However, Dr. Brill says there is compelling evidence that HBO does have a beneficial effect. Last year. Medicare published a decision memorandum regarding the coverage of HBO and Dr. Brill says this document provides a good synopsis of the HBO studies that have been conducted so far. However, he does caution that there are major flaws such as comparability of patients, treatment bias and the inability to adequately blind the studies.
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.”