By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC
Kelly Willenberg & 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 of each tool. Clinical research professionals must determine which tools will be most effective at their site.
New challenges in billing compliance continually arise. Many of these challenges are related to the use of multiple electronic systems by clinical research sites. Some clinical research sites use up to 10 systems, with separate systems for accounting and other parts of billing compliance. The complexity and challenges are increased when a site uses an electronic medical record system and a separate accounting system for billing. Some clinical research professionals have developed creative ways to use their existing digital tools to facilitate billing compliance.
Billing compliance must be viewed broadly (Table 1). Clinical research sites need billing grids, budgets, and coverage analyses. Clinical research professionals must segregate research costs from routine costs, which is a major challenge and a time-consuming process. Until the pharmaceutical sponsors and the cooperative groups start segregating research costs from routine costs, this task has fallen on research coordinators and research finance professionals. Cooperative groups are starting to become involved in segregating research costs from routine costs, and you will see coverage analysis forthcoming from the research bases.
When clinical research professionals do segregate research costs from routine costs, they build better study budgets because they know the cost of charges. Better study budgets can result in higher revenue because clinical research sites can see which studies are and are not doing well financially and can choose to focus on studies that generate higher revenue. For the most part, however, the goal is for studies to break even. Many studies, especially cooperative group studies, lose money. Having a mixed portfolio will help a site financially.
Determining the defensible and fair market value for sponsor billing and provider payment as part of the coverage analysis enables clinical research professionals to defend the costs. This is important for compliance.
Clinical research professionals must assist research participants with meeting protocol requirements and deadlines. One way to do that is to have a good budget and a good coverage analysis that includes time points for various study activities, including enrollment and reporting of drug adherence. This provides research coordinators with a better tool for following participants, and it provides accounting professionals with a better tool for handling study finances. The budget and coverage analysis can be used to monitor recruitment and to enroll more research participants faster.
Activities must be tracked across any network of hospitals or other facilities that are participating in a study. This includes tracking:
- Timely accounts receivable
- Correct payment to providers
- Appropriate reporting of transactions in enterprise-wide accounting systems.
Some clinical research professionals do this using paper, which may be better in some ways than using a clinical trial management system (CTMS). A CTMS is one piece of billing compliance; however, these systems have both benefits and disadvantages. There are many CTMSs; however, no single system does everything that is required to manage a clinical trial. Often, challenges related to compliance occur due to non-compliant home-grown systems used at some clinical research sites. It is difficult to persuade decision-makers that it is necessary to move to a commercial CTMS.
In order to run reports and create metrics and benchmarks to improve the efficiency of the study, including faster enrollment and knowing which studies are losing money, clinical research sites need a way to collect data. Some clinical research professionals do this using paper. Others use tickler files or complete monthly tracking forms. Electronic systems can make data collection, reporting, and analysis easier. Any method that works is fine.
Best Practices in Billing Compliance
Billing compliance can be seen as a pyramid with three levels. Best practice billing compliance is at the pinnacle. The middle level is hospital bills or facility-side billing, sponsor invoicing, and physician office- or professional-side billing. The bottom level is contract, coverage analysis, budget, informed consent, and protocol.
In order to achieve best practice billing compliance, first and foremost, clinical research sites must be performing a coverage analysis for each study. The coverage analysis should guide all of the billing compliance work and should not be done separately. It guides the development of the contract and the budget and is used to validate the informed consent form against the final protocol.
Hospital bills or facility-side billing and physician office or professional-side billing must be consistent. Auditors often find that this is not the case. Practices do not know when patients are enrolled in a study or when a visit is a study visit. There is no electronic mechanism for communicating this information, and the practice has a different system than the clinical research site. In order for the site to invoice the sponsor correctly at the end of the study and receive the money that is owed, all billing must be consistent.
If billing is not correct, the site may have violated the False Claims Act. The main clinical research site or a practice involved in the study might not be double-billing; however, if any hospital, facility, or office is not billing correctly, the False Claims Act can be violated.
There is a disconnect between the two sides: billing compliance professionals at hospital facilities and the physician practices conducting research. Physicians do not understand the consequences of a lack of billing compliance when a practice bills independent of the hospital facility. They may think that the amount of research conducted is too small to be concerned or that any revenue generated will be too little for any worry. It does not matter, however, if a clinical research site is conducting 1 study or 700; billing compliance is necessary. What does matter is what physician practices are involved and how they are notified of billing compliance intelligence.
Sponsors sometimes discuss studies with physicians without involving billing compliance professionals. The physician then wants to conduct the study, or the physician even signs documents agreeing to conduct the study without considering the billing compliance requirements. Billing compliance professionals must then raise the issues related to billing compliance. It is possible to reach the pinnacle of billing compliance. This, however, takes time and an appreciation of the billing rules and guidelines.
Digital Tools Available to Assist in Clinical Trial Billing
Mobile phones, social media, and health information technology can all be used to assist in billing compliance. Some clinical research sites are using social media for recruitment. Research participants are very active on social media such as Twitter and Facebook and often comment on their participation. Clinical research professionals cannot stop this; however, they can use it to their advantage. It is necessary to understand the advantages and disadvantages of mobile phones and social media in relation to clinical trials.
Digital tools can assist in clinical trial billing. Some clinical research sites, for example, have all of their coverage analyses on iPads, enabling the clinical research professional to look at the coverage analysis for a study when meeting with a research participant. Informed consent forms are sometimes put on iPads or other electronic tools. The use of iPads and other digital tools in clinical trials will become increasingly common over the next several years.
National Institutes of Health Director Dr. Francis Collins recently said:
“Many opportunities to improve health very much depend upon cell phone technologies, since cell phones are so rapidly expanding in many parts of the world that otherwise don’t have much access to communication.”
Table 2 provides an overview of mobile technology challenges and benefits as well as the way in which mobile technology can be used to facilitate billing compliance. People in the United States are very dependent on their mobile phones and take them for granted. However, many people do not have any digital access in some parts of the world where clinical trials are being conducted. Even within the United States, capacity differs. For example, not all patients have access to an iPad or the Internet, so that they may read the informed consent form before meeting with clinical research professionals to discuss a study to ensure that it is not the only method.
Another challenge of mobile technology is reliance on research participants to enter data, such as quality of life surveys, and again, lack of access to the Internet by some research participants to take Web-based surveys. Some clinical research sites have a kiosk for research participants to use during study visits to enter data.
Smart phones can store personal data as well as incriminating photos and video. For example, the phone’s owner could record a conversation without telling the other person, or a video could be posted on YouTube without the other person’s knowledge or consent. Smart phones can also be hacked.
Mobile phones can be used to identify research participants at multiple points of interest, for example, to alert clinical research professionals when a patient who is eligible for a study is in the clinic. They can help with many tasks including some that facilitate billing compliance, like reminders in the form of sensors or alarms, and for recruitment, mobile phones can help with the tasks of retention, diary submission, and informed consent. There can, however, be legal issues in doing this and in using cell phones to contact patients and research participants. Clinical research professionals who use cell phones to communicate with patients and research participants must know their state laws, and they should talk to legal counsel and their compliance group to learn what they can and cannot do.
Like mobile technology, the use of social media in clinical trials has both challenges and benefits (Table 3). Use of Facebook and Twitter by research participants can skew data. Research participants find each other on social media and share information, including the side effects of study interventions. They also listen to other research participants regarding whether they should participate in a study.
The benefits of using social media in clinical trials include creating collaboration with community physicians and assisting in the prevention of having competing trials within one system. One clinical research site that the author works with has three hospitals in one region. Clinical research professionals use a cell phone tool that they developed to keep all of the hospitals updated on which patients are enrolling in studies, and they do this without using any patient names.
The use of health information technology in clinical trials also has both challenges and benefits (Table 4). Many systems, including CTMSs, Epic and other electronic medical records systems, and accounting systems do not interface. Often, physicians in hospitals have different systems, so interface can be difficult.
Appropriate accounting for research revenue is difficult unless the clinical trials office has an accounting mechanism. Clinical research sites often leave billing compliance with the research coordinators, who generally do not have the time or training to do this. Lack of ability to identify potential research participants is another challenge, resulting in slow accrual. This problem has increased recently, including cooperative group studies. The reasons for lower accrual can be many, and barriers including payer issues cannot be discounted.
Automation is a key benefit of health information technology, such as electronic medical records, for clinical trials.
Health information technology automates manual tasks, resulting in improved efficiency. Automation of financial processes increases accuracy and financial reporting, and it enables data mining for potential research participants. Clinical research sites can extract information from systems by flagging certain types of patients or by having a clinical trial number in a billing system. However, CMS can also data mine research participants and compare their information. This will be frightening for clinical research sites. Health information technology automation enables publication of data and clinical trial results and enables clinical research sites to generate accurate information about the number of research participants in each clinical trial.
Sponsors are using automated health information technology to compare and select clinical research sites. They can visit ClinicalTrials.gov to see which sites are conducting certain types of studies. Sponsors are asking sites to use their electronic medical records to access data on potential research participants, for example, the number of patients with a certain diagnostic code. They are also using health information technology to optimize protocols and enhance study design, which benefits clinical research sites. This will enable faster recruitment of research participants, and studies can be conducted more efficiently.
Many billing systems for clinical research sites, hospitals, and physicians are available, including Epic, Cerner, Mosaiq, Allscripts, McKesson, Nextgen, and Aria. The following brief case studies illustrate some of the challenges in using health information technology in clinical trials.
Case Study #1
How do hospital systems identify patients as research participants?
Hospital systems can identify patients as research participants by flagging patients with a “For Your Information” (FYI) or research flag by developing dual encounter forms or by using the research study number as the financial class. Some of these tasks can be done electronically, such as using power trials for Cerner or Epic. They can also be done simply, for example, through fax communication.
A CTMS can be used to enhance communications. Which system is best for a specific hospital system depends on the hospital’s operations and billing system. The informed consent process should be incorporated into the pre-authorization process for insurance coverage so that staff members know that a patient is considering participating in a study before a patient is consented or a claim is submitted. The billing system should also be used to identify patients who are research participants.
Case Study #2
How do hospital systems notify outside physician offices and vendors about research participants?
Some large hospital systems are affiliated with many non-employed physician practices. Billing for non-employed physician practices is challenging. It is necessary to ensure that these practices have information about research participants including the coverage analysis; however, the way in which the information is shared depends on the systems used. Differerent billing systems have different needs that must be considered. The solution includes providing read-only access to shared study files. CTMSs make it easy to do this and enhance communication, especially with the accounting professionals.
Case Study #3
How do hospital systems manage information from research participants when they are submitting questionnaires via survey monkey?
One clinical research site that the author works with uses Survey Monkey to test research participants’ understanding of the informed consent process. The institutional review board approves the survey. Whether research participants complete paper or electronic questionnaires, the data must be validated and source documentation must be kept.
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.
- Develop billing grids and budgets that:
- Appropriately aid in the segregation of routine costs and research-related charges
- Build better budgets for higher revenue
- Determine defensible and fair market value for sponsor billing and provider payment
- Assist patients with
meeting protocol requirements and deadlines
- Provide a method for reporting medication adherence
- Assist with quality of life for surveys for recognition and data collection
- Assist with recruitment and clinical trial awareness
- Track activities taking
place across a network of hospitals and sites to ensure:
- Timely accounts receivable
- Providers paid correctly
- Transactions tracked and reported appropriately in enterprise-wide accounting systems
- Use collected data and
generated metrics to:
- Improve efficiency and reduce rework associated with financial processes
- Provide forecasts of study related cash flow and associated labor needs
- Provide proper accounting of study funds flow
Mobile Technology in Clinical Trials
- Not everyone has the same capacity for understanding technology
- Reliance on research participants to enter data
- Most smart phones can store personal data
- Incriminating pictures, video, and data can be found on cell phones
- Mobile technologies could be hacked
- Identifying research participants at multiple points of entry into a system by using digital tools
- Notifying outside service providers of incoming research participants
- Providing correct billing information to outside service providers through mobile mechanisms
- Use for billing compliance:
- Reminders in the form of sensors or alarms
- Diary submission
- Informed consent
Social Media in Clinical Trials
- Use of Facebook and Twitter by participants can skew data
- Sharing on social media of side effects
- Participants learning from other patients regarding study selection mechanisms
- Creates collaboration with community physicians
- Helps to prevent competing trials within one system
Health Information Technology in Clinical Trials
- Health information technologychallenges:
- Many systems at sites that do not interface
- Physician practices and hospitals often do not bill appropriately
- Accounting for research revenue
- Lack of ability to identify research participants
- Health information technologybenefits:
- Automation of manual tasks improves efficiencies
- Automation of financial processes increases accuracy and financial reporting
- Automation and data mining for potential research participants
- Automation of publication of data and clinical trial results