Guest blog post by Dick Clarke of National Baromedical Services
On August 1 of this year, a bill entitled the “North Carolina Veterans Traumatic Brain Injury (TBI) and Posttraumatic Stress Disorder (PTSD) Treatment and Recovery Act” (House Bill 50 / SL 2019-175) became law in North Carolina and took effect October 1, 2019.
The law allows any veteran residing in North Carolina and diagnosed with TBI or PTSD to receive hyperbaric oxygen therapy within the state. Although North Dakota, California, Florida, Oklahoma and Texas have recently introduced similar “hyperbaric access” measures, North Carolina’s situation is different, hence the dilemma. In the aforementioned states, eligible veterans will receive treatment at a hyperbaric chamber-equipped Veteran’s Administration Medical Center (VAMC) hospital. Since no such capabilities exist within the North Carolina VA health system, the likely alternative is the civilian hospital setting. North Carolina hyperbaric practitioners are starting to seek guidance as to how they should proceed in the event such patients present at their wound clinic with expectation of treatment.
To help practitioners, here are key questions that would need to be addressed, with evidence-based answers.
1. Will HBO help TBI and PTSD?
It is presently unclear how much HBOT might help TBI and PTSD. This uncertainty should be discussed during the informed consent process. The Department of Defense (DOD) funded several prospective, sham-controlled and blinded clinical trials, the findings of which became available beginning in 2012. Uniformly, these trials failed to replicate the encouraging results that prompted formal study. Advocates for the use of HBOT in these conditions have roundly criticized the DOD data for reasons that I will review in an upcoming Today’s Wound Clinic article. Despite the controversy, the law in North Carolina requires that HBOT be provided to these individuals and does not stipulate whether or not any prior therapies must have been employed.
2. What about informed consent for HBOT treatment of TBI and PTSD under this law?
TBI and PTSD are not on the FDA’s list of approved HBOT uses. By definition, therefore, they are off-label indications. While approved by the state, the recommendation is that patients still be consented for off-label indications.
3. Is the diagnosis of TBI or PTSD established?
Providers should first confirm that a formal diagnosis exists and has been documented within the patient’s medical record.
4. What would be the hyperbaric dosing protocol for TBI and/or PTSD?
NC law states that treatment “shall comply with standard approved treatment protocols for this therapy.” In the context of TBI and PTSD, there are no standard approved treatment protocols. Published data involves chamber pressures of either 1.2, 1.5, 2.0 or 2.4 atmosphere’s absolute (ATA). Exposure periods range from 60-90 minutes, and considerable variation exists in treatment course. Providers will have be guided by their interpretation of prevailing data and this, as suggested, is no easy task. To offer any sort of recommendation would be at odds with prevailing high quality evidence that has demonstrated lack of efficacy. Providers might choose a protocol associated with a study that purported to show benefit. An example would be 1.5 ATA oxygen for 60 minutes for 30-40 sessions.
5. Who will pay for HBOT under this North Carolina law?
Possibly no one. There appears no funding mechanism associated with this Act, suggesting that the state is not going to be on the hook for related charges. Medicare, Medicaid and commercial insurers do not consider HBOT medically necessary for TBI or PTSD, so it is not reimbursable. The same applies to TRICARE, the health insurance program for uniformed service members and retirees. In fact, TRICARE specifically states within its hyperbaric oxygen coverage policy that TBI is not reimbursable.
National Baromedical Services
Columbia, South Carolina