Medicare may cover some investigational devices as Investigational Device Exemptions (IDEs). There are two categories of IDEs:
- Category A Devices: Although the devices themselves are considered experimental and are not covered, Medicare may pay for the routine costs of clinical trials involving a Category A IDE.
- Category B Devices: They are defined as newer generations of proven technologies for which questions about safety and effectiveness have been resolved. Category B devices may be covered by Medicare if they meet billing requirements for IDEs, listed below. If the Category B device is billed under a Category B IDE Study, and the device meets the billing requirements for IDEs, both the device itself and the routine costs associated with its use are eligible for payment.
Requirements for Claim Submission for IDEs:
- If you are participating in an IDE trial and anticipate filing Medicare claims for associated services, you must notify the Fiscal Intermediary (National Government Services) and the Carrier (Palmetto GBA) before you submit a claim. This is true for claims for routine costs associated with clinical trials involving Category A IDEs and claims for and routine costs associated with Category B IDEs.
- Submit the required information to the Fiscal Intermediary first, then to Palmetto GBA along with the Intermediary's letter of approval:
- A copy of the FDA-approval letter provided to the sponsor or manufacturer of the device. The approved IDE code number must be on the letter
- The name of the device (both trade, common or usual, and classification name)
- Any action taken to conform to any applicable IDE special controls
- A narrative description of the device sufficient to make a payment determination
- A statement indicating how the device is similar to and/or different from other comparable products
- Indication of whether the device will be billed on an inpatient or outpatient claim
- A brief summary of the study design or a copy of the actual trial protocol
- The provider's protocol for obtaining informed consents for beneficiaries participating in the clinical trial
Submit the required information to Palmetto GBA:
Robert R. Kamps, M.D.
Investigational Device Exemption Process
4249 Easton Way, Suite 400
Columbus, Ohio 43219
Change in Category B Status
- If a study's sponsor loses its Category B status for a device or violates relevant IDE requirements necessitating the FDA's withdrawal of approval, Medicare can no longer reimburse claims for the device or routine costs associated with the device
- If you have requested and received approval for services associated with a Category B IDE and the Category B IDE has a change in its status, you must notify Palmetto GBA within 30 days of the change in status
Submitting Claims for Routine Costs of Clinical Trials
- Claims for routine costs of clinical trials associated with Category A and Category B IDEs must be submitted with the correct HCPCS modifier to identify the service as related to an IDE device trial
- For services provided on or before December 31, 2007, submit HCPCS modifier QV (item or service provided as routine care in a Medicare qualifying clinical trial) and the IDE number. You may (but are not required to) report the IDE number.
- For services provided on or after January 1, 2008, submit HCPCS modifier Q0 (investigational clinical service provided in a clinical research study that is in an approved clinical research study). You may (but are not required to) report the IDE number.
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