Category: Blog

Cell-Based Meat: Meet the Future

In recent years, plant-based meat products have gone from an option for a vegan diet to a popular dish, in fact one in every ten Americans say they do not eat meat. However, plant-based meat products are no longer the only alternative to traditional meat. Cell-based meat is a new alternative that is way “beyond” plant-based meat—it is real meat. Cell-based meat is grown in a laboratory from cells taken from living animals. This technique requires zero animal slaughter,  uses fewer natural resources,  potentially produces less air pollution, and yields less potential for environmental contamination.

The evolution of cell-based meat and sea food as a potential human food has resulted in significant disagreement about how and who should regulate the products. Since cell-based meat is produced by stem cells obtained from the species of livestock and parts of the animals, the meat may satisfy the U.S. Department of Agriculture’s (USDA) current definition of meat and trigger its jurisdiction. Still, the Food and Drug Administration (FDA) has jurisdiction over most food products according to the Federal Drug and Cosmetic Act, which authorizes, among many other things, the FDA’s jurisdiction over biologics. Appropriately, the FDA has taken the lead role involving the safety determination of new biotechnological approaches to foods. Under 7 U.S.C § 1639(1), bioengineered food refers to food made up of genetic material that is modified in vitro using certain laboratory techniques and which modification could not have been obtained through conventional breeding or found in nature. The FDA and USDA agreed in 2019 to ensure that, when it comes to the market, cell-based meat is “safe and properly labeled.” FDA will oversee the cell collection, banking, and growth, using existing rules such as facility registration, and Current Good Manufacturing practices while USDA will conduct inspections and develop labeling for cell-based meat.

When asked about consumers being worried about a product in the market that may have such recent FDA approval, Arye Elfenbein, co-founder at Wildtype Foods, one of the food biotechnology companies that is currently working on the field of cell-based salmon, answered “the imminent availability of cultivated meat and seafood options have resulted in an illuminating dialogue between us and our future customers… the process of FDA consultation has mirrored our discussion with future customers, resulting in a thoughtful and productive exchange from the beginning.” He also added that “the process with FDA is one that has transpired over the past 4 years; it’s been an extremely thorough review, one that we believe will further bolster customer confidence when these products hit the market,” giving us a bit of an insight of the rigorous FDA approval process every cell-based startup is currently going through.

In December 2020, Singapore became the first nation to approve the sale of cultivated meat—chicken nuggets from the company Eat Just. In comparison the U.S. seems to be making regulatory strides to get cell-based meat approved by administrative agencies. The agencies published a request for comment in November of last year, asking interested parties to suggest what the cell-based meat should be called. More excitedly, as of November 16, 2022, the FDA announced the pre-approval of Upside foods, a cell-based chicken startup, making it the first company in the U.S. cell-based space to receive pre-approval from FDA. Products are expected to appear as early as 2023, and it will be interesting to see how the American public will respond to this new innovative and refreshing idea to the market.

States Support Abortion in Midterm Elections

Abortion has long been a contentious issue in American politics, but the debate has been revived, perhaps more than ever, since the Supreme Court’s decision to overturn Roe v. Wade, altering the landscape of abortion access across the nation. One major impact of the Dobbs decision was a distinct shift in the scope of abortion policy to the state level. Elisabeth Smith, Director for State Policy and Advocacy for the Center for Reproductive Rights, says that in a post-Roe United States, “state constitutions are now the best vehicle to protect abortion rights and ensure access.”

The midterms held earlier this month were the first major elections held across the United States since Roe was overturned, providing many voters with an opportunity to contribute to abortion decisions in their states. Elected state officials such as governors, legislative representatives, and judges can play significant roles in shaping abortion policies and access in their states. In addition to the elected officials in the midterms, abortion was directly on the ballot in a record number of states with abortion-related legislative proposals.

With so much at stake for the right to abortion in midterm elections, many voters took advantage of the opportunity to make their voices heard. According to polling conducted by the Keiser Family Foundation, the Supreme Court decision to overturn Roe v. Wade had a major impact on voter turnout and choice for at least half of democratic voters, first time voters, and younger women voters.

The results of this voter turnout are clear: in each of the five states where abortion was directly on the ballot, proposed abortion protections were expanded, and proposed restrictions were rejected. Voters in California, Michigan, and Vermont approved amendments to their state constitutions to protect reproductive freedoms, and limit government intrusion into reproductive health care decisions. In Kentucky and Montana, voters rejected efforts to further restrict access to abortion. These results are following Kansas’ rejection of an anti-abortion state initiative in August. Although these states range from liberal, moderate, to conservative, where abortion was directly on the ballot, the people ultimately voted in support of abortion rights.

The election results are promising for abortion advocates. President and Chief Executive of the Center for Reproductive Rights, Nancy Northup called the midterms “a seismic win for abortion rights,” and emphasized that the outcomes show that “when people can vote directly on abortion in a non-partisan ballot initiative, abortion rights win.” The outcomes of the first major elections after the Dobbs decision may make the case for a glimmer of hope for the future of abortion rights and access in the United States.

Effects of Domestic Violence Mandatory Reporting in Health Care

While research and education regarding domestic violence and abuse continues to grow, domestic violence remains a prevalent issue accounting for roughly ten million victims per year in the United States. National statistics show that on average, twenty people per minute are victimized by domestic violence, with roughly one in four women and one in nine men suffering either physical or mental abuse by their partner. Additionally, one in four women and one in seven men are abused through severe physical violence such as beating, burning, or strangulation throughout their lifetime by an intimate partner. While abused individuals are at risk for various physical, mental, sexual, reproductive, and substance abuse issues, only thirty four percent of victims receive medical care for their injuries. 

There are social stigmas surrounding disclosure of abuse from victims for fear of additional harm by their abuser and judgment by society, making domestic violence hard to measure. Previous studies have found that forty four percent of victims have talked to someone about their abuse, with only thirty seven percent of those individuals disclosing their abuse to a healthcare provider. 

Many state and federal laws have required individuals working in a professional capacity to report signs of possible abuse regardless of the patient’s disclosure. Majority of these statutes specify health professionals such as therapists, nurses, and doctors as mandated reporters for domestic violence. State legislation typically falls into four categories: requiring reporting of injuries caused by weapons; reporting injuries that are caused as a result of violence, through non-accidental means, or in violation of criminal law; specifically addressing domestic violence reporting; or there is no general requirement related to mandatory reporting. However, with difficulty around accurately measuring rates of domestic abuse, it is hard to discern if areas with mandated reporting laws truly assist victims, or if they create an additional risk and barrier to those that have not personally disclosed their abuse. 

Two large discussions on mandatory reporting for health professionals include the effectiveness of reporting in maintaining victim’s safety and the victim’s rights to medical privacy. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) addresses privacy protection issues between health care professionals and their patients. However, when health professionals observe clear signs of abuse, especially when they feel the patient is in danger, abuse must be reported. Regardless of a victim’s request to remain confidential, HIPAA does not cover protected health information if a crime has occurred. HIPPA does not prohibit law enforcement officers from gaining access to patients who were victims of a crime and allows officers to obtain information directly from a patient if it relates to a crime.

Many patient visits of domestic abuse victims do not meet the standards for mandatory reporting. For instance, visits related to extreme harm like stab wounds or gun shots would require a report. However, visits associated with abuse, like chronic health conditions of memory loss or depression, would not constitute a report. During these appointments, patients may describe and disclose forms of domestic abuse, but depending on local laws, health providers may not be required to disclose the abuse that is reported to them.

Despite these mandates, one study notes that most primary care physicians do not routinely screen for signs of abuse. Though screening is separate from reporting, two thirds of women who have been abused said they would have wanted their health professional to ask about domestic abuse . Contrastingly, with various state laws, there is a misconception as to what health professionals must report. Particularly with minority or undocumented victims, individuals avoid seeking medical care because they fear the abuser will find out or that deportation agencies will be contacted. Nevertheless, health professionals remain cautious in their reports, hoping that patients will continue to seek care without fear of a privacy breach.

Ultimately, applying mandatory reporting laws creates a fine line between help and harm. Professionals continue to try and decrease domestic violence, but with the understanding that some patients may experience increased harm; alternative measures and a harsh analysis of local laws must be used to provide patient safety. Possible solutions include amending law to refer patients to professionally trained domestic and sexual violence services instead of to the police.   

Shift to the Balance: Changes to Balance Billing Dispute Resolution Under the No Surprises Act

The Final Rule for the No Surprises Act was released in August 2022, containing changes to the materials an independent dispute resolution (IDR) entity must consider in the IDR process. The No Surprises Act, a part of the 2021 Consolidated Appropriations Act, restricted healthcare providers from balance billing patients enrolled in job-based and individual health plans when receiving out-of-network emergency care, non-emergency care from out-of-network providers within in-network facilities, and air-ambulance services from out-of-network providers. The July 2021 Interim Rules for the No Surprises Act established an IDR process to place the burden of negotiating a fair price for any out-of-network services on providers and health plans.

Before the No Surprises Act, insured patients who received services from an out-of-network provider could receive a bill for the difference between the provider’s charge and their health plan’s allowed amount, a practice referred to as balance billing. Patients receiving emergency care from out-of-network facilities and non-emergency care from out-of-network doctors within in-network facilities could be subjected to balance billing. As a result of a provider being out-of-network and non-contracting with a patient’s health plan, the provider could bill the patient over the plan’s allowed amount. Typically, the allowed amount is a pre-negotiated rate a contracted provider will receive from the health plan and the patient based on the services rendered. Contracted providers cannot balance bill a patient to exceed the patient’s health plan’s allowed amount. However, if a patient received a balance bill from an out-of-network provider, they were responsible for the bill on their own. The No Surprises Act intends to prevent these unfair balance billing practices from plaguing patients.

Throughout this past year, the Act created to safeguard patients’ rights was met with resistance from the American Hospital Association (AHA) and the American Medical Association (AMA). The AHA and AMA criticized the Act’s IDR process, which established a negotiating forum for health plans and out-of-network providers unable to determine appropriate payment. The Act’s July 2021 Interim Rules required government-certified IDR entities to select the settlement offer closest to the health plan’s qualifying payment amount (QPA). The QPA is the health plan’s median contracted rate for the same or similar services in the geographic area relevant to the dispute.  Healthcare providers were quick to point out that the IDR process heavily favored health plans, as a health plan’s QPA swayed the IDR process’ possible outcome.

Medical providers pursued litigation in early 2022 regarding the legality of the IDR process. In February 2022, Texas Medical Associates sued the U.S. Department of Health & Human Services, claiming the IDR process skewed arbitration results in favor of health plans. The District Court found that the October 2021 Interim Rules created unbalanced arbitration processes and caused a procedural injury to providers. Thus, the court vacated the Act’s Interim Rules relating to the IDR process.

In response to the lawsuit, the Act’s Interim Rules were revised in August 2022, removing the regulations the District Court vacated. The Final Rules of August 2022 specify that an IDR entity should select the offer that best represents the value of the service after considering the QPA and all permissible information submitted by the parties to reflect the appropriate out-of-network rate. While the QPA will continue to be a factor in the IDR process, the settlement offer is not predetermined by the QPA alone.  To facilitate health plan transparency, the updated Final Rules also require health plans to disclose “downcode” information, which is the health plan’s reasoning for changing or removing the coding of a disputed claim.

Between April 2022 and August 2022, over 46,000 IDR claims were initiated, a substantially higher amount than the Department for Health & Human Services anticipated for the whole year. Further litigation can be expected regarding the IDR process. While the August 2022 Final Rules substantially adjusted the IDR bargaining field, the AMA and AHA have stated they intend to “make their voices heard in court” soon about ongoing issues with the Act’s IDR process still favoring health plans through the use of the QPA.

NAEP, Literacy, and Health Outcomes: Why Health Law and Policy Leaders Must Focus on Literacy as a Vehicle for Patient Welfare and Decision-Making

The National Assessment for Educational Progress (NAEP) is the largest nationally representative and continuous assessment of what students throughout the United States know and can perform in specific subjects. NAEP is one of several tools guiding state and federal lawmakers as they draft legislation and craft strategies for educational improvement. This assessment, delivered every two years, was delayed in 2021 due to the COVID-19 pandemic, meaning this assessment now gives policymakers, education leaders, and other concerned stakeholders a sense of how the COVID-19 pandemic impacted student achievement.

In October, the latest NAEP results were released. Fourth-grade reading averages are lower than all previous assessment years going back to 2005, and the 2022 average mirrors the 1992 average. Eighth-grade reading averages are the lowest the nation has seen since 1998, and not significantly different compared to 1992. Importantly, the years between 1992 and 2022 show little variance in reading proficiency, and inequities in reading proficiency persist. Policymakers and education leaders are responding by investing in research-backed solutions, like diversifying the teacher workforce, implementing the science of reading, and increasing access to high-dosage tutoring. These investments have and will continue to prove effective, but education policy leaders and practitioners should not be the only parties responsible for this task. Health law and policy leaders should also prioritize improving literacy rates as there is a direct relationship between literacy and health outcomes.  

Literacy proficiency is critical to success, both in the classroom and later in life. Additionally, literacy and health are closely connected. Limited literacy is a barrier to accessing health information, proper medication use, and utilization of preventative services. In terms of medication, medication management capacity (MMC) is critical for identifying medications and understanding how they should be taken. MMC is critical for patients dealing with temporary and chronic ailments and diseases. Research confirms the significant association between low literacy and difficulty identifying medications. One example connecting literacy and MMC pertains to the use of asthma treatment. Determining the relationship between literacy and asthma knowledge and self-care, researchers found that eighty-nine percent of patients reading at less than a third-grade level had difficulty using a meter-dosed inhaler (MDI) properly. In contrast, just less than half of patients reading at a high-school level struggled using an MDI. Research also confirms that patients with low literacy skills are more likely to ask fewer questions about their medical care, which may affect their ability to learn about their medical conditions and treatments.

Reading and health outcomes go hand in hand. Investing in literacy is a key strategy for ensuring stronger health outcomes in the long term, and healthcare practitioners are pushing for the healthcare field to increase involvement in literacy. In Ohio, healthcare leaders speak about the continued difficulties patients face in understanding the condition of their health due to limited literacy, and those leaders are making investments to eliminate the barriers low literacy creates in healthcare. Kettering Health, a healthcare non-profit, invested $60,000 to start an Imagination Library Program in Green County, Ohio. Kettering’s involvement in early literacy sets an example for other states to follow and exemplifies the role health law and policy leaders can play in ensuring better patient outcomes.

A patient’s ability to make critical healthcare decisions rests on reading proficiently. Healthcare law and policy leaders should pay close attention to what NAEP reveals about the state of literacy, partner with state and local education leaders to craft early literacy strategies and convince lawmakers to prioritize early literacy investment. Literacy is a key vehicle for health equity. If healthcare leaders do not respond quickly to last month’s NAEP results, barriers to accessing health information and proper care will persist.

America’s Gun Violence Epidemic

Every year in the United States, thousands of people die at the hands of a public health crisis that has plagued the country for decades. Gun violence is responsible for the death of more than 110 Americans every day and firearms are the leading cause of death for children and teens in the United States. It is a detriment to the health, safety, and well-being of people across the country and has continuously infiltrated all our communities. Similar to most public health crises, gun violence also disproportionately impacts poorer communities and communities of color.

Lack of both education and regulation around these weapons continues to create an environment where children are scared to go to school in fear of losing their lives. In the United States, individuals only have to be 18 years old to buy an assault rifle like the one that was used to kill 19 children and two teachers at Robb Elementary School in Uvalde, Texas this past May, making it the deadliest school shooting in almost a decade.

While debates continue over issues related to the Second Amendment, families are stuck grieving the unfair loss of their loved ones. While no parent should have to experience this pain, the reality in the United States is bleak — even during a time monopolized by the COVID-19 pandemic, the country witnessed twenty-seven school shootings that took the lives of hundreds of children just this year.

Congress has responded to this public health crisis by annually allocating $25 million to the Centers for Disease Control (“CDC”) and the National Institutes of Health (“NIH”) to research gun violence. The CDC uses a public health approach in analyzing gun violence by providing data to inform action, applying science to identify effective solutions, and promoting collaboration across multiple sectors to address the problem. Additionally, the CDC’s Division of Violence Prevention is currently funding ten state health departments, up to $225,000 per recipient, as part of an initiative to provide surveillance data on near-real time emergency visits for nonfatal firearm injuries.

Furthermore, Congress introduced and passed the Bipartisan Safer Communities Act (“BSCA”) this session, which will enhance background checks for buyers under 21 years old, disarm domestic abusers, invest in mental health services, and provide federal funding for Red Flag Laws. Though this was a monumental step in curbing the terror of gun violence, barriers still exist to achieving a country free from this crisis. In June 2022, the United States Supreme Court decided New York State Rifle and Pistol Association v. Bruen. This decision struck down a New York state law that restricted individuals from carrying handguns in public by requiring them to “demonstrate a special need for self-protection.” Removing these strict limitations on carrying firearms in public further threatens the health and safety of Americans across the country. Given the Supreme Court’s current conservative majority, it is critical that local, federal, and administrative leaders step up to save the thousands of lives that could be lost to gun violence in the coming years.

In February 2021, Senator Blumenthal of Connecticut introduced Ethan’s Law, which aimed to establish a federal framework to regulate the storage of firearms on residential premises at the federal, state, and tribal levels. Although the bill did not pass federally, it is still possible to replicate these safety measures at the local and state level. So far, 23 states have adopted these laws, forcing gun owners to make a reasonable effort to safely store and lock their firearms so that they cannot be accessed by children. Through this effort, policymakers will reduce the almost 350 deaths annually that result from children unintentionally shooting themselves or others due to improper storage of firearms in their homes.

As demonstrated by the attempts detailed above, gun violence will not be an easy problem to solve. There must be a willingness to do whatever it takes to prevent guns from taking any more of our loved ones. This includes taking steps like securely storing firearms, advocating for bi-partisan legislation, and educating our communities on this public health crisis. It is through these tangible steps that our society can start to curb the terror of gun violence in the United States.