CMS NEWS

FOR IMMEDIATE RELEASE
May 2, 2019

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CMS outlines comprehensive strategy to foster innovation for transformative medical technologies

Today at the Medical Device Manufacturers Association (MDMA) Annual Meeting, Centers for Medicare & Medicaid Services (CMS) 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 today’s address build on recently released CMS policies to unleash innovation in our healthcare system, reinforcing the Trump Administration’s commitment to encouraging a competitive market that lowers cost and increases the quality of and access to healthcare for all Americans.

“Innovation is the fuel that powers the engine of progress and creativity. That is why the Trump Administration is taking action in every possible way to promote, enhance, and foster innovation within the healthcare system,” said CMS Administrator Seema Verma. “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.”

The Administrator highlighted two specific actions in today’s address.

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.

Taken together with other CMS actions, these two actions represent key components of a comprehensive CMS strategy to address barriers to medical innovation in the Medicare program. Just last week in the Inpatient Prospective Payment System (IPPS) 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. The agency’s strategy overall will help ensure predictable coverage pathways, enhance opportunities for coverage for transformative technologies, reduce wait times to apply for permanent codes, and modernize payment for innovative services.

Administrator Verma’s speech can be viewed at: https://www.cms.gov/newsroom/press-releases/speech-remarks-administrator-seema-verma-medical-device-manufacturers-association.