ASTRO joined coalition partners sending a letter to HHS OIG supporting broader, more diverse participation in clinical trials. The Department of Health and Human Services (HHS) released an annual solicitation to “identify and develop safe harbors that protect beneficial and innocuous arrangements and safeguard Federal health care programs and their beneficiaries from the harms caused by fraud and abuse.” ASTRO joined 20 other coalition partners proposing a new regulatory safe harbor to the federal health care program anti-kickback statute. This proposed language would help ensure that indirect patient costs (those associated with travel, parking, lodging, childcare, lost wages, etc.) are offset without violating anti-kickback laws. People with cancer who can locate and join a clinical trial should not be penalized or prohibited from participation due to costs that, but for enrolling in the trial, they would not have incurred.

ASTRO strongly supports increased access to clinical trials, and by effectively eliminating a significant economic barrier to participation of diverse populations, we can ensure trial participation is representative of the U.S. population. With respect to people with cancer undergoing treatment and living in rural areas specifically, studies have shown that while these patients traditionally have had poorer treatment outcomes when compared to urban-dwelling counterparts, this disparity is erased when rural patients are enrolled in clinical trials. As HHS reviews all submissions, ASTRO will continue to support wider access and diversity in clinical trials and encourage HHS to adopt this common sense, patient-centered safe harbor to encourage trial participation.