The IAB concludes that regenerative medicine procedures, including orthobiologic injections, do not constitute “reasonable” or “necessary” treatment for a compensable lumbar spine condition.

The claimant injured her lumbar spine in a compensable work accident on January 7, 2019, while working as a bus driver for the State of Delaware. She came under the care of Dr. B. Rudin, an orthopaedic spine surgeon, and after she did not improve from therapy, medications or steroid injections, Dr. Rudin believed the only options for improvement were an expensive, two-level fusion surgery or the less costly/invasive options afforded by regenerative medicine/orthobiologic treatment. The claimant proceeded with the orthobiologic treatment procedures beginning in early 2020. The employer denied the treatment as not reasonable, necessary or causally related to the work accident based on the opinions of Dr. S. Rushton. The claimant filed a petition for payment with the Industrial Accident Board.

The Board concluded that the work accident aggravated the claimant’s preexisting, asymptomatic low back issues and that the condition remained causally related to the work accident. The Board felt that ongoing treatment of some kind was necessary, however, the option chosen did not satisfy either of the required “reasonableness” or “necessity” prongs for compensability. Dr. Rudin’s opinions were rejected for several reasons, including: (1) he testified in 2020 that orthobiologic/regenerative medicine/stem cell treatment for the spine was approved and waiting finalization to be included in the Delaware Practice Guidelines, but now conceded it was not approved or even under consideration at this time; (2) the “study” relied upon by Dr. Rudin to support his methodology was his own, involved 100 patients and was not subject to peer review; (3) he provided no information about the methodology of his “study”; (4) he was an owner of Spine Care DE, where the orthobiologics procedures took place; (5) he does not perform surgeries anymore, which was the other option for the claimant; and (6) it was just as likely that the claimant’s sudden and significant weight loss improved her symptomatology as her treatment.

The Board accepted Dr. Rushton’s opinions that there was a lack of scientific support for the methodology used by Dr. Rudin. Moreover, the Board emphasized that there were strong indications of bias from the claimant’s expert, commenting: “Dr. Rudin’s experience and the close nature of his relationship, financially and otherwise, to acceptance of this methodology cannot be ignored.” The treatment was not reasonable in the context of the claimant’s injuries, and the petition was denied.

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