OCR826: Billing for Device Studies


  • This compliance training will help you understand what types of device studies require FDA and Medicare pre-approvals before you can start enrolling subjects.
  • It will cover the reimbursement policy for Category A & B devices approved by FDA under the Investigational Devices Exemption (IDE) rule, which includes information about 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 UF Health requirements for procuring and/or storing research devices will be covered.

Target Audience: All UF personnel who work on human subjects medical device studies.

Prerequisite: OCR820:Human Subjects Clinical Research Billing Risks

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

  • Discuss US Food & Drugs Administration (FDA) device classifications
  • Explain how the FDA classification is related to the Medicare Coverage Determination for device studies
  • List the types of device studies that require Medicare pre-approval
  • Describe the UF Health workflows that are required for compliant device study billing

Duration: This training should take approximately 60 minutes to complete

Modality: Online

Technology: This training is best viewed with Chrome or Firefox (Window) or Safari or Chrome (Mac).

Grading: At the end of this training, completion of a final assessment is required. To successfully complete this training, you must obtain a score of 80% (80/100 points) or higher. 

To Register for this Course:

  1. Click on this link to access the registration page in the myTraining system.
  2. Click the blue [START] button.
  3. Note: If you are unable to register through myTraining, please contact OCR-Training@ahc.ufl.edu.