RBC807: Billing for Device Studies

Modality: Zoom/Virtual/Remote until further notice

Description: Does your human subjects device study require Medicare pre-approval before enrolling patients? If you are not sure, your device study could have increased billing compliance risks with financial repercussions.

This course will help you understand what types of device studies require Medicare pre-approval and the reimbursement policy for Category A & B devices approved by FDA under the Investigational Devices Exemption (IDE) rules.

We will also discuss what items/services can be billed to Medicare/third party payers on pre-approved studies and how to appropriately code these claims. In addition, the Shands Hospital requirements for procuring and/or storing research devices will be covered.

Audience: If you work as a human subjects clinical research investigator, administrator, coordinator, or coding or billing specialist for device studies, or have a role that involves ordering any protocol-required clinical services for device studies, this intermediate-advanced level course is for you!

Learning Objectives: As a result of participation in this activity, participants should be able to:

  • Discuss the complexity of Food & Drugs Administration (FDA) device classifications.
  • Explain how the FDA classification is related to the Medicare Coverage Determination for device studies.
  • List the three types of device studies that require Medicare pre-approval.
  • Assign correct Medicare codes to covered items/services for pre-approved device study claims.
  • Describe the different time points where communication with Shands is necessary for device studies.

Duration: 2 Hours

Nursing CE Contact Hours: Not Available

Conflicts of Interest: The presenters/authors/members of the planning committee for this course do not have financial arrangements, interests or affiliations related to the subject matter of the presentation.

Prerequisites: RBC800: Clinical Research Billing Crash Course

To Register for this Course

  1. Click on this link to access the registration page in the myTraining system.
  2. Click the blue [REGISTER]  button – all upcoming sessions will be listed.
  3. Click on the small radio button on the left side of the session entry and click on Submit (lower right of the screen).

You must have already completed (or be registered for) the prerequisite RBC800  in order to see upcoming sessions.

Note: If you are unable to register through myTraining, please contact OCR-Training@ahc.ufl.edu.