Billing Notice: This form is generated by the Clinical Research Coordinator at each study visit involving hospital tests and/or procedures and must be submitted to CORA. Information provided on this form includes study visit information needed to facilitate proper billing to the patient's insurance, as well as to facilitate proper invoicing of the study sponsor.
Clinical Effectiveness Committee: The CEC is the governing body that oversees Clinical Supply Chain for St. Joseph Health. The CEC also approves the work plan for the review of products and services as well as reviewing emerging product technologies.
Contract and Budget Negotiation: CORA assesses study budgets to insure the hospital and researchers are compensated at Fair Market Value rates. Contracts are facilitated to insure all parties are protected and relationships are in accordance to state and federal regulations.
Feasibility Assessment: Utilizing the Feasibility Assessment Form (FAF) and conducting a FAF meeting with study staff and identified hospital department personnel, CORA reviews a study's impact upon the hospital and its staff, identifies standard of care and non-standard of care procedures, and performs funding analysis and logistical review.
GAP Analysis: An analysis of the cost to the hospital for conducting a non-industry-sponsored clinical trial. The costs of study procedures and salaries plus benefits are compared to the anticipated revenue for the study. Prior to study start, approval is obtained from hospital administration for any study that is anticipated to result in a revenue loss for the ministry.
Go Letter: Upon completion of the Pre-Award process, Researchers will receive a Go Letter providing approval to begin patient enrollment. For device studies, this letter will also provide the status of the Medicare Intermediary Submission, providing information related to the ability to enroll Medicare patients.
Institutional Official for Research: Each ministry engaged in research activities has designated an Institutional Official for Research (IO). This individual, appointed by the ministry's CEO, will be responsible for approving local research activities and signing research contracts.
Intake Form: This form is customized for each study by CORA and provided to the Clinical Research Coordinator. It must be submitted to the hospital's Admitting or Registration department for all patient visits occurring within the hospital. Information provided on this form includes the study name, financial codes for billing purposes, a description of the services to be provided by the hospital and physician orders to be signed by the Principal or Sub-Investigator(s).
Medicare Coverage Analysis (MCA): This is a document that identifies and analyzes who the appropriate payer (i.e. Sponsor, Medicare or third party payer) is for each item and service required by a clinical research trial. The MCA is a required in order to ensure proper billing practices are followed and assists sponsor budget negotiations.
Medicare Intermediary: Medicare Fiscal Intermediaries (FIs) are private insurance companies that serve as the federal government's agents in the administration of the Medicare program, including the payment of claims. There are two primary functions of the FI: reimbursement review and medical coverage review. The Medicare intermediary reviews medical device studies at the request of the hospital and/or provider who participates in a device study.
Submissions for provider reimbursement (Part B) are not facilitated by CORA and are the responsibility of the Investigator to submit.
New technology submission: For investigational device studies only and if the study device is not provided by the Sponsor, submission of the New Product Request From to the SJH Clinical Effectiveness Committee is required. The CEC reviews proposed study devices with supporting documentation, provided by Investigators, and determines if the study device has the potential to provide benefits above and beyond currently utilized devices.
Pregnancy Prevention Language Review: One of the first steps of the CORA process is a review of protocol pregnancy prevention language. As SJH is a Catholic institution, its ministries are required to follow the
Ethical and Religious Directives of the US Conference of Catholic Bishops. These Directives place firm restriction on research protocols requiring specific methods of birth control. If a conflict in language is present, CORA will work with the PI, CRC and Sponsor to reconcile the language to the