August 23, 2023

ACR Submits Comments About CMS Proposed Coverage With Evidence Development Guidance Document

The American College of Radiology® (ACR®) submitted comments in response to the Centers for Medicare and Medicaid Services (CMS) proposed Coverage with Evidence Development (CED) guidance document. ACR strongly supports updates to factors CMS considers in making National Coverage Determinations (NCDs) using the CED framework to provide more predictable and transparent evidence development. Additionally, CMS must ensure a clear pathway from CED to a coverage determination.

To encourage innovation and accelerate beneficiary access to new items and services, CMS published the proposed guidance document. CED provides an opportunity for beneficiaries to participate in medical research for promising treatments before there is adequate evidence for Medicare coverage under the reasonable and necessary statute. The proposed guidance describes the history of CED and establishes principles for CED studies that are supported by the Agency for Healthcare Research and Quality.

ACR participated in the February Medicare Evidence Development and Coverage Advisory Committee public meeting to examine general requirements for clinical studies submitted for CMS coverage under CED. The College will continue to track and monitor Medicare coverage activities.

If you have questions regarding NCDs, contact Alicia Blakey, ACR Principal Economic Policy Analyst.