The Wyoming Supreme Court issued a ruling that says that a medical device or treatment does not necessarily have to be approved by the United States Food and Drug Administration (FDA) for it to be deemed “reasonable and necessary” for workers’ compensation purposes. Still, the Wyoming Workers’ Compensation Division may require a claimant who requests such a device or treatment to produce reliable documentation of its safety and effectiveness against their specific condition. In the case at hand, the cost of the alternative device implanted into an injured worker did not need to be paid by her employer because she could not provide sufficient evidence of its safety and effectiveness, so the court determined it was an alternative treatment and did not qualify for workers’ comp.

Linda Harborth worked for the Powder River Coal Company as a driller at the Caballo Mine. She suffered a compensable injury to her thoracic and lumbar spine in 2006. She was able to work while she treated the injury with physical therapy and chiropractic manipulation, but her treatments were not working so she underwent a hemilaminotomy and discectomy in 2009. Her pain returned and her surgeon recommended a laminectomy. She got a second opinion from Dr. Sharad Rajpal who recommended a foraminotomy and TLIFs. That surgery would cost $400,000 and after peer review of the proposed surgery it was preauthorized. Harborth was apprehensive about the surgery because of post-surgery quality of life. It was not recommended that she return to work afterwards. After doing research she discovered a German orthopedic surgeon who performed artificial disc replacement surgery with an M6 artificial disc, which is approved in many other countries but not the United States. She thought having this surgery instead would allow her to continue working. She traveled to Germany to have the surgery, which cost $61,000. The Workers’ Comp Division approved the physician, Dr. Ritter-Lang, as her new provider but told her all bills would be reviewed. She paid out of pocket and had the surgery. The Division denied her compensation, saying it was not a reasonable and necessary medical treatment.

The Medical Commission affirmed their denial because she could not prove that the surgery was reasonable and necessary, therefore the M6 device was noncompensable as alternative medicine. She couldn’t provide evidence that it was necessary.

Read the full case here.