CMS Announces Changes to Processes for Payment for Emerging Technologies

On June 23, 2023, CMS issued a public notice describing its new regulatory pathway process for breakthrough devices through the national coverage determination process. The announcement states that the new Transitional Coverage for Emerging Technologies pathway will use a review process parallel with the Food and Drug Administration (FDA) marketing review to determine whether the device needs additional evidence development and whether it is reasonable and necessary for Medicare beneficiary treatment. It will be an expedited review process that will allow CMS to issue transitional coverage for these products that is tied to an evidence development plan issued by the Agency for Healthcare Research and Quality.

Although this rule is not official, CMS believes implementation of this plan is within its existing authority. This comes after the Biden administration in 2021 repealed the rule that had provided expedited coverage for any breakthrough device that had achieved pre-market authorization through the FDA. That rule was one of the last-minute Trump administration add-ons that was subsequently included in the regulatory freeze by the Biden administration and never took effect before it was repealed.

To read the announcement, see here.