What

A Medicare Coverage Analysis (MCA) is required for research studies which may bill protocol required routine care services to patients or third-party payors (medical insurance companies). The MCA assists ISMMS in meeting the Centers for Medicare and Medicaid Services (CMS) billing compliance requirements for routine care in research.

When

Prior to the IRB submission or as part of your IRB/RUTH application.

How

The FACTS office reviews research applications submitted to the IRB to identify studies that require a Medical Coverage Analysis (MCA). This review is based on the Payment Options built into the Ancillary Review Form as part of the IRB/RUTH submission.

There are 2 ways to determine if your study requires an MCA:

A. Prior to IRB submission:

  • Review the Payment Options below prior to IRB submission. The Payment Options will help determine if your study requires an MCA.
    • No MCA Required:
      • All protocol required clinical services will be paid for by study sponsor
    • MCA Required:
      • Only protocol required clinical services provided for research purposes will be paid for by sponsor* all other protocol required clinical services will be billed to patient or health insurance carrier
    • NO MCA Required:
      • Research study involves protocol required clinical services and all services are billable to patient or health insurance
    • NO MCA Required:
      • Research study is data collection (chart review), data coordinating center/clinical coordinating center
  • If an MCA is needed, email FACTS at facts@mssm.edu to request an MCA and attach the supporting documents (consent, protocol, contract/budget, FDA letter of IND or IDE and the ClinicalTrials.gov NCT).
    • FACTS will coordinate the process of having an MCA performed by BRANY. The MCA will then be sent to the investigator to review and formally approve.

B. As part of your IRB/RUTH submission:

  • The study team will be required to complete an Ancillary Review Form which will prompt the investigator to select the following payment options:
    • No MCA Required:
      • All protocol required clinical services will be paid for by study sponsor
    • MCA Required:
      • Only protocol required clinical services provided for research purposes will be paid for by sponsor* all other protocol required clinical services will be billed to patient or health insurance carrier
    • NO MCA Required:
      • Research study involves protocol required clinical services and all services are billable to patient or health insurance
    • NO MCA Required:
      • Research study is data collection (chart review), data coordinating center/clinical coordinating center
  • The study team will be required to assign an ancillary review to FACTS via the Manage Ancillary Review tab in RUTH.
  • Study teams are required to include a copy of the completed Ancillary Review Form in the IRB/RUTH submission.
  • FACTS will notify the the investigator via email if they have questions and if it is determined that an MCA is necessary. FACTS will coordinate the process of having an MCA performed by BRANY. The MCA will then be sent to the investigator to review and formally approve.

Fee

There is a fee for conducting MCAs. This fee must be built into the study budget. Refer to the 2021 Institutional Research Fee Schedule for the current BRANY MCA fee.

Questions

Contact the FACTS office at (646) 605-7251 or FACTS@mssm.edu.

MCA Mandatory Training

Principal Investigators with studies that require an MCA are required to complete the Clinical Research Billing Rules for Investigators training in PEAK before final approval is granted from the IRB.

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