Perils of AI in Healthcare

Donna Cryer, JD and Deborah Sobel

As the founder and CEO of Global Liver Institute (GLI), and a liver transplant patient myself, I know it is imperative to connect the dots between real-world experiences of patients and policy solutions. Deborah Sobel has been part of our patient advocacy network for many years, participating in our engagement with the Food and Drug Administration (FDA) in efforts to advance approval of a treatment for primary biliary cholangitis (PBC). I want to say her story is unique – it is not. Her story should scare us all that artificial intelligence seems to be dictating coverage of healthcare for patients.

Deb’s Story

My name is Deborah Sobel. As a person with a rare disease myself, I just experienced firsthand how algorithms used by insurers to cover – or deny – healthcare put our very lives at risk. 

It is no secret that many rare diseases lack a treatment specifically indicated for them. Mine is an autoimmune disease called Autoimmune Myelofibrosis, an ultra-rare disease. My bone marrow is attacked by my immune system so I need help to produce blood. For a long time, I had to get biweekly blood transfusions. About 10 years ago, my doctor was able to find a treatment for me that allowed me to avoid the dangers associated with so many blood transfusions, using a drug called Cyclosporine. Because my very rare condition does not have an associated code for billing purposes, my doctor would use a different autoimmune disease code and make a notation that allowed my medication to be covered by my insurance. 

Then came my switch to Medicare Advantage.

Suddenly, my insurer was consistently kicking back denials to my pharmacist, claiming my medication was not indicated for the coded condition. Of course not – my condition doesn’t even have a code much less an indicated treatment. I could not reach a pharmacist at my insurer to explain why my medication is medically necessary. Despite trying, at no point was my doctor able to connect with my insurer.  Three months went by and my fear and anxiety peaked as I realized that this new insurer just might kill me.

Finally, my doctor and I were given the opportunity to argue my case in front of an administrative law judge. The representative for my insurer arrived late and had no idea what my case was about. In response to the judge questioning if FDA had approved a drug for my condition, my doctor explained my treatment was crafted as a solution for me to avoid dangerous blood transfusions. During the proceedings, my insurer would not even admit my rare condition merited the drug, instead insisting it be covered as a treatment for my primary biliary cholangitis (PBC) – managing my Autoimmune Myelofibrosis is important to managing my PBC. Clearly my insurer was trying to find a rationale for their mistake by claiming not to have known about my PBC.

The judge praised how communication makes all the difference, as it did that day. It was clear that my drug was medically necessary, something the insurer would have known if they had bothered to have a pharmacist review my case. Yet, my insurer had no pathway for a patient to try to explain their point of view and to facilitate conversation. I felt silenced and unheard. It took my Senator getting involved for a customer service representative to contact me.

Throughout this process, I have worked closely with Global Liver Institute to understand how this happened and to elevate my story to policymakers – their engagement to make federally contracted payers like mine accountable to Medicare beneficiaries like me is essential. I learned that Medicare Advantage plans are allowed to use algorithms and artificial intelligence in coverage determinations. When an adverse decision happens, like mine, the insurer is to base its decisions on the circumstances of each specific individual, including the patient’s medical history, physician recommendations, and clinical notes. Arguably, I got my day in court and finally I have access to my medication. Waiting over 3 months, just as my meds are running out, to get this resolved was just not right and certainly not what federal regulators had in mind when creating these rules for Medicare Advantage plans.

I recognize my privilege as a patient who has a history of being involved in advocacy alongside my peers at Global Liver Institute. Without feeling empowered to fight this denial, I may have just given up and gone back to my blood transfusions, even with all the risks of infection. I am lucky. I had a doctor willing to fight with me and take time off to be by my side. Not everyone has that kind of support.

Therefore, I am here telling my story and working with Global Liver Institute to connect my story to a policy solution. I am grateful to have survived this, but there are others that will not if insurers are not held accountable to give patients with rare diseases a timely individualized review of their appeals for coverage.

Global Liver Institute Advancing Policy Solutions

For Global Liver Institute, Deb’s story sounds the alarm that artificial intelligence offers both opportunities and peril. We are committed to advocating policy solutions. We agree people with rare diseases should have a fast track to appeal the automatic denials from use of algorithms and artificial intelligence. And policymakers should work to ensure that this technology is not playing doctor with Medicare beneficiaries. Doctors prescribe care, not machines.

Her story is a harrowing example of something that will continue without policy solutions to avoid it. On behalf of Deb and so many others, Global Liver Institute will continue to work with the health field and AI community to navigate such perilous waters.