New office ready to support research community's needs

MUSC clinical investigators, grant administrators, study coordinators and research service providers will have a new shop to support them with clinical research studies through a new campus resource called the Office of Clinical Research. The OCR will form part of MUSC’s central Research Administration Offices.

The creation of the OCR at MUSC was the result of several years of planning. Currently, academic medical centers across the country have instituted similar types of offices or are beginning to develop them. Studies have shown that a central office is critical to providing guidance and support to research teams in specialized areas, such as research opportunity identification, feasibility assessment, the site selection process, billing compliance, budget development, sponsor negotiation and invoicing and participant remuneration.  With the increasing burden of federal, state and institutional requirements, the OCR will serve as MUSC’s billing compliance hub. Two primary goals are to mitigate the risk of federal audit findings due to non-compliance with federal research billing requirements and reduce any related negative publicity.

“The idea of establishing an office for clinical research has evolved over the last four to five years,” said Kathleen Brady, M.D., Ph.D., vice president for Research. “Other academic medical institutions also are actively contemplating developing their own offices of clinical research. A driving factor for establishing OCRs is the development of electronic health records at hospitals and clinical institutions, and the mandate to use these systems for billing. While research has long been conducted within the clinical setting, there is a history of issues related to accurately billing for research services separately from clinical services.  The process has become more complicated now that electronic health record systems are automatically generating bills. The OCR will help with billing compliance and improve the efficiency of research processes. As a bonus, the electronic health record also brought about opportunities such as improving awareness of available clinical trials to patients at their clinic visit and increasing recruitment into those trials.  The OCR will help ensure MUSC continues to bring cutting-edge clinical studies to our region, and as the number of trials increases, that billing remains accurate and efficient.”

In October 2016, a memorandum of understanding was signed by senior leaders representing the MUSC Office of the Vice President for Research, MUHA, MUSC Physicians, the College of Medicine and the Office of the Provost, to support this effort. Royce Sampson, who also serves as chief operations officer for the South Carolina Clinical & Translational Research Institute (SCTR), was named as the OCR Director.

“It’s a complicated research environment today. EHR — electronic health records — have changed the billing process for research studies. The changes have resulted in research coordinators and investigators trying to understand and comply with laws that drive billing, which include requiring cost language in consent forms and building complex billing calendars in electronic systems.  By centralizing support and oversight for the billing process, the OCR will meet federal billing compliance requirements and free up study teams to focus on their research.  The OCR will consolidate services and expertise on campus to fill identified gaps in study team support. Our goal is to provide services that are of value to the research community,” said Sampson.

In today’s competitive clinical research environment, it’s important that investigators and research teams stay in compliance. Inaccuracies could jeopardize future study opportunities and research funding necessary to discover tomorrow’s cures.

“It’s impossible, particularly in the research world, to have all of this knowledge,” Sampson said. “Study coordinators already have a great burden managing active studies while continuing required training. They can’t possibly stay current with all of the billing compliance requirements.”

Nationally, there’s a drive to create more efficient processes that can lead to studies being activated quickly, better patient recruitment, improved operational performance to shorten the timeframe to get new treatments and study drugs to market.”  The OCR is tasked with ensuring that efficient processes are in alignment with best practices through metric tracking, reporting and continuous quality improvement.

Another valuable service provided through the OCR will be data tracking throughout the course of a study. Providing continuous data collection is important to MUSC, said Brady. “This gives MUSC the ability to bring in high-quality trials. It elevates the types of research opportunities we can attract.  Plus, the OCR will help investigators be successful in industry trials site selection and recruitment.”

For the past six months, both Brady and Sampson have been busy promoting OCR’s expertise to the research community. They’ve set up training on campus with Aegis Ethics and Compliance, a national expert compliance consultant and training firm.  Additional training is provided by the OCR related to budgeting, billing compliance, invoicing, metric tracking and other relevant topics.

Susan Holland is a grants administrator with the Department of Radiology and Radiological Science. She works closely with clinical researchers, grant administrators and study coordinators in the coordination and management of information for NIH grants and clinical and multicenter trials for sponsored and principal investigator-initiated studies. According to Holland, her department has operated with the necessary tools to help manage and maintain study trials, but recently it turned to the OCR to collaborate and share best clinical research practices.

“Our Department of Radiology’s research study teams are experienced in the pre-award, award, post-award and closeout phases of clinical studies and we are sharing ideas with the OCR to simplify the process,” said Holland.  She hopes their collaboration will create a shared system that can accurately capture procedure costs, and their related ancillary costs such as reading X-rays, during a study.

In an alternative role, Holland and her radiology colleagues also serve as providers to campus research teams, which they hope to expand, by reviewing study protocols for correct radiology services and procedures.

According to Sampson, OCR staff will be busy, and their top priorities in this first year will be ambitious: recruiting staff which include research process, reimbursement, budgeting and sponsor invoicing, training, and metric tracking experts; developing and implementing policies, workflows and training; implementing prospective reimbursement analysis (PRA) for all MUSC clinical research studies; and piloting study invoicing procedures to sponsors. In year two, the implementation of a Clinical Trials Management System (CTMS), in collaboration with our MUSC Biomedical Informatics Center (BMIC), will support enterprise-wide sponsor invoicing for services provided through clinical trials.

For information about the OCR, visit horseshoe.musc.edu/research/ocr.

Office of Clinical Research FAQ

What services does the Office of Clinical Research offer?         

• Study documents and contract analysis for consistent, clear and allowable cost language

• Budget development and sponsor negotiation support
• Identification of services and pricing to support research studies including MUHA and MUSCP costs in collaboration with hospital and departmental service providers
• Coverage analysis

• Verification of insurance coverage for MUSC Health services associated with research studies to be paid by third party payers with regulatory justification

• Support for renegotiation of these costs when not covered by insurance
• Building research billing calendars in SPARCRequest to push to Epic for studies with MUSC Health billable services

• Identify research orders to support the Epic research team’s order set builds

• Research billing support to ensure that all MUSC Health charges associated with research are billed to the appropriate funding source and with the required codes and modifiers

• Identification of clinical trial opportunities and investigator matching

• Feasibility assessment and site selection support

• Metric tracking and reporting to ensure efficient study activation timelines, improved participant accrual and optimal financial performance

• Management of Greenphire, participant remuneration system

• Enterprisewide sponsor invoicing

• Providing CTMS research project management in collaboration with MUSC’s Biomedical Informatics Center who will lead system implementation and maintenance 

• Management of education and training for study teams to navigate the clinical research process

How will this make life easier for the clinical investigator?

Currently, it is the responsibility of the study team, often the research coordinators, to interpret the research study protocol and translate that information into CPT-coded services and construct a research billing calendar. In the future, the analysis of research protocols will be done by research teams in concert with the Office of Clinical Research. The OCR team will support the research teams in the identification of clinical services required to conduct the study, map those to CPT-coded services in SPARCRequest and build the study billing calendar.

Who are the key leadership people that brought this together?

Authorizing signatures on the Office of Clinical Research MOU include:

David J. Cole, M.D., FACS, MUSC president; Patrick J. Cawley, M.D., CEO of MUHA and vice president of health affairs; Lisa K. Saladin, Ph.D., interim provost; Kathleen Brady, M.D., Ph.D., vice president for research; Raymond N. DuBois, M.D., Ph.D., College of Medicine dean; Bruce M. Elliott, M.D., chief physician executive of MUSC Physicians

MUSC Office of Clinical Research

Royce Sampson, RN, CRA, OCR director; Leila Forney, DNP, CCRP, prospective reimbursement analysis (PRA) associate director — oversees prospective reimbursement analysis and the PRA team; Cullen McWhite, CCRC, and Sarah Brewer, CCRA, PRA managers; Signe Denmark, CCRP, research opportunities and collaborations associate director — oversees research opportunity identification and site selection support and strategic sponsor partnerships; Kate Lenert, research learning and development  associate director — oversees the design and development of research education and training; Kyle Hutson, project manager — oversees metric tracking and reporting; Ryan Mulligan, CCRP, Greenphire project manager; and Isaac Chery, CRA will join the OCR in July to lead sponsor invoicing. The office is also recruiting one additional senior level position for the PRA Team.