Office of Research and Development

Office of Research and Development
The Queen’s Medical Center
1301 Punchbowl Street, UHT 508
Honolulu, HI 96813

Medicare Coverage Analysis (MCA)

What is Medicare Coverage Analysis?

Medicare Coverage Analysis (MCA) or Coverage Analysis (CA) is a systematic review that determines how each protocol-required item/service should be billed: to the study participant/payor or to the research account. It requires a three-part process according to NCD 310.1 to determine:

  • Whether a study meets Medicare’s definition of a Qualifying Clinical Trial that may support billing to a payor

  • Which items/services meet Medicare’s definition of a Routine Cost

  • Whether other Medicare rules allow or limit coverage for the items/services (e.g., NCDs/LCDs)

  • The document resulting from the review is referred to as a Coverage Analysis (CA) and used to direct medical related charges.

Why is MCA Important?

MCA ensures clinical research billing compliance and protects both our institution and study participants from major consequences of improper billing. Examples of improperly billing a payor include:

  • Billing for items/services that are for research-purposes only

  • Billing for items/services that a`re already paid for by the Sponsor (double billing)

  • Billing for items/services promised free in the informed consent form (ICF)

  • Billing for items/services variably between study participants

When is MCA Required?

The Coverage Analysis Coordinator will determine if a MCA is needed.

MCA is required for:

  • Prospective Studies

  • Data Registry with funding

  • Questionnaire with funding

  • Data Collection Studies with funding.

When an MCA is not required, only a study shell will be built. Study Shells are individual study entries in the Clinical Trial Management System Clinical Conductor that documents basic study details without a Coverage Analysis.  A MCA is not required for:

  • Data Registry with no funding

  • Questionnaire with no funding

  • Data Collection Studies with no funding.

How to Request an MCA?

Medicare Coverage Analysis Instructions

Additional Information

If you have additional questions about MCAs or Study Shells, please contact Jeremiah Villasin ( or Rebecca Ohta (