Finance Administrative Policies and Procedures
Section: 4- Grants and Contracts Accounting
Policy Procedure: 4-3.16
Subject: Charging Clinical Costs to a Sponsored Project
Effective Date: 9/14/2001
Responsible Department: Grants and Contracts Accounting

Overview

This procedure provides guidelines for charging clinical expenses to Sponsored Projects in accordance with the allocation principle included in Federal cost principles and Medicare/Medicaid regulations.

Procedures

1. The Principal Investigator must work closely with the Departmental Grants Coordinator so that the clinical trial or clinical research study costs are coded accurately and billed to the Sponsored Project UDAKs as soon as possible. The determination of the incremental items or services required by the study and the UDAK to be charged should be made at the time the patient is placed in the study. It is essential that the Sponsored Project be billed on a timely basis because cost transfers made on a delayed basis to Federal projects are subject to audit scrutiny and potential disallowance.

2. Costs of routine and conventional patient care must be charged to the patient or third party payors and not to the Sponsored Project.

General Guidelines

The nature of the clinical research process means that the Principal Investigator holds the primary responsibility for the accurate determination of the proper allocation of the direct costs of clinical trials and clinical research studies. In his or her dual role as physician and investigator, the Principal Investigator is responsible for making a timely and accurate determination of the appropriate portion of patient, professional, and technical fees, and other clinical costs that are directly and solely attributable to the study. As long as the costs are allowable under the terms of the agreement between the sponsor and MUSC, all incremental or additional clinical expenditures arising from a patient being included in a study must be charged directly to the Sponsored Project UDAK and not to the patient, Medicare/Medicaid, and other third party payors.

Examples of incremental charges that must be charged to the Sponsored Project include:

a. Fees relating to additional hospital services directly associated with the patient being included in the clinical trial that otherwise would not have been necessary for the patient?s care (e.g., additional room and board);

b. Fees relating to the particular item or service being investigated (e.g., cost of the drug or treatment under the study); and,

c. Fees relating to items and services provided solely to satisfy data collection needs not otherwise necessary for the patient?s care (e.g., additional laboratory and diagnostic testing required by the study's protocol but not necessary for conventional patient care).

Questions regarding allocation of clinical costs should be addressed to the appropriate Grants and Contracts Accounting Accountant based on departmental assignment. (see Distribution of Grants by Administrator) or at 792-2850.