CONGRESSIONAL SUMMARY
Undersea & Hyperbaric Medical Society
American College of Hyperbaric Medicine

Background: SARS-CoV-2 coronavirus (COVID-19) Acute Respiratory Distress Syndrome (ARDS) is the number one cause of mortality for this disease. A rapid cytokine storm is triggered in many patients causing an intense inflammatory reaction in the lungs, often requiring long duration ventilator support. If patients survive, they are often left with permanently damaged lungs and lifelong disability as well as ICU delirium and psychosis that can negatively impact their long-term quality of life.

Treatment consists of multiple novel pharmacologic, postural and non-invasive approaches to reduce inflammation and support respiration/oxygenation while vaccine research is ongoing. No single modality has been curative, and all show varying levels of success in preventing progression to intubation and mechanical ventilation. Once intubated the mortality rate is high, therefore many approaches are aimed at providing non-invasive ventilatory support in order to lower the threshold for intubation.

HBO₂ provides therapeutic benefit through two primary mechanisms: mitigation of the inflammatory cascade, and optimal treatment of hypoxia. Preliminary [phase 1/2/] trials have demonstrated safety and clinical benefit. Treated patients have shown perisistent improvement in tissue oxgen levels, a reduction in the work-of-breathing, and improvement in their overall clinical status. Most patients have undergone as few as 4-6 treatments. One NYU study reported a greater than 50% reduction in mortality.

The Problem: Phase 3 randomized control trials are necessary to determine the role of HBO₂ in the treatment of severely compromised COVID-19 patients. The initial costs to organize and conduct this level of research is an overwhelming financial burden for any hyperbaric treatment facility, especially during the current financial impact that COVID-19 is having on the healthcare system. Many hospital systems are resistant to add HBO₂ treatments into the inpatient diagnosis related group (DRG), fearing these additional services, as is currently the case, would be provided without commensurate reimbursement.

The Solution: Funding of Phase 3 trials in the range of $50M included in the CARES Act to be administered through the Biomedical Advanced research Development Authority (BARDA). This would allow CMS to create an emergency use “carve out” to include no more than 15 HBO₂ treatments per COVID-19 patient, fund the establishment of a research team to facilitate collection of data, ensure ethical and Investigational Review Board participation, and comply with all federal standards for participation in clinical trials. Of note, there are thousands of “mothballed” HBO₂ chambers around the country with chamber support equipment to enable rapid deployment and scaling to meet the clinical demand. There is no current lack of emergency equipment; the FDA roadblocked this modality and activation of necessary equipment by making the equipment CE mark rated.

Action: Please support the addition of HBO₂ research funding and “carve out” reimbursement treatment of COVID-19 patients with HBO₂.