Patient Care Costs

Patient care costs are those charges that are usual and customary for a particular process or procedure. Indicate in detail the basis for estimating costs in this category, including the number of patient days, estimated cost per day, and cost per test or treatment. If both in-patient and out-patient costs are requested, provide information for each separately. If multiple sites are to be used, provide the information by detail by site.

Frequently Asked Questions about Patient Care Costs

Background from NIH Grants Policy Statement: The following definition should be kept in mind when answering questions regarding research patient-care costs. Research patient-care costs are 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 or amounts (hereafter “rates”). Research patient-care costs do not include:

1.) 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;

2.) 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;

3.) recruitment or retention fees; or

4.) the data management or statistical analysis of clinical research results

Here are some helpful definitions from the NIH Grants Policy Statement:

  • Routine Services: Regular room services, minor medical and surgical supplies, and the use of equipment and facilities, for which a separate charge is not customarily made.
  • Ancillary Services: Those special services for which charges are customarily made in addition to routine services, e.g., x-ray, operating room, laboratory, pharmacy, blood bank, and pathology.
  • Outpatient Services: Services rendered to subjects/volunteers/donors who are not hospitalized.
  • Usual Patient Care: Items and services (routine and ancillary) ordinarily furnished in the treatment of patients by providers of patient care under the supervision of the physician or other responsible health professional. Such items or services may be diagnostic, therapeutic, rehabilitative, medical, psychiatric, or any other related professional health services. These expenses are for care that would have been incurred even if the research study did not exist. The patient and/or third-party insurance generally will provide for reimbursement of charges for “usual patient care” as opposed to not reimbursing those charges generated solely because of participation in a research protocol.

FAQ’s

1. What about lab work or procedures done by a hospital that is NOT Shands? Are these considered patient care? Each hospital must develop its own patient‐care rates, which usually are their Medicare rates for each specific service it provides to research subjects. These costs would be considered allowable patient‐care costs and excluded from the application of F&A.

2. What about lab work that is sent to a non‐hospital lab? Per the NIH policy, costs of ancillary tests performed outside the hospital on a fee‐for‐service basis by an independent, privately owned laboratory or performed at a medical school/university (UF) laboratory (Quest, CTSI, CRC, AMRIS etc.) are NOT considered patient‐care and would incur F&A.

3. What about professional fees for medical procedures (UFP)? Per the NIH policy, patient‐care costs do not include consulting physician fees. Ordinarily, physicians who are named as co‐investigators or other key persons on a project will be compensated through their effort on the project, fulfilling their time as part of their professorial duties to conduct research. These charges would incur F&A.

a. UF Professional fees do not meet the definition of patient‐care costs and F&A should be budgeted at the time of proposal submission.

b. UF expects that when professionals are identified as participating on an NIH grant submission, their professional services are presented in the budget with appropriate effort and salary compensation.

c. Shands Technical fees meet the definition of patient‐care costs and no F&A should be budgeted at the time of proposal submission.

Helpful Hints: If Shands bills for the medical services, these services are patient‐care costs and no F&A is charged; if UF bills for medical services, these are non‐patient‐care costs and F&A is charged. For example, an MRI or a blood draw provided at Shands or its clinics is a patient‐care cost; an MRI at the McKnight Brain Institute or a blood draw in UF research space is a non‐patient‐care cost. The term patient care may include services, such as a blood draw, that are not strictly “care” of the patient but would meet the NIH definition of patient‐care costs

Recommendation at Proposal Stage: if you are unsure of where the services will be performed, include the costs in the ‘Other’ section of your budget and assess IDC.

4. What about research subject specimens that UF receives from another clinical site to be tested at UF? As these tests would not be conducted by Shands laboratory and the specimens are not from UF’s subjects, they would not be considered patient‐care costs. These charges would incur F&A.

5. What about the maintenance, administrative overhead, record retention and dispensing charges from Investigational Drug Services (IDS)? When we are paying IDS directly, the costs to dispense the drugs from IDS for our participants would be considered patient care costs and would not incur F&A. Protocol maintenance, administrative overhead and record retention costs would not be considered patient care costs. These charges would incur F&A.

6. What about the imaging CD I need from Radiology for the protocol required CT scan? The CD would not be considered patient care costs. These charges would incur F&A.

7. What about the required UF Staff health assessments at the Student Health Center needed in order to work on a particular study? These are not considered patient care costs. These charges would incur F&A.

REMINDER: The PI must seek prior approval from the NIH program officer when there is a significant change in scope of work. UF does not consider re‐budgeting categories for a change in the service location (from UF to Shands or vice versa) as a change in scope. The change of location of services can result in an increase/decrease of patient care costs and thus a change to IDC distribution. This change may require change in R99 status for Shands billing.

For further guidance, please refer to Chapter 19, Research Patient Care Costs, NIH Grants Policy Statement, October 1, 2010.