Bill of Health - A worker gives directions as motorists wait in lines to get the coronavirus (COVID-19) vaccine in a parking lot at Dodger Stadium, Friday, Jan. 15, 2021, in Los Angeles, covid vaccine distribution

Countercyclical Aid Is Not Enough to Fix the Broken US Approach to Public Health Financing

By Philip Rocco

In the last month, the U.S. Centers for Disease Control and Prevention’s failed responses to COVID-19, ranging from “testing to data to communications,” have prompted a call to reorganize the agency.

Yet restructuring the CDC will have little effect on pandemic preparedness if the decentralized American approach to health finance remains in place. This structure was already stripped bare by decades of state and local austerity even before the first cases of COVID-19 were identified, and has been further worn down since 2020.

If the pandemic has taught us anything about public policy, it is that the model of countercyclical federal aid — which expands at the onset of an economic crisis but abates as that crisis is resolved — is fundamentally inadequate when applied to the realm of public health.

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New York, USA, November 2021: Pfizer Covid-19 Paxlovid treatment box isolated on a white background.

How to Fairly Allocate Scarce COVID-19 Therapies

By Govind Persad, Monica Peek, and Seema Shah

Vaccines are no longer our only medical intervention for preventing severe COVID-19. Over the past few months, we have seen the arrival and wider availability of treatments such as monoclonal antibodies (mAbs), and more recently, of novel oral antiviral drugs like Paxlovid and molnupiravir.

The recent Delta and Omicron surges have made these therapies scarce. The Delta variant led the federal government to resume control over mAb supply and promulgate allocation guidelines. The Omicron variant exacerbated scarcity because only one of the currently available mAbs, sotrovimab, appears to be effective against it. While Paxlovid and molnupiravir are effective against Omicron, both will likely be in short supply for many months. Paxlovid is currently constrained by a lengthy manufacturing process. Molnupiravir — which is substantially less effective — is contraindicated for use in patients under 18 and not recommended for use during pregnancy.

To allocate COVID-19 vaccines, the CDC’s Advisory Committee on Immunization Practices, the National Academies of Sciences, Engineering and Medicine (NASEM), and the World Health Organization (WHO) identified ethical goals for prioritization, such as maximizing benefit and minimizing harm, mitigating health inequities, and reciprocity. These committees, particularly the NASEM and WHO committees, included ethics experts as well as experts in social science, biology, and medicine. Current federal guidelines for therapy allocation, in contrast, do not identify ethical objectives or involve ethics expertise.

In an open-access Viewpoint in Clinical Infectious Diseases, we identify ethical goals for the allocation of scarce therapies. We argue that the same ethical goals identified for vaccine allocation–in particular maximizing benefit, minimizing harm, and mitigating health inequities — are also relevant for therapy allocation. Because many people have now taken steps to mitigate pandemic scarcity, for instance by protecting themselves through vaccination, we argue that reciprocity is also relevant.

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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.

Illustration of cell phones and prescription pill bottles

Access as Equity: Efforts to Use Telemedicine to Expand Abortion Access

By Oliver Kim

I’ve written here before about areas where technology could play a role in providing access to complicated, controversial healthcare services. Earlier this year, I presented a forthcoming paper co-authored with a colleague on how technology can be used to provide greater equity in women’s health and how the law is being used to encourage such advances or block them. Given the political battles over women’s health, it should be no surprise that technology’s role in abortion access is under increasing scrutiny from lawmakers.

A medication abortion involves a two-step regimen: the woman first takes mifepristone, generally in a clinical setting, and 24 to 48 hours later, she takes misoprostol, generally in the privacy of her home. Recent research, though, suggests that women may not need to take mifepristone in a clinical setting: the World Health Organization revised its guidelines on whether the medications require “close medical supervision,” and a recent op-ed in the New England Journal of Medicine called on the Food and Drug Administration to revise its restrictions on mifepristone.

Given these findings, abortion providers have recognized that telemedicine could be utilized to expand access into areas where abortion services are limited due to geography, legal restrictions, or both. Since 2008, Planned Parenthood in Iowa has used telemedicine to overcome both provider shortages and geographic challenges: a physician can use video conferencing services to appear virtually at health centers across the state, reviewing a patient’s ultrasound and medical history remotely and providing counseling over a secure, private system. The majority of the medical literature finds that using telemedicine to provide medication abortions is just as safe and effective as if a woman met with a clinician in person.

As we discuss in our paper, when technology expands access to care that is politically controversial, policymakers may use the law to restrict such technological advances. In response to this use of telemedicine, states hostile to abortion began passing bans. When Iowa’s medical board attempted to restrict such a use of telemedicine, the Iowa Supreme Court struck down the board’s regulation, holding that it would be an undue burden on a woman’s right to an abortion. Some hailed the Iowa decision as groundbreaking and hopefully influential on other state supreme courts. (Later that same year, the U.S. Supreme Court in Whole Woman’s Health would strike down two Texas statutory restrictions on abortion providers as undue burdens on a woman’s right to an abortion.)

What I find interesting—and what came out after we submitted our paper—is how telemedicine and abortion are being treated in neighboring Kansas and how it reflects the larger legal debate over these issues. In 2011, Kansas first attempted to ban telemedicine abortions by requiring a physician to be physically present when administering mifepristone, thus eliminating the value of telemedicine. Subsequently, the Kansas state legislature modified the ban in 2015 by clarifying that a physician would not need to be physically present in a medical emergency; in 2018, the legislature passed explicit language in the Kansas Telemedicine Act that nothing in this new telemedicine legislation authorized the use of telemedicine for abortion. However, a Kansas court enjoined the Kansas attorney general, the only defendant in this line of cases, from enforcing this provision or the in-person requirements under the court’s prior 2011 decision.

Even more remarkable, in the same state that elected Sam Brownback governor twice, the Kansas Supreme Court recently held in Hodes & Nauser v. Schmidt that the Kansas constitution provided a fundamental right to an abortion.

Thus, it may seem surprising that in a subsequent decision, a district court refused to grant a preliminary injunction for Trust Women, a Wichita-based abortion provider, to prohibit the state from enforcing the telemedicine abortion restrictions. Part of this new case turns on standing as well as recognizing that the prior line of telemedicine-abortion cases only enjoined the state attorney general and was silent on whether the state health department or county attorneys were similarly enjoined from enforcing the telemedicine-abortion bans.

Further, the court also turned part of its decision on whether Trust Women would suffer an irreparable injury: the court found that there was insufficient evidence of an injury because Trust Women still required patients to be present physically at its Wichita clinic in its telemedicine pilot, and Trust Women had taken no preliminary steps to open clinics in remote rural parts of the state. Indeed, the court decried the prior telemedicine-abortion rulings as “a growing procedural backwater” and suggested that the court needs to be able “to resolve the underlying merits of the telemedicine abortion issue,” necessitating that “the parties… present additional evidence and more probing legal analysis than has occurred at this early stage.”

While the district court has significant discretion in considering a request for a preliminary injunction, it does feel troubling that the court suggests that Trust Women should have invested time and resources into a telemedicine strategy that might be illegal before seeking relief. In light of the bans and the legislature’s hostility, it seems unlikely that Trust Women could have raised the funds necessary to create a telemedicine infrastructure and build clinics in remote rural areas. After all, although the Kansas Supreme Court’s decision was not on the telemedicine restrictions, it seems unlikely that they would survive a strict scrutiny review under Hodes since the state will bear the burden of justifying the law. Moreover, it’s also likely that the restrictions might not survive review under Whole Woman’s Health given the weight of medical evidence that suggests singling out abortion from all other services provided by telemedicine, is suspect.

This is also playing out on the national stage as the Fifth Circuit in June Medical v. Gee seemingly sent a direct challenge to Whole Woman’s Health where the Fifth Circuit upheld Louisiana abortion restrictions that were basically identical to the Texas restrictions that were struck down. How June Medical is ultimately resolved will have ramifications for telemedicine in this particular context.

While medical evidence demonstrates that telemedicine is a safe means of providing medication abortion (as well as providing other benefits for women such as privacy), there are of course those that dispute this notion. One could see a conservative court finding that a telemedicine ban is not an undue burden: under the Trust Women preliminary injunction ruling, women in rural areas are no worse off than they were before since they never had access to abortion via telemedicine to begin with. Further, if waiting periods and similar barriers are upheld post-Whole Woman’s Health, this could put rural access even further at risk. In other words, a woman still has access to abortion, just not via telemedicine. Of course many such arguments could be applied to any telemedicine application, so the question turns back again: Why place restrictions just on abortion services?

In so many areas, though, telemedicine has been hailed as a way to increase access for all patients. The issues arise in the same areas where there have always been strong opinions, but the evidence and the trend lines are overwhelmingly in favor of expanded telemedicine access. The law should follow.