What does "off-label" mean?


Our soft-sided chamber fully inflated with the protective dark blue sleeve  on.
Our soft-sided chamber fully inflated

Here at Iowa HBOT, we offer “off-label” hyperbaric oxygen therapy. The term “off-label” may sound sort of strange. According to the FDA, there are 14 recognized and approved conditions for which HBOT can be utilized. These are considered “on-label” conditions.


For clarification, here are the 14 FDA-approved conditions for HBOT:

  • Air or Gas Embolism

  • Carbon Monoxide Poisoning

  • Clostridial Myositis and Myonecrosis (Gas Gangrene)

  • Crush Injuries, Compartment Syndrome and Other Acute Traumatic Ischemia

  • Decompression Sickness

  • Arterial Insufficiencies, such as Central Retinal Artery Occlusion

  • Severe Anemia

  • Intracranial Abscess

  • Necrotizing Soft Tissue Infections

  • Osteomyelitis (Refractory)

  • Delayed Radiation Injury (Soft Tissue and Bony Necrosis)

  • Compromised Grafts and Flaps

  • Acute Thermal Burn Injury

  • Idiopathic Sudden Sensorineural Hearing Loss


Internationally, however, there are 140+ recognized and approved conditions in which HBOT is utilized - what a difference! These “off-label” uses are the focus of our mission at Iowa HBOT.


Research and “off-label” uses of therapies:


In our healthcare system, pharmaceuticals can be utilized in an off-label fashion. And in fact, this is quite common. Off-label use often then triggers greater research, leading to FDA approval for that use.


Current research is showing that hyperbaric oxygen therapy may help in a significant number of conditions. And it is this research that patients are using to help inform their decision about when and how to utilize hyperbaric treatments. Research on the many off-label conditions that may benefit from HBOT treatments can be found here: https://www.iowahbot.com/research.


“Off-label” implications for insurance coverage


Iowa HBOT will be offering treatments for off-label uses only. Categorically, this means that our tanks are not covered by health insurance, Medicare, or Medicaid, which is why we use the term “off-label”. We hope that this process will change as hyperbaric therapy becomes more widely known and accepted. We do accept cash, check, HSA/Flex dollars, and credit cards.


It is not that on-label treatments are right and that off-label treatments are wrong; it may just be that the health care system hasn’t yet approved these new symptoms/diagnoses for which hyperbaric treatments can be utilized. Therefore, we look forward to seeing more research so that even more patients can access hyperbaric treatments.


To schedule an appointment, contact us at 515-421-4002.


And as always, our disclaimer exists and is relevant to this discussion:


Disclaimer: This website does not provide medical advice.

The information, including but not limited to, text, graphics, images and other material contained on this website are for informational purposes only. No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.