{"id":573920,"date":"2026-08-03T22:44:12","date_gmt":"2026-08-03T22:44:12","guid":{"rendered":"https:\/\/www.newsbeep.com\/il\/573920\/"},"modified":"2026-08-03T22:44:12","modified_gmt":"2026-08-03T22:44:12","slug":"medicare-eliminates-key-pathways-used-by-breakthrough-devices-for-extra-payments","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/il\/573920\/","title":{"rendered":"Medicare eliminates key pathways used by &#8216;breakthrough&#8217; devices for extra payments"},"content":{"rendered":"<p class=\"author-bio\">Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag of clinical AI, digital health at the FDA, and the boom in direct-to-consumer telehealth. Confidential tips can be sent on Signal at palmer.01.<\/p>\n<p class=\"wp-block-paragraph\">Medicare is removing flexibilities that have allowed medical devices designated as \u201cbreakthroughs\u201d by the Food and Drug Administration to leapfrog qualifications for extra payments.\u00a0\u00a0<\/p>\n<p class=\"wp-block-paragraph\">Until now, alternative pathways have allowed authorized <a href=\"https:\/\/www.statnews.com\/feature\/stat-plus\/breakthrough-device-designation-fda-tracker\/\" rel=\"nofollow noopener\" target=\"_blank\">breakthrough devices<\/a> to qualify for supplemental payments without proving their novelty or substantial clinical improvement over alternatives. In its rule for inpatient hospital payments, the Centers for Medicare and Medicaid Services finalized a proposal to repeal those pathways for both inpatient and outpatient settings, starting in fiscal year 2028.\u00a0<\/p>\n<p class=\"wp-block-paragraph\">Such payments are meant to incentivize hospitals to use new, transformative technology while it\u2019s still expensive, and give its makers time to prove their value. Requiring breakthrough devices to demonstrate substantial clinical improvement, the rule reads, \u201censures that additional Medicare payments are used to support Medicare beneficiaries\u2019 access to innovations that are demonstrated to improve outcomes compared to the currently available treatment.\u201d\u00a0<\/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\/il\/wp-content\/uploads\/2025\/09\/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":"Katie covers the impact of health technology on patients, clinicians, and businesses. Her stories explore the price tag&hellip;\n","protected":false},"author":2,"featured_media":573921,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[40836,1143,163,3239,521,85,46,12948,4555,15830],"class_list":["post-573920","post","type-post","status-publish","format-standard","has-post-thumbnail","category-healthcare","tag-cms","tag-fda","tag-health","tag-health-tech","tag-healthcare","tag-il","tag-israel","tag-medical-devices","tag-policy","tag-stat"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/573920","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=573920"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/573920\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/573921"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=573920"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=573920"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=573920"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}