1. Identification & Distinction of Clinical Trial Participant Charges Bethany Martell Office of Clinical Research Associate Director- Financial Operations

2. The Policy: Identification & Distinction of Clinical Trial Participant Charges Final Approval: 6/12/06 Purpose To ensure that clinical care services and supplies provided to participants in clinical trials are accurately billed by distinguishing the services and charges provided as research-related or conventional care. This distinction will help ensure that non-billable research- related charges are appropriately and accurately charged to a research account rather than to the research participant and/or their third party payor. Oversight Responsibility: This policy is managed by the Medical Center Office of Clinical Research. Revisions to the policy will be made periodically by the Clinical Research Policy Board.

3. Scope of the Policy This policy applies to all clinical trials for which patient care charges are generated. Registry studies or studies that involve quality of life assessments or survey administration, do not require Identification & Distinction of Clinical Trial Participant Charges. Identification & Distinction of Clinical Trial Participant Charges Clinical services and supplies provided only for research purposes are never billed to a research participant or their third party payer. Conventional care services provided in compliance with federal, state and local regulations may be billed to the research participant and/or their third party payer. The definition of conventional care services and routine costs as described in the CMS Final National Coverage Decision shall be used when designating charges as research related or conventional care. This policy requires that the Principal Investigator of a clinical trial, whether the trial is internally or externally funded, review the protocol and identify those services and items that are research-related and those that are considered conventional care. Once reviewed, approved and signed by the principal investigator, this distinction of services will serve as the primary tool for creating an internal line item budget that will be used to establish billing procedures for the services provided to participants in the clinical trial. To ensure that all active studies have the same fiscal documentation, any clinical research study currently open and resulting in patient care charges must have documentation of distinction of charges on file at the time of annual Institutional Review Board continuing review.

4. PI Responsibilities Documentation of the identification and distinction of charges is usually done on the Protocol Schedule of Events/ Schema. All items considered either research-related or items that should be charged to/ paid for by the sponsor, should be circled. This reviewed Schedule of Events should be signed and dated by the PI. The Cover Memo has been created as a tool to outline the expectations of the review process.

5. Cover Memo

6. Cover Memo- Up Close Using the clinical trial protocol, please indicate the clinical encounters, tests and/or procedures that are considered research- related and should be paid for by the study/sponsor (a schedule of events/schema may be helpful). In making your assessment, consider the following: A) the encounters, tests and/or procedures are required for research purposes only as part of this clinical trial and are not part of conventional care for patients with this medical condition B) the sponsor of the trial is providing compensation for a service and therefore it is not considered billable to a subject and/or their third party Per the CMS National Coverage Decision Sept. 2000, only services considered routine costs of qualifying clinical trials, are “billable” to Medicare. All coverage rules and payment requirements (i.e. local coverage decisions) must still be met. To be “billable” to the subject and/or their third party, all services considered routine/ conventional care must meet the following criteria: –The services are considered safe and effective based on authoritative evidence as generally accepted by the medical community. –The services are considered medically necessary. –The services are not unproven or experimental in nature. –Supported by other institutional billing requirements

7. Cover Memo continued: Other Budget Related Items: (please answer all questions) 1. How many subject do you plan to enroll? 2. If using an investigational drug, will the Investigational Pharmacy be used? 3. If applicable, will labs be processed Locally or at a Central Lab? 4. Do you plan to provide: a) Patient Compensation? If so, how much? b) Parking vouchers? If so, for which visits? 5.Will you require funds for Advertising? If so, how much and for what? 6.Will you be using the CRC? 7. Will the study interactions occur INPATIENT _____ OUTPATIENT ______ or BOTH _____ If Outpatient, which visits will be conducted only by a nurse, thus subject to the nursing facility fee? 8. Will any drug(s) be supplied by the sponsor? If yes, which? __________________ 9. Will any device (s) be supplied by the sponsor? If yes, which? _________________

8. PI Attestation on Cover Memo Your signature below, will serve as your attestation that following your review of the clinical trial protocol, all clinical services you expect to perform have been identified and labeled as either clinical trial/ research-related or conventional care. PI Signature: Date:

9. Sample: Reviewed Schedule of Events

10. The “Distinction” document says All items circled are consider research- related All items uncircled are considered standard of care/ billable to subject or insurance. –AKA- Standard of Care as a component of research

11. Questions Please contact the Office of Clinical Research with any and all questions. Bethany Martell, Associate Director 4-9799 bmartell@bsd.uchicago.edu