{"id":605699,"date":"2026-04-25T14:06:40","date_gmt":"2026-04-25T14:06:40","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/605699\/"},"modified":"2026-04-25T14:06:40","modified_gmt":"2026-04-25T14:06:40","slug":"cms-fda-propose-new-faster-coverage-for-breakthrough-devices","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/605699\/","title":{"rendered":"CMS, FDA propose new, faster coverage for breakthrough devices"},"content":{"rendered":"<p class=\"author-bio\">Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech\u2019s promise. He\u2019s also the co-author of the free, twice weekly <a href=\"https:\/\/www.statnews.com\/signup\/health-tech\/\" rel=\"nofollow noopener\" target=\"_blank\">STAT Health Tech newsletter<\/a>. You can reach Mario on Signal at mariojoze.13.<\/p>\n<p class=\"author-bio\">Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy \u2014 with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can reach Katie on Signal at palmer.01.<\/p>\n<p>Federal regulators on Thursday announced a new Medicare coverage pathway for devices deemed breakthroughs by the Food and Drug Administration. The program aims to address long-standing industry complaints that it takes too long for Medicare to pay for innovative technology.<\/p>\n<p>The new Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, will try to synchronize the FDA\u2019s premarket review process, which determines whether products are safe and effective, and Medicare\u2019s independent process which determines whether paying for devices is reasonable and necessary. The goal is to collect and review enough data before authorization that Medicare can cover the products soon after a product hits the market. <\/p>\n<p>RAPID is the latest effort to speed up patient access to breakthrough devices. However, it does not deliver the automatic reimbursement industry has been lobbying for.<\/p>\n<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2025\/12\/1765280600_844_stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 and get additional analysis of the technologies disrupting health care \u2014 by subscribing to STAT+.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" rel=\"nofollow noopener\" target=\"_blank\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics.&hellip;\n","protected":false},"author":2,"featured_media":605700,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[10212,246,97,252,37583,253,10653,1343,248],"class_list":{"0":"post-605699","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health-care","8":"tag-cms","9":"tag-fda","10":"tag-health","11":"tag-health-care","12":"tag-health-tech","13":"tag-healthcare","14":"tag-medical-devices","15":"tag-policy","16":"tag-stat"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/605699","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=605699"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/605699\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/605700"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=605699"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=605699"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=605699"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}