{"id":9082,"date":"2025-03-20T10:36:23","date_gmt":"2025-03-20T14:36:23","guid":{"rendered":"https:\/\/www.med.unc.edu\/intranet\/?p=9082"},"modified":"2025-03-20T10:36:23","modified_gmt":"2025-03-20T14:36:23","slug":"critical-compliance-requirement-for-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/","title":{"rendered":"Critical Compliance Requirement for Clinical Trials"},"content":{"rendered":"<p>The Centers for Medicare &amp; Medicaid Services (CMS) requires documentation of the appropriateness of qualified\u00a0clinical\u00a0trials for patients receiving\u00a0Medicaid\u00a0benefits. The attestation requires signature of the Principal Investigator, and in some cases, a Referring Physician. CMS requires that the attestation form be completed and uploaded to the patient\u2019s medical record upon enrollment to a\u00a0qualifying\u00a0clinical\u00a0trial.<\/p>\n<p><u>No clinical trial activities that have associated costs may be completed for patients receiving\u00a0Medicaid\u00a0benefits participating in a qualified clinical trial until after\u00a0a completed attestation form is uploaded to the patient\u2019s medical record.\u00a0<\/u><\/p>\n<p>Failure to complete and upload the attestation form prior to conducting any study-related activities with associated costs may result in those study costs being billed to the research accounts.<\/p>\n<p>Resources:<\/p>\n<ul>\n<li>Consult your study&#8217;s BCA for the qualified clinical trial determination<\/li>\n<li>Review <a href=\"https:\/\/research.unc.edu\/wp-content\/uploads\/2024\/05\/Medicaid-Billing-Requirements.pdf\">how to complete the attestation form<\/a><\/li>\n<li>Access the fillable <a href=\"https:\/\/research.unc.edu\/wp-content\/uploads\/2024\/05\/medicaid-attest-form-fillable.pdf\">attestation form<\/a><\/li>\n<li>Review a <a href=\"https:\/\/unchcs.sharepoint.com\/sites\/TrainingLibrary\/Training%20Library\/Forms\/AllItems.aspx?id=%2Fsites%2FTrainingLibrary%2FTraining%20Library%2FResearch%20%2D%20Medicaid%20QCT%20Reporting%20for%20Research%20Staff%2Epdf&amp;parent=%2Fsites%2FTrainingLibrary%2FTraining%20Library\">tipsheet on managing processes in Epic<\/a>\u00a0(UNC Health login required)<\/li>\n<\/ul>\n<p>Also, please note a mandatory training was issued via UNC Health LMS for all personnel with research roles in Epic in June, 2024. Personnel who have not yet completed the training have been notified.<\/p>\n<p>Please contact Laura Viera, Assistant Vice Chancellor for Clinical Research, with any questions: <a href=\"mailto:laura_viera@med.unc.edu\">laura_viera@med.unc.edu<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Centers for Medicare &amp; Medicaid Services (CMS) requires documentation of the appropriateness of qualified\u00a0clinical\u00a0trials for patients receiving\u00a0Medicaid\u00a0benefits. The attestation requires signature of the Principal Investigator, and in some cases, a Referring Physician. CMS requires that the attestation form be completed and uploaded to the patient\u2019s medical record upon enrollment to a\u00a0qualifying\u00a0clinical\u00a0trial. No clinical trial &hellip; <a href=\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\" aria-label=\"Read more about Critical Compliance Requirement for Clinical Trials\">Read more<\/a><\/p>\n","protected":false},"author":103134,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[1],"tags":[],"class_list":["post-9082","post","type-post","status-publish","format-standard","hentry","category-uncategorized","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Critical Compliance Requirement for Clinical Trials - School of Medicine Intranet<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Critical Compliance Requirement for Clinical Trials - School of Medicine Intranet\" \/>\n<meta property=\"og:description\" content=\"The Centers for Medicare &amp; Medicaid Services (CMS) requires documentation of the appropriateness of qualified\u00a0clinical\u00a0trials for patients receiving\u00a0Medicaid\u00a0benefits. The attestation requires signature of the Principal Investigator, and in some cases, a Referring Physician. CMS requires that the attestation form be completed and uploaded to the patient\u2019s medical record upon enrollment to a\u00a0qualifying\u00a0clinical\u00a0trial. No clinical trial &hellip; Read more\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\" \/>\n<meta property=\"og:site_name\" content=\"School of Medicine Intranet\" \/>\n<meta property=\"article:published_time\" content=\"2025-03-20T14:36:23+00:00\" \/>\n<meta name=\"author\" content=\"menglun1\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"menglun1\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\"},\"author\":{\"name\":\"menglun1\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/f01e5388b5756f5f43dd540e6197053e\"},\"headline\":\"Critical Compliance Requirement for Clinical Trials\",\"datePublished\":\"2025-03-20T14:36:23+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\"},\"wordCount\":218,\"articleSection\":[\"News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\",\"url\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\",\"name\":\"Critical Compliance Requirement for Clinical Trials - School of Medicine Intranet\",\"isPartOf\":{\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/#website\"},\"datePublished\":\"2025-03-20T14:36:23+00:00\",\"author\":{\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/f01e5388b5756f5f43dd540e6197053e\"},\"breadcrumb\":{\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/www.med.unc.edu\/intranet\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Critical Compliance Requirement for Clinical Trials\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/#website\",\"url\":\"https:\/\/www.med.unc.edu\/intranet\/\",\"name\":\"School of Medicine Intranet\",\"description\":\"For School of Medicine and UNC Health Faculty and Staff\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.med.unc.edu\/intranet\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/f01e5388b5756f5f43dd540e6197053e\",\"name\":\"menglun1\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/fe8a77782a3a3cdae2a05b6d07f482d868f356b288e8d9592de95c1b76025517?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/fe8a77782a3a3cdae2a05b6d07f482d868f356b288e8d9592de95c1b76025517?s=96&d=mm&r=g\",\"caption\":\"menglun1\"},\"url\":\"https:\/\/www.med.unc.edu\/intranet\/author\/menglun1\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Critical Compliance Requirement for Clinical Trials - School of Medicine Intranet","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/","og_locale":"en_US","og_type":"article","og_title":"Critical Compliance Requirement for Clinical Trials - School of Medicine Intranet","og_description":"The Centers for Medicare &amp; Medicaid Services (CMS) requires documentation of the appropriateness of qualified\u00a0clinical\u00a0trials for patients receiving\u00a0Medicaid\u00a0benefits. The attestation requires signature of the Principal Investigator, and in some cases, a Referring Physician. CMS requires that the attestation form be completed and uploaded to the patient\u2019s medical record upon enrollment to a\u00a0qualifying\u00a0clinical\u00a0trial. No clinical trial &hellip; Read more","og_url":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/","og_site_name":"School of Medicine Intranet","article_published_time":"2025-03-20T14:36:23+00:00","author":"menglun1","twitter_card":"summary_large_image","twitter_misc":{"Written by":"menglun1","Est. reading time":"1 minute"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/#article","isPartOf":{"@id":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/"},"author":{"name":"menglun1","@id":"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/f01e5388b5756f5f43dd540e6197053e"},"headline":"Critical Compliance Requirement for Clinical Trials","datePublished":"2025-03-20T14:36:23+00:00","mainEntityOfPage":{"@id":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/"},"wordCount":218,"articleSection":["News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/","url":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/","name":"Critical Compliance Requirement for Clinical Trials - School of Medicine Intranet","isPartOf":{"@id":"https:\/\/www.med.unc.edu\/intranet\/#website"},"datePublished":"2025-03-20T14:36:23+00:00","author":{"@id":"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/f01e5388b5756f5f43dd540e6197053e"},"breadcrumb":{"@id":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.med.unc.edu\/intranet\/2025\/03\/critical-compliance-requirement-for-clinical-trials\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.med.unc.edu\/intranet\/"},{"@type":"ListItem","position":2,"name":"Critical Compliance Requirement for Clinical Trials"}]},{"@type":"WebSite","@id":"https:\/\/www.med.unc.edu\/intranet\/#website","url":"https:\/\/www.med.unc.edu\/intranet\/","name":"School of Medicine Intranet","description":"For School of Medicine and UNC Health Faculty and Staff","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.med.unc.edu\/intranet\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/f01e5388b5756f5f43dd540e6197053e","name":"menglun1","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.med.unc.edu\/intranet\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/fe8a77782a3a3cdae2a05b6d07f482d868f356b288e8d9592de95c1b76025517?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/fe8a77782a3a3cdae2a05b6d07f482d868f356b288e8d9592de95c1b76025517?s=96&d=mm&r=g","caption":"menglun1"},"url":"https:\/\/www.med.unc.edu\/intranet\/author\/menglun1\/"}]}},"featured_image":false,"featured_image_medium":false,"featured_image_medium_large":false,"featured_image_large":false,"featured_image_thumbnail":false,"featured_image_alt":false,"category_details":[{"name":"News","link":"https:\/\/www.med.unc.edu\/intranet\/category\/uncategorized\/"}],"tag_details":[],"_links_to":[],"_links_to_target":[],"_links":{"self":[{"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/posts\/9082","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/users\/103134"}],"replies":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/comments?post=9082"}],"version-history":[{"count":0,"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/posts\/9082\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/media?parent=9082"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/categories?post=9082"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.med.unc.edu\/intranet\/wp-json\/wp\/v2\/tags?post=9082"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}