{"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(大象传媒 Health login required)<\/li>\n<\/ul>\n<p>Also, please note a mandatory training was issued via 大象传媒 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 v23.9 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\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. 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