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Double-dipping refers to instances of medical malpractice in which the

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THE MULTIFACETED UNIVERSE OF CLINICAL RESEARCH This article proposes a model that may be tailored to the needs of specific organizations to tackle their prevailing problem of billing errors related to
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THE MULTIFACETED UNIVERSE OF CLINICAL RESEARCH This article proposes a model that may be tailored to the needs of specific organizations to tackle their prevailing problem of billing errors related to research and sponsored projects. Pukar Ratti, MSChE, MSHCM, CIM, CCRP Billing Errors in Clinical Research Is There Room to Say Oops...? Double-dipping refers to instances of medical malpractice in which the research institution is paid once by Medicare, Medicaid, third-party insurance, or a research subject and again by the research study sponsor (a pharmaceutical company, the National Institutes of Health, etc.) for the medical services performed solely to follow a research study protocol. 1 Such actions can cause vigorous scrutiny and lead to tough allegations under the False Claims Act (1986) for erroneous billing to a government agency or the Insurance Fraud Prevention Act (1994) (part of the Omnibus Crime Bill) for erroneous billing to private insurers. 2 With regard to false claims liability, there is no special provision for research activities; instead, these are subject to the same laws that govern clinical activities associated with routine standard of care. 3 Moreover, the availability of a new Stark II exception for academic medical centers does not preempt the legal requirements pertaining to billing compliance. 4 Practically speaking, the occurrence of billing errors in clinical research is a burgeoning problem that may arise at any stage ranging from patient admittance to the handling of charge sheets by the research team, from coding errors to billing department activities, and elsewhere. Clearly, the elimination of billing errors is not a one-person war. Just as it takes a whole village to raise a child, accurate billing in clinical research is a complex and challenging process that can appear daunting at first glance. This modus operandi requires a diverse group of professionals working cohesively and collaboratively with one another in their individual medical practice settings. This article proposes a model that may be tailored to the needs of specific organizations to tackle their prevailing problem of billing errors related to research and sponsored projects. This model is exemplary of the modern leadership and financial stewardship qualities that are necessary to advance the research enterprise. Internal Controls One of the top priorities for the business offices of each institution participating in research activities and sponsored projects should be to periodically evaluate, assess, revise, implement, and monitor the effectiveness of their internal controls. Internal controls can be defined as parameters that essentially result in good business practice. 5 These controls allow decreases in wasteful spending, elimination of fraudulent activities, enhancements in the accuracy of accounting/finance data, compliance with institutional policies, and increases in overall efficiency. 42 MONITOR OCTOBER 2009 A 10-step working model (Figure 1) has been designed and implemented by the Leonard J. Chabert Medical Center (LJCMC) in Houma, La., one of the seven hospitals within the Louisiana State University (LSU) Health System. The LSU Health System is the fifth largest public hospital system in the United States, and is the medical provider for almost 20% of Louisiana s population. The occurrence of billing errors in clinical research is a burgeoning problem that may arise at any stage. quality management, and pharmacy. The CROC meets once a month to discuss issues surrounding research and sponsored projects; its foremost goal is to ensure smooth overall research operations. The purview of the committee includes approving newly proposed protocols, ensuring that the research team is compliant with institutional policies, monitoring consistent institutional review board (IRB) approvals, and other responsibilities. The CROC constantly oversees the efficiency of the existing internal controls pertaining to accuracy of billing in clinical research. No principal investigator can initiate a study on campus until a letter granting site approval and detailing the conditions of said approval has been obtained from the CROC. 2. Centralization of Research Operations LJCMC reorganized and consolidated all of its operations pertaining to Figure 1 BEST-WORM (Billing Errors System-wide Trimmer WORking Model) Internal controls drive in The model depicted in Figure 1 is defined by LJCMC as BEST-WORM (Billing Errors System-wide Trimmer WORking Model). The circle is a pictorial representation of a research institution. This schematic shows that billing errors are driven out of the research institution as more internal controls are introduced and implemented in that setting. Mathematically speaking, it may be said that the rate of displacement of billing errors is directly proportional to the number of internal controls established at that research institution. As seen in Figure 1, additional internal controls can be accommodated, if needed. The following unique practices are the 10 internal controls within BEST-WORM that jointly have reduced the possibilities of billing errors in clinical research and sponsored projects at LJCMC: BPW CROC Research institution RA/CFO Training of admit staff Policies IA ORASP C/PO BIP Creativity 1. Establishment of a Watchdog Committee A Clinical Research Oversight Committee (CROC) was formed to serve as a watchdog committee chaired by a physician and including representatives from administration, medicine, nursing, finance, compliance, research, Billing errors drive out Legend: BPW = Billing Plan Worksheet; RA/CFO = Research Accountant/Chief Financial Officer; IA = Internal Audits; BIP = Billing Insurance Plan; CROC = Clinical Research Oversight Committee; ORASP = Office of Research and Sponsored Projects; C/PO = Compliance/Privacy Officer 43 research and sponsored projects in a central office called the Office of Research and Sponsored Projects (ORASP). ORASP promotes the culture of centralization, harmonization, and integration of all institutional research operations. It is comprised of a department head, clinical research coordinators (CRCs), and research nurses (RNs and LPNs) who perform actual research operations in close conjunction with physicians, physician extenders, clinic nurses, pharmacies, laboratories, imaging centers, compliance offices, business offices, local IRBs, and extramural sponsors. The office develops complex and sophisticated strategies for the implementation of research projects (ongoing and future), data analysis, record keeping, and reporting. Additionally, the ORASP staff is responsible Billing errors are driven out of the research institution as more internal controls are introduced and implemented in that setting. for fiscal matters pertaining to acquisitions, travel, capital outlays, cost analysis, budget negotiations with the sponsor, earnings reports, and expenditures associated with the sponsored projects. The ORASP serves as a first gateway to all activities surrounding research and sponsored projects, and essentially serves as a liaison between the hospital s research and billing arms Exercise to Determine Coverage Analysis With their awareness of the actual research study protocol as a guide, the ORASP staff are responsible for the rigorous exercise of filling out a billing plan worksheet (BPW) (Figure 2) document for each sponsored project. 7 Data from the study protocol, informed consent form, clinical trial agreement, and proposed budget are precisely extracted to complete the BPW. 1 This succinct document helps with the meticulous assignment of the billable costs associated with protocol-specific clinical services, drugs, devices, and medical tests to the Figure 2 Billing Plan Worksheet TITLE OF STUDY: STUDY ARM(S): List ALL procedures, tests, visits, etc. beyond standard care that patients in this study will receive. CPT Code Frequency Standard Care: Y/N # of procedures to be billed Study UCC or Nonbillable 3 rd Party Payor Total # Payment from Sponsor UP TO PATIENTS TO BE ENROLLED Patients will be followed for years Charge Cost to Hospital Subtotal Total Cost per patient for Arm First year Total cost per patient for Arm For each additional year 44 MONITOR OCTOBER 2009 appropriate responsible parties (sponsor, government agency, insurance company, or individual research subject). The BPW also helps with the calculation of financial feasibility and reduction of potential financial risk to the institution. The research accountant... closely monitors the financial aspects of all ongoing sponsored project activities throughout the project life-cycle, thereby ensuring compliance with institutional, local, state, and federal policies 4. Appointment of a Fiscal Point-of- Contact Although the chief financial officer is the ultimate authority for fiscal matters, the research accountant (RA) serves as a primary point-of-contact in the finance/business office at LJCMC for fiscal matters pertaining to research operations. The RA closely monitors the financial aspects of all ongoing sponsored project activities throughout the project life-cycle, thereby ensuring compliance with institutional, local, state, and federal policies (such as the federal Office of Management and Budget Circulars A-21, A-110, A-133, and 45CFR46). The RA has access to the most updated list of research subjects enrolled at the hospital and meticulously reviews each of their claims after services are performed, but before those claims are sent to the respective payor. The RA is also responsible for raising red flags and placing administrative holds each time there is a billing error, coding error, cost overrun, unallowable expense, inaccurate reimbursement amount, noncompliance, questionable claim, or any other suspicious financial activity until the ORASP staff has provided justifiable clarifications of the activity. The RA also provides annual/monthly fiscal reports and program income reports. 5. Performance of Random Internal Audits A team of certified internal auditors from the Office of Internal Audit within the LSU Health System promotes a culture of accountability, reliability, and integrity in research operations. These auditors perform random financial, operational, and compliance audits with an impartial and unbiased attitude while avoiding any possible conflicts of interest. 8 They are authorized for unlimited and unrestricted access to all areas and information sources, including records, property, and personnel, that are related to research and sponsored projects activities. 8 Audit reports further ameliorate the evaluation of risk management strategies, internal controls, operational efficiencies, corrective action plans, governance processes, insufficiencies, and other inconsistencies. 8 This in turn leads to continuous quality improvement and an overall reduction in the number of billing errors. 6. Monitoring by Compliance/Privacy Officer The institutional compliance/privacy officer and/or his or her staff may also monitor the compliance of applicable medical billing requirements. All alleged violations related to billing processes are immediately reported to the compliance office. This incorporates billing issues that have been reported, but remain unresolved. The officer s staff perform random audits, address pending allegations, and see to other monitoring tasks, as deemed necessary Assignment of Billing Insurance Plan Numbers A unique Billing Insurance Plan (BIP) number, such as M01, M02, etc., is All alleged violations related to billing processes are immediately reported to the compliance office. assigned by the Central Billing Office of LSU s Health Care Services Division to facilitate effective monitoring of financial activities pertaining to governmental health insurance programs (i.e., Medicare, Medicaid) and private insurance programs (i.e., Cigna, Humana, Blue Cross/Blue Shield). The ORASP emulates the same tactic, and submits a request to the Central Billing Office to assign a BIP number (i.e., F06, G09) to each clinical trial, research study, grant, or sponsored project. In absence of the above, tracking of the ORASP s total fiscal activities under one single BIP number can become unduly cumbersome; the process of finding solutions to any discrepancies would be extremely laborious. The pending charges for research protocol specific services keep accumulating under these unique BIP numbers for a period of time, until the reimbursement check has arrived from the respective sponsor and has been verified by the ORASP and the RA. This prudent exercise allows for prompt and timely tracing of any underpayments or overpayments from the sponsor. An appropriate BIP number is used for all operational and financial activities flowing from admittance of the research subject to the hospital through to the acquisition of final reimbursement from the respective sponsor. BIP numbers also allow for an efficient auditing process by providing cleaner audit trails. 8. Training of Admittance Staff It is an established fact that prevention is far better than cure. Properly trained staff performing the admittance paperwork for research subjects 45 ensures that the correct BIP number is used from the first step of the research activities and proactively serves as the first line of defense against billing errors. A research staff member always accompanies the research subject to doublecheck the admittance paperwork, and holds the admittance card until all research protocol specific clinical activities have been performed. If, after this, the research subject is scheduled to see another doctor for a nonresearch-related procedure, the subject is required to go through the admittance process once again before undergoing those clinical activities at the hospital. Absence of research staff at this point prompts the admittance staff to use a new BIP number, rather than the research-related BIP number on file for the subject. This proactive approach works very well to reduce billing errors at a very early stage, and spares the institution of the work of back end fixing. A research staff member always accompanies the research subject to doublecheck the admittance paperwork, and holds the admittance card until all research protocol specific clinical activities have been performed. 9. Enforcement of the Guidebook (Policy) The LSU Health Care Services Division s institutional policy on Sponsored Projects/Clinical Research and Billing Compliance provides a uniform set of guidelines, policies, forms, and minimum requirements to conduct sponsored projects and ultimately achieve rational outcomes. This policy clarifies the detailed list of responsibilities and duties of essential employees. Enforcement of this policy has made a dramatic improvement in the handling of financial aspects of sponsored projects via unduplicated charges, accurate reporting, improved bookkeeping, and a well-planned process for determination of feasibility Colors of Creativity As simple a trick as changing the color of charge sheets from plain white to bright yellow has made a significant difference in shrinking the number of billing errors. The moment the billing office receives a bright yellow charge sheet, it is able to identify it easily as a bill arriving from the ORASP. A little creativity like this can go a long way. Results In 2007, the average number of questionable claims that were sent back to the research staff for clarifications were two per month. At that time, there were only two sponsored projects ongoing at LJCMC. Today, upon implementation of BEST-WORM, the average number of questionable claims that are routed back to the ORASP for clarifications is one per month. Currently, there are 12 sponsored projects ongoing at LJCMC. Thus, there has been a significant reduction in billing errors since the implementation of BEST-WORM. More evidence comes from a recent audit report. The team of internal auditors randomly audited the financial and compliance documents related to ongoing clinical trials at LJCMC. The auditors were satisfied with the detailed documentations that were furnished, and found no billing errors. The LSU Health Care Services Division is now considering implementation of the same model at the other six hospitals in the system. Conclusions The 10-step working model (Figure 1) for BEST-WORM described in this article has evolved over a period of several years at LJCMC, and has substantially mitigated billing errors. There is no set-in-stone protocol to follow blindly, since each institution has a distinct medley of factors that is unique to the dynamics of its individual organizational setting. All institutions around the globe that are engaged in research and sponsored projects may adopt BEST-WORM and refine it as needed. There has been a significant reduction in billing errors since the implementation of BEST-WORM. The simple rule-of-thumb to avoid prospective billing errors or fraudulent activities should be simply not to bill a third party when research protocol specific services and items are covered by the sponsor. 9 Open communications and early discussions with a wide array of professionals at the institution are the keys to reaching an optimally compliant operational and financial management system for billing in research and sponsored project activities. Another option for avoidance of billing errors is to harmoniously engage professionals at various levels in oversight activities. For institutions where the research operations are decentralized, a novel system should be established to centralize at least the billing practices across the institution. 4 Everyone involved in the lifecycle of billing in clinical research must be made aware of the latent legal risks associated with noncompliance. This model attempts to address how research organizations can go about closing the gaps between ideal practices and actual performance. 46 MONITOR OCTOBER 2009 Everyone involved in the lifecycle of billing in clinical research must be made aware of the latent legal risks associated with noncompliance. A strong proactive approach, rather than a reactive approach, may alleviate the problem of billing errors and provide much-needed clarity to the labyrinthine billing process. Not only does the risk of becoming liable for civil and criminal penalties warrant scrupulously accurate billing activities, but also the associated potential for a tarnished reputation of the research enterprise from negative federal audits, whistleblower suits, and expensive fines. In conclusion, when it comes to billing errors in clinical research, there is really no room to say oops. Acknowledgements The author would like to sincerely thank Shannon McNabb, director of research at LSU Health Care Services Division, for drafting the Billing Plan Worksheet (Figure 2) and kindly permitting it to be part of this article. References 1. Pitler LR, Bonomi PD Developing an effective and compliant plan for billing clinical trials. Journal of Oncology Practice 2(6). 2. Title 31, Subtitle III, Chapter 37, 3729, False Claims. 3. U.S. Department of Health and Human Services, Office of Inspector General, hhs.gov/, accessed April 22, Handler M Resolving Key Billing Issues in Clinical Research Endeavors. Epstein, Becker and Green Publications. Available at 23, accessed April 19, Pfadenhauer JB Navigating the clinical trial billing maze. Journal of Oncology Practice 2(6). 6. California State University Northridge, Office of Internal Audit. Available at csun.edu/audit/good.htm, accessed July 2, Louisiana State University Health Care Services Division. Policy # , Sponsored Projects/Clinical Research Billing and Compliance Policy. Available at Hospitals/LJC/LJC-Research9.html, accessed May 5, Louisiana State University Health System, Office of Internal Audit. Available at www. lsuhospitals.org/internalaudit/default.html, accessed April 20, Bo
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