During the recent Medical Device Manufacturers Association (MDMA) Annual Meeting, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma discussed the agency’s vision to better connect patients with healthcare innovations. In her announcement, Verma said the agency is committed to eliminating “government barriers and modernizing regulations” that would give patients quicker access to new technology while still maintaining the new treatments are safe and effective.
The overall goal, said the agency, is to make coverage guidelines predictable, more applicable to for transformative technologies, reduce wait times to apply for permanent codes, and modernize payment for innovative services.
Among other CMS actions, the agency said it will focus on two specific strategies that represent key components of a comprehensive plan to address barriers to medical innovation in the Medicare program:
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.
Technologies with Current Procedural Terminology (CPT) Category III codes: 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.
Also, in the recently proposed Inpatient Prospective Payment System (IPPS) rule, CMS is suggesting several 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. The agency also plans to modify payment policies for medical devices that meet FDA’s Breakthrough Devices designation.
