Large Insurer Says Shockwave Doesn`t Meet Coverage Criteria

Does your insurance provider cover extracorporeal shockwave therapy (ESWT) for musculoskeletal indications like plantar fasciitis? Some providers may re-examine their coverage, following a decision by the Blue Cross Blue Shield Association Technology Evaluation Center to reverse its recommendations on the scientific efficacy of the therapy. After evaluating several studies, the center found shock wave treatment does not meet its criteria for coverage. The recent assessment reverses a December 2001 recommendation that shockwave therapy met the criteria of improving health outcomes. The Technology Evaluation Center provides scientific evidence to 43 independent Blue Cross Blue Shield plans, which can then accept or reject the assessment, according to the center’s Executive Director Naomi Aronson, PhD. She did not have information on which of the plans accepted or rejected the assessment. The change in assessment occurred because of the results of three recent shockwave studies. “In our view, there was a very substantial change in the literature,” says Dr. Aronson. One cited study, headed by Rachelle Buchbinder, MBBS, MSc, was published in the Journal of the American Medical Association (JAMA) in September 2002. The placebo controlled study assessed 166 patients undergoing extracorporeal shock wave therapy for plantar fasciitis and concluded there was “no evidence to support a beneficial effect on pain, function and quality of life” when shockwave therapy was compared to the placebo therapy. Will Forthcoming Studies Reverse The Reversal? Lowell Scott Weil Sr., DPM, had criticized the JAMA study last year and recently noted the study was conducted only with a variable power setting, not all patients could tolerate the same dose and some patients had heel pain for only six weeks. He says Lowell Scott Weil, Jr., DPM, will present a long-term retrospective study at the American Podiatric Medical Association (APMA) meeting next month. In this study of shockwave therapy, Dr. Weil found an 82 percent success rate after six months with the rate dropping only slightly to 75 percent after three years. Dr. Weil Sr. also notes three blinded FDA studies will soon be released. He says there may be some surprises in store and believes the studies will help prove the efficacy of the therapy. Another study, of which the Weils co-authored, was published in the Journal of Foot and Ankle Surgery in May/June 2002 and assessed 40 feet. The researchers concluded 83 percent of patients undergoing shockwave therapy said it improved their symptoms. The Weils compared these patients to a group which had undergone percutaneous plantar fasciotomy for plantar fasciitis. The insurance company assessment says the evidence “does not permit conclusions concerning the effect of the technology on health outcomes of plantar fasciitis.” “Overall, the results of the trials are inconclusive,” the assessment says. “If ESWT provided a clinically significant improvement in plantar fasciitis, one would expect consistent improvement across multiple ways of measuring pain and function (e.g., morning pain, use of pain medications, ability to walk without pain). But the results of various measures within studies and across studies do not give a consistent picture.” “We couldn’t get a clear and robust picture that there were large and significant changes,” notes Dr. Aronson. Dr. Weil says the change in assessment has not affected his practice because his Blue Cross Blue Shield carrier in Illinois is covering shock wave and his practice has its own equipment. He does not think other insurance companies will change their assessment. “What it affects is the less affluent patients who pay for it out of pocket,” says Dr. Weil, a Past President of the American College of Foot and Ankle Surgeons. He notes it is not easy for podiatrists who lease shockwave equipment, noting cases must first be approved by the company owning the device. “I’m sure it’s affecting a lot of people and it’s unfair.” Study Detects Higher Amputation Rates In Mexican Americans By Brian McCurdy, Associate Editor A new study has found some intriguing insights into the prevalence of diabetes in Mexican Americans. The study, which was recently published in Diabetes Care, notes Mexican Americans have higher amputation rates than non-Hispanic whites. The study was conducted over 24 months on 1,666 patients enrolled in a diabetes screening program. Researchers discovered amputations occurred 7.4 times per 1,000 Mexican American patients whereas the amputation rate in Caucasians was 4.1 per 1,000. As the researchers say, this discovery belies the fact that rates of ulceration, infection, vascular disease and lower-extremity bypass are similar in both groups. The study also discovered Mexican Americans sustained more failed bypasses (33 percent) than non-Hispanic Caucasians (7.1 percent). Researchers also determined Mexican Americans in the study were 3.8 times more likely to have a failed bypass, which would lead to an amputation, or be diagnosed as “nonbypassable” than non-Hispanic Caucasians (75 percent vs. 44 percent). “We continued to be puzzled about this finding,” notes study co-author David G. Armstrong, DPM, who calls for a second study. He says since all patients had complete access to all aspects of care, there should have been no difference in their outcomes based on their ethnicity. However, Dr. Armstrong, a member of the American Diabetes Association Board of Directors, says the results could point to the fact that “Mexican Americans may have a different quality or distribution of disease which rendered bypasses less effective.” Since all patients were treated according to a set standard, Dr. Armstrong says another potential partial explanation for the results is patients may have sought care later in the course of the disease, although there is no direct evidence for this in the study. What About Cultural Factors? What explains the difference in amputation rates between the two cultures? Study co-author Lawrence Lavery, DPM, says although cultural factors may come into play, researchers did not study cultural issues, which were beyond the project’s scope. However, Dr. Lavery says in a previous study, he identified a “significantly higher incidence” of diabetes-related amputations in Mexican Americans in South Texas than in non-Hispanic Caucasians. “We thought that issues such as access to care, fatalism or religious beliefs about healthcare, ability to access prevention services, self-care practices, education/knowledge of disease, transportation and a variety of other factors might influence disease outcomes,” says Dr. Lavery of the previous study. Dr. Lavery notes the diabetes disease management program Diabetex, which managed the center where the study was conducted, helped to break down or eliminate some of the perceived or real access and referral issues which might influence care. The program helps screen, risk-stratify and treat high-risk patients. “I think a lot of the evidence suggests outcomes were the same when the playing field was leveled,” he notes. Dr. Lavery also notes in the study there were simply more cases of peripheral vascular disease which could not be bypassed. He says the explanation for this was probably because either the disease “was so severe that there was not a good target vessel to bypass into or because the patient was not a good surgical candidate because of the systemic disease.” Dr. Lavery says the explanation for the study results may be more than likely a combination of cultural issues and diabetes being a more virulent disease process in minorities. Taking Another Look At Orthotics And Heel Pain By Brian McCurdy, Associate Editor In one of the many lectures planned for the upcoming APMA annual meeting, Douglas Richie, Jr., DPM, will be discussing recent cadaver research that may shed a new light on therapy for plantar fasciitis. Work with cadavers has revealed some traditional orthotic remedies may actually prolong plantar fasciitis by increasing strain in the fascia, according to Dr. Richie. He notes there is “considerable debate and even more misunderstanding” among podiatrists and orthopedists over the role of foot orthoses in treating plantar fasciitis, but believes emerging research on the subject may provide better answers. “Only recently have legitimate cadaver studies been undertaken to determine the role of orthoses and footwear to relieve strain in the plantar fascia,” says Dr. Richie, whose lecture will be based on his studies and recent literature. Editor’s Note: The APMA annual meeting will be held from Aug. 7-10 in Washington, D.C. For more information, check out www.apma.org.