VCU clinical research coverage analysis

Coverage analysis is the process of evaluating each clinical research study to:

• Determine if a clinical study qualifies for coverage of "routine care" costs in accordance with the requirements of Medicare and the U.S. Patient Protection and Affordable Care Act
• Document the appropriate responsible payer (i.e., third-party payer or study sponsor) of each study related clinical service/item
• Develop a comprehensive billing plan which supports compliance with essential reporting and clinical billing requirements throughout the conduct of a clinical study

What is required?

VCU requires a Coverage Analysis Screening Form for each clinical research study to document whether a coverage analysis is required for a particular study. If a coverage analysis is not required, the screening form is retained with other essential documents. If a coverage analysis is required (the study involves billable services), then:

• The protocol and supporting documents will be reviewed by a VCU coverage analysis specialist to determine if the study is qualified for secondary payer coverage of clinical services. There are two forms that support this review — one for non-device studies and one for device studies.
• If the study qualifies for coverage of "routine care" costs, a billing plan will be prepared in OnCore by the VCU coverage analysis specialist, with the input of the research team. This billing plan will be relied upon for identifying the appropriate payer for clinical care services and items over the course of the study.
• Any changes to the study should be identified using the CA Amendment Form 5 and updated in the OnCore system (as applicable) to ensure the billing plan in OnCore remains accurate.

How do I get started?

Contact your school or center research administration office for the support of an institutionally designated VCU coverage analysis specialist. The timing for beginning the coverage analysis process may depend on your study sponsorship type. Typically, corporate-sponsored research requires a coverage analysis as part of the budget development process, while competitive submissions may only require a screening form or draft qualification form at the time of a proposal submission. In this case, a final coverage analysis is required at the time of award.

VCU coverage analysis specialists

Both the School of Medicine Research Administration Office and Massey Cancer Center Clinical Trials Office offer full-service coverage analysis services through an institutionally designated coverage analysis specialists. Additionally, the School of Medicine provides requisite coverage analysis services to schools/centers (fee-based).

Forms

You will need a VCU eID and password to access the following forms.
Coverage Analysis Form 1 – Screening
Coverage Analysis Form 2A – Non-Devices
Coverage Analysis Form 2B – Devices
Coverage Analysis Form 3 – (discontinued)
Coverage Analysis Form 4 – (discontinued)
Coverage Analysis Form 5 – Amendment

Forms and resources

• Clinical Trial Billing Compliance course (via CITI) – highly recommended for research teams
• VCU coverage analysis guidance – VCU eID and password required to access page
• School of Medicine coverage analysis webpage
• Massey Cancer Center clinical trials webpage
• VCU/VCU Health System Clinical Research SOP CR-ST-215.1 Coverage Analysis
• VCU compliance notice 16-002 Clinical Research Coverage Analysis
• VCU Health billing questions: clinicaltrialbilling@vcuhealth.org
• Patient Protection and Affordable Care Act (42 United States Code 300GG-8 – Coverage for Individuals Participating in Approved Clinical Trials)
• U.S. CMS National Coverage Determination for Routine Costs in Clinical Trials §310.1
• Code of Virginia §38.2-3418.8 – Coverage for Clinical Trials for Treatment Studies on Cancer and §38.2-3453 – Clinical Trials