Summary: The U.S. Department of Labor (DOL), under its Wage and Hour Division (WHD), recently released an opinion letter (WHD Letter) clarifying that leave under the federal Family and Medical Leave Act (FMLA) may be used by eligible employees for treatment of a serious health condition as part of a clinical trial.
Read on for more information.
FMLA Background
The Family and Medical Leave Act (FMLA) requires covered employers to provide eligible employees with up to 12 weeks of unpaid, job-protected leave for an eligible employee’s own serious health condition or to care for the eligible employee’s spouse, child, or parent with a serious health condition. Eligible employees may also take up to 26 workweeks of leave during a single 12-month period to care for a covered servicemember with a serious injury or illness, if the employee is the spouse, child, parent, or next of kin of the servicemember.
FMLA leave is also available for eligible employees to take time off work for the birth, adoption, or foster care placement of a child and to bond with the child.
Eligible Employees: Employees are eligible for FMLA leave if they work for a covered employer for at least 12 months, have at least 1,250 hours of service for the employer during the 12 months before the leave, and work at a location where the employer has at least 50 employees within 75 miles.
Covered Employers: Covered employers under the FMLA are those who employ 50 or more employees for 20 or more workweeks in the current or preceding calendar year, including joint employers or successors in interest to another covered employer.
Serious Health Condition is defined under the FMLA as an illness, injury, impairment, or physical or mental condition that involves either inpatient care or continuing treatment by a health care provider.
WHD Letter
Background: This WHD Letter was released on November 8, 2024, in response to a request for clarification from an organization dedicated to finding a cure for a long-term, severe disease through participation in clinical trials. The organization noted that concern around taking time off work is a “significant barrier” to participation of underserved and under-resourced patients.
As referenced in the WHD Letter, a clinical trial is a “research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.”[1]
Broad Definition of Treatment: The WHD Letter noted the broad definition of “treatment” under FMLA and confirmed that the medical interventions typically involved in clinical trials are similar to the examples provided in the definition, such as prescription medication, equipment, or other significant interventions.[2] The fact that treatment in clinical trials may be experimental, or involve the use of placebos, does not matter for “treatment” purposes under FMLA since there is no requirement in the definition that the treatment “meet a certain level of efficacy or that it achieves a certain result.”
Although treatment provided during a clinical trial may be considered optional, voluntary, or elective, the WHD Letter confirmed that these elements should not be considered when determining if an employee may take FMLA leave to receive treatment. In a similar vein, the DOL determined that a course of treatment can be new, experimental, a placebo, or not proven to meet certain criteria for efficacy, and still be considered “continuing treatment” under the FMLA.
Medical Certification: The WHD Letter further noted that the FMLA regulations “neither require nor permit an employer to inquire into the effectiveness of a particular treatment for purposes of determining whether an employee may take FMLA leave to receive that treatment.” Employers may verify that an employee has a serious health condition that involves treatment through the medical certification process[3], and an employee is not required to disclose specific details about prescribed medication or their precise treatment plan.
Family Members/Covered Servicemembers: FMLA leave may also be taken to care for a family member with a serious health condition, and FMLA military caregiver leave may be taken to care for a covered servicemember, when the person being cared for is participating in a clinical trial.
Illustrative Examples in the WHD Letter include the following:
- Janelle has sarcoidosis, an inflammatory autoimmune disease that affects her breathing. Janelle receives treatment for sarcoidosis at least twice a year and 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.
Employer Takeaways
While this WHD Letter is generally limited to the facts presented here, it does provide valuable and instructive guidance for employers as they navigate FMLA requests from employees, particularly when a request involves participation in treatment for a serious health condition as part of a clinical trial.
Covered employers who outsource FMLA administration to an external vendor are advised to confirm that their vendor is aware of, and complying with, the guidance detailed in this WHD Letter.
Risk Strategies is here to help. Contact your Risk Strategies account team with any questions or contact us directly here.
[1] https://www.nih.gov/health-information/nih-clinical-research-trials-you/glossary-common-terms#clinicaltrial
[2] See 29 C.F.R. § 825.113(c).
[3] See 29 C.F.R. § 825.306.
