October 2019

Death of a Gravesite: Alternatives to the Traditional Burial Practice

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.


Should the FDA Strengthen Pet Food Regulation?

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.

 


Putting Patient Values in Value-Based Medicare

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.


Mystery Medicine: How AI in Healthcare Is (or Isn’t) Different From Current Medicine

Jack Brooksbank, MJLST Staffer

Artificial Intelligence (AI) is a funny creature. When we say AI, generally we mean algorithms, such as neural networks, that are “trained” based on some initial dataset. This dataset can be essentially anything, such as a library of tagged photographs or the set of rules to a board game. The computer is given a goal, such as “identify objects in the photos” or “win a game of chess.” It then systematically iterates some process, depending on which algorithm is used, and checks the result against the known results from the initial dataset. In the end, the AI finds some pattern— essentially through brute force  —and then uses that pattern to accomplish its task on new, unknown inputs (by playing a new game of chess, for example).

AI is capable of amazing feats. IBM-made Deep Blue famously defeated chess master Gary Kasparov back in 1997, and the technology has only gotten better since. Tesla, Uber, Alphabet, and other giants of the technology world rely on AI to develop self-driving cars. AI is used to pick stocks, to predict risk for investors, spot fraud, and even determine whether to approve a credit card application.

But, because AI doesn’t really know what it is looking at, it can also make some incredible errors. One  neural network AI trained to detect sheep  in photographs instead noticed that sheep tend to congregate in grassy fields. It then applied the “sheep” tag to any photo of such a field, fluffy quadrupeds or no. And when shown a photo of sheep painted orange, it handily labeled them “flowers.” Another cutting-edge AI platform has, thanks to a quirk of the original dataset it was trained on, a known propensity to spot giraffes where none exist. And the internet is full of humorous examples of AI-generated weirdness, like one neural net that invented color names such as  “snowbonk,” “stargoon,” and “testing.”

One area of immense potential for AI applications is healthcare. AIs are being investigated for applications including diagnosing diseases  and aiding in drug discovery. Yet the use of AI raises challenging legal questions. The FDA has been given a statutory mandate to ensure that many healthcare items, such as drugs or medical devices, are safe. But the review mechanisms the agency uses to ensure that drugs or devices are safe generally rely on knowing how the thing under review works. And patients who receive sub-standard care have legal recourse if they can show that they were not treated with the appropriate standard of care.  But AI is helpful essentially because we don’t know how it works—because AI develops its own patterns beyond what humans can spot. The opaque nature of AI could make effective regulatory oversight very challenging. After all, a patient mis-diagnosed by a substandard AI may have no way of proving that the AI was flawed. How could they, when nobody knows how it actually works?

One possible regulatory scheme that could get around this issue is to have AI remain “supervised” by humans. In this model, AI could be used to sift through data and “flag” potential points of interest. A human reviewer would then see what drew the AI’s interest, and make the final decision independently. But while this would retain a higher degree of accountability in the process, it would not really be using the AI to its full potential. After all, part of the appeal of AI is that it could be used to spot things beyond what humans could see. And there would also be the danger that overworked healthcare workers would end up just rubber stamping the computer’s decision, defeating the purpose of having human review.

Another way forward could be foreshadowed by a program the FDA is currently testing for software update approval. Under the pre-cert program, companies could get approval for the procedures they use to make updates. Then, as long as future updates are made using that process, the updates themselves would be subject to a greatly reduced approval burden. For AI, this could mean agencies promulgating standardized methods for creating an AI system—lists of approved algorithm types, systems for choosing the dataset the AI are trained on—and then private actors having to show only that their system has been set up well.

And of course, another option would be to simply accept some added uncertainty. After all, uncertainty abounds in the current healthcare system today, despite our best efforts. For example, Lithium is prescribed to treat bipolar disorder, despite uncertainty in the medical community of how it works. Indeed, the mechanism for many drugs remains mysterious. We know that these drugs work, even if we don’t know how; perhaps using the same standard for AI in medicine wouldn’t really be so different after all.


Undocumented Americans and a Pathway to Health Care Coverage

Jacob Hauschild, MJLST Staffer

In a June Democratic Primary debate, moderator Savannah Guthrie asked the field of candidates who would provide undocumented immigrants access to health care coverage. When all ten candidates raised their hands, the issue of health care access for undocumented immigrants was pushed to the forefront of the health care reform debate.

Despite this apparent unanimity, Democrats are far from aligned on the issue—never mind the policy’s poor popularity among voters. But lacking from the public discourse is due attention to how undocumented immigrants currently engage with our health care system.

Health care coverage is usually attained by U.S. citizens through one of three sources: (1) employer-sponsored insurance (ESI), (2) public health care programs (for example, Medicare and Medicaid), and (3) the individual market. Not all of these doors are open to undocumented immigrants, however. While some do have access to ESI, undocumented immigrants are generally prohibited from enrolling in federal public programs such as Medicare and Medicaid[1], and they are also not permitted to purchase health insurance on the federal or state-based marketplaces. While they can buy short- or long-term coverage directly from an insurer or an insurance broker, this coverage is often prohibitively expensive. Therefore, undocumented immigrants who cannot access health care insurance through their employer are often left with no coverage options; in fact, undocumented immigrants are uninsured at a rate of about 45%, compared to the only 8% of citizens who are uninsured.

The lack of access to health care coverage causes lower utilization of health care services, particularly preventative care. Some uninsured patients have access to income-based Community Health Centers—which are an “important source of primary care” for the uninsured—but these facilities often lack “stable revenue streams [and] sufficient staffing support.” Further, most hospital systems have “Charity Care” programs, but these programs tend to focus on paying for health care costs already incurred, rather than promoting use of preventative care to help patients stay healthy and reduce future cost.

Low access to preventative care services results in poorer health care outcomes and more complex and expensive health care needs later in life for the undocumented and other uninsured groups. That care is often delivered in the emergency room, where care for an emergency medical condition cannot be denied due to ability to pay. The financial burden of this uncompensated care weighs on the entire health care system and poses a detriment to the financial and physical wellness of our communities. Further, the financial loss from this uncompensated care is ultimately spread among all health care consumers—for example, through increased taxes; diversion of public funds from other programs; and, as is often claimed, increases to the costs of private health insurance—and is leading to the insolvency of health care systems in communities with fewer commercially insured patients.

Keeping in mind the impact of high uninsurance among undocumented immigrants, the manner in which health care access is “expanded” is of tremendous consequence. Proposals like Joe Biden’s only allow for undocumented immigrants to purchase coverage at full cost on the ACA marketplaces, without access to tax subsidies. Due to excessive cost and the fact that undocumented immigrants live in poverty at twice the rate of U.S. born citizens, it is unlikely for such a policy change to reduce uninsurance amongst this population. Meanwhile, plans like Bernie Sanders’ Medicare-for-All apparently cover all residents of the United States, regardless of immigration status. Such expansive health care reform is controversial in its own right, and should Medicare-for-All or a similar proposal advance through Congress in the future, it seems likely that access—and the extent of that access—to undocumented immigrants will be a dividing point among Democrats, as well as a nonstarter among many Republicans.

Yet the issue merits attention. Because the health care costs of undocumented immigrants are spread across the health care system regardless of whether or not they have access to coverage, it is good policy to curb those costs with preventative care, particularly when we consider the specific health care needs of the population, which in the modern era include significant trauma. A solution could take several forms, ranging from full access to the marketplace and its tax credits; to Medicaid benefits for income-eligible, undocumented children; to expanded funding for Community Health Centers and culturally competent outreach. Whatever that solution may be, it will affect not only the 10.7 million undocumented immigrants in the United States but also each and every health care consumer in the country.

[1] Sixteen states permit undocumented women who are pregnant and meet income guidelines to temporarily access Medicaid by utilizing federal CHIP funding to cover the unborn child, and income-eligible individuals who receive emergency services in an emergency room may be eligible for Medicaid to exclusively cover those costs.


Will the Vaping Industry Go Up in Smoke?

Stephen Wood, MJLST Staffer

It’s no secret that vaping has become increasingly popular. The number of users has increased from 7 million in 2011 to 41 million as of 2018. The total market is now worth an estimated $19.3 billion. Less clear is the future of industry regulation in light of the recent respiratory illnesses linked to vaping. On September 24, 2019, the Centers for Disease Control and Prevention reported that vaping was attributed to 805 illnesses and 12 deaths. Pressure is building on the industry’s major players. In the last week, we have seen the cancellation of a merger between two of the largest tobacco companies, Altria and Philip Morris, and the release of the CEO of Juul, Kevin Burns.

However, the respiratory illnesses associated with vaping haven’t been linked to a specific product, and it is unclear what the long-term effects of vaping are. Because of this uncertainty, some states have implemented blanket restrictions on the sale of vaping products, President Trump has proposed new regulations, and the CDC has issued warnings regarding their safety. This is blindsiding the industry, which has been free from regulation by the FDA until recently.

Vaping devices, also known as electronic nicotine delivery systems (ENDS), became subject to the FDA’s regulatory scheme for all tobacco products on August 8, 2016. The Deeming Rule placed ENDS in the same category of products as cigarettes and other traditional tobacco products, which have been regulated under the Family Smoking Prevention and Tobacco Control Act since 2009. For this reason, the minimum age for purchasing ENDS is 18 years old, and the marketing, manufacturing, and distribution of ENDS is heavily regulated.

Juul, in particular, has come under fire for its marketing strategies. Among other claims, many lawsuits allege that the company specifically targeted minors through its use of social media and distribution of enticing flavors. These practices have also been the focal point of the recent surge of state regulations, which “are filling what many see as a regulatory void caused by federal inaction.” For example, in Michigan, Governor Gretchen Whitmer implemented an emergency ban, limiting the sale of vaping products to those which are tobacco flavored. New York did the same but exempted menthol from the ban. Massachusetts, notably, implemented a four-month emergency ban on all products. President Trump’s proposed ban, on the other hand, would be limited to flavored products.

If President Trump’s proposal is adopted, the industry would see an estimated 80% loss in sales. It will be interesting to see what the regulatory landscape looks like once the smoke clears.