November 05, 2020

ACR Submits Comments on Medicare Coverage Proposed Rule

On Monday, Nov. 2, the American College of Radiology® (ACR®) responded to a proposed rule on Medicare Coverage of Innovative Technology (MCIT) and the definition of “reasonable and necessary” used to make Medicare local and national coverage decisions. In the rule, the Centers for Medicare and Medicaid Services (CMS) proposed a MCIT pathway that would provide immediate national coverage for breakthrough devices. Coverage would begin on the date of United States Food and Drug Administration (FDA) market authorization and continue for up to four years, unless CMS determines the device does not have a Medicare benefit category as determined by CMS. In the comment letter, the ACR urged CMS to be transparent and allow opportunity for public feedback on MCIT decisions. Specifically, the ACR suggested that CMS provide public notice and an opportunity for public comment prior to accepting a device under the MCIT pathway; and requested that CMS work with the FDA to maintain up-to-date lists of all devices being considered under the Breakthrough Devices and MCIT programs.

In addition, CMS proposed the addition of consideration of commercial health insurer coverage in the definition of “reasonable and necessary” that is used in both the national and local coverage determination processes. A commercial market analysis would be initiated if an item/service fails to fulfill the existing criteria but fulfills safe and effective and not experimental or investigational criteria. The ACR supported this change, specifically citing CT colonography (CTC) as an example of an exam not currently covered by Medicare, but with widespread commercial insurance coverage. Consideration of commercial insurance coverage would ensure continuity of care for patients. Using the CTC example, a patient is currently able to choose CTC for colorectal cancer screening under most commercial insurance plans until they reach Medicare age. At that time, another screening method would have to be chosen. Many patients cannot or will not undergo a colonoscopy or other screening test, instead choosing to forego this important cancer screening.

For questions on this Medicare rule and ACR comments, please contact Kathryn Keysor at