If UF plans on billing items or services in an Investigational Device Exemption (IDE) study to subjects/insurance, the study must be pre-approved by the FDA and Medicare prior to study start-up.
FDA Review of IDE Studies
- Studies of Significant Risk investigational devices require a submission to FDA for an Investigational Device Exemption (IDE), which allows the study sponsor to ship and use the un-approved device in the study.
- This FDA submission is required regardless of whether any routine costs will be billed to patients/insurance.
- This FDA IDE submission should be completed BEFORE the study is submitted to the UF Office of Clinical Research (OCR) or the IRB.
- The FDA IDE holder (typically the study sponsor) must have an official FDA letter that indicates the IDE reimbursement category that the device falls under.
- The study team should obtain a copy of this letter so it can be forwarded to the IRB, OCR, Shands, Medicare, etc. as required.
The FDA places all IDEs into one of two categories:
- Category A – experimental: These devices consist of novel, first-of-a-kind technologies. These are innovative devices for which initial questions of safety and effectiveness have not been resolved and the absolute risk of the device type has not been established. The FDA has insufficient evidence to determine whether these device types can be safe and effective. The Category A device itself is not subject to Medicare reimbursement; however, the routine care costs may be covered.
- Category B – investigational, non-experimental: These devices are newer generation devices of already- proven technologies where the initial questions of safety and effectiveness of these devices have been resolved. The Category B device as well as the routine care costs may be covered.
Medicare Pre-Approval of IDE Studies for Billing
Legacy Process and Form
- For Investigational Device Exemption (IDE) studies with an initial FDA IDE letter dated before 01/01/15, the UF Health Research Billing Office (RBO) must obtain Medicare pre-approval from our local Medicare contractor before enrolling subjects into an IDE study that plans to bill subjects/insurance for protocol-required items/services.
- After IRB approval, but PRIOR to enrolling any subjects, the UF study team must work with the UF Health Research Billing Office (RBO) to do the following:
- Study team completes the FCSO IDE Approval Submission Form
- Study team should NOT send the form to First Coast Service Options (FCSO).
- Study team sends the form and attached documents to the RBO via UF-ShandsResearchBillingTeam@shands.ufl.edu.
- RBO will forward the request to FCSO.
- FCSO will review and respond to RBO within 45 days.
- For Investigational Device Exemption (IDE) studies with an initial FDA IDE letter dated after 12/31/14, Medicare pre-approval is obtained at the federal level by the IDE holder prior to submission to OCR. For details, see www.cms.gov/Medicare/Coverage/IDE.
- The resulting pre-approval letter must be included in the study’s OCR submission.
- The OCR Coverage Analysis and Budget (CAB) team will ensure that the pre-approval letter is uploaded to OnCore and that the UF Health Research Billing Office (RBO) is notified to submit “FYI” information to our local Medicare contractor to enable claims processing for this IDE study.
Private Insurance Coverage of IDEs
- If any subjects have private insurance, you MUST obtain written pre-authorization for the IDE from the carrier BEFORE enrolling the participant into the study.
- Some private insurers will follow the Medicare benefit policy; however, they also have discretion to deny coverage regardless of Medicare’s coverage determination.
IDE Device Claims Coding
- The study team must ensure that each billable item/service in the study is pre-identified as “M0” or M1” on the billing grids so that the UF Health Research Billing Office (RBO) will know the correct coding for claims.
- These pre-approved IDE studies will also require the Z00.6 diagnosis code, the IDE number, and the ClinicalTrials.gov NCT number.
- For more details, please see use of Z00.6 &Q0Q1 Modifiers.