By Martine G. Brousse
Patient Advocate, Certified Mediator
February 7, 2022
ALL WENT WELL UNTIL ...
Susan was very happy with the result of her recent ankle surgery. Everything had gone without a hitch, and the graft tissue had healed better than expected. The office had obtained an authorization ahead of time. Every claim except the facility’s had already been processed and paid.
Susan was about to schedule a date with her surgeon to operate on her other ankle when the bill came: $ 7,500.00 for the graft tissue. The insurance denial: “experimental”, a clear exclusion on her policy. Calls to the insurance confirmed that the authorization did not cover this specific brand and type of graft tissue, and that her liability was the total amount billed by the hospital.
Susan contacted me for help after her appeal to the insurance was denied. She could not understand: after all, her surgeon’s office had assured her the paperwork was in order.
RESEARCH AND UNCOVERINGS
1. A quick search through the FDA website confirmed that the manufacturer of the graft tissue was only in the process of applying for approval. The insurance was within its rights to deny payment. No appeal would be able to change that.
2. When I reviewed the authorization request by the office, it became clear that although the surgery was approved, the use of that specific graft tissue was never mentioned. The gal at the office confirmed “all knew this was not FDA-approved and therefore we did not bother requesting coverage”. The surgeon wanted to “try it out” and Susan would be the first patient.
However, Susan was never told in writing or verbally of the FDA status of the graft tissue, nor was she asked to sign the usual disclosure form. That form informs a patient that (1) the use of the graft tissue is not FDA-approved (2) full effectiveness, safety and side effects have not yet been established (3) no insurance will cover its cost and (4) the cost was $ 7,500.00.
This was an unforgivable error or oversight on the office part, which Susan took hard. “I never signed on to be a guinea pig” she told me, “and certainly not at my own expense!” The office could not provide a copy of the signed form. It was never given to her. Neither did the surgeon’s note mention the use of experimental tissue or notice given to the patient.
3. The hospital’s medical records revealed another unacceptable fact: three representatives from a medical supply wholesale firm had been allowed in the operating room to see how the graft tissue was being used. Susan, who was under general anesthesia, was never made aware of this until I uncovered a short sentence in a nursing report. The hospital should have asked Susan written permission for external, non-medical observers to be present in the operating room. “There is no way I would ever allow this” she told me. “The more people around me, especially without a medical license, the more at risk they put me!”
4. I contacted the wholesaler and the manufacturer to ask about this highly unusual occurrence. Both assured me that the surgeon had invited the representatives, and that either she or the hospital was required to ask permission from the patient. The surgeon never mentioned the presence of these observers in her op report.
Once I had the previously unknown facts in hand, I applied the right pressure and offered the right carrots to offer a resolution that would wipe out Susan’s bill.
1. By calling the surgeon and her staff on their lack of integrity, their failure to notify Susan about the non-approved use of the graft tissue and the presence of three strangers while she was under, and their misleading Susan in believing the insurance authorization covered all costs, I was able to get them to talk the hospital administration into accepting an alternative form of payment.
2. By calling the wholesaler on its failure to confirm that Susan had, in writing, been informed of the presence of its representatives, and on allowing non-medical personal to enter an operating room, I was able to have them agree to act as “go between” and facilitate the alternative form of payment I had procured.
3. By offering that Susan write a letter of testimony and of appreciation to add to their application to the FDA, I was able to get the manufacturer to agree to donate the same amount of tissue to the wholesaler as had been used on her.
4. The wholesaler then forwarded it to the hospital, as a “donation”.
5. The hospital accepted the donated tissue, and credited Susan with $7,500.00.
Although no money changed hands, as every party had something to lose once Susan found out the truths about the product and the practices which were never disclosed to her. All were eager to see the matter settled without legal action.
Within a few days, Susan received a $ 0.00 balance statement from the hospital.
After some pondering, she decided to trust the surgeon and the graft tissue and scheduled a second surgery. This time we made arrangements ahead of time, and the product donated by the manufacturer was applied toward Susan’s second bill ahead of time.
The last I heard from Susan, she had quickly returned to a full and active life, with two perfectly repaired and healthy ankles.
Martine Brousse is a Patient Advocate and Certified Mediator located in CA and the founder of AdvimedPro, which she started after 20 years as a billing manager for physicians.
@ Martine G. Brousse 2022