At the Medical Device Manufacturers Association Annual Meeting on Thursday, Centers for Medicare and Medicaid Services Administrator Seema Verma for the first time walked through the agency's comprehensive strategy to improve patients' access to emerging technologies.
The future directions outlined in yesterday's address build on recently released CMS policies to encourage innovation in the healthcare system -- in line with the administration's stated efforts to encourage a competitive market that lowers cost and increases quality and access.
Verma highlighted two specific actions in the address.
First, for issuing Healthcare Common Procedure Coding System 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 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 Category III codes -- temporary codes used for emerging technologies -- CMS is clarifying that for technologies that do not fall under an existing local coverage determination, Medicare contractors are required to follow the transparent new LCD 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 on Thursday.
Taken together with other moves CMS has made, the two actions represent components of a strategy to address barriers to medical innovation in the Medicare program.
Just last week in the Inpatient Prospective Payment System proposed rule, CMS proposed a number of changes to advance innovation, including proposing to increase the new technology add-on payment which provides hospitals with additional payments for cases with high costs involving new technology. CMS also proposed to modernize payment policies for medical devices that meet FDA's breakthrough devices designation.
"Innovation is the fuel that powers the engine of progress and creativity," Verma said. "That is why the Trump Administration is taking action in every possible way to promote, enhance, and foster innovation within the healthcare system. We are committed to removing government barriers and modernizing regulations around new technologies to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care."