All costs of subjects' hospitalization on the UCLA-GCRC are not necessarily paid by the center. Costs of an inpatient admission include nursing, room and board, and ancillary services. Costs of an outpatient visit include visit and procedure charges, and ancillary services. Ancillary services are defined by NIH as services routinely available through the hospital departments for all patients in the hospital; for example, routine blood and urine tests, x-rays, medications, IV supplies, etc. Generally speaking, investigators can request that these costs be covered by the center if they are directly related to research. The center, however, cannot assume the costs of high cost (>$150) ancillary services such as CT scans, MRI scans, etc.
Subject Categories and Costs
There are specific categories for the classification of subjects: "A" (purely research study participants in which the center pays for all hospitalization costs, or research study patients in which the center pays for some of the research-related hospitalization costs and other sources pay the remaining hospitalization costs), "B", and "D".
Category "A" - Research Patients
These are research patient days or outpatient visits utilized solely for research purposes. All hospitalization costs associated with category A days or visits are the financial responsibility of the center or an investigator's research funds. Persons who are hospitalized for research purposes only, but whose care is partly supported by non-center funds (e.g., other grants, industry) may also be classified as category A. This category includes normal volunteers or controls. Subjects may participate in research projects which include unproved forms of therapy or diagnostic techniques. Those therapies and diagnostic techniques may subsequently become standards of medical therapy or diagnosis.
Category "B" - Research Service Patients
This category includes patients who require hospitalization for diagnosis or treatment according to established standards of care, and who are admitted to the UCLA-GCRC to participate in a research project. The cost of established medical care for category B patients cannot be assumed by the center. The patient or third-party carrier is responsible for costs which relate to non-research charges. The hospital is responsible for all billings and collections on these patients. A patient care credit (offset) for each category B inpatient day or outpatient visit is credited to the hospitalization category of the center grant. The cost of those ancillary services performed solely for research on category B patients and not related to their routine medical care may be assumed by the center, and shall not appear on the patient's bill which is submitted by the hospital to the patient or the insurance carrier. Patients appropriate for category B may not be classified as category A simply because they lack applicable hospitalization insurance.
This category includes patients who require hospitalization for diagnosis or treatment according to established standards of care, and who are admitted to the UCLA-GCRC to participate in a research project. The cost of established medical care for category B patients cannot be assumed by the center. The patient or third-party carrier is responsible for costs which relate to non-research charges. The hospital is responsible for all billings and collections on these patients. A patient care credit (offset) for each category B inpatient day or outpatient visit is credited to the hospitalization category of the center grant. The cost of those ancillary services performed solely for research on category B patients and not related to their routine medical care may be assumed by the center, and shall not appear on the patient's bill which is submitted by the hospital to the patient or the insurance carrier.
Patients appropriate for category B may not be classified as category A simply because they lack applicable hospitalization insurance.
Category "D" - Industry-Initiated Projects
These are inpatient days or outpatient visits utilized for industry-initiated studies. All charges are paid directly by industry through the responsible investigator. For each category D inpatient day and outpatient visit, a credit is provided to the patient care category of the GCRC grant. In addition, a credit is provided to the center grant for usage of other center resources by industry-initiated studies. Those projects which are designed by proprietary organizations will be considered industry- initiated, and the proprietary organization is expected to pay for the use of the UCLA-GCRC facilities at the same rates it would pay for any other hospital beds and ancillary charges. This is accomplished by classifying patients on such projects as category D patients. All category D patient charges are to be paid to the UCLA Medical Center from funds provided by the proprietary organization. In some cases, investigators may add additional research aims to the project. In those cases, the GCRC Advisory Committee ascertains the relative resource needs to be contributed by industry, the UCLA-GCRC, and the investigator's resources. All industry- initiated projects must be approved for use of the UCLA-GCRC by the GCRC Advisory Committee. Industry-initiated projects should constitute only a small portion of total UCLA-GCRC activity. Once a category D study is approved and activated, the center administrator will charge the appropriate fee to the study's funds in consultation with the responsible investigator.
These are inpatient days or outpatient visits utilized for industry-initiated studies. All charges are paid directly by industry through the responsible investigator. For each category D inpatient day and outpatient visit, a credit is provided to the patient care category of the GCRC grant. In addition, a credit is provided to the center grant for usage of other center resources by industry-initiated studies.
Those projects which are designed by proprietary organizations will be considered industry- initiated, and the proprietary organization is expected to pay for the use of the UCLA-GCRC facilities at the same rates it would pay for any other hospital beds and ancillary charges. This is accomplished by classifying patients on such projects as category D patients. All category D patient charges are to be paid to the UCLA Medical Center from funds provided by the proprietary organization. In some cases, investigators may add additional research aims to the project. In those cases, the GCRC Advisory Committee ascertains the relative resource needs to be contributed by industry, the UCLA-GCRC, and the investigator's resources. All industry- initiated projects must be approved for use of the UCLA-GCRC by the GCRC Advisory Committee. Industry-initiated projects should constitute only a small portion of total UCLA-GCRC activity.
Once a category D study is approved and activated, the center administrator will charge the appropriate fee to the study's funds in consultation with the responsible investigator.
Center funds may be used to pay all costs (usual care costs which are part of the research project as well as research care costs) for the entire period of hospitalization, or research tests or services for participants who would not have been hospitalized or received such tests or services except for their participation in the research study. Any exceptions will be documented in UCLA- GCRC administrative records for the project.
Industry-Supported Investigator-Initiated Research
In some cases a proprietary organization may provide funds for an investigator-initiated study. Investigator-initiated projects which are partially supported by a proprietary organization through a grant of unrestricted funds or by a donation of drugs or devices may be pursued on the UCLA-GCRC as category A or category B research, subject to the usual Human Subject Protection Committee and GCRC Advisory Committee review and approval. Funds from the proprietary organization which are budgeted for research patient care items will be credited to the patient care category of the center grant. Copies of the agreement (including the budget) signed by the UCLA Office of Contract and Grant Administration - Financial office, the principal investigator, and the drug company or other source must be maintained in the center's administrative files. In addition, copies of other relevant correspondence, along with the FDA letter assigning an investigational new drug (IND) number to an experimental drug or device, are to be maintained in the center's research project files. If approved by the GCRC Advisory Committee, such investigator-initiated projects will be eligible for full use of center facilities.
In order to determine whether an industry- sponsored study is category A/category B (investigator-initiated) or category D (industry- initiated) the following documentation needs to accompany the proposal: 1) all pertinent communication between the investigator and the industrial source that resulted in funding; 2) a copy of the agreement (including the budget) signed by the UCLA Office of Contract and Grants Administration, the principal investigator, and the drug company or other source; and 3) any other documentation that will assist the GCRC Advisory Committee in deciding whether the study is category A, category B or category D.
Investigators who receive industry support for projects conducted on the UCLA-GCRC must be free to publish or distribute data from such studies without restriction.
Scatter Bed Costs
Some studies require that patients be cared for in areas away from the discrete unit, referred to as scatter beds. Support for these studies consists of nursing and research-related ancillary services.
Ancillary Services
All ancillary services performed solely for research for category A patients and category B patients can be supported by the center. Ancillary services are defined by NIH as services routinely available through the hospital departments for all patients in the hospital (e.g., blood tests, x-rays, medications, etc.). This definition applies even when these services are purchased from sources outside the hospital for reasons of economy or efficiency. Tests needed by individual investigators for their research are not proper charges to the center if the tests are not routinely available to all patients in the hospital. Also, services provided either by the laboratory of a UCLA-GCRC investigator for that investigator's patients or by a UCLA Medical Center laboratory which is directed by a UCLA-GCRC investigator may not be charged to the center, even if that investigator has a contractual arrangement with the hospital to provide these services.
Professional Fees
The GCRC Advisory Committee has decided that physicians' fees or other professional services (e.g., from anesthesiology, pathology, or radiology) are not supported by the center for category A patients or for research-related services on category B patients. However, professional fees may be charged directly to category B, C or D patients or to third-party payors for routine medical care not related to research.