Clinical Trials Research Coverage Analyst (Remote)

Job Summary:

This role supports the Clinical Trials Research Revenue Cycle by performing Medicare Coverage Analysis (MCA) in accordance with Medicare’s Clinical Trial Policy (NCD 310.1) and providing guidance to research staff on billing processes for clinical research studies. The analyst will assist in ensuring compliance with Medicare coverage requirements and contribute to the accurate preparation and submission of coverage analyses, while maintaining alignment with regulatory standards and research billing procedures. This position also involves collaboration with various teams to manage and resolve any billing-related issues. The role requires strong attention to detail, communication skills, and a commitment to supporting the organization’s mission and policies.

Key Responsibilities:

• Maintain in-depth knowledge of Medicare’s Clinical Trial Policy (NCD 310.1) and relevant guidance documents.
• Prepare detailed and accurate coverage analyses, including budget overlays, in a timely manner.
• Review clinical trial protocols and regulatory documents to create billing plans for medical procedures and services in research projects.
• Determine which procedures in clinical trials are routine and therefore billable to Medicare and other third-party payers, based on CMS policy and National and Local Coverage Determinations (NCDs and LCDs), as well as professional practice guidelines. This requires extensive independent research to identify applicable guidelines.
• Review informed consent forms to ensure they clearly inform patients of which procedures will be billed to their insurance and which will be covered by the study’s budget, as per the MCA.
• Ensure consistency between coverage analysis, clinical trial protocol, informed consent templates, study budget, and contract terms regarding payment terms.
• Document MCA determinations comprehensively to support the decision-making process.
• Assess whether a formal Medicare Coverage Analysis is needed for specific research protocols.
• Work closely with investigators to ensure clinical trials meet CMS criteria for qualifying clinical trials.
• Collaborate with IRB staff and investigators to resolve any issues related to MCA determinations or informed consent form language.
• Communicate effectively with investigators, research teams, Patient Financial Services, IRB, and Research Compliance teams about MCA issues and determinations.
• Stay updated on FDA regulations, Medicare policies, and relevant state laws regarding clinical research billing.
• Contribute to special departmental projects as assigned.
• Prepare applications for approval of billing related to investigational devices.
• Serve as a resource in the development and analysis of research protocols and budgets, ensuring alignment between budget justification and sponsor requirements.
• Organize and present budget justifications, explaining cost categories such as salaries, equipment, travel, supplies, and indirect costs in the context of research study budgets.
• Ensure the accuracy of all finalized budget documents, ensuring the budget narrative aligns with dollar amounts and language.
• Explain the importance of budget items in relation to the study’s objectives and methodology.
• Provide detailed explanations to the clinical study team regarding budget line items, not just restating expenditures.
• Justify the rationale for budget overlays with clear and sufficient documentation.

Required Qualifications:

• Bachelor’s Degree in a health-related field (e.g., pharmacology, nursing, biology).
• 1 to 5 years of coding experience, or equivalent professional experience.
• Must achieve AAPC or AHIMA certification in coding (e.g., CPC, CCS, or CMC) within one year of hire, with a focus on research medical billing and coding.
• Proficiency in medical terminology and research billing language, with expertise in the current coding systems: CPT, ICD-10-CM, and HCPCS Level II.
• Strong investigative and analytical skills.
• Proficiency with MS Excel, including tables, formatting, and basic calculations.
• Exceptional attention to detail and a demonstrated ability to work effectively in a team environment.
• Ability to learn and apply technical knowledge in clinical research, medical coding, and revenue cycle management.
• Excellent written and verbal communication skills, with the ability to interact directly with senior management and various departments.
• Strong organizational skills, with the ability to manage multiple tasks and meet deadlines.
• A customer service-focused mindset with strong problem-solving and financial analytical skills.
• High level of accuracy and precision in analyses and processes.

Preferred Qualifications:

• Familiarity with different types of clinical research and the drug development process.
• Knowledge of FDA regulations for clinical trials involving Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• Understanding of Medicare coverage decisions, benefit policies, and research billing processes.
• Previous experience in research billing, budgeting analysis for clinical trials, coverage analysis, or related research finance roles.