Melanie Hawkins, BSN, RN, CCRC Director, Clinical Research Billing Compliance Kristin Pattee Couture, CCRP Clinical Research Coverage Analyst

Transcription

1 NEW CLINICAL RESEARCH BILLING SCHEDULE Melanie Hawkins, BSN, RN, CCRC Director, Clinical Research Billing Compliance Kristin Pattee Couture, CCRP Clinical Research Coverage Analyst

2 What is a billing schedule and when do I need to complete one? A form listing all clinical activities in the protocol and identifying who will be paying for each Required for all studies involving clinical services (any procedure, test, or exam performed by an OHSU licensed practitioner including, but not limited to, blood draws, imaging g procedures, clinical lab tests, noninvasive examinations, and dental work) in the context of a research study Form is located in the eirb IRQ and must be completed and submitted with all initial IRB submissions involving clinical services

3 Why do I need a billing schedule? In order to bill accurately, a detailed list of clinical services associated with each protocol and how each is to be billed is necessary. Improper billing or billing for services paid for by a study sponsor (double billing) is illegal. For research subjects with Medicare Advantage insurance, clinical services that are part of a study (except device studies) must be billed to Medicare. Knowing which services to bill to Medicare is critical. To inform the budgeting process.

4 Who uses the completed form? Clinical Research Billing Office (CRBO): Makes sure that all protocol-driven services are listed and that the cost language g in the consent and grant/contract match. Coders: Codes the services and encounters that are part of the study. Billers: Place special modifiers on services related to studies per Medicare (and other payer) requirements.

5 What is different about the new form? Every clinical service required by the protocol must be listed even if everything will be paid for by the study sponsor. Different categories Old form: Standard of Care and Research New form: each clinical service must be coded according to how, or whether, it should be billed: INS for insurance RES for research industrial account NC for no charge NC for no charge Effective 12/1/10, all initial IRB submissions including clinical services must use the new billing schedule.

6 How do I find information on completing the billing schedule? OHSU policy on billing of research related clinical services cfm?id=954 provides guidance: On what can and can t be billed to a patient or their insurance How to process the billing schedule Protocol-driven clinical services: Any clinical item or service set out in the Schedule of Events (or otherwise stated) in the protocol as a required item or service (with the exception of services that are part of the study inclusion criteria, such as a surgery in which the research is conducted after the surgical procedure) All protocol-driven clinical services must be listed in the billing schedule

7 How do I know which code to use? Research-only services: Protocol-driven clinical services that would not be provided except for the study (e.g. scans or labs performed more frequently than usual for the condition) Research-only services must be billed to the research study and cannot be billed to the patient or patient's third party payer(s) Research-only services in the billing schedule must be coded with RES or NC Conventional care (formerly standard of care): Protocol-driven clinical services that would typically be provided absent a clinical study Can be billed to either the patient, patient's third party payer(s) or, with IRB approval and research sponsor agreement, to the research study Conventional care items can be coded with INS, RES or NC depending on whether or not they are included in the study budget

8 Sample Schedule of Events (from protocol)

9 Clinical Research Billing Schedule

10 Clinical Research Billing Schedule (continued)

11 Questions? Effective Date 12/1/2010 Clinical Research Billing website t/integrity/irb/clinical-research- billing.cfm Contacts: All new submissions must use the new billing schedule hdl as of this date. Kristin Pattee-Couture, Clinical Research Coverage Analyst, x Melanie Hawkins, Director, Clinical Research Billing Compliance, x4-8586