Third-Party Payor Coverage of Experimental Surgery Discussed in FAI Journal

FAI features new interactive discussion section entitled FootForum 

Rosemont, IL – June 2, 2009 - Foot & Ankle International (FAI), the official journal of the American Orthopaedic Foot & Ankle Society (AOFAS), has recently added a new highlight to its monthly publication. The section is entitled FootForum and is written by AOFAS member Michael S. Pinzur, MD, Professor, Orthopaedic Surgery, Loyola University Medical School, Maywood, IL. In the May issue, the FootForum topic is Experimental Surgery. In it, he discusses who or what are the appropriate bodies to decide that clarification in reference to a medical procedure such as the total ankle replacement (TAR).

Dr. Pinzur states that the regulatory process for the introduction of a new orthopaedic implant (total ankle replacement) is the responsibility of the United States Food & Drug Administration (FDA). Before a new product can enter the commercial market, manufacturers must follow a strict process to receive this approval. The goal behind this process is the protection of the public from unsafe devices. However, it is the insurance companies who often make the final decision as to whether a medical procedure should be reimbursed. This increases the need for proper data being used in these decisions.

Dr. Pinzur comments, “Who should be making the decisions as to what is appropriate for patients: physicians and professional societies or the payors? As we move forward with this new health care initiative, should the insurance companies decide if a treatment is medically appropriate?”

What is the current medical evidence available on the safety and effectiveness of a total ankle replacement? In a recently completed long-term, multi-centered clinical trial, FDA data showed that a TAR is at least equivalent, if not better, than an ankle fusion in many instances. In an ankle fusion, the bones of the ankle and leg are fused together limiting movement. In an ankle replacement, the damaged bones are replaced often leading to a more natural motion. These ankle bones have deteriorated over time due to painful and disabling ankle arthritis. At this point in time, three models of total ankle replacements have been approved by the FDA for marketing in the United States, with an additional one having received FDA approval this month, yet many patients must still struggle for approval of coverage for this procedure from their insurance companies.

“Each patient’s condition is unique and the appropriate choice of treatment must be able to be made. In some instances, fusion is the best course and sometimes a total ankle replacement is the best route. A good total ankle replacement is more functional than an ankle fusion, although the complication rate can be greater. The new ankle replacements have been much more effectively designed which should decrease the complication rate.

Evidence is clear today that a good total ankle replacement is better than a good fusion although with higher possibility of complication. But who should be making the decision of what is appropriate for his patient: a fellowship trained orthopaedist or an insurance company?” concluded Dr. Pinzur.

About the AOFAS
The AOFAS promotes quality, ethical and cost-effective patient care through the education, research and training of orthopaedic surgeons and other health care providers. The Society creates public awareness for the prevention and treatment of foot and ankle disorders, provides leadership, and serves as a resource for government and industry as well as the national and international health care communities.​
About Orthopaedic Foot and Ankle Surgeons
Orthopaedic foot and ankle surgeons are medical doctors (MD and DO) who specialize in the diagnosis and treatment of musculoskeletal disorders and injuries of the foot and ankle. Orthopaedic foot and ankle surgeons use medical, physical and rehabilitative methods as well as surgery to treat patients of all ages. Relying on four years of medical school training, five years of post-graduate training and often a fellowship in foot and ankle care, orthopaedic foot and ankle surgeons perform reconstructive procedures, treat sports injuries, and manage and treat trauma of the foot and ankle.

Jennifer Hicks
Public Education Manager
Office: 847-384-4379