NBS was recently involved in an appeal for denial of benefits on behalf of a client hospital that had treated a Medicare beneficiary with hyperbaric oxygen for radiation cystitis. The basis for denial was that the patient had not first received standard care. We felt strongly that this was an incorrect determination so elected to initiate an appeal. It was denied by Medicare’s internal review process. We requested a re-consideration; so referred to an outsourced medical claim review organization. They upheld Medicare’s decision. We remained convinced of the validity of our arguments which eventually brought us before an Administrative Law Judge. Prior to hearing our appeal, the judge had asked if I could help him understand why the hyperbaric chamber was used for patients other than injured divers. I had a couple of hours’ notice of his request so quickly drafted the following…which was formulated to arrive at the condition under review.
Your honor, from the late 19th century to the present recompression in a hyperbaric chamber has represented the undisputed treatment standard for diving/decompression accidents.
The late 1950’s saw the hyperbaric chamber first used to support open heart surgery. Surgeons had long struggled with the very short periods a heart can be stopped to affect repairs in the pre-heart lung machine era. Blood plasma becomes heavily laden with oxygen while in the chamber to the point that a heart can be stopped for several orders of magnitude longer than while at normal atmospheric pressure. Major medical centers in this country and elsewhere installed hyperbaric chambers specifically for this purpose. By the late 1960’s, however, the heart lung machine had been perfected, passed its regulatory hurdles, was capable of mass production and quickly evolved as cardiac surgery standard of care. This eliminated any further need for a hyperbaric chamber. The chamber’s unique therapeutic hyperoxygenation mechanism, however, was not to be lost and soon adopted to treat other acutely ischemic issues…failing skin flaps, extremity crush injuries, thermal burns, are examples.
During the 1960’s anti-microbial/infection fighting properties of hyperbaric oxygen were identified and have since evolved as a helpful adjunct treatment of gas gangrene, necrotizing fasciitis (flesh eating bacteria) and certain bone infections.
Work undertaken by USAF researchers in San Antonio, TX and others beginning in the 1970’s showed that certain types of deficient wound healing states benefited from daily exposure to the hyperbaric chamber. This finding initially focused on diabetic patients. Soon thereafter, again involving pioneering work within the USAF, healing of radiation damaged facial bones, principally the mandible, markedly improved thanks to hyperbaric oxygenation.
As the damaging effects of radiotherapy on healthy tissue surrounding tumors are not anatomic specific, the use of hyperbaric oxygen began to be employed elsewhere. The pelvic region happens to be a very common site for such damage. Over the ensuing decades specialists dealing with this complication have increasingly referred patients to the hyperbaric medicine service, to such an extent that in 2021 it is arguably the most common use of the chamber.
However, strength of clinical evidence, or proof of effectiveness, has long been less than expected in this modern evidence-based medicine era. This is in fact the case for many other medical management strategies. We sought to correct this hyperbaric medicine shortcoming via design and implementation of a multicenter clinical trial. This initiative resulted in the first level 1 evidence of efficacy, or proof of therapeutic effect, and was published in a leading radiation oncology journal in 2008. It did indeed involve the pelvis and specifically the rectum. Critically, it was also the first formal clinical trial to show that HBO was disease modifying. Traditional ‘standard care’ is unable to resolve the underlying disease, short of removal of the damaged organ. Rather, it is limited to addressing patient symptoms and related findings, so subsequent relapse is a common clinical course, requiring another round of symptomatic management, with further relapse likely. HBO in many instances resolves the underlying disease, thereby eliminating this frustrating remitting - relapsing sequence, with attendant ongoing costs to the health care delivery system and adverse patient quality of life.
Your honor, those who purchase health care have been slow to grasp this key disease-modifying concept, the therapeutic importance of which cannot be overstated.
As noted, our study addressed the rectum. Given that the case before you today involves the bladder, you will be encouraged to learn that similar high quality scientific research reported in the journal Lancet Oncology in 2019 demonstrated this very same efficacy and disease modifying effect on the radiation damaged bladder. One additional observation by this research group, again pertinent to today’s case, was that patients responded best to hyperbaric chamber exposures the earlier they were referred. So, the practice of holding off/restricting hyperbaric referral until symptomatic management have proven unsuccessful contradicts current best evidence and is clearly not in the best interest of these patients.
Finally, and again relative to the case before you, your honor, is a 2019 article in the British Journal of Urology International, a highly regarded source with almost a century of publication history. It offers the urologist a thoughtful clinical practice guideline to address the radiation damaged bladder, including a comprehensively structured management algorithm. Of relevance for today’s hearing your honor, every single pathway within the algorithm, no matter the presenting signs and symptoms, arrives at hyperbaric oxygenation as consolidative treatment, rather than a treatment of last resort.
At this point the judge stated that he was living proof you can teach an old dog new tricks! Given the informality of his comment, I felt more at ease so replied in a similar lighthearted vein that my presentation might qualify him for a CLE (the legal equivalent of a CME)!
NBS enjoys a 5-0 record for previous ALJ appeals. We hope this judge will rule in our favor, so it remains unblemished.