{"id":10777,"date":"2025-08-21T12:47:04","date_gmt":"2025-08-21T17:47:04","guid":{"rendered":"https:\/\/ibio.org\/?p=10777"},"modified":"2025-08-21T12:47:04","modified_gmt":"2025-08-21T17:47:04","slug":"ibio-joins-advamed-coalition-pushing-for-faster-medicare-coverage-of-medical-devices","status":"publish","type":"post","link":"https:\/\/ibio.org\/ibio-joins-advamed-coalition-pushing-for-faster-medicare-coverage-of-medical-devices\/","title":{"rendered":"iBIO Joins AdvaMed Coalition Pushing for Faster Medicare Coverage of Medical Devices"},"content":{"rendered":"<p class=\"p1\"><span class=\"s1\">iBIO has joined AdvaMed and 65 other organizations in urging the Centers for Medicare and Medicaid Services (CMS) to create a streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology. The coalition\u2019s letter to CMS Administrator Dr. Mehmet Oz addresses a critical problem: nearly six years pass between FDA authorization and Medicare coverage for technologies requiring new reimbursement pathways.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">\u201cPatients should not be forced to wait the better part of a decade for access to safe and effective medical technology that holds the potential to meaningfully improve their health and life,\u201d the letter states. The coalition includes patient advocacy groups and state medtech and life sciences associations.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">\u201cFDA is the global gold standard with its rigorous medtech safety and efficacy standards,\u201d said Scott Whitaker, AdvaMed president and CEO. \u201cWhen FDA has identified a medtech solution as a \u2018breakthrough\u2019 and cleared it as safe and effective for patients, we believe Medicare should cover it.\u201d<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">The coalition\u2019s proposal draws from the withdrawn Medicare Coverage of Innovative Technology (MCIT) framework, which would have provided immediate national coverage for four years for breakthrough medical devices. The effort is gaining momentum as FDA Commissioner Marty Makary said he and Dr. Oz are working on automatic coverage of FDA-authorized breakthrough medtech to avoid a \u201crepeat, duplicative approval process.\u201d<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">U.S. senators have also introduced the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act to accelerate Medicare coverage. The groups argue that existing programs \u201cfall short of providing the consistent, timely and predictable access that breakthrough technologies demand.\u201d<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">iBIO\u2019s participation reflects the company\u2019s commitment to advancing biotechnology innovation and patient access, recognizing that reimbursement challenges can significantly impact breakthrough technology adoption.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Read the <a href=\"https:\/\/ibio.org\/wp-content\/uploads\/Stakeholder-Letter-Encouraging-Breakthrough-Rule_August-2025.pdf\" target=\"_blank\" rel=\"noopener\">letter<\/a>. Read AdvaMed\u2019s <a href=\"https:\/\/www.advamed.org\/industry-updates\/news\/advamed-patient-groups-state-medtech-associations-urge-medicare-coverage-of-breakthrough-medtech\/\" target=\"_blank\" rel=\"noopener\">press release<\/a>.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>iBIO has joined AdvaMed and 65 other organizations in urging the Centers for Medicare and Medicaid Services (CMS) to create a streamlined pathway for Medicare patients to access FDA-authorized breakthrough medical technology. The coalition\u2019s letter to CMS Administrator Dr. Mehmet Oz addresses a critical problem: nearly six years pass between FDA authorization and Medicare coverage [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":10618,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[146],"tags":[688,687,372],"class_list":["post-10777","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-policy-news","tag-breakthrough","tag-cms","tag-fda"],"_links":{"self":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts\/10777","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/comments?post=10777"}],"version-history":[{"count":2,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts\/10777\/revisions"}],"predecessor-version":[{"id":10779,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/posts\/10777\/revisions\/10779"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/media\/10618"}],"wp:attachment":[{"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/media?parent=10777"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/categories?post=10777"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ibio.org\/wp-json\/wp\/v2\/tags?post=10777"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}