earned a STEM degree science, tech, engineering or math degree, you can get an additional 24 months of occupational practical training. To me, that’s great to me for bringing people here, and we’re educating them, we should keep them here and you know, give them jobs here. I mean, we there’s no reason that you know, we should be training talent and, you know, bringing in talent from across the world, and then just sending them, you know, back to, you know, their home country, particularly if they’re willing to stay and work here and become members of society in good standing that contribute pay taxes. Why not? Even if you were you came in, you knew you were coming in across the border, see, you’re still a kid, and then you turn over all of your information to the government when you’re 17 or 18 years old. And then, you know, four, eight years later, the Trump ministration says that they are going to get rid of it and it goes through courts who put it back in and take it out and put it back in and then there’s an injunction lifted, and these are hundreds of thousands of lives in people’s hands. People really have to recognize that there are faces to these individuals that have deferred action that have temporary protected status that there are faces to them. And it’s more than just politics. But could you imagine if you were in that position with deferred action, not knowing should I finish going to college should I spend the money should I take a job, what do I do next?

Jessica  15:01

COVID already caused a very large limbo feeling if you’re coming from another country, or you’ve been here, and then you might be told, “oh, you gotta go back to where you came from.” And I can’t imagine being young when you come here and then going back to a country you don’t even really know.

Rachel  15:17

So we wanted to get your viewpoints on Ukrainian refugees and immigration, how does this compare to other refugee crises that we’ve had in the past

Raymond Lahoud 15:27

Ukraine refugee crisis has brought the US government to its peak when it comes to refugees, and the like, they’ve acted very quickly, to bring in them what’s called Temporary Protected Status. You compare it to you know, what happened in Afghanistan and the lake, there are a lot of differences, I would say just that how quickly they are granted temporary protected status. You know, if you’re from Ukraine, there’s countries that are setting up policies like Canada to try to bring in people from Ukrainian. And I hope that these policies that these countries are putting together to help refugees in times of crisis will stay for other countries to beyond Ukraine’s. Hopefully this won’t be the last time that you’ll see other countries open their doors to help people. My mom and dad are both born in Lebanon and immigrated here during the civil war in the late 70s. And it was devastating. And the US opened its doors to the Christians from the north, they came in and became an integral part of the society life here in Pennsylvania, it’s good to see that in Ukraine, but we’re going to have other countries that are going to have similar issues. And who knows where, you know, President Putin may stop, we just really have to think long term about it. Because we also have to be realistic. And we can only handle so many people in our country. I hate to say that.

Rachel  16:49

How does that factor into maybe some of the more, like, long-term policy changes that the country could implement? Is there a need to sort of rethink how we bring in refugees, and how many people we can take and how that process really goes?

Raymond Lahoud 17:02

There is, there is, but how do you rethink that? You know, how do you it’s even just saying, you know, how many people can we take in I know you just feel I feel internally bad because you don’t want to turn anybody away, that’s really hurting, you know, and but we have to, thankfully, I’m not in Congress to make up those decisions. But I think there has to be, you know, some sense of reason, and balance. And I’m not really sure what that is.

Rachel  17:29

Like the US has to work together with other countries to make sure that we help them out of people that need to be helped. I don’t think it’s realistic for one country to sort of shoulder most of the burden.

Raymond Lahoud 17:38

It’s very hard to get refugee status. I mean, you don’t just kind of come into the United States and walk-in and may take years to go through I mean, if you’re going to the Iraqi refugee have to go in through the United Nations refugee program, there’s a huge process you have to go through, it’s not easy. The things that happened in Afghanistan kind of made known the issues with our you know, the refugee program and the lake. But it’s not, it’s not an easy process to go through. You can’t just walk into an embassy, US Embassy and say, Hey, I’m I’m afraid of where I’m living, I want to go to United States,

Rachel  18:09

Right, yeah. And I imagine on top of even having to be in a situation where you have to flee your home.

Raymond Lahoud 18:15

Anybody that goes through pain, like a harm or fear, you know, I mean, whether it’s domestic violence, and those are the worst of cases where I have clients who are coming in suffered extreme domestic violence, like at the hands of their spouses and the like, and, and with those, you know, you know, what you do, you can send them back, you know, when that when the spouse is going to kill them on, you know, they’re dead on arrival. And so those are cases that we’re dealing with inside the United States right now. It’s like we have refugees coming in. But we also have asylees, here in the United States that were people who are in here applying affirmatively for asylum, we have a lot of people in the United States that are here on like a protective status we do. We do so much. And other countries are recognizing that if you take a look at Australia, so people are coming into the to Australia, they don’t go into the country, they sit off-island for a long period of time for they claim asylum or anything like that. The other countries that are out there, I think that they all have some pretty unique set of circumstances that are there, and in ours has a lot of issues that we have to really work through.

Rachel  19:16

So you’ve written about policy changes in Pennsylvania aimed at helping undocumented immigrants, you know, entrepreneurs, people who are getting driver’s licenses, things like that. I was curious to get your insight on how you see these changes impacting both immigrants in the state as a whole, like what sort of have been the changes there?

Raymond Lahoud 19:33

Driver’s licenses in Pennsylvania, we’re seeing a movement. New Jersey, just fair aware, they pass legislation in the implement to the driver’s licenses, people who may not have a social security number or the like, right now in Pennsylvania. I believe it’s in the House Committee. It’s being discussed. I don’t see it moving out of there given the current makeup of the legislature. I don’t foresee it happening in Pennsylvania anytime soon. It does keep coming up a lot by members of the State House, I think it’s a good idea because people are driving. Let’s get real. There are people without papers in the United States. I mean, if we don’t realize that, I think that we’re just fooling ourselves. So, you know, it’s if it’s a way for them, they’re voluntarily providing their information, you know, why not register it, they can get their insurance. It’s not a federal issue. It’s a state issue as the as right to get driver’s licenses, it’s state-by-state. Pennsylvania considers that they look at it, they bring it up, but it always fills in committee doesn’t go anywhere. Pennsylvania, has the political planet as a swing state, as we all know, and immigration is a hot topic issue here.

Rachel  20:37

I’m glad to hear that at least it’s even if it’s not, you know, moving forward, I think it being on people’s minds is a good thing. So in terms of changes like that, and maybe large scale changes, like we spoken about how we just need really large scale immigration reform, I was wondering, we could talk about the changes that you think need be made to both attract and retain immigrants in the United States, I think there’s a lot of talk about specifically, after the Trump administration, a lot of international students to stop coming here, you know, the United States is losing talent to countries like Canada and other places like that. So I was curious to get your thoughts on that.

Raymond Lahoud 21:14

COVID-19 opened up a different way of kind of operating, we had spoken earlier, where, you know, these companies are now recognizing that they could get that global talent opened up a facility in India or, you know, have somebody remote in from Canada, or actually just physically move their locations to Canada, or their offices or their manufacturing sites to another country, because it’s easier to bring labor in. I think that other countries are starting to embrace certain kinds of immigration, like I know that Canada is, you know, they’ve implemented that another investment-based immigration system, they’ve made it easier for Indian workers a certain kind of ticket during COVID in the light. So there are countries that are taking no more proactive approach to bringing in people but during the Trump administration, people from abroad really felt they weren’t welcomed in the United States. And I saw that a lot with students, and there was a significant number. It’s coming back, and I’m seeing the numbers come back, and just from the schools locally, that that we’re working with. So in terms of the International Student Program, you know, I do feel that it’s picking back up after COVID. And after the Trump administration, I just think we have to kind of keep going with it to make sure that, you know, we know that the people that we’re inviting into our country, we know that we have to welcome them here and treat them kindly, and work with them. Because we’re just we are one world one people. I’m really just, I think it’s a realist here, and that, you know, you have immigration lawyers who, you know, will just, you know, push things to like an end and say, No, open borders, and you have no people on another end that would say, you know, close everything to anybody. And but I think we have to have recent ability. I mean, you just can’t close the United States to everything. I mean, you can’t close the United States to the globe’s cultures, we just have to find a middle ground. And I hope that, you know, I was able to kind of present some of that reason that no middle ground, that’s there being immigration where it’s hard to take, you know, some things that Trump did weren’t necessarily I’m going to do but if somebody heard me say that, and I will now, you know, they would be shocked at it. But I think that’s what the issue is, is that there’s no meeting of minds. People just become enemies, because somebody has a different political opinion. You know, I think there really has to come a realization that we just can’t shut the borders down completely. And you can’t open the borders up completely. There just has to be a middle ground that we all have to reach in. Our members of Congress really have to grow up and hopefully, they will. And hopefully, they’ll work with the Biden ministration. We’ll get somewhere.

Jessica  23:52

I actually have an interesting question. Since you’re located in Pennsylvania; Lancaster’s, a certified welcoming status for refugees. Do you think that’s helpful in situations like Ukraine? And like if more cities did that, do you see that as a positive direction?

Raymond Lahoud 24:06

I do, I do. I mean, like…Philadelphia has, like a welcome center for Lancaster was one of the counties like that. It’s really what they do with it is, yeah, it certainly hops. The more the better. Governor Wolf has actually taken very proactive actions towards the Ukrainian community here, even locally. But again, there’s more than just the Ukrainian community that are suffering from prosecution. So hopefully, it’ll open our minds to how we deal with other areas and in the future when this happens and how other countries can work together with it. But yeah, it does. It does help because it shows that we care you know, things like that only they can start shows that we care. You know, even if you know, New Jersey, they couldn’t give them give people a real ID driver’s license, but they gave them a license to drive and pencil and they can leave the state drive and add to it, it’s still a driver’s license so they can give What they want to know as much as they can give them and if that’s what Lancaster was able to give them, that’s what it was. They can’t give driver’s licenses but um, you know, that opens up a door for immigrants and to have stuff like that it’s good for them to have programs like that is good.

Rachel  25:14

Well, excellent. Thanks again, Ray for joining us today. We had a great conversation.

Raymond Lahoud 25:20

 It’s really been good being here talking about immigration. It’s an interesting topic. And hopefully, we’ll see things changing in the years to come and I’m here to talk to you whenever. Yeah, thank you for having me.

OUTRO  25:40

Thank you for listening to The National Law Review’s Legal News Reach podcast. Be sure to follow us on Apple Podcasts, Spotify, or wherever you get your podcasts for more episodes for the latest legal news. Interested in publishing and advertising with us? Visit www.natlawreview.com. We’ll be back soon with our next episode.

Article By Rachel Popa and Jessica Scheck of The National Law Review / The National Law Forum LLC

For more Legal News Reach podcasts, click here to visit the National Law Review.

Copyright ©2022 National Law Forum, LLC

FDA and FTC Issue Warning Letters to CBD Companies

  • On March 28, 2022, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued seven warning letters to companies marketing cannabidiol (CBD) products with COVID-19 related claims.
  • Specifically, the agencies warned the following companies regarding the promotion of their respective products with claims that they cure, mitigate, treat or prevent COVID-19: Cureganics, Heaven’s Organics LLC, Functional Remedies, LLC D/B/A Synchronicity Hemp Oil, Greenway Herbal Products LLC, CBD Social, UPSY LLC, and Nature’s Highway. Examples of claims include: “Our research suggest that CBD . . . can block SARS-Cov-2 infection at early and even later stages of infection. . .”, “Studies Show CBD Compounds Prevent COVID Cells From Replicating”, and “Can CBD Help with the Fight Against COVID? Some of the worst effects of COVID are caused by inflammation, and CBD is a potent anti-inflammatory.”
  • By way of background, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs. Therefore, the agencies classified the products as unapproved and misbranded drugs that may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • The letters included a cease-and-desist demand from FTC, prohibiting the companies from making such COVID-19 related claims. The companies were provided with 48 hours to respond with specific steps that were taken to correct the violations.

Article By Food and Drug Law Practice Group at Keller and Heckman LLP

For more food and drug law legal news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

Better Late than Never, Just About – UK Government Issues Workplace Guidance on Living with COVID

So with Covid 19 now officially behind us for all purposes (except actual reality, obviously), we have now been graced by the Government’s new “Living with Covid” guidance.  This was due to come into force on 1 April and was released fashionably late in the afternoon on, well, 1st April.  You could say with some justification that this did not give employers much time to prepare, but that is OK because on close review of the guidance there is in fact very little to prepare for.  As a steer to businesses, this is little short of directionless.

First, it makes the obvious point that the abolition of the requirement to give covid express consideration in workplace risk assessments does not take away any of the employer’s obligations to continue to comply with its health & safety, employment and equality duties (in the latter two cases, although unsaid, presumably as they may be affected by the former).

From there, the Government moves to normalise covid through a long list of symptoms common to it, colds, flu and other respiratory diseases – fair enough so far – but also to other quite unrelated conditions such as hangovers, migraines, food poisoning, being unfit, malaria and frankly just getting old (“unexplained tiredness, lack of energy”).  The list is significantly expanded from the traditional trio of continuous cough, fever, loss of taste and smell and now also includes muscle pain, diarrhoea, headache, loss of appetite and “feeling sick” (what, really?). Some medical practitioners say that this is long overdue recognition of all the things covid can do to you. However, it is still a wincingly unhappy expansion for employers, since the published list now essentially includes something from pretty much every ailment known to man. The guidance notes that it will not usually be possible to tell whether you have covid or something else from the symptoms alone and of course the free testing by which that could have been determined in the past is now largely withdrawn.  Therefore the guidance to individuals is that “if you have symptoms of a respiratory infection such as covid and you have a high temperature or you do not feel well enough to go to work, you are advised to try to stay at home and avoid contact with other people” and then “Try to work from home if you can.  If you are unable to work from home you should talk to your employer about options available to you”.  Given the rich panoply of symptoms now available to the discerning malingerer, justifying taking yourself home for five days while you work out whether your headache is covid or just a headache has never been so easy.

As a result, the burden is shifted squarely to employers to keep up the anti-covid fight, and in particular to decide whether to maintain restrictions on entry to their premises for those who are unvaccinated and/or untested.  Both will be increasingly difficult to sustain in view of the obvious official indifference to the question evidenced by the guidance, which focuses instead on the traditional measures of ventilation, regular cleaning of high-touch surfaces, provision of sanitiser and hygiene advice, etc. The other big hole in the guidance is as to the employer’s rights (or is it obligation?) to send someone home if they have one or more of that long list of potentially relevant symptoms, and even if the employee himself feels able to work and/or cannot work from home.  Nor does it deal with the employees’ sick pay rights in those cases.

Taking a reasonably hawkish view of those two questions:-

  1. If you know that the employee has symptoms which could well indicate that he is suffering from covid, and even if it could equally be something less serious, are you complying with your Health & Safety at Work Act duty to take all reasonably practicable steps to maintain a safe system of work if you allow him in anyway?  If he works in a sparsely –occupied well-ventilated area, perhaps yes, but otherwise probably not.  Given the virulence of Omicron, it is unarguably foreseeable that allowing someone who may have it to breathe wantonly on other people may lead to their contracting it too.  It is also clearly foreseeable, if no longer as much so as with the earlier covid variants, that those other people may become properly ill or die as a result.  Put mathematically, breach of duty + foreseeable risk of injury + causation + actual injury = liability.

So in my view, despite the vacuum in the new guidance, an employer not just can, but really should send home immediately an employee with any material case of the symptoms listed, as a minimum until it becomes clear that the real issue is something else (though not malaria – best not let them in either).

A firm stance on this will also help combat reluctance to return to the office among those staff concerned about the health risk of doing so.  If they or their cohabitants are particularly vulnerable, the knowledge that basically no precautions are being taken to ensure that those present in the workplace are all covid-free will only feed those anxieties.

  1. If the employee is sent home on these grounds and cannot work there, will he be entitled to full salary (as it was not by his choice) or sick pay only?  In many cases he will be back within a week and the two may be the same.  Where they are not, however, I believe that it would strictly be sick pay only – though the employee may himself be physically able to work, he is practically unable to do so by reason of his own possible medical condition, the risk it may pose to others in the workplace and the duty of the employer to take reasonable steps to head off that risk.  That said, there are employment relations arguments both ways on this – on the one hand, that the symptoms listed are so varied and transient that they represent an easy avenue for abuse, and on the other that if reporting them means you get packed off home on reduced pay (perhaps none until SSP kicks in on day 4), you are much less likely to report them in the first place and will probably prefer to pass your day posing an undeclared but potentially quite serious risk to your colleagues.

Article By David Whincup of Squire Patton Boggs (US) LLP

For more coronavirus legal news, click here to visit the National Law Review.

© Copyright 2022 Squire Patton Boggs (US) LLP

Debt Ceiling Shrinks for Small Business Bankruptcies

Subchapter V of Chapter 11 of the Bankruptcy Code, which took effect in February 2020, creates a more streamlined and less expensive Chapter 11 reorganization path for small business debtors.  Under the law as originally passed, to be eligible for Subchapter V, a debtor (whether an entity or an individual) had to be engaged in commercial activity and its total debts — secured and unsecured – had to be less than $2,725,625.  At least half of those debts must have come from business activity.

In March 2020, in response to the COVID-19 pandemic, Congress passed the CARES Act, which raised the Subchapter V debt ceiling to $7.5 million for one year.  Congress extended it to March 27, 2022.  A bipartisan Senate bill would make the Subchapter V debt limit permanent at $7.5 million and index it to inflation.  But Congress has not yet passed the legislation or sent it to President Biden for signature.  So, for now, the debt ceiling has shrunk to the original $2,725,625.

Subchapter V has proven popular, with over 3,100 cases filed in the last two years (78 in North Carolina).  Many of those cases could not have proceeded under Subchapter V but for the higher debt limits.  The American Bankruptcy Institute has reported that Subchapter V cases are experiencing higher plan-confirmation rates, speedier plan confirmation, more consensual plans, and improved cost-effectiveness than if those cases had been filed as a traditional Chapter 11.  Anecdotally, most debtors in North Carolina are filing under Subchapter V if they are eligible.

We will continue to monitor legislative activity and report if Congress passes a law to reinstate the $7.5 million debt ceiling.

Article By Lance P. Martin of Ward and Smith, P.A.

For more financial and business legal news, click here to visit the National Law Review.

© 2022 Ward and Smith, P.A.. All Rights Reserved.

Four Indicted for $16 Million Money Laundering Scheme

Four Indicted for $16 Million Money Laundering Scheme

On March 23, 2022, an indictment was unsealed in the Western District of Arkansas, charging four men for their involvement in wire fraud and money laundering schemes involving fake investment offerings amounting to an alleged $16 million.

According to court documents, the four men allegedly engaged in an investment fraud scheme between 2013 and 2021 in which they falsely represented the nature of their investment offerings and promised large returns, which they could not and did not yield. The indictment also alleges that two of the defendants encouraged victims to send their funds to bank accounts controlled by the other two defendants, and then transferred the money through a complex series of accounts worldwide.

The defendants were charged with wire fraud, conspiracy to commit wire fraud, and conspiracy to commit money laundering. One defendant was further charged with money laundering. If convicted, the men will face up to 20 years in prison for each count. The additional count of money laundering carries an additional sentence of up to 10 years.

The DOJ press release can be found here.

California Man Pleads Guilty To Stealing Government COVID-19 Relief Funds

On March 18, 2022, a California man pleaded guilty in the Central District of California to misappropriating COVID-19 relief funds obtained through the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Under the CARES Act Provider Relief Fund, CARES Act health care providers who were financially harmed by the impact of the COVID-19 pandemic are granted federal funds to provide care to patients suffering from COVID-19. According to court documents, the defendant admitted he owned a hospice agency in North Hollywood that was never operational during the COVID-19 pandemic, yet he received approximately $89,162 designated for the medical treatment and care of COVID-19 patients. The defendant admitted he misappropriated the CARES Act funds by spending them for his personal use and then transferring the funds to family members, including one family member in Armenia, rather than using the funds in any way related to the pandemic relief efforts as required.

As part of his guilty plea, the defendant further admitted that he submitted five Economic Injury Disaster Loan (EIDL) applications to the Small Business Administration (SBA) on behalf of his hospice agency and four other entities he controlled. As a result of his fraudulent applications, the SBA disbursed approximately $428,100 in EIDL funds to the man, which he used for his benefit against EIDL requirements.

The man pleaded guilty to three counts of theft of government property and is scheduled to be sentenced on June 13, facing up to 10 years in prison for each count.

The DOJ press release can be found here.

New Jersey Man Convicted for Fraudulently Obtaining US Visas for Chinese Government Employees

On March 23, 2022, a New Jersey man was convicted by a federal jury of one count of conspiracy to defraud the United States and to commit visa fraud for his participation in a conspiracy to fraudulently obtain United States visas for Chinese government employees.

According to court documents, the defendant was involved in a scheme to fraudulently obtain J-1 research scholar visas for employees of the government of the People’s Republic of China (PRC) to allow them to covertly work for the PRC government while in the United States. The defendant operated an office of the China Association for the International Exchange of Personnel (CAIEP), an agency of the PRC government, in New Jersey that seeks to recruit US scientists, academics, engineers, and other experts for the PRC.

The J-1 research scholar program allows foreign nationals to visit the United States to conduct research at a corporate research facility, library, museum, university, or other research institution. The defendant allegedly worked to obtain a J-1 research scholar visa for a prospective employee based on the false representation that the employee would conduct research at a United States university, to conceal unlawful work of another employee who was present in the United States on a J-1 visa sponsored by a US university. The two employees represented to the US government that they were entering the US for the primary purpose of conducting research at US universities, but their actual purpose consisted of working for the CAIEP. The defendant reported the employee’s arrival to the United States to the US universities, procured a local driver’s license for her and disguised her CAIEP salary as a subsidy for research scholar living expenses to make her presence as a research scholar appear legitimate.

As a result of his conviction, the defendant faces a maximum sentence of five years; he is scheduled to be sentenced on July 11.

The Department of Justice (DOJ) press release can be found here.

UPS To Pay $5.3 Million for False Claims Act Allegations

On March 21, 2022, the DOJ announced that United Parcel Service Inc. (UPS) agreed to pay approximately $5.3 million to settle allegations that the company falsely reported information about the transfer of U.S. mail to foreign posts or other intended recipients under contracts with the U.S. Postal Service (USPS), in violation of the False Claims Act (FCA).

UPS was engaged by USPS to pick up U.S. mail at various locations and deliver it to its international and domestic destinations. As a condition of payment, UPS was required to submit electronic scans to USPS to report when the mail was delivered, and there were specified penalties for mail that was delivered late or to the wrong location. The settlement resolves allegations that scans submitted by UPS were falsified times and that UPS, in fact, transferred possession of the mail.

According to DOJ, this is the fifth civil settlement involving air carrier liability for false delivery scans under the USPS International Commercial Air Contracts, pursuant to which the United States has recovered more than $70 million.

The DOJ press release can be found here.

Article By D. Jacques Smith, Randall A. Brater, Mattie Bowden, and Rebecca W. Foreman of ArentFox Schiff LLP

For more white collar crime legal news, click here to visit the National Law Review.

© 2022 ArentFox Schiff LLP