In 2005, the Centers for Medicare and Medicaid Services introduced the Coverage with Evidence Development (CED) paradigm that requires Medicare patients to enroll in a CMS-approved CED clinical study as a condition of coverage for that product or service. Although CED has never been explicitly authorized by Congress, over the years, CED has been employed 27 times across 8 therapeutic areas, with 20 remaining CED policies in place for over 15 years, and with little indication from CMS on the conclusion of its CED data-collection progression.

While these CED requirements remain in place, patients and providers face increased burden to obtain coverage, potentially limiting patients’ access to life-saving treatments. The implications of CED are additional administrative, financial, and operational costs to healthcare providers (HCPs) to enroll patients in CED studies and facilitate data collection and monitoring to fulfill the CED requirements. Coverage for CED-restricted products or services is limited to patients willing and able to participate in CED-approved studies and who have access to a provider willing to do the same. This undue burden placed on patients disproportionately affects rural, lower-income, and lower-resourced communities, leading to widening gaps in healthcare disparity and delayed initiation to appropriate treatment for many patients.

This paper aims to provide insights into the burdens and challenges associated with CED studies and draws from survey findings with HCPs and in-depth interviews with HCPs, patients, and policy experts who have experience with CED. In addition, should CMS continue to move forward with this paradigm, this paper offers recommendations on how the CED process must be improved to ensure it operates for the benefit of patients without limiting factors.