There are numerous anecdotal and retrospective studies that support using hyperbaric oxygen in problem wounds, according to Dr. Sage. He says these studies are nicely summarized on www.hyperbaricmedicine.org
, the Web site of the American College of Hyperbaric Medicine. Dr. Armstrong says he is not certain if there are any good, evidence-based or even anecdotally-based protocols that would drive one to use or not use HBO. However, he does cite a few intriguing studies. Kalani, et. al., from the Karolinska Institute in Sweden, presented a small randomized, controlled trial of 38 patients. Dr. Armstrong says this study suggested that using 40 to 60 dives of HBO per patient appeared to accelerate healing and lower the prevalence of amputations in a three-year follow-up. According to Dr. Sage, Faglia, et. al., may have done the best study to date of using HBO in Wagner Grade III ulcers with their 1996 study published in Diabetes Care
. The study was comprised of 35 patients who had standard wound care and 33 patients who received HBO. Dr. Sage says the amputation rate was 100 percent in the standard care group whereas the HBO group had a 25 percent amputation rate. However, Dr. Armstrong says studies, such as the one by Faglia, et. al., have been “fatally flawed” in one way or another. Dr. Armstrong points out that, in Faglia’s study, far more people in the HBO group received lower-extremity bypasses than in the non-HBO group, rendering the data less than helpful. While the study may be flawed, Dr. Sage says it was considered to be “pivotal” in the recent decision by the CMS to reimburse hyperbaric oxygen therapy for diabetic ulcers, according to the American College of Hyperbaric Medicine. While Dr. Armstrong notes there is a physiologic rationale for why HBO should work, he says “translating that into viable indications has been problematic for many.” Q: What are the current reimbursement issues in regard to insurance companies and Medicare paying for this modality? A:
HBO is a reimbursable procedure under Medicare, according to Drs. Kominsky and Sage. (Editor’s Note: For further info, see “CMS Expands Coverage Of HBO To Diabetic Foot Ulcers,” News & Trends, April issue.) Dr. Kominsky says HBO is also reimbursable under many of the managed care plans as well. Dr. Kominsky does caution that pre-authorization is necessary in some instances. He also points out that some third-party carriers limit the number of dives. In these cases, Dr. Kominsky says you may need to provide photo documentation in order to continue using the therapy to wound closure. Dr. Armstrong has heard that recent Medicare findings are very promising in terms of funding this type of therapy. However, he does express concern that when facilities invest in the chambers, there may be an accompanying pressure to use the therapy on patients who may or may not have the appropriate indications. “Frequently, the decision by an HBO specialist is ‘Let’s give it a try and see how it works,’” explains Dr. Armstrong. “Unfortunately, giving HBO a try is a bit more expensive than modifying an offloading modality or using a different dressing. I will admit this is changing, but it’s not changing fast enough or in enough centers to satisfy many skeptical physicians.” Q: What complications have you seen in using systemic HBO? A:
Drs. Armstrong and Brill say claustrophobia is the most common sequela. Dr. Brill says claustrophobia cases can be resolved by providing adequate sedation for the patient. He notes that some patients have had trouble clearing their ears when the chamber is going to depth, but Dr. Brill says this can be alleviated with nasal decongestants or via a myringotomy in troublesome cases. Dr. Armstrong adds that he has had patients who had perforated eardrums after undergoing HBO therapy, but says these incidents were his fault and that they could have been prevented with better evaluation along with his colleagues in ear, nose and throat and/or prophylaxis of the patients beforehand. Certain ear problems, cardiac and pulmonary conditions may be affected by HBO treatment, notes Dr. Sage. Accordingly, he emphasizes that hyperbaric care should be supervised by a physician who is experienced in using this modality. Dr. Sage also recommends that DPMs continue to provide optimal wound care and monitor the progress of the wound during HBO therapy. While Dr.