December 23, 2024

DOL Issues Opinion Letters on Setting Regular Rate Under FLSA and on Covering Clinical Trials Under FMLA

On November 8, 2024, the U.S. Department of Labor (DOL) published its first two Opinion Letters for 2024. Opinion Letters are not binding on courts but are offered as a guide to how the DOL interprets fact situations offered by inquiring employers. The letters do not identify the inquiring parties and are published as guidance for all stakeholders. One of the letters addresses when daily expense payments can be excluded from an employee’s regular rate when calculating overtime pay under the Fair Labor Standards Act. (FLSA) The other letter addresses whether 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.

Opinion Letter FLSA2024-01: The Opinion Letter clarifies limitations on how an employer may exclude employee payments to offset expenses when calculating the regular rate of pay for overtime payment purposes. The conclusion is that excludable payment or reimbursement must be either the actual expense or a reasonably approximate amount of the actual expense. Under the FLSA, all non-exempt employees must be paid not less than one and one-half times the employee’s regular rate of pay for all hours worked beyond 40 in a workweek. As the term is applied under the FLSA, the regular rate is the average hourly rate calculated by dividing the total amount paid to an employee during a workweek by the total number of hours worked. Employers often stumble in making this calculation by failing to include all payments, including bonuses or other payments made to an employee during the workweek. Among the limited kinds of payments that the FLSA allows to be excluded from the calculation are reasonable payments for expenses incurred by an employee in furtherance of the employer’s interest, such as travel, use of personal equipment, or other expenses.

Opinion Letter FMLA2024-01-A: In this Opinion Letter, the DOL concludes that when all other FMLA eligibility requirements are met, it is permissible to use FMLA leave for voluntary participation in clinical trials. A serious health condition that involves either inpatient care or continuing treatment by a health care provider, including when such care or treatment consists of an individual’s voluntary participation in a clinical trial, qualifies the employee to use FMLA leave.

DOL’s example of when clinical trial participation could be covered by FMLA:

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.

Both Opinion Letters are linked on the DOL website: https://www.dol.gov/agencies/whd/opinion-letters/search.