Coverage with Evidence Development Requirements Position Statement

Recognizing that the results of randomized controlled clinical trials are often not available to prospectively inform coverage decisions governing emerging radiation therapy modalities or techniques, ASTRO supports the concept of Coverage with Evidence Development (CED). Radiation therapy provided for patients treated under the CED paradigm should be covered by the insurance carrier provided the patient is enrolled in either an IRB-approved clinical trial or in a multi-institutional patient registry adhering to Medicare requirements for CED.

In this context, ASTRO defines a clinical trial as a formal investigation that is hypothesis-driven and has defined objectives and eligibility criteria. A trial is approved and monitored by an Institution Review Board (IRB), and patients provide informed consent to participate.

A registry is defined as data collected that is intended to provide information for quality improvement in the management of patients with a particular clinical condition. A patient registry suitable for CED should gather data from multiple institutions. A registry owned and/or managed by an individual should not be considered a valid registry for CED. It is expected that the data will be reviewed periodically, typically at least once per year, to assess clinical outcomes and explore potential connections between clinical or treatment parameters and subsequent quality of patient outcome.

The CED window for a given treatment should close once accumulated clinical trial and/or registry data have been reported in peer-reviewed publications to permit an informed coverage decision.