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
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
Responding to Mr. Clarke’s timely post on NC Law. Actually, NC is the seventh state to pass legislation calling for the use of Hyperbaric Oxygen Therapy for TBI/PTSD [OK, TX, IN, KY, AZ, FL, NC and a Resolution to the same effect in LA]. Here are some clarifying points to put the use of HBOT in the proper context: we are in the midst of a suicide epidemic and the States seek to do what the DoD and VA will not.
1. We face epidemics, admitted by DoD/VA/CDC, of: suicide; TBI; mental health; prescribed drug overdoses; violence against families and friends of brain-wound veterans; sexual abuse; female service member suicides.
2. The rules when facing an epidemic are: early detection, early response. In short, there is nothing close to appropriate response being performed with respect to the service member suicide epidemic, which DoD this week increased to 21 per day. The lack of a sense of urgency, coupled with active and passive resistance to hyperbaric oxygenation, keeps brain-wounded veterans and active duty military in the dark about a non-invasive, drug-free safe and effective intervention with remarkable success.
3. Compound the suicide epidemic with more fine-grain articulation of the suicide numbers across all Services:
• In 2018, active duty Army suicides reached a five-year high;
• suicide among active-duty Marines reached an almost 10-year high;
• active-duty Navy suicides hit a record high;
• USAF suicides highest ever;
• Special Operations Suicides continue to rise;
• For each year, from 2005 to 2017, Veterans with recent VHA use had higher suicide rates than other Veterans;
• The 2017 rate of suicide among women Veterans was 2.2 times the rate among non-Veteran women.
4. HBOT is a proven suicide prevention therapy as it reduces and/or eliminates suicide ideation associated with TBI/PTSD, and selected medications used to treat some of the common symptoms of these injuries.
5. The nation has registered alarm about suicides and declared SUICIDE PREVENTION as the major interest, both in DoD and the VA. Yet they WILL NOT USE A PROVEN SUICIDE PREVENTION TOOL, HBOT. A comprehensive approach to Veteran suicide prevention is the President’s Roadmap to Empower Veterans and End the National Tragedy of Suicide (PREVENTS), mandated by an executive order signed by the President in March 2019. A 365-day task will develop a national roadmap for suicide prevention, which will include proposals and plans addressing integration and collaboration across sectors, a national research strategy, and a cohesive implementation strategy. Treatment without HBOT continues, while “prevention” is a concept that includes “suicide standdowns” to talk about techniques to recognize and intervene, but not to treat.
6. Dozens of Special Operators, and thousands of veterans, have sought out HBOT treatment and all who completed 40 dives show significant medical improvement. SpecOps warriors have been kept on active duty when they were about to be medically separated, and almost all have been treated WITHOUT KNOWLEDGE OF THEIR COMMAND for fear of retribution. Veterans have been warned about losing benefits if they try HBOT.
7. Interventions used in DoD and the VA have led to the deaths of thousands of active duty and veteran brain wounded. NO ONE HAS DIED when being treated with HBOT under normal protocols.
8. More and more research $$$ for long-term studies of TBI/PTSD that are the equivalent of studying untreated brain injuries WHEN WE HAVE A TREATMENT THAT THEY WILL NOT USE OR EVEN TALK ABOUT, EVEN GOING SO FAR AS TO PUNISH THOSE WHO TRY IT.
9. DOD/VA/Army conducted HBOT studies producing DATA that show HBOT works: it is safe and effective.
10. The VA continues to insist that HBOT DOES NOT WORK despite comments within their own ranks that their conclusions are WRONG and that HBOT is safe and effective and should be used.
11. Worldwide research, including the USGovernment’s own studies, confirm that HBOT is safe AND effective and cost-efficient.
12. Business as usual affects over 800,000 post-9/11 wounded [and an equal number of Vietnam veterans] and their families while BILLIONS of $$$ are expended on drugs and fruitless psychological and other unproven interventions.
13. The cost to the wounded: interminable wait times, mis-diagnoses, drugs and semi-permanent welfare status, families in crises, wives with secondary TBI/PTSD, and degraded quality of life in the ripple effect through families and society.
14. The cost to the nation: 21+ suicides a day, hollowing out of Special Operations forces, $60,000 cost/per year for each untreated brain injury, and corrosive effects of wounded who are told: “There is no treatment to help you, only psychopharmacology and cognitive psychotherapy.”
15. Yet an active treatment does exist: Hyperbaric Oxygen Therapy when used by the TreatNOW Coalition and multiple clinics across the US and world. We have peer-reviewed positive scientific and clinical evidence in over 6,100 cases.
16. “Informed consent” and the rules of medical ethics are violated when a treatment is withheld, not talked about, and denied to patients. They will not discuss, except negatively, a drug-free treatment that returns patients to a life denied them by DOD/VA/Army. Case in point, HBOT has been FDA approved since 2003 for successfully treating diabetic foot ulcers. The VA amputated over 9,000 limbs in 2018, 75% related to diabetic health issues. 80% of diabetic amputees die within 5 years. The VA has refused to treat with HBOT while allowing our veterans to die when an FDA approved HBOT protocol could save their lives.
17. EIGHT states have passed laws or Resolutions [OK, TX, IN, KY, AZ, FL, NC, LA] calling for use of HBOT for brain-wounded veterans with TBI/PTSD.
18. For the fifth time, Congress has proposed legislation to demand the VA use HBOT for TBI/PTSD.
19. The VA retorts that HBOT is too risky, too expensive, and unproven.
20. VA researchers continue to insist that they are going to “put the final nail in the coffin of HBOT.” At the same time, those same hired researchers assert that HBOT is a healing environment; that everyone in their studies showed significant medical improvement; and that HBOT studies have produced enough scientific data to validate its use against TBI and PTSD.
21. The VA started a Pilot Demonstration project, now in 5 sites, watching the use of HBOT for PTSD/TBI. All treated patients have shown significant medical improvement. The VA cannot or will not talk about how long the Pilot will last or what they will do once they discover, again, that HBOT is safe, effective, and is recommended by their own researchers as safe and effective. In two years, at four sites, the VA has treated a total of 12 veterans, all successfully. The protocol to be accepted into the program was made so difficult, cumbersome, and bureaucratic, only 12 qualified. During the same time period, hundreds of veterans have been treated in private clinics across the US.
22. The White House signed legislation, the MISSION ACT, that extends insured coverage to veterans and service member who go outside the DoD/VA medical systems for treatments NOT AVAILABLE inside the system. HBOT is not available within the system. Thousands of HBOT treatments for insured indications are performed every day outside military and VA facilities. No one has died in those treatments and data show HBOT is used routinely, safely and effectively. Invoices are paid because of the effectiveness of those treatments.
23. The NFL and the NCAA brag of a Concussion Protocol that does nothing to heal the wound to the brain. It is all about “watchful waiting,” rest, reaching milestones and hoping symptoms go away.
24. Dr Daphne Denham, MD out of Fargo ND and Chicago, IL demonstrated (http://bit.ly/2jwdUwI) that patients (348 out of 350) diagnosed with acute concussions completely resolved her/his symptoms in five or less treatments (average of 2.4 treatments per concussion). That’s back in school symptom-free, within a week, sometimes over the weekend. You can learn more about this by viewing a short film entitled “Concussion Help in a Hyperbaric Chamber?” https://tinyurl.com/ybldktqn.
25. Simple justice demands that HBOT be made available to brain wounded. NOTHING currently is use is approved for use with TBI; all is experimental. Yet the single brain-healing treatment, HBOT, is not made available.
26. Additionally: HBOT can be viewed as a first line defense against suicide and opioid overdose and death: all treated patients get off almost all their drugs and they quit thinking about suicide. Based on evidence, HBOT can be considered a preventative to suicidal ideation and a successful intervention for substance abuse. Pain and time to withdrawal are reduced up to 50% when HBOT is used.
A research shows that hyperbaric treatment heal brain injuries faster. In hyperbaric chamber huge amount of oxygen flows enhances our tissue function and helps our bodies fight e.g. infection that’s been slowing down our healing.
this is very informative and helpful for us planning to get this treatment.