Clinics in Fort Worth, Texas

FDA clears hyperbaric chambers as Class II medical devices under 21 CFR 878.5550. FDA has approved hyperbaric oxygen therapy for 14 specific indications aligned with the Undersea and Hyperbaric Medical Society (UHMS). Use for those indications is evidence-based and generally covered by Medicare and commercial insurance when documentation supports medical necessity. Any use outside the 14 approved indications is considered off-label and is not FDA-approved. FDA issued consumer updates in 2013 and again in 2021 warning patients and providers against marketing HBOT for unapproved conditions such as autism, cancer, Alzheimer disease, and long COVID.

• Texas Medical Practice Act (Texas Occupations Code Title 3, Subtitle B)
  Governs physician scope, delegation, and advertising standards applicable to HBOT in Texas.
• NFPA 99 Chapter 14 (adopted by state fire code)
  Sets facility safety requirements for hyperbaric chamber operation.

The Texas Medical Board investigates advertising complaints under 22 TAC 164. The Texas Health and Human Services Commission licenses healthcare facilities. CMS MAC Novitas adjudicates Medicare HBOT claims in Texas and has pursued overpayment recoveries for HBOT billed outside covered indications. The Texas Attorney General enforces the Deceptive Trade Practices Act against deceptive medical advertising. Texas has been a focal state for DOJ HBOT enforcement.