Browsing by Author "Josephson, Michelle A."

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    The demise of islet allotransplantation in the United States: A call for an urgent regulatory update
    (Wiley, 2021-04) Witkowski, Piotr; Philipson, Louis H.; Kaufman, Dixon B.; Ratner, Lloyd E.; Abouljoud, Marwan S.; Bellin, Melena D.; Buse, John B.; Kandeel, Fouad; Stock, Peter G.; Mulligan, David C.; Markmann, James F.; Kozlowski, Tomasz; Andreoni, Kenneth A.; Alejandro, Rodolfo; Baidal, David A.; Hardy, Mark A.; Wickrema, Amittha; Mirmira, Raghavendra G.; Fung, John; Becker, Yolanda T.; Josephson, Michelle A.; Bachul, Piotr J.; Pyda, Jordan S.; Charlton, Michael; Millis, J. Michael; Gaglia, Jason L.; Stratta, Robert J.; Fridell, Jonathan A.; Niederhaus, Silke V.; Forbes, Rachael C.; Jayant, Kumar; Robertson, R. Paul; Odorico, Jon S.; Levy, Marlon F.; Harland, Robert C.; Abrams, Peter L.; Olaitan, Oyedolamu K.; Kandaswamy, Raja; Wellen, Jason R.; Japour, Anthony J.; Desai, Chirag S.; Naziruddin, Bashoo; Balamurugan, Appakalai N.; Barth, Rolf N.; Ricordi, Camillo; Surgery, School of Medicine
    Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and “more than minimally manipulated” human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as “minimally manipulated tissue” and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
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    Existing Transplant Nephrology Compensation Models and Opportunities for Equitable Pay
    (Wolters Kluwer, 2022) Josephson, Michelle A.; Wiseman, Alexander C.; Tucker, J. Kevin; Segal, Mark S.; Schmidt, Rebecca J.; Mujtaba, Muhammad A.; Gurley, Susan B.; Gaston, Robert S.; Doshi, Mona D.; Brennan, Daniel C.; Moe, Sharon M.; Medicine, School of Medicine
    The American Society of Nephrology (ASN) formed the ASN Task Force on Academic Nephrologist Compensation and Productivity in 2020 to understand how the subspecialty is evolving and where there are needs for alignment in compensation in US transplant centers. The task force's review of the roles and responsibilities of transplant nephrologists is in the companion perspective (1). Transplant nephrologists are required for successful kidney transplantation, the ideal treatment from a survival and quality-of-life perspective for patients with kidney failure (2,3). Unfortunately, work relative value unit (wRVU) requirements for compensation models vary tremendously across institutions and limit the ability to adequately staff programs. This article addresses transplant nephrology models of care, how different models affect funds flow and compensation, and opportunities to more equitably compensate transplant nephrologists.
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    Operational challenges in the COVID‐19 era: Asymptomatic infections and vaccination timing
    (Wiley, 2021-11) Axelrod, David A.; Ince, Dilek; Harhay, Meera N.; Mannon, Roslyn B.; Alhamad, Tarek; Cooper, Matthew; Josephson, Michelle A.; Caliskan, Yasar; Sharfuddin, Asif; Kumar, Vineeta; Guenette, Alexis; Schnitzler, Mark A.; Ainapurapu, Sruthi; Lentine, Krista L.; Medicine, School of Medicine
    The coronavirus disease 2019 (COVID-19) pandemic has created unprecedented challenges for solid organ transplant programs. While transplant activity has largely recovered, appropriate management of deceased donor candidates who are asymptomatic but have positive nucleic acid test (NAT) for COVID-19 is unclear as this may reflect active infection or prolonged viral shedding. Furthermore, candidates who are unvaccinated or partially vaccinated continue to receive donor offers. In the absence of prospective data, transplant professionals at U.S. adult kidney transplant centers were surveyed to determine community practice (N: 92 centers, capturing 40.8% of centers and 56.6% of transplants performed). The majority (96.8%) of responding centers declined organs for asymptomatic NAT+ patients without documented prior infection. However, 31.6% of centers proceeded with kidney transplant in NAT+ patients who were at least 30 days from initial diagnosis with negative chest imaging. Less than 7% of programs reported inactivating patients who were unvaccinated or partially vaccinated. In conclusion, despite national recommendations to wait for negative testing, many centers are proceeding with transplant in patients with positive tests due to presumed viral shedding. Furthermore, very few centers are requiring COVID-19 vaccination prior to transplantation despite early evidence suggesting reduced immunogenicity in transplant patients on immunosuppression.
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    The Importance of Transplant Nephrology to a Successful Kidney Transplant Program
    (Wolters Kluwer, 2022) Moe, Sharon M.; Brennan, Daniel C.; Doshi, Mona D.; Gaston, Robert S.; Gurley, Susan B.; Mujtaba, Muhammad A.; Schmidt, Rebecca J.; Segal, Mark S.; Tucker, J. Kevin; Wiseman, Alexander C.; Josephson, Michelle A.; Medicine, School of Medicine
    Nephrologists are responsible for the care of patients with a diverse array of systemic diseases, comorbidities, and kidney issues across a variety of service locations (clinic, inpatient, dialysis unit). As the field of nephrology becomes increasingly complex, there has been a need for advanced training and subspecialization, similar to the transformation cardiology experienced with heart failure, electrophysiology, and interventional cardiology. As a result, the American Society of Nephrology (ASN) formed the ASN Task Force on Academic Nephrologist Compensation and Productivity to begin to understand the needed transformation, especially as it relates to assessing clinical productivity and compensation. Members of the task force included nephrology division chiefs, transplant program directors, and transplant nephrologists, representing academic and community transplant programs across the United States. The group met virtually throughout 2021 to discuss specific job functions, roles, responsibilities, and compensation models, and the discussion and conclusions follow. The flow of transplant funds from the hospital to the physician and transplant nephrology models of care are further discussed in a companion Perspective.