Clinical Trial Coverage Analyst

Sutter Health • Sacramento, CA

3d

About The Position

Responsible for determining if a study is a qualifying clinical trial, and performing the initial coverage analysis review by analyzing individual research protocol clinical services to assure federally compliant billing and reimbursement. Ensuring complete submission of documents required to conduct a coverage analysis and activate a study and submitting notification of participation letter to Noridian (MAC) when needed. Determining and documenting billing support for clinical items by reviewing the protocol, investigator brochures, sponsor budget, sponsor proposed contract, and consent template, the evidence of medical necessity justifications, and appropriate payers of protocol-specific services and federally required research-related claims modifications for service payment by insurance. Conducting the final review and analysis of study documents to assure all study-related documents are harmonized. Interpreting Medicare/Medicaid coverage decisions, national guidelines as they apply to specific clinical trial medical items and services. Supporting Current Procedural Terminology (CPT)/Healthcare Common Procedure Coding System (HCPCS) billing determinations of clinical trial items and services and applying all applicable local coverage decisions, national and local coverage determinations, and third-party payer rules for clinical trial coverage analyses. Interfacing with various Sutter Health research affiliates, administrative staff, principal investigators, essential partners, and clinical trial sponsors regarding reimbursement for research services. Implementing an integrated support function that standardizes the administrative and financial support functions of clinical trial billing compliance thereby improving service to the Sutter Health research community and providing an increased level of research compliance.

Requirements

• Bachelors or equivalent education/experience
• 5 years recent relevant experience
• Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance
• Knowledge of Medicare benefit categories, statutory exclusions, and national and local coverage determination
• Knowledge of national medical practice guidelines, Food and Drug Administration investigational drug and device research
• Knowledge of medical coding, protocol visit span allowances, protocol-specified clinical services, and basic research study demographics
• Knowledge of clinical research financial activities and documentation required before study initiation, including research protocol, internal budget, sponsor contract and budget, and consent template
• Demonstrated written, oral, electronic communication; presentation and interpersonal skills
• Ability to use multiple technical systems as intended
• Ability to collaborate across revenue cycle, compliance, and research operations teams
• Attention to detail
• Analytical and computer skills, including proficiency in Microsoft Word, Outlook, and Excel
• Ability to work independently and to accept responsibility for complex and sensitive decision making as it relates to the position
• Outstanding organization skills to manage many competing timetables and responsibilities
• Demonstrated leadership skills, including team building, and coaching/mentoring with the ability to motivate and engage others
• Ability to build and establish effective working partnership with employees, peers and/or leaders to achieve business objectives
• Verbal and written communication, and interpersonal skills
• Organizational and time management skills, with the ability to prioritize multiple projects while delivering quality service and achieving business results
• Demonstrates tactical and analytical thinking and planning skills, and is able to develop plan to accomplish objectives, identify obstacles and resolve operational issues
• Demonstrated skill in communicating and collaborating with Sutter Health essential partners (Legal Services, ECS, SHIRB) and research institute personnel

Responsibilities

• Determining if a study is a qualifying clinical trial
• Performing the initial coverage analysis review by analyzing individual research protocol clinical services to assure federally compliant billing and reimbursement
• Ensuring complete submission of documents required to conduct a coverage analysis and activate a study
• Submitting notification of participation letter to Noridian (MAC) when needed
• Determining and documenting billing support for clinical items by reviewing the protocol, investigator brochures, sponsor budget, sponsor proposed contract, and consent template
• Reviewing evidence of medical necessity justifications, and appropriate payers of protocol-specific services and federally required research-related claims modifications for service payment by insurance
• Conducting the final review and analysis of study documents to assure all study-related documents are harmonized
• Interpreting Medicare/Medicaid coverage decisions, national guidelines as they apply to specific clinical trial medical items and services
• Supporting Current Procedural Terminology (CPT)/Healthcare Common Procedure Coding System (HCPCS) billing determinations of clinical trial items and services
• Applying all applicable local coverage decisions, national and local coverage determinations, and third-party payer rules for clinical trial coverage analyses
• Interfacing with various Sutter Health research affiliates, administrative staff, principal investigators, essential partners, and clinical trial sponsors regarding reimbursement for research services
• Implementing an integrated support function that standardizes the administrative and financial support functions of clinical trial billing compliance

Benefits

• Comprehensive benefits package

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level