Category: Blog

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.

In early April 2020, the New York Times published
an article showing the tracked movement of Americans in the midst of the COVID-19
pandemic by analyzing cellphone location data across the entire country. Similarly,
Tectonix, a data analytics firm who used locations of anonymized mobile
devices, tweeted
an analysis of the movement and spread of 5.6 thousand individuals identified
on a Ft. Lauderdale beach on a specific day. While this near-real time analysis
highlights the usefulness and practicality of Big Data in the fight against the
pandemic, it also raises consumer privacy concerns in a largely unregulated
sector.

As previously
discussed, the U.S. relies on a patchwork of regulations to govern the
collection and use of Big Data and to protect consumer privacy; this patchwork creates
large gaps in regulation for Big Data usage. On April 9, 2020, the U.S. Senate
Committee on Commerce, Science, & Transportation held a paper
hearing entitled, “Enlisting Big Data in the Fight Against Coronavirus,” in
order to address these concerns. The primary goal of the Committee’s hearing
was to find the best way to maximize potential benefits of Big Data while
minimizing the privacy risks to consumers.

Leading privacy
experts submitted written testimony to the Committee recognizing the
crucial impact of Big Data in the fight against the current pandemic, and the
need for legislation that can protect consumer privacy while not diminishing
its effectiveness. From identifying where social distancing is failing and
understanding future transmission hotspots, to identifying environmental and
geographic factors affecting the rate of disease transmission, Big Data
provides actionable
insight that other sectors are unable to provide. Still, enabling such
unregulated use of Big Data during this outbreak may be risky; history
has shown that practices enacted during emergencies are hard to undo.

The Future of Privacy Forum,
a leader in privacy standards and principled data practices in support of
emerging technologies, recommends
four components to a “comprehensive federal privacy legislation that [is] flexible
enough to support data-driven public health initiatives under the right
safeguards and within limits consistent with privacy and civil liberties.”
These components are: legal protections for sensitive data that includes not
just health information but also geo-location data; mandatory privacy risk
assessments for corporations involved in high-risk data processing; mandatory
independent ethical review boards overseeing research that utilizes sensitive
data—especially in sectors that are currently unregulated in their Big Data
usage; and strict purpose limitation policies, which would require scientific
research utilizing personal data to be “compatible” with the initial purpose
for which the personal data was processed—pursuant to the European model.

Additionally, a consistent theme across proposals for
increased regulation is the necessity
for transparency. The mounting number of non-HIPAA-covered entities that
are regularly collecting, using, and sharing sensitive consumer information,
makes it increasingly more difficult for individuals to know who has access to
their information and how that information is being used. However, increased
transparency, in coordination with other privacy regulations, may encourage
individuals to participate in data-related studies and ease concerns about how private
information may be used.

The COVID-19 pandemic continues to test countless aspects of
our societal norms, economy, and legal system. Big Data pulls together many of
these issues by calling into question how much, and under what circumstances, individual
privacy should be exchanged for public health and safety. The Senate’s paper
hearing on April 9 confirmed the importance of Big Data in responding to the
current pandemic and also signaled potential legislative action to protect consumer
privacy in the modern digital world. While Big Data is playing a critical role
in fighting the pandemic, this crisis has nonetheless exposed legislative gaps
in protecting consumer privacy.