CMS Outlines Comprehensive Strategy to Foster Innovation for Transformative Medical Technologies

The Administrator highlighted two specific actions:

First, for issuing Healthcare Common Procedure Coding System (HCPCS) codes, CMS is changing the current process of allowing only one opportunity per year to apply for new Level II codes. The agency is moving to a process with quarterly opportunities to apply for drugs, and semi-annual opportunities to apply for devices. CMS anticipates this will greatly improve the ability for technologies to move through the adoption curve, and additional details will be forthcoming on the updates to the process.

Second, for technologies with Current Procedural Terminology (CPT) Category III codes (which are temporary codes used for emerging technologies), CMS is clarifying that for technologies that do not fall under an existing LCD, Medicare contractors are required to follow the transparent new Local Coverage Determination process for every local coverage decision, including reviewing the evidence with respect to the technology. This clarification was part of a list of answers to commonly asked questions about the Local Coverage Determination process that the agency posted online earlier today.


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