The U.S. Department of Labor (DOL) issued DOL Opinion Letter FMLA2024-01-A on November 8, 2024. The Opinion Letter clarifies that eligible employees may take leave under the Family and Medical Leave Act (FMLA) when "continuing treatment" of a serious health condition includes participation in a clinical trial.
The FMLA provides up to 12 weeks of protected leave time for treating serious health conditions and other family and health-related reasons. Generally, employers with 50 or more employees must permit FMLA leave and continue to provide coverage under their group health plans. Employees must work for the employer for at least a year and work a certain number of hours in 12 months to qualify for FMLA leave.
According to the DOL, the FMLA broadly defines "treatment" to include medical interventions that may be unsuccessful for some patients. Likewise, the statute provides an expansive definition of "continuing treatment" to include ongoing prescription medication or therapy necessitating special equipment. Since clinical trials typically involve prescription medication, equipment, or other medical interventions, they qualify as "continuing treatment," regardless of their effectiveness.
The DOL also reiterated that employers should not attempt to substitute their judgment for that of an employee's medical provider when it comes to treatment. As a result, employers should assume that participation in clinical trials is a permissible use of FMLA leave by eligible employees.
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