THE BILLING GRID
A weekly column on research billing and coverage analysis, by Krishma Shah
A coordinator submits a lab requisition. The central lab bills it to the site. The site bills it to Medicare. The sponsor also reimburses it on the per-patient invoice. Nobody flagged the double charge because the Medical Coverage Analysis said “routine labs” with no visit-level detail and no citation. That is the fact pattern that produces a False Claims Act exposure, and it is more common than most research billing teams want to admit.
The Rush University Medical Center settlement in 2005 is the canonical public example of what happens when research billing controls fail. The core allegation was straightforward: items that the sponsor was contractually obligated to pay were billed to Medicare as if they were ordinary clinical care. The settlement did not require proof of intent. The False Claims Act reaches billing that is knowingly inaccurate, and “we did not check the MCA” is not a defense an auditor will accept.
A Medical Coverage Analysis, or MCA, is a visit-by-visit, procedure-by-procedure grid that assigns each item in a protocol a billing designation. The three designations that matter are SOC (standard of care, billable to Medicare or a commercial insurer when the trial qualifies), RES (research-paid, meaning the sponsor bears the cost and the item must never appear on a patient or payer claim), and NB/INV (non-billable or...
THE BILLING GRID A weekly column on research billing and coverage analysis, by Krishma Shah A coordinator submits a lab requisition. The central lab bills it to the site. The site bills it to Medi...