Roles & Responsibilities — Budgeting

Roles & Responsibilities — Budgeting

PI and/or Study Coordinator

• Determines study eligibility for Medicare NCD.
• Identifies patient care costs in the study that are routine care versus research costs to be paid by the sponsor.
• Completes Clinical & Translational Research Planning Workbook (CTRP Workbook).
• Determines the level of effort required for study personnel to execute a study.
• Identifies the locations where the research related items will be performed.
• If study qualifies under NCD, works with CT RPM to determine if any research costs can be billed to insurance.
• Consults with hospital ancillary services experts to correctly analyze feasibility, identify protocol required procedures and to schedule study subjects with hospital specialty areas.
• For procedures that are not included on the CTRP workbook, provides CPT codes for research related procedures.
• May need to provide patient information for unusual or complex procedures in order to obtain billing reports.
• Department DFA participates in approvals of unusual circumstances.
• For device studies, prepares Medicare FI preauthorization packet for submission to Patient Financial Services.

Spectrum OTC (Operations, Training & Compliance)

• Provides budget/billing training, advises on hospital or regulatory issues as needed.
• Coordinates RAC review of studies with issues related to hospital billing or adverse event.
• Tracks submission of Medicare Pre-authorization requests to Patient Financial Services (PFS).

Research Management Group (RMG)

• Reads protocol, IRB application, consent.
• Reviews sponsor payment schedule and contract.
• Meets with PI/Study Coordinator to evaluate protocol, obtain budget information, and review payment terms.
• Provides guidance on NCD determination and whether research costs can be billed to insurance.
• Compares CTRP Workbook vs consent vs payment schedule vs protocol to ensure consistency.
• Acquires prices from available databases or Hospital Departments.
• Creates budget, revises as needed, and obtains PI approval.
• Consults with OSR, IRB, Hospital, Spectrum OTC, PFS as needed.
• Obtains Hospital approval for device studies.
• Negotiates budget and payment terms with sponsor.
• Obtains waivers as needed.
• Obtains Medicare FI approval prior to completing budget.
• Revises payment schedule to match approved and negotiated budget.
• For PI-initiated studies, RMG prepares budget and obtains approvals prior to submission of proposal to the funding agency.
• Revises internal budget as needed to match sponsor award.

Hospital

• Provides technical assistance in determining appropriate codes for tests/procedures.
• Establishes discounts for research prices.
• Provides pricing information as needed.
• Submits Medicare Pre-authorization requests to the Fiscal Intermediary.