- 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
Technology: This training is best viewed with Internet Explorer 7 or higher.
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.