On November 8th, the U.S. Department of Labor’s (DOL) Wage and Hour Division issued an opinion letter (FMLA2024-01-A) stating the DOL’s position on the use of leave by employees under the Family and Medical Leave Act (FMLA) for participation in clinical medical trials. Specifically, the DOL opined that the FMLA’s scope and purpose mandates that FMLA qualifying employers must provide FMLA leave for FMLA eligible employees if requested as part of participation in clinical trials. This is significant for employers, as this opinion letter clarifies the scope of permitted uses of FMLA leave to include medical interventions provided as part of clinical trials, regardless of whether the treatment is experimental or involves placebos.
The DOL letter provides two illustrative examples of how this works:
- Janelle has sarcoidosis, an inflammatory autoimmune disease that affects her breathing. Janelle receives treatment for sarcoidosis at least twice a year and, as such, the condition qualifies as a chronic serious health condition under the FMLA. Janelle meets the FMLA eligibility criteria. Janelle is interested in volunteering to participate in a clinical trial for the treatment of sarcoidosis but is concerned that if she changes her current treatment plan the amount of time she needs to take off work may change. Under the FMLA, Janelle may use FMLA leave to receive treatment in the clinical trial and recover from treatment, including if there are changes in treatment or in her response to treatment due to her participation in the clinical trial.
- Bernard has cancer and is participating in a clinical trial for a new drug intended to help patients manage side effects from chemotherapy. Bernard meets the FMLA eligibility criteria. In the clinical trial, Bernard does not know whether he has been prescribed the new drug or a placebo. Bernard may use FMLA leave intermittently for time spent receiving chemotherapy and participating in the clinical trial, including recovery time.
Considering the sheer number of clinical trials that are taking place across the country at any given point in time, the DOL’s opinion letter is pretty big news in terms of the business community’s leave of absence obligations for employees who opt to become part of one of those trials. Here are some of the main takeaways to consider:
- Employees still have to qualify for FMLA leave in order to receive it as part of a clinical trial, including having worked a year of service and at least 1,250 hours during that year of service.
- The DOL opinion letter broadly defines “treatment” to include courses of treatment that are unproven, experimental, optional, and voluntary. However, this should not extend so far as to cover elective cosmetic procedures (e.g. plastic surgery) which are generally not deemed a qualifying “serious health condition” under the FMLA.
- Employers may not ask about the effectiveness of a treatment, the specific medications prescribed or the detailed treatment plan when determining if an employee is eligible to take FMLA leave for a medical trial. The certification process for FMLA leave remains unchanged. Employers may only verify that an employee has a serious health condition requiring “treatment” by a healthcare provider when responding to a leave request.
- The DOL opinion letter also indicates FMLA leave should be offered for situations in which the employee is caring for a qualifying family member with a serious health condition, or taking FMLA military caregiver leave to care for a covered service member, when the person being cared for is participating in a clinical trial.
Identifying, tracking, and administering FMLA leave is a tricky area for human resources professionals and is fraught with technical compliance issues that can be hard to navigate. The DOL’s November 8 opinion letter has added another wrinkle to that complicated job. So, be sure to keep all of this new information in mind, and if you have any management-side FMLA questions or concerns that need to be addressed, the Labor and Employment Practice Group at Crowe & Dunlevy is ready to help.