The Russian Olympic Committee (ROC) is in the middle of yet another Olympic doping scandal. One of ROC’s women’s figure skaters, Kamila Valieva, tested positive for the medication trimetazidine. She was favored to win gold before the Games started. Trimetazidine (TMZ), a metabolic modulator, has been banned by the International Olympic Committee (IOC) since 2014. The medication is listed under the section non-specified Hormone and Metabolic Modulators, S4.1. The substances listed under this section are prohibited at all-times, both in and out of competition. Russia is not allowed to compete as a country and is competing as the ROC due to a history of doping. A disqualification would move the United States team into the gold medal position. Prior to the World Championships, Valieva tested positive for this medication through random testing that Olympic-level athletes are subjected to. There is little information on how she was reprimanded then, but no official warning or ban was issued. Additionally, she was still able to compete at the World Championships and qualify for the 2022 Winter Olympics. The official results of the drug test did not make it to the IOC until after the Olympics had started, even though the Russian Anti-Doping commission was aware of the substance in her system. Valieva faced up to a two-year ban from competition as a result of this infraction. However, she was allowed to continue with her Olympic competition.

Trimetazidine, also known as TMZ, is commonly used to treat coronary heart diseases such as angina or to assist with blood flow through stints. The idea behind banning this medication is that TMZ helps your heart to function better under immense stress. Athletes during competition are often putting their heart under stress and TMZ could help performance by pushing more blood to the rest of the body. The IOC does have medical allowances for use of TMZ, but no news of a medical exemption request on behalf of Valieva to the IOC has surfaced. The IOC has previously given warnings about banned drug use to competitors. Those times are limited to “protected persons” (those under the age of 16) who can prove that their use of the banned medication is “unintentional.”

The standard of proof for unintentionality is handled on a case-by-case basis to allow for the inclusion of emerging technology and medications as well as extenuating circumstances. I find it hard to believe that a 15-year-old would not be able to find the prohibited medications list. In a matter of five minutes and a google search, I was able to find a complete list of all banned substances with all necessary qualifiers. Additionally, as tensions rise between Russia and the United States, disqualifying Russia and keeping them from two gold medals might increase tensions. Especially because this could lead to the United States taking home both medals. It is entirely possible that the warning or ban might be kept from the public as it has been for other competitors. The difference between previous instances and the present one is the national news coverage Kamila Valieva has received for her excellence and Russia’s current ban from competition.

In the end, the IOC has specifically listed TMZ as a banned substance for four Olympic cycles. Many doctors believe that TMZ would not have actually advantaged a competitor, but that does not change its status as a banned substance. As the United States saw with the disqualification of favored sprinter Sha’Carrie Richardson, in the 2020 summer Olympics, using a banned substance is taken very seriously. Sha’Carrie Richardson tested positive for cannabinoids prior to the Olympics and was banned from competition. Cannabinoids are only banned while an athlete is competition season. TMZ is banned at any point throughout the year before an athlete retires, regardless of the competition season. While many will say that cannabinoids and TMZ are not similar in any way, the previous Olympic cycle set a precedent to ban competitors for testing positive with a substance on the banned list. Following this precedent, Valieva should be stripped of her medals and receive a ban from competition. However, there are extenuating circumstances such as Valieva’s age and Russia’s history of doping. This was the result of the arbitration. Vaileva has started competition and will not be banned from further competition citing that she is under 16 years old and qualified as a “protected person.” While that is technically correct, it is not the only thing necessary to escape reprimand. There is no news on how Vaileva proved this was unintentional. We do know, however, that Valieva did appear virtually at the arbitration and was able to plead her case.

This decision has angered many former and current Olympians that have been training and preparing the correct way for years. TMZ in particular is banned both in and out of competition. The focus has shifted in the IOC’s view from Valieva to her coaches and Russia. The IOC plans to launch an independent investigation of the coaches, but it doesn’t satiate the anger from other Olympians who feel that she was handed a gold medal unfairly. ROC is expected to make a podium sweep in Women’s individual figure skating. This Olympic cycle has been riddled with accusations of corruption and this situation is no different.

Allowing Valieva to skate was a slap in the face to every athlete that competes clean and every athlete that hasn’t. It goes against the spirit of competition that the IOC has stated they want to see from all competitors. In the end, Valieva did not get gold. She finished in fourth place. Her teammate, Anna Shcherbakova, won gold. This was the most heartbreaking of circumstances. Valieva fell four times during her performance, solidifying her teammate’s gold medal. However, ROC’s coaches did not celebrate with Shcherbakova. She was shown on camera, alone, clutching a teddy bear while her coaches tended to a dejected Valieva after her performance. I can only suspect that the arbitration and uncertainty around the competition affected Valieva’s mental ability to skate. However, that does not excuse the way Valieva and the ROC coaches reacted when she didn’t win. They should have celebrated with their teammate, another young girl. Another ROC skater, Alexandra Trusova, was consoled when she found out she could not win silver saying that she “never [wants] to skate again.” Ignoring the win of one teammate and participating in a doping scandal reiterates that ROC’s coaches have failed to protect their young skaters. The coaches were the only people these skaters could depend on at the Olympics especially because coronavirus prevented many people from traveling. ROC’s coaches failed these skaters in every way, and I look forward to seeing the results of the coaches’ investigation.

There have been two recent lawsuits brought to challenge portions of the health insurance price transparency rules promulgated under the Trump Administration, one of which was recently withdrawn. These rules are supposed to go into effect in stages, but the eventual goal is to have pricing information of items and services covered by health insurance companies available to the public.

In both legal challenges, groups are suing the Department of Health and Human Services (HHS). The first lawsuit was brought by the Chamber of Commerce. Chamber of Commerce of the United States of America et al v. United States Department of Health and Human Services et al, 6:21CV00309. The Chamber was challenging the section of the rule that requires insurers to post internal pricing data, including the “historical net prices” of prescription drugs, in three machine-readable files on a website. The Chamber was arguing that this provision of the rule was unlawful because it violated notice-and-comment rulemaking as well as went beyond the statutory authority of HHS in the Affordable Care Act.

The Affordable Care Act requires disclosures that are made to the public to be made in “plain language.” The Chamber argued that this pricing data is highly technical and could not be understood by the average consumer. Finally, the Chamber was arguing that the disclosure of prices would lead to increase cost to patients as it reduced competition among insurers.

Since the Biden administration delayed enforcement of provisions of the rule that were the basis of the lawsuit, the suit was withdrawn on August 25, 2021. The Chamber has said that they are going to watch the development of the rules to decide whether to refile the suit.

The second lawsuit was brought by The Pharmaceutical Care Management Association (PCMA). Pharmaceutical Care Management Association v. United States Department of Health and Human Services et al, 1:21-cv-02161. The basis of the PCMA lawsuit is very similar to the Chamber lawsuit. The PCMA is challenging the posting of historical net prices of prescription drugs on the basis that it is unlawful and would result in increased costs to patients.

A similar lawsuit in a DC federal appeals court saw the upholding of a similar rule. This rule required hospitals to disclose the negotiated rates between hospitals and insurance companies. The American Hospital Association challenged the rule on the basis that it went beyond the statutory authority in the ACA. I believe that this means that a court could decide the PMCA lawsuit the same way – by upholding the rule as not going beyond the statutory authority of the ACA.

In my opinion, if the enforcement of these rules moves forward, health insurance companies might attempt to lobby Congress to change these rules under the Congressional Review Act to protect the disclosure of their negotiated rates. I do not think that these rules exceed beyond the statutory authority of HHS in the ACA because the goal is to eventually have the information be easily searchable and understandable by the average consumer. I think that the transparency of negotiations as well as the eventual pricing of services and goods would be important for consumers and I believe that as consumers of health insurance, we deserve to have more transparency into health insurance pricing generally.

The prestigious Health Law Fellows Program provides DePaul College of Law Students with opportunities to participate in the substantive work of the Jaharis Health Law Institute (JHLI). Students can apply to become Fellows by submitting an application, and they maintain fellowship status by participating in a variety of activities throughout the academic year, including attending the lunch lecture series events, posting on our blog, research and writing, mentoring, planning and attending the annual symposium, and various health law program social events. One of the many benefits of maintaining fellowship status is that Fellows are eligible to apply for the JHLI Summer Scholars Program. This Program provides students with paid legal internship placements at a variety of health law job sites that run the gamut between positions in-house with health systems and corporations, to law firms, to policy and direct legal service organizations. Often times these positions are unfunded, but the Summer Scholars Program allows students interested in health law to pursue their interests and gain valuable legal experience without financial barriers.

As a JHLI Fellow and Summer Scholar in both 2020 and 2021, I worked in the Medical Prosecutions Unit at the Illinois Department of Financial and Professional Regulation (IDFPR) and received a $5,000 stipend from JHLI each summer as compensation. My work at IDFPR helped me gain valuable knowledge about health law generally and further allowed me to hone my reading, writing, and researching skills. Some of the work I performed included drafting, issuing, and filing discovery motions and consent orders, compiling and sending file materials to medical experts for review, and performing and collecting medical literature and case research. This position also allowed me to connect with other established attorneys in field of health law, including my supervisor and other attorneys in the office. These newfound relationships have resulted in letters of recommendation, referrals for other positions, and will undoubtedly benefit me in my career path after graduation. Although this job at IDFPR was of interest to me, I was initially hesitant to accept the position because it was unpaid. However, the Summer Scholars Program stepped in and allowed me to pursue my passion in health law while still receiving a wage. Other placements this summer include Sinai Health System, The American Medical Association, Walgreens, Shirley Ryan Ability Center, iRythym, HillRom, Malecki and Brooks, Legal Aid Chicago, and many more. I encourage any DePaul College of Law students interested in health law to learn more about the Health Law Fellowship and Summer Scholar Program.

For more information or to submit your application, please email our Executive Director, Alice Setrini.

Health law in an incredibly broad and dynamic field centered around technology. The field is ever changing as health care law and technology advance. In some aspects, the field is advancing as medical technology improves. However, the COVID-19 pandemic produced significant questions and concerns regarding technology and health disparities.

Last week, the Jaharis Health Law Institute hosted a Spring Symposium addressing Health Disparities: Is Technology the Answer? Ana Santos Rutschman, Assistant Professor of Law, Center for Health Law Studies at Saint Louis University School of law, discussed the production and distribution of COVID-19 vaccines with respect to health law related issues. She highlighted that to some extent, the law and society treat vaccines and other life-saving goods as commodities.

How do we as society produce vaccines and allocate emerging health goods at such a rapid rate? Professor Rutschman explained that the production of COVID-19 vaccines are subject to contracts and reflect an intellectual property framework. Generally speaking, she noted that scientifically, the United States succeeds in producing critically needed health goods, vaccines in particular. For example, the United States controlled the Ebola virus outbreak, and in record timing, approved the Ebola vaccine.

Even with the ability to produce critical health goods at such a rapid pace, the United States struggles to distribute vaccines equally among minority racial and ethnic groups. Theories of inequalities in distribution and production of COVID-19 vaccines reflect under-enrollment of racial minorities in clinical medical trials. Professor Rutschman, quoting Dr. Anthony Fauci, mentioned that COVID-19 clinical trials failed to properly reflect the racial and ethnic makeup of the United States. The law requires some representation of minorities but this minimum is very low compared to actual numbers.

Vaccines in particular come with data and trust deficits which cause uncertainty among minority communities. Professor Rutschman believes minorities are systematically short changed within the field of health. In order to make a difference and combat health disparities, Professor Rutschman argues that meaningful changes are required. Vaccine distribution and contract law must work together. Systematic changes are needed. The government can correct some inefficiencies regarding vaccine production and distribution, however administrative changes are needed to do so.

COVID-19 has exposed the structural barriers at the root of health disparities in the United States. This year’s Jaharis Symposium focused on the premise that while technological advances have the potential to revolutionize the delivery of health care, they also raise significant questions about who has access to these innovations and whether they are advancing the interests of the populations with the greatest needs.

As part of this symposium, Valarie Blake, a Professor of Law at the University of West Virginia, presented her research on telehealth in rural America with a focus on the Appalachian region. Professor Blake explained that the health status of Appalachians is near the bottom of America when it comes to health outcomes, such as poisoning deaths, diabetes deaths, HIV prevalence, and more. This is due in part to the many tangible and intangible barriers that people living in rural Appalachia face when it comes to healthcare, such as a lack of sufficient healthcare force, travel barriers, low health literacy, the normalization of poor health, and a general mistrust of medical professionals. Telehealth could be a solution to some of these barriers, Professor Blake explained, but it cannot and should not be the only option. Telehealth has the potential to address problems with transportation and provider shortages, but poor internet speed and coverage can bring more issues. Furthermore, the advent of telehealth presents significant long-term challenges in areas such as quality of care, privacy, fraud, and equality. For example, safeguards are needed for long-term prescribing of controlled substances, many rural states lack sophisticated fraud detection forces, and the lifting of HIPAA enforcement, while meant to improve the speed of entry into telehealth, may be an unnecessary deregulation. For these reasons, Professor Blake argued that telehealth should be considered an additional service to in-person care, and not the sole tool in making healthcare services equally accessible.

Alex Pearlman, a science and technology journalist and bioethicist, presented at the Jaharis Health Law Institute’s Symposium on April 29, 2021. Pearlman’s background is reporting on emerging issues in research, health policy and biotechnology and her work has appeared in numerous leading national and international media outlets, including Stat, New Scientist, MIT Technology Review, The Boston Globe and Vice. Pearlman works as a digital ethnographer and researcher in the Wexler Lab at the University of Pennsylvania Department of Medical Ethics & Health Policy, where she is studying ethical issues in the Community Biology movement during the COVID-19 pandemic. Pearlman also is a research affiliate with the Community Biotechnology Initiative at the MIT Media Lab, where she studies the intersection of the Community Biology movement with issues in ethics and policy, and she is working on the creation of a research ethics framework for use by independent community labs. For the symposium, Pearlman presented on biohackers.

A biohacker is “a do-it-yourself tinkerer, [o]ften participating in self experimentation, gene editing interventions, and agitating against the patent system.” These biohackers, driven by altruistic motives, have “hacked” certain elements of healthcare to provide cheaper options for medication. Some examples of this are the one hour at-home COVID-19 test, open insulin, and the EpiPencil, which is an off-the-shelf answer to increase in price of the EpiPen. Pearlman focused much of the presentation on Glybera, a gene therapy for LPLD, and its pirated counterpart. When Glybera first came on the market, it was the most expensive gene therapy ever at $1 million. Biohackers reverse engineered Glybera using published studies and named the product “Slybera.” Slybera has never been tested as no one will touch the hacked therapy. While biohackers raise many questions of ethics and standards, Pearlman asks, “if there are low cost alternatives, isn’t it in everyone’s best interest to get them resources?”

Dr. Theodosia Stavroulaki is a Jaharis Faculty fellow at DePaul University College of Law. Dr. Stavroulaki teaches and researches topics in Health Law, Public Health, and Anti-Trust law, and has published work in World Competition, Law & Economics Review, Loyola Consumer Law Review, CPI Antitrust Chronicle and the American Journal of Law & Medicine. Her presentation focused on the major issues that arise when health insurance companies merge with powerful drug suppliers. Professor Stavroulaki mentioned that when insurance companies, like Aetna, merge with drug companies like CVS, they can then use big data analytics to identify the likelihood and risks of certain diseases, and design health plans that will discourage high risk patients from purchasing their programs. She further discussed a blind spot in antitrust law, which is that it does not distinguish between different socio-economic groups. This poses a problem because by placing all consumers into one unidentifiable group, antitrust law fails to consider the effects of certain conduct on different consumers.

Dr. Stavroulaki further discussed three ways in which antitrust enforcers should consider the harm these mergers may impose. She first mentioned how vulnerable, high-risk consumers constitute a separate relevant market. Further she discussed how this type of merger will make it difficult for insurance companies to enter the market in the future, seeing as acquiring a retail pharmacy would be a prerequisite. Second, Dr. Stavroulaki suggested that antitrust enforcers can consider how the merger’s negative impact on high-risk consumers should weigh more heavily than its positive impact on low-risk ones, notwithstanding that the net effect of the merger should be assessed. Finally, the proposed merger may facilitate health insurer’s efforts to violate the Affordable Care Act that prohibits discriminatory premium rates. On the other hand, she mentioned the merger might allow for the identification of patients who are not being properly treated in order to provide them with access to the care they require. Dr. Stavroulaki provided an insightful and interesting view into mergers that harm our health.

Talking about end-of-life care is challenging for many people, health care providers included. This is particularly true if a patient completely loses the ability to communicate. In March 2021, the Jaharis Health Law Institute hosted a webinar, which addressed a broad array of concerns central to end-of-life care.

Dr. Anuj K. Shah is an integrative family physician of Heartland Health Centers. He gave an insightful presentation on how effective communication can facilitate the achievement of important end-of-life goals. Decisions regarding end-of-life care are deeply personal, as most patients during end-of-life care contend with fears, needs, and desires. End-of-life decision-making is an ongoing and dynamic process among the patient, their family, and their physician. Patients and their families value open and honest communication. It is therefore critical to have a patient-centered communication to foster a respectful relationship with the patient and to develop a treatment plan.

A physician should make sure that the patient understands the communication, including the patient’s understanding about treatment options. Dr. Shah shared his experience with setting and achieving that goal. For example, he employs an “educate-me-back” technique: when he explains treatment options and consequences to a patient, he always asks the patient to explain these concepts back to him in the patient’s own words so that Dr. Shah knows that the patient understands these concepts and can make an informed decision.

When the patients lack decision-making capacity, a physician would coordinate with the patient’s family to determine treatment options. During that process, by interacting with a patient’s family and friends, a doctor may identify the patient’s end-of-life decisions as if the patient was still responsive.

From a legal perspective, the questions of who may make medical decisions for individuals who have lost capacity is more complex. As the Founder and Managing Attorney of Rao Legal, LLC, Ms. Mitha Rao has observed that too often people assume the answer is their beloved ones or best friends as “they know me.” The reality is that these beloved ones or best friends may not be the ones who can legally make these decisions, unless these individuals have been designated by appropriate legal documents such as advance directives. Ms. Rao offered insights into the role of advance directives in end-of-life decision making.

For example, an individual may appoint an agent to make medical decisions for the individual by executing a health care power of attorney. Having a designated surrogate decision-maker would eliminate the need to institute a guardianship proceeding to decide the individual’s best interests. That often can be too late in emergent situations. A living will is another type of advance directive that states a person’s preferences for end-of-life medical care if he or she later could not voice decisions. In Illinois, a living will permits a person to give medical directions that impact the end-of-life care, including withholding or withdrawing death delaying procedures.

An advance directive could be important in communicating end-of-life issues. Without an advance directive in place, as mentioned by Dr. Shah, family members and doctors are left to guess what the patient would prefer in terms of treatment. That occasionally leads to unintended consequences. These discussions are important to have, and decisions are important to make before there is a critical or urgent need because the appropriate time and consideration can be had outside of a crisis situation.

The Summer Scholars Program is offered by the Jaharis Health Law Institute and the Center for Intellectual Property & Information Technology. This Program offers 1L and 2L health law fellows or IP-focused students the opportunity to work at a diverse selection of firms, associations, organizations, and companies specializing in either health law or the intersection between health and intellectual property.  Summer scholars will receive exceptional hands-on experience wherever they are placed as well as a $5,000 stipend for the summer. Previous placements have included positions at Sinai Health System, Robert H. Lurie Medical Research Center,  the American Medical Association, and many more.

I was a Summer Scholar my 2L summer, which helped me apply concepts I had learned in class, network with other health law professionals, and obtain another health law related position during my 3L year. To this day, I keep in touch with my mentor from that experience and she has helped connect me with other attorneys that I may potentially work with after graduation. Being a Summer Scholar is a great opportunity and can help expand your network and help you obtain a post-graduate job in the health law field.

To be eligible, you need to be a JHLI fellow, in the IP legal writing section, or have permission from professor Gutiontov. Email Alice Setrini with any questions, and please submit your applications to Alice by February 19^th, 2021 at 5pm at asetrini@depaul.edu.

Health law practitioners have specialized training and knowledge that should be utilized to take on health challenges facing our communities. We also have a moral and ethical duty to advocate for change where we see evidence of systemic inequities, and we are currently in a moment where these skills can effect important and lasting change.

As we learn more about COVID-19 from scientists, public health experts, and medical practitioners, we are getting a clearer picture of which individuals and groups are most at risk from the virus.  However, along with these identified risk factors, there is growing evidence of racial health disparities associated with the disease. Specifically, African Americans are contracting COVID-19 at higher rates than other racial groups, and are more likely to die from the disease than their non-African American counterparts. Here in Chicago, 72 percent of the city’s COVID-19 deaths have been Black Chicagoans, even though only 30 percent of the city’s population is Black. And there are similar patterns in the data from other cities and states.

The explanation for why communities of color are disproportionately affected by COVID-19 could be the same reason that we see other health disparities in those communities. The Social Determinants of Health (SDH) are the conditions in which people are born, grow, work, live, and age, and the wider set of forces and systems shaping the conditions of daily life. And according to the World Health Organization’s definition, these forces and systems include culture and history that make up social norms, economic policies, and political systems. The history of this country, with its legacy of slavery, segregation and discrimination, influences the structures and systems in place that affect population health.

Communities of color are doubly vulnerable to this particular disease, as they have higher infection exposure risks, as well as systemic and institutional risks that increase mortality. A recent report by the Chicago Urban League explains how longstanding elements of structural racism contribute to increasing these vulnerabilities as a higher proportion of people of color work in low-paying service jobs deemed essential. For example, about one-third of all Americans have the types of jobs that allow them to work from home, compared to less than one-fifth of Black Americans with those types of jobs. Communities of color are also frequently located in areas with poor air and water quality. These environmental hazards leave residents more vulnerable to chronic and acute respiratory and cardiac illness.

Academics and professionals engaged in the health care field have a key role in addressing systemic disparities through community engagement, for data collection, information sharing, and confronting root causes of negative social determinants of health. This advocacy can only be successful where we partner with communities of color, as there can be “nothing about us without us.” Those partnerships should extend not only to gathering and sharing data, but also to informing research and policy. Building trusting and genuine partnerships is not easy, and takes a lot of sustained effort, but achieving health equity requires centering and amplifying the voices of those with lived experience. Community members and leaders are subject matter experts, and have crucial insights into what interventions are necessary and can succeed.

Some  ideas from UIC’s School of Public Health for immediate action include sharing factual information and data that have been vetted by reliable sources, acknowledging and responding to widespread mistrust and misinformation, remaining connected to community partners, and supporting legal and policy responses that address social determinants—both those that are root causes as well as immediate needs.

For example, mass incarceration and detention are potentially responsible for increased spread of infection, as jails, prisons, and detention facilities have a steady stream of people into and out of the facilities, and are often overcrowded, making it impossible for residents to maintain social distance and good hygiene practices. Black and Latinx community members are incarcerated and detained at a much higher rate than other sectors of the population. Decarceration efforts by organizations like Uptown People’s Law Center here in Chicago use both a civil rights and a health equity lens to push for reforms that address root causes, as well as urgent immediate needs.

Using a health equity lens to advocate for changes in employment, housing, and public benefits policy is well within the wheelhouse of health law professionals, but why should we take on this role?

The preamble to the model rules of professional conduct urges attorneys in their roles as public citizens to “seek improvement of the law, access to the legal system, and the administration of justice.” A lawyer should “cultivate knowledge of the law beyond its use for clients, and employ that knowledge to reform the law” where inequities are observed. Our role in society and our moral obligations as lawyers also moves us to act in the public interest, particularly those of us who have experience and practice in the health law space to champion these types of reforms. Finally, as members of the DePaul University community, we have the responsibility to further the mission of this institution—to apply our “specialized expertise in ways that contribute to the societal, economic, cultural and ethical quality of life in the metropolitan area and beyond.”