"YCCI Pre-Award Medicare Coverage Analyst"

Overview

The Pre-Award Medicare Coverage Analyst is responsible for ensuring compliance with Medicare coverage policies and guidelines in clinical research studies. The role involves evaluating clinical trials for Medicare qualification, assigning and/or completing Coverage Analyses, reviewing vendor completed Coverage Analysis for accuracy, and performing quality checks on completed coverage analyses and budgets. The position works closely with investigators, study teams, sponsors, Clinical Research Organizations (CROs), legal teams, and other internal stakeholders to ensure billing compliance and alignment with study requirements and institutional policies.

This is a remote position.  Job seekers who live within one of Yale’s approved work states are encouraged to apply.

Key Responsibilities

Qualified Clinical Trial Evaluation (QCT):

• Conduct thorough evaluations to determine which clinical trials qualify under Medicare guidelines and institutional policies.
• Documents results of the evaluation clearly and concisely in the site’s Clinical Trial Management System (CTMS), OnCore.

Medicare Coverage Analysis (MCA):

• Completion of Coverage Analysis or assignment to third-party vendors, ensuring adherence to all applicable national and local coverage determinations, Medicare policies, and other relevant guidance.
• Thorough knowledge of a broad scope of trials including but not limited to Pediatric, Non- Oncology, and Oncology indications.
• Deep understanding of Medicare benefit categories and other study factors that may impact qualifying status (e.g., compassionate use, comparative effectiveness, coverage with evidence development, etc.).

Budgets and Negotiation:

• Review detailed study budgets and advise on budget development alongside Medicare Coverage Analysis.
• Support budget negotiations with sponsors to ensure financial viability and compliance.

Quality Assurance:

• Performs quality checks on Coverage Analyses and budgets completed by internal staff or external vendors.
• Ensure consistency and accuracy with established guidelines and protocols.
• Conduct congruency evaluations to ensure alignment of study Calendar, Budget, ICF, and Medicare Coverage Analysis.

Training and Development:

• Assist in the development of department SOP’s and workflows related to Coverage Analysis and billing designations.
• Develop training materials and conduct training sessions for both clinical and non-clinical research staff on Medicare coverage policies, as assigned.
• Build and maintain positive relationships with Yale and industry partners; Provide ongoing support and guidance to research teams and Protocol Activation and Lifecycle Management (PALM) team members.

Documentation and Reporting:

• Retain comprehensive records of coverage analyses and quality checks.
• Work with leadership and other team members on a case-by-case basis to align documentation with current policies and procedures.

Compliance and Risk Management:

• Evaluate past and current studies for alignment with billing compliance, coding, charge review, and clinical practices.
• Ensure all activities comply with federal, state, and institutional regulations and policies.
• Identify and mitigate any risks associated with clinical trial billing and coverage of study services.

Required Skills and Abilities

1. Demonstrated experience developing detailed Medicare Coverage Analysis. Advanced understanding of Medicare coverage policies and guidelines.
2. Proven experience training, developing and leading a team of coverage analysts. Excellent communication, negotiation, and stakeholder management skills. Ability to maintain a professional work environment. Ability to maintain a high level of autonomy when working independently and as part of a team. Commitment to collaboration, compliance, and research integrity.
3. Effective project management skills with the ability to handle multiple projects simultaneously. Ability to independently maintain a high-volume central inbox while also completing personal workload and meeting coverage analysis review timelines
4. Strong analytical and problem-solving skills with attention to detail. Adaptability in a fast-paced, remote work environment. Excellent time management skills.
5. Strong understanding of financial analysis and budget negotiation. Advanced skills utilizing Microsoft Office Suite, including Excel, and clinical trial management systems (CTMS) or financial tracking tools.

Preferred Skills and Abilities

1. Degree in healthcare administration, clinical research, healthcare compliance or a related field. Advanced degree preferred.
2. At least 5 years of experience in clinical research billing, coverage analysis, or a related area. Experience in academic medical centers, CROs, or pharmaceutical/biotech organizations.
3. Familiarity with Good Clinical Practice (GCP) guidelines and clinical trial regulatory requirements. Professional certification (e.g., CCRA, CCRP, or financial certifications).
4. Knowledge of clinical trial contracts, billing compliance, and charge review processes. Experience utilizing sub-designations and recording charge master events. Familiarity with federal grant budgeting and cost principles.
5. Familiarity with Oncore and Salesforce systems.

Principal Responsibilities

1.  Master various data systems available to the practice and understand their applications and integrability. Extract and consolidate data from multiple sources both internally and externally.
2.  Analyze data, including medical revenue, insurance fee schedules, cost reporting, and other sources available. Design and create accurate and timely reports to meet business needs.
3.  Use statistical modeling skills to provide historic, current, and predictive views on the clinical business’s financial performance. 
4.  Interpret data, summarize findings, and present recommendations to all levels of management regarding financial plans and other complex financial matters. Contribute to the planning and improvement of practices, processes and systems
5.  Work collaboratively with business leaders, physician executives, IT, billing, and management team members across the YSM and YNHHS. Provide a high level of service that cultivates and maintains strong working relationships and communicates effectively. Take ownership and accountability for timeliness, accuracy and relationship management. 
6.  Translate department finance goals into objectives. Identify and raise potential financial opportunities, issues, risks, ideas and solutions. Identify the appropriate stakeholders to include in consultations, communications, approvals or buy-ins for designing and implementing changes.
7.  Supervise various resources in the development and implementation of strategic programs and initiatives. 
8.  Perform other duties as assigned.

Required Education and Experience

Bachelor’s degree in Accounting, Business, Economics, Finance, or related field and three years of related experience or an equivalent combination of education and experience.