YCCI Pre- Award Medicare Coverage Analyst

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community‑eligible for opportunities through the New Haven Hiring Initiative or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale!

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.

Qualified Clinical Trial Evaluation (QCT)

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

Medicare Coverage Analysis (MCA)

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

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

• Perform 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 SOPs 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.