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Mastering Clinical Research For previous presentations and upcoming schedule, visit:. 2. Null. http://winshipcancer.emory.edu/mcr. Mastering Clinical Research. PRE QUESTIONS. 1. What does the M/S designation on the PRA mean?. A. Bill to Medicare/third party payer. B. Bill to the sponsor.
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Mastering Clinical ResearchFor previous presentations and upcoming schedule, visit: 2 Null • http://winshipcancer.emory.edu/mcr
Mastering Clinical Research PRE QUESTIONS
1. What does the M/S designation on the PRA mean? A Bill to Medicare/third party payer B Bill to the sponsor C Bill to Medicare or the sponsor
2. Which study team member should answer CTBD questions for a service designated M/S on the PRA? A CRC B PI C Regulatory Staff
Clinical Research at Emory:Understanding the PRA By Pamela G. Terry, RN, MBA, CHRC Associate Executive Director, Pre-award, Office for Clinical Research
Prospective Reimbursement Analysis (PRA) • PRA used by EHC Clinical Trial Billing Department (CTBD) to ensure billable services are billed correctly to either the patient’s insurance or the study grant. • Any study with EHC or Grady billable services, which could incorrectly be billed to third party payers, needs a PRA per Dean’s Mandate 6/11/2007. • Billable services are services with CPT or CDM codes. • OCR reviews study documents to develop the PRA grid which lists protocol billable services, the time points those services occur, and the justification of why the services can or can not be billed to third party payers. • Analysis based on Medicare Guidelines: NCDs, LCDs, and clinical care guidelines such as NCCN. If an NCD or LCD explicitly prohibits billing an item to Medicare, that item will need to be paid for by the sponsor, i.e. pregnancy test. Medical record documentation also needs to support billing to third party payers.
Payer Designations on the PRA Grid M - Routine or investigational clinical service (device, procedure, or drug) billable to Medicare/third party payers. M/S - Billed to Medicare/third party payers or sponsor/study grant based on patient diagnosis and frequency and/or timing of procedure. Contact PI for additional clinical information if needed. S - Paid for by sponsor/study grant. N/A - Part of bundled service or outside the scope of the research activities of the protocol. CL - Central Laboratory (Some labs may be performed locally as well, at the discretion of the PI, for lab results which may affect immediate treatment decisions. It is outside the scope of this analysis to pre-determine which labs the PI will order for purposes of clinical management.) LL - Local Laboratory
PI Responsibility with the PRA • Read the protocol to become familiar with the study requirements. • Work with the CRC to determine how the study will be conducted at Emory, i.e. central vs. local labs, biopsy procedure and analysis, Ambulatory Surgery Center. • Review the draft PRA to understand the payer designations and the supporting comments, ask questions, and approve. • Respond timely to PRA questions (preferably within 2 days). • Notify WinshipRegulatory of new protocol amendments. • Respond to CTBD billing inquiries about the M/S designation on the PRA.
