About the JHLI Fellowship and Summer Scholars Program – by Samuel Rossi

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.

 

 

JHLI Symposium 2021: Production and Distribution of COVID-19 Vaccines – Professor Ana Santos Rutschman by Courtney Berlin

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.

 

 

JHLI Symposium 2021: Telehealth in Rural America – Professor Valarie Blake by Samuel Rossi

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.

JHLI Symposium 2021: Biohackers – Alex Pearlman by Reagan Airey

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?”

JHLI Symposium 2021: Mergers that Harm Our Health – Dr. Theodosia Stavroulaki by Jessica Vishny

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.

Planning for the Future: Legal and Medical Components of End-of-life Decisions by Sheng Tong

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.

 

JHLI Paid Summer Employment Opportunities- by Palak Desai

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 19th, 2021 at 5pm at asetrini@depaul.edu.

What Health Law Practitioners Can Do Now to Address Disparities Highlighted by COVID-19

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.”

Pharma Patents and Well-Being [Seminar by Professor Buccafusco]

On Thursday, Feb. 20, the Jaharis Health Law Institute hosted Professor Christopher Buccafusco, Director of the Intellectual Property and Information Law Program and Associate Dean for Faculty Development at Cardozo School of Law, for his lecture, “Pharma Patents and Happiness: how patent law should make people better off,” , in line with his co-authored book, “Law and Happiness.”

He began by looking at the language of Patent Clause, Article I, Section 8, Clause 8:

[The Congress shall have power] “To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.

(emphasis added by Professor Buccafusco)

Drawing on this provision, he noted that U.S. patent laws exist to promote people’s welfare through inventions and innovations that make people better off. He pointed out little attention has been paid to figure out what it means to promote people’s welfare via patent law, and how to measure them. He opined that, “law and happiness,” although two seemingly  unrelated concepts, are indeed closely related. Taking a hedonic approach, he briefly introduced the main arguments in his book: how the law affects people’s life, and how it can do so in a better way.

Acknowledging the difficulties of measuring individuals’ wellbeing and its subjectivity, Prof. Buccafusco advocates a market-based approach to achieve these goals of U.S. patent law. This is particularly so given that the U.S. patent law has long been recognized on utilitarian or consequentialist grounds.

Under this theory, people’s welfare can be fairly understood as satisfying individual preferences. Professor Buccafusco took a smartphone as an example, to show how market dynamics affect the patent system to make people’s lives better off. He expounded that the market can be used as a mechanism through which patent law can make people’s lives better, by incentivizing innovations. For example, we, as consumers, are not only those who decide whether to buy the phone, but also those who further decide: which phone, when, where, and how much. By doing so, individual consumers satisfy their own preferences at their own expense, based on their own decision.

The problem in the pharmaceutical markets, however, he explained, is that market dynamics that affect supply and demand of patented products in a certain market, do not exist in the patent-based pharmaceutical markets. Moreover, considering the billing system of pharmaceuticals that generally rely on insurance companies,  Medicaid or  Medicare, addressing market-effects gets much more complicated.

Unlike the patent system, he also noted that, government-sponsored grants or prizes generally do not rely on markets, and thus necessarily may not be linked to individual preferences as a measure of welfare that can be, or should be produced through the sponsored-innovation.

Focusing on exclusive rights afforded under the U.S. patent laws, which permit patent owner to  benefit through monopolized prices for a certain period, he elaborated on how to measure welfare based on Health-related quality of life (HRQoL) and quality-adjusted life-years (QALYs).

Combining a market-based approach and a welfare-measurement mechanism, Professor Buccafusco opined that the patent term should be afforded differently, at least for pharmaceuticals, based on welfare-maximizing effects that can be promoted, rather than simply relying on satisfying consumer preferences under existing supply-demand relationships.

The bottom line is, as he suggested, that different patent terms and rules should be adopted for different types of technology in order to encourage innovation by virtue of improving welfare. As technology develops and social norms change, maybe it’s time to reshape the patent regime, waiving to goodbye to rigid rules and uniformity.

[Ed: Prof. Buccafusco’s presentation was partly based on his recent paper, “Disability and Design,” (Buccafusco, Christopher J., Disability and Design (December 3, 2019). New York University Law Review, Forthcoming. Available at SSRN: https://ssrn.com/abstract=3497902 or http://dx.doi.org/10.2139/ssrn.3497902).]

Federal Interest in Health Information Technology

On February 19, 2020, the Jaharis Health Law Institute (JHLI) was honored to have John Travis, Vice President of Regulatory Research and Strategy at Cerner Corporation, speak during another installment of the JHLI Lunch Lecture Series. Mr. Travis’s presentation focused on the federal interest in health information technology (HIT) and interoperability in compliance with federal health insurance programs.

Cerner is the largest publicly traded HIT and electronic health record (EHR) company, so staying up to date with the ever-changing regulatory environment is a constant priority.  Beginning with the enactment of the Healthcare Insurance Portability and Accountability Act (HIPAA) in the mid-90s, the federal government created major privacy and security elements that impacted HIT. It gave patients more rights with regards to their health records, including the ability to amend and correct their records. Further, it created the need for technical, physical and administrative controls to protect electronic health information (EHI).

With HIPAA as the foundation, the federal government continued to enact more legislation to increase the use of HIT. The government slowly moved away from voluntary compliance, where only entities utilizing HIT had to comply with rules, to actively incentivizing the adoption of HIT. Stark Law and Anti-Kickback Statute safe harbors permitted donations of HIT to physicians so long as the HIT enabled interoperability, privacy and security. The Medicare Improvements for Patients and Providers Act (MIPPA) established the first “use” incentive for physicians relative to HIT by introducing a reduction in payment for failure to adopt. This was a precursor for an even more involved role to come for the federal government.

The HITECH Act was the federal government’s transition from experimenting, encouraging and incentivizing of HIT to a very direct role. It created major changes, most notability Meaningful Use which established penalties for failure to use HIT. HITECH also created HIPAA updates specific to EHR. Further, it changed the legal liabilities for entities in the HIT space by creating the Business Associate (BA) designation. For companies like Cerner, becoming a BA puts them on the same footing as providers in terms of compliance with these federal privacy and security laws.

With so much regulatory change over the last 25 plus years, where is the industry going from here? Mr. Travis highlighted a continued push towards value-based payments and the impact it will have on HIT and interoperability. Further, Mr. Travis said that we could see expansions of HIT use beyond physicians and hospitals along with expansions of federal programs and incentives for adopting HIT. Ultimately, Mr. Travis said, the goal of federal policy in HIT and interoperability is to make EHI access, use and exchange ubiquitous to the point of including for care, consumer use, research, or even population health planning.