CMS Expands Coverage Of HBO To Diabetic Foot Ulcers

Beginning this month, the Centers for Medicare and Medicaid Services (CMS) will expand its coverage of hyperbaric oxygen therapy (HBO) to include the treatment of diabetic wounds in the lower extremities. According to the CMS, in order to qualify for this coverage, patients must have: type 1 or type 2 diabetes and a lower extremity wound due to diabetes; a wound that is classified as a Wagner grade III or higher; and have failed an adequate course of standard wound therapy. Caroline Fife, MD, says the expanded coverage is a “big step forward.” “It represents an understanding on the part of Medicare of the overwhelming data on the effectiveness of HBO in improving limb salvage in diabetic foot ulcers,” says Dr. Fife, a Clinical Associate Professor within the Department of Anesthesiology at the University of Texas Health Science Center. While Medicare and other insurers have provided coverage for HBO over the years to treat conditions ranging from necrotizing fasciitis and chronic bone infections to crush injuries, Dr. Fife says there was a lack of uniformity in coding across the various regional Medicare carriers. “As a result, in some regions, it was easier for wounds to be treated than in others,” recalls Dr. Fife. Now there is a specific code (HCPCS 99183) for using HBO to treat diabetic lower extremity wounds. Dr. Fife emphasizes that if patients are properly screened, HBO therapy can be a cost-effective option because it “prevents costly amputations.” The CMS notes that HBO will only be covered as an adjunctive therapy after all standard wound care treatment has failed to yield measurable signs of healing after a 30-day period. When using HBO therapy, you need to evaluate the wound every 30 days to ensure that it is healing properly. Also keep in mind that continued treatment with HBO will not be covered if there are no measurable signs of healing within any 30-day period of treatment, according to the CMS. Dr. Fife cautions that improved coverage may not improve the availability of treatment since the FDA-approved hyperbaric chambers are not commonplace. “An increase in coverage does not equal an increase in awareness of the benefits of hyperbaric therapy,” maintains Dr. Fife. Study Offers Mixed Results On Topical Oxygen Therapy In a somewhat related development, a new study by researchers at Ohio State University revealed that using topical oxygen therapy alone led to healing of difficult wounds in more than two-thirds of the 30 patients in the study. Researchers of the study, which was published in a recent issue of Pathophysiology, noted that acute traumatic and post-surgical wounds on the trunk, arms and hands showed a 75 and 100 percent healing rate respectively. However, lower extremity wounds did not fare as well in comparison. The study authors noted that only half of acute wounds on the legs and feet healed with topical oxygen alone. “While topical oxygen helps wounds heal, it alone may not be adequate for managing lower extremity wounds,” noted Dr. Chandan Sen, the lead author of the study, to ThatFootSite.com. However, he said that using topical oxygen “may be helpful” if one uses it adjunctively with other wound care modalities or surgery. The authors of the study applied topical oxygen therapy for 90 minutes a day over a four-day period, which was followed by three days of rest. According to the study, the duration of treatment ranged from 24 days to eight months. Many of the participants had at least one health condition such as cancer, an active infection or diabetes. The aforementioned CMS decision to expand coverage of HBO to lower extremity diabetic wounds does not apply to topical oxygen therapy. Dr. Fife says Medicare doesn’t pay for topical oxygen because there is not enough clinical evidence to support its use. “To date, no one has been able to show significant increases in tissue oxygen tension using any kind of topical oxygen,” explains Dr. Fife. In comparison, Dr. Fife points out that hyperbaric oxygen has been demonstrated to increase tissue oxygen levels to between 200 and 1000 mmHg using transcutaneous electrodes. She adds that a few early studies on topical oxygen showed that it actually made wound healing worse. Studies Reveal Shoe Size Dilemmas For People With Diabetes By Brian McCurdy, Associate Editor The question of whether diabetic patients wear shoes that are the correct size is one that has not been explored very often. Two recent studies conclude many people with diabetes choose shoes that are too small, which can cause ulceration. One study, which will be presented at the Symposium On Advanced Wound Care (SAWC) later this month, tracked 100 patients at a high-risk foot clinic, 74 percent of whom were diabetic and 24 percent of whom had active diabetic ulcerations. Researchers determined a mere 37 percent wore appropriately sized shoes and those with ulcerations are 3.8 times more likely to present with poorly fitting shoes than those without wounds. “This implies that appropriate meticulous screening for shoe/foot mismatches may be useful in reducing the risk for lower extremity ulceration,” the researchers maintain in the abstract of the study. A second study reaches similar conclusions. Recently presented at the American College of Foot and Ankle Surgeons (ACFAS) Annual Meeting and Scientific Seminar, the study involved 28 patients who chose their own shoes and also wore shoes chosen by pedorthists. After comparing acetate tracings of patients’ feet and both pairs of shoes, researchers found that 82 percent of patients selected shoes that were too narrow (by an average of 3.55 mm) and 75 percent chose shoes that were too short (by an average of 5.17 mm). “These high-risk patients should be fitted by a professionally trained pedorthist to ensure proper fit,” conclude the authors, who note that doing so can eliminate excessive pressure by shoe gear and likely decrease patients’ chances of having a foot complication. How Neuropathy Plays A Role Why do so many patients chose inappropriately sized shoes? Co-authors of both studies say part of the problem is neuropathy. David G. Armstrong, DPM, a co-author of the SAWC study, says once patients are diagnosed with neuropathy, it is critical that a professional fit their shoes. Dr. Armstrong, a member of the National Board of Directors of the American Diabetes Association, says you should let patients know that “without the gift of pain, they will very commonly not choose the appropriately sized shoe.” After recently measuring the feet of nearly 1,000 veterans (the majority of whom are geriatric males), Brent Nixon, DPM, notes that most of them wear shoes that fit or are one-half size off. However, Dr. Nixon points out that the incidence of problems rises in those who wear shoes that are off by one and one-half sizes. “We have taken a subset of diabetics and have seen a higher rate of problems,” notes Dr. Nixon, a co-author of the SAWC study. “I have also noted that people wearing the so-called diabetic shoes can also have problems despite wearing a more suitable pair of shoes.” Lawrence Lavery, DPM, a co-author of the ACFAS study, agrees that specialists need to fit diabetics for shoes and patients need more education in this area. He points out that those with neuropathy experience no pain when their shoes are too small. “Because of neuropathy, they may select shoes that are small so they can feel the shoe on their foot,” says Dr. Lavery. Co-author Misty McNeill, DPM, agrees and says patients need to know shoe size varies among manufacturers. “I also think that the size of your foot changes as you age, (but patients) think they should wear the same size that they did when they were 20 or 30,” adds Dr. Lavery, an Associate Professor in the Department of Orthopaedics Surgery and Rehabilitation at Loyola University Medical Cednter. “I usually ask my patients if they wear the same size pants that they did when they were 20.” Editor’s Note: The abstract of the aforementioned study co-authored by Drs. Armstrong and Nixon will be presented at the 16th Annual Symposium on Advanced Wound Care, which will be held from April 28 to May 1 at Caesar’s Palace in Las Vegas, Nev. For more information, please see www.woundcaresymposium.com. Xerosis Study Looks At Current Treatments Researchers showed in a recent study that two topical creams are effective in treating moderate to severe xerosis, a condition that occurs more often in winter months and is known to have a higher incidence among patients with diabetes. Published in a recent issue of Cutis, the study demonstrated the effectiveness of pure lanolin and ammonium lactate 12% cream in treating the condition, without any significant difference between the two medications. The researchers followed 92 patients in a double-blind, randomized controlled study over a four-week period. Patients applied the medications twice a day, using a different one for each foot. Donna Alfieri, DPM, a co-author of the study, says it served to educate about current treatment modalities because xerosis is a condition that is “often under-treated.” Dr. Alfieri, who is with the New York College of Podiatric Medicine, says untreated xerosis can lead to fissure formation, which provides an environment for bacterial and/or fungal infection. She notes this can lead to potentially more serious complications in diabetic patients. — G.D.