WASHINGTON, D.C. – Yesterday, the American Cancer Society Cancer Action Network (ACS CAN) was joined by 24 other organizations in proposing 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 non-medical costs associated with clinical trial participation, such as travel, parking and lodging.
Indirect costs are non-medical 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 as a result of attending appointments related to the clinical trial. The letter reads in part:
“In a 2024 study, 29 percent of clinical trial participants needed $501–$1,000 per month to compensate for trial-related expenses, 16 percent needed between $1,001 and $2,000 per month, and 18 percent 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 percent 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.”
Read the full letter here.
The following is a list of groups that signed the letter: American Cancer Society Cancer Action Network, American Association for Cancer Research, American Lung Association, American Society for Radiation Oncology, Association of American Cancer Institutes, Association for Clinical Oncology, Blood Cancer United, Color of Gastrointestinal Illnesses, Digestive Disease National Coalition, Fight CRC, Foundation for Sarcoidosis Research, Friends of Cancer Research, Global Liver Institute, International Myeloma Foundation, LUNGevity Foundation, Melanoma Research Foundation, National Brain Tumor Society, National Cancer Registrars Association, National Comprehensive Cancer Network, The National Pancreas Foundation, Oncology Nursing Society, Ovarian Cancer Research Alliance, Pennsylvania Prostate Cancer Coalition, Susan G. Komen, Triage Cancer.