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A shortened version of this article was published in the July/August 2008 edition of Orthopaedic Product News.
In the United States hundreds of thousands1 of patients receive knee and hip replacements as a result of debilitating arthritis and injuries. Fortunately for these patients, they are able to have surgeries to correct the problems without worrying about the financial considerations associated with the procedures. That is because private insurance companies and the Federal government's Medicare Program cover most of the financial costs of these surgical procedures. However, thousands of patients who have some of the same problems, such as rheumatoid arthritis, osteoarthritis, or a traumatic injury to the ankle, are not so fortunate. Most insurance companies consider total ankle replacements, called arthroplasty, to be "not medically necessary," "experimental," or "investigational."
Total ankle replacements have been performed in Europe for over 30 years and actually began in the United States in the 1970's. According to James K. DeOrio, M.D., who specializes in total ankle replacement at Duke University Medical Center, Durham, NC, and has done over 300 ankle replacement surgeries, early results were not satisfactory. In part, this was because only a small number of patients in various regions of the country had ankle replacements, usually performed by the designer of the implant. Additionally the ankle replacements had poor design features and were usually cemented. Studies at that time were not as well structured as they are today, and the new devices used did not have to demonstrate safety and efficacy to the U.S. Food and Drug Administration (FDA). Implants were becoming loose because the cement was giving way and the ankles were painful. Further, no revision techniques were available and the primary treatment for these failures became removal of the implant and ankle fusion. For the next 20 years, enthusiasm for ankle replacement waned and treatment options usually consisted of fusing the ankle.2
Ankle fusions mean locking the ankle bone (talus) to the shin bone (tibia), completely restricting ankle motion. However, in 1984 Franklin G. Alvine, M.D., designed and began implanting total ankles, which he called the Agility. They are now called the Agility™ LP (4th generation) and were approved by the FDA in 2006. Other prostheses, such as the INBONE and Salto-Talaris™ total ankle replacements, are approved by the FDA and are currently being used successfully. Recent studies have been conducted and anecdotal evidence has shown that total ankle replacements that are being done now have a high success rate, unlike those done during the early years. In fact, at the 2007 American Orthopaedic Foot and Ankle Society's annual summer meeting in Toronto, Canada, a study conducted by Charles Saltzman, M.D., Professor, Orthopaedic Surgery and Engineering, University of Iowa, indicated that in the nine years following ankle replacement using the Agility Total Ankle, patients in the survey population demonstrated a success rate of 89%.
Steven Haddad, M.D., Associate Professor of Clinical Orthopaedic Surgery, Northwestern University Feinberg School of Medicine, citing a 2006 study by Daniels, et al, in the Journal of Bone and Joint, concludes there is a lot of data supporting the validity of ankle replacements. The study lends credence to the practice of ankle replacement for cases of primary osteoarthritis, rheumatoid arthritis and post-traumatic degenerative arthritis. According to Dr. Haddad, who has also performed over 300 total ankle replacements, the ankle replacement offers increased value over the ankle fusion. With ankle fusion, stress gets transferred to the surrounding areas, often requiring costly supplementary surgery. Dr. Haddad maintains that patients are functionally better off with ankle replacement over fusion, have a lower rate of supplementary surgery at joints adjacent to the ankle joint, and have a better quality of life.3
However, like other types of surgeries, there are potential complications associated with ankle replacements. In addition, total ankle replacement surgery is complicated and difficult, requiring very skilled surgeons. The learning curve and training to perform this exacting surgery is substantial.
Despite the fact that the FDA has cleared at least four medical devices for total ankle replacements and recommended approval of a 5th and despite studies showing successful results, some insurance companies still argue that the procedures are "experimental." Many of our country's finest foot and ankle surgeons do not agree with the insurance companies, but they lack the ability to persuade changes to the insurance company's decisions. It is interesting that most insurance companies cover ankle fusions, even though fusions in the long term often result in painful arthritic conditions in other areas of the foot and ankle. Dr. Haddad states in the November 2007 issue of Orthopedics that ankle fusion doesn't make sense economically over the long term. Some longer-term studies reveal decreased rates of patient satisfaction when compared to ankle replacement. He cited a recent survey in which ankle fusion recipients expressed lower rates of satisfaction (73-74%)than ankle replacement recipients (93-94%).
There is a small group of patients who have either already had total ankle replacements or are waiting to have the procedure, who call themselves the "Blessed Ankles." It is a group formed online and with phone conversations after many of us read an article written by Gay Shook. In her "Over Coffee" online column at www.theweekly.com, Mrs. Shook discussed her "miracle" total ankle replacement that was performed by Dr. DeOrio in October 2007. She was contacted online by several patients who badly need ankle replacements according to their doctors.
The problem they face is that although their doctors are recommending ankle replacements, the insurance companies are denying them coverage. Take two cases in point. Thomas W. Stallings lives in Branson, Missouri. On December 27, 2006, his world was changed forever. While traveling after Christmas, his family was rear-ended by a semi-trailer on a rural highway. He was airlifted to the closest trauma hospital about 20 miles away, where he remained for over two weeks. He has little memory of the skilled neurosurgeons who reconstructed a fracture-filled head during ten hours of brain surgery. The doctors, however, did not treat the three breaks in his left ankle. He was told that it was a soft tissue wound and allowed to walk on it for seven weeks. Since that time, two of the breaks healed on their own. The third one will never heal. He has dealt with an ankle cast, a brace, injections, arthroscopic surgery, and he has two opinions from orthopedic surgeons recommending ankle replacement. Anthem Blue Cross/Blue Shield denied coverage three times, citing "not medically necessary" and "investigational." His surgeon had been denied the opportunity to help Mr. Stallings three times, first as a routine pre-approval and twice as an appeal, and he does not consider the replacement procedure to be "investigational." It is likely that BC/BS will pay for an ankle fusion, but neither his surgeon nor Mr. Stallings believe that fusion is the best route. It provides lifestyle limitations not imposed by a replacement, and offers the likelihood of further complications to other parts of the body. His last avenue for hope is an appeal to the Missouri Department of Insurance. That appeal was filed in mid-May, but Mr. Stallings is not expecting a change in the initial decision.
The other case involves Jennifer Miller. Mrs. Miller is the victim of the debilitating disease Lupus. At the age of 20 she was diagnosed with Systemic Lupus, Lupus Nephritis. She now has Avascular Necrosis (AVN) as a result of the high doses of steroids in the last couple of years prescribed for her Lupus. Her Lupus has been in remission for several years, but the AVN has continued to wreak havoc on her joints and has affected the overall quality of her life. She has had several surgeries, including hip replacements, knee arthroscopy, and wrist carpectomy.
She notified her rheumatologist that she was experiencing pain in her knees and ankles in April 2007. In February 2008 the pain became intolerable and her rheumatologist scheduled an MRI. Results showed AVN with significant damage in the left ankle. After a week or two, the right ankle began to hurt and the pain was more intense than before. The MRI results were similar to the left ankle with significant signs of AVN in her right ankle and a small stress fracture.
Her local orthopedic surgeon referred her to Dr. James K. DeOrio at Duke University. Dr. DeOrio reviewed the MRI of both ankles and recommended total ankle replacements in both ankles. Mrs. Miller walks in constant pain whether it is an ache, stabbing, throbbing, crushing, catching or popping. She uses a cane at times to steady herself and to help with walking, but with a 16-month-old child, the cane and crutches sometimes become a danger to her baby and herself. Mrs. Miller also works part-time for her family business and tries to take care of her 73-year-old mother, who is in a wheelchair. Without ankle replacements, Mrs. Miller's ankles will likely totally collapse resulting in her being wheelchair-bound for the rest of her life. The ankle replacement surgery was scheduled, but just two days before the surgery she received a call from CIGNA Insurance Company saying that the surgery would not be covered. The Company has remained firm in their denial despite Jennifer's full use of the appeal process, which Dr. DeOrio has participated in to help her. The Company stated ...
"Review of the records provided would support that this 32-year-old young lady has a very complicated history of lupus with avascular necrosis of her tibia, talus, calcaneous bilaterally with collapse. With this diagnosis, tibial arthroplasty which is ankle replacement would be considered experimental, investigational, or unproven and not as good and/or better than standard of care in this case; therefore, it is not a covered benefit".
These are just two of probably thousands of cases where insurance companies deny coverage to people who have very severe conditions requiring ankle replacements. It's time for insurance companies to step up and do what is ethically and morally right. An argument may have been made that these surgeries were experimental or investigational years ago, but the same argument can no longer be used.
As Dr. Haddad states, the U.S. Government accepts this procedure as appropriate and provides coverage to Medicare patients... yet many Managed Care Organizations (MCO's) persist in considering ankle replacements to be experimental devices despite the fact that MCO's claim to use Medicare as a template for coverage decisions. Although some MCO's do cover replacement on a case-by-case basis after extensive peer-to-peer review, the procedure is still not covered by many big insurance companies. Finally, as Dr. Haddad suggests, "It's almost a crime how insurance companies can get away with dodging this bullet."
It's now time for insurance companies to immediately begin doing the right thing!
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1. Shirley A. Engelhardt, Orthopaedic Product News, July/August 2007, entitled "Total Ankle Replacement Segment Expected to Proliferate," excerpted from the July/August 2007 issue and used with the permission of Knowledge Enterprises, Inc.
2. James K. DeOrio, M.D., Northeast Florida Medicine, Vol. 57, No.3, 2006, pgs. 9-10, entitled, "You Mean You Can Replace the Ankle Joint."
3. Steven L. Haddad, M.D., Orthopedics, dated November 2007, p. 9, entitled, "Ankle Replacement Makes Gains, Faces Resistance."
This article was prepared by four of the Blessed Ankles: Jerry Armstrong, Texas; Tom Stallings, Missouri; Jennifer Miller, West Virginia, and Gay Shook, Georgia.
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