VCU Clinical Research Coverage Analysis
The VCU Coverage Analysis process begins with a screening form to determine/document if any billable clinical services are included in the clinical research activity. If billable clinical services are included, the process also includes:
- a brief review of the study to determine if the study is qualified for secondary payer coverage of clinical services and
- a billing plan to identify clinical services by payer (supporting both study financial management and billing compliance).
In accordance with VCU Compliance Notice 16-002 Clinical Research Coverage Analysis, requisite forms must be reviewed and approved by an Institutionally‐designated Coverage Analysis Specialist (within your school or center and also available via VCU Clinical Research Services). Click here for the Coverage Analysis Process. You will need a VCU eID and password to access this page.
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 – Billing Plan
Coverage Analysis Form 4 – (discontinued)
Coverage Analysis Form 5 – Amendment
Coverage Analysis Guidance
Click here for Coverage Analysis Guidance. You will need a VCU eID and password to access this page.
- VCU Compliance Notice 16-002 Clinical Research Coverage Analysis
- Billing Questions: email VCUHS billing-related questions to email@example.com
- The Patient Protection and Affordable Care Act (42 United States Code 300GG-8 – Coverage for Individuals Participating in Approved Clinical Trials)
- The U.S. CMS National Coverage Determination for Routine Costs in Clinical Trials §310.1
- The Code of Virginia §38.2-3418.8 – Coverage for Clinical Trials for Treatment Studies on Cancer and §38.2-3453 – Clinical Trials.
VCU Coverage Analysis Specialists by Area
- Massey Cancer Center: Amber Hendrix and Juelisa Secosky
- School of Medicine: Elham Almousa, Carolyn Frey, Margie Halverson, and John Thrift
- Other: Contact your school or center for guidance as to who is authorized to review and approve your Coverage Analysis documents.