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Carly Michaud, MJLST Staffer

At the end of October, the CDC broadened the eligibility for COVID-19 vaccines by adding booster shots for people with specific risk factors who have already been vaccinated, and the long-awaited authorization of shots for children ages 5-11. But with eligibility expanding, the fights over public-school vaccine mandates are sure to increase in intensity. The ultimate question is who has the final say on the health and safety of children in public school: the educators, the parents, or perhaps the students themselves. In addition to the rights of public schools and parents to make decisions around childhood vaccinations, states and public health experts have started to endorse legal processes for teens to consent to vaccination without parental consent.

School Authority

School districts can issue and enforce vaccine mandates through a delegation of state police powers. Through the doctrine of parens patriae, the state holds the power to intervene to protect citizens, including children when the parent is not adequately assuring their health and safety. However, in comparison to the broadness of parens patriae, schools have traditionally had a duty to protect children via the doctrine of in loco parentis, which gives the school the authority of the parents while the child is attending. Schools districts retain authority because of the need to protect the health of children and staff at their facility.

All states have some required vaccinations for children attending public schools, including MMR, Tdap, and varicella (aka. Chickenpox). MMR and Tdap are both combination vaccines protecting against measles, mumps, rubella, (MMR) and diphtheria, tetanus, and pertussis (Tdap). Vaccination mandates are a common public health measure taken particularly for those who are considered medically vulnerable populations and those who work with those populations. Children are considered medically vulnerable due to a variety of factors, including  psychological development, behavioral development, and significantly more daily person-to-person social contacts, making them unique from adults.

Mandatory vaccination has been a common public health practice since the turn of the 20th century and the widespread development and availability of vaccines. In 1905 the Supreme Court upheld a smallpox vaccine mandate enforced by a municipal Board of Health in Massachusetts as a reasonable exercise of state police power. As vaccine availability grew the Supreme Court also affirmed the applicability of vaccine mandates for school children in Zucht v. King. This doctrine has remained well-settled even to the present day, as mere days ago the Supreme Court denied injunctive relief to stop a state level vaccine mandate for health care workers.

Parent/Guardian Authority

The parent or guardian is automatically assumed to care for their child and have a right to do so in the way the parent or guardian sees fit, which is protected under the Fourteenth Amendment’s fundamental rights of parents. The state has been deferential to parental rights under the Fourteenth Amendment, however that deference has not extended to unvaccinated children attending schools without a legally approved exception. Despite the legal control parents have over their children, school districts are able to use their authority to compel students attending their facility to be vaccinated against certain diseases.

Self-Authorizing?

Due to the COVID-19 pandemic, more jurisdictions in the United States have given children ages 11 or 12 and older the ability to consent to vaccinations without parental consent. Ethicists have affirmed this policy noting that as children develop autonomy, it is reasonable to rely on their ability to consent to high benefit and low risk health decisions. This policy has been in place in a variety of states and municipalities for numerous years for other vaccines and medical decisions. Now it is being utilized by teens for COVID-19 vaccines.

The American Medical Association is in favor of autonomous teen vaccination as it “maximize[s] immunization opportunities for children” and is already the standard for teens who are effectively independent due to homelessness, unaccompanied status, or military service. This policy also offers protection for teens who do not want to inform a parent of their desire to receive specific preventable or immediate medical care. Many of these laws exist to allow teenagers to choose to receive contraception and the HPV vaccine.

While teens are able to make some health decisions for themselves, the majority of children in the United States are between the ages of 0 and 11. The most recent authorization applies to children in the age 5-11 group, who are still reliant on school vaccine mandates to protect their health and stop the spread of COVID-19 in schools.

Vaccine mandates in schools protect the health of students, faculty and the larger community from the spread of disease. In the case of COVID-19, the Pfizer-BioNTech vaccine has been approved for children ages 5-11 and is over 90% effective, and for children ages 12-15 and has the same efficacy as the original vaccine for adults. (Children ages 16-18 were included in the original Emergency Use Authorization for Pfizer’s vaccine, which is over 95% effective). It is vital schools maintain the power to require student vaccinations to prevent the unnecessary death of students and teachers from a lack of vaccine access and acceptance.

Minnesota Journal of Law, Science & Technology

The Journal is pleased to announce our editorial board and staff members for Volume 23. We look forward to sharing with you the latest research and musings of scholars around the world and our own staff members. Follow along on this blog, on the Journal’s website, and on Twitter.

Jennifer Novo, MJLST Staffer

Halloween is often a time for ghosts, the dead, and for some, is the perfect time to make a trip to a local graveyard or cemetery. The obvious association with death as the final resting place for many makes graveyards an inherently spooky destination. Burial is just one of the many methods used for the final disposition of human remains around the world and is a common practice in the United States. However, considering environmental and economic factors, it may be time to consider alternative forms of final disposition.

In the United States, there is a presumed right to a decent burial under common law. Beyond that, different jurisdictions within the United States have their own regulations for the disposal of dead bodies and the reporting of deaths and final dispositions of the remains. For example, Minnesota Statute § 149A outlines regulations with the purpose of “regulat[ing] the removal, preparation, transportation, arrangements for disposition, and final disposition of dead human bodies for purposes of public health and protection of the public.” This chapter outlines license requirements, safety standards, and guidelines for a number of disposition practices, not just burial.

There are a number of negatives, from environmental to economic, to the modern burial. Modern burials consist of burying a casket containing embalmed remains. This practice has serious environmental effects. Embalming is used to delay the decay of a body, and the chemicals used for embalming include formaldehyde, phenol, methanol, and glycerin, all of which are irritants and some of which are carcinogenic or toxic. Over time, once the body and the casket have decomposed, these chemicals will seep into the soil and water table of the surrounding area and pose a health risk to the living. Burials also negatively affect the environment by using a large amount of resources to create caskets (hundreds of thousands of tons of various metals and concrete as well as millions of board feet of wood). Another primary negative environmental impact that burial has is that graveyards use up a lot of space (as of late 2018, there are a little under 145,000 graveyards across the United States totaling to approximately 1 million acres of land). This land requires a lot of maintenance, water, and fertilizer to keep green. In addition to the environmental effects, burials are expensive. By 2017, funeral expenses increased 227.1% and the cost of burial caskets rose by 230% since 1986. The current cost of a traditional full-service burial in North America is between $7,000 and $10,000.

In 2017, a report by the National Funeral Directors Association (NFDA) found that for the first time, more Americans were cremated than buried. Researchers ascribed this change to shifting religious beliefs and generational differences. Economically, cremations are less expensive than traditional burials. Additionally, cremation removes the need for large swaths of land required by burials. However, like burials, cremation has negative environmental impacts. For example, studies have suggested that the high level of energy required to cremate a body damages the environment. Additionally, the cremation process releases various chemicals (such as carbon monoxide, sulfur dioxide, and mercury) and soot into the atmosphere, and the resulting sterile ashes lack nutrients that could contribute to ecological cycles.

As people are becoming more aware of the downsides to traditional burial and cremation, other methods of final disposition have been created and adopted that address some of these concerns.

One alternative comparable to a traditional burial is a natural or green burial, in which a body is buried either in a shroud or a biodegradable container without going through the embalming process. Some types of natural burial (conservation burial) take this a step further in that some of the fees associated with the burial go towards protecting the land through a conservation easement.

One alternative comparable to traditional cremation is a flameless cremation process known as alkaline hydrolysis, in which the body is dissolved, leaving bone powder and a liquid that can then be “recycled” in a local wastewater treatment plant. Only a handful of states, including Minnesota, have formally adopted regulations for this final disposition process.

A number of states, including Minnesota, do not have many (or any) restrictions on remains post-cremation, so a number of alternatives focus on ways cremated remains can be used to negate the negative environmental effects of the traditional cremation process. Some examples include sending ashes in a concrete ball to the ocean floor to promote the growth of coral reefs, placing ashes in a pod that will eventually grow into a tree, and mixing ashes with fertilizer to feed a particular tree in lieu of having a gravestone.

Death is frightening and uncomfortable to think about, and contemplating the treatment of a loved one’s (or one’s own) remains is depressing. However, decisions on these matters have lasting effects for friends, family, and even the general population. There is a lot of legal leeway surrounding final disposition, so it never hurts to consider the options before it’s too late.

Jennifer Satterfield, MJLST Staffer

Recently, the Food and Drug Administration (FDA) began an investigation following numerous reports of dilated cardiomyopathy (DCM), a type of heart disease, in dogs. The FDA is exploring a potential connection between DCM and certain diets containing legumes (e.g., peas or lentils), legume seeds (pulses), or potatoes as main ingredients. These ingredients are commonly associated with “BEG” diets (boutique companies, exotic ingredients, or grain-free diets). The FDA has compiled a spreadsheet of all the DCM reports prior to April 30, 2019. The most frequently identified brands include: “Acana (67), Zignature (64), Taste of the Wild (53), 4Health (32), Earthborn Holistic (32), Blue Buffalo (31), Nature’s Domain (29), Fromm (24), Merrick (16), California Natural (15), Natural Balance (15), Orijen (12), Nature’s Variety (11), NutriSource (10), Nutro (10), and Rachael Ray Nutrish (10).”

The DCM scare has led pet owners to question the safety of pet food products and turn to online forums for help, including a popular Facebook group called Taurine-Deficient (Nutritional) Dilated Cardiomyopathy. This group’s purpose is to “share information concerning Nutritionally-Mediated DCM among veterinarians, breeders, members of the Ph.D. & DVM research community, nutritionists, food brand representatives, nutrient suppliers, and concerned dog owners.” Some of the most common concerns among dog owners in this group are “what should I be feeding my dog?” and “what food is safe for the long term?”

Unfortunately, the FDA only requires that pet food be “[s]afe to eat; [p]roduced under sanitary conditions; [f]ree of harmful substances; and [t]ruthfully labeled.” However, the Federal Food, Drug, and Cosmetic Act (FFDCA), the statute that gives the FDA the authority to regulate pet food, does not require any pre-market review. Hence, pet foods do not need to be formally approved or undergo testing before hitting the shelves. Consequently, the federal government may have inadvertently allowed pet foods to reach the market that may not be safe for animals in the long term. For example, french fries are “safe to eat.” But, eating just french fries every day for a person’s entire life is not healthy, and will probably lead to medical complications. Since dogs generally eat the same dog food over the course of their entire lives, the food may be “safe to eat,” but may not be healthy as the dog’s sole source of nutrition.

Although the FDA has partnered with the Association of American Feed Control Officials (AAFCO), AAFCO does not have regulatory authority. For a dog or cat food to have a “complete and balanced” label, it must meet either one of the nutrient profiles established by AAFCO or pass a feeding trial using AAFCO standards. But AAFCO cannot enforce its standards, and, what is more, its recommendations may not even be good enough to ensure pet food safety in the long term. For example, both the nutrient profile and feeding trial methods leave uncertainty regarding nutrient bioavailability (the nutrients the animal’s body actually absorbs and uses).

Moreover, the AAFCO feeding trial protocol only requires eight animals to participate and only six out of the eight need to complete the entire trial over a period of twenty-six weeks. This extremely small number of test subjects over a relatively short period of time is not enough to make a determination on the safety or nutritional longevity of a specific pet food. As a comparison, a human-controlled feeding clinical trial used a “relatively small” sample size of twenty two people per group. Logically, pet food companies should be conducting feeding trials with a substantially larger number of test subjects over a much longer time period.

To prevent another scare, like the surprising potential link between DCM and certain dog foods, and to ensure the safety of pet food, the FDA should require stringent pre-market testing using sound scientific methods. But, since it is likely that the FDA does not have the statutory authority to increase its regulatory oversight of the pet food industry based on the FFDCA, Congress should step in and require it. It is also important to note that, while pet food is also regulated by states, these regulations typically deal with labeling and nutrient profiles. Considering the federal government’s failure to ensure pet food safety, states may also be able to step up and require pre-market testing. For many people pets are like family and, surely, pet owners want the safest, healthiest options for their beloved family members.

Peter J. Teravskis, MJLST Staffer

The vast majority of payments to medical providers are based on a fee-for-service reimbursement model. The fee-for-service model reimburses providers for every test, exam, intervention, and procedure they perform, potentially contributing to over-billing, increased health care costs, and waste. On the other hand, value-based care models tie provider reimbursement to efficiency of care and measures of patient wellness and satisfaction. For this reason, in recent years, there has been a nationwide effort to transition provider reimbursement away from fee-for-service towards value-based care.

In line with this effort, the Affordable Care Act contains many provisions designed to encourage the transition to value-based care. In 2015, then-Secretary of Health and Human Services Sylvia M. Burwell tasked the Centers for Medicare and Medicaid Services (CMS) with two goals for 2018: increasing (1) value-based purchasing practices, and (2) use of value-based reimbursement models (called alternative payment models or “APMs”) by Medicare providers. The hospital value-based purchasing program rewards acute-care providers for making purchasing decisions based on quality metrics rather than the volume of services provided while still operating in a fee-for-service framework. On the other hand, the APM adoption plan seeks to discard fee-for-service reimbursement entirely by encouraging the adoption of payment models that reimburse providers based on patient outcomes and efficiency of care rather than volume.

While CMS efforts have resulted in increased adoption of value-based care models, early data suggests that these models may not deliver the health and financial benefits initially promised. For example, recent studies indicate that multiple value-based Medicare reimbursement models in several clinical contexts fail to demonstrate meaningful improvements in hospital readmission rates, health outcomes, quality of care, and patient satisfaction. Nevertheless, some marginal cost savings have been reported. However, cost savings may be even more limited than the studies suggest. Government metrics may overestimate the actual adoption of value-based practices given the loose definition of “value-based care.” Further, the New York Times Upshot reports that CMS may overestimate the adoption of value-based purchasing metrics by miscounting many volume-based purchases as value-based purchases.

CMS’s attempt to implement value-based care through this top-down incentive structure is also ethically fraught. Current value-based care models have been criticized for making assumptions about what patients actually value, rather than adopting a pluralistic understanding of patient values. This “monistic” value system decreases patient autonomy in their health care decisions. Indeed, ethicists contend that it is only ethical to impose value-based decisions on patients if there is “strong and sound evidence” that they deliver “equivalent or greater clinical benefit at lower cost.” This ethical principle greatly limits the number of value-based reforms that can be instituted at the national- or hospital-level. Indeed, all other value-based decisions should be made in consultation with individual patients, taking into account their unique value systems. Furthermore, it is “ethically suspect” to withhold otherwise beneficial treatments based on cost savings alone. Unfortunately, value-based care models favor health care market efficiency and could penalize providers who tailor care to patient values rather than the monistic value structure described above.

Given the ethical limitations of value-based decisions that can be made without patient input, the early empirical shortcomings of Medicare’s value-based care initiatives may be partially explained by the slow process of aligning care to patient values. Specifically, the value-based decisions most likely to improve care and costs require physicians to (1) understand individual patients’ values, and (2) tailor efficient and effective care to align with those values. Unlike the APM adoption initiative which takes a holistic approach to incentivize value-based care, the hospital value-based purchasing plan does not allow for significant patient-provider collaboration, especially in the acute care setting where patient interactions are brief.

Recently, the Trump administration has reoriented value-based purchasing agreements to focus on drug price reduction and signaled it will slow the pace of APM adoption (a move that was criticized for creating uncertainty among health care market stakeholders). This deceleration likely stems, in part, from concerns over mandating the adoption of certain APMs in rural communities. Regardless of the motive, decelerating APM adoption will likely prove beneficial. The process of aligning care with patient values is largely intangible in the short-term; therefore providers and patients alike will benefit from the additional flexibility of a slower, voluntary transition away from fee-for-service reimbursement. Nevertheless, CMS must not lose sight of the goal of providing Medicare beneficiaries high-value-care while still affording providers the time and financial latitude to ensure that long-term benefits are genuinely patient-value-centric.