New And Emerging CMS Policies: Medicaid's New Clinical Trial Policy

By Jake Meyer, Senior Manager of Business Operation Services

In April 2022, the Centers for Medicare & Medicaid Services (CMS) took a significant step forward by releasing a letter that outlined routine costs associated with clinical trials, particularly focusing on patients eligible for Medicaid. Notably, the letter also highlighted expanded coverage options tailored to pediatric patients. Despite this promising development, a year has elapsed without any subsequent updates on the matter or any advancements in the enrollment of Medicaid beneficiaries in clinical trials.

Without the proper guidance, it becomes imperative for institutions to proactively prepare for the changes that could arise from the letter's implications. In addition, the landscape of clinical trials is constantly evolving, making a solid understanding of the new guidelines crucial for ensuring smooth transitions and maximizing benefits for both patients and research organizations.

In this article, the author explores the key considerations your institution should take into account to best navigate this impending change and what should be anticipated for the future of clinical trial enrollment for Medicaid beneficiaries.