Earlier this week, 25 health-care organizations proposed that the Health and Human Services Office of Inspector General adopt a new regulatory safe harbor from the Anti-Kickback Statute that would allow clinical trial sponsors to financially support patients to offset indirect or nonmedical costs associated with clinical trial participation, such as travel, parking, and lodging.
Indirect costs are nonmedical costs that the trial participant sustains in accordance with fulfilling trial participation requirements. These costs might include costs associated with travel, parking, lodging, childcare, and lost wages that the participant incurred because of attending appointments related to the clinical trial. The letter reads in part:
“In a 2024 study, 29% of clinical trial participants needed between $501 and $1,000 per month to compensate for trial-related expenses, 16% needed between $1,001 and $2,000 per month, and 18% needed more than $2,000 per month. Not all indirect expenses are equal, of course. According to the same 2024 study, travel-related expenses were the most frequently reported financial hardship stemming from cancer clinical trial participation, with almost 75% of participants reporting financial burdens as a result of traveling to receive trial treatment.”
“Also not surprisingly, those living in remote or rural areas had more than twice the risk of financial hardship compared to those traveling shorter distances, and this is exacerbated by the fact that patients who have low incomes may be more likely to live in areas with less health care or clinical trial resources, and thus be required to travel farther distances to a site that offers cancer clinical trials. For example, the 2024 study referenced above found patients with lower incomes traveled a mean of 238 miles to participate in a clinical trial, compared to just 49 and 43 miles for those with middle and high incomes, respectively. Not only is the risk of financial hardship higher in rural areas, but the risk of cancer itself is also higher. Rates of lung, cervical, and colorectal cancer are about 40%, 30%, and 20% higher, [respectively].”
