Off-The-ShelfTM Medicare Coverage Analysis

Da Vinci Research Solutions is introducing the Off-The-ShelfTM Medicare Coverage Analysis.


In order to bill Medicare for routine care costs of items and services, a clinical trial must first meet certain criteria to qualify for reimbursement.  An MCA documents whether a trial qualifies for reimbursement of routine costs. The MCA also includes a billing grid that delineates whom to bill for each test or service provided within the context of a clinical trial. This document is crucial to the function of billing personnel within hospitals and clinics, to avoid fines and penalties. A provider's or institution's non-compliance may result in fines and penalties including, but not limited to, the loss of Principal Investigator status, debarment, suspension, exclusions, criminal and/or civil sanctions, loss of funding, and settlement costs and/or damages arising from actions under the Federal and State False Claims Act.


An Off-The-ShelfTM MCA provides many benefits to institutions. By leveraging the volume inherent with multi-site studies, DRS is able to offer Off-The-ShelfTM MCAs for a nominal fee. Outsourcing this key component of your trial will allow the study staff to focus more on activities that increase patient safety, regulatory compliance and revenue. Also, with a complete Off-The-ShelfTM MCA your site will hold the highest quality research compliance documentation, also used by many other sites. The Off-The-ShelfTM MCA provides the following items:

  • Documentation for a "qualifying" or "not qualifying" determination.
  • A detailed study-specific billing grid, tailored to the language of billing personnel.
  • Research codes required at each visit.
  • Documentation provided with an Excel workbook, pre-formatted for printing or PDF conversion.
  • A Guidance and Interpretation document. 


DRS is continually releasing new Off-The-ShelfTM MCAs for distribution. If your site requires an MCA that is not currently available, DRS will develop the MCA at the Off-The-ShelfTM rate if the study was opened to enrollment within the past 12 months and is being conducted in at least 20 sites.