Category: Blog

The start of the holiday season—the busiest travel period in the United States—is just weeks away. Though the number of Americans taking to the skies this Thanksgiving is sure to be less than the 26 million travelers who passed through Transportation Security Administration checkpoints last year, passenger volume is nonetheless expected to surge.

However, potential travelers will have to weigh the risks of a COVID-19 resurgence against the range of travel options in an industry that remains largely outside the scope of any federally mandated COVID-19 safety regulations. The reticence to issue firm federal regulations to keep both passengers and workers safe has been a familiar narrative during this health crisis, and the airline industry has arguably been one of the most scrutinized segments of travel.

This unprecedented public health crisis begs the question: who is responsible for regulating passenger safety on airplanes as it pertains to COVID-19?

This is not a novel question. On March 14, 2020, in the early stages of the COVID-19 outbreak in the U.S., the Director of the Centers for Disease Control and Prevention (CDC) Dr. Robert Redfield issued a No Sail Order for all cruise ships operating within the United States, effectively shutting down cruise lines until further notice. In the No Sail Order, the Director rooted his decision in scientific information about the transmission of COVID-19 and on the powers granted to him as the CDC Director in 42 CFR § 71.32(b). Dr. Redfield justified issuing this federal mandate as he determined that the scope of this pandemic “cannot be controlled sufficiently by the cruise ship industry or individual state or local health authorities.”

However, the federal government has enacted no other substantive regulatory measures on other sectors of the travel industry during the course of the COVID-19 crisis. Instead, the CDC has opted for issuing non-binding COVID-19 safety guidelines for different industries, leaving sectors, such as the airline industry, to individually self-regulate.

The result of this recommended guidelines approach is a wide array of safety policies that differ between airlines with no legal mechanism for enforcement, meaning that the repercussions for consumer noncompliance extend only as far as what is within the company’s power to implement (e.g. denying service, customer banning, etc.). Furthermore, this range of options forces the consumer to compare health and safety measures between available choices or settle for the only option available to them.

Opponents to national standards often cite a disdain for government regulations as a driving factor for inaction. The Department of Transportation (DOT) recently denied a petition requesting the implementation of a nationwide mask policy for airports and air travel under their rule making powers found in 5 U.S.C. § 553(b)(3)(B). In DOT’s response, General Counsel Steven Bradbury stated his reasons for the denial being that guidelines recommending masks already exist, most air carriers have enacted mask policies, and DOT “embraces the notion that there should be no more regulations than necessary.”

Similarly, the New York Times reported that the CDC drafted a mandate last month that would require masks on all commercial and private transportation. The mandate was rooted in the CDC’s quarantine powers found in 42 USC § 264, 268, and was backed by the Secretary of Health and Human Services (HHS) Alex Azar II. However, the White House reportedly blocked the mandate, instead deferring to state and local authorities to issue their own guidance; Vice President Pence “declined to even discuss [the mandate]” with the White House Coronavirus Task Force.

This vacuum of federal safety regulation has led to a patchwork of self-regulation between industries and state officials attempting to establish legal standards to allow for enforcement of these standards. Some states, such as Virginia, have taken it upon themselves to codify CDC guidelines to provide legal standards for businesses and individuals alike whereas other states continue to pass the responsibility of public safety off to industries and individuals.

For interstate industries such as airlines, differing state and company standards are not sufficient to effectively manage the risks COVID-19 presents. Yet, a path toward the creation of national safety standards and a means of enforcement does exist. The CDC, DOT, HHS, and the president are provided various statutory powers while Congress has the ability to pass legislation—similar to some legislation passed at the state level—to create a national set of safety standards for certain industries.

As we approach the 2020 holiday travel season amidst the backdrop of a global pandemic, it is abundantly clear that the airline industry and the American people would be better served by a set of national safety regulations for air travel. The implementation of national safety regulations will provide the airline industry with means of legal enforcement for noncompliance, restore confidence in air travel, and provide airlines the best guidance from health experts to ensure consumer safety.

As the October deadline for states to submit their COVID-19 vaccine distribution plan to the CDC approaches, public health officials across the country are feeling the pressure. Questions about storage, dosing, and the uncertainty of an authorized supplier continue to plague immunization managers. While it is a virtual certainty that frontline healthcare workers will be among the first to receive the vaccine, the distribution scheme beyond the folks in scrubs becomes a delicate ethical question.

In early October, the National Academy of Medicine revealed its recommendations for this very dilemma in a report commissioned by the National Institutes of Health and the U.S. Centers for Disease Control (CDC). The framework in the report recommends a four-phase distribution plan prioritizing health care workers and first responders as well as older adults and those with pre-existing conditions as predictable initial recipients. However, it also makes novel use of the CDC’s Social Vulnerability Index (SVI) to ensure equity in vaccine allocation. The SVI uses U.S. Census data to map fifteen social factors—including poverty and crowded housing—which are then used to estimate the type and amount of a resource needed by a certain community. 

While a valuable assessment tool for analyzing community vulnerability, some argue the SVI Is not robust enough, failing to capture rates of pre-existing health conditions known to increase the risk of mortality for COVID-19, and the capacity of community healthcare systems. In order to more accurately and comprehensively assess vulnerability, the Surgo Foundation created the COVID-19 Community Vulnerability Index (CCVI). The CCVI expands on the SVI foundation to offer a six-theme calculation for community vulnerability, which policymakers can rely upon when making decisions about where to direct resources.

Understanding COVID-19’s specific relationship to community vulnerability is essential. On a national level, the virus consistently has a disparate impact along race and class lines, as well as on individuals with intellectual and developmental disabilities.

Various state guidance publications all spell out a version of the same vague plan, deferring to CDC guidance and prioritizing “high risk” groups. Given that the CDC has the greatest influence over how vaccines are used and distributed by health departments in the U.S., it should promote and incorporate the robust analytical framework created by the Surgo Foundation as a socioeconomically conscious improvement on existing CDC guidance. Presently, the CDC includes the Surgo Foundation’s work in its COVID-19 Research Guide as a secondary data and statistics source.

The CCVI could be used to create community risk profiles and to overcome the infrastructure barriers to health access, like the strictures on telemedicine implementation in rural communities. Whatever needs are addressed by use of the CCVI, COVID-19 has exposed the inequity of the systemic healthcare structure in the U.S. as more dire than previously thought, and only an equitable approach to distribution will bring equitable relief.

2020 has undoubtedly become the year for telemedicine. The COVID-19 pandemic has created unprecedented demand for virtual visits to support the continued need for timely, safe care while avoiding in-person contact. By offering many ambulatory care services, telemedicine protects both patients and healthcare providers by reducing possible exposure to COVID-19. Federal policymakers temporarily relaxed regulations that impede telemedicine utilization and expanded Medicare coverage of remote appointments to encourage this shift, which is so popular among patients and providers that the technology changes may become permanent. Yet, despite these efforts, some patients continue to face barriers to telemedicine due to disparities in digital access and “unread[iness]” to use the requisite technology. As policymakers consider permanent use of telemedicine, they must address these barriers to ensure that those with much to gain from virtual care are not left behind.

            The amended rules implemented by policymakers made telemedicine visits easier to obtain, but also assumed that individuals have access to technology that enables home video visits. According to an August study of Medicare beneficiaries, 26.3% of beneficiaries (approximately fifteen million people) had neither a home computer with a high-speed internet connection nor a smartphone with a wireless plan, making telemedicine video visits unlikely for those individuals. Furthermore, this technology gap disproportionally impacts low-income individuals, persons eighty-five years or older, and people of color—all of whom form a vulnerable population in terms of their health and economic characteristics. The ability of individuals in these groups to access care was already a concern pre-COVID, and the shift to a virtual system may widen existing disparities in access to care. One solution from a study authored by Health Policy Researchers at the University of Pittsburgh and Harvard Medical School, proposed to expand the Federal Communications Commission’s Lifeline program, which provides phone or internet service at a reduced-cost. Lowering the cost of virtual care, however, will not be enough. As telemedicine utilization rises, the issues contributing to the technology gap must be addressed.

            Even if the technology gap was mitigated, there are additional barriers that may prevent a person from engaging with telemedicine. The ability of some individuals to use telemedicine enabling technology prevents many people from accessing virtual care. To have a successful video visit, individuals need to know how to get online, use audiovisual equipment, and communicate without in-person social cues. A study conducted by medical researchers affiliated with the University of California, San Francisco indicated that, of Medicare beneficiaries age sixty-five and older, 38% of these individuals were “unready” to have video visits, largely stemming from inexperience with technology, and 20% were “unready” due to difficulty hearing, difficulty communicating, or dementia. Similarly, this accessibility gap disproportionately impacts people of color, low-income individuals, and persons eighty-five years or older.

Live closed captioning during virtual visits and digital literacy programs during may help make telemedicine more accessible. Recognizing the need for accommodations in virtual visits is crucial to safeguarding equity in the telemedicine boom. Telemedicine will likely become an increasingly important aspect of health care delivery as the COVID-19 pandemic continues. By developing policies that recognize and bridge the digital divide, policymakers would ensure that the virtual migration does not worsen existing disparities and inequity in health care and improve access to telemedicine.

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With over 82,000 members, the American College of Surgeons (ACS) is the largest organization of surgeons on the planet. Founded in 1913, the ACS sets the highest standards for medical care and organizes the largest medical conference in the world, the Clinical Congress. The Clinical Congress hosts about 26,000 surgeons a year for five days of educational and networking events. In between annual medical presentations and demonstrations are social events; such as meet and greets, happy hours, and a host of other activities from the SurgeonsPAC ( Political Action Committee) where member surgeons (referred to as “Fellows”) can join in on early morning yoga classes, touring, and participate in “Surgeons who Selfie.” However, the Clinical Congress looked a little different this year.

For the first time in more than a century, the Clinical Congress was virtual…. and free.

The event took place October 3^rd–7^th of this year, and the Clinical Congress still hosted presentations on various topics across the surgical field and a virtual exhibit hall. However, there was no travelling to and taking over a new city this year as the social events were distinctly…. socially distant. Nevertheless, the SurgeonsPAC met and the schedule of full and robust presentations occurred simultaneously.

The fact that the event was free this year is not insignificant. Typically,  new Fellows would pay a $200.00 application fee on top of the annual cost of $659.00 to attend this event. This year, the application fee is waived for new Fellows and discounted for non-surgical new members. This was a good opportunity for new surgeons to attend and have the educational experience and connect with surgeons around the world amidst the pandemic. Even non-surgeon members were offered a fifty percent reduction of their application fee.

The Clinical Congress is not the first health conference this year to go virtual and it won’t likely be the last. The European Society of Cardiology (ESC) also hosted its annual meeting, the ESC Congress, online for the first time as well. The American College of Medical Toxicology (ACMT) 2020 Annual Scientific Meeting was planned to be in person in New York City in March, but on the first day and in preparation for the pandemic, the entire conference switched to a virtual platform.

The COVID-19 pandemic has both personally and professionally impacted individuals across the world since its spread began in December 2019. The first confirmed COVID-19 case in the United States occurred on January 21, 2020. By March 17, 2020, the virus was present in all 50 states with over 5,800 confirmed cases.

Like many other countries, the United States experienced, and continues to experience, significant alterations in its daily operations. For example, by May 7, 2020, 48 states, and Washington D.C., had either recommended or ordered schools to close for the remaining of the 2019-2020 school year. A Burbio study aggregating school and community calendars from across the nation confirmed that many of these schedule alterations are persisting into the fall semester, with 52% of U.S. students attending school virtually and 19% participating in hybrid schedules.

Along with students’ transition to virtual learning came many professionals’ transition to working remote to enable social distancing, as the CDC recommends. However, many employees nationwide had to continue going into work because working remotely was not an option for their job. Some of these individuals include healthcare professionals, emergency services, agriculture, transportation, etc. As a result, a range of questions arose regarding employees’ rights and how companies should implement guidelines amidst the global pandemic. Can an employee be fired for not reporting to work based on health concerns? What happens when an employer runs out of appropriate personal protective equipment for employees? What accommodations should employers make for medically at-risk employees? Lawsuits against employers have already begun and some individuals anticipate a “tidal wave” of lawsuits to come.

One specific consideration expected to be at-issue in a number of lawsuits is whether businesses with COVID-19 outbreaks are responsible for take-home infections. In other words, can an employer be held liable for loved ones contracting COVID-19 who never came into the office but are exposed by an employee who contracts COVID-19 at work and spreads the virus in their home? Out of the 200,000 COVID-19 related deaths in the United States, between 7% and 9% are believed to have been attributed to take-home infections.

Senate Majority Leader Mitch McConnell recently proposed legislation that included liability shields that would provide “a safe harbor [from COVID-related lawsuits] for institutions that make good-faith efforts to follow guidelines available to them” because “[n]obody should have to face an epidemic of lawsuits on the heels of the pandemic that we already have related to the coronavirus.” However, the Senate blocked this legislation in a 53-47 vote on September 10^th, so businesses may very well face notable lawsuits involving take-home Coronavirus infections.

An Illinois woman has already filed a “take-home” lawsuit. She is suing Aurora Packing Co’s meat processing plant and is alleging that her mother died from COVID-19 because her father, who worked at the plant, contracted it there while working “shoulder to shoulder” in the processing line before bringing it home. The complaint further alleges that the plant knew there was an outbreak within the plant, but it did not warn the employees.

One step in these take-home suits requires a showing of a “causal chain” between the infected family member and the business. Lawyers on both sides of the suit noted that this “causal chain” might be difficult to establish because it requires the plaintiff to show that the business’ failure to properly implement safety measures is what led to the worker contracting the virus and infecting their family member. There have been successful causal connections proved in previous take-home infection cases, though, such as the 2013 California case where a jury awarded compensatory and punitive damages to a woman whose lawyers argued that her mesothelioma diagnosis was connected to the asbestos fibers on her husband’s work clothes.

While it is likely true that (a) most business owners do no want to “deal with” lawsuits amid the COVID-19 pandemic and (b) adequately displaying a “causal chain” may be difficult, there is value in providing employees and their families the ability to seek compensation where compensation might be due.

In March 2020, for the first time in this nation’s history, all 50 states declared a major disaster due to the novel coronavirus (“Covid-19”).  In response to the declaration, the Federal Emergency Management Agency (“FEMA”) began procuring domestic vendors to fulfill contracts for personal protective equipment (“PPE”) and testing supplies.

Months later, FEMA is under review for granting Covid-19 emergency contracts to businesses that were unable to meet their contractual obligations.  Typically, FEMA engages in a competitive bidding process prior to choosing a vendor to fulfill a contract, as outlined in 2 CFR § 200.320.  Abandoning its own protocol, FEMA awarded contracts to new vendors to manufacture PPE without evaluating the vendors or their capabilities.  FEMA awarded approximately 1.8 billion dollars in contracts without engaging in a competitive bidding process. Now vendors have defaulted on contacts claiming they are unable to meet delivery deadlines or production quantities.  Without the necessary PPE, hospitals and governmental officials are at increased risk of contracting Covid-19.  The 2020 PPE shortage demonstrates the necessity of the competitive bidding process to prevent fraud and waste of taxpayer funds.

Some of the contract awardees had only come into existence a few days before they accepted contracts.  Several vendors had no history of manufacturing PPE or any other type of medical equipment.  These vendors attempted to act as intermediates between FEMA and foreign manufacturers, accepting contacts and then assigning their contractual rights.  Without proper evaluation of vendors, the possibility of ethical violations arises.  One vendor, founded by a former White House aide, was awarded a three million dollar contract for masks.  The company had no experience manufacturing masks and delivered several defective masks.

The competitive bidding process is not new to FEMA or the federal government. There are multiple methods used for the proposal bidding process but the suggested method is a sealed bid. Bids are publicly solicited and a firm fixed price contract is awarded to the responsible bidder whose bid, conforming with all the material terms and conditions of the solicitation, offers the lowest in price.  When a sealed bid process is not used, then a competitive proposal process is sought. The competitive proposal process is normally conducted with more than one source submitting an offer, and either a fixed price or cost-reimbursement type contract is awarded. Contracts must be awarded to the responsible firm whose proposal is most advantageous to the program, with price and other factors considered.

FEMA does have discretion to allow for noncompetitive procurements under certain circumstances, including when FEMA determines that immediate actions required to address a public exigency or emergency and cannot be delayed by use of a competitive solicitation.  Even under its discretion, FEMA should take administrative steps to protect federal funds from fraud, waste, and abuse.