Monday, June 15, 2015

The FDA Has Approved Ankle Replacements, so Why Do Some Health Plans Refuse to Cover Them?

MAYWOOD, Il. -- 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.

About Loyola University Health System

Loyola University Health System (LUHS) is part of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. Loyola University Medical Center’s campus is conveniently located in Maywood, 13 miles west of Chicago’s Loop and 8 miles east of Oak Brook, Ill. At the heart of the medical center campus is a 559-licensed-bed hospital that 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 Loyola University Chicago Stritch School of Medicine, Loyola University Chicago Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.

Trinity Health is a national Catholic health system with an enduring legacy and a steadfast mission to be a transforming and healing presence within the communities we serve. Trinity is committed to being a people-centered health care system that enables better health, better care and lower costs. Trinity Health has 88 hospitals and hundreds of continuing care facilities, home care agencies and outpatient centers in 21 states and 119,000 employees.