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The SOP details the steps involved after a study's finalization, including LIUMC Clinical Research (LUMC CR), LUMC Revenue Integrity, and the study team's initiation of a coverage analysis on all study-related patient care items and services. It emphasizes that coverage analysis, in the industry, is best practice for assessing which patient care items or services are routine costs (also referred to as standard of care) and which are solely for research purposes. The document specifies that items and services not justifiable as routine costs should be billed to the patient or the insurance. It also addresses the workflow for transplant financial counselors, who utilize this SOP for obtaining prior authorization for transplant patients, guiding them through the process of checking account information, verifying current enrollment, and reviewing the patient's research chart. The document highlights potential issues such as missing Flag status, billing errors, and the need for thorough documentation and confirmation from the Investigational Device Manufacturer. Furthermore, it instructs FCC colleagues to obtain prior authorization for research through normal processes or coordinate with external entities when necessary. The SOP concludes with references and a list of associated documents, underscoring the importance of accurate financial clearance for research participants.",{"@graph":63,"@context":119},[64,80,102],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/obtaining-prior-authorization-for-patients-participating-in-research-pat-004/254784/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/obtaining-prior-authorization-for-patients-participating-in-research-pat-004/254784.png","ImageObject",442,249,{"name":88,"@type":89},"Mimi","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-26","2026-09-13",true,{"@type":98,"interactionType":99,"userInteractionCount":101},"InteractionCounter",{"@type":100},"ViewAction",9,{"@type":103,"mainEntity":104},"FAQPage",[105,111,115],{"name":106,"@type":107,"acceptedAnswer":108},"What is the purpose of this SOP?","Question",{"text":109,"@type":110},"The purpose of this SOP is to provide a standardized approach for Financial Clearance Center (FCC) colleagues who are obtaining research authorization for a service for a patient who is enrolled in a research study.","Answer",{"name":112,"@type":107,"acceptedAnswer":113},"What are the key steps in the procedure for FCC colleagues?",{"text":114,"@type":110},"FCC colleagues must check the patient's header for Research: Active indicator, check patient care status and research, and if the patient is enrolled in a study, assess if the item or service is authorized for by the research team by reviewing the patient's Reg-Reg FV Flags and SOP PAT-003.",{"name":116,"@type":107,"acceptedAnswer":117},"What should be done if a study is expected to enroll more than 20 participants?",{"text":118,"@type":110},"If a study is expected to enroll greater than 20 participants, the study team and LUMC CR prepare a packet with information about the study's routine costs to be sent to LUMC's top two payers (not including CMS) at the time of the study initiation.","https://schema.org",{"og:url":78,"og:type":121,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":123,"canonical":78},"index,follow",{"doc_id":125,"site_id":56},254784,1790477269,{"code":4,"msg":5,"data":128},{"doc_id":125,"user_id":129,"nickname":88,"user_avatar":130,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":60,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":101,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":73,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":139,"read_time":9},2336477974920,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","cbCaitshAucWVHHw","https://ap.wps.com/l/cbCaitshAucWVHHw","pdf",681533,"English","# SCOPE\n# PROCEDURES\n# REFERENCES\n# ASSOCIATED DOCUMENTS AND FORMS\n# APPROVALS","[{\"question\":\"What is the purpose of this SOP?\",\"answer\":\"The purpose of this SOP is to provide a standardized approach for Financial Clearance Center (FCC) colleagues who are obtaining research authorization for a service for a patient who is enrolled in a research study.\"},{\"question\":\"What are the key steps in the procedure for FCC colleagues?\",\"answer\":\"FCC colleagues must check the patient's header for Research: Active indicator, check patient care status and research, and if the patient is enrolled in a study, assess if the item or service is authorized for by the research team by reviewing the patient's Reg-Reg FV Flags and SOP PAT-003.\"},{\"question\":\"What should be done if a study is expected to enroll more than 20 participants?\",\"answer\":\"If a study is expected to enroll greater than 20 participants, the study team and LUMC CR prepare a packet with information about the study's routine costs to be sent to LUMC's top two payers (not including CMS) at the time of the study initiation.\"}]","Obtaining Prior Authorization for Patients Participating in Research PAT-004 | PDF",1789281771]