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CMS Reimbursement for Breakthrough Medical Devices
(Thursday, August 15, 2024) The Centers for Medicare & Medicaid Services (CMS) announced a new program to provide coverage to medical devices approved under the Breakthrough Device program. Most breakthrough devices are approved with limited safety and efficacy data and it would be hard to secure coverage under the conventional review process. The new program is designed to address this gap. The CMS has established the Transitional Coverage for Emerging Technologies (TCET) Pathway to streamline and accelerate the Medicare coverage process for FDA-designated Breakthrough Devices. The TCET pathway is a voluntary program under which manufacturers can nominate their Breakthrough Devices for the TCET pathway by providing information additional to that used to secure the FDA approval, to fill the gaps in the supporting evidence needed to grant coverage by CMS. A critical aspect of the pathway is the emphasis on evidence development, especially in cases where there are notable gaps in the data needed to make informed Medicare coverage decisions by the CMS. CMS will accept up to five candidates for the TCET pathway per year. Once accepted CMS aims to finalize a national coverage determination (NCD) within six months of FDA market authorization. This process includes an Evidence Preview, which involves a focused literature review to identify strengths and weaknesses in the available evidence and inform both CMS and the manufacturers about the best available coverage options. The pathway encourages manufacturers to develop an Evidence Development Plan (EDP) to address any identified evidence gaps. This plan may involve traditional clinical studies or fit-for-purpose study designs that leverage real-world data. CMS collaborates closely with the Agency for Healthcare Research and Quality (AHRQ) to ensure that these plans meet the highest standards of scientific integrity and are relevant to the Medicare population. Once a device receives FDA market authorization and is accepted into the TCET pathway, CMS will initiate the NCD process. Coverage under the TCET NCD is transitional and will continue as long as necessary to generate the required evidence. Typically, this coverage lasts for approximately five years, after which CMS will conduct an updated evidence review to determine the appropriate long-term coverage status. Not all FDA-designated Breakthrough Devices will automatically qualify for the TCET pathway. CMS has set specific criteria for eligibility, including the device's potential benefit to the Medicare population, its classification within a Medicare benefit category, and whether it is already covered under an existing NCD. Additionally, in vitro diagnostic devices, including diagnostic laboratory tests, are generally excluded from the TCET pathway and are typically reviewed by specialized Medicare Administrative Contractors. CMS developed the TCET pathway based on extensive feedback from stakeholders, including patient groups, medical professionals, and device manufacturers. This feedback emphasized the need for a more agile and iterative evidence review process that can adapt to the specific needs of breakthrough technologies. CMS has made several adjustments between the proposed and final notices of the TCET pathway, incorporating changes such as earlier engagement with manufacturers and more frequent review cycles. For manufacturers interested in the TCET pathway, CMS has provided clear guidelines and deadlines for submission. The TCET program seeks to reduce uncertainties in coverage decisions by engaging with manufacturers early in the process to evaluate the potential benefits and harms of emerging technologies such as Breakthrough Devices. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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