The FDA has approved ankle replacements, so why don’t all insurance plans cover them?

It’s been a decade since the U.S. Food and Drug Administration approved the first total ankle-replacement system for patients with severe ankle arthritis.

But several insurance companies still deny coverage, Loyola University Health System orthopaedic surgeon Dr. Michael Pinzur writes in a FootForum commentary in Foot & Ankle International, the official journal of the American Orthopaedic Foot and Ankle Society.

“It seems curious that the FDA agrees with the [foot and ankle society] that total ankle replacement is a reasonable treatment option . . . while several insurance providers do not find ankle replacement as a reasonable treatment option for ankle arthritis,” Pinzur writes in the June issue.

An ankle replacement is an option for certain patients who suffer severe osteoarthritis, rheumatoid arthritis or injury-related arthritis that does not respond to more conservative treatments. In such patients, arthritis has destroyed cartilage, so the ankle joint is bone-on-bone.

An ankle replacement is similar to a knee or hip replacement. An implant is attached to the bottom of the tibia (shinbone) and to the talus (the first large bone of the foot). The smooth plastic surface of the tibial implant rotates on the polished metal surface of the talar implant.

Since approving the first total ankle-replacement system in 1999, the FDA has approved two other systems and given tentative approval to a third system. In 2003, the American Orthopaedic Foot and Ankle Society issued a statement that said a total ankle replacement “is a viable option for the treatment of ankle arthritis.” And Medicare routinely covers ankle replacements.

Nevertheless, several insurance companies still deny coverage. They base their decision on a “meta-analysis” that concluded an ankle replacement was not a preferred treatment option. The meta-analysis compiled data from previous studies. It was sponsored by insurance companies and based on studies published in 2002 or earlier, Pinzur wrote.

“Should insurance companies make decisions on what treatments are appropriate and what treatments are deemed experimental?” Pinzur’s commentary asks.

Pinzur is a professor in the Department of Orthopaedic Surgery and Rehabilitation at Loyola University Chicago Stritch School of Medicine. He has performed more than 50 ankle replacements.

Based in the western suburbs of Chicago, Loyola University Health System is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and 25 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus, Loyola University Hospital, is a 561-licensed-bed facility. It houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children’s Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola’s Gottlieb Memorial Hospital campus in Melrose Park includes the 264-bed community hospital, the Gottlieb Center for Fitness and the Marjorie G. Weinberg Cancer Care Center.

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