“I’m so sorry but we have to cancel your surgery”—10 words any warm-blooded surgeon dreads uttering. This time around, it was not for the typical reasons. Our patients’ blood pressure wasn’t sky high in pre-op, and our case wasn’t being bumped for the trauma du jour. Regrettably, Medicaid unexpectedly denied approval of an investigational thoracic endovascular repair (TEVAR) for this 65-year-old Black male with a known history of a complicated type B aortic dissection (TBAD) two weeks prior to his planned intervention. Though insurance denials are not uncommon for “out-of-network patients” at our institution (an issue ripe for a follow-up editorial at a later date), our team was both surprised and devastated to find that this patient’s “in-network” procedure was denied because cardiovascular trial devices were not covered under his Illinois Medicaid insurance policy—with no exceptions. Our surgical plan was not only toast, but this man’s hopes of obtaining a cutting-edge thoracic repair were gone simply because of his reliance on state medical aid.
Like so many of our vulnerable patients on the underserved South Side of Chicago, this man’s path towards a repair was anything but linear. The patient was originally diagnosed in 2015 but was lost to follow-up for several years. He re-presented to our institution in March 2022 as a victim of gun violence in an altercation where he suffered an injury to his left arm—his wife and son were killed in the incident. A trauma pan-scan at the time showed that his TBAD had grown significantly and therefore met criteria for repair. The dissection remained distal to the left subclavian, and the aneurysmal portion was predominantly in the descending thoracic aorta. The patient had, in the intervening seven years, also suffered a stroke and myocardial infarction. Given that his multiple comorbidities also included morbid obesity and diabetes, the patient was not an optimal candidate for an open thoracoabdominal repair. Furthermore, the patient was anatomically not a candidate for a TEVAR with or without traditional debranching to allow for landing in zone 1 or 2. Given these findings, the patient was enrolled in the Nexus-ENDOSPAN trial for an arch device with zone 0 landing.
The patient was seen multiple times preoperatively, and the trial was explained to him in detail. He was eager to participate, something not always encountered given the understandable mistrust of the research process often seen in Black patients. His anatomy was evaluated by the review board, and he was found to be an excellent candidate for the investigative device. The patient was scheduled for the two-part surgery in early August. After being notified of the denial, we participated in a lengthy peer-to-peer conversation with a physician representative from the patient’s Medicaid provider, but our efforts failed. The procedure was canceled. And there we were—highly trained surgeons technically able to offer all options to the patient but handcuffed to an open approach, which carried with it a much higher morbidity and mortality for this particular patient.
The investigational process is well regulated by both federal (Food and Drug Administration, or FDA) and institutional (IRB) oversight committees. The oversight and approval process has been in place for many years, and, at its core, has the safety of patients in mind. Clinical trials provide safe access to novel devices for select patients with complex problems.
As for “select”— this is an interesting word choice in this context. Typically, patients must meet specific eligibility criteria to be enrolled in a clinical trial. The criteria commonly include such factors as a minimum and maximum age. In addition, specific anatomic characteristics are assessed as part of the trial design and vary based on the investigational device. As a frequent site for clinical trials, our institution commonly uses such standards in our decision-making on who is safe to be treated and who is not. Noticeably absent from this algorithm is the categorization of patients based on their insurance status. This is an appropriate omission given that uniformly that data point is irrelevant in deciding whether a patient should or should not be entered into a trial. In other words, patients should never be “selected” or excluded due to their insurance status. This unfair decision specifically targets an already marginalized group of patients. Clinical trials should be available to all patients. This fact is highlighted by the paradoxical elimination of a high-risk patient as seen in this scenario. The reality is that this is a patient who unequivocally needs our care the most.
As practicing vascular surgeons on the South Side of Chicago, we treat individuals from our local community and from all over the Midwest. It is reasonable to surmise that most physicians who find themselves in this particular corner of the city chose to work here to plant roots at an innovative medical institution with the ability to provide outstanding care to all patients regardless of race, ethnicity, gender, sexual orientation, and insurance status. To deny us the ability to do so feels like a dereliction of duty and a contradiction to the Hippocratic oath we all swore to uphold. The challenges we faced with this particular patient also bring to light a much larger question of how advocacy plays a role in our daily lives as vascular surgeons. Collectively, our reasons for entering the field are varied, but fundamentally we all have an interest in serving patients and providing the best surgical care possible. Advocates are defined as individuals who fight for a cause or a particular group, so it is no stretch of the imagination to think advocacy is actually intimately involved in our work as surgeons.1 Moreover, for many of us who work in under-resourced regions, our efforts in this area are not only important, but in many cases life- and limb-salvaging.
For some, the idea of becoming an “advocate” may seem daunting, especially given the paucity of information that is passed along to surgeons during their training surrounding this topic.2 In thinking about how to approach this issue, it is important to keep in mind that advocacy comes in all shapes and sizes. For us and this situation, we began by contacting the clinical leadership team at our hospital to better understand the policies preventing this patient from obtaining care through this clinical trial. This ultimately led to further discussions with the institution’s leadership as well as those involved in government relations for the university as a whole. We have recently connected with our state’s legislators, and we are now working to ensure this patient’s story is heard loud and clear in our state’s capitol in the coming months.
Alternatively, for some, there may be an urge to get more involved with grassroots organizations, depending upon the issue at hand. In other circumstances, you may feel inclined to contact your local legislator directly, or you may find avenues to get more deeply involved with specific local, state, or national healthcare policy.1 In recent years, the Society for Vascular Surgery (SVS) and larger organizations like the American College of Surgeons (ACS) have made it easier for us to get involved by providing educational resources and offering ample opportunities to have our surgical voice heard on Capitol Hill.3,4 Whether we like it or not, times have changed. No longer can we ignore or choose not to acknowledge that the clinical care we provide is intimately intertwined in the complex social circumstances of our patients. Advocacy is in our DNA as vascular surgeons. The sooner we acknowledge it, the sooner we can get to work.
References
- Political advocacy in surgery: The case for individual engagement. The Bulletin https://bulletin.facs.org/2015/08/ political-advocacy-in-surgery-the-case-for-individual-engagement/ (2015).
- Surgeon advocacy in action: Challenges, accomplishments, and futuredirection. The Bulletin https://bulletin.facs.org/2021/08/surgeon-advocacy-in-action-challenges-accomplishments-and-future-direction/ (2021).
- News & Advocacy | Society for Vascular Surgery. https://vascular.org/news-advocacy.
- Participate. ACS https://www.facs.org/advocacy/get-involved/.
Chelsea Dorsey, MD, is an associate professor of surgery at The University of Chicago. Luka Pocivavsek, MD, is an assistant professor at the same institution. Ross Milner, MD, is the The University of Chicago’s vascular section chief.
