“This includes waiving the requirement for ‘substantial clinical improvement,’ which is one of the criteria that must be met for CMS to make additional payments,” said Verma. “Simply put, our goal is to get new innovations to our beneficiaries concurrent with FDA approval by removing government barriers to innovation and harmonizing CMS coverage, coding, and payment processes.”ĬMS has proposed several changes to payment policies for medical devices that receive “breakthrough device” designations from the FDA. “With the remarkable number of transformative technologies coming to market - many with unprecedented price tags - Medicare must develop new frameworks that will support tomorrow’s innovations and endure the test of time,” she said. Oftentimes, coverage for a “new” technology or device can lag behind commercial coverage by as much as a decade.Īs the pace of innovation accelerates as the healthcare industry enters the age of artificial intelligence, this snail’s pace is simply no longer acceptable, said Verma, especially as other agencies such as the FDA take proactive steps to modernize their processes. Medicare can take years to make these decisions. Lastly, the agency makes a payment determination, taking into account the site and purpose of use in addition to other criteria. Then the agency must determine if the new technology can be coded for payment with existing codes or if new codes are needed. Integrating new products and services into the Medicare fee schedule can be a lengthy and complex process, however, said Verma.ĬMS and its Medicare Administrative Contractors (MACs) must first make coverage decisions on a national or local level. In essence, keeping new technologies and treatments moving from bench to bedside-and into the hands of those who need them most.”ĬMS is anticipating the continued development of medical devices and other products that incorporate advanced analytics, data interoperability, and machine learning to offer actionable insights for patients and providers at the point of care.
“The advent of novel medical technologies requires CMS to remove barriers to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care. “Our vision is ambitious yet achievable: to protect and secure Medicare and ensure beneficiaries have access to the latest medical technologies,” said Verma. May 03, 2019 - CMS is working with other federal agencies and lawmakers in Congress to modernize its approach to coverage for data-driven medical devices and other innovative technologies.Īs digital tools, companion apps, and analytics technologies become more commonplace across the industry, CMS hopes to speed up the process of determining payment rates for breakthrough advances in patient care, CMS Administrator Seema Verma said in a speech at the Medical Device Manufacturers Association Annual Meeting this week.
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