Sign that reads "Racism is a pandemic too."

Editor’s Choice: Important Reads on Race and Health

By Chloe Reichel

Racism was embedded in the founding of the United States and has persisted in virtually all aspects of our society through the present day.

In 2020, structural racism was made especially apparent in the disproportionate toll the COVID-19 pandemic has taken on communities of color, which can be traced back to the social determinants of health, and in grotesque displays of police violence, such as the killings of Breonna Taylor, George Floyd, Ahmaud Arbery, and Elijah McClain.

Racism is the public health issue of our time, after having been woefully un- or under-addressed for centuries. The following posts, which were published on Bill of Health this year, highlight some of the most pressing issues to confront, as well as potential ways forward.

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America divided concept, american flag on cracked background.

COVID-19 Unmasks Issues Around Public Health Preemption

By Jessica Amoroso and Sarah Winston

States across the U.S. are using preemption to stifle local authority aimed at mitigating the spread of COVID-19, resulting in confusion and a fragmented response.

Historically, local governments have played an important role in providing direct and indirect services to their communities, as they have a heightened awareness of their needs compared to state governments. This has proven especially true during the COVID-19 pandemic, as city and municipal initiatives often have been the initial access point for virus-related services.

But state preemption is increasingly being used as a legal tool to prevent cities and municipalities from legislating on issues of importance to public health.

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This 2006 image depicted a nurse, who was administering an intramuscular vaccination into a middle-aged man’s left shoulder muscle. The nurse was using her left hand to stabilize the injection site.

An Equity-Based Strategy for COVID-19 Vaccine Distribution

By Megan J. Shen

How COVID-19 vaccines roll out in the U.S. will highlight the nation’s priorities, and potentially also its persistent disparities.

Top of the list to receive the vaccine are frontline healthcare workers, who were the first to receive Pfizer’s new vaccine this week.

Next will come long-term care facility residents and workers. This is critical, as long-term care residents have suffered perhaps the most devastating death toll, killing over 100,000 residents.

But there is still a long winter ahead where many will not yet have access to the vaccine. And it remains unclear how the next round of vaccine recipients will be allocated to serve the most vulnerable populations.

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Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Spoonful of sugar.

From “A Spoonful of Sugar” to Operation Warp Speed: COVID-19 Vaccines and Their Metaphors

By Ross D. Silverman, Katharine J. Head, and Emily Beckman

As professors studying public health policy, narrative medicine, and how providers and the public communicate about vaccines, we recognize the power and peril of using the rhetorical tool of metaphors in vaccination and, more broadly, the COVID-19 response efforts.

Metaphors can be an effective shorthand to help people understand complex ideas, but we also must remain cognizant of the many ways metaphors may distort, divide, or misrepresent important details.

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Field with sky and clouds.

COVID-19 in Rural America and the Indian Nations: Refocusing Development to Support At-Risk Communities

By Chris Zheng, J.D.

For many, the COVID-19 pandemic is likely to conjure scenes of once-bustling urban centers grinding to a halt. However, for the one in five Americans that live in rural communities, the reality of the pandemic has been markedly different from that of its metropolitan neighbors. The combination of insufficient resources and a particularly vulnerable population has resulted in disproportionate and devastating effects on remote communities.

COVID-19 has also exacerbated gaps in access to care for the 54 % of American Indian and Alaska Native people who live in rural towns or reservations. As such, there have been many questions as to what legal measures native groups can take to protect their communities. This piece will first address the unique public health challenges facing rural and native communities during the COVID-19 pandemic. Then, it will conclude by proposing group-specific solutions towards mitigating further harm.

Rural Risk Factors

While initial research into community transmission of the Coronavirus focused on dense population centers, it is clear that early-spared rural communities are actually more susceptible to infection than their urban counterparts. In fact, a study in April found that COVID-19 spread 57% faster in rural areas than in metropolitan areas, and another study in May designated 33% of rural counties as highly susceptible to COVID-19.

Public health experts point to several factors that cause such vulnerability. For one, rural populations often have higher rates of cigarette smoking, obesity, disability, high blood pressure, and pre-existing comorbidities, all of which increase the risk of infection and death from COVID-19. Many of these patients are also uninsured and have limited access to broadband internet, restricting tech-driven solutions. Rural communities at-large lack the capital necessary to fund pandemic recovery, resulting in inadequate access to physicians, health infrastructure, and mental health services. That third factor is especially worrisome since rural communities are already subject to increased risk for depression and suicide, now made worse by the need to social distance and isolate.

Increased attention must also be given to the demographic discrepancies in COVID-19’s effects on rural areas. The data is clear that persons of color are disproportionately affected by COVID-19, largely due to systemic discrimination in healthcare access, a reluctance to trust healthcare systems, housing instability, and education and income gaps. The risk for communities of color is substantial — most of America’s poorest areas, known as persistent poverty counties, are located in rural areas, and 60% of people who live in those counties are persons of color. This includes a sizable Native American population, which is 3.5 times more likely to be infected by Coronavirus than non-Hispanic white persons. Tragically, increased risk has translated into dramatic quantitative impacts — the CDC reports that, compared to death rates of White Americans from COVID-19, Black or African American persons have died at a rate 2.1 times higher, Hispanic or Latino persons have died at a rate 1.1 times higher, and American Indian or Alaska Native persons have died at a rate 1.4 times higher.

Complications to Care in Rural America

In dealing with the many problems that hinder effective care in rural communities, four challenges are of particular importance to policymakers’ immediate ability to fight the virus. The first is combatting the Digital Divide, a term that refers to the lack of internet access and technological hardware in many rural areas. In 2019, 37% of rural Americans did not have broadband internet connection. On tribal land, the FCC reports that above 40% of residents lack access. Not only is high-speed internet crucial to economic opportunity, education, and civic engagement, but it is also one of the most promising methods of providing safe medical care to vulnerable residents who may not be capable of visiting a doctor’s office. Thus, healthcare providers’ turn towards telemedicine is promising, but it risks exacerbating existing health disparities in rural communities.

The second challenge concerns the capacity for medical facilities to handle the influx of COVID-19 patients. Since 2005, more than 170 rural hospitals have closed, including 18 just last year. Rural hospitals’ ability to serve patients has long depended on income from emergency room visits, doctor’s appointments, and elective surgeries — all of which have declined in the wake of the pandemic. Without those crucial funding measures, hospitals may be forced to cut staff or shut down, profoundly threatening community care. Prior to the pandemic, a study found that after a hospital closure, death rates in surrounding rural communities increased by almost 6%.

The third challenge similarly involves rural hospitals’ need for dependable financial support. In April, the Centers for Medicare and Medicaid Services (CMS), pursuant to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), allowed applications for Medicaid advances to hospitals, subject to a 120-day repayment period. As 65% of rural hospitals operated at a deficit before the pandemic, many jumped at this critical lifeline. However, from the passage of the CARES Act onward, CMS failed to update hospitals on whether or not it would adjust the repayment deadline. As a result, hospitals found it difficult to depend on federal aid for fear of needing to repay the loans in the midst of the pandemic. This uncertainty was alleviated only on October 1st as part of the government’s continuing resolution, which extended the 120 day repayment period to 29 months to pay in full. However, as many rural hospitals have long been operating in the red and their primary channels of funding have been depleted by COVID-19, the ability for hospitals to pay back these loans, even on an extended schedule, remains uncertain.

Finally, the fourth challenge is an absence of financial institutions in rural areas, which hinders both short-term and long-term recovery efforts. Under the CARES Act, the Small Business Administration (SBA) began offering Paycheck Protection Program (PPP) loans and Economic Injury Disaster Loans (EIDL). Upon implementation, however, rural small business owners found that personal relationships with a banker were necessary to access PPP funds. This was an insurmountable obstacle for many remote communities who had not seen a bank branch in over a decade. Additionally, the SBA relied on online application systems for loan applications, which resulted in rural users on poor internet connections getting kicked off the server. Thus, for federal funding to successfully reach rural communities, additional investment is necessary to establish banking infrastructure necessary to access vital funds.

COVID’s Reach to Native Reservations

In addition to the aforementioned problems, native populations face additional unique social, economic, and legal problems. For one, many Native Americans don’t live in nuclear families, but rather in large family structures and integrated communities that can foster the spread of COVID-19. On the economic side, several tribes over the years have come to rely heavily on tourism and gaming revenue to raise funds for vital public services. However, due to COVID-19’s interruption to travel and recreation, tribal funds are running low when they are needed most.

The complicated relationship between tribes and the US government has also created issues with inconsistent information and policy implementation. Federal tracking of COVID-19 cases largely omits race and ethnicity information, making it difficult to determine the exact rate of coronavirus cases among the indigenous population. Furthermore, tribal health centers that collect data from reservations are not required to share information with the US federal government. In July, less than half of tribal health centers provided case information to the Indian Health Service. Inconsistencies in data may make it more difficult for agency determinations on which communities are most in need.

Additionally, though tribes are sovereign entities, the reach of their jurisdictions is limited. For instance, implementation of health directives can often be challenged by non-Indian landowners on reservations, and tribal directives cannot be enforced on border communities which may threaten reservation residents. For instance, members of the Navajo Nation are often forced to shop for groceries in neighboring communities due to an inadequate number of grocery retailers on the reservation, increasing exposure risk. These jurisdictional concerns require tribes to continuously justify the legality of their public health orders, which in turn may slow the execution of pandemic responses. For instance, when the Cheyenne River Sioux Tribe instituted tribal health and safety checkpoints on federal and state highways crossing their reservation, South Dakota filed suit to enjoin the action as an impermissible disruption of essential travel. The U.S. District Court for the District of South Dakota later ruled in favor of the tribe, holding that, following precedent established in Rosebud Sioux Tribe v. South Dakota, the State does not have jurisdiction over highways on reservation land. Additionally, the court upheld the Sioux’s right to exclude any non-Indians from reservation land established in the 1868 Fort Laramie Treaty. As tribes continue to face legal challenges to their public health protocols, one might sympathize with the response of Sioux Tribal Chairman Harold Frazier to South Dakota’s challenge: “We will not apologize for being an island of safety in a sea of uncertainty and death.”

Prospective Solutions: Refocusing Rural Development

To address the pain points highlighted above, the following possible solutions focus on economic recovery, community-based medical development, and technological investment. To support economies in crisis, local leaders say that additional funding streams targeting rural healthcare infrastructure, struggling waste and water systems, and minority-owned businesses are key. One method of doing so is to increase grants through the Community Development Financial Institutions Fund (CDFI). In response to banking deficiencies that inhibited PPP distribution, Congress could amend the Community Reinvestment Act to create incentives for the banking industry to invest alongside rural communities. Strategic financing can protect these areas from bank divestment and ensure economic support both during the pandemic and after. Additionally, Congress should continue to provide relief through direct payments to households as part of an ongoing program throughout the pandemic. Reports have shown that the $1,200 checks distributed under the CARES Act led to increased revenue for small businesses, especially in Southern rural communities.

To address deficient hospital access, legislators need to protect rural hospitals that are still operating. In the coming years, state and local governments will need an estimated $915 billion to cover shortfalls. Thus, at the very least, Congress should create more grant options with longer time horizons accounting for the pandemic. Even further, the American Hospital Association recommends Medicaid loan forgiveness and extending the current delay on cuts to the Medicaid Disproportionate Share Hospital (DSH) Program through FY2021. This would eliminate the uncertainty that prevents hospitals from taking full advantage of grant funds, translating into larger capacity for patient care.

Other possible solutions to increase access to medical care include expanding Collaborative Practice Agreements (CPAs) which create relationships between pharmacists and physicians to expand the services which pharmacists may administer. By doing so, pharmacists can be integrated into ambulatory care clinics and create on-the-ground planning for future vaccine distribution. Where rural communities are currently facing physician shortages, broadening pharmacists’ practice could help to alleviate demand. Another possible avenue is expanding authorities under the Right to Try Act for rural hospitals to allow for the compassionate or off-label use of drugs, thus circumventing Random Clinical Trials (RCT). The rationale is that, while urban hospitals are able to conduct clinical trials that provide seriously ill patients with the opportunity to use experimental drugs, rural hospitals do not have the funding or capabilities to do RCTs, forcing their desperate patients to wait through a long and arduous drug approval process before they can get treated.

Finally, rural communities need support in bridging the Digital Divide. More work needs to be done towards expanding high-speed Internet access, possibly by making internet access a utility. In the shorter term, federal, state, and local budgets can be directed towards fixing the hardware gap by funding free computer programs, home routers, antennas, and broadband towers. Some communities have seen success by installing Wi-Fi hotspots on busses and parking them outside rural communities. Hospitals pivoting towards telemedicine can also ensure care for all their patients by creating free cellphone programs for those in need and establishing care locations where patients can drive and park to complete telemedicine appointments on stable high-speed internet.

Responses and Solutions specific to Native Communities

Indigenous Nations have been largely successful in using their sovereign authority to establish public health orders and should continue to use their judgement to do so, supplemented by use of their legal right to exclude. For instance, the Navajo issued weekly curfew hours from 8:00PM MDT-5:00AM MDT and a 57-hour weekend shelter-in-place lockdown for the first two weekends of October. The Rosebud Sioux in May announced a plan to create the largest Tribally-owned bison herd and processing facility in the country to increase tribal food independence and alleviate shortages caused by COVID-19. Finally, the Mille Lacs Band of Ojibwe used its rights under the Indian Gaming Regulatory Act to close its casinos for 77 days. These examples represent the vast range of possibilities for tribes to use their legal authority established by a patchwork of federal law and treaties to respond to the pandemic.

Within that legal framework, a prescriptive solution to increase efficacy of future public emergency response is for federal, local, and tribal governments to create Mutual Aid Agreements (MAA) which create formal arrangements on how governments will reimburse aid, assign liability, license emergency responders, accept insurance policies, share data, coordinate public messaging, and resolve disputes. For instance, in Washington, seven tribes and three local health departments created an MAA to assist and share resources during a public emergency. The formation of these agreements establishes pandemic plans which can be quickly executed for the safety of tribal residents.

Finally, the federal government needs to provide substantially more support in economic aid to fulfill its trust and treaty responsibility to tribes. Federal resources can be directed towards establishing or bolstering clean water and sanitation services which are critical to fighting the virus. Additionally, the Department of Health and Human Services should increase the current $80 million fund for tribal COVID-19 response while extending Imminent Threat Funding established by the CARES Act. However, increasing funding alone is not a panacea; more must be done to ensure access to those funds. As of June of this year, Congress had obligated only $614 million of the $1.1 billion promised to the Indian Health Service through the CARES Act, due to complicated requirements for bilateral amendment processes which drastically slowed down funds distribution. Thus, the federal government should amend the lengthy bilateral amendment process and streamline competitive grant applications to immediately free up allocated funds to tribes in need.

A Stronger Rural America

Rural communities and Indigenous Nations still face an uphill battle as COVID-19 cases continue to rise. However, with strategic investment and creative programming, the resiliency of rural communities will continue to build, and even the most remote residents will be safer for it.

 

Thank you to Professor Robert Anderson for his generous guidance on tribes’ COVID-19 responses.

 

This post was originally published on the COVID-19 and the Law blog.

Chris Zheng graduated from Harvard Law School in May 2021.

Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

HHS Recognizes Key Role of Telehealth in Amended PREP Act Declaration

By Vrushab Gowda

On December 3rd, the Department of Health and Human Services (HHS) extended its provisions to cover telehealth services in amending its Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID–19.

This represents the first time HHS has covered telehealth services under the authority of the PREP Act. Telehealth providers are now permitted to deliver a range of COVID-related care across the country, including states in which they do not hold professional licenses. The Declaration, moreover, offers them expansive liability protection, effectively immunizing them against a host of claims in connection to their administration of designated countermeasures.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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Close up of a Doctor making a vaccination in the shoulder of patient.

Authorize Emergency Vaccines for COVID-19, but Do It Well

By Holly Fernandez Lynch, Alison Bateman-House, and Arthur Caplan

The U.S. Food and Drug Administration (FDA) is expected to grant emergency use authorization (EUA) for one or more COVID-19 vaccines before the end of the year — perhaps even before the end of the day, given today’s advisory committee meeting.

The agency’s decision on these EUAs will balance the need for additional data on safety and efficacy against the potential to protect at-risk groups as quickly as possible. EUAs tip the balance in favor of speed, which can be reasonable for these populations given the circumstances, especially in light of the strong trial data reported for three COVID-19 vaccines since mid-November. But the tradeoff is very real: vaccine EUAs will substantially lower the likelihood of ongoing trials completing and new trials successfully recruiting volunteers. There are a few ways to minimize these consequences.

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