The NIH defines Patient Care Costs as “the costs of routine and ancillary services provided by hospitals to individuals participating in research programs.” The costs of these services normally are assigned to specific research projects through the development and application of research patient care rates. You should ensure that you understand your funding agency’s policy on the determination and reimbursement of research patient care costs prior to budget submission.
- Patient care is any cost that is above the standard of care or that the sponsor is willing to pay for.
- Account for all expenses that are above the standard of care:
- Drugs or devices,
- Facility fees, and
- Staff time.
- Charges for visits that are not part of the standard of care.
- The Research Administration Department will obtain the marginal or research cost for each item. This is the actual cost to the hospital for providing the care.
- The budget will reflect a per-patient cost that captures the entire cost for a patient who enrolls and completes the study.
- Account for all expenses that are above the standard of care:
- As principal investigator, you need to consider all patient care items such as:
- Items or Procedures,
- Charge and CPT Codes,
- Cost Per Unit,
- Frequency,
- Patients, and
- Inpatient Care Costs/Outpatient Care Costs.
- According to the NIH, research patient care costs do not include:
- The otherwise allowable items of personal expense reimbursement, such as patient travel or subsistence, consulting physician fees, or any other direct payments related to all classes of individuals, including inpatients, outpatients, subjects, volunteers, and donors,
- Costs of ancillary tests performed in facilities outside the hospital on a fee-for-service basis (e.g., in an independent, privately-owned laboratory) or laboratory tests performed at a medical school/university not associated with a hospital routine or ancillary service,
- Recruitment or retention fees or
- The data management or statistical analysis of clinical research results.
- Remember to list the total for inpatient costs and outpatient costs in the appropriate row per your funding agency’s template or form.
- In the Budget Justification, do not forget to justify the costs associated with inpatient/outpatient care.
- Provide cost information for inpatient and outpatient care separately.