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 (Ideate) application.

How

The FACTS office reviews all research applications submitted in Ideate to identify studies that require a Medical Coverage Analysis (MCA). This review is based on the Payment Options table built into the Ideate IRB application.

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 (Ideate) submission.
    • The Payment Options will direct you through questions that will help determine if your study requires an MCA.
  • 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 (IDEATE) application:

  • The Payment Options below are also built into the IRB (Ideate) application.
  • Once the IRB submission is completed, a FACTS analyst will automatically review the information in your Ideate submission.
    • The investigator will be notified 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.

Payment Options for Protocol Required Clinical Services

No protocol-required services will be billed to patients or third-party payers because:

  • Option 1A: Department/collaborating departments will act as internal sponsor paying for all protocol- required services and no protocol-required services will be billed to patients or third party payers.
  • Option1B: Study involves protocol-required clinical services and an External Sponsor (i.e., industry, government, or philanthropic source) will pay for all protocol-required services.

Is an MCA Required?

Does Not Need MCA

Protocol-required services (i.e., routine care services) will be billed to patients or third-party payers.

  • Option 2A: Department/collaborating departments will act as internal sponsor paying for services that are solely conducted for research purposes only, and other protocol-required services (i.e., routine care services) will be billed to patients or third-party payers.
  • Option 2B: Study involves protocol-required clinical services and External Sponsor (i.e., industry, government, or philanthropic source) will only pay for services that are solely conducted for research purposes.

Is an MCA Required?

Must Have MCA

Study is initiated and federally funded by a Government Sponsored Cooperative Group who will only pay for services that are solely conducted for research purposes and other protocol-required services (i.e., routine care services) will be billed to patients or third-party payers.

Is an MCA Required?

Billing Grid Only Required, No MCA

Study involves only data collection and has no protocol-required clinical services.

Is an MCA Required?

Does not need an MCA.

Study is not described in any of the previous payment options. Please describe the study and specify whether External Sponsor (i.e., industry, government, or philanthropic source) and/or patient/third party payer will pay for protocol required services.

Is an MCA Required?

May Be Required

Fee

There is a fee for conducting MCAs. This fee must be built into the study budget. Download the Budget Template for 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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