**9. Coverage with evidence**

*Advancement and New Understanding in Brain Injury*

The clearest example to date that demonstrates that these gas/pressure combinations have a therapeutic effect on brain injury models is the article by Malek et al. [65] They demonstrated that HBO (100% O2) and HBA (21% O2/79% N2) were equivalent in protecting neurons after transient forebrain ischemia in the gerbil using 2.5 ATA. The role of a potential placebo effect was ruled out in this study and

demonstrates the activity of HBO and HBA in a neurologic injury model.

oxygen concentration and/or pressure is a medical intervention.

**8. The economic argument in favor of coverage**

The certainty that hyperbaric medicine begins with any increase in oxygen concentration and/or pressure is further substantiated by on-going work at the University of Wisconsin [66]. Animal studies already show a significant increase in mobilized stem progenitor cells and decrease in Inflammatory cytokines when HBOT and HBAT (room-air) are applied at pressures as low as 1.2ata. Together these findings support the likelihood of biologic activity, consubstantial with HBOT, being activated at much lower dose of hyperoxia than previously postulated. Those results, coupled with decades of experiments by the US Navy and US Air Force [67], demonstrate that the Army's and UHMS's claims that hyperbaric medicine only occurs at pressures higher than 1.4ata are fallacious. Any increase in

The USAF TBI study used the Agency for Healthcare Quality and Research recommendations for future HBOT research for TBI. One pertinent comment was the following: "Whether placebo-controlled trials are necessary to evaluate HBOT has received a great deal of attention in discussions about HBOT. Participants on all sides of this debate make the assumption that an "evidence-based" approach implies devotion to double-blind, placebo-controlled trials without regard to practical or ethical considerations. This assumption is false. Double-blind, placebo-controlled trials are the "gold standard" for government regulators overseeing the approval of new pharmaceuticals, but not for clinical decision-making or insurance coverage decisions. Evidence-based clinical decisions rely more heavily on comparisons of one treatment to other potentially effective therapies, not to placebos." [68].

In what will be a ground-breaking analysis released on Veterans' Day, November

11, 2020, The TreatNOW Coalition, building on the seminal work done in 2011 [69], will update and expand the "true cost of ownership" to the American taxpayer of untreated brain injuries. Most studies attempting to estimate costs typically pay attention to the obvious cost categories – drugs, yearly health care costs, ER visits, hospitalizations, psychiatric care, home health care, long term care, lost wages, and sometimes even the impact on the family. TreatNOW has gone much further in

The Study looks at impact on the family in categories such as physical and mental damage to immediate family members, including children and care-givers; social services for children affected by turmoil; and spousal suicides occasioned by violence and abuse. Divorce, homelessness, drug abuse, incarceration, death-bycop, and the estimated 135 people seemingly affected with every suicide [70].

A major "cost" to society beyond the medical expenditures are the tax implications of taking a brain-wounded citizen out of the work force. In too many cases, that actually equates to two lost incomes and taxes because a care-giver is typically a

Brain Injury Facts about veterans are hard to pin down accurately since there are so much missing data. For example, the VA estimates that 70% of veterans are not part of the VA system. The VA also estimates TBIs alone for the period of 2000–2017 is over 414,000. RAND estimates that about one-third of all returning vets reported

examining the "ripple effect" through the family and into society.

**130**

full-time aide to the wounded.

Should further research be required before HBOT for TBI receives an indication, the Center for Medicare and Medicaid (CMS) issued Guidance for the Public, Industry, and CMS Staff, Coverage with Evidence Development, November 20, 2014 [71]. CMS and AHRQ declared that the principal purpose of the study would be to test whether the item or service (HBOT for TBI) meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects. Unsurprisingly, the data and the demographics support immediate use of HBOT.
