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For workers’ compensation purposes, approval of a medical device or treatment by the U.S. Food and Drug Administration (FDA) is not required to establish that it was reasonable and necessary; but the Wyoming Workers’ Compensation Division may nevertheless require a claimant requesting a non-FDA-approved medical device or treatment to produce reliable documentation of its safety and effectiveness against her specific medical condition. The Supreme Court of Wyoming held, therefore, that while implantation of non-FDA-approved artificial discs at adjacent levels of the injured worker’s lumbar spine was not an “off-label” use of medical services, substantial evidence supported the Medical Commission’s determination that the worker failed to provide sufficient documentation of the procedure’s safety and effectiveness, thus rendering it “alternative medicine” for which workers’ compensation benefits were properly denied. Here, the worker traveled to Germany to have spinal surgery because the procedure had not been approved in the United States.
Thomas A. Robinson, J.D., the Feature National Columnist for the LexisNexis Workers’ Compensation eNewsletter, is co-author of Larson’s Workers’ Compensation Law (LexisNexis).
LexisNexis Online Subscribers: Citations below link to Lexis Advance.
See In re Worker's Comp. Claim v. State ex rel. Dep't of Workforce Servs., 2018 Wyo. LEXIS 102 (Aug. 22, 2018)
See generally Larson’s Workers’ Compensation Law, § 94.02.
Source: Larson’s Workers’ Compensation Law, the nation’s leading authority on workers’ compensation law