General Summary

Under limited supervision, and with the latitude for initiative and independent judgment, performs, coordinates, and manages the creation and outsourcing of billing analysis in accordance with the Center for Medicaid and Medicare Services (CMS) regulations and the Clinical Trial Policy for all clinical trials. The billing analysis must be compliant with the Medicare billing rules.

This position also serves as liaison with the investigators, research teams, healthcare providers, budgeting and contracting offices at UMMS and UMB, and in coordination with departmental clinical trial management processes. This position works with various systems including Epic and HPM Explorer for the purpose of segregating charges to ensure compliant billing for research services as well as providing pricing for budgeting purposes.

This position provides guidance and support to the Clinical Trial Analysts, and acts as a subject matter expert on coverage analysis, CMS regulations, as well as local and federal coverage determinations.

Principal Responsibilities and Tasks

The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. These are not to be construed as an exhaustive list of all job duties performed by personnel so classified.

• Creates coverage analysis grids and analyzes the performance of the actual coverage analysis.
• Researches and applies policies, guidance and guidelines from various sources including federal, state, UMMS and the University of Maryland Baltimore (UMB).
• Responsible for the dissemination of relevant documents and information to various parties.
• Performs basic and complex billing and budget analysis in accordance with CMS regulations for all clinical trials performed at UMMS affiliates and FPI practice offices and clinics.
• Applies CMS regulations, FDA guidance, ethical policies when performing coverage analysis.
• Develops grids/schedule of events to serve as the basis for the coverage analysis.
• Develops the coverage analysis including reviewing each potentially billable item within the clinical trial and citing specific resources for justification of the appropriate designations.
• Applies the appropriate CDM and/or CPT codes for potentially billable items in the coverage analysis in order to assist in the management of claims review, as well as identifying items that are to be billed to the sponsor via the budgeting and contract teams at the Office of Research and Development (ORD) at University of Baltimore (UMB).
• Collaborates with research teams in performing the coverage analysis, as well as facilitating the clinical trial management process involving UMB, UMMS, and FPI.
• Serves as liaison and contact with the clinical research teams and healthcare providers.
• Researches and applies regulations and law related to Medicare regulations, OIG regulations, FDA guidance, and related compliance documents using various resources including computer search modalities.
• Synchronizes the final coverage analysis with appropriate final study documents.
• Triages coverage analysis requests to our coverage analysis vendor when applicable. Acts as the intermediary between the vendor and the study teams during coverage analysis creation, tracks progress, and reports results.
• Assists as needed with segregation of charges in distinguishing research charges billed to the study versus those research charges that can be billed to insurance.
• Reviews and resolves invoice discrepancies with the Central Billing Office and the study teams,
• Creates Fee Schedules in Epic for each research study.
• Initiates request of RSH records in Epic for research studies after coverage analyses are completed
• Organizes monthly CA and charge segregation internal reviews with the clinical trial analysts to ensure accuracy.
• Serves as the subject matter expert for UMMS on coverage analysis creation and current research billing guidelines as well as research billing compliance
• Other duties as assigned.