CMS finalizes rule to speed up Medicare coverage of breakthrough imaging devices

The Centers for Medicare & Medicaid Services finalized a rule on Tuesday that will speed up coverage of “breakthrough” devices in imaging and other fields of medicine.

Typically, there is a lag time between when the U.S. Food and Drug Administration approves new technology and Medicare covers it. However, this newly established payment pathway will eliminate this so-called “valley of death,” granting immediate reimbursement for multiple years.

“Despite being deemed safe and effective by the FDA, Medicare beneficiaries have not had predictable, immediate access to innovative breakthrough devices,” CMS Administrator Seema Verma said Jan. 12.

The agency first proposed this rule back in September, drawing praise from imaging device manufacturers and some skepticism from providers. In particular, the American College of Radiology in November urged the feds to operate with transparency when granting breakthrough status. That could include providing public notice and an opportunity to comment before accepting proposals through the new pathway, CEO William Thorwarth Jr. said at the time.

Under the final rule, CMS will grant simultaneous national coverage with FDA approval, up to a period of four years. After that, the feds will then reevaluate the device based on clinical data to determine whether payment should persist. Also, after the rule takes effect on March 15, Medicare may cover eligible breakthrough devices that have already gained FDA market authorization over the past two years.

CMS said it made a few modifications from the initial proposal, based on public comment. Those include a more flexible start date for Medicare Coverage of Innovative Technology to better align with market availability, ending reimbursement if the FDA withdraws its approval, and gathering more info about commercial insurers’ corresponding policies.

The Advanced Medical Technology Association praised CMS’ announcement on Tuesday, calling it an “important step forward.”

“It’s good government, and it’s good commonsense to recognize that if doctors and scientists at the FDA—the global gold standard for medical technology regulation—determine a device is safe and effective, another federal agency can then move quickly to ensure patients can access that lifechanging and often lifesaving technology,” President and CEO Scott Whitaker said in a statement.