Is a Non-FDA drug or service authorized under FS 440 et seq
My workers compensation authorized treating doctor (ATP) has recommended a non-FDA approved experimental drug; however this has been denied by Worker’s Compensation — is this par for the course? The response to most legal questions is “it depends” and in this situation it truly does depend on several factors.
Pursuant to FS 440 et seq, compensable medical care does not include services or medication that are experimental, investigative in nature or part of a research project. However, an exception arises if the Department of Financial Services (DFS) gives prior approval. The Department must decide each situation on a case-by case basis as no two cases are alike. Keep in mind, prior to January 1994, this was the responsibility of the DFS however effective October 2003, the legislature repealed the exception noting that experimental or investigative services are not compensable.
Now the term “experimental” includes medical services, procedures, drugs, equipment, or supplies. These are considered experimental if their efficacy has not been proven for a particular diagnosis, or if their safety and validity is unclear or unknown. Likewise, the term investigative includes these same services and devices when they are known to be safe but their efficacy is still under investigation. Before denying a claim for medical treatment on the argument that the treatment is experimental or investigative the carrier must first refer the request for treatment to the Department of Financial Services.