FMLA covers serious health conditions. But what about clinical trials for serious health conditions?

Earlier this month, the U.S. Department of Labor issued an opinion letter concluding that, under certain circumstances, an employee may use leave under the Family and Medical Leave Act (FMLA) to treat a serious health condition when treatment is provided as part of a clinical trial.

Let’s explore why.

Actually, before we do that, let’s define some terms:

• 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.
• A serious health condition is an illness, injury, impairment, or physical or mental condition involving inpatient care in a hospital, hospice, or residential medical care facility or continuing treatment by a health care provider. A serious health condition involving continuing treatment by a health care provider includes health conditions involving incapacity and treatment, pregnancy or prenatal care, chronic conditions, permanent or long-term conditions, and conditions requiring multiple treatments.
• Treatment includes (but is not limited to) examinations to determine if a serious health condition exists and evaluations of the condition. A regimen of continuing treatment includes, for example, a course of prescription medication (e.g., an antibiotic) or therapy requiring special equipment to resolve or alleviate the health condition (e.g., oxygen). In contrast, treatment does not include routine physical examinations, and a regimen of continuing treatment does not include standing alone, taking over-the-counter medications, or activities such as bed rest that can be initiated without a visit to a health care provider.

These definitions are pretty broad, aren’t they? That’s intentional because most employers aren’t medical professionals and shouldn’t be second-guessing health care provider advice. Indeed, the DOL likened the medical interventions generally involved in clinical trials to treatment often involving prescription medication, equipment, or other significant interventions.

Hold up! Is voluntary treatment consistent with medically necessary FMLA leave? Sure, after all, all treatments and surgery are voluntary. No one is forced to go to the doctor.

But clinical studies may be experimental. Shouldn’t that count for something? No, because the FMLA regulations do not require that the treatment be effective or achieve a certain result.

The DOL provides an example of a man with cancer participating in a clinical trial for a new drug intended to help patients manage side effects from chemotherapy. He meets the FMLA eligibility criteria, even if he receives a placebo, and may use FMLA leave intermittently for time spent receiving chemotherapy and participating in the clinical trial, including recovery time.

“In summary,” writes the DOL, “treatment for a serious health condition that is rendered as part of a clinical trial can be a qualifying reason for FMLA leave.”