Administration postpones Trump-era rule to grant faster Medicare coverage for 'breakthrough' devices

The federal government is pushing back implementation of a Trump-era rule that would grant instant Medicare coverage of “breakthrough” devices in imaging and other specialties amid concerns about safety.

Finalized in January, the policy would eliminate lag time between the Food and Drug Administration approving new technology and the Centers for Medicare & Medicaid Services covering it. The finale rule was set to go into effect Saturday but will now wait until Dec. 15.

In an update posted Friday, May 14, Health and Human Services said it received mounds of feedback on the Medicare Coverage of Innovative Technology rule, and the feds agreed with some stakeholders’ reservations.

“We share commenters’ concerns that guaranteeing coverage for all breakthrough devices receiving market-authorization for any Medicare patient—with possibly minimal or no evidence on the Medicare population and no requirement to develop evidence on the Medicare population—could be problematic in ensuring these devices are demonstrating value and do not have additional risks for Medicare beneficiaries,” HHS noted in its announcement.

Officials said the delay will give the administration time to address issue raised by commenters. Those include protecting Medicare patients and ensuring coordination between coverage, coding and payment.

This is the second such delay after the Biden administration pushed back the go-live date earlier this year, opening a 30-day window that produced 215 responses. Provider groups such as the American College of Radiology previously expressed reservations about the rule change, while manufacturers have strongly supported it.

Thirty-eight House Democrats last week urged the White House to implement the rule immediately, prior to the latest delay.

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