The Family and Medical Leave Act (FMLA) offers eligible employees 12 weeks of unpaid, job-protected leave. Employees can take this leave for a variety of events, including the treatment of a serious illness. But does FMLA extend to seriously ill employees whose treatment is part of a clinical trial?
That’s the question the U.S. Department of Labor (DOL) answered in its most recent opinion letter. Below, we break down the Department’s answer and the reasoning behind it.
DOL: Eligible employees can use FMLA for clinical trial treatment
The biggest news from the opinion letter? Eligible employees are allowed to take FMLA leave to receive treatment that’s part of a clinical trial. To explain its decision, the DOL turns to long-standing FMLA regulations. Here’s what you need to know:
Key takeaway #1: Clinical trials count as “continuing treatment”
The law says that employees with serious health conditions can take FMLA leave to receive treatment, a term that includes examinations, evaluations, and, importantly, regimen of continuing treatment.
The FMLA defines this phrase — continuing treatment — very broadly, the DOL notes. Consider the examples the law uses in its definition: continuing treatment may entail prescription medication or therapy with specialized equipment. The regulations stipulate that continuing treatment generally surpasses routine physical examinations or over-the-counter medications.
The DOL notes that the treatment provided in clinical trials generally fits the FMLA’s definition of continuing treatment. Clinical-trial treatment usually involves prescription medication, special equipment, “or other significant interventions.”
Key takeaway #2: Voluntary participation doesn’t impact eligibility
The Labor Department adds that its interpretation of continuing treatment aligns with its earlier, “deliberate choice” to give the term “treatment” a broad definition.
When the DOL implemented the FMLA regulations in 1995, it had considered prohibiting leave for “voluntary treatments” that weren’t medically necessary. But it decided against this position, not wanting to encourage employers “to second-guess a health care provider’s judgment that a treatment is advisable… by questioning whether it is ‘necessary.’”
The Department’s wide interpretation of the term “treatment” makes room for employees who volunteer or elect to participate in a clinical trial. Their choosing to take part in the trial “is not a factor in the determination of whether an employee may take FMLA leave,” the DOL says.
Key takeaway #3: Treatment success is also irrelevant
A treatment’s status as new, experimental, or placebo should likewise have no effect on an employee’s eligibility for leave, the DOL says. Again, the Department reasons that the regulatory definition of treatment does not require a certain outcome.
In fact, the FMLA prohibits employers from looking into the effectiveness of a particular treatment in determining whether an employee can take FMLA to receive that treatment. Employers are only allowed to verify that an employee has a serious health condition that involves treatment. Even then, employers must come by that information through the appropriate certification process — “and only in response to an employee’s leave request,” the DOL notes.
The Department reminds employers that the FMLA is clear about what information employers can request from employees. Employees are not required, for example, to disclose specific details about their precise treatment plan.
How does this guidance play out in the workplace?
In its opinion letter, the Labor Department provides two hypothetical examples to illustrate how its guidance may play out in a real workplace. Consider the cases below:
Example #1: An employee wants to volunteer for a clinical trial
Let’s say you employ a person named Janelle, who has sarcoidosis, an autoimmune disease affecting her breathing. Janelle gets treated for sarcoidosis at least twice per year, which means she has a chronic serious health condition under the FMLA.
Janelle wants to volunteer in a clinical trial for sarcoidosis treatment. She is concerned, however, that doing so may require her to take off more work. Could she take FMLA leave to participate in the treatment?
According to the DOL, Janelle would be able to use FMLA leave to receive treatment in the clinical trial, assuming she meets all the other requirements for eligibility. She would also be able to take time off to recover from the treatment.
Key takeaway: Eligible employees may use FMLA leave to receive treatment for their serious illness via a clinical trial.
Example #2: An employee considers an experimental cancer drug
Now let’s say you employ a person named Bernard. Bernard has cancer, and he’s participating in a clinical trial for a new drug aimed at helping patients manage chemotherapy side effects.
Bernard does not know whether he has been prescribed the new drug or a placebo, and he’s concerned that may impact his ability to use FMLA leave. According to the DOL, Bernard can use FMLA leave intermittently for time spent receiving chemotherapy and participating in the clinical trial.
Key takeaway: Employers may not consider the effectiveness or outcome of an employee’s treatment in determining their eligibility for FMLA leave.
AbsenceSoft simplifies and streamlines FMLA management
When the DOL hands down guidance like this, it reminds leave managers just how complicated FMLA management can be. AbsenceSoft can help you manage FMLA requests simply, effectively, and compliantly. Our team of compliance experts stay on top of the DOL’s updates and other legislative changes so you never make a decision that’s out of step with the latest guidelines.
To learn how AbsenceSoft can streamline your FMLA management processes, schedule a demo today.