This author takes a look at a law governing hyperbaric access in North Carolina and its implications for wound clinics.
On Oct. 1, a bill entitled the “North Carolina Veterans Traumatic Brain Injury (TBI) and Posttraumatic Stress Disorder (PTSD) Treatment and Recovery Act” took effect in North Carolina.1 The law allows any veteran residing in North Carolina and diagnosed with traumatic brain injury or PTSD to receive hyperbaric oxygen therapy (HBOT) 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 Veterans Administration Medical Center (VAMC) hospital equipped with a hyperbaric chamber. Since no such capabilities exist within the North Carolina VA health system, the likely alternative is the civilian hospital setting. As is the case nationally, most hospital chambers reside within an outpatient wound clinic setting.
North Carolina wound care providers 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 several key questions that would need to be addressed, with evidence-based answers.
Will HBOT Help Traumatic Brain Injuries and PTSD?
It is presently unclear how much HBOT might help traumatic brain injury and PTSD. This uncertainty should be discussed during the informed consent process. Large treatment effects reported in mostly uncontrolled case series generated intense pressure on the federal government to broaden access for injured veterans.2-8 The Department of Defense (DOD) response was to fund several prospective, sham-controlled and blinded clinical trials, the findings of which became available beginning in 2012.9 Uniformly, these trials failed to replicate the encouraging results that prompted formal study.9-15
HBOT advocates have roundly criticized the DOD data, particularly in the context of what constitutes an effective sham exposure. One criticism directed at the sham profiles employed in these clinical trials was that even a modest degree of chamber pressure increase using air to “blind” sham patients was in some way therapeutic.16-18 One aspect of this argument included a study that found no improvement in either group at the completion of active intervention, although both groups had improved “more than one would have expected” at follow-up. Also criticized was the selection of hyperbaric chamber pressures, usually at odds with earlier reports that showed benefit. Trial authors vigorously defended their study designs and challenged a number of what they believed were ill-founded assumptions supporting the role of HBOT.18 This back and forth took the form of “Letters to the Editor” exchanges in medical journals and vigorous debate within academic and political spaces.19-27 A 2018 Department of Veterans Affairs “Evidence Brief” took something of a neutral view, in that it disagreed with both sides that evidence clearly points to one explanation over another.2 The VA added that the use of HBOT as an initial treatment does not appear warranted but suggested it might be reasonable for those who fail to respond to conventional treatment options.
Despite the above mentioned 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 prior to its use.1 It is perhaps understandable that layperson legislators have been prompted to act in this manner. After all, the patients in question were injured in the defense of our country and now suffer long-term injurious consequences. Providing something of a counterpoint to provision of care based upon political sentiments, one military veteran argued in the Sept. 23, 2019 issue of The Hill that VA treatments should be based on medical evidence, not political pressure.28
Is the Diagnosis of TBI or PTSD Established?
Providers should first confirm that a formal diagnosis of TBI or PTSD exists and has been documented within the patient’s medical record. Not only is this required in order to prescribe HBOT under the terms of this law; it is the necessary foundation to subsequent assessment any treatment effect.
What About Informed Consent for HBOT Treatment of TBI and PTSD Under This Law?
TBI and PTSD are not on the Food and Drug Administration’s (FDA) list of approved HBOT uses. By definition, therefore, they are off-label indications. While approved by the state, my recommendation is that patients are still consented for off-label indications. Many clinics use a separate consent form for this purpose, as they would for those referred with retinal artery occlusion or sensorineural healing loss.
What Is the Hyperbaric Dosing Protocol for TBI and/or PTSD?
This is yet another unknown. North Carolina law states that treatment “shall comply with standard approved treatment protocols for this therapy.”1 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 ATA. Exposure periods range from 60 to 90 minutes and considerable variation exists as to the treatment course. Providers will need to 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 a lack of efficacy. With a little solid guidance, then, 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 to 40 sessions.5
Who Will Pay for HBOT Under This North Carolina Law?
There appears no funding mechanism associated with this Act, suggesting that the state is not going to be on the hook for related charges.1 Medicare, Medicaid and commercial insurers do not consider HBOT medically necessary for TBI or PTSD, so HBOT 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 traumatic brain injury is not reimbursable for HBOT.29
It is improbable that hospital and physician providers will offer their services without charge. While some might be inclined to do so for an individual case, the incidence of TBI and PTSD (the “signature” injuries of the Middle East conflicts) is alarming. Some 350,000 veterans have been diagnosed with traumatic brain injury since 2000, according to the Defense and Veterans Brain Injury Center.30 Wound clinics could, therefore, be become overwhelmed. Patients are unlikely to have the financial means for what would likely be an expensive treatment course, given customary hyperbaric fee schedules. It is unlikely that most will be inclined to sign an Advance Beneficiary Notice. The bottom line here is that it is going to be an individual provider decision on how payment will be reconciled.
Dick Clarke is the President of National Baromedical Services in Columbia, SC.
1. North Carolina General Assembly. House Bill 50/SL 2019-175. Available at. https://www.ncleg.gov/BillLookUp/2019/H50.
2. Peterson K, Bourne D, Anderson J, et al. Evidence brief: Hyperbaric oxygen therapy (HBOT) for traumatic brain injury and/or post-traumatic stress disorder. VA Evidence Synthesis Program Evidence Briefs. 2018 Feb.
3. Harch PG, Kriedt C, Van Meter KW, et al. Hyperbaric oxygen therapy improves spatial learning and memory in a rat model of chronic traumatic brain injury. Brain Research. 2007;1174:120-129.
4. Wright JK, Zant E, Groom K, et al. Case Report: Treatment of mild traumatic brain injury with hyperbaric oxygen. Undersea Hyperb Med. 2009;36(6):391-399.
5. Harch P, Andrews S, Fogarty E, et al. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012;29(1):168-85.
6. Stoller KP. Hyperbaric oxygen therapy (1.5 ATA) in treating sports related TBI/CTE: two case reports. Med Gas Res. 2011;1(1):17.
7. Figueroa XA, Wright JK. Hyperbaric oxygen: B-level evidence in mild traumatic brain injury clinical trials. Neurology. 2016;87(13):1400-6.
8. Harch PG, Andrews SR, Fogarty EF, et al. Case control study: Hyperbaric oxygen treatment of mild traumatic brain injury persistent post-concussion syndrome and post-traumatic stress disorder. Med Gas Res. 2017;7(3):156-174.
9. Wolf G, Cifu D, Baugh L, et al. The effect of hyperbaric oxygen on symptoms after mild traumatic brain injury. J Neurotrauma. 2012;29(17):2606-12.
10. Cifu DX, Walker WC, West SL, et al. Hyperbaric oxygen for blast-related postconcussion syndrome: three-month outcomes. Ann Neurol. 2014;75(2):277-86.
11. Cifu DX, Hart BB, West SL, et al. The effect of hyperbaric oxygen on persistent postconcussion symptoms. J Head Trauma Rehabil. 2014;29(1):11-20.
12. Miller RS, Weaver LK, Bahraini N, et al. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. Jama Intern Med. 2015;175(1):43-52.
13. Cifu DX, Hoke KW, Wetzel PA, et al. Effects of hyperbaric oxygen on eye tracking abnormalities in males after mild traumatic brain injury. J Rehabil Res Dev. 2014;52(7):1047-56.
14. Hawkins JR, Gonzales KE, Heumann KJ, et al. The effectiveness of hyperbaric oxygen therapy as a treatment for postconcussion symptoms. J Sport Rehabil. 2017;26(3):290-294.
15. Crawford C, Teo L, Yang E, et al. Is hyperbaric oxygen therapy effective for traumatic brain injury? A rapid evidence assessment of the literature and recommendations for the field. J Head Trauma Rehabil. 2017;32(3):e27-e37.
16. Harch PG. Department of defense trials for hyperbaric oxygen and TBI: Issues of design and questionable conclusions. Undersea Hyperb Med. 2013;40(5):471-472.
17. Harch P. Hyperbaric oxygen therapy for post-concussion syndrome: Contradictory conclusions from a study mischaracterized as sham-controlled. J Neurotrauma. 2013;30(23):1995-1999.
18. Weaver LK, Cifu DX, Hart B, et al. Reply: Department of defense trials for hyperbaric oxygen and TBI: Issues of study design and questionable conclusions. Undersea Hyperb Med. 2013;40(5):469-470.
19. Hoge CW, Jonas WB. The ritual of hyperbaric oxygen and lessons for the treatment of persistent postconcussion symptoms in military personnel. JAMA Intern Med. 2015;175(1):53-4.
20. Marois P, Mukherjee A, Ballaz L, et al. Hyperbaric oxygen treatment for persistent postconcussion symptoms - A placebo effect. JAMA Intern Med. 2015;175(7):1239-40.
21. Hoge CW, Jonas WB. Hyperbaric oxygen treatment for persistent postconcussion symptoms - A placebo effect. JAMA Intern Med. 2015;175(7):1241.
22. Gottlieb SF. TBI study questioned. Undersea Hyperb Med 2017;44(1):81-82
23. Weaver LK, Lindblad As, Wilson SH, et al. TBI study questioned: Dr. Weaver response. Undersea Hyperb Med. 2017;44(1):83-85.
24. Gottlieb SF. TBI study questioned: Dr. Gottlieb’s response to Dr. Weaver. Undersea Hyperb Med. 2017;44(1):85.
25. Figueroa SA, Wright JK. Clinical results in brain injury trials using HBO2 therapy: Another perspective. Undersea Hyperb Med. 2015;42(4):333-351.
26. Armistead-Jehle P, Lee D. Response to the Harch group’s “A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder.” J Neurotrauma. 2012;29(15):2513-2515.
27. Harch PG, Andres SR, Pezzullo JC, et al. Response to the letter to the editor by Armistead-Jehle and Lee on Harch et al., A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrama. 2012;29(15):2516-2519.
28. Williams K. VA treatment should be based on evidence, not political pressure. The Hill. Available at https://thehill.com/opinion/healthcare/462542-va-treatment-should-be-based-on-evidence-not-political-pressure. Published Sept. 23, 2019.
29. Tricare. Available at https://tricare.mil/CoveredServices/IsItCovered/HyperbaricOxygenTherapy.aspx?sc_database=web .
30. The Defense and Veterans Brain Injury Center. Available at https://tbi.cemmlibrary.org/Resources/The-Defense-and-Veterans-Brain-Injury-Center.
31. Fife CE. Ethical issues in hyperbaric medicine. Today’s Wound Clinic. 2008; 2(4):3.