Billing Plans & Exemptions

Billing Plans

The OCT will generate a billing plan, if it is required, after reviewing the Institutional Review Board application form that accompanies each protocol and associated materials. Primary Investigators are no longer required to submit billing plans. After the OCT has reviewed the application, a draft billing plan will be provided to the PI for review and approval.

To generate a required billing plan and perform a Medicare Coverage Analysis on applicable projects, the OCT must have a copy of the protocol and the IRB application form. Additional documentation might be required and will be requested as needed, including:

• Any Templates or Drafts (ICF, Contract)
• Investigator's Brochure (if available)
• NOGA or Budget Award
• Draft Budget (if available)
  

Exemptions

If a research project meets the published billing plan exemption criteria as noted on the IRB application form, an email notice will be sent to the PI, IRB, and all impacted affiliates indicating that no billing plan is required.

Medicare Coverage Analysis

OCT is responsible for creating a Medicare Coverage Analysis for any procedure within a clinical trial that will be billed to the patient’s insurance. The purpose of this analysis is to show that third party payers will cover the tests/procedures. This is an internal document and is used for auditing purposes. More on Medicare coverage analysis documentation is available.