{"id":297,"date":"2020-04-23T20:30:39","date_gmt":"2020-04-23T20:30:39","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=297"},"modified":"2020-12-29T21:26:51","modified_gmt":"2020-12-29T21:26:51","slug":"digital-tools-for-billing-compliance","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/digital-tools-for-billing-compliance\/","title":{"rendered":"Digital Tools for Billing Compliance"},"content":{"rendered":"\n<h5>By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC <br>Kelly Willenberg &amp; Associates  <\/h5>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"alignleft is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/05\/Copy-of-CRA-Technology-Blog-Post-1024x512.png\" alt=\"\" class=\"wp-image-139\" width=\"319\" height=\"160\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/05\/Copy-of-CRA-Technology-Blog-Post.png 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/05\/Copy-of-CRA-Technology-Blog-Post-300x150.png 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2019\/05\/Copy-of-CRA-Technology-Blog-Post-768x384.png 768w\" sizes=\"(max-width: 319px) 100vw, 319px\" \/><\/figure><\/div>\n\n\n\n<p><strong><em>Abstract<\/em><\/strong><em>: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. This article describes digital tools that clinical research professionals already have that they can use to facilitate billing compliance as well as the benefits and challenges of each tool. Clinical research professionals must determine which tools will be most effective at their site.<\/em><\/p>\n\n\n\n<!--more-->\n\n\n\n<p><strong>Introduction<\/strong><\/p>\n\n\n\n<p>New challenges in billing\ncompliance continually arise. Many of these challenges are related to the use\nof multiple electronic systems by clinical research sites. Some clinical\nresearch sites use up to 10 systems, with separate systems for accounting and\nother parts of billing compliance. The complexity and challenges are increased\nwhen a site uses an electronic medical record system and a separate accounting\nsystem for billing. Some clinical research professionals have developed\ncreative ways to use their existing digital tools to facilitate billing\ncompliance.<\/p>\n\n\n\n<p>Billing compliance must be\nviewed broadly (Table 1). Clinical research sites need billing grids, budgets,\nand coverage analyses. Clinical research professionals must segregate research\ncosts from routine costs, which is a major challenge and a time-consuming\nprocess. Until the pharmaceutical sponsors and the cooperative groups start segregating\nresearch costs from routine costs, this task has fallen on research\ncoordinators and research finance professionals. Cooperative groups are\nstarting to become involved in segregating research costs from routine costs,\nand you will see coverage analysis forthcoming from the research bases. <\/p>\n\n\n\n<p>When clinical research\nprofessionals do segregate research costs from routine costs, they build better\nstudy budgets because they know the cost of charges. Better study budgets can result\nin higher revenue because clinical research sites can see which studies are and\nare not doing well financially and can choose to focus on studies that generate\nhigher revenue. For the most part, however, the goal is for studies to break\neven. Many studies, especially cooperative group studies, lose money. Having a\nmixed portfolio will help a site financially. <\/p>\n\n\n\n<p>Determining the defensible\nand fair market value for sponsor billing and provider payment as part of the\ncoverage analysis enables clinical research professionals to defend the costs.\nThis is important for compliance.<\/p>\n\n\n\n<p>Clinical research\nprofessionals must assist research participants with meeting protocol\nrequirements and deadlines. One way to do that is to have a good budget and a\ngood coverage analysis that includes time points for various study activities,\nincluding enrollment and reporting of drug adherence. This provides research coordinators\nwith a better tool for following participants, and it provides accounting\nprofessionals with a better tool for handling study finances. The budget and\ncoverage analysis can be used to monitor recruitment and to enroll more research\nparticipants faster.<\/p>\n\n\n\n<p>Activities must be tracked\nacross any network of hospitals or other facilities that are participating in a\nstudy. This includes tracking:<\/p>\n\n\n\n<ul><li>Timely accounts receivable <\/li><li>Correct payment to providers <\/li><li>Appropriate reporting of transactions in enterprise-wide\n     accounting systems.<\/li><\/ul>\n\n\n\n<p>Some clinical research\nprofessionals do this using paper, which may be better in some ways than using\na clinical trial management system (CTMS). A CTMS is one piece of billing compliance;\nhowever, these systems have both benefits and disadvantages. There are many CTMSs;\nhowever, no single system does everything that is required to manage a clinical\ntrial. Often, challenges related to compliance occur due to non-compliant home-grown\nsystems used at some clinical research sites. It is difficult to persuade\ndecision-makers that it is necessary to move to a commercial CTMS.<\/p>\n\n\n\n<p>In order to run reports and create\nmetrics and benchmarks to improve the efficiency of the study, including faster\nenrollment and knowing which studies are losing money, clinical research sites\nneed a way to collect data. Some clinical research professionals do this using\npaper. Others use tickler files or complete monthly tracking forms. Electronic\nsystems can make data collection, reporting, and analysis easier. Any method that\nworks is fine.<\/p>\n\n\n\n<p><strong>Best Practices in Billing Compliance <\/strong><\/p>\n\n\n\n<p>Billing compliance can be\nseen as a pyramid with three levels. Best practice billing compliance is at the\npinnacle. The middle level is hospital bills or facility-side billing, sponsor\ninvoicing, and physician office- or professional-side billing. The bottom level\nis contract, coverage analysis, budget, informed consent, and protocol.<\/p>\n\n\n\n<p>In order to achieve best\npractice billing compliance, first and foremost, clinical research sites must\nbe performing a coverage analysis for each study. The coverage analysis should\nguide all of the billing compliance work and should not be done separately. It guides\nthe development of the contract and the budget and is used to validate the\ninformed consent form against the final protocol.&nbsp; <\/p>\n\n\n\n<p>Hospital bills or facility-side\nbilling and physician office or professional-side billing must be consistent.\nAuditors often find that this is not the case. Practices do not know when\npatients are enrolled in a study or when a visit is a study visit. There is no\nelectronic mechanism for communicating this information, and the practice has a\ndifferent system than the clinical research site. In order for the site to invoice\nthe sponsor correctly at the end of the study and receive the money that is\nowed, all billing must be consistent. <\/p>\n\n\n\n<p>If billing is not correct,\nthe site may have violated the False Claims Act. The main clinical research\nsite or a practice involved in the study might not be double-billing; however,\nif any hospital, facility, or office is not billing correctly, the False Claims\nAct can be violated.<\/p>\n\n\n\n<p>There is a disconnect between\nthe two sides: billing compliance professionals at hospital facilities and the\nphysician practices conducting research. Physicians do not understand the\nconsequences of a lack of billing compliance when a practice bills independent\nof the hospital facility. They may think that the amount of research conducted\nis too small to be concerned or that any revenue generated will be too little for\nany worry. It does not matter, however, if a clinical research site is\nconducting 1 study or 700; billing compliance is necessary. What does matter is\nwhat physician practices are involved and how they are notified of billing\ncompliance intelligence. <\/p>\n\n\n\n<p>Sponsors sometimes discuss\nstudies with physicians without involving billing compliance professionals. The\nphysician then wants to conduct the study, or the physician even signs\ndocuments agreeing to conduct the study without considering the billing\ncompliance requirements. Billing compliance professionals must then raise the\nissues related to billing compliance. It is possible to reach the pinnacle of\nbilling compliance. This, however, takes time and an appreciation of the\nbilling rules and guidelines. <\/p>\n\n\n\n<p><strong>Digital Tools Available to Assist in Clinical Trial\nBilling<\/strong><\/p>\n\n\n\n<p>Mobile phones, social media,\nand health information technology can all be used to assist in billing\ncompliance. Some clinical research sites are using social media for\nrecruitment. Research participants are very active on social media such as\nTwitter and Facebook and often comment on their participation. Clinical\nresearch professionals cannot stop this; however, they can use it to their\nadvantage. It is necessary to understand the advantages and disadvantages of\nmobile phones and social media in relation to clinical trials.<\/p>\n\n\n\n<p>Digital tools can assist in clinical\ntrial billing. Some clinical research sites, for example, have all of their\ncoverage analyses on iPads, enabling the clinical research professional to look\nat the coverage analysis for a study when meeting with a research participant.\nInformed consent forms are sometimes put on iPads or other electronic tools.\nThe use of iPads and other digital tools in clinical trials will become\nincreasingly common over the next several years.<\/p>\n\n\n\n<p>National Institutes of Health\nDirector Dr. Francis Collins recently said:<\/p>\n\n\n\n<p>\u201cMany\nopportunities to improve health very much depend upon cell phone technologies,\nsince cell phones are so rapidly expanding in many parts of the world that\notherwise don&#8217;t have much access to communication.\u201d<\/p>\n\n\n\n<p>Table 2 provides an overview\nof mobile technology challenges and benefits as well as the way in which mobile\ntechnology can be used to facilitate billing compliance. People in the United\nStates are very dependent on their mobile phones and take them for granted. However,\nmany people do not have any digital access in some parts of the world where\nclinical trials are being conducted. Even within the United States, capacity\ndiffers. For example, not all patients have access to an iPad or the Internet, so\nthat they may read the informed consent form before meeting with clinical\nresearch professionals to discuss a study to ensure that it is not the only\nmethod.<\/p>\n\n\n\n<p>Another challenge of mobile\ntechnology is reliance on research participants to enter data, such as quality\nof life surveys, and again, lack of access to the Internet by some research\nparticipants to take Web-based surveys. Some clinical research sites have a\nkiosk for research participants to use during study visits to enter data.&nbsp; <\/p>\n\n\n\n<p>Smart phones can store personal\ndata as well as incriminating photos and video. For example, the phone\u2019s owner\ncould record a conversation without telling the other person, or a video could\nbe posted on YouTube without the other person\u2019s knowledge or consent. Smart\nphones can also be hacked.<\/p>\n\n\n\n<p>Mobile phones can be used to identify\nresearch participants at multiple points of interest, for example, to alert\nclinical research professionals when a patient who is eligible for a study is\nin the clinic. They can help with many tasks including some that facilitate\nbilling compliance, like reminders in the form of sensors or alarms, and for recruitment,\nmobile phones can help with the tasks of retention, diary submission, and\ninformed consent. There can, however, be legal issues in doing this and in\nusing cell phones to contact patients and research participants. Clinical\nresearch professionals who use cell phones to communicate with patients and\nresearch participants must know their state laws, and they should talk to legal\ncounsel and their compliance group to learn what they can and cannot do. <\/p>\n\n\n\n<p>Like mobile technology, the\nuse of social media in clinical trials has both challenges and benefits (Table\n3). Use of Facebook and Twitter by research participants can skew data. Research\nparticipants find each other on social media and share information, including the\nside effects of study interventions. They also listen to other research\nparticipants regarding whether they should participate in a study. <\/p>\n\n\n\n<p>The benefits of using social\nmedia in clinical trials include creating collaboration with community\nphysicians and assisting in the prevention of having competing trials within\none system. One clinical research site that the author works with has three hospitals\nin one region. Clinical research professionals use a cell phone tool that they\ndeveloped to keep all of the hospitals updated on which patients are enrolling\nin studies, and they do this without using any patient names. <\/p>\n\n\n\n<p>The use of health information\ntechnology in clinical trials also has both challenges and benefits (Table 4). Many\nsystems, including CTMSs, Epic and other electronic medical records systems,\nand accounting systems do not interface. Often, physicians in hospitals have\ndifferent systems, so interface can be difficult. <\/p>\n\n\n\n<p>Appropriate accounting for\nresearch revenue is difficult unless the clinical trials office has an accounting\nmechanism. Clinical research sites often leave billing compliance with the\nresearch coordinators, who generally do not have the time or training to do\nthis. Lack of ability to identify potential research participants is another\nchallenge, resulting in slow accrual. This problem has increased recently,\nincluding cooperative group studies. The reasons for lower accrual can be many,\nand barriers including payer issues cannot be discounted. <\/p>\n\n\n\n<p>Automation is a key benefit\nof health information technology, such as electronic medical records, for\nclinical trials.<\/p>\n\n\n\n<p>Health information technology\nautomates manual tasks, resulting in improved efficiency. Automation of financial\nprocesses increases accuracy and financial reporting, and it enables data\nmining for potential research participants. Clinical research sites can extract\ninformation from systems by flagging certain types of patients or by having a\nclinical trial number in a billing system. However, CMS can also data mine research\nparticipants and compare their information. This will be frightening for\nclinical research sites. Health information technology automation enables publication\nof data and clinical trial results and enables clinical research sites to\ngenerate accurate information about the number of research participants in each\nclinical trial.<\/p>\n\n\n\n<p>Sponsors are using automated\nhealth information technology to compare and select clinical research sites.\nThey can visit ClinicalTrials.gov to see which sites are conducting certain types\nof studies. Sponsors are asking sites to use their electronic medical records\nto access data on potential research participants, for example, the number of\npatients with a certain diagnostic code. They are also using health information\ntechnology to optimize protocols and enhance study design, which benefits\nclinical research sites. This will enable faster recruitment of research\nparticipants, and studies can be conducted more efficiently.<\/p>\n\n\n\n<p>Many billing systems for\nclinical research sites, hospitals, and physicians are available, including\nEpic, Cerner, Mosaiq, Allscripts, McKesson, Nextgen, and Aria. The following brief\ncase studies illustrate some of the challenges in using health information\ntechnology in clinical trials.<\/p>\n\n\n\n<p><strong>Case Study #1<\/strong><\/p>\n\n\n\n<p><em>How do hospital systems identify patients\nas research participants?<\/em> <\/p>\n\n\n\n<p>Hospital systems can identify\npatients as research participants by flagging patients with a \u201cFor Your Information\u201d\n(FYI) or research flag by developing dual encounter forms or by using the research\nstudy number as the financial class. Some of these tasks can be done\nelectronically, such as using power trials for Cerner or Epic. They can also be\ndone simply, for example, through fax communication.<\/p>\n\n\n\n<p>A CTMS can be used to enhance\ncommunications. Which system is best for a specific hospital system depends on the\nhospital\u2019s operations and billing system. The informed consent process should\nbe incorporated into the pre-authorization process for insurance coverage so\nthat staff members know that a patient is considering participating in a study\nbefore a patient is consented or a claim is submitted. The billing system\nshould also be used to identify patients who are research participants.<\/p>\n\n\n\n<p><strong>Case Study #2<\/strong><\/p>\n\n\n\n<p><em>How do hospital systems notify outside physician\noffices and vendors about research participants? <\/em><\/p>\n\n\n\n<p>Some large hospital systems are\naffiliated with many non-employed physician practices. Billing for non-employed\nphysician practices is challenging. It is necessary to ensure that these\npractices have information about research participants including the coverage\nanalysis; however, the way in which the information is shared depends on the\nsystems used. Differerent billing systems have different needs that must be\nconsidered. The solution includes providing read-only access to shared study\nfiles. CTMSs make it easy to do this and enhance communication, especially with\nthe accounting professionals.<\/p>\n\n\n\n<p><strong>Case Study #3<\/strong><\/p>\n\n\n\n<p><em>How do hospital systems manage information from\nresearch participants when they are submitting questionnaires via survey\nmonkey? <\/em><\/p>\n\n\n\n<p>One clinical research site\nthat the author works with uses Survey Monkey to test research participants\u2019 understanding\nof the informed consent process. The institutional review board approves the\nsurvey. Whether research participants complete paper or electronic questionnaires,\nthe data must be validated and source documentation must be kept.<\/p>\n\n\n\n<p><strong>Conclusion<\/strong><\/p>\n\n\n\n<p>Hospital systems must consider the best ways to use digital tools in clinical trials. All digital tools have both challenges and benefits; however, they can be used to facilitate billing compliance.<strong><br><\/strong><strong><br><\/strong><\/p>\n\n\n\n<p><strong>TABLE 1<\/strong><\/p>\n\n\n\n<p><strong>Billing Compliance<\/strong><\/p>\n\n\n\n<ul><li>Develop billing grids and budgets that:<ul><li>Appropriately aid in the segregation of routine costs and\n      research-related charges <\/li><li>Build better budgets for higher revenue <\/li><li>Determine defensible and fair market value for sponsor billing\n      and provider payment<\/li><\/ul><\/li><li>&nbsp; Assist patients with\n     meeting protocol requirements and deadlines <ul><li>Provide a method for reporting medication adherence <\/li><li>Assist with quality of life for surveys for recognition and data collection<\/li><li>Assist with recruitment and clinical trial awareness <\/li><\/ul><\/li><li>&nbsp;Track activities taking\n     place across a network of hospitals and sites to ensure:<ul><li>Timely accounts receivable <\/li><li>Providers paid correctly<\/li><li>Transactions tracked and reported appropriately in\n      enterprise-wide accounting systems<\/li><\/ul><\/li><li>&nbsp; Use collected data and\n     generated metrics to:<ul><li>Improve efficiency and reduce rework associated with financial\n      processes<\/li><li>Provide forecasts of study related cash flow and associated labor\n      needs<\/li><li>Provide proper accounting of study funds flow <\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong>TABLE 2<\/strong><\/p>\n\n\n\n<p><strong>Mobile Technology in\nClinical Trials<\/strong><\/p>\n\n\n\n<ul><li>Challenges:<ul><li>Not everyone has the same capacity for understanding technology<\/li><li>Reliance on research participants to enter data <\/li><li>Most smart phones can store personal data<\/li><li>Incriminating pictures, video, and data can be found on cell\n      phones<\/li><li>Mobile technologies could be hacked<\/li><\/ul><\/li><li>Benefits:<ul><li>Identifying research participants at multiple points of entry\n      into a system by using digital tools<\/li><li>Notifying outside service providers of incoming research participants<\/li><li>Providing correct billing information to outside service\n      providers through mobile mechanisms<\/li><\/ul><\/li><li>Use for billing compliance:<ul><li>Reminders in the form of sensors or alarms <\/li><li>Recruitment<\/li><li>Retention<\/li><li>Diary submission<\/li><li>Informed consent<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong><br>\n<\/strong><\/p>\n\n\n\n<p><strong>TABLE 3<\/strong><\/p>\n\n\n\n<p><strong>Social Media in\nClinical Trials<\/strong><\/p>\n\n\n\n<ul><li>Challenges:<ul><li>Use of Facebook and Twitter by participants can skew data<\/li><li>Sharing on social media of side effects <\/li><li>Participants learning from other patients regarding study\n      selection mechanisms<\/li><\/ul><\/li><li>Benefits:<ul><li>Creates collaboration with community physicians <\/li><li>Helps to prevent competing trials within one system<\/li><\/ul><\/li><\/ul>\n\n\n\n<p><strong><br>\n<\/strong><\/p>\n\n\n\n<p><strong>TABLE 4<\/strong><\/p>\n\n\n\n<p><strong>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Health Information Technology in\nClinical Trials<\/strong><\/p>\n\n\n\n<ul><li>Health information technologychallenges: <ul><li>Many systems at sites that do not interface<\/li><li>Physician practices and hospitals often do not bill appropriately<\/li><li>Accounting for research revenue<\/li><li>Lack of ability to identify research participants<\/li><\/ul><\/li><li>Health information technologybenefits: <ul><li>Automation of manual tasks improves efficiencies<\/li><li>Automation of financial processes increases accuracy and\n      financial reporting<\/li><li>Automation and data mining for potential research participants<\/li><li>Automation of publication of data and clinical trial results<\/li><\/ul><\/li><\/ul>\n","protected":false},"excerpt":{"rendered":"<p>By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC Kelly Willenberg &amp; Associates Abstract: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. This article describes digital tools that clinical research professionals already have that they can use to facilitate billing compliance as well as the benefits and challenges &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/digital-tools-for-billing-compliance\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Digital Tools for Billing Compliance<\/span> &rarr;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[73,12,85,44],"tags":[76,75,74,43,37],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Digital Tools for Billing Compliance - SOCRA Blog<\/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.socra.org\/blog\/digital-tools-for-billing-compliance\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digital Tools for Billing Compliance - SOCRA Blog\" \/>\n<meta property=\"og:description\" content=\"By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC Kelly Willenberg &amp; Associates Abstract: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. 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