Clinical Trials Office

Medicare Coverage Analysis

Are You a Patient?

All clinical trials require a Medicare Coverage Analysis “MCA” where our team of experts review protocols and determine whether there are local or national coverage determinations that justify charging certain procedures in a clinical trial to Medicare.

What is the primary reason for an MCA?
Medicare Coverage Analysis (MCA) is a required review process for clinical trials involving patient care services, designed to determine which items and services can be billed as routine costs and which are research-only and must be covered by the study sponsor. The MCA is based on the Medicare Clinical Trial Policy (National Coverage Determination [NCD] 310.1) and ensures that it meets billing compliance rules and regulations.

Does my study need an MCA even if the study participants aren’t Medicare Beneficiaries?
Yes. Medicare rules are considered the industry “gold standard”, and many commercial payers and state laws follow these guidelines.

What documents are required for the Medicare Coverage analysis?

List of Essential Documents

Pre-Award: Coverage Analyst Team Bios and Responsibilities

Maria Rios

Coverage Analysis Manager, joined the Clinical Trials office in 2016 with over 10 years experience in Clinical Trial Administration, encompassing diverse therapeutic areas with particular focus in oncology and device trials. She leads the Coverage Analysis team in conducting comprehensive coverage analysis for industry-sponsored clinical trials, adhering to institutional practices and Medicare billing guidelines and regulations.

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Joanne Pak

Clinical Trials Operations Manager, is responsible for performing Medicare coverage analysis on non-industry studies. Liaison between CTO and Cancer Center to aid collaboration efforts between two departments.

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Sherlonda Allen

Medicare Coverage Administrator, responsible for completion of Medicare Coverage Analysis for clinical trials, oncology experience preferred. Lead kick-off meetings at study initiation to obtain timely justification and feedback from Principal investigator and Study Team. Act as the point person for tracking project related items/issues.

Cultivate and maintain relationships with stakeholders to provide updates and process guidelines, and obtain feedback and approvals. Provide coding and pricing for research procedures based on MCA. Other duties as assigned.

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Taison Tran

Project Specialist, joined the Clinical Trials Office in 2019 and currently is responsible for coverage analysis for cancer clinical trials with emphasis on hematological, genito-urinary, and some Phase I trials. Previous clinical trial experience came with working for USC Norris as a Phase I oncology study coordinator and data manager since 2009.

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