- The Principal Investigator must complete and submit an OnCore Study Start up Form.
- YCCI will input all information received from the PI and Study Team into OnCore and will create the PC Console shell.
- The protocol, sponsor informed consent form, sponsor proposed budget, and lab manual if available;
- Clarifications regarding questions related to the protocol.
- determining whether a study is deemed to be a Medicare Qualifying Trial (MQT); and
- assessing the billing risk associated with a designated MQT study. Note that studies deemed not to be a MQT will not have any procedures billed to insurance.
PIs and their study staff are responsible for managing the study subjects in OnCore, which includes registering subjects, checking in visits, adding any additional visits and managing the subjects’ statuses.
To insure proper billing compliance:
- Subjects must be Consented in OnCore on the day of signing consent, close of business day.
- Subsequent visits must be occurred in OnCore within 24 hours after visit completion.
Note: you must be on the Yale University or Yale-New Haven Hospital network to view the documents below. If you are off-site, please connect through the VPN.
The following documents are available to assist in the proper management of subject information:
- An initial protocol billing compliance assessment; and
- A proactive risk-based bill review of randomly selected Medicare Qualifying Trials.
In order to comply with federal, state and institutional regulations and standards for clinical trial billing, the Yale Center for Clinical Investigation (YCCI) is responsible for establishing effective processes to ensure that all services for a study are billed properly. The purpose of this training is to inform both faculty and staff about the complexities surrounding clinical trial billing and to ensure that billing of these trials are appropriately directed to either the research sponsor or the designated insurer/third-party payer. This course is offered in two formats to better serve you. Please click on the course title below to register for the instructor led course or complete the online requirement.
Completion of either the Online Module or Instructor-Led Course titles will satisfy the requirement for Research Billing Compliance (2019). Go to the Training page for the Online Module or to sign up for instructor led training.
- Yes. Pre-authorization is required from private insurers for coverage of the standard of care (routine care) costs associated with the clinical trial.
- Yes. The routine patient care costs associated with clinical trials covered by Medicare’s Clinical Trial policy will qualify for private insurance coverage.
- Routine patient costs include all items and services consistent with the coverage provided in the plan (or coverage) that is typically covered for a qualified individual who is not enrolled in a clinical trial.
- The Yale Center for Clinical Investigation (YCCI) Medicare Coverage Analysis Unit.
- Performing an MCA ensures the following:
- Develop a budget;
- Assist in budget negotiations;
- Facilitate billing compliance;
- Mitigate risk and avoid billing errors which can result in civil and criminal penalties; and
- Ensure compliance with billing rules.
- Once the MCA is completed, a study-specific billing summary listing all items and services is available to the PI and study team. The billing summary must identify what services should be billed to the research study sponsor and what can be billed to Medicare or third-party payers.